diff --git a/DESCRIPTION b/DESCRIPTION index cf0b299..33d51e9 100644 --- a/DESCRIPTION +++ b/DESCRIPTION @@ -21,14 +21,14 @@ License: Apache License 2.0 | file LICENSE URL: https://github.com/insightsengineering/scda.test/ BugReports: https://github.com/insightsengineering/scda.test/issues Depends: - formatters (>= 0.5.5), + formatters (>= 0.5.5.9018), R (>= 4.2), - rlistings (>= 0.2.7), - rtables (>= 0.6.6), - tern (>= 0.9.3) + rlistings (>= 0.2.7.9011), + rtables (>= 0.6.6.9011), + tern (>= 0.9.3.9028) Imports: pharmaverseadam (>= 0.2.0), - random.cdisc.data (>= 0.3.14.9006) + random.cdisc.data (>= 0.3.15.9001) Suggests: broom, checkmate, diff --git a/tests/testthat/_snaps/listing_lbl01.md b/tests/testthat/_snaps/listing_lbl01.md index b18ea8a..2d01168 100644 --- a/tests/testthat/_snaps/listing_lbl01.md +++ b/tests/testthat/_snaps/listing_lbl01.md @@ -5,62 +5,62 @@ Output Listing of Laboratory Test Results - 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- Days Since - Study Last Dose of ALB ALKPH ALT AST BASO BASOLE BILI BUN CA CHOLES CK CL CREAT EOS EOSLE GGT GLUC HCT HGB LYMPH LYMPHLE MCH MCHC MCV MONO MONOLE PH PHOS PLAT POTAS PROT RBC SODIUM SPGRAV TSH URATE VITB12 WBC HBA1C - Treatment Center/Patient ID Day Study Drug (g/dL / NCI CTCAE grade) (U/L / NCI CTCAE grade) (U/L / NCI CTCAE grade) (U/L / NCI CTCAE grade) (THOU/uL / NCI CTCAE grade) (FRACTION / NCI CTCAE grade) (mg/dL / NCI CTCAE grade) (mg/dL / NCI CTCAE grade) (mg/dL / NCI CTCAE grade) (mg/dL / NCI CTCAE grade) (U/L / NCI CTCAE grade) (mEq/L / NCI CTCAE grade) (mg/dL / NCI CTCAE grade) (THOU/uL / NCI CTCAE grade) (FRACTION / NCI CTCAE grade) (U/L / NCI CTCAE grade) (mg/dL / NCI CTCAE grade) (% / NCI CTCAE grade) (g/dL / NCI CTCAE grade) (THOU/uL / NCI CTCAE grade) (FRACTION / NCI CTCAE grade) (pg / NCI CTCAE grade) (g/dL / NCI CTCAE grade) (fL / NCI CTCAE grade) (THOU/uL / NCI CTCAE grade) (FRACTION / NCI CTCAE grade) (NO UNITS / NCI CTCAE grade) (mg/dL / NCI CTCAE grade) (THOU/uL / NCI CTCAE grade) (mEq/L / NCI CTCAE grade) (g/dL / NCI CTCAE grade) (MILL/uL / NCI CTCAE grade) (mEq/L / NCI CTCAE grade) (NO UNITS / NCI CTCAE grade) (uIU/mL / NCI CTCAE grade) (mg/dL / NCI CTCAE grade) (pg/mL / NCI CTCAE grade) (THOU/uL / NCI CTCAE grade) (% / NCI CTCAE grade) - 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- Placebo 701/1015 -7 NA 38.00 34.00 / L0 27.00 40.00 / H1 NA 0.40 / HNA 10.26 3.57 2.20 5.95 70.00 106.00 79.56 NA 0.30 / HNA 15.00 4.72 0.42 8.87 NA 0.05 / LNA 1.68 21.10 80.00 NA 0.50 / HNA 5.00 1.23 266.00 4.50 61.00 5.30 140.00 1.01 1.68 267.66 294.38 5.78 NA - 15 22 39.00 50.00 41.00 / H1 33.00 NA 0.15 / HNA 8.55 3.57 2.35 5.48 54.00 103.00 88.40 NA 0.00 19.00 4.66 0.43 8.87 NA 0.30 1.68 20.48 81.00 NA 0.05 5.00 1.26 306.00 4.40 77.00 5.30 142.00 1.01 NA 291.45 NA 5.33 NA - 29 14 38.00 41.00 18.00 21.00 0.02 NA 6.84 2.86 2.27 4.99 45.00 107.00 70.72 0.08 NA 15.00 4.39 0.39 8.32 1.93 NA 1.68 21.10 78.00 / LNA 0.23 NA NA 1.13 238.00 4.50 69.00 5.00 140.00 NA NA 261.71 NA 4.54 NA - 42 13 37.00 43.00 26.00 26.00 0.04 NA 5.13 4.28 2.30 5.64 64.00 105.00 88.40 0.08 NA 14.00 5.11 0.40 8.56 1.51 NA 1.68 21.10 80.00 0.28 NA NA 1.23 237.00 4.60 68.00 5.10 140.00 NA NA 273.61 NA 4.25 NA - 63 21 38.00 47.00 22.00 21.00 0.05 NA 8.55 3.93 2.22 5.53 49.00 105.00 88.40 0.09 NA 14.00 4.55 0.42 8.69 1.97 NA 1.68 20.48 83.00 0.24 NA NA 1.16 266.00 4.10 69.00 5.10 141.00 NA NA 273.61 NA 5.35 NA - 84 21 38.00 53.00 27.00 22.00 0.04 NA 6.84 3.57 2.35 5.64 56.00 99.00 79.56 0.13 NA 23.00 4.83 0.41 8.32 2.09 NA 1.68 20.48 81.00 0.24 NA 5.00 1.23 260.00 3.60 70.00 5.00 139.00 1.01 NA 261.71 NA 5.24 NA - 126 42 37.00 41.00 17.00 23.00 0.03 NA 6.84 3.57 2.20 5.51 50.00 103.00 88.40 0.09 NA 15.00 4.77 0.41 8.75 2.02 NA 1.68 21.72 79.00 / LNA 0.33 NA NA 1.29 266.00 4.10 68.00 5.20 141.00 NA NA 255.76 NA 5.62 NA - 140 14 37.00 45.00 21.00 19.00 0.03 NA 6.84 3.93 2.17 5.35 50.00 108.00 79.56 0.06 NA 17.00 4.88 0.40 8.50 1.78 NA 1.74 21.72 80.00 0.28 NA NA 1.10 233.00 4.30 68.00 4.90 142.00 NA NA 279.56 NA 4.36 NA - 168 28 38.00 46.00 23.00 23.00 0.04 NA 6.84 4.28 2.22 5.20 42.00 103.00 79.56 0.09 NA 20.00 4.50 0.44 8.69 2.55 NA 1.68 19.86 82.00 0.31 NA 5.00 1.26 259.00 4.10 66.00 5.30 140.00 1.00 / LNA NA 303.35 NA 7.23 NA - 182 14 38.00 44.00 23.00 19.00 0.03 NA 5.13 3.93 2.20 5.53 44.00 104.00 88.40 0.07 NA 16.00 5.11 0.45 8.87 2.03 NA 1.68 19.86 84.00 0.31 NA NA 1.36 300.00 4.50 69.00 5.40 140.00 NA NA 309.30 NA 5.43 NA - 701/1023 -14 NA 40.00 98.00 23.00 21.00 NA 0.50 / HNA 11.97 6.43 2.47 6.78 85.00 106.00 123.76 NA 0.00 18.00 5.33 0.49 10.05 NA 0.20 / LNA 1.86 20.48 92.00 NA 0.25 / HNA 5.00 1.29 217.00 4.90 74.00 5.30 142.00 1.02 1.28 398.52 408.00 8.78 NA - 23 37 36.00 90.00 30.00 25.00 NA 0.10 / HNA 6.84 7.50 2.35 6.13 77.00 108.00 132.60 NA 0.20 / HNA 22.00 5.77 0.46 9.25 NA 0.45 / HNA 1.92 20.48 95.00 NA 0.45 / HNA 5.00 1.19 222.00 4.80 69.00 4.80 140.00 1.03 NA 368.78 NA 8.55 NA - 29 6 35.00 99.00 38.00 30.00 0.04 NA 8.55 6.07 2.37 6.08 76.00 106.00 114.92 0.07 NA 22.00 5.44 0.48 9.50 1.40 NA 1.86 19.86 92.00 0.58 NA 5.00 1.10 198.00 4.70 71.00 5.20 141.00 1.02 NA 362.83 NA 7.67 NA - 701/1047 -21 NA 42.00 78.00 22.00 25.00 NA 0.40 / HNA 6.84 6.43 2.30 6.08 90.00 105.00 88.40 NA 0.40 / HNA 14.00 5.55 0.46 9.50 NA 0.35 2.05 21.10 97.00 NA 0.45 / HNA 5.00 1.32 224.00 4.30 69.00 4.70 144.00 1.02 0.46 231.97 431.61 7.15 NA - 14 35 38.00 67.00 16.00 21.00 NA 0.35 / HNA 8.55 6.43 2.25 5.43 80.00 109.00 88.40 NA 0.30 / HNA 12.00 5.55 0.43 8.69 NA 0.25 1.92 20.48 95.00 NA 0.30 / HNA 5.00 0.97 224.00 3.90 63.00 4.50 141.00 1.01 NA 285.50 NA 5.88 NA - 27 13 38.00 71.00 20.00 24.00 0.04 NA 6.84 7.14 2.12 4.71 77.00 108.00 79.56 0.22 NA 12.00 6.00 0.40 8.38 2.06 NA 1.99 21.10 94.00 0.37 NA NA 1.00 225.00 3.90 66.00 4.30 142.00 NA NA 255.76 NA 5.68 NA - 46 19 NA NA NA NA 0.03 NA NA NA NA NA NA NA NA 0.21 NA NA NA 0.40 8.25 1.84 NA 1.99 20.48 96.00 0.42 NA 5.00 NA 194.00 NA NA 4.20 NA 1.02 NA NA NA 7.68 NA - 55 9 38.00 75.00 17.00 21.00 NA NA 6.84 5.35 2.15 4.89 85.00 NA 88.40 NA NA 11.00 3.83 NA NA NA NA NA NA NA NA NA NA 0.81 NA NA 65.00 NA NA NA NA 279.56 NA NA NA - 701/1118 -13 NA 39.00 65.00 15.00 15.00 0.04 NA 11.97 5.35 2.27 4.60 110.00 108.00 88.40 0.32 NA 13.00 4.05 0.45 9.68 1.94 NA 1.99 21.72 92.00 0.73 NA 6.00 1.26 268.00 4.70 70.00 4.90 141.00 1.03 1.85 249.82 213.22 7.89 NA - 15 28 42.00 76.00 7.00 13.00 0.02 NA 8.55 4.64 2.25 5.02 41.00 110.00 88.40 0.09 NA 13.00 4.88 0.45 9.62 1.40 NA 1.92 21.72 88.00 0.39 NA 6.00 1.32 285.00 4.60 71.00 5.10 142.00 1.03 NA 279.56 NA 6.07 NA - 29 14 44.00 67.00 15.00 14.00 0.04 NA 10.26 4.28 2.32 4.55 49.00 100.00 106.08 0.08 NA 13.00 5.11 0.44 9.68 1.72 NA 1.92 21.72 88.00 0.54 NA NA 1.29 308.00 4.70 74.00 5.00 134.00 NA NA 243.87 NA 5.89 NA - 43 14 41.00 62.00 11.00 15.00 0.03 NA 8.55 5.35 2.30 4.76 42.00 103.00 97.24 0.17 NA 14.00 5.22 0.42 9.62 2.05 NA 2.05 22.96 90.00 0.42 NA NA 1.32 274.00 4.80 70.00 4.70 139.00 NA NA 237.92 NA 6.59 NA - 58 15 39.00 67.00 15.00 18.00 0.05 NA 10.26 4.28 2.15 5.28 49.00 104.00 88.40 0.17 NA 18.00 3.83 0.45 9.74 2.80 NA 1.99 21.72 91.00 0.88 NA NA 1.07 334.00 4.30 72.00 4.90 139.00 NA NA 273.61 NA 8.22 NA - 86 28 40.00 70.00 16.00 13.00 0.04 NA 8.55 3.93 2.22 4.58 36.00 106.00 106.08 0.13 NA 15.00 5.88 0.47 9.74 1.62 NA 1.92 20.48 92.00 0.45 NA 5.00 0.97 293.00 4.20 72.00 5.10 142.00 1.03 NA 226.02 NA 6.33 NA - 113 27 41.00 65.00 15.00 18.00 0.03 NA 10.26 6.07 2.30 4.86 88.00 106.00 97.24 0.16 NA 14.00 4.83 0.44 9.68 1.67 NA 1.92 21.72 88.00 0.52 NA NA 1.13 304.00 4.50 72.00 5.00 141.00 NA NA 249.82 NA 6.69 NA - 141 28 41.00 62.00 13.00 14.00 0.04 NA 10.26 6.43 2.30 5.04 41.00 102.00 106.08 0.08 NA 15.00 5.16 0.45 9.74 1.65 NA 1.92 21.72 88.00 0.51 NA NA 1.39 324.00 4.20 71.00 5.10 139.00 NA NA 297.40 NA 7.01 NA - 169 28 42.00 58.00 13.00 11.00 0.11 NA 8.55 5.00 2.30 4.81 36.00 105.00 97.24 0.09 NA 15.00 5.11 0.48 9.50 1.57 NA 1.92 19.86 96.00 0.52 NA 6.00 1.36 313.00 4.60 68.00 5.00 142.00 1.03 NA 249.82 NA 7.10 NA - 182 13 39.00 56.00 10.00 12.00 0.04 NA 8.55 4.28 2.10 / L1 4.89 50.00 104.00 97.24 0.11 NA 16.00 4.94 0.42 9.25 1.72 NA 1.99 22.34 89.00 0.44 NA NA 1.49 271.00 4.10 67.00 4.70 139.00 NA NA 309.30 NA 5.95 NA - 701/1130 -6 NA 37.00 61.00 15.00 24.00 0.03 NA 8.55 7.14 2.12 4.68 57.00 104.00 123.76 0.16 NA 9.00 / L0 5.05 0.36 / LNA 7.51 / LNA 2.19 NA 1.99 21.10 95.00 0.59 NA 5.00 1.26 196.00 4.20 73.00 3.80 / LNA 140.00 1.02 3.59 392.57 261.92 6.55 NA - 15 21 38.00 61.00 14.00 26.00 0.07 NA 10.26 7.14 2.27 5.33 53.00 104.00 123.76 0.20 NA 12.00 5.66 0.37 7.82 2.12 NA 1.99 21.10 94.00 0.98 / HNA NA 5.00 1.26 232.00 4.50 75.00 3.90 / LNA 138.00 1.02 NA 386.62 NA 10.73 / H0 NA - 29 14 33.00 / L1 68.00 18.00 25.00 0.03 NA 5.13 9.28 / HNA 2.22 4.50 60.00 105.00 176.80 / H1 0.18 NA 11.00 6.16 0.31 / LNA 6.52 / LNA 1.63 NA 2.05 21.10 97.00 0.61 NA NA 1.26 210.00 4.60 71.00 3.20 / LNA 140.00 NA NA 380.67 NA 6.90 NA - 43 14 36.00 63.00 13.00 19.00 0.05 NA 6.84 6.43 2.22 4.84 42.00 103.00 123.76 0.17 NA 12.00 5.16 0.35 / LNA 7.32 / LNA 2.07 NA 1.99 21.10 96.00 0.65 NA NA 1.10 255.00 4.30 72.00 3.60 / LNA 138.00 NA NA 422.31 NA 6.64 NA - 57 14 36.00 58.00 10.00 18.00 0.04 NA 10.26 7.14 2.20 4.86 52.00 104.00 114.92 0.17 NA 10.00 5.16 0.33 / LNA 6.95 / LNA 2.18 NA 1.99 21.10 96.00 0.58 NA NA 1.29 185.00 4.50 69.00 3.50 / LNA 139.00 NA NA 368.78 NA 6.58 NA - 91 34 37.00 63.00 13.00 21.00 0.04 NA 8.55 8.92 / HNA 2.17 4.84 67.00 106.00 123.76 0.21 NA 10.00 6.11 0.33 / LNA 7.14 / LNA 2.34 NA 2.05 21.72 94.00 0.64 NA 5.00 1.29 194.00 4.40 72.00 3.50 / LNA 140.00 1.02 NA 392.57 NA 8.15 NA - 113 22 39.00 65.00 12.00 19.00 0.05 NA 10.26 6.78 2.32 5.12 52.00 103.00 132.60 0.07 NA 12.00 4.88 0.38 7.39 / LNA 2.15 NA 2.05 19.24 105.00 / HNA 0.55 NA NA 1.32 184.00 4.00 77.00 3.60 / LNA 141.00 NA NA 440.15 NA 6.89 NA - 138 25 34.00 / L1 62.00 11.00 19.00 0.05 NA 6.84 7.50 2.22 4.47 53.00 105.00 132.60 0.22 NA 10.00 4.88 0.33 / LNA 6.89 / LNA 2.29 NA 1.99 20.48 96.00 0.72 NA NA 1.19 229.00 4.00 70.00 3.50 / LNA 143.00 NA NA 416.36 NA 7.12 NA - 169 31 38.00 65.00 13.00 22.00 0.04 NA 11.97 7.14 2.30 4.94 59.00 107.00 132.60 0.22 NA 11.00 4.88 0.37 7.57 / LNA 2.13 NA 2.05 20.48 99.00 0.57 NA 6.00 1.29 211.00 4.30 74.00 3.70 / LNA 141.00 1.02 NA 422.31 NA 7.40 NA - 183 14 39.00 67.00 10.00 19.00 0.05 NA 10.26 6.43 2.15 4.76 56.00 103.00 132.60 0.38 NA 10.00 5.22 0.34 / LNA 7.57 / LNA 2.55 NA 2.11 / HNA 22.34 94.00 0.63 NA NA 1.29 203.00 4.20 77.00 3.60 / LNA 139.00 NA NA 422.31 NA 8.35 NA - 701/1153 -17 NA 39.00 65.00 13.00 24.00 0.06 NA 5.13 3.93 2.32 6.98 65.00 107.00 88.40 0.07 NA 11.00 5.50 0.39 8.01 1.16 NA 1.68 20.48 81.00 0.41 NA 5.00 0.87 293.00 3.70 69.00 4.80 140.00 1.00 / LNA 0.38 279.56 254.54 5.06 NA - 16 33 42.00 64.00 14.00 25.00 0.08 NA 6.84 5.35 2.32 7.32 51.00 109.00 79.56 0.04 NA 11.00 5.00 0.41 8.38 1.30 NA 1.74 20.48 85.00 0.31 NA 5.00 1.10 314.00 4.00 71.00 4.80 139.00 1.02 NA 267.66 NA 5.98 NA - 27 11 40.00 58.00 14.00 22.00 0.05 NA 6.84 5.00 2.30 7.45 48.00 103.00 88.40 0.03 NA 11.00 4.77 0.39 7.88 1.30 NA 1.74 20.48 86.00 0.32 NA 5.00 1.03 325.00 3.90 68.00 4.50 137.00 1.02 NA 267.66 NA 5.13 NA - 43 16 40.00 54.00 14.00 22.00 0.05 NA 6.84 5.35 2.20 7.29 58.00 106.00 79.56 0.04 NA 7.00 4.88 0.38 8.07 1.22 NA 1.80 21.10 87.00 0.29 NA NA 1.00 296.00 4.00 65.00 4.40 140.00 NA NA 285.50 NA 4.68 NA - 57 14 40.00 60.00 11.00 21.00 0.04 NA 5.13 3.57 2.25 6.44 50.00 107.00 79.56 0.04 NA 11.00 5.16 0.38 7.94 1.24 NA 1.68 21.10 81.00 0.39 NA NA 0.77 326.00 3.90 67.00 4.70 142.00 NA NA 261.71 NA 5.86 NA - 85 28 40.00 57.00 13.00 22.00 0.05 NA 6.84 4.28 2.30 7.55 54.00 105.00 88.40 0.05 NA 9.00 5.50 0.40 8.07 1.38 NA 1.74 20.48 85.00 0.36 NA 5.00 1.03 281.00 3.90 70.00 4.70 141.00 1.02 NA 309.30 NA 5.76 NA - 87 2 NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA 5.00 NA NA NA NA NA NA 1.01 NA NA NA NA NA - 108 21 40.00 53.00 17.00 25.00 0.06 NA 8.55 4.64 2.22 8.02 / H2 61.00 105.00 79.56 0.04 NA 11.00 5.22 0.39 7.88 1.34 NA 1.68 20.48 82.00 0.55 NA 7.00 1.10 286.00 3.70 69.00 4.70 139.00 1.01 NA 285.50 NA 5.63 NA - 142 34 40.00 60.00 14.00 24.00 0.04 NA 5.13 4.28 2.35 7.47 53.00 111.00 70.72 0.04 NA 9.00 5.11 0.39 8.19 1.71 NA 1.74 21.10 84.00 0.44 NA NA 0.97 293.00 3.90 72.00 4.60 141.00 NA NA 243.87 NA 5.61 NA - 170 28 42.00 63.00 13.00 22.00 0.04 NA 6.84 5.00 2.20 7.63 52.00 103.00 88.40 0.02 NA 10.00 5.33 0.38 7.94 1.23 NA 1.74 21.10 82.00 0.28 NA 7.00 0.90 263.00 3.80 67.00 4.60 140.00 1.01 NA 267.66 NA 4.63 NA - 191 21 37.00 57.00 14.00 23.00 0.03 NA 5.13 3.57 2.20 6.21 77.00 106.00 79.56 0.02 NA 9.00 5.66 0.37 7.51 1.23 NA 1.68 20.48 83.00 0.40 NA NA 1.07 262.00 3.60 66.00 4.40 145.00 NA NA 285.50 NA 5.05 NA - 701/1203 -8 NA 38.00 87.00 13.00 20.00 0.02 NA 5.13 4.28 2.30 5.77 96.00 107.00 88.40 0.04 NA 11.00 8.27 0.39 7.94 2.03 NA 1.80 20.48 88.00 0.27 NA 5.00 1.19 253.00 4.10 71.00 4.40 141.00 1.02 4.80 297.40 362.26 5.79 NA - ————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— + —————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— + Days Since + Study Last Dose of ALB ALKPH ALT AST BILI BUN CA CHOLES CREAT GGT PHOS PROT SODIUM URATE + Treatment Center/Patient ID Day Study Drug (g/dL / NCI CTCAE grade) (U/L / NCI CTCAE grade) (U/L / NCI CTCAE grade) (U/L / NCI CTCAE grade) (mg/dL / NCI CTCAE grade) (mg/dL / NCI CTCAE grade) (mg/dL / NCI CTCAE grade) (mg/dL / NCI CTCAE grade) (mg/dL / NCI CTCAE grade) (U/L / NCI CTCAE grade) (mg/dL / NCI CTCAE grade) (g/dL / NCI CTCAE grade) (mEq/L / NCI CTCAE grade) (mg/dL / NCI CTCAE grade) + —————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— + Placebo 701/1015 -7 NA 38.00 34.00 / L0 27.00 40.00 / H1 10.26 3.57 2.20 5.95 79.56 15.00 1.23 61.00 140.00 267.66 + 15 22 39.00 50.00 41.00 / H1 33.00 8.55 3.57 2.35 5.48 88.40 19.00 1.26 77.00 142.00 291.45 + 29 14 38.00 41.00 18.00 21.00 6.84 2.86 2.27 4.99 70.72 15.00 1.13 69.00 140.00 261.71 + 42 13 37.00 43.00 26.00 26.00 5.13 4.28 2.30 5.64 88.40 14.00 1.23 68.00 140.00 273.61 + 63 21 38.00 47.00 22.00 21.00 8.55 3.93 2.22 5.53 88.40 14.00 1.16 69.00 141.00 273.61 + 84 21 38.00 53.00 27.00 22.00 6.84 3.57 2.35 5.64 79.56 23.00 1.23 70.00 139.00 261.71 + 126 42 37.00 41.00 17.00 23.00 6.84 3.57 2.20 5.51 88.40 15.00 1.29 68.00 141.00 255.76 + 140 14 37.00 45.00 21.00 19.00 6.84 3.93 2.17 5.35 79.56 17.00 1.10 68.00 142.00 279.56 + 168 28 38.00 46.00 23.00 23.00 6.84 4.28 2.22 5.20 79.56 20.00 1.26 66.00 140.00 303.35 + 182 14 38.00 44.00 23.00 19.00 5.13 3.93 2.20 5.53 88.40 16.00 1.36 69.00 140.00 309.30 + 701/1023 -14 NA 40.00 98.00 23.00 21.00 11.97 6.43 2.47 6.78 123.76 18.00 1.29 74.00 142.00 398.52 + 23 37 36.00 90.00 30.00 25.00 6.84 7.50 2.35 6.13 132.60 22.00 1.19 69.00 140.00 368.78 + 29 6 35.00 99.00 38.00 30.00 8.55 6.07 2.37 6.08 114.92 22.00 1.10 71.00 141.00 362.83 + 701/1047 -21 NA 42.00 78.00 22.00 25.00 6.84 6.43 2.30 6.08 88.40 14.00 1.32 69.00 144.00 231.97 + 14 35 38.00 67.00 16.00 21.00 8.55 6.43 2.25 5.43 88.40 12.00 0.97 63.00 141.00 285.50 + 27 13 38.00 71.00 20.00 24.00 6.84 7.14 2.12 4.71 79.56 12.00 1.00 66.00 142.00 255.76 + 55 28 38.00 75.00 17.00 21.00 6.84 5.35 2.15 4.89 88.40 11.00 0.81 65.00 NA 279.56 + 701/1118 -13 NA 39.00 65.00 15.00 15.00 11.97 5.35 2.27 4.60 88.40 13.00 1.26 70.00 141.00 249.82 + 15 28 42.00 76.00 7.00 13.00 8.55 4.64 2.25 5.02 88.40 13.00 1.32 71.00 142.00 279.56 + 29 14 44.00 67.00 15.00 14.00 10.26 4.28 2.32 4.55 106.08 13.00 1.29 74.00 134.00 243.87 + 43 14 41.00 62.00 11.00 15.00 8.55 5.35 2.30 4.76 97.24 14.00 1.32 70.00 139.00 237.92 + 58 15 39.00 67.00 15.00 18.00 10.26 4.28 2.15 5.28 88.40 18.00 1.07 72.00 139.00 273.61 + 86 28 40.00 70.00 16.00 13.00 8.55 3.93 2.22 4.58 106.08 15.00 0.97 72.00 142.00 226.02 + 113 27 41.00 65.00 15.00 18.00 10.26 6.07 2.30 4.86 97.24 14.00 1.13 72.00 141.00 249.82 + 141 28 41.00 62.00 13.00 14.00 10.26 6.43 2.30 5.04 106.08 15.00 1.39 71.00 139.00 297.40 + 169 28 42.00 58.00 13.00 11.00 8.55 5.00 2.30 4.81 97.24 15.00 1.36 68.00 142.00 249.82 + 182 13 39.00 56.00 10.00 12.00 8.55 4.28 2.10 / L1 4.89 97.24 16.00 1.49 67.00 139.00 309.30 + 701/1130 -6 NA 37.00 61.00 15.00 24.00 8.55 7.14 2.12 4.68 123.76 9.00 / L0 1.26 73.00 140.00 392.57 + 15 21 38.00 61.00 14.00 26.00 10.26 7.14 2.27 5.33 123.76 12.00 1.26 75.00 138.00 386.62 + 29 14 33.00 / L1 68.00 18.00 25.00 5.13 9.28 / HNA 2.22 4.50 176.80 / H1 11.00 1.26 71.00 140.00 380.67 + 43 14 36.00 63.00 13.00 19.00 6.84 6.43 2.22 4.84 123.76 12.00 1.10 72.00 138.00 422.31 + 57 14 36.00 58.00 10.00 18.00 10.26 7.14 2.20 4.86 114.92 10.00 1.29 69.00 139.00 368.78 + 91 34 37.00 63.00 13.00 21.00 8.55 8.92 / HNA 2.17 4.84 123.76 10.00 1.29 72.00 140.00 392.57 + 113 22 39.00 65.00 12.00 19.00 10.26 6.78 2.32 5.12 132.60 12.00 1.32 77.00 141.00 440.15 + 138 25 34.00 / L1 62.00 11.00 19.00 6.84 7.50 2.22 4.47 132.60 10.00 1.19 70.00 143.00 416.36 + 169 31 38.00 65.00 13.00 22.00 11.97 7.14 2.30 4.94 132.60 11.00 1.29 74.00 141.00 422.31 + 183 14 39.00 67.00 10.00 19.00 10.26 6.43 2.15 4.76 132.60 10.00 1.29 77.00 139.00 422.31 + 701/1153 -17 NA 39.00 65.00 13.00 24.00 5.13 3.93 2.32 6.98 88.40 11.00 0.87 69.00 140.00 279.56 + 16 33 42.00 64.00 14.00 25.00 6.84 5.35 2.32 7.32 79.56 11.00 1.10 71.00 139.00 267.66 + 27 11 40.00 58.00 14.00 22.00 6.84 5.00 2.30 7.45 88.40 11.00 1.03 68.00 137.00 267.66 + 43 16 40.00 54.00 14.00 22.00 6.84 5.35 2.20 7.29 79.56 7.00 1.00 65.00 140.00 285.50 + 57 14 40.00 60.00 11.00 21.00 5.13 3.57 2.25 6.44 79.56 11.00 0.77 67.00 142.00 261.71 + 85 28 40.00 57.00 13.00 22.00 6.84 4.28 2.30 7.55 88.40 9.00 1.03 70.00 141.00 309.30 + 108 23 40.00 53.00 17.00 25.00 8.55 4.64 2.22 8.02 / H2 79.56 11.00 1.10 69.00 139.00 285.50 + 142 34 40.00 60.00 14.00 24.00 5.13 4.28 2.35 7.47 70.72 9.00 0.97 72.00 141.00 243.87 + 170 28 42.00 63.00 13.00 22.00 6.84 5.00 2.20 7.63 88.40 10.00 0.90 67.00 140.00 267.66 + 191 21 37.00 57.00 14.00 23.00 5.13 3.57 2.20 6.21 79.56 9.00 1.07 66.00 145.00 285.50 + 701/1203 -8 NA 38.00 87.00 13.00 20.00 5.13 4.28 2.30 5.77 88.40 11.00 1.19 71.00 141.00 297.40 + 22 30 37.00 90.00 14.00 20.00 5.13 4.64 2.27 5.79 97.24 12.00 1.19 69.00 142.00 303.35 + 29 7 37.00 82.00 10.00 16.00 6.84 5.71 2.25 5.84 106.08 9.00 1.19 70.00 141.00 321.19 + —————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— NCI CTCAE grade is displayed as abnormal high (H) or low (L) followed by the grade. diff --git a/tests/testthat/_snaps/listing_lbl01_rls.md b/tests/testthat/_snaps/listing_lbl01_rls.md index cb4068c..809e9a4 100644 --- a/tests/testthat/_snaps/listing_lbl01_rls.md +++ b/tests/testthat/_snaps/listing_lbl01_rls.md @@ -5,62 +5,62 @@ Output Listing of Laboratory Test Results Using Roche Safety Lab Standardization - ———————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— - Days Since - Study Last Dose of ALB ALKPH ALT AST BASO BASOLE BILI BUN CA CHOLES CK CL CREAT EOS EOSLE GGT GLUC HCT HGB LYMPH LYMPHLE MCH MCHC MCV MONO MONOLE PH PHOS PLAT POTAS PROT RBC SODIUM SPGRAV TSH URATE VITB12 WBC HBA1C - Treatment Center/Patient ID Day Study Drug (g/dL) (U/L) (U/L) (U/L) (THOU/uL) (FRACTION) (mg/dL) (mg/dL) (mg/dL) (mg/dL) (U/L) (mEq/L) (mg/dL) (THOU/uL) (FRACTION) (U/L) (mg/dL) (%) (g/dL) (THOU/uL) (FRACTION) (pg) (g/dL) (fL) (THOU/uL) (FRACTION) (NO UNITS) (mg/dL) (THOU/uL) (mEq/L) (g/dL) (MILL/uL) (mEq/L) (NO UNITS) (uIU/mL) (mg/dL) (pg/mL) (THOU/uL) (%) - ———————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— - Placebo 701/1015 -7 NA 38.00 34.00 / L 27.00 40.00 / HH NA 0.40 / H 10.26 3.57 2.20 5.95 70.00 106.00 79.56 NA 0.30 / H 15.00 4.72 0.42 8.87 NA 0.05 / LL 1.68 21.10 80.00 NA 0.50 / H 5.00 1.23 266.00 4.50 61.00 5.30 140.00 1.01 1.68 267.66 294.38 5.78 NA - 15 22 39.00 50.00 41.00 / HH 33.00 NA 0.15 / H 8.55 3.57 2.35 5.48 54.00 103.00 88.40 NA 0.00 19.00 4.66 0.43 8.87 NA 0.30 1.68 20.48 81.00 NA 0.05 5.00 1.26 306.00 4.40 77.00 5.30 142.00 1.01 NA 291.45 NA 5.33 NA - 29 14 38.00 41.00 18.00 21.00 0.02 NA 6.84 2.86 2.27 4.99 45.00 107.00 70.72 0.08 NA 15.00 4.39 0.39 8.32 1.93 NA 1.68 21.10 78.00 / L 0.23 NA NA 1.13 238.00 4.50 69.00 5.00 140.00 NA NA 261.71 NA 4.54 NA - 42 13 37.00 43.00 26.00 26.00 0.04 NA 5.13 4.28 2.30 5.64 64.00 105.00 88.40 0.08 NA 14.00 5.11 0.40 8.56 1.51 NA 1.68 21.10 80.00 0.28 NA NA 1.23 237.00 4.60 68.00 5.10 140.00 NA NA 273.61 NA 4.25 NA - 63 21 38.00 47.00 22.00 21.00 0.05 NA 8.55 3.93 2.22 5.53 49.00 105.00 88.40 0.09 NA 14.00 4.55 0.42 8.69 1.97 NA 1.68 20.48 83.00 0.24 NA NA 1.16 266.00 4.10 69.00 5.10 141.00 NA NA 273.61 NA 5.35 NA - 84 21 38.00 53.00 27.00 22.00 0.04 NA 6.84 3.57 2.35 5.64 56.00 99.00 79.56 0.13 NA 23.00 4.83 0.41 8.32 2.09 NA 1.68 20.48 81.00 0.24 NA 5.00 1.23 260.00 3.60 70.00 5.00 139.00 1.01 NA 261.71 NA 5.24 NA - 126 42 37.00 41.00 17.00 23.00 0.03 NA 6.84 3.57 2.20 5.51 50.00 103.00 88.40 0.09 NA 15.00 4.77 0.41 8.75 2.02 NA 1.68 21.72 79.00 / L 0.33 NA NA 1.29 266.00 4.10 68.00 5.20 141.00 NA NA 255.76 NA 5.62 NA - 140 14 37.00 45.00 21.00 19.00 0.03 NA 6.84 3.93 2.17 5.35 50.00 108.00 79.56 0.06 NA 17.00 4.88 0.40 8.50 1.78 NA 1.74 21.72 80.00 0.28 NA NA 1.10 233.00 4.30 68.00 4.90 142.00 NA NA 279.56 NA 4.36 NA - 168 28 38.00 46.00 23.00 23.00 0.04 NA 6.84 4.28 2.22 5.20 42.00 103.00 79.56 0.09 NA 20.00 4.50 0.44 8.69 2.55 NA 1.68 19.86 82.00 0.31 NA 5.00 1.26 259.00 4.10 66.00 5.30 140.00 1.00 / LL NA 303.35 NA 7.23 NA - 182 14 38.00 44.00 23.00 19.00 0.03 NA 5.13 3.93 2.20 5.53 44.00 104.00 88.40 0.07 NA 16.00 5.11 0.45 8.87 2.03 NA 1.68 19.86 84.00 0.31 NA NA 1.36 300.00 4.50 69.00 5.40 140.00 NA NA 309.30 NA 5.43 NA - 701/1023 -14 NA 40.00 98.00 23.00 21.00 NA 0.50 / H 11.97 6.43 2.47 6.78 85.00 106.00 123.76 NA 0.00 18.00 5.33 0.49 10.05 NA 0.20 / LL 1.86 20.48 92.00 NA 0.25 / H 5.00 1.29 217.00 4.90 74.00 5.30 142.00 1.02 1.28 398.52 408.00 8.78 NA - 23 37 36.00 90.00 30.00 25.00 NA 0.10 / H 6.84 7.50 2.35 6.13 77.00 108.00 132.60 NA 0.20 / H 22.00 5.77 0.46 9.25 NA 0.45 / H 1.92 20.48 95.00 NA 0.45 / H 5.00 1.19 222.00 4.80 69.00 4.80 140.00 1.03 NA 368.78 NA 8.55 NA - 29 6 35.00 99.00 38.00 30.00 0.04 NA 8.55 6.07 2.37 6.08 76.00 106.00 114.92 0.07 NA 22.00 5.44 0.48 9.50 1.40 NA 1.86 19.86 92.00 0.58 NA 5.00 1.10 198.00 4.70 71.00 5.20 141.00 1.02 NA 362.83 NA 7.67 NA - 701/1047 -21 NA 42.00 78.00 22.00 25.00 NA 0.40 / H 6.84 6.43 2.30 6.08 90.00 105.00 88.40 NA 0.40 / H 14.00 5.55 0.46 9.50 NA 0.35 2.05 21.10 97.00 NA 0.45 / H 5.00 1.32 224.00 4.30 69.00 4.70 144.00 1.02 0.46 231.97 431.61 7.15 NA - 14 35 38.00 67.00 16.00 21.00 NA 0.35 / H 8.55 6.43 2.25 5.43 80.00 109.00 88.40 NA 0.30 / H 12.00 5.55 0.43 8.69 NA 0.25 1.92 20.48 95.00 NA 0.30 / H 5.00 0.97 224.00 3.90 63.00 4.50 141.00 1.01 NA 285.50 NA 5.88 NA - 27 13 38.00 71.00 20.00 24.00 0.04 NA 6.84 7.14 2.12 4.71 77.00 108.00 79.56 0.22 NA 12.00 6.00 0.40 8.38 2.06 NA 1.99 21.10 94.00 0.37 NA NA 1.00 225.00 3.90 66.00 4.30 142.00 NA NA 255.76 NA 5.68 NA - 46 19 NA NA NA NA 0.03 NA NA NA NA NA NA NA NA 0.21 NA NA NA 0.40 8.25 1.84 NA 1.99 20.48 96.00 0.42 NA 5.00 NA 194.00 NA NA 4.20 NA 1.02 NA NA NA 7.68 NA - 55 9 38.00 75.00 17.00 21.00 NA NA 6.84 5.35 2.15 4.89 85.00 NA 88.40 NA NA 11.00 3.83 NA NA NA NA NA NA NA NA NA NA 0.81 NA NA 65.00 NA NA NA NA 279.56 NA NA NA - 701/1118 -13 NA 39.00 65.00 15.00 15.00 0.04 NA 11.97 5.35 2.27 4.60 110.00 108.00 88.40 0.32 NA 13.00 4.05 0.45 9.68 1.94 NA 1.99 21.72 92.00 0.73 NA 6.00 1.26 268.00 4.70 70.00 4.90 141.00 1.03 1.85 249.82 213.22 7.89 NA - 15 28 42.00 76.00 7.00 13.00 0.02 NA 8.55 4.64 2.25 5.02 41.00 110.00 88.40 0.09 NA 13.00 4.88 0.45 9.62 1.40 NA 1.92 21.72 88.00 0.39 NA 6.00 1.32 285.00 4.60 71.00 5.10 142.00 1.03 NA 279.56 NA 6.07 NA - 29 14 44.00 67.00 15.00 14.00 0.04 NA 10.26 4.28 2.32 4.55 49.00 100.00 106.08 0.08 NA 13.00 5.11 0.44 9.68 1.72 NA 1.92 21.72 88.00 0.54 NA NA 1.29 308.00 4.70 74.00 5.00 134.00 NA NA 243.87 NA 5.89 NA - 43 14 41.00 62.00 11.00 15.00 0.03 NA 8.55 5.35 2.30 4.76 42.00 103.00 97.24 0.17 NA 14.00 5.22 0.42 9.62 2.05 NA 2.05 22.96 90.00 0.42 NA NA 1.32 274.00 4.80 70.00 4.70 139.00 NA NA 237.92 NA 6.59 NA - 58 15 39.00 67.00 15.00 18.00 0.05 NA 10.26 4.28 2.15 5.28 49.00 104.00 88.40 0.17 NA 18.00 3.83 0.45 9.74 2.80 NA 1.99 21.72 91.00 0.88 NA NA 1.07 334.00 4.30 72.00 4.90 139.00 NA NA 273.61 NA 8.22 NA - 86 28 40.00 70.00 16.00 13.00 0.04 NA 8.55 3.93 2.22 4.58 36.00 106.00 106.08 0.13 NA 15.00 5.88 0.47 9.74 1.62 NA 1.92 20.48 92.00 0.45 NA 5.00 0.97 293.00 4.20 72.00 5.10 142.00 1.03 NA 226.02 NA 6.33 NA - 113 27 41.00 65.00 15.00 18.00 0.03 NA 10.26 6.07 2.30 4.86 88.00 106.00 97.24 0.16 NA 14.00 4.83 0.44 9.68 1.67 NA 1.92 21.72 88.00 0.52 NA NA 1.13 304.00 4.50 72.00 5.00 141.00 NA NA 249.82 NA 6.69 NA - 141 28 41.00 62.00 13.00 14.00 0.04 NA 10.26 6.43 2.30 5.04 41.00 102.00 106.08 0.08 NA 15.00 5.16 0.45 9.74 1.65 NA 1.92 21.72 88.00 0.51 NA NA 1.39 324.00 4.20 71.00 5.10 139.00 NA NA 297.40 NA 7.01 NA - 169 28 42.00 58.00 13.00 11.00 0.11 NA 8.55 5.00 2.30 4.81 36.00 105.00 97.24 0.09 NA 15.00 5.11 0.48 9.50 1.57 NA 1.92 19.86 96.00 0.52 NA 6.00 1.36 313.00 4.60 68.00 5.00 142.00 1.03 NA 249.82 NA 7.10 NA - 182 13 39.00 56.00 10.00 12.00 0.04 NA 8.55 4.28 2.10 / LL 4.89 50.00 104.00 97.24 0.11 NA 16.00 4.94 0.42 9.25 1.72 NA 1.99 22.34 89.00 0.44 NA NA 1.49 271.00 4.10 67.00 4.70 139.00 NA NA 309.30 NA 5.95 NA - 701/1130 -6 NA 37.00 61.00 15.00 24.00 0.03 NA 8.55 7.14 2.12 4.68 57.00 104.00 123.76 0.16 NA 9.00 / L 5.05 0.36 / LL 7.51 / L 2.19 NA 1.99 21.10 95.00 0.59 NA 5.00 1.26 196.00 4.20 73.00 3.80 / L 140.00 1.02 3.59 392.57 261.92 6.55 NA - 15 21 38.00 61.00 14.00 26.00 0.07 NA 10.26 7.14 2.27 5.33 53.00 104.00 123.76 0.20 NA 12.00 5.66 0.37 7.82 2.12 NA 1.99 21.10 94.00 0.98 / H NA 5.00 1.26 232.00 4.50 75.00 3.90 / L 138.00 1.02 NA 386.62 NA 10.73 / H NA - 29 14 33.00 / L 68.00 18.00 25.00 0.03 NA 5.13 9.28 / H 2.22 4.50 60.00 105.00 176.80 / HH 0.18 NA 11.00 6.16 0.31 / LL 6.52 / L 1.63 NA 2.05 21.10 97.00 0.61 NA NA 1.26 210.00 4.60 71.00 3.20 / L 140.00 NA NA 380.67 NA 6.90 NA - 43 14 36.00 63.00 13.00 19.00 0.05 NA 6.84 6.43 2.22 4.84 42.00 103.00 123.76 0.17 NA 12.00 5.16 0.35 / LL 7.32 / L 2.07 NA 1.99 21.10 96.00 0.65 NA NA 1.10 255.00 4.30 72.00 3.60 / L 138.00 NA NA 422.31 NA 6.64 NA - 57 14 36.00 58.00 10.00 18.00 0.04 NA 10.26 7.14 2.20 4.86 52.00 104.00 114.92 0.17 NA 10.00 5.16 0.33 / LL 6.95 / L 2.18 NA 1.99 21.10 96.00 0.58 NA NA 1.29 185.00 4.50 69.00 3.50 / L 139.00 NA NA 368.78 NA 6.58 NA - 91 34 37.00 63.00 13.00 21.00 0.04 NA 8.55 8.92 / H 2.17 4.84 67.00 106.00 123.76 0.21 NA 10.00 6.11 0.33 / LL 7.14 / L 2.34 NA 2.05 21.72 94.00 0.64 NA 5.00 1.29 194.00 4.40 72.00 3.50 / L 140.00 1.02 NA 392.57 NA 8.15 NA - 113 22 39.00 65.00 12.00 19.00 0.05 NA 10.26 6.78 2.32 5.12 52.00 103.00 132.60 0.07 NA 12.00 4.88 0.38 7.39 / L 2.15 NA 2.05 19.24 105.00 / HH 0.55 NA NA 1.32 184.00 4.00 77.00 3.60 / L 141.00 NA NA 440.15 NA 6.89 NA - 138 25 34.00 / L 62.00 11.00 19.00 0.05 NA 6.84 7.50 2.22 4.47 53.00 105.00 132.60 0.22 NA 10.00 4.88 0.33 / LL 6.89 / L 2.29 NA 1.99 20.48 96.00 0.72 NA NA 1.19 229.00 4.00 70.00 3.50 / L 143.00 NA NA 416.36 NA 7.12 NA - 169 31 38.00 65.00 13.00 22.00 0.04 NA 11.97 7.14 2.30 4.94 59.00 107.00 132.60 0.22 NA 11.00 4.88 0.37 7.57 / L 2.13 NA 2.05 20.48 99.00 0.57 NA 6.00 1.29 211.00 4.30 74.00 3.70 / L 141.00 1.02 NA 422.31 NA 7.40 NA - 183 14 39.00 67.00 10.00 19.00 0.05 NA 10.26 6.43 2.15 4.76 56.00 103.00 132.60 0.38 NA 10.00 5.22 0.34 / LL 7.57 / L 2.55 NA 2.11 / H 22.34 94.00 0.63 NA NA 1.29 203.00 4.20 77.00 3.60 / L 139.00 NA NA 422.31 NA 8.35 NA - 701/1153 -17 NA 39.00 65.00 13.00 24.00 0.06 NA 5.13 3.93 2.32 6.98 65.00 107.00 88.40 0.07 NA 11.00 5.50 0.39 8.01 1.16 NA 1.68 20.48 81.00 0.41 NA 5.00 0.87 293.00 3.70 69.00 4.80 140.00 1.00 / LL 0.38 279.56 254.54 5.06 NA - 16 33 42.00 64.00 14.00 25.00 0.08 NA 6.84 5.35 2.32 7.32 51.00 109.00 79.56 0.04 NA 11.00 5.00 0.41 8.38 1.30 NA 1.74 20.48 85.00 0.31 NA 5.00 1.10 314.00 4.00 71.00 4.80 139.00 1.02 NA 267.66 NA 5.98 NA - 27 11 40.00 58.00 14.00 22.00 0.05 NA 6.84 5.00 2.30 7.45 48.00 103.00 88.40 0.03 NA 11.00 4.77 0.39 7.88 1.30 NA 1.74 20.48 86.00 0.32 NA 5.00 1.03 325.00 3.90 68.00 4.50 137.00 1.02 NA 267.66 NA 5.13 NA - 43 16 40.00 54.00 14.00 22.00 0.05 NA 6.84 5.35 2.20 7.29 58.00 106.00 79.56 0.04 NA 7.00 4.88 0.38 8.07 1.22 NA 1.80 21.10 87.00 0.29 NA NA 1.00 296.00 4.00 65.00 4.40 140.00 NA NA 285.50 NA 4.68 NA - 57 14 40.00 60.00 11.00 21.00 0.04 NA 5.13 3.57 2.25 6.44 50.00 107.00 79.56 0.04 NA 11.00 5.16 0.38 7.94 1.24 NA 1.68 21.10 81.00 0.39 NA NA 0.77 326.00 3.90 67.00 4.70 142.00 NA NA 261.71 NA 5.86 NA - 85 28 40.00 57.00 13.00 22.00 0.05 NA 6.84 4.28 2.30 7.55 54.00 105.00 88.40 0.05 NA 9.00 5.50 0.40 8.07 1.38 NA 1.74 20.48 85.00 0.36 NA 5.00 1.03 281.00 3.90 70.00 4.70 141.00 1.02 NA 309.30 NA 5.76 NA - 87 2 NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA 5.00 NA NA NA NA NA NA 1.01 NA NA NA NA NA - 108 21 40.00 53.00 17.00 25.00 0.06 NA 8.55 4.64 2.22 8.02 / H 61.00 105.00 79.56 0.04 NA 11.00 5.22 0.39 7.88 1.34 NA 1.68 20.48 82.00 0.55 NA 7.00 1.10 286.00 3.70 69.00 4.70 139.00 1.01 NA 285.50 NA 5.63 NA - 142 34 40.00 60.00 14.00 24.00 0.04 NA 5.13 4.28 2.35 7.47 53.00 111.00 70.72 0.04 NA 9.00 5.11 0.39 8.19 1.71 NA 1.74 21.10 84.00 0.44 NA NA 0.97 293.00 3.90 72.00 4.60 141.00 NA NA 243.87 NA 5.61 NA - 170 28 42.00 63.00 13.00 22.00 0.04 NA 6.84 5.00 2.20 7.63 52.00 103.00 88.40 0.02 NA 10.00 5.33 0.38 7.94 1.23 NA 1.74 21.10 82.00 0.28 NA 7.00 0.90 263.00 3.80 67.00 4.60 140.00 1.01 NA 267.66 NA 4.63 NA - 191 21 37.00 57.00 14.00 23.00 0.03 NA 5.13 3.57 2.20 6.21 77.00 106.00 79.56 0.02 NA 9.00 5.66 0.37 7.51 1.23 NA 1.68 20.48 83.00 0.40 NA NA 1.07 262.00 3.60 66.00 4.40 145.00 NA NA 285.50 NA 5.05 NA - 701/1203 -8 NA 38.00 87.00 13.00 20.00 0.02 NA 5.13 4.28 2.30 5.77 96.00 107.00 88.40 0.04 NA 11.00 8.27 0.39 7.94 2.03 NA 1.80 20.48 88.00 0.27 NA 5.00 1.19 253.00 4.10 71.00 4.40 141.00 1.02 4.80 297.40 362.26 5.79 NA - ———————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— + —————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— + Days Since + Study Last Dose of ALB ALKPH ALT AST BILI BUN CA CHOLES CREAT GGT PHOS PROT SODIUM URATE + Treatment Center/Patient ID Day Study Drug (g/dL) (U/L) (U/L) (U/L) (mg/dL) (mg/dL) (mg/dL) (mg/dL) (mg/dL) (U/L) (mg/dL) (g/dL) (mEq/L) (mg/dL) + —————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— + Placebo 701/1015 -7 NA 38.00 34.00 / L 27.00 40.00 / HH 10.26 3.57 2.20 5.95 79.56 15.00 1.23 61.00 140.00 267.66 + 15 22 39.00 50.00 41.00 / HH 33.00 8.55 3.57 2.35 5.48 88.40 19.00 1.26 77.00 142.00 291.45 + 29 14 38.00 41.00 18.00 21.00 6.84 2.86 2.27 4.99 70.72 15.00 1.13 69.00 140.00 261.71 + 42 13 37.00 43.00 26.00 26.00 5.13 4.28 2.30 5.64 88.40 14.00 1.23 68.00 140.00 273.61 + 63 21 38.00 47.00 22.00 21.00 8.55 3.93 2.22 5.53 88.40 14.00 1.16 69.00 141.00 273.61 + 84 21 38.00 53.00 27.00 22.00 6.84 3.57 2.35 5.64 79.56 23.00 1.23 70.00 139.00 261.71 + 126 42 37.00 41.00 17.00 23.00 6.84 3.57 2.20 5.51 88.40 15.00 1.29 68.00 141.00 255.76 + 140 14 37.00 45.00 21.00 19.00 6.84 3.93 2.17 5.35 79.56 17.00 1.10 68.00 142.00 279.56 + 168 28 38.00 46.00 23.00 23.00 6.84 4.28 2.22 5.20 79.56 20.00 1.26 66.00 140.00 303.35 + 182 14 38.00 44.00 23.00 19.00 5.13 3.93 2.20 5.53 88.40 16.00 1.36 69.00 140.00 309.30 + 701/1023 -14 NA 40.00 98.00 23.00 21.00 11.97 6.43 2.47 6.78 123.76 18.00 1.29 74.00 142.00 398.52 + 23 37 36.00 90.00 30.00 25.00 6.84 7.50 2.35 6.13 132.60 22.00 1.19 69.00 140.00 368.78 + 29 6 35.00 99.00 38.00 30.00 8.55 6.07 2.37 6.08 114.92 22.00 1.10 71.00 141.00 362.83 + 701/1047 -21 NA 42.00 78.00 22.00 25.00 6.84 6.43 2.30 6.08 88.40 14.00 1.32 69.00 144.00 231.97 + 14 35 38.00 67.00 16.00 21.00 8.55 6.43 2.25 5.43 88.40 12.00 0.97 63.00 141.00 285.50 + 27 13 38.00 71.00 20.00 24.00 6.84 7.14 2.12 4.71 79.56 12.00 1.00 66.00 142.00 255.76 + 55 28 38.00 75.00 17.00 21.00 6.84 5.35 2.15 4.89 88.40 11.00 0.81 65.00 NA 279.56 + 701/1118 -13 NA 39.00 65.00 15.00 15.00 11.97 5.35 2.27 4.60 88.40 13.00 1.26 70.00 141.00 249.82 + 15 28 42.00 76.00 7.00 13.00 8.55 4.64 2.25 5.02 88.40 13.00 1.32 71.00 142.00 279.56 + 29 14 44.00 67.00 15.00 14.00 10.26 4.28 2.32 4.55 106.08 13.00 1.29 74.00 134.00 243.87 + 43 14 41.00 62.00 11.00 15.00 8.55 5.35 2.30 4.76 97.24 14.00 1.32 70.00 139.00 237.92 + 58 15 39.00 67.00 15.00 18.00 10.26 4.28 2.15 5.28 88.40 18.00 1.07 72.00 139.00 273.61 + 86 28 40.00 70.00 16.00 13.00 8.55 3.93 2.22 4.58 106.08 15.00 0.97 72.00 142.00 226.02 + 113 27 41.00 65.00 15.00 18.00 10.26 6.07 2.30 4.86 97.24 14.00 1.13 72.00 141.00 249.82 + 141 28 41.00 62.00 13.00 14.00 10.26 6.43 2.30 5.04 106.08 15.00 1.39 71.00 139.00 297.40 + 169 28 42.00 58.00 13.00 11.00 8.55 5.00 2.30 4.81 97.24 15.00 1.36 68.00 142.00 249.82 + 182 13 39.00 56.00 10.00 12.00 8.55 4.28 2.10 / LL 4.89 97.24 16.00 1.49 67.00 139.00 309.30 + 701/1130 -6 NA 37.00 61.00 15.00 24.00 8.55 7.14 2.12 4.68 123.76 9.00 / L 1.26 73.00 140.00 392.57 + 15 21 38.00 61.00 14.00 26.00 10.26 7.14 2.27 5.33 123.76 12.00 1.26 75.00 138.00 386.62 + 29 14 33.00 / L 68.00 18.00 25.00 5.13 9.28 / H 2.22 4.50 176.80 / HH 11.00 1.26 71.00 140.00 380.67 + 43 14 36.00 63.00 13.00 19.00 6.84 6.43 2.22 4.84 123.76 12.00 1.10 72.00 138.00 422.31 + 57 14 36.00 58.00 10.00 18.00 10.26 7.14 2.20 4.86 114.92 10.00 1.29 69.00 139.00 368.78 + 91 34 37.00 63.00 13.00 21.00 8.55 8.92 / H 2.17 4.84 123.76 10.00 1.29 72.00 140.00 392.57 + 113 22 39.00 65.00 12.00 19.00 10.26 6.78 2.32 5.12 132.60 12.00 1.32 77.00 141.00 440.15 + 138 25 34.00 / L 62.00 11.00 19.00 6.84 7.50 2.22 4.47 132.60 10.00 1.19 70.00 143.00 416.36 + 169 31 38.00 65.00 13.00 22.00 11.97 7.14 2.30 4.94 132.60 11.00 1.29 74.00 141.00 422.31 + 183 14 39.00 67.00 10.00 19.00 10.26 6.43 2.15 4.76 132.60 10.00 1.29 77.00 139.00 422.31 + 701/1153 -17 NA 39.00 65.00 13.00 24.00 5.13 3.93 2.32 6.98 88.40 11.00 0.87 69.00 140.00 279.56 + 16 33 42.00 64.00 14.00 25.00 6.84 5.35 2.32 7.32 79.56 11.00 1.10 71.00 139.00 267.66 + 27 11 40.00 58.00 14.00 22.00 6.84 5.00 2.30 7.45 88.40 11.00 1.03 68.00 137.00 267.66 + 43 16 40.00 54.00 14.00 22.00 6.84 5.35 2.20 7.29 79.56 7.00 1.00 65.00 140.00 285.50 + 57 14 40.00 60.00 11.00 21.00 5.13 3.57 2.25 6.44 79.56 11.00 0.77 67.00 142.00 261.71 + 85 28 40.00 57.00 13.00 22.00 6.84 4.28 2.30 7.55 88.40 9.00 1.03 70.00 141.00 309.30 + 108 23 40.00 53.00 17.00 25.00 8.55 4.64 2.22 8.02 / H 79.56 11.00 1.10 69.00 139.00 285.50 + 142 34 40.00 60.00 14.00 24.00 5.13 4.28 2.35 7.47 70.72 9.00 0.97 72.00 141.00 243.87 + 170 28 42.00 63.00 13.00 22.00 6.84 5.00 2.20 7.63 88.40 10.00 0.90 67.00 140.00 267.66 + 191 21 37.00 57.00 14.00 23.00 5.13 3.57 2.20 6.21 79.56 9.00 1.07 66.00 145.00 285.50 + 701/1203 -8 NA 38.00 87.00 13.00 20.00 5.13 4.28 2.30 5.77 88.40 11.00 1.19 71.00 141.00 297.40 + 22 30 37.00 90.00 14.00 20.00 5.13 4.64 2.27 5.79 97.24 12.00 1.19 69.00 142.00 303.35 + 29 7 37.00 82.00 10.00 16.00 6.84 5.71 2.25 5.84 106.08 9.00 1.19 70.00 141.00 321.19 + —————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— Abnormalities are flagged as high (H) or low (L) if outside the Roche standard reference range; high high (HH) or low low (LL) if outside the Roche marked reference range with a clinically relevant change diff --git a/tests/testthat/_snaps/listing_lbl02a.md b/tests/testthat/_snaps/listing_lbl02a.md index 4d1b8da..14ca87b 100644 --- a/tests/testthat/_snaps/listing_lbl02a.md +++ b/tests/testthat/_snaps/listing_lbl02a.md @@ -10,56 +10,56 @@ Study Last Dose of Lab Normal CTCAE Treatment Lab Test (Unit) Center/Patient ID Day Date Study Drug Result Range Grade —————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— - Placebo Alanine Aminotransferase (U/L) 701/1015 15 16JAN2014 0 41.0 6.0 - 34.0 H1 - 701/1234 100 07JUL2013 0 40.0 6.0 - 35.0 H1 - 704/1388 -9 28NOV2012 0 36.0 6.0 - 35.0 H1 - 704/1445 32 11JUN2014 0 44.0 6.0 - 35.0 H1 - 46 25JUN2014 14 43.0 6.0 - 35.0 H1 - 60 09JUL2014 14 48.0 6.0 - 35.0 H1 - 88 06AUG2014 28 42.0 6.0 - 35.0 H1 - 116 03SEP2014 28 48.0 6.0 - 35.0 H1 - 705/1186 -5 03JAN2014 0 50.0 6.0 - 32.0 H1 - 16 23JAN2014 21 104.0 6.0 - 32.0 H2 - 19 26JAN2014 3 95.0 6.0 - 32.0 H1 - 22 29JAN2014 3 107.0 6.0 - 32.0 H2 - 25 01FEB2014 3 92.0 6.0 - 32.0 H1 - 31 07FEB2014 6 73.0 6.0 - 32.0 H1 - 705/1349 26 04APR2013 0 39.0 6.0 - 32.0 H1 - 169 25AUG2013 143 33.0 6.0 - 32.0 H1 - 708/1286 167 23FEB2014 0 124.0 6.0 - 32.0 H2 - 709/1301 -12 07JUL2013 0 69.0 6.0 - 34.0 H1 - -5 14JUL2013 7 55.0 6.0 - 34.0 H1 - 15 02AUG2013 20 56.0 6.0 - 34.0 H1 - 24 11AUG2013 9 45.0 6.0 - 34.0 H1 - 43 30AUG2013 19 42.0 6.0 - 34.0 H1 - 57 13SEP2013 14 63.0 6.0 - 34.0 H1 - 714/1035 -38 10MAR2014 0 37.0 6.0 - 32.0 H1 - 40 26MAY2014 78 37.0 6.0 - 32.0 H1 - 49 04JUN2014 9 36.0 6.0 - 32.0 H1 - 62 17JUN2014 13 35.0 6.0 - 32.0 H1 - 85 10JUL2014 23 35.0 6.0 - 32.0 H1 - 112 06AUG2014 27 36.0 6.0 - 32.0 H1 - 718/1150 42 01MAR2013 0 76.0 6.0 - 32.0 H1 - 58 17MAR2013 16 44.0 6.0 - 32.0 H1 - 84 12APR2013 26 64.0 6.0 - 32.0 H1 - 140 07JUN2013 56 48.0 6.0 - 32.0 H1 - Albumin (g/dL) 701/1130 29 15MAR2014 0 33.0 35.0 - 46.0 L1 - 138 02JUL2014 109 34.0 35.0 - 46.0 L1 - 701/1415 141 10FEB2014 0 33.0 35.0 - 46.0 L1 - 703/1299 17 28SEP2012 0 34.0 35.0 - 46.0 L1 - 705/1186 -5 03JAN2014 0 34.0 35.0 - 46.0 L1 - 16 23JAN2014 21 32.0 35.0 - 46.0 L1 - 19 26JAN2014 3 30.0 35.0 - 46.0 L1 - 22 29JAN2014 3 32.0 35.0 - 46.0 L1 - 25 01FEB2014 3 31.0 35.0 - 46.0 L1 - 31 07FEB2014 6 32.0 35.0 - 46.0 L1 - 705/1349 -14 24FEB2013 0 32.0 35.0 - 46.0 L1 - -7 03MAR2013 7 34.0 35.0 - 46.0 L1 - 15 24MAR2013 22 31.0 35.0 - 46.0 L1 - 26 04APR2013 11 29.0 35.0 - 46.0 L2 - 53 01MAY2013 27 28.0 35.0 - 46.0 L2 - 80 28MAY2013 27 28.0 35.0 - 46.0 L2 - 108 25JUN2013 28 33.0 35.0 - 46.0 L1 + Placebo Alanine Aminotransferase (U/L) 701/1015 15 16JAN2014 0 41.0 6.0 - 34.0 H1 + 701/1234 100 07JUL2013 0 40.0 6.0 - 35.0 H1 + 704/1388 -9 28NOV2012 0 36.0 6.0 - 35.0 H1 + 704/1445 32 11JUN2014 0 44.0 6.0 - 35.0 H1 + 46 25JUN2014 14 43.0 6.0 - 35.0 H1 + 60 09JUL2014 14 48.0 6.0 - 35.0 H1 + 88 06AUG2014 28 42.0 6.0 - 35.0 H1 + 116 03SEP2014 28 48.0 6.0 - 35.0 H1 + 705/1186 -5 03JAN2014 0 50.0 6.0 - 32.0 H1 + 16 23JAN2014 21 104.0 6.0 - 32.0 H2 + 19 26JAN2014 3 95.0 6.0 - 32.0 H1 + 22 29JAN2014 3 107.0 6.0 - 32.0 H2 + 25 01FEB2014 3 92.0 6.0 - 32.0 H1 + 31 07FEB2014 6 73.0 6.0 - 32.0 H1 + 705/1349 26 04APR2013 0 39.0 6.0 - 32.0 H1 + 169 25AUG2013 143 33.0 6.0 - 32.0 H1 + 708/1286 167 23FEB2014 0 124.0 6.0 - 32.0 H2 + 709/1301 -12 07JUL2013 0 69.0 6.0 - 34.0 H1 + -5 14JUL2013 7 55.0 6.0 - 34.0 H1 + 15 02AUG2013 20 56.0 6.0 - 34.0 H1 + 24 11AUG2013 9 45.0 6.0 - 34.0 H1 + 43 30AUG2013 19 42.0 6.0 - 34.0 H1 + 57 13SEP2013 14 63.0 6.0 - 34.0 H1 + 714/1035 -38 10MAR2014 0 37.0 6.0 - 32.0 H1 + 40 26MAY2014 78 37.0 6.0 - 32.0 H1 + 49 04JUN2014 9 36.0 6.0 - 32.0 H1 + 62 17JUN2014 13 35.0 6.0 - 32.0 H1 + 85 10JUL2014 23 35.0 6.0 - 32.0 H1 + 112 06AUG2014 27 36.0 6.0 - 32.0 H1 + 718/1150 42 01MAR2013 0 76.0 6.0 - 32.0 H1 + 58 17MAR2013 16 44.0 6.0 - 32.0 H1 + 84 12APR2013 26 64.0 6.0 - 32.0 H1 + 140 07JUN2013 56 48.0 6.0 - 32.0 H1 + Albumin (g/dL) 701/1130 29 15MAR2014 0 33.0 35.0 - 46.0 L1 + 138 02JUL2014 109 34.0 35.0 - 46.0 L1 + 701/1415 141 10FEB2014 0 33.0 35.0 - 46.0 L1 + 703/1299 17 28SEP2012 0 34.0 35.0 - 46.0 L1 + 705/1186 -5 03JAN2014 0 34.0 35.0 - 46.0 L1 + 16 23JAN2014 21 32.0 35.0 - 46.0 L1 + 19 26JAN2014 3 30.0 35.0 - 46.0 L1 + 22 29JAN2014 3 32.0 35.0 - 46.0 L1 + 25 01FEB2014 3 31.0 35.0 - 46.0 L1 + 31 07FEB2014 6 32.0 35.0 - 46.0 L1 + 705/1349 -14 24FEB2013 0 32.0 35.0 - 46.0 L1 + -7 03MAR2013 7 34.0 35.0 - 46.0 L1 + 15 24MAR2013 22 31.0 35.0 - 46.0 L1 + 26 04APR2013 11 29.0 35.0 - 46.0 L2 + 53 01MAY2013 27 28.0 35.0 - 46.0 L2 + 80 28MAY2013 27 28.0 35.0 - 46.0 L2 + 108 25JUN2013 28 33.0 35.0 - 46.0 L1 —————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— NCI CTCAE grade is displayed as abnormal high (H) or low (L) followed by the grade. diff --git a/tests/testthat/_snaps/listing_lbl02a_rls.md b/tests/testthat/_snaps/listing_lbl02a_rls.md index cb0ce46..a3d9bdf 100644 --- a/tests/testthat/_snaps/listing_lbl02a_rls.md +++ b/tests/testthat/_snaps/listing_lbl02a_rls.md @@ -11,56 +11,56 @@ Study Last Dose of from Reference Reference Change Abnormality Treatment Lab Test (Unit) Center/Patient ID Day Study Drug Result Baseline Range Range Dec./Inc. Flag ———————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— - Placebo Alanine Aminotransferase (U/L) 701/1015 -7 0 27.0 0.0 10.0 - 29.0 6 - 34 40% / 40% - 15 22 41.0 51.9 10.0 - 29.0 6 - 34 40% / 40% H - 29 14 18.0 -33.3 10.0 - 29.0 6 - 34 40% / 40% - 42 13 26.0 -3.7 10.0 - 29.0 6 - 34 40% / 40% - 63 21 22.0 -18.5 10.0 - 29.0 6 - 34 40% / 40% - 84 21 27.0 0.0 10.0 - 29.0 6 - 34 40% / 40% - 126 42 17.0 -37.0 10.0 - 29.0 6 - 34 40% / 40% - 140 14 21.0 -22.2 10.0 - 29.0 6 - 34 40% / 40% - 168 28 23.0 -14.8 10.0 - 29.0 6 - 34 40% / 40% - 182 14 23.0 -14.8 10.0 - 29.0 6 - 34 40% / 40% - 701/1023 -14 0 23.0 0.0 10.0 - 29.0 6 - 43 40% / 40% - 23 37 30.0 30.4 10.0 - 29.0 6 - 43 40% / 40% - 29 6 38.0 65.2 10.0 - 29.0 6 - 43 40% / 40% - 701/1047 -21 0 22.0 0.0 10.0 - 29.0 6 - 32 40% / 40% - 14 35 16.0 -27.3 10.0 - 29.0 6 - 32 40% / 40% - 27 13 20.0 -9.1 10.0 - 29.0 6 - 32 40% / 40% - 55 28 17.0 -22.7 10.0 - 29.0 6 - 32 40% / 40% - 701/1118 -13 0 15.0 0.0 10.0 - 29.0 6 - 43 40% / 40% - 15 28 7.0 -53.3 10.0 - 29.0 6 - 43 40% / 40% - 29 14 15.0 0.0 10.0 - 29.0 6 - 43 40% / 40% - 43 14 11.0 -26.7 10.0 - 29.0 6 - 43 40% / 40% - 58 15 15.0 0.0 10.0 - 29.0 6 - 43 40% / 40% - 86 28 16.0 6.7 10.0 - 29.0 6 - 43 40% / 40% - 113 27 15.0 0.0 10.0 - 29.0 6 - 43 40% / 40% - 141 28 13.0 -13.3 10.0 - 29.0 6 - 43 40% / 40% - 169 28 13.0 -13.3 10.0 - 29.0 6 - 43 40% / 40% - 182 13 10.0 -33.3 10.0 - 29.0 6 - 43 40% / 40% - 701/1130 -6 0 15.0 0.0 10.0 - 29.0 6 - 35 40% / 40% - 15 21 14.0 -6.7 10.0 - 29.0 6 - 35 40% / 40% - 29 14 18.0 20.0 10.0 - 29.0 6 - 35 40% / 40% - 43 14 13.0 -13.3 10.0 - 29.0 6 - 35 40% / 40% - 57 14 10.0 -33.3 10.0 - 29.0 6 - 35 40% / 40% - 91 34 13.0 -13.3 10.0 - 29.0 6 - 35 40% / 40% - 113 22 12.0 -20.0 10.0 - 29.0 6 - 35 40% / 40% - 138 25 11.0 -26.7 10.0 - 29.0 6 - 35 40% / 40% - 169 31 13.0 -13.3 10.0 - 29.0 6 - 35 40% / 40% - 183 14 10.0 -33.3 10.0 - 29.0 6 - 35 40% / 40% - 701/1153 -17 0 13.0 0.0 10.0 - 29.0 6 - 32 40% / 40% - 16 33 14.0 7.7 10.0 - 29.0 6 - 32 40% / 40% - 27 11 14.0 7.7 10.0 - 29.0 6 - 32 40% / 40% - 43 16 14.0 7.7 10.0 - 29.0 6 - 32 40% / 40% - 57 14 11.0 -15.4 10.0 - 29.0 6 - 32 40% / 40% - 85 28 13.0 0.0 10.0 - 29.0 6 - 32 40% / 40% - 108 23 17.0 30.8 10.0 - 29.0 6 - 32 40% / 40% - 142 34 14.0 7.7 10.0 - 29.0 6 - 32 40% / 40% - 170 28 13.0 0.0 10.0 - 29.0 6 - 32 40% / 40% - 191 21 14.0 7.7 10.0 - 29.0 6 - 32 40% / 40% - 701/1203 -8 0 13.0 0.0 10.0 - 29.0 6 - 32 40% / 40% - 22 30 14.0 7.7 10.0 - 29.0 6 - 32 40% / 40% - 29 7 10.0 -23.1 10.0 - 29.0 6 - 32 40% / 40% + Placebo Alanine Aminotransferase (U/L) 701/1015 -7 0 27.0 0.0 10.0 - 29.0 6 - 34 40% / 40% + 15 22 41.0 51.9 10.0 - 29.0 6 - 34 40% / 40% HH + 29 14 18.0 -33.3 10.0 - 29.0 6 - 34 40% / 40% + 42 13 26.0 -3.7 10.0 - 29.0 6 - 34 40% / 40% + 63 21 22.0 -18.5 10.0 - 29.0 6 - 34 40% / 40% + 84 21 27.0 0.0 10.0 - 29.0 6 - 34 40% / 40% + 126 42 17.0 -37.0 10.0 - 29.0 6 - 34 40% / 40% + 140 14 21.0 -22.2 10.0 - 29.0 6 - 34 40% / 40% + 168 28 23.0 -14.8 10.0 - 29.0 6 - 34 40% / 40% + 182 14 23.0 -14.8 10.0 - 29.0 6 - 34 40% / 40% + 701/1023 -14 0 23.0 0.0 10.0 - 29.0 6 - 43 40% / 40% + 23 37 30.0 30.4 10.0 - 29.0 6 - 43 40% / 40% + 29 6 38.0 65.2 10.0 - 29.0 6 - 43 40% / 40% + 701/1047 -21 0 22.0 0.0 10.0 - 29.0 6 - 32 40% / 40% + 14 35 16.0 -27.3 10.0 - 29.0 6 - 32 40% / 40% + 27 13 20.0 -9.1 10.0 - 29.0 6 - 32 40% / 40% + 55 28 17.0 -22.7 10.0 - 29.0 6 - 32 40% / 40% + 701/1118 -13 0 15.0 0.0 10.0 - 29.0 6 - 43 40% / 40% + 15 28 7.0 -53.3 10.0 - 29.0 6 - 43 40% / 40% + 29 14 15.0 0.0 10.0 - 29.0 6 - 43 40% / 40% + 43 14 11.0 -26.7 10.0 - 29.0 6 - 43 40% / 40% + 58 15 15.0 0.0 10.0 - 29.0 6 - 43 40% / 40% + 86 28 16.0 6.7 10.0 - 29.0 6 - 43 40% / 40% + 113 27 15.0 0.0 10.0 - 29.0 6 - 43 40% / 40% + 141 28 13.0 -13.3 10.0 - 29.0 6 - 43 40% / 40% + 169 28 13.0 -13.3 10.0 - 29.0 6 - 43 40% / 40% + 182 13 10.0 -33.3 10.0 - 29.0 6 - 43 40% / 40% + 701/1130 -6 0 15.0 0.0 10.0 - 29.0 6 - 35 40% / 40% + 15 21 14.0 -6.7 10.0 - 29.0 6 - 35 40% / 40% + 29 14 18.0 20.0 10.0 - 29.0 6 - 35 40% / 40% + 43 14 13.0 -13.3 10.0 - 29.0 6 - 35 40% / 40% + 57 14 10.0 -33.3 10.0 - 29.0 6 - 35 40% / 40% + 91 34 13.0 -13.3 10.0 - 29.0 6 - 35 40% / 40% + 113 22 12.0 -20.0 10.0 - 29.0 6 - 35 40% / 40% + 138 25 11.0 -26.7 10.0 - 29.0 6 - 35 40% / 40% + 169 31 13.0 -13.3 10.0 - 29.0 6 - 35 40% / 40% + 183 14 10.0 -33.3 10.0 - 29.0 6 - 35 40% / 40% + 701/1153 -17 0 13.0 0.0 10.0 - 29.0 6 - 32 40% / 40% + 16 33 14.0 7.7 10.0 - 29.0 6 - 32 40% / 40% + 27 11 14.0 7.7 10.0 - 29.0 6 - 32 40% / 40% + 43 16 14.0 7.7 10.0 - 29.0 6 - 32 40% / 40% + 57 14 11.0 -15.4 10.0 - 29.0 6 - 32 40% / 40% + 85 28 13.0 0.0 10.0 - 29.0 6 - 32 40% / 40% + 108 23 17.0 30.8 10.0 - 29.0 6 - 32 40% / 40% + 142 34 14.0 7.7 10.0 - 29.0 6 - 32 40% / 40% + 170 28 13.0 0.0 10.0 - 29.0 6 - 32 40% / 40% + 191 21 14.0 7.7 10.0 - 29.0 6 - 32 40% / 40% + 701/1203 -8 0 13.0 0.0 10.0 - 29.0 6 - 32 40% / 40% + 22 30 14.0 7.7 10.0 - 29.0 6 - 32 40% / 40% + 29 7 10.0 -23.1 10.0 - 29.0 6 - 32 40% / 40% ———————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— Standard reference range, marked reference range and clinically relevant change from baseline are from the Roche Safety Lab Standardization guideline. Abnormalities are flagged as high (H) or low (L) if outside the standard reference range; high high (HH) or low low (LL) if outside the marked reference range with a clinically relevant change from baseline. diff --git a/tests/testthat/_snaps/listing_lbl02b.md b/tests/testthat/_snaps/listing_lbl02b.md index aa2dcf7..34fc3f2 100644 --- a/tests/testthat/_snaps/listing_lbl02b.md +++ b/tests/testthat/_snaps/listing_lbl02b.md @@ -5,62 +5,62 @@ Output Listing of Laboratory Abnormalities Defined by NCI CTCAE Grade >= 2 - ——————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— - Days Since NCI - Study Last Dose of Lab Normal CTCAE - Treatment Lab Test Center/Patient ID Day Date Study Drug Result Unit Range Grade - ——————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— - Placebo Alanine Aminotransferase 705/1186 16 23JAN2014 0 104.0 U/L 6.0 - 32.0 H2 - 22 29JAN2014 6 107.0 U/L 6.0 - 32.0 H2 - 708/1286 167 23FEB2014 0 124.0 U/L 6.0 - 32.0 H2 - Albumin 705/1349 26 04APR2013 0 29.0 g/dL 35.0 - 46.0 L2 - 53 01MAY2013 27 28.0 g/dL 35.0 - 46.0 L2 - 80 28MAY2013 27 28.0 g/dL 35.0 - 46.0 L2 - 136 23JUL2013 56 26.0 g/dL 35.0 - 46.0 L2 - 708/1286 167 23FEB2014 0 29.0 g/dL 35.0 - 46.0 L2 - Alkaline Phosphatase 705/1186 -5 03JAN2014 0 565.0 U/L 35.0 - 115.0 H2 - 16 23JAN2014 21 672.0 U/L 35.0 - 115.0 H3 - 19 26JAN2014 3 601.0 U/L 35.0 - 115.0 H3 - 22 29JAN2014 3 657.0 U/L 35.0 - 115.0 H3 - 25 01FEB2014 3 651.0 U/L 35.0 - 115.0 H3 - 31 07FEB2014 6 686.0 U/L 35.0 - 115.0 H3 - 709/1339 168 08JUN2013 0 499.0 U/L 35.0 - 115.0 H2 - 184 24JUN2013 16 624.0 U/L 35.0 - 115.0 H3 - Anisocytes 701/1015 -7 26DEC2013 0 1.0 NO UNITS NA - NA NA - 701/1234 -10 20MAR2013 0 1.0 NO UNITS NA - NA NA - 701/1415 28 20OCT2013 0 1.0 NO UNITS NA - NA NA - 703/1042 27 28MAR2013 0 1.0 NO UNITS NA - NA NA - 704/1164 180 17MAR2013 0 1.0 NO UNITS NA - NA NA - 198 04APR2013 18 1.0 NO UNITS NA - NA NA - 704/1233 113 11JUL2013 0 1.0 NO UNITS NA - NA NA - 704/1351 -16 26SEP2013 0 1.0 NO UNITS NA - NA NA - -9 03OCT2013 7 1.0 NO UNITS NA - NA NA - 704/1388 27 02JAN2013 0 1.0 NO UNITS NA - NA NA - 55 30JAN2013 28 1.0 NO UNITS NA - NA NA - 83 27FEB2013 28 1.0 NO UNITS NA - NA NA - 143 28APR2013 60 1.0 NO UNITS NA - NA NA - 704/1445 15 25MAY2014 0 1.0 NO UNITS NA - NA NA - 705/1059 -3 02AUG2013 0 1.0 NO UNITS NA - NA NA - 123 05DEC2013 126 1.0 NO UNITS NA - NA NA - 705/1186 31 07FEB2014 0 1.0 NO UNITS NA - NA NA - 705/1349 80 28MAY2013 0 1.0 NO UNITS NA - NA NA - 183 08SEP2013 103 1.0 NO UNITS NA - NA NA - 706/1041 43 11FEB2014 0 1.0 NO UNITS NA - NA NA - 708/1087 118 16FEB2013 0 1.0 NO UNITS NA - NA NA - 708/1342 41 07FEB2013 0 1.0 NO UNITS NA - NA NA - 57 23FEB2013 16 1.0 NO UNITS NA - NA NA - 709/1259 28 22FEB2013 0 1.0 NO UNITS NA - NA NA - 709/1301 141 06DEC2013 0 1.0 NO UNITS NA - NA NA - 710/1027 56 24APR2014 0 1.0 NO UNITS NA - NA NA - 710/1271 43 08NOV2012 0 1.0 NO UNITS NA - NA NA - 710/1368 85 15JAN2014 0 1.0 NO UNITS NA - NA NA - 713/1256 57 14NOV2012 0 1.0 NO UNITS NA - NA NA - 85 12DEC2012 28 1.0 NO UNITS NA - NA NA - 138 03FEB2013 53 1.0 NO UNITS NA - NA NA - 172 09MAR2013 34 1.0 NO UNITS NA - NA NA - 714/1035 40 26MAY2014 0 1.0 NO UNITS NA - NA NA - 49 04JUN2014 9 1.0 NO UNITS NA - NA NA - ——————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— + —————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— + Days Since NCI + Study Last Dose of Lab Normal CTCAE + Treatment Lab Test Center/Patient ID Day Date Study Drug Result Unit Range Grade + —————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— + Placebo Alanine Aminotransferase 705/1186 16 23JAN2014 0 104.0 U/L 6.0 - 32.0 H2 + 22 29JAN2014 6 107.0 U/L 6.0 - 32.0 H2 + 708/1286 167 23FEB2014 0 124.0 U/L 6.0 - 32.0 H2 + Albumin 705/1349 26 04APR2013 0 29.0 g/dL 35.0 - 46.0 L2 + 53 01MAY2013 27 28.0 g/dL 35.0 - 46.0 L2 + 80 28MAY2013 27 28.0 g/dL 35.0 - 46.0 L2 + 136 23JUL2013 56 26.0 g/dL 35.0 - 46.0 L2 + 708/1286 167 23FEB2014 0 29.0 g/dL 35.0 - 46.0 L2 + Alkaline Phosphatase 705/1186 -5 03JAN2014 0 565.0 U/L 35.0 - 115.0 H2 + 16 23JAN2014 21 672.0 U/L 35.0 - 115.0 H3 + 19 26JAN2014 3 601.0 U/L 35.0 - 115.0 H3 + 22 29JAN2014 3 657.0 U/L 35.0 - 115.0 H3 + 25 01FEB2014 3 651.0 U/L 35.0 - 115.0 H3 + 31 07FEB2014 6 686.0 U/L 35.0 - 115.0 H3 + 709/1339 168 08JUN2013 0 499.0 U/L 35.0 - 115.0 H2 + 184 24JUN2013 16 624.0 U/L 35.0 - 115.0 H3 + Aspartate Aminotransferase 705/1186 16 23JAN2014 0 118.0 U/L 9.0 - 34.0 H2 + 19 26JAN2014 3 115.0 U/L 9.0 - 34.0 H2 + 22 29JAN2014 3 135.0 U/L 9.0 - 34.0 H2 + 25 01FEB2014 3 114.0 U/L 9.0 - 34.0 H2 + 708/1286 167 23FEB2014 0 168.0 U/L 9.0 - 34.0 H2 + Bilirubin 701/1363 168 13NOV2013 0 NA mg/dL 3.0 - 21.0 NA + 705/1186 16 23JAN2014 0 116.3 mg/dL 3.0 - 21.0 H3 + 19 26JAN2014 3 124.8 mg/dL 3.0 - 21.0 H3 + 22 29JAN2014 3 124.8 mg/dL 3.0 - 21.0 H3 + 25 01FEB2014 3 99.2 mg/dL 3.0 - 21.0 H3 + 31 07FEB2014 6 71.8 mg/dL 3.0 - 21.0 H3 + 711/1036 169 13JAN2013 0 NA mg/dL 3.0 - 21.0 NA + Blood Urea Nitrogen 701/1130 29 15MAR2014 0 9.3 mg/dL 1.4 - 8.6 HNA + 91 16MAY2014 62 8.9 mg/dL 1.4 - 8.6 HNA + 701/1415 183 24MAR2014 0 8.9 mg/dL 1.4 - 8.6 HNA + 703/1100 31 12APR2013 0 8.9 mg/dL 1.4 - 8.6 HNA + 705/1059 60 03OCT2013 0 8.9 mg/dL 1.4 - 8.6 HNA + 123 05DEC2013 63 10.4 mg/dL 1.4 - 8.6 HNA + 707/1206 112 16FEB2014 0 8.9 mg/dL 1.4 - 8.6 HNA + 709/1001 113 28JAN2014 0 10.0 mg/dL 1.4 - 8.6 HNA + 141 25FEB2014 28 8.9 mg/dL 1.4 - 8.6 HNA + 710/1027 -25 03FEB2014 0 8.9 mg/dL 1.4 - 8.6 HNA + 173 19AUG2014 198 8.9 mg/dL 1.4 - 8.6 HNA + 710/1077 68 23JAN2014 0 8.9 mg/dL 1.4 - 8.6 HNA + 710/1078 -11 06SEP2013 0 8.9 mg/dL 1.4 - 8.6 HNA + 20 06OCT2013 31 10.4 mg/dL 1.4 - 8.6 HNA + 34 20OCT2013 14 8.9 mg/dL 1.4 - 8.6 HNA + 48 03NOV2013 14 10.7 mg/dL 1.4 - 8.6 HNA + 146 09FEB2014 98 10.0 mg/dL 1.4 - 8.6 HNA + 188 23MAR2014 42 9.6 mg/dL 1.4 - 8.6 HNA + 710/1183 -23 24OCT2013 0 9.3 mg/dL 1.4 - 8.6 HNA + 715/1397 113 24JUL2013 0 9.3 mg/dL 1.4 - 8.6 HNA + 141 21AUG2013 28 8.9 mg/dL 1.4 - 8.6 HNA + 169 18SEP2013 28 9.6 mg/dL 1.4 - 8.6 HNA + —————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— NCI CTCAE grade is displayed as abnormal high (H) or low (L) followed by the grade. diff --git a/tests/testthat/_snaps/table_aet01.md b/tests/testthat/_snaps/table_aet01.md index 23c31ef..604846d 100644 --- a/tests/testthat/_snaps/table_aet01.md +++ b/tests/testthat/_snaps/table_aet01.md @@ -6,22 +6,22 @@ Placebo Xanomeline High Dose Xanomeline Low Dose (N=86) (N=72) (N=96) ———————————————————————————————————————————————————————————————————————————————————————————————————————————————————— - Total number of patients with at least one AE 69 (80.2%) 70 (97.2%) 86 (89.6%) - Total number of AEs 301 436 454 + Total number of patients with at least one AE 37 (43.0%) 61 (84.7%) 64 (66.7%) + Total number of AEs 75 197 181 Total number of deaths 2 (2.3%) 0 1 (1.0%) Total number of patients withdrawn from study due to an AE 9 (10.5%) 5 (6.9%) 10 (10.4%) Total number of patients with at least one - AE with fatal outcome 2 (2.3%) 5 (6.9%) 7 (7.3%) - Serious AE 0 1 (1.4%) 2 (2.1%) + AE with fatal outcome 2 (2.3%) 2 (2.8%) 2 (2.1%) + Serious AE 0 0 0 Serious AE leading to withdrawal from treatment 0 0 0 - Serious AE leading to dose modification/interruption 0 0 1 (1.0%) + Serious AE leading to dose modification/interruption 0 0 0 Related Serious AE 0 0 0 - AE leading to withdrawal from treatment 23 (26.7%) 20 (27.8%) 16 (16.7%) - AE leading to dose modification/interruption 49 (57.0%) 57 (79.2%) 64 (66.7%) + AE leading to withdrawal from treatment 6 (7.0%) 10 (13.9%) 10 (10.4%) + AE leading to dose modification/interruption 16 (18.6%) 35 (48.6%) 34 (35.4%) Related AE 0 0 0 Related AE leading to withdrawal from treatment 0 0 0 Related AE leading to dose modification/interruption 0 0 0 - Severe AE (at greatest intensity) 7 (8.1%) 8 (11.1%) 16 (16.7%) + Severe AE (at greatest intensity) 2 (2.3%) 2 (2.8%) 8 (8.3%) # Safety Summary Variant 2 (with Medical Concepts Section) works as expected @@ -31,22 +31,22 @@ Placebo Xanomeline High Dose Xanomeline Low Dose (N=86) (N=72) (N=96) ———————————————————————————————————————————————————————————————————————————————————————————————————————————————————— - Total number of patients with at least one AE 69 (80.2%) 70 (97.2%) 86 (89.6%) - Total number of AEs 301 436 454 + Total number of patients with at least one AE 37 (43.0%) 61 (84.7%) 64 (66.7%) + Total number of AEs 75 197 181 Total number of deaths 2 (2.3%) 0 1 (1.0%) Total number of patients withdrawn from study due to an AE 9 (10.5%) 5 (6.9%) 10 (10.4%) Total number of patients with at least one - AE with fatal outcome 2 (2.3%) 5 (6.9%) 7 (7.3%) - Serious AE 0 1 (1.4%) 2 (2.1%) + AE with fatal outcome 2 (2.3%) 2 (2.8%) 2 (2.1%) + Serious AE 0 0 0 Serious AE leading to withdrawal from treatment 0 0 0 - Serious AE leading to dose modification/interruption 0 0 1 (1.0%) + Serious AE leading to dose modification/interruption 0 0 0 Related Serious AE 0 0 0 - AE leading to withdrawal from treatment 23 (26.7%) 20 (27.8%) 16 (16.7%) - AE leading to dose modification/interruption 49 (57.0%) 57 (79.2%) 64 (66.7%) + AE leading to withdrawal from treatment 6 (7.0%) 10 (13.9%) 10 (10.4%) + AE leading to dose modification/interruption 16 (18.6%) 35 (48.6%) 34 (35.4%) Related AE 0 0 0 Related AE leading to withdrawal from treatment 0 0 0 Related AE leading to dose modification/interruption 0 0 0 - Grade 3-5 AE 23 (26.7%) 33 (45.8%) 32 (33.3%) + Grade 3-5 AE 8 (9.3%) 14 (19.4%) 16 (16.7%) Total number of patients with at least one SMQ01 (BROAD) 4 (4.7%) 10 (13.9%) 6 (6.2%) SMQ02 (NARROW) 3 (3.5%) 5 (6.9%) 6 (6.2%) @@ -60,18 +60,18 @@ Placebo Xanomeline High Dose Xanomeline Low Dose (N=86) (N=72) (N=96) ———————————————————————————————————————————————————————————————————————————————————————————————————————————————————— - Total number of patients with at least one AE 69 (80.2%) 70 (97.2%) 86 (89.6%) - Total number of AEs 301 436 454 + Total number of patients with at least one AE 37 (43.0%) 61 (84.7%) 64 (66.7%) + Total number of AEs 75 197 181 Total number of deaths 2 (2.3%) 0 1 (1.0%) Total number of patients withdrawn from study due to an AE 9 (10.5%) 5 (6.9%) 10 (10.4%) Total number of patients withdrawn informed consent 0 0 0 Total number of patients with at least one - AE with fatal outcome 2 (2.3%) 5 (6.9%) 7 (7.3%) - Serious AE 0 1 (1.4%) 2 (2.1%) - AE leading to withdrawal from treatment 23 (26.7%) 20 (27.8%) 16 (16.7%) + AE with fatal outcome 2 (2.3%) 2 (2.8%) 2 (2.1%) + Serious AE 0 0 0 + AE leading to withdrawal from treatment 6 (7.0%) 10 (13.9%) 10 (10.4%) Related AE 0 0 0 - Grade 3-5 AE 23 (26.7%) 33 (45.8%) 32 (33.3%) - Grade 4/5 AE 15 (17.4%) 17 (23.6%) 21 (21.9%) + Grade 3-5 AE 8 (9.3%) 14 (19.4%) 16 (16.7%) + Grade 4/5 AE 6 (7.0%) 7 (9.7%) 11 (11.5%) # Safety Summary Variant 4 (with Rows Counting Events and Additional Sections) works as expected @@ -81,27 +81,27 @@ Placebo Xanomeline High Dose Xanomeline Low Dose (N=86) (N=72) (N=96) ———————————————————————————————————————————————————————————————————————————————————————————————————————————————————— - Total number of patients with at least one AE 69 (80.2%) 70 (97.2%) 86 (89.6%) - Total number of AEs 301 436 454 + Total number of patients with at least one AE 37 (43.0%) 61 (84.7%) 64 (66.7%) + Total number of AEs 75 197 181 Total number of deaths 2 (2.3%) 0 1 (1.0%) Total number of patients withdrawn from study due to an AE 9 (10.5%) 5 (6.9%) 10 (10.4%) Total number of patients with at least one - AE with fatal outcome 2 (2.3%) 5 (6.9%) 7 (7.3%) - Serious AE 0 1 (1.4%) 2 (2.1%) - AE leading to withdrawal from treatment 23 (26.7%) 20 (27.8%) 16 (16.7%) - AE leading to dose modification/interruption 49 (57.0%) 57 (79.2%) 64 (66.7%) + AE with fatal outcome 2 (2.3%) 2 (2.8%) 2 (2.1%) + Serious AE 0 0 0 + AE leading to withdrawal from treatment 6 (7.0%) 10 (13.9%) 10 (10.4%) + AE leading to dose modification/interruption 16 (18.6%) 35 (48.6%) 34 (35.4%) Related AE 0 0 0 - Grade 3-5 AE 23 (26.7%) 33 (45.8%) 32 (33.3%) + Grade 3-5 AE 8 (9.3%) 14 (19.4%) 16 (16.7%) Total number of unique preferred terms which are - Serious AE 0 1 1 - AE leading to dose modification/interruption 50 49 72 + Serious AE 0 0 0 + AE leading to dose modification/interruption 9 10 10 Related AE 0 0 0 - Grade 3-5 AE 26 27 27 - Grade 4/5 AE 14 14 18 + Grade 3-5 AE 7 7 8 + Grade 4/5 AE 4 4 8 Total number of adverse events which are - Serious AE 0 1 2 - AE leading to dose modification/interruption 82 117 122 + Serious AE 0 0 0 + AE leading to dose modification/interruption 21 52 48 Related AE 0 0 0 - Grade 3-5 AE 31 41 41 - Grade 4/5 AE 18 18 22 + Grade 3-5 AE 11 16 19 + Grade 4/5 AE 7 7 11 diff --git a/tests/testthat/_snaps/table_aet01_aesi.md b/tests/testthat/_snaps/table_aet01_aesi.md index dd5b98c..b987c4c 100644 --- a/tests/testthat/_snaps/table_aet01_aesi.md +++ b/tests/testthat/_snaps/table_aet01_aesi.md @@ -6,20 +6,20 @@ Placebo Xanomeline High Dose Xanomeline Low Dose (N=86) (N=72) (N=96) ——————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— - Total number of patients with at least one AE 69 (80.2%) 70 (97.2%) 86 (89.6%) - Total number of AEs 301 436 454 + Total number of patients with at least one AE 37 (43.0%) 61 (84.7%) 64 (66.7%) + Total number of AEs 75 197 181 Total number of patients with at least one AE by worst grade - Grade 1 22 (25.6%) 18 (25.0%) 19 (19.8%) - Grade 2 24 (27.9%) 19 (26.4%) 35 (36.5%) - Grade 3 8 (9.3%) 16 (22.2%) 11 (11.5%) - Grade 4 12 (14.0%) 16 (22.2%) 19 (19.8%) - Grade 5 (fatal outcome) 3 (3.5%) 1 (1.4%) 2 (2.1%) + Grade 1 16 (18.6%) 28 (38.9%) 30 (31.2%) + Grade 2 13 (15.1%) 19 (26.4%) 18 (18.8%) + Grade 3 2 (2.3%) 7 (9.7%) 5 (5.2%) + Grade 4 5 (5.8%) 6 (8.3%) 9 (9.4%) + Grade 5 (fatal outcome) 1 (1.2%) 1 (1.4%) 2 (2.1%) Total number of patients with study drug withdrawn due to AE 0 0 0 Total number of patients with dose modified/interrupted due to AE 0 0 0 - Total number of patients with treatment received for AE 69 (80.2%) 70 (97.2%) 86 (89.6%) - Total number of patients with all non-fatal AEs resolved 6 (7.0%) 3 (4.2%) 6 (6.2%) - Total number of patients with at least one unresolved or ongoing non-fatal AE 63 (73.3%) 67 (93.1%) 80 (83.3%) - Total number of patients with at least one serious AE 0 1 (1.4%) 2 (2.1%) + Total number of patients with treatment received for AE 37 (43.0%) 61 (84.7%) 64 (66.7%) + Total number of patients with all non-fatal AEs resolved 7 (8.1%) 1 (1.4%) 4 (4.2%) + Total number of patients with at least one unresolved or ongoing non-fatal AE 30 (34.9%) 60 (83.3%) 60 (62.5%) + Total number of patients with at least one serious AE 0 0 0 Total number of patients with at least one related AE 0 0 0 # AET01_AESI Variant 2 works as expected @@ -30,29 +30,29 @@ Placebo Xanomeline High Dose Xanomeline Low Dose (N=86) (N=72) (N=96) —————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— - Total number of patients with at least one AE 69 (80.2%) 70 (97.2%) 86 (89.6%) - Total number of AEs 301 436 454 + Total number of patients with at least one AE 37 (43.0%) 61 (84.7%) 64 (66.7%) + Total number of AEs 75 197 181 Total number of patients with at least one AE by worst grade - Grade 1 22 (25.6%) 18 (25.0%) 19 (19.8%) - Grade 2 24 (27.9%) 19 (26.4%) 35 (36.5%) - Grade 3 8 (9.3%) 16 (22.2%) 11 (11.5%) - Grade 4 12 (14.0%) 16 (22.2%) 19 (19.8%) - Grade 5 (fatal outcome) 3 (3.5%) 1 (1.4%) 2 (2.1%) + Grade 1 16 (18.6%) 28 (38.9%) 30 (31.2%) + Grade 2 13 (15.1%) 19 (26.4%) 18 (18.8%) + Grade 3 2 (2.3%) 7 (9.7%) 5 (5.2%) + Grade 4 5 (5.8%) 6 (8.3%) 9 (9.4%) + Grade 5 (fatal outcome) 1 (1.2%) 1 (1.4%) 2 (2.1%) Total number of patients with study drug withdrawn due to AE 0 0 0 Total number of patients with dose modified/interrupted due to AE 0 0 0 - Total number of patients with treatment received for AE 69 (80.2%) 70 (97.2%) 86 (89.6%) - Total number of patients with all non-fatal AEs resolved 6 (7.0%) 3 (4.2%) 6 (6.2%) + Total number of patients with treatment received for AE 37 (43.0%) 61 (84.7%) 64 (66.7%) + Total number of patients with all non-fatal AEs resolved 7 (8.1%) 1 (1.4%) 4 (4.2%) No. of patients with study drug withdrawn due to resolved AE 0 0 0 No. of patients with dose modified/interrupted due to resolved AE 0 0 0 - No. of patients with treatment received for resolved AE 6 (7.0%) 3 (4.2%) 6 (6.2%) - Total number of patients with at least one unresolved or ongoing non-fatal AE 63 (73.3%) 67 (93.1%) 80 (83.3%) + No. of patients with treatment received for resolved AE 7 (8.1%) 1 (1.4%) 4 (4.2%) + Total number of patients with at least one unresolved or ongoing non-fatal AE 30 (34.9%) 60 (83.3%) 60 (62.5%) No. of patients with study drug withdrawn due to unresolved or ongoing AE 0 0 0 No. of patients with dose modified/interrupted due to unresolved or ongoing AE 0 0 0 - No. of patients with treatment received for unresolved or ongoing AE 63 (73.3%) 67 (93.1%) 80 (83.3%) - Total number of patients with at least one serious AE 0 1 (1.4%) 2 (2.1%) + No. of patients with treatment received for unresolved or ongoing AE 30 (34.9%) 60 (83.3%) 60 (62.5%) + Total number of patients with at least one serious AE 0 0 0 No. of patients with study drug withdrawn due to serious AE 0 0 0 No. of patients with treatment received for serious AE 0 0 0 - No. of patients with dose modified/interrupted due to serious AE 0 1 (1.4%) 2 (2.1%) + No. of patients with dose modified/interrupted due to serious AE 0 0 0 Total number of patients with at least one related AE 0 0 0 No. of patients with study drug withdrawn due to related AE 0 0 0 No. of patients with dose modified/interrupted due to related AE 0 0 0 @@ -67,37 +67,37 @@ Placebo Xanomeline High Dose Xanomeline Low Dose (N=86) (N=72) (N=96) ———————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— - Total number of patients with at least one AE 69 (80.2%) 70 (97.2%) 86 (89.6%) - Total number of AEs 301 436 454 + Total number of patients with at least one AE 37 (43.0%) 61 (84.7%) 64 (66.7%) + Total number of AEs 75 197 181 Total number of patients with at least one AE by worst grade - Grade 1 22 (25.6%) 18 (25.0%) 19 (19.8%) - Grade 2 24 (27.9%) 19 (26.4%) 35 (36.5%) - Grade 3 8 (9.3%) 16 (22.2%) 11 (11.5%) - Grade 4 12 (14.0%) 16 (22.2%) 19 (19.8%) - Grade 5 (fatal outcome) 3 (3.5%) 1 (1.4%) 2 (2.1%) + Grade 1 16 (18.6%) 28 (38.9%) 30 (31.2%) + Grade 2 13 (15.1%) 19 (26.4%) 18 (18.8%) + Grade 3 2 (2.3%) 7 (9.7%) 5 (5.2%) + Grade 4 5 (5.8%) 6 (8.3%) 9 (9.4%) + Grade 5 (fatal outcome) 1 (1.2%) 1 (1.4%) 2 (2.1%) Total number of patients with study drug 1 withdrawn due to AE 0 0 0 Total number of patients with study drug 2 withdrawn due to AE 0 0 0 Total number of patients with dose of study drug 1 modified/interrupted due to AE 0 0 0 Total number of patients with dose of study drug 2 modified/interrupted due to AE 0 0 0 - Total number of patients with treatment received for AE 69 (80.2%) 70 (97.2%) 86 (89.6%) - Total number of patients with all non-fatal AEs resolved 6 (7.0%) 3 (4.2%) 6 (6.2%) + Total number of patients with treatment received for AE 37 (43.0%) 61 (84.7%) 64 (66.7%) + Total number of patients with all non-fatal AEs resolved 7 (8.1%) 1 (1.4%) 4 (4.2%) No. of patients with study drug 1 withdrawn due to resolved AE 0 0 0 No. of patients with study drug 2 withdrawn due to resolved AE 0 0 0 No. of patients with dose of study drug 1 modified/interrupted due to resolved AE 0 0 0 No. of patients with dose of study drug 2 modified/interrupted due to resolved AE 0 0 0 - No. of patients with treatment received for resolved AE 6 (7.0%) 3 (4.2%) 6 (6.2%) - Total number of patients with at least one non-fatal unresolved or ongoing AE 63 (73.3%) 67 (93.1%) 80 (83.3%) + No. of patients with treatment received for resolved AE 7 (8.1%) 1 (1.4%) 4 (4.2%) + Total number of patients with at least one non-fatal unresolved or ongoing AE 30 (34.9%) 60 (83.3%) 60 (62.5%) No. of patients with study drug 1 withdrawn due to unresolved or ongoing AE 0 0 0 No. of patients with study drug 2 withdrawn due to unresolved or ongoing AE 0 0 0 No. of patients with dose of study drug 1 modified/interrupted due to unresolved or ongoing AE 0 0 0 No. of patients with dose of study drug 2 modified/interrupted due to unresolved or ongoing AE 0 0 0 - No. of patients with treatment received for unresolved or ongoing AE 63 (73.3%) 67 (93.1%) 80 (83.3%) - Total number of patients with at least one serious AE 0 1 (1.4%) 2 (2.1%) + No. of patients with treatment received for unresolved or ongoing AE 30 (34.9%) 60 (83.3%) 60 (62.5%) + Total number of patients with at least one serious AE 0 0 0 No. of patients with study drug 1 withdrawn due to serious AE 0 0 0 No. of patients with study drug 2 withdrawn due to serious AE 0 0 0 No. of patients with dose of study drug 1 modified/interrupted due to serious AE 0 0 0 No. of patients with dose of study drug 2 modified/interrupted due to serious AE 0 0 0 - No. of patients with treatment received for serious AE 0 1 (1.4%) 2 (2.1%) + No. of patients with treatment received for serious AE 0 0 0 Total number of patients with at least one AE related to study drug 1 0 0 0 No. of patients with study drug 1 withdrawn due to AE related to study drug 1 0 0 0 No. of patients with study drug 1 withdrawn due to AE related to study drug 2 0 0 0 diff --git a/tests/testthat/_snaps/table_aet02.md b/tests/testthat/_snaps/table_aet02.md index 224ca03..32aaa27 100644 --- a/tests/testthat/_snaps/table_aet02.md +++ b/tests/testthat/_snaps/table_aet02.md @@ -3,1693 +3,160 @@ Code res Output - MedDRA System Organ Class Placebo Xanomeline High Dose Xanomeline Low Dose All Patients - MedDRA Preferred Term (N=86) (N=72) (N=96) (N=254) - ———————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— - Total number of patients with at least one adverse event 69 (80.2%) 70 (97.2%) 86 (89.6%) 225 (88.6%) - Overall total number of events 301 436 454 1191 - GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - Total number of patients with at least one adverse event 21 (24.4%) 36 (50.0%) 51 (53.1%) 108 (42.5%) - Total number of events 48 118 126 292 - APPLICATION SITE PRURITUS 6 (7.0%) 21 (29.2%) 23 (24.0%) 50 (19.7%) - APPLICATION SITE ERYTHEMA 3 (3.5%) 14 (19.4%) 13 (13.5%) 30 (11.8%) - APPLICATION SITE DERMATITIS 5 (5.8%) 7 (9.7%) 9 (9.4%) 21 (8.3%) - APPLICATION SITE IRRITATION 3 (3.5%) 9 (12.5%) 9 (9.4%) 21 (8.3%) - APPLICATION SITE VESICLES 1 (1.2%) 5 (6.9%) 5 (5.2%) 11 (4.3%) - FATIGUE 1 (1.2%) 5 (6.9%) 5 (5.2%) 11 (4.3%) - OEDEMA PERIPHERAL 2 (2.3%) 2 (2.8%) 1 (1.0%) 5 (2.0%) - APPLICATION SITE SWELLING 0 2 (2.8%) 1 (1.0%) 3 (1.2%) - APPLICATION SITE URTICARIA 0 1 (1.4%) 2 (2.1%) 3 (1.2%) - CHILLS 1 (1.2%) 1 (1.4%) 1 (1.0%) 3 (1.2%) - MALAISE 0 2 (2.8%) 1 (1.0%) 3 (1.2%) - PYREXIA 2 (2.3%) 0 1 (1.0%) 3 (1.2%) - APPLICATION SITE PAIN 0 2 (2.8%) 0 2 (0.8%) - APPLICATION SITE PERSPIRATION 0 2 (2.8%) 0 2 (0.8%) - APPLICATION SITE REACTION 1 (1.2%) 1 (1.4%) 0 2 (0.8%) - ASTHENIA 1 (1.2%) 0 1 (1.0%) 2 (0.8%) - CHEST DISCOMFORT 0 1 (1.4%) 1 (1.0%) 2 (0.8%) - CHEST PAIN 0 2 (2.8%) 0 2 (0.8%) - OEDEMA 0 0 2 (2.1%) 2 (0.8%) - PAIN 0 1 (1.4%) 1 (1.0%) 2 (0.8%) - APPLICATION SITE BLEEDING 0 0 1 (1.0%) 1 (0.4%) - APPLICATION SITE DESQUAMATION 0 0 1 (1.0%) 1 (0.4%) - APPLICATION SITE DISCHARGE 0 1 (1.4%) 0 1 (0.4%) - APPLICATION SITE DISCOLOURATION 0 0 1 (1.0%) 1 (0.4%) - APPLICATION SITE INDURATION 1 (1.2%) 0 0 1 (0.4%) - APPLICATION SITE WARMTH 0 0 1 (1.0%) 1 (0.4%) - CYST 0 0 1 (1.0%) 1 (0.4%) - FEELING ABNORMAL 0 1 (1.4%) 0 1 (0.4%) - FEELING COLD 0 1 (1.4%) 0 1 (0.4%) - INFLAMMATION 0 0 1 (1.0%) 1 (0.4%) - SECRETION DISCHARGE 0 0 1 (1.0%) 1 (0.4%) - SUDDEN DEATH 0 0 1 (1.0%) 1 (0.4%) - SWELLING 0 0 1 (1.0%) 1 (0.4%) - ULCER 0 0 1 (1.0%) 1 (0.4%) - SKIN AND SUBCUTANEOUS TISSUE DISORDERS - Total number of patients with at least one adverse event 21 (24.4%) 42 (58.3%) 42 (43.8%) 105 (41.3%) - Total number of events 47 111 118 276 - PRURITUS 8 (9.3%) 26 (36.1%) 23 (24.0%) 57 (22.4%) - ERYTHEMA 9 (10.5%) 14 (19.4%) 15 (15.6%) 38 (15.0%) - RASH 5 (5.8%) 11 (15.3%) 13 (13.5%) 29 (11.4%) - HYPERHIDROSIS 2 (2.3%) 8 (11.1%) 4 (4.2%) 14 (5.5%) - SKIN IRRITATION 3 (3.5%) 5 (6.9%) 6 (6.2%) 14 (5.5%) - BLISTER 0 1 (1.4%) 5 (5.2%) 6 (2.4%) - RASH PRURITIC 0 2 (2.8%) 1 (1.0%) 3 (1.2%) - PRURITUS GENERALISED 0 1 (1.4%) 1 (1.0%) 2 (0.8%) - RASH ERYTHEMATOUS 0 0 2 (2.1%) 2 (0.8%) - URTICARIA 0 1 (1.4%) 1 (1.0%) 2 (0.8%) - ACTINIC KERATOSIS 0 1 (1.4%) 0 1 (0.4%) - ALOPECIA 1 (1.2%) 0 0 1 (0.4%) - COLD SWEAT 1 (1.2%) 0 0 1 (0.4%) - DERMATITIS ATOPIC 1 (1.2%) 0 0 1 (0.4%) - DERMATITIS CONTACT 0 0 1 (1.0%) 1 (0.4%) - DRUG ERUPTION 1 (1.2%) 0 0 1 (0.4%) - RASH MACULO-PAPULAR 0 1 (1.4%) 0 1 (0.4%) - RASH PAPULAR 0 1 (1.4%) 0 1 (0.4%) - SKIN EXFOLIATION 0 0 1 (1.0%) 1 (0.4%) - SKIN ODOUR ABNORMAL 0 1 (1.4%) 0 1 (0.4%) - SKIN ULCER 1 (1.2%) 0 0 1 (0.4%) - NERVOUS SYSTEM DISORDERS - Total number of patients with at least one adverse event 12 (14.0%) 25 (34.7%) 22 (22.9%) 59 (23.2%) - Total number of events 16 43 42 101 - DIZZINESS 2 (2.3%) 11 (15.3%) 9 (9.4%) 22 (8.7%) - HEADACHE 7 (8.1%) 6 (8.3%) 3 (3.1%) 16 (6.3%) - SYNCOPE 0 2 (2.8%) 5 (5.2%) 7 (2.8%) - SOMNOLENCE 2 (2.3%) 1 (1.4%) 3 (3.1%) 6 (2.4%) - TRANSIENT ISCHAEMIC ATTACK 0 1 (1.4%) 2 (2.1%) 3 (1.2%) - BURNING SENSATION 0 2 (2.8%) 0 2 (0.8%) - LETHARGY 0 1 (1.4%) 1 (1.0%) 2 (0.8%) - AMNESIA 0 1 (1.4%) 0 1 (0.4%) - BALANCE DISORDER 0 0 1 (1.0%) 1 (0.4%) - COGNITIVE DISORDER 0 1 (1.4%) 0 1 (0.4%) - COMPLEX PARTIAL SEIZURES 0 0 1 (1.0%) 1 (0.4%) - COORDINATION ABNORMAL 0 0 1 (1.0%) 1 (0.4%) - HEMIANOPIA HOMONYMOUS 0 0 1 (1.0%) 1 (0.4%) - HYPERSOMNIA 0 1 (1.4%) 0 1 (0.4%) - PARAESTHESIA 0 1 (1.4%) 0 1 (0.4%) - PARAESTHESIA ORAL 0 0 1 (1.0%) 1 (0.4%) - PARKINSON'S DISEASE 1 (1.2%) 0 0 1 (0.4%) - PAROSMIA 0 1 (1.4%) 0 1 (0.4%) - PARTIAL SEIZURES WITH SECONDARY GENERALISATION 0 1 (1.4%) 0 1 (0.4%) - PSYCHOMOTOR HYPERACTIVITY 1 (1.2%) 0 0 1 (0.4%) - STUPOR 0 0 1 (1.0%) 1 (0.4%) - SYNCOPE VASOVAGAL 0 1 (1.4%) 0 1 (0.4%) - GASTROINTESTINAL DISORDERS - Total number of patients with at least one adverse event 17 (19.8%) 20 (27.8%) 16 (16.7%) 53 (20.9%) - Total number of events 26 35 26 87 - DIARRHOEA 9 (10.5%) 3 (4.2%) 6 (6.2%) 18 (7.1%) - VOMITING 3 (3.5%) 6 (8.3%) 4 (4.2%) 13 (5.1%) - NAUSEA 3 (3.5%) 6 (8.3%) 3 (3.1%) 12 (4.7%) - ABDOMINAL PAIN 1 (1.2%) 1 (1.4%) 3 (3.1%) 5 (2.0%) - SALIVARY HYPERSECRETION 0 4 (5.6%) 0 4 (1.6%) - DYSPEPSIA 1 (1.2%) 1 (1.4%) 1 (1.0%) 3 (1.2%) - ABDOMINAL DISCOMFORT 0 1 (1.4%) 0 1 (0.4%) - CONSTIPATION 1 (1.2%) 0 0 1 (0.4%) - DYSPHAGIA 0 0 1 (1.0%) 1 (0.4%) - FLATULENCE 1 (1.2%) 0 0 1 (0.4%) - GASTROINTESTINAL HAEMORRHAGE 0 1 (1.4%) 0 1 (0.4%) - GASTROOESOPHAGEAL REFLUX DISEASE 1 (1.2%) 0 0 1 (0.4%) - GLOSSITIS 1 (1.2%) 0 0 1 (0.4%) - HIATUS HERNIA 1 (1.2%) 0 0 1 (0.4%) - RECTAL HAEMORRHAGE 0 0 1 (1.0%) 1 (0.4%) - STOMACH DISCOMFORT 0 1 (1.4%) 0 1 (0.4%) - CARDIAC DISORDERS - Total number of patients with at least one adverse event 13 (15.1%) 15 (20.8%) 16 (16.7%) 44 (17.3%) - Total number of events 27 30 34 91 - SINUS BRADYCARDIA 2 (2.3%) 8 (11.1%) 7 (7.3%) 17 (6.7%) - MYOCARDIAL INFARCTION 4 (4.7%) 4 (5.6%) 2 (2.1%) 10 (3.9%) - ATRIAL FIBRILLATION 1 (1.2%) 2 (2.8%) 2 (2.1%) 5 (2.0%) - ATRIOVENTRICULAR BLOCK SECOND DEGREE 2 (2.3%) 1 (1.4%) 2 (2.1%) 5 (2.0%) - SUPRAVENTRICULAR EXTRASYSTOLES 1 (1.2%) 1 (1.4%) 1 (1.0%) 3 (1.2%) - VENTRICULAR EXTRASYSTOLES 0 1 (1.4%) 2 (2.1%) 3 (1.2%) - ATRIAL FLUTTER 0 1 (1.4%) 1 (1.0%) 2 (0.8%) - ATRIOVENTRICULAR BLOCK FIRST DEGREE 1 (1.2%) 0 1 (1.0%) 2 (0.8%) - BUNDLE BRANCH BLOCK RIGHT 1 (1.2%) 0 1 (1.0%) 2 (0.8%) - PALPITATIONS 0 0 2 (2.1%) 2 (0.8%) - ATRIAL HYPERTROPHY 1 (1.2%) 0 0 1 (0.4%) - BRADYCARDIA 1 (1.2%) 0 0 1 (0.4%) - BUNDLE BRANCH BLOCK LEFT 1 (1.2%) 0 0 1 (0.4%) - CARDIAC DISORDER 0 1 (1.4%) 0 1 (0.4%) - CARDIAC FAILURE CONGESTIVE 1 (1.2%) 0 0 1 (0.4%) - SINUS ARRHYTHMIA 1 (1.2%) 0 0 1 (0.4%) - SUPRAVENTRICULAR TACHYCARDIA 0 0 1 (1.0%) 1 (0.4%) - TACHYCARDIA 1 (1.2%) 0 0 1 (0.4%) - VENTRICULAR HYPERTROPHY 1 (1.2%) 0 0 1 (0.4%) - WOLFF-PARKINSON-WHITE SYNDROME 0 0 1 (1.0%) 1 (0.4%) - INFECTIONS AND INFESTATIONS - Total number of patients with at least one adverse event 16 (18.6%) 13 (18.1%) 10 (10.4%) 39 (15.4%) - Total number of events 35 20 18 73 - NASOPHARYNGITIS 2 (2.3%) 6 (8.3%) 4 (4.2%) 12 (4.7%) - UPPER RESPIRATORY TRACT INFECTION 6 (7.0%) 3 (4.2%) 1 (1.0%) 10 (3.9%) - INFLUENZA 1 (1.2%) 1 (1.4%) 1 (1.0%) 3 (1.2%) - URINARY TRACT INFECTION 2 (2.3%) 1 (1.4%) 0 3 (1.2%) - CYSTITIS 1 (1.2%) 1 (1.4%) 0 2 (0.8%) - EAR INFECTION 2 (2.3%) 0 0 2 (0.8%) - LOCALISED INFECTION 1 (1.2%) 0 1 (1.0%) 2 (0.8%) - BRONCHITIS 1 (1.2%) 0 0 1 (0.4%) - CELLULITIS 0 0 1 (1.0%) 1 (0.4%) - CERVICITIS 1 (1.2%) 0 0 1 (0.4%) - GASTROENTERITIS VIRAL 1 (1.2%) 0 0 1 (0.4%) - HORDEOLUM 0 1 (1.4%) 0 1 (0.4%) - LOWER RESPIRATORY TRACT INFECTION 0 1 (1.4%) 0 1 (0.4%) - ONYCHOMYCOSIS 0 0 1 (1.0%) 1 (0.4%) - PNEUMONIA 0 0 1 (1.0%) 1 (0.4%) - RHINITIS 0 1 (1.4%) 0 1 (0.4%) - VAGINAL MYCOSIS 1 (1.2%) 0 0 1 (0.4%) - VIRAL INFECTION 0 0 1 (1.0%) 1 (0.4%) - RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - Total number of patients with at least one adverse event 10 (11.6%) 10 (13.9%) 10 (10.4%) 30 (11.8%) - Total number of events 15 22 16 53 - COUGH 3 (3.5%) 5 (6.9%) 6 (6.2%) 14 (5.5%) - NASAL CONGESTION 3 (3.5%) 3 (4.2%) 1 (1.0%) 7 (2.8%) - DYSPNOEA 1 (1.2%) 1 (1.4%) 1 (1.0%) 3 (1.2%) - EPISTAXIS 0 2 (2.8%) 1 (1.0%) 3 (1.2%) - PHARYNGOLARYNGEAL PAIN 0 1 (1.4%) 1 (1.0%) 2 (0.8%) - RHINORRHOEA 0 1 (1.4%) 1 (1.0%) 2 (0.8%) - ALLERGIC GRANULOMATOUS ANGIITIS 0 1 (1.4%) 0 1 (0.4%) - DYSPHONIA 0 0 1 (1.0%) 1 (0.4%) - EMPHYSEMA 1 (1.2%) 0 0 1 (0.4%) - HAEMOPTYSIS 1 (1.2%) 0 0 1 (0.4%) - PHARYNGEAL ERYTHEMA 0 1 (1.4%) 0 1 (0.4%) - POSTNASAL DRIP 1 (1.2%) 0 0 1 (0.4%) - PRODUCTIVE COUGH 0 1 (1.4%) 0 1 (0.4%) - RALES 1 (1.2%) 0 0 1 (0.4%) - RESPIRATORY TRACT CONGESTION 0 1 (1.4%) 0 1 (0.4%) - PSYCHIATRIC DISORDERS - Total number of patients with at least one adverse event 10 (11.6%) 8 (11.1%) 11 (11.5%) 29 (11.4%) - Total number of events 14 11 15 40 - CONFUSIONAL STATE 2 (2.3%) 1 (1.4%) 3 (3.1%) 6 (2.4%) - AGITATION 2 (2.3%) 0 3 (3.1%) 5 (2.0%) - ANXIETY 1 (1.2%) 0 3 (3.1%) 4 (1.6%) - INSOMNIA 2 (2.3%) 2 (2.8%) 0 4 (1.6%) - DELUSION 1 (1.2%) 1 (1.4%) 0 2 (0.8%) - DEPRESSED MOOD 0 1 (1.4%) 1 (1.0%) 2 (0.8%) - IRRITABILITY 1 (1.2%) 0 1 (1.0%) 2 (0.8%) - COMPLETED SUICIDE 1 (1.2%) 0 0 1 (0.4%) - DELIRIUM 0 1 (1.4%) 0 1 (0.4%) - DISORIENTATION 1 (1.2%) 0 0 1 (0.4%) - HALLUCINATION 0 1 (1.4%) 0 1 (0.4%) - HALLUCINATION, VISUAL 0 1 (1.4%) 0 1 (0.4%) - LIBIDO DECREASED 0 1 (1.4%) 0 1 (0.4%) - LISTLESS 0 1 (1.4%) 0 1 (0.4%) - NIGHTMARE 0 1 (1.4%) 0 1 (0.4%) - RESTLESSNESS 0 0 1 (1.0%) 1 (0.4%) - INVESTIGATIONS - Total number of patients with at least one adverse event 10 (11.6%) 5 (6.9%) 8 (8.3%) 23 (9.1%) - Total number of events 19 6 15 40 - ELECTROCARDIOGRAM ST SEGMENT DEPRESSION 4 (4.7%) 0 1 (1.0%) 5 (2.0%) - ELECTROCARDIOGRAM T WAVE INVERSION 2 (2.3%) 1 (1.4%) 1 (1.0%) 4 (1.6%) - BLOOD GLUCOSE INCREASED 0 1 (1.4%) 1 (1.0%) 2 (0.8%) - ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED 1 (1.2%) 0 1 (1.0%) 2 (0.8%) - BIOPSY 0 1 (1.4%) 0 1 (0.4%) - BIOPSY PROSTATE 0 1 (1.4%) 0 1 (0.4%) - BLOOD ALKALINE PHOSPHATASE INCREASED 1 (1.2%) 0 0 1 (0.4%) - BLOOD CHOLESTEROL INCREASED 0 1 (1.4%) 0 1 (0.4%) - BLOOD CREATINE PHOSPHOKINASE INCREASED 1 (1.2%) 0 0 1 (0.4%) - BLOOD URINE PRESENT 1 (1.2%) 0 0 1 (0.4%) - BODY TEMPERATURE INCREASED 0 0 1 (1.0%) 1 (0.4%) - CYSTOSCOPY 1 (1.2%) 0 0 1 (0.4%) - HEART RATE INCREASED 1 (1.2%) 0 0 1 (0.4%) - HEART RATE IRREGULAR 1 (1.2%) 0 0 1 (0.4%) - NASAL MUCOSA BIOPSY 0 0 1 (1.0%) 1 (0.4%) - NEUTROPHIL COUNT INCREASED 0 0 1 (1.0%) 1 (0.4%) - URINE ANALYSIS ABNORMAL 0 0 1 (1.0%) 1 (0.4%) - WEIGHT DECREASED 0 0 1 (1.0%) 1 (0.4%) - WHITE BLOOD CELL COUNT INCREASED 0 0 1 (1.0%) 1 (0.4%) - MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS - Total number of patients with at least one adverse event 5 (5.8%) 8 (11.1%) 7 (7.3%) 20 (7.9%) - Total number of events 8 11 10 29 - BACK PAIN 1 (1.2%) 3 (4.2%) 1 (1.0%) 5 (2.0%) - ARTHRALGIA 1 (1.2%) 1 (1.4%) 2 (2.1%) 4 (1.6%) - SHOULDER PAIN 1 (1.2%) 0 2 (2.1%) 3 (1.2%) - ARTHRITIS 1 (1.2%) 1 (1.4%) 0 2 (0.8%) - FLANK PAIN 0 2 (2.8%) 0 2 (0.8%) - MUSCLE SPASMS 0 1 (1.4%) 1 (1.0%) 2 (0.8%) - MUSCULAR WEAKNESS 0 0 1 (1.0%) 1 (0.4%) - MYALGIA 0 1 (1.4%) 0 1 (0.4%) - PAIN IN EXTREMITY 1 (1.2%) 0 0 1 (0.4%) - INJURY, POISONING AND PROCEDURAL COMPLICATIONS - Total number of patients with at least one adverse event 4 (4.7%) 5 (6.9%) 5 (5.2%) 14 (5.5%) - Total number of events 9 8 12 29 - CONTUSION 1 (1.2%) 2 (2.8%) 1 (1.0%) 4 (1.6%) - EXCORIATION 2 (2.3%) 1 (1.4%) 1 (1.0%) 4 (1.6%) - FALL 1 (1.2%) 1 (1.4%) 2 (2.1%) 4 (1.6%) - HIP FRACTURE 1 (1.2%) 2 (2.8%) 0 3 (1.2%) - SKIN LACERATION 1 (1.2%) 0 2 (2.1%) 3 (1.2%) - FACIAL BONES FRACTURE 0 1 (1.4%) 0 1 (0.4%) - JOINT DISLOCATION 0 0 1 (1.0%) 1 (0.4%) - WOUND 0 0 1 (1.0%) 1 (0.4%) - RENAL AND URINARY DISORDERS - Total number of patients with at least one adverse event 4 (4.7%) 3 (4.2%) 4 (4.2%) 11 (4.3%) - Total number of events 5 4 4 13 - MICTURITION URGENCY 1 (1.2%) 1 (1.4%) 1 (1.0%) 3 (1.2%) - DYSURIA 1 (1.2%) 0 1 (1.0%) 2 (0.8%) - NEPHROLITHIASIS 1 (1.2%) 1 (1.4%) 0 2 (0.8%) - CALCULUS URETHRAL 0 1 (1.4%) 0 1 (0.4%) - ENURESIS 0 0 1 (1.0%) 1 (0.4%) - INCONTINENCE 0 0 1 (1.0%) 1 (0.4%) - POLLAKIURIA 1 (1.2%) 0 0 1 (0.4%) - METABOLISM AND NUTRITION DISORDERS - Total number of patients with at least one adverse event 6 (7.0%) 3 (4.2%) 1 (1.0%) 10 (3.9%) - Total number of events 8 5 1 14 - DECREASED APPETITE 1 (1.2%) 1 (1.4%) 0 2 (0.8%) - FOOD CRAVING 1 (1.2%) 0 1 (1.0%) 2 (0.8%) - INCREASED APPETITE 1 (1.2%) 1 (1.4%) 0 2 (0.8%) - DEHYDRATION 1 (1.2%) 0 0 1 (0.4%) - DIABETES MELLITUS 1 (1.2%) 0 0 1 (0.4%) - HYPERCHOLESTEROLAEMIA 0 1 (1.4%) 0 1 (0.4%) - HYPONATRAEMIA 1 (1.2%) 0 0 1 (0.4%) - VASCULAR DISORDERS - Total number of patients with at least one adverse event 3 (3.5%) 1 (1.4%) 4 (4.2%) 8 (3.1%) - Total number of events 7 1 5 13 - HYPERTENSION 1 (1.2%) 0 2 (2.1%) 3 (1.2%) - HYPOTENSION 2 (2.3%) 0 1 (1.0%) 3 (1.2%) - HOT FLUSH 0 0 1 (1.0%) 1 (0.4%) - ORTHOSTATIC HYPOTENSION 1 (1.2%) 0 0 1 (0.4%) - WOUND HAEMORRHAGE 0 1 (1.4%) 0 1 (0.4%) - EYE DISORDERS - Total number of patients with at least one adverse event 4 (4.7%) 1 (1.4%) 2 (2.1%) 7 (2.8%) - Total number of events 8 2 2 12 - CONJUNCTIVITIS 2 (2.3%) 0 0 2 (0.8%) - VISION BLURRED 0 1 (1.4%) 1 (1.0%) 2 (0.8%) - CONJUNCTIVAL HAEMORRHAGE 0 0 1 (1.0%) 1 (0.4%) - EYE ALLERGY 1 (1.2%) 0 0 1 (0.4%) - EYE PRURITUS 1 (1.2%) 0 0 1 (0.4%) - EYE SWELLING 1 (1.2%) 0 0 1 (0.4%) - GLAUCOMA 1 (1.2%) 0 0 1 (0.4%) - SURGICAL AND MEDICAL PROCEDURES - Total number of patients with at least one adverse event 2 (2.3%) 2 (2.8%) 1 (1.0%) 5 (2.0%) - Total number of events 2 2 1 5 - CATARACT OPERATION 1 (1.2%) 0 1 (1.0%) 2 (0.8%) - ACROCHORDON EXCISION 0 1 (1.4%) 0 1 (0.4%) - EYE LASER SURGERY 1 (1.2%) 0 0 1 (0.4%) - SKIN LESION EXCISION 0 1 (1.4%) 0 1 (0.4%) - EAR AND LABYRINTH DISORDERS - Total number of patients with at least one adverse event 1 (1.2%) 1 (1.4%) 2 (2.1%) 4 (1.6%) - Total number of events 2 1 3 6 - VERTIGO 0 1 (1.4%) 1 (1.0%) 2 (0.8%) - CERUMEN IMPACTION 0 0 1 (1.0%) 1 (0.4%) - EAR PAIN 1 (1.2%) 0 0 1 (0.4%) - TINNITUS 0 0 1 (1.0%) 1 (0.4%) - CONGENITAL, FAMILIAL AND GENETIC DISORDERS - Total number of patients with at least one adverse event 0 2 (2.8%) 1 (1.0%) 3 (1.2%) - Total number of events 0 2 1 3 - VENTRICULAR SEPTAL DEFECT 0 2 (2.8%) 1 (1.0%) 3 (1.2%) - NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - Total number of patients with at least one adverse event 0 1 (1.4%) 2 (2.1%) 3 (1.2%) - Total number of events 0 1 3 4 - COLON CANCER 0 0 1 (1.0%) 1 (0.4%) - MALIGNANT FIBROUS HISTIOCYTOMA 0 0 1 (1.0%) 1 (0.4%) - PROSTATE CANCER 0 1 (1.4%) 0 1 (0.4%) - REPRODUCTIVE SYSTEM AND BREAST DISORDERS - Total number of patients with at least one adverse event 2 (2.3%) 1 (1.4%) 0 3 (1.2%) - Total number of events 4 1 0 5 - BENIGN PROSTATIC HYPERPLASIA 1 (1.2%) 1 (1.4%) 0 2 (0.8%) - PELVIC PAIN 1 (1.2%) 0 0 1 (0.4%) - IMMUNE SYSTEM DISORDERS - Total number of patients with at least one adverse event 0 1 (1.4%) 1 (1.0%) 2 (0.8%) - Total number of events 0 1 2 3 - HYPERSENSITIVITY 0 0 1 (1.0%) 1 (0.4%) - SEASONAL ALLERGY 0 1 (1.4%) 0 1 (0.4%) - HEPATOBILIARY DISORDERS - Total number of patients with at least one adverse event 1 (1.2%) 0 0 1 (0.4%) - Total number of events 1 0 0 1 - HYPERBILIRUBINAEMIA 1 (1.2%) 0 0 1 (0.4%) - SOCIAL CIRCUMSTANCES - Total number of patients with at least one adverse event 0 1 (1.4%) 0 1 (0.4%) - Total number of events 0 1 0 1 - ALCOHOL USE 0 1 (1.4%) 0 1 (0.4%) + MedDRA System Organ Class Placebo Xanomeline High Dose Xanomeline Low Dose All Patients + MedDRA Preferred Term (N=86) (N=72) (N=96) (N=254) + ——————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— + Total number of patients with at least one adverse event 37 (43.0%) 61 (84.7%) 64 (66.7%) 162 (63.8%) + Overall total number of events 75 197 181 453 + SKIN AND SUBCUTANEOUS TISSUE DISORDERS + Total number of patients with at least one adverse event 19 (22.1%) 34 (47.2%) 35 (36.5%) 88 (34.6%) + Total number of events 37 86 90 213 + PRURITUS 8 (9.3%) 26 (36.1%) 23 (24.0%) 57 (22.4%) + ERYTHEMA 9 (10.5%) 14 (19.4%) 15 (15.6%) 38 (15.0%) + RASH 5 (5.8%) 11 (15.3%) 13 (13.5%) 29 (11.4%) + SKIN IRRITATION 3 (3.5%) 5 (6.9%) 6 (6.2%) 14 (5.5%) + GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS + Total number of patients with at least one adverse event 10 (11.6%) 29 (40.3%) 31 (32.3%) 70 (27.6%) + Total number of events 20 72 73 165 + APPLICATION SITE PRURITUS 6 (7.0%) 21 (29.2%) 23 (24.0%) 50 (19.7%) + APPLICATION SITE ERYTHEMA 3 (3.5%) 14 (19.4%) 13 (13.5%) 30 (11.8%) + APPLICATION SITE IRRITATION 3 (3.5%) 9 (12.5%) 9 (9.4%) 21 (8.3%) + GASTROINTESTINAL DISORDERS + Total number of patients with at least one adverse event 4 (4.7%) 10 (13.9%) 6 (6.2%) 20 (7.9%) + Total number of events 6 21 10 37 + VOMITING 3 (3.5%) 6 (8.3%) 4 (4.2%) 13 (5.1%) + NAUSEA 3 (3.5%) 6 (8.3%) 3 (3.1%) 12 (4.7%) + NERVOUS SYSTEM DISORDERS + Total number of patients with at least one adverse event 7 (8.1%) 6 (8.3%) 3 (3.1%) 16 (6.3%) + Total number of events 8 9 4 21 + HEADACHE 7 (8.1%) 6 (8.3%) 3 (3.1%) 16 (6.3%) + CARDIAC DISORDERS + Total number of patients with at least one adverse event 4 (4.7%) 4 (5.6%) 2 (2.1%) 10 (3.9%) + Total number of events 4 8 4 16 + MYOCARDIAL INFARCTION 4 (4.7%) 4 (5.6%) 2 (2.1%) 10 (3.9%) + VASCULAR DISORDERS + Total number of patients with at least one adverse event 0 1 (1.4%) 0 1 (0.4%) + Total number of events 0 1 0 1 + WOUND HAEMORRHAGE 0 1 (1.4%) 0 1 (0.4%) # AET02 variant 2 is produced correctly Code res Output - MedDRA System Organ Class Placebo Xanomeline High Dose Xanomeline Low Dose All Patients - MedDRA Preferred Term (N=86) (N=72) (N=96) (N=254) - ———————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— - Total number of patients with at least one adverse event 69 (80.2%) 70 (97.2%) 86 (89.6%) 225 (88.6%) - Overall total number of events 301 436 454 1191 - GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - Total number of patients with at least one adverse event 21 (24.4%) 36 (50.0%) 51 (53.1%) 108 (42.5%) - APPLICATION SITE PRURITUS 6 (7.0%) 21 (29.2%) 23 (24.0%) 50 (19.7%) - APPLICATION SITE ERYTHEMA 3 (3.5%) 14 (19.4%) 13 (13.5%) 30 (11.8%) - APPLICATION SITE DERMATITIS 5 (5.8%) 7 (9.7%) 9 (9.4%) 21 (8.3%) - APPLICATION SITE IRRITATION 3 (3.5%) 9 (12.5%) 9 (9.4%) 21 (8.3%) - APPLICATION SITE VESICLES 1 (1.2%) 5 (6.9%) 5 (5.2%) 11 (4.3%) - FATIGUE 1 (1.2%) 5 (6.9%) 5 (5.2%) 11 (4.3%) - OEDEMA PERIPHERAL 2 (2.3%) 2 (2.8%) 1 (1.0%) 5 (2.0%) - APPLICATION SITE SWELLING 0 2 (2.8%) 1 (1.0%) 3 (1.2%) - APPLICATION SITE URTICARIA 0 1 (1.4%) 2 (2.1%) 3 (1.2%) - CHILLS 1 (1.2%) 1 (1.4%) 1 (1.0%) 3 (1.2%) - MALAISE 0 2 (2.8%) 1 (1.0%) 3 (1.2%) - PYREXIA 2 (2.3%) 0 1 (1.0%) 3 (1.2%) - APPLICATION SITE PAIN 0 2 (2.8%) 0 2 (0.8%) - APPLICATION SITE PERSPIRATION 0 2 (2.8%) 0 2 (0.8%) - APPLICATION SITE REACTION 1 (1.2%) 1 (1.4%) 0 2 (0.8%) - ASTHENIA 1 (1.2%) 0 1 (1.0%) 2 (0.8%) - CHEST DISCOMFORT 0 1 (1.4%) 1 (1.0%) 2 (0.8%) - CHEST PAIN 0 2 (2.8%) 0 2 (0.8%) - OEDEMA 0 0 2 (2.1%) 2 (0.8%) - PAIN 0 1 (1.4%) 1 (1.0%) 2 (0.8%) - APPLICATION SITE BLEEDING 0 0 1 (1.0%) 1 (0.4%) - APPLICATION SITE DESQUAMATION 0 0 1 (1.0%) 1 (0.4%) - APPLICATION SITE DISCHARGE 0 1 (1.4%) 0 1 (0.4%) - APPLICATION SITE DISCOLOURATION 0 0 1 (1.0%) 1 (0.4%) - APPLICATION SITE INDURATION 1 (1.2%) 0 0 1 (0.4%) - APPLICATION SITE WARMTH 0 0 1 (1.0%) 1 (0.4%) - CYST 0 0 1 (1.0%) 1 (0.4%) - FEELING ABNORMAL 0 1 (1.4%) 0 1 (0.4%) - FEELING COLD 0 1 (1.4%) 0 1 (0.4%) - INFLAMMATION 0 0 1 (1.0%) 1 (0.4%) - SECRETION DISCHARGE 0 0 1 (1.0%) 1 (0.4%) - SUDDEN DEATH 0 0 1 (1.0%) 1 (0.4%) - SWELLING 0 0 1 (1.0%) 1 (0.4%) - ULCER 0 0 1 (1.0%) 1 (0.4%) - Total number of events 48 118 126 292 - SKIN AND SUBCUTANEOUS TISSUE DISORDERS - Total number of patients with at least one adverse event 21 (24.4%) 42 (58.3%) 42 (43.8%) 105 (41.3%) - PRURITUS 8 (9.3%) 26 (36.1%) 23 (24.0%) 57 (22.4%) - ERYTHEMA 9 (10.5%) 14 (19.4%) 15 (15.6%) 38 (15.0%) - RASH 5 (5.8%) 11 (15.3%) 13 (13.5%) 29 (11.4%) - HYPERHIDROSIS 2 (2.3%) 8 (11.1%) 4 (4.2%) 14 (5.5%) - SKIN IRRITATION 3 (3.5%) 5 (6.9%) 6 (6.2%) 14 (5.5%) - BLISTER 0 1 (1.4%) 5 (5.2%) 6 (2.4%) - RASH PRURITIC 0 2 (2.8%) 1 (1.0%) 3 (1.2%) - PRURITUS GENERALISED 0 1 (1.4%) 1 (1.0%) 2 (0.8%) - RASH ERYTHEMATOUS 0 0 2 (2.1%) 2 (0.8%) - URTICARIA 0 1 (1.4%) 1 (1.0%) 2 (0.8%) - ACTINIC KERATOSIS 0 1 (1.4%) 0 1 (0.4%) - ALOPECIA 1 (1.2%) 0 0 1 (0.4%) - COLD SWEAT 1 (1.2%) 0 0 1 (0.4%) - DERMATITIS ATOPIC 1 (1.2%) 0 0 1 (0.4%) - DERMATITIS CONTACT 0 0 1 (1.0%) 1 (0.4%) - DRUG ERUPTION 1 (1.2%) 0 0 1 (0.4%) - RASH MACULO-PAPULAR 0 1 (1.4%) 0 1 (0.4%) - RASH PAPULAR 0 1 (1.4%) 0 1 (0.4%) - SKIN EXFOLIATION 0 0 1 (1.0%) 1 (0.4%) - SKIN ODOUR ABNORMAL 0 1 (1.4%) 0 1 (0.4%) - SKIN ULCER 1 (1.2%) 0 0 1 (0.4%) - Total number of events 47 111 118 276 - NERVOUS SYSTEM DISORDERS - Total number of patients with at least one adverse event 12 (14.0%) 25 (34.7%) 22 (22.9%) 59 (23.2%) - DIZZINESS 2 (2.3%) 11 (15.3%) 9 (9.4%) 22 (8.7%) - HEADACHE 7 (8.1%) 6 (8.3%) 3 (3.1%) 16 (6.3%) - SYNCOPE 0 2 (2.8%) 5 (5.2%) 7 (2.8%) - SOMNOLENCE 2 (2.3%) 1 (1.4%) 3 (3.1%) 6 (2.4%) - TRANSIENT ISCHAEMIC ATTACK 0 1 (1.4%) 2 (2.1%) 3 (1.2%) - BURNING SENSATION 0 2 (2.8%) 0 2 (0.8%) - LETHARGY 0 1 (1.4%) 1 (1.0%) 2 (0.8%) - AMNESIA 0 1 (1.4%) 0 1 (0.4%) - BALANCE DISORDER 0 0 1 (1.0%) 1 (0.4%) - COGNITIVE DISORDER 0 1 (1.4%) 0 1 (0.4%) - COMPLEX PARTIAL SEIZURES 0 0 1 (1.0%) 1 (0.4%) - COORDINATION ABNORMAL 0 0 1 (1.0%) 1 (0.4%) - HEMIANOPIA HOMONYMOUS 0 0 1 (1.0%) 1 (0.4%) - HYPERSOMNIA 0 1 (1.4%) 0 1 (0.4%) - PARAESTHESIA 0 1 (1.4%) 0 1 (0.4%) - PARAESTHESIA ORAL 0 0 1 (1.0%) 1 (0.4%) - PARKINSON'S DISEASE 1 (1.2%) 0 0 1 (0.4%) - PAROSMIA 0 1 (1.4%) 0 1 (0.4%) - PARTIAL SEIZURES WITH SECONDARY GENERALISATION 0 1 (1.4%) 0 1 (0.4%) - PSYCHOMOTOR HYPERACTIVITY 1 (1.2%) 0 0 1 (0.4%) - STUPOR 0 0 1 (1.0%) 1 (0.4%) - SYNCOPE VASOVAGAL 0 1 (1.4%) 0 1 (0.4%) - Total number of events 16 43 42 101 - GASTROINTESTINAL DISORDERS - Total number of patients with at least one adverse event 17 (19.8%) 20 (27.8%) 16 (16.7%) 53 (20.9%) - DIARRHOEA 9 (10.5%) 3 (4.2%) 6 (6.2%) 18 (7.1%) - VOMITING 3 (3.5%) 6 (8.3%) 4 (4.2%) 13 (5.1%) - NAUSEA 3 (3.5%) 6 (8.3%) 3 (3.1%) 12 (4.7%) - ABDOMINAL PAIN 1 (1.2%) 1 (1.4%) 3 (3.1%) 5 (2.0%) - SALIVARY HYPERSECRETION 0 4 (5.6%) 0 4 (1.6%) - DYSPEPSIA 1 (1.2%) 1 (1.4%) 1 (1.0%) 3 (1.2%) - ABDOMINAL DISCOMFORT 0 1 (1.4%) 0 1 (0.4%) - CONSTIPATION 1 (1.2%) 0 0 1 (0.4%) - DYSPHAGIA 0 0 1 (1.0%) 1 (0.4%) - FLATULENCE 1 (1.2%) 0 0 1 (0.4%) - GASTROINTESTINAL HAEMORRHAGE 0 1 (1.4%) 0 1 (0.4%) - GASTROOESOPHAGEAL REFLUX DISEASE 1 (1.2%) 0 0 1 (0.4%) - GLOSSITIS 1 (1.2%) 0 0 1 (0.4%) - HIATUS HERNIA 1 (1.2%) 0 0 1 (0.4%) - RECTAL HAEMORRHAGE 0 0 1 (1.0%) 1 (0.4%) - STOMACH DISCOMFORT 0 1 (1.4%) 0 1 (0.4%) - Total number of events 26 35 26 87 - CARDIAC DISORDERS - Total number of patients with at least one adverse event 13 (15.1%) 15 (20.8%) 16 (16.7%) 44 (17.3%) - SINUS BRADYCARDIA 2 (2.3%) 8 (11.1%) 7 (7.3%) 17 (6.7%) - MYOCARDIAL INFARCTION 4 (4.7%) 4 (5.6%) 2 (2.1%) 10 (3.9%) - ATRIAL FIBRILLATION 1 (1.2%) 2 (2.8%) 2 (2.1%) 5 (2.0%) - ATRIOVENTRICULAR BLOCK SECOND DEGREE 2 (2.3%) 1 (1.4%) 2 (2.1%) 5 (2.0%) - SUPRAVENTRICULAR EXTRASYSTOLES 1 (1.2%) 1 (1.4%) 1 (1.0%) 3 (1.2%) - VENTRICULAR EXTRASYSTOLES 0 1 (1.4%) 2 (2.1%) 3 (1.2%) - ATRIAL FLUTTER 0 1 (1.4%) 1 (1.0%) 2 (0.8%) - ATRIOVENTRICULAR BLOCK FIRST DEGREE 1 (1.2%) 0 1 (1.0%) 2 (0.8%) - BUNDLE BRANCH BLOCK RIGHT 1 (1.2%) 0 1 (1.0%) 2 (0.8%) - PALPITATIONS 0 0 2 (2.1%) 2 (0.8%) - ATRIAL HYPERTROPHY 1 (1.2%) 0 0 1 (0.4%) - BRADYCARDIA 1 (1.2%) 0 0 1 (0.4%) - BUNDLE BRANCH BLOCK LEFT 1 (1.2%) 0 0 1 (0.4%) - CARDIAC DISORDER 0 1 (1.4%) 0 1 (0.4%) - CARDIAC FAILURE CONGESTIVE 1 (1.2%) 0 0 1 (0.4%) - SINUS ARRHYTHMIA 1 (1.2%) 0 0 1 (0.4%) - SUPRAVENTRICULAR TACHYCARDIA 0 0 1 (1.0%) 1 (0.4%) - TACHYCARDIA 1 (1.2%) 0 0 1 (0.4%) - VENTRICULAR HYPERTROPHY 1 (1.2%) 0 0 1 (0.4%) - WOLFF-PARKINSON-WHITE SYNDROME 0 0 1 (1.0%) 1 (0.4%) - Total number of events 27 30 34 91 - INFECTIONS AND INFESTATIONS - Total number of patients with at least one adverse event 16 (18.6%) 13 (18.1%) 10 (10.4%) 39 (15.4%) - NASOPHARYNGITIS 2 (2.3%) 6 (8.3%) 4 (4.2%) 12 (4.7%) - UPPER RESPIRATORY TRACT INFECTION 6 (7.0%) 3 (4.2%) 1 (1.0%) 10 (3.9%) - INFLUENZA 1 (1.2%) 1 (1.4%) 1 (1.0%) 3 (1.2%) - URINARY TRACT INFECTION 2 (2.3%) 1 (1.4%) 0 3 (1.2%) - CYSTITIS 1 (1.2%) 1 (1.4%) 0 2 (0.8%) - EAR INFECTION 2 (2.3%) 0 0 2 (0.8%) - LOCALISED INFECTION 1 (1.2%) 0 1 (1.0%) 2 (0.8%) - BRONCHITIS 1 (1.2%) 0 0 1 (0.4%) - CELLULITIS 0 0 1 (1.0%) 1 (0.4%) - CERVICITIS 1 (1.2%) 0 0 1 (0.4%) - GASTROENTERITIS VIRAL 1 (1.2%) 0 0 1 (0.4%) - HORDEOLUM 0 1 (1.4%) 0 1 (0.4%) - LOWER RESPIRATORY TRACT INFECTION 0 1 (1.4%) 0 1 (0.4%) - ONYCHOMYCOSIS 0 0 1 (1.0%) 1 (0.4%) - PNEUMONIA 0 0 1 (1.0%) 1 (0.4%) - RHINITIS 0 1 (1.4%) 0 1 (0.4%) - VAGINAL MYCOSIS 1 (1.2%) 0 0 1 (0.4%) - VIRAL INFECTION 0 0 1 (1.0%) 1 (0.4%) - Total number of events 35 20 18 73 - RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - Total number of patients with at least one adverse event 10 (11.6%) 10 (13.9%) 10 (10.4%) 30 (11.8%) - COUGH 3 (3.5%) 5 (6.9%) 6 (6.2%) 14 (5.5%) - NASAL CONGESTION 3 (3.5%) 3 (4.2%) 1 (1.0%) 7 (2.8%) - DYSPNOEA 1 (1.2%) 1 (1.4%) 1 (1.0%) 3 (1.2%) - EPISTAXIS 0 2 (2.8%) 1 (1.0%) 3 (1.2%) - PHARYNGOLARYNGEAL PAIN 0 1 (1.4%) 1 (1.0%) 2 (0.8%) - RHINORRHOEA 0 1 (1.4%) 1 (1.0%) 2 (0.8%) - ALLERGIC GRANULOMATOUS ANGIITIS 0 1 (1.4%) 0 1 (0.4%) - DYSPHONIA 0 0 1 (1.0%) 1 (0.4%) - EMPHYSEMA 1 (1.2%) 0 0 1 (0.4%) - HAEMOPTYSIS 1 (1.2%) 0 0 1 (0.4%) - PHARYNGEAL ERYTHEMA 0 1 (1.4%) 0 1 (0.4%) - POSTNASAL DRIP 1 (1.2%) 0 0 1 (0.4%) - PRODUCTIVE COUGH 0 1 (1.4%) 0 1 (0.4%) - RALES 1 (1.2%) 0 0 1 (0.4%) - RESPIRATORY TRACT CONGESTION 0 1 (1.4%) 0 1 (0.4%) - Total number of events 15 22 16 53 - PSYCHIATRIC DISORDERS - Total number of patients with at least one adverse event 10 (11.6%) 8 (11.1%) 11 (11.5%) 29 (11.4%) - CONFUSIONAL STATE 2 (2.3%) 1 (1.4%) 3 (3.1%) 6 (2.4%) - AGITATION 2 (2.3%) 0 3 (3.1%) 5 (2.0%) - ANXIETY 1 (1.2%) 0 3 (3.1%) 4 (1.6%) - INSOMNIA 2 (2.3%) 2 (2.8%) 0 4 (1.6%) - DELUSION 1 (1.2%) 1 (1.4%) 0 2 (0.8%) - DEPRESSED MOOD 0 1 (1.4%) 1 (1.0%) 2 (0.8%) - IRRITABILITY 1 (1.2%) 0 1 (1.0%) 2 (0.8%) - COMPLETED SUICIDE 1 (1.2%) 0 0 1 (0.4%) - DELIRIUM 0 1 (1.4%) 0 1 (0.4%) - DISORIENTATION 1 (1.2%) 0 0 1 (0.4%) - HALLUCINATION 0 1 (1.4%) 0 1 (0.4%) - HALLUCINATION, VISUAL 0 1 (1.4%) 0 1 (0.4%) - LIBIDO DECREASED 0 1 (1.4%) 0 1 (0.4%) - LISTLESS 0 1 (1.4%) 0 1 (0.4%) - NIGHTMARE 0 1 (1.4%) 0 1 (0.4%) - RESTLESSNESS 0 0 1 (1.0%) 1 (0.4%) - Total number of events 14 11 15 40 - INVESTIGATIONS - Total number of patients with at least one adverse event 10 (11.6%) 5 (6.9%) 8 (8.3%) 23 (9.1%) - ELECTROCARDIOGRAM ST SEGMENT DEPRESSION 4 (4.7%) 0 1 (1.0%) 5 (2.0%) - ELECTROCARDIOGRAM T WAVE INVERSION 2 (2.3%) 1 (1.4%) 1 (1.0%) 4 (1.6%) - BLOOD GLUCOSE INCREASED 0 1 (1.4%) 1 (1.0%) 2 (0.8%) - ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED 1 (1.2%) 0 1 (1.0%) 2 (0.8%) - BIOPSY 0 1 (1.4%) 0 1 (0.4%) - BIOPSY PROSTATE 0 1 (1.4%) 0 1 (0.4%) - BLOOD ALKALINE PHOSPHATASE INCREASED 1 (1.2%) 0 0 1 (0.4%) - BLOOD CHOLESTEROL INCREASED 0 1 (1.4%) 0 1 (0.4%) - BLOOD CREATINE PHOSPHOKINASE INCREASED 1 (1.2%) 0 0 1 (0.4%) - BLOOD URINE PRESENT 1 (1.2%) 0 0 1 (0.4%) - BODY TEMPERATURE INCREASED 0 0 1 (1.0%) 1 (0.4%) - CYSTOSCOPY 1 (1.2%) 0 0 1 (0.4%) - HEART RATE INCREASED 1 (1.2%) 0 0 1 (0.4%) - HEART RATE IRREGULAR 1 (1.2%) 0 0 1 (0.4%) - NASAL MUCOSA BIOPSY 0 0 1 (1.0%) 1 (0.4%) - NEUTROPHIL COUNT INCREASED 0 0 1 (1.0%) 1 (0.4%) - URINE ANALYSIS ABNORMAL 0 0 1 (1.0%) 1 (0.4%) - WEIGHT DECREASED 0 0 1 (1.0%) 1 (0.4%) - WHITE BLOOD CELL COUNT INCREASED 0 0 1 (1.0%) 1 (0.4%) - Total number of events 19 6 15 40 - MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS - Total number of patients with at least one adverse event 5 (5.8%) 8 (11.1%) 7 (7.3%) 20 (7.9%) - BACK PAIN 1 (1.2%) 3 (4.2%) 1 (1.0%) 5 (2.0%) - ARTHRALGIA 1 (1.2%) 1 (1.4%) 2 (2.1%) 4 (1.6%) - SHOULDER PAIN 1 (1.2%) 0 2 (2.1%) 3 (1.2%) - ARTHRITIS 1 (1.2%) 1 (1.4%) 0 2 (0.8%) - FLANK PAIN 0 2 (2.8%) 0 2 (0.8%) - MUSCLE SPASMS 0 1 (1.4%) 1 (1.0%) 2 (0.8%) - MUSCULAR WEAKNESS 0 0 1 (1.0%) 1 (0.4%) - MYALGIA 0 1 (1.4%) 0 1 (0.4%) - PAIN IN EXTREMITY 1 (1.2%) 0 0 1 (0.4%) - Total number of events 8 11 10 29 - INJURY, POISONING AND PROCEDURAL COMPLICATIONS - Total number of patients with at least one adverse event 4 (4.7%) 5 (6.9%) 5 (5.2%) 14 (5.5%) - CONTUSION 1 (1.2%) 2 (2.8%) 1 (1.0%) 4 (1.6%) - EXCORIATION 2 (2.3%) 1 (1.4%) 1 (1.0%) 4 (1.6%) - FALL 1 (1.2%) 1 (1.4%) 2 (2.1%) 4 (1.6%) - HIP FRACTURE 1 (1.2%) 2 (2.8%) 0 3 (1.2%) - SKIN LACERATION 1 (1.2%) 0 2 (2.1%) 3 (1.2%) - FACIAL BONES FRACTURE 0 1 (1.4%) 0 1 (0.4%) - JOINT DISLOCATION 0 0 1 (1.0%) 1 (0.4%) - WOUND 0 0 1 (1.0%) 1 (0.4%) - Total number of events 9 8 12 29 - RENAL AND URINARY DISORDERS - Total number of patients with at least one adverse event 4 (4.7%) 3 (4.2%) 4 (4.2%) 11 (4.3%) - MICTURITION URGENCY 1 (1.2%) 1 (1.4%) 1 (1.0%) 3 (1.2%) - DYSURIA 1 (1.2%) 0 1 (1.0%) 2 (0.8%) - NEPHROLITHIASIS 1 (1.2%) 1 (1.4%) 0 2 (0.8%) - CALCULUS URETHRAL 0 1 (1.4%) 0 1 (0.4%) - ENURESIS 0 0 1 (1.0%) 1 (0.4%) - INCONTINENCE 0 0 1 (1.0%) 1 (0.4%) - POLLAKIURIA 1 (1.2%) 0 0 1 (0.4%) - Total number of events 5 4 4 13 - METABOLISM AND NUTRITION DISORDERS - Total number of patients with at least one adverse event 6 (7.0%) 3 (4.2%) 1 (1.0%) 10 (3.9%) - DECREASED APPETITE 1 (1.2%) 1 (1.4%) 0 2 (0.8%) - FOOD CRAVING 1 (1.2%) 0 1 (1.0%) 2 (0.8%) - INCREASED APPETITE 1 (1.2%) 1 (1.4%) 0 2 (0.8%) - DEHYDRATION 1 (1.2%) 0 0 1 (0.4%) - DIABETES MELLITUS 1 (1.2%) 0 0 1 (0.4%) - HYPERCHOLESTEROLAEMIA 0 1 (1.4%) 0 1 (0.4%) - HYPONATRAEMIA 1 (1.2%) 0 0 1 (0.4%) - Total number of events 8 5 1 14 - VASCULAR DISORDERS - Total number of patients with at least one adverse event 3 (3.5%) 1 (1.4%) 4 (4.2%) 8 (3.1%) - HYPERTENSION 1 (1.2%) 0 2 (2.1%) 3 (1.2%) - HYPOTENSION 2 (2.3%) 0 1 (1.0%) 3 (1.2%) - HOT FLUSH 0 0 1 (1.0%) 1 (0.4%) - ORTHOSTATIC HYPOTENSION 1 (1.2%) 0 0 1 (0.4%) - WOUND HAEMORRHAGE 0 1 (1.4%) 0 1 (0.4%) - Total number of events 7 1 5 13 - EYE DISORDERS - Total number of patients with at least one adverse event 4 (4.7%) 1 (1.4%) 2 (2.1%) 7 (2.8%) - CONJUNCTIVITIS 2 (2.3%) 0 0 2 (0.8%) - VISION BLURRED 0 1 (1.4%) 1 (1.0%) 2 (0.8%) - CONJUNCTIVAL HAEMORRHAGE 0 0 1 (1.0%) 1 (0.4%) - EYE ALLERGY 1 (1.2%) 0 0 1 (0.4%) - EYE PRURITUS 1 (1.2%) 0 0 1 (0.4%) - EYE SWELLING 1 (1.2%) 0 0 1 (0.4%) - GLAUCOMA 1 (1.2%) 0 0 1 (0.4%) - Total number of events 8 2 2 12 - SURGICAL AND MEDICAL PROCEDURES - Total number of patients with at least one adverse event 2 (2.3%) 2 (2.8%) 1 (1.0%) 5 (2.0%) - CATARACT OPERATION 1 (1.2%) 0 1 (1.0%) 2 (0.8%) - ACROCHORDON EXCISION 0 1 (1.4%) 0 1 (0.4%) - EYE LASER SURGERY 1 (1.2%) 0 0 1 (0.4%) - SKIN LESION EXCISION 0 1 (1.4%) 0 1 (0.4%) - Total number of events 2 2 1 5 - EAR AND LABYRINTH DISORDERS - Total number of patients with at least one adverse event 1 (1.2%) 1 (1.4%) 2 (2.1%) 4 (1.6%) - VERTIGO 0 1 (1.4%) 1 (1.0%) 2 (0.8%) - CERUMEN IMPACTION 0 0 1 (1.0%) 1 (0.4%) - EAR PAIN 1 (1.2%) 0 0 1 (0.4%) - TINNITUS 0 0 1 (1.0%) 1 (0.4%) - Total number of events 2 1 3 6 - CONGENITAL, FAMILIAL AND GENETIC DISORDERS - Total number of patients with at least one adverse event 0 2 (2.8%) 1 (1.0%) 3 (1.2%) - VENTRICULAR SEPTAL DEFECT 0 2 (2.8%) 1 (1.0%) 3 (1.2%) - Total number of events 0 2 1 3 - NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - Total number of patients with at least one adverse event 0 1 (1.4%) 2 (2.1%) 3 (1.2%) - COLON CANCER 0 0 1 (1.0%) 1 (0.4%) - MALIGNANT FIBROUS HISTIOCYTOMA 0 0 1 (1.0%) 1 (0.4%) - PROSTATE CANCER 0 1 (1.4%) 0 1 (0.4%) - Total number of events 0 1 3 4 - REPRODUCTIVE SYSTEM AND BREAST DISORDERS - Total number of patients with at least one adverse event 2 (2.3%) 1 (1.4%) 0 3 (1.2%) - BENIGN PROSTATIC HYPERPLASIA 1 (1.2%) 1 (1.4%) 0 2 (0.8%) - PELVIC PAIN 1 (1.2%) 0 0 1 (0.4%) - Total number of events 4 1 0 5 - IMMUNE SYSTEM DISORDERS - Total number of patients with at least one adverse event 0 1 (1.4%) 1 (1.0%) 2 (0.8%) - HYPERSENSITIVITY 0 0 1 (1.0%) 1 (0.4%) - SEASONAL ALLERGY 0 1 (1.4%) 0 1 (0.4%) - Total number of events 0 1 2 3 - HEPATOBILIARY DISORDERS - Total number of patients with at least one adverse event 1 (1.2%) 0 0 1 (0.4%) - HYPERBILIRUBINAEMIA 1 (1.2%) 0 0 1 (0.4%) - Total number of events 1 0 0 1 - SOCIAL CIRCUMSTANCES - Total number of patients with at least one adverse event 0 1 (1.4%) 0 1 (0.4%) - ALCOHOL USE 0 1 (1.4%) 0 1 (0.4%) - Total number of events 0 1 0 1 + MedDRA System Organ Class Placebo Xanomeline High Dose Xanomeline Low Dose All Patients + MedDRA Preferred Term (N=86) (N=72) (N=96) (N=254) + ——————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— + Total number of patients with at least one adverse event 37 (43.0%) 61 (84.7%) 64 (66.7%) 162 (63.8%) + Overall total number of events 75 197 181 453 + SKIN AND SUBCUTANEOUS TISSUE DISORDERS + Total number of patients with at least one adverse event 19 (22.1%) 34 (47.2%) 35 (36.5%) 88 (34.6%) + PRURITUS 8 (9.3%) 26 (36.1%) 23 (24.0%) 57 (22.4%) + ERYTHEMA 9 (10.5%) 14 (19.4%) 15 (15.6%) 38 (15.0%) + RASH 5 (5.8%) 11 (15.3%) 13 (13.5%) 29 (11.4%) + SKIN IRRITATION 3 (3.5%) 5 (6.9%) 6 (6.2%) 14 (5.5%) + Total number of events 37 86 90 213 + GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS + Total number of patients with at least one adverse event 10 (11.6%) 29 (40.3%) 31 (32.3%) 70 (27.6%) + APPLICATION SITE PRURITUS 6 (7.0%) 21 (29.2%) 23 (24.0%) 50 (19.7%) + APPLICATION SITE ERYTHEMA 3 (3.5%) 14 (19.4%) 13 (13.5%) 30 (11.8%) + APPLICATION SITE IRRITATION 3 (3.5%) 9 (12.5%) 9 (9.4%) 21 (8.3%) + Total number of events 20 72 73 165 + GASTROINTESTINAL DISORDERS + Total number of patients with at least one adverse event 4 (4.7%) 10 (13.9%) 6 (6.2%) 20 (7.9%) + VOMITING 3 (3.5%) 6 (8.3%) 4 (4.2%) 13 (5.1%) + NAUSEA 3 (3.5%) 6 (8.3%) 3 (3.1%) 12 (4.7%) + Total number of events 6 21 10 37 + NERVOUS SYSTEM DISORDERS + Total number of patients with at least one adverse event 7 (8.1%) 6 (8.3%) 3 (3.1%) 16 (6.3%) + HEADACHE 7 (8.1%) 6 (8.3%) 3 (3.1%) 16 (6.3%) + Total number of events 8 9 4 21 + CARDIAC DISORDERS + Total number of patients with at least one adverse event 4 (4.7%) 4 (5.6%) 2 (2.1%) 10 (3.9%) + MYOCARDIAL INFARCTION 4 (4.7%) 4 (5.6%) 2 (2.1%) 10 (3.9%) + Total number of events 4 8 4 16 + VASCULAR DISORDERS + Total number of patients with at least one adverse event 0 1 (1.4%) 0 1 (0.4%) + WOUND HAEMORRHAGE 0 1 (1.4%) 0 1 (0.4%) + Total number of events 0 1 0 1 # AET02 variant 3 is produced correctly Code res Output - MedDRA System Organ Class - High Level Term Placebo Xanomeline High Dose Xanomeline Low Dose - MedDRA Preferred Term (N=86) (N=72) (N=96) - ————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— - Total number of patients with at least one adverse event 69 (80.2%) 70 (97.2%) 86 (89.6%) - Overall total number of events 301 436 454 - GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - Total number of patients with at least one adverse event 21 (24.4%) 36 (50.0%) 51 (53.1%) - Total number of events 48 118 126 - HLT_0317 - Total number of patients with at least one adverse event 6 (7.0%) 21 (29.2%) 23 (24.0%) - Total number of events 10 34 34 - APPLICATION SITE PRURITUS 6 (7.0%) 21 (29.2%) 23 (24.0%) - HLT_0617 - Total number of patients with at least one adverse event 3 (3.5%) 14 (19.4%) 13 (13.5%) - Total number of events 3 22 21 - APPLICATION SITE ERYTHEMA 3 (3.5%) 14 (19.4%) 13 (13.5%) - HLT_0061 - Total number of patients with at least one adverse event 3 (3.5%) 9 (12.5%) 9 (9.4%) - Total number of events 7 16 18 - APPLICATION SITE IRRITATION 3 (3.5%) 9 (12.5%) 9 (9.4%) - HLT_0343 - Total number of patients with at least one adverse event 5 (5.8%) 7 (9.7%) 9 (9.4%) - Total number of events 9 12 15 - APPLICATION SITE DERMATITIS 5 (5.8%) 7 (9.7%) 9 (9.4%) - HLT_0043 - Total number of patients with at least one adverse event 1 (1.2%) 5 (6.9%) 5 (5.2%) - Total number of events 2 5 5 - FATIGUE 1 (1.2%) 5 (6.9%) 5 (5.2%) - HLT_0180 - Total number of patients with at least one adverse event 1 (1.2%) 5 (6.9%) 5 (5.2%) - Total number of events 2 5 6 - APPLICATION SITE VESICLES 1 (1.2%) 5 (6.9%) 5 (5.2%) - HLT_0661 - Total number of patients with at least one adverse event 2 (2.3%) 2 (2.8%) 1 (1.0%) - Total number of events 5 3 1 - OEDEMA PERIPHERAL 2 (2.3%) 2 (2.8%) 1 (1.0%) - HLT_0105 - Total number of patients with at least one adverse event 0 2 (2.8%) 1 (1.0%) - Total number of events 0 3 1 - APPLICATION SITE SWELLING 0 2 (2.8%) 1 (1.0%) - HLT_0196 - Total number of patients with at least one adverse event 0 1 (1.4%) 2 (2.1%) - Total number of events 0 1 2 - APPLICATION SITE URTICARIA 0 1 (1.4%) 2 (2.1%) - HLT_0310 - Total number of patients with at least one adverse event 2 (2.3%) 0 1 (1.0%) - Total number of events 2 0 1 - PYREXIA 2 (2.3%) 0 1 (1.0%) - HLT_0456 - Total number of patients with at least one adverse event 0 2 (2.8%) 1 (1.0%) - Total number of events 0 3 2 - MALAISE 0 2 (2.8%) 1 (1.0%) - HLT_0586 - Total number of patients with at least one adverse event 1 (1.2%) 1 (1.4%) 1 (1.0%) - Total number of events 3 1 2 - CHILLS 1 (1.2%) 1 (1.4%) 1 (1.0%) - HLT_0205 - Total number of patients with at least one adverse event 1 (1.2%) 0 1 (1.0%) - Total number of events 2 0 1 - ASTHENIA 1 (1.2%) 0 1 (1.0%) - HLT_0283 - Total number of patients with at least one adverse event 0 2 (2.8%) 0 - Total number of events 0 3 0 - APPLICATION SITE PERSPIRATION 0 2 (2.8%) 0 - HLT_0314 - Total number of patients with at least one adverse event 0 1 (1.4%) 1 (1.0%) - Total number of events 0 1 2 - PAIN 0 1 (1.4%) 1 (1.0%) - HLT_0339 - Total number of patients with at least one adverse event 1 (1.2%) 1 (1.4%) 0 - Total number of events 2 1 0 - APPLICATION SITE REACTION 1 (1.2%) 1 (1.4%) 0 - HLT_0342 - Total number of patients with at least one adverse event 0 2 (2.8%) 0 - Total number of events 0 2 0 - APPLICATION SITE PAIN 0 2 (2.8%) 0 - HLT_0593 - Total number of patients with at least one adverse event 0 1 (1.4%) 1 (1.0%) - Total number of events 0 1 1 - CHEST DISCOMFORT 0 1 (1.4%) 1 (1.0%) - HLT_0656 - Total number of patients with at least one adverse event 0 0 2 (2.1%) - Total number of events 0 0 2 - OEDEMA 0 0 2 (2.1%) - HLT_0717 - Total number of patients with at least one adverse event 0 2 (2.8%) 0 - Total number of events 0 2 0 - CHEST PAIN 0 2 (2.8%) 0 - HLT_0040 - Total number of patients with at least one adverse event 0 0 1 (1.0%) - Total number of events 0 0 1 - ULCER 0 0 1 (1.0%) - HLT_0121 - Total number of patients with at least one adverse event 0 0 1 (1.0%) - Total number of events 0 0 1 - APPLICATION SITE DISCOLOURATION 0 0 1 (1.0%) - HLT_0142 - Total number of patients with at least one adverse event 0 0 1 (1.0%) - Total number of events 0 0 1 - SUDDEN DEATH 0 0 1 (1.0%) - HLT_0200 - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 1 0 - APPLICATION SITE DISCHARGE 0 1 (1.4%) 0 - HLT_0260 - Total number of patients with at least one adverse event 0 0 1 (1.0%) - Total number of events 0 0 2 - APPLICATION SITE WARMTH 0 0 1 (1.0%) - HLT_0340 - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 1 0 - FEELING COLD 0 1 (1.4%) 0 - HLT_0351 - Total number of patients with at least one adverse event 0 0 1 (1.0%) - Total number of events 0 0 1 - APPLICATION SITE DESQUAMATION 0 0 1 (1.0%) - HLT_0524 - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 1 0 - FEELING ABNORMAL 0 1 (1.4%) 0 - HLT_0582 - Total number of patients with at least one adverse event 0 0 1 (1.0%) - Total number of events 0 0 1 - INFLAMMATION 0 0 1 (1.0%) - HLT_0658 - Total number of patients with at least one adverse event 0 0 1 (1.0%) - Total number of events 0 0 1 - SWELLING 0 0 1 (1.0%) - HLT_0683 - Total number of patients with at least one adverse event 0 0 1 (1.0%) - Total number of events 0 0 2 - SECRETION DISCHARGE 0 0 1 (1.0%) - HLT_0696 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 1 0 0 - APPLICATION SITE INDURATION 1 (1.2%) 0 0 - HLT_0718 - Total number of patients with at least one adverse event 0 0 1 (1.0%) - Total number of events 0 0 1 - APPLICATION SITE BLEEDING 0 0 1 (1.0%) - HLT_0763 - Total number of patients with at least one adverse event 0 0 1 (1.0%) - Total number of events 0 0 1 - CYST 0 0 1 (1.0%) - SKIN AND SUBCUTANEOUS TISSUE DISORDERS - Total number of patients with at least one adverse event 21 (24.4%) 42 (58.3%) 42 (43.8%) - Total number of events 47 111 118 - HLT_0778 - Total number of patients with at least one adverse event 8 (9.3%) 26 (36.1%) 23 (24.0%) - Total number of events 11 38 35 - PRURITUS 8 (9.3%) 26 (36.1%) 23 (24.0%) - HLT_0284 - Total number of patients with at least one adverse event 9 (10.5%) 14 (19.4%) 15 (15.6%) - Total number of events 13 22 24 - ERYTHEMA 9 (10.5%) 14 (19.4%) 15 (15.6%) - HLT_0762 - Total number of patients with at least one adverse event 5 (5.8%) 11 (15.3%) 13 (13.5%) - Total number of events 9 18 18 - RASH 5 (5.8%) 11 (15.3%) 13 (13.5%) - HLT_0583 - Total number of patients with at least one adverse event 3 (3.5%) 5 (6.9%) 6 (6.2%) - Total number of events 4 8 13 - SKIN IRRITATION 3 (3.5%) 5 (6.9%) 6 (6.2%) - HLT_0587 - Total number of patients with at least one adverse event 2 (2.3%) 8 (11.1%) 4 (4.2%) - Total number of events 2 10 5 - HYPERHIDROSIS 2 (2.3%) 8 (11.1%) 4 (4.2%) - HLT_0752 - Total number of patients with at least one adverse event 0 1 (1.4%) 5 (5.2%) - Total number of events 0 2 8 - BLISTER 0 1 (1.4%) 5 (5.2%) - HLT_0127 - Total number of patients with at least one adverse event 0 2 (2.8%) 1 (1.0%) - Total number of events 0 3 2 - RASH PRURITIC 0 2 (2.8%) 1 (1.0%) - HLT_0123 - Total number of patients with at least one adverse event 0 1 (1.4%) 1 (1.0%) - Total number of events 0 1 4 - PRURITUS GENERALISED 0 1 (1.4%) 1 (1.0%) - HLT_0336 - Total number of patients with at least one adverse event 0 0 2 (2.1%) - Total number of events 0 0 2 - RASH ERYTHEMATOUS 0 0 2 (2.1%) - HLT_0420 - Total number of patients with at least one adverse event 0 1 (1.4%) 1 (1.0%) - Total number of events 0 2 3 - URTICARIA 0 1 (1.4%) 1 (1.0%) - HLT_0005 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 2 0 0 - SKIN ULCER 1 (1.2%) 0 0 - HLT_0056 - Total number of patients with at least one adverse event 0 0 1 (1.0%) - Total number of events 0 0 2 - DERMATITIS CONTACT 0 0 1 (1.0%) - HLT_0077 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 1 0 0 - ALOPECIA 1 (1.2%) 0 0 - HLT_0124 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 3 0 0 - COLD SWEAT 1 (1.2%) 0 0 - HLT_0236 - Total number of patients with at least one adverse event 0 0 1 (1.0%) - Total number of events 0 0 2 - SKIN EXFOLIATION 0 0 1 (1.0%) - HLT_0430 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 1 0 0 - DRUG ERUPTION 1 (1.2%) 0 0 - HLT_0480 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 1 0 0 - DERMATITIS ATOPIC 1 (1.2%) 0 0 - HLT_0500 - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 3 0 - RASH MACULO-PAPULAR 0 1 (1.4%) 0 - HLT_0510 - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 1 0 - SKIN ODOUR ABNORMAL 0 1 (1.4%) 0 - HLT_0549 - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 2 0 - RASH PAPULAR 0 1 (1.4%) 0 - HLT_0609 - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 1 0 - ACTINIC KERATOSIS 0 1 (1.4%) 0 - NERVOUS SYSTEM DISORDERS - Total number of patients with at least one adverse event 12 (14.0%) 25 (34.7%) 22 (22.9%) - Total number of events 16 43 42 - HLT_0619 - Total number of patients with at least one adverse event 2 (2.3%) 11 (15.3%) 9 (9.4%) - Total number of events 3 17 14 - DIZZINESS 2 (2.3%) 11 (15.3%) 9 (9.4%) - HLT_0064 - Total number of patients with at least one adverse event 7 (8.1%) 6 (8.3%) 3 (3.1%) - Total number of events 8 9 4 - HEADACHE 7 (8.1%) 6 (8.3%) 3 (3.1%) - HLT_0440 - Total number of patients with at least one adverse event 0 2 (2.8%) 5 (5.2%) - Total number of events 0 3 7 - SYNCOPE 0 2 (2.8%) 5 (5.2%) - HLT_0160 - Total number of patients with at least one adverse event 2 (2.3%) 1 (1.4%) 3 (3.1%) - Total number of events 3 1 5 - SOMNOLENCE 2 (2.3%) 1 (1.4%) 3 (3.1%) - HLT_0041 - Total number of patients with at least one adverse event 0 1 (1.4%) 2 (2.1%) - Total number of events 0 1 3 - TRANSIENT ISCHAEMIC ATTACK 0 1 (1.4%) 2 (2.1%) - HLT_0027 - Total number of patients with at least one adverse event 0 1 (1.4%) 1 (1.0%) - Total number of events 0 1 1 - LETHARGY 0 1 (1.4%) 1 (1.0%) - HLT_0775 - Total number of patients with at least one adverse event 0 2 (2.8%) 0 - Total number of events 0 2 0 - BURNING SENSATION 0 2 (2.8%) 0 - HLT_0003 - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 1 0 - SYNCOPE VASOVAGAL 0 1 (1.4%) 0 - HLT_0231 - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 1 0 - HYPERSOMNIA 0 1 (1.4%) 0 - HLT_0258 - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 2 0 - PAROSMIA 0 1 (1.4%) 0 - HLT_0265 - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 1 0 - COGNITIVE DISORDER 0 1 (1.4%) 0 - HLT_0279 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 1 0 0 - PARKINSON'S DISEASE 1 (1.2%) 0 0 - HLT_0315 - Total number of patients with at least one adverse event 0 0 1 (1.0%) - Total number of events 0 0 1 - COORDINATION ABNORMAL 0 0 1 (1.0%) - HLT_0383 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 1 0 0 - PSYCHOMOTOR HYPERACTIVITY 1 (1.2%) 0 0 - HLT_0481 - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 1 0 - PARAESTHESIA 0 1 (1.4%) 0 - HLT_0501 - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 2 0 - AMNESIA 0 1 (1.4%) 0 - HLT_0541 - Total number of patients with at least one adverse event 0 0 1 (1.0%) - Total number of events 0 0 3 - BALANCE DISORDER 0 0 1 (1.0%) - HLT_0558 - Total number of patients with at least one adverse event 0 0 1 (1.0%) - Total number of events 0 0 1 - COMPLEX PARTIAL SEIZURES 0 0 1 (1.0%) - HLT_0595 - Total number of patients with at least one adverse event 0 0 1 (1.0%) - Total number of events 0 0 1 - STUPOR 0 0 1 (1.0%) - HLT_0603 - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 1 0 - PARTIAL SEIZURES WITH SECONDARY GENERALISATION 0 1 (1.4%) 0 - HLT_0639 - Total number of patients with at least one adverse event 0 0 1 (1.0%) - Total number of events 0 0 1 - HEMIANOPIA HOMONYMOUS 0 0 1 (1.0%) - HLT_0727 - Total number of patients with at least one adverse event 0 0 1 (1.0%) - Total number of events 0 0 1 - PARAESTHESIA ORAL 0 0 1 (1.0%) - GASTROINTESTINAL DISORDERS - Total number of patients with at least one adverse event 17 (19.8%) 20 (27.8%) 16 (16.7%) - Total number of events 26 35 26 - HLT_0148 - Total number of patients with at least one adverse event 9 (10.5%) 3 (4.2%) 6 (6.2%) - Total number of events 10 3 8 - DIARRHOEA 9 (10.5%) 3 (4.2%) 6 (6.2%) - HLT_0016 - Total number of patients with at least one adverse event 3 (3.5%) 6 (8.3%) 4 (4.2%) - Total number of events 3 8 5 - VOMITING 3 (3.5%) 6 (8.3%) 4 (4.2%) - HLT_0742 - Total number of patients with at least one adverse event 3 (3.5%) 6 (8.3%) 3 (3.1%) - Total number of events 3 13 5 - NAUSEA 3 (3.5%) 6 (8.3%) 3 (3.1%) - HLT_0217 - Total number of patients with at least one adverse event 1 (1.2%) 1 (1.4%) 3 (3.1%) - Total number of events 1 2 3 - ABDOMINAL PAIN 1 (1.2%) 1 (1.4%) 3 (3.1%) - HLT_0374 - Total number of patients with at least one adverse event 0 4 (5.6%) 0 - Total number of events 0 5 0 - SALIVARY HYPERSECRETION 0 4 (5.6%) 0 - HLT_0244 - Total number of patients with at least one adverse event 1 (1.2%) 1 (1.4%) 1 (1.0%) - Total number of events 2 1 2 - DYSPEPSIA 1 (1.2%) 1 (1.4%) 1 (1.0%) - HLT_0012 - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 1 0 - ABDOMINAL DISCOMFORT 0 1 (1.4%) 0 - HLT_0065 - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 1 0 - STOMACH DISCOMFORT 0 1 (1.4%) 0 - HLT_0159 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 2 0 0 - HIATUS HERNIA 1 (1.2%) 0 0 - HLT_0250 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 1 0 0 - GLOSSITIS 1 (1.2%) 0 0 - HLT_0353 - Total number of patients with at least one adverse event 0 0 1 (1.0%) - Total number of events 0 0 2 - RECTAL HAEMORRHAGE 0 0 1 (1.0%) - HLT_0354 - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 1 0 - GASTROINTESTINAL HAEMORRHAGE 0 1 (1.4%) 0 - HLT_0356 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 2 0 0 - FLATULENCE 1 (1.2%) 0 0 - HLT_0402 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 1 0 0 - CONSTIPATION 1 (1.2%) 0 0 - HLT_0407 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 1 0 0 - GASTROOESOPHAGEAL REFLUX DISEASE 1 (1.2%) 0 0 - HLT_0563 - Total number of patients with at least one adverse event 0 0 1 (1.0%) - Total number of events 0 0 1 - DYSPHAGIA 0 0 1 (1.0%) - CARDIAC DISORDERS - Total number of patients with at least one adverse event 13 (15.1%) 15 (20.8%) 16 (16.7%) - Total number of events 27 30 34 - HLT_0644 - Total number of patients with at least one adverse event 2 (2.3%) 8 (11.1%) 7 (7.3%) - Total number of events 2 12 10 - SINUS BRADYCARDIA 2 (2.3%) 8 (11.1%) 7 (7.3%) - HLT_0649 - Total number of patients with at least one adverse event 4 (4.7%) 4 (5.6%) 2 (2.1%) - Total number of events 4 8 4 - MYOCARDIAL INFARCTION 4 (4.7%) 4 (5.6%) 2 (2.1%) - HLT_0365 - Total number of patients with at least one adverse event 1 (1.2%) 2 (2.8%) 2 (2.1%) - Total number of events 1 3 3 - ATRIAL FIBRILLATION 1 (1.2%) 2 (2.8%) 2 (2.1%) - HLT_0415 - Total number of patients with at least one adverse event 2 (2.3%) 1 (1.4%) 2 (2.1%) - Total number of events 2 2 2 - ATRIOVENTRICULAR BLOCK SECOND DEGREE 2 (2.3%) 1 (1.4%) 2 (2.1%) - HLT_0050 - Total number of patients with at least one adverse event 0 1 (1.4%) 2 (2.1%) - Total number of events 0 1 4 - VENTRICULAR EXTRASYSTOLES 0 1 (1.4%) 2 (2.1%) - HLT_0188 - Total number of patients with at least one adverse event 1 (1.2%) 1 (1.4%) 1 (1.0%) - Total number of events 2 1 2 - SUPRAVENTRICULAR EXTRASYSTOLES 1 (1.2%) 1 (1.4%) 1 (1.0%) - HLT_0419 - Total number of patients with at least one adverse event 1 (1.2%) 0 1 (1.0%) - Total number of events 1 0 1 - ATRIOVENTRICULAR BLOCK FIRST DEGREE 1 (1.2%) 0 1 (1.0%) - HLT_0477 - Total number of patients with at least one adverse event 0 1 (1.4%) 1 (1.0%) - Total number of events 0 2 1 - ATRIAL FLUTTER 0 1 (1.4%) 1 (1.0%) - HLT_0493 - Total number of patients with at least one adverse event 0 0 2 (2.1%) - Total number of events 0 0 2 - PALPITATIONS 0 0 2 (2.1%) - HLT_0751 - Total number of patients with at least one adverse event 1 (1.2%) 0 1 (1.0%) - Total number of events 2 0 1 - BUNDLE BRANCH BLOCK RIGHT 1 (1.2%) 0 1 (1.0%) - HLT_0082 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 2 0 0 - TACHYCARDIA 1 (1.2%) 0 0 - HLT_0094 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 2 0 0 - SINUS ARRHYTHMIA 1 (1.2%) 0 0 - HLT_0104 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 1 0 0 - VENTRICULAR HYPERTROPHY 1 (1.2%) 0 0 - HLT_0271 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 2 0 0 - ATRIAL HYPERTROPHY 1 (1.2%) 0 0 - HLT_0281 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 1 0 0 - BUNDLE BRANCH BLOCK LEFT 1 (1.2%) 0 0 - HLT_0507 - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 1 0 - CARDIAC DISORDER 0 1 (1.4%) 0 - HLT_0511 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 1 0 0 - CARDIAC FAILURE CONGESTIVE 1 (1.2%) 0 0 - HLT_0612 - Total number of patients with at least one adverse event 0 0 1 (1.0%) - Total number of events 0 0 2 - WOLFF-PARKINSON-WHITE SYNDROME 0 0 1 (1.0%) - HLT_0640 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 4 0 0 - BRADYCARDIA 1 (1.2%) 0 0 - HLT_0692 - Total number of patients with at least one adverse event 0 0 1 (1.0%) - Total number of events 0 0 2 - SUPRAVENTRICULAR TACHYCARDIA 0 0 1 (1.0%) - INFECTIONS AND INFESTATIONS - Total number of patients with at least one adverse event 16 (18.6%) 13 (18.1%) 10 (10.4%) - Total number of events 35 20 18 - HLT_0036 - Total number of patients with at least one adverse event 2 (2.3%) 6 (8.3%) 4 (4.2%) - Total number of events 4 8 9 - NASOPHARYNGITIS 2 (2.3%) 6 (8.3%) 4 (4.2%) - HLT_0520 - Total number of patients with at least one adverse event 6 (7.0%) 3 (4.2%) 1 (1.0%) - Total number of events 12 5 2 - UPPER RESPIRATORY TRACT INFECTION 6 (7.0%) 3 (4.2%) 1 (1.0%) - HLT_0125 - Total number of patients with at least one adverse event 1 (1.2%) 1 (1.4%) 1 (1.0%) - Total number of events 2 1 1 - INFLUENZA 1 (1.2%) 1 (1.4%) 1 (1.0%) - HLT_0161 - Total number of patients with at least one adverse event 2 (2.3%) 1 (1.4%) 0 - Total number of events 4 1 0 - URINARY TRACT INFECTION 2 (2.3%) 1 (1.4%) 0 - HLT_0435 - Total number of patients with at least one adverse event 1 (1.2%) 0 1 (1.0%) - Total number of events 2 0 1 - LOCALISED INFECTION 1 (1.2%) 0 1 (1.0%) - HLT_0739 - Total number of patients with at least one adverse event 1 (1.2%) 1 (1.4%) 0 - Total number of events 1 1 0 - CYSTITIS 1 (1.2%) 1 (1.4%) 0 - HLT_0757 - Total number of patients with at least one adverse event 2 (2.3%) 0 0 - Total number of events 4 0 0 - EAR INFECTION 2 (2.3%) 0 0 - HLT_0052 - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 2 0 - LOWER RESPIRATORY TRACT INFECTION 0 1 (1.4%) 0 - HLT_0211 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 1 0 0 - GASTROENTERITIS VIRAL 1 (1.2%) 0 0 - HLT_0239 - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 1 0 - RHINITIS 0 1 (1.4%) 0 - HLT_0251 - Total number of patients with at least one adverse event 0 0 1 (1.0%) - Total number of events 0 0 2 - PNEUMONIA 0 0 1 (1.0%) - HLT_0275 - Total number of patients with at least one adverse event 0 0 1 (1.0%) - Total number of events 0 0 1 - ONYCHOMYCOSIS 0 0 1 (1.0%) - HLT_0508 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 2 0 0 - VAGINAL MYCOSIS 1 (1.2%) 0 0 - HLT_0604 - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 1 0 - HORDEOLUM 0 1 (1.4%) 0 - HLT_0613 - Total number of patients with at least one adverse event 0 0 1 (1.0%) - Total number of events 0 0 1 - CELLULITIS 0 0 1 (1.0%) - HLT_0634 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 1 0 0 - BRONCHITIS 1 (1.2%) 0 0 - HLT_0651 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 2 0 0 - CERVICITIS 1 (1.2%) 0 0 - HLT_0733 - Total number of patients with at least one adverse event 0 0 1 (1.0%) - Total number of events 0 0 1 - VIRAL INFECTION 0 0 1 (1.0%) - RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - Total number of patients with at least one adverse event 10 (11.6%) 10 (13.9%) 10 (10.4%) - Total number of events 15 22 16 - HLT_0701 - Total number of patients with at least one adverse event 3 (3.5%) 5 (6.9%) 6 (6.2%) - Total number of events 4 7 9 - COUGH 3 (3.5%) 5 (6.9%) 6 (6.2%) - HLT_0118 - Total number of patients with at least one adverse event 3 (3.5%) 3 (4.2%) 1 (1.0%) - Total number of events 3 4 1 - NASAL CONGESTION 3 (3.5%) 3 (4.2%) 1 (1.0%) - HLT_0296 - Total number of patients with at least one adverse event 1 (1.2%) 1 (1.4%) 1 (1.0%) - Total number of events 1 1 1 - DYSPNOEA 1 (1.2%) 1 (1.4%) 1 (1.0%) - HLT_0386 - Total number of patients with at least one adverse event 0 2 (2.8%) 1 (1.0%) - Total number of events 0 2 1 - EPISTAXIS 0 2 (2.8%) 1 (1.0%) - HLT_0130 - Total number of patients with at least one adverse event 0 1 (1.4%) 1 (1.0%) - Total number of events 0 1 1 - PHARYNGOLARYNGEAL PAIN 0 1 (1.4%) 1 (1.0%) - HLT_0635 - Total number of patients with at least one adverse event 0 1 (1.4%) 1 (1.0%) - Total number of events 0 2 2 - RHINORRHOEA 0 1 (1.4%) 1 (1.0%) - HLT_0020 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 2 0 0 - RALES 1 (1.2%) 0 0 - HLT_0073 - Total number of patients with at least one adverse event 0 0 1 (1.0%) - Total number of events 0 0 1 - DYSPHONIA 0 0 1 (1.0%) - HLT_0114 - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 1 0 - ALLERGIC GRANULOMATOUS ANGIITIS 0 1 (1.4%) 0 - HLT_0172 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 2 0 0 - POSTNASAL DRIP 1 (1.2%) 0 0 - HLT_0192 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 2 0 0 - HAEMOPTYSIS 1 (1.2%) 0 0 - HLT_0330 - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 1 0 - RESPIRATORY TRACT CONGESTION 0 1 (1.4%) 0 - HLT_0545 - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 1 0 - PRODUCTIVE COUGH 0 1 (1.4%) 0 - HLT_0591 - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 2 0 - PHARYNGEAL ERYTHEMA 0 1 (1.4%) 0 - HLT_0698 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 1 0 0 - EMPHYSEMA 1 (1.2%) 0 0 - PSYCHIATRIC DISORDERS - Total number of patients with at least one adverse event 10 (11.6%) 8 (11.1%) 11 (11.5%) - Total number of events 14 11 15 - HLT_0642 - Total number of patients with at least one adverse event 2 (2.3%) 1 (1.4%) 3 (3.1%) - Total number of events 2 1 3 - CONFUSIONAL STATE 2 (2.3%) 1 (1.4%) 3 (3.1%) - HLT_0140 - Total number of patients with at least one adverse event 2 (2.3%) 0 3 (3.1%) - Total number of events 2 0 3 - AGITATION 2 (2.3%) 0 3 (3.1%) - HLT_0297 - Total number of patients with at least one adverse event 2 (2.3%) 2 (2.8%) 0 - Total number of events 3 2 0 - INSOMNIA 2 (2.3%) 2 (2.8%) 0 - HLT_0559 - Total number of patients with at least one adverse event 1 (1.2%) 0 3 (3.1%) - Total number of events 2 0 4 - ANXIETY 1 (1.2%) 0 3 (3.1%) - HLT_0198 - Total number of patients with at least one adverse event 1 (1.2%) 1 (1.4%) 0 - Total number of events 1 1 0 - DELUSION 1 (1.2%) 1 (1.4%) 0 - HLT_0627 - Total number of patients with at least one adverse event 1 (1.2%) 0 1 (1.0%) - Total number of events 2 0 1 - IRRITABILITY 1 (1.2%) 0 1 (1.0%) - HLT_0784 - Total number of patients with at least one adverse event 0 1 (1.4%) 1 (1.0%) - Total number of events 0 1 2 - DEPRESSED MOOD 0 1 (1.4%) 1 (1.0%) - HLT_0026 - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 1 0 - HALLUCINATION 0 1 (1.4%) 0 - HLT_0186 - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 1 0 - NIGHTMARE 0 1 (1.4%) 0 - HLT_0299 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 1 0 0 - DISORIENTATION 1 (1.2%) 0 0 - HLT_0338 - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 1 0 - LIBIDO DECREASED 0 1 (1.4%) 0 - HLT_0369 - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 1 0 - HALLUCINATION, VISUAL 0 1 (1.4%) 0 - HLT_0376 - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 1 0 - DELIRIUM 0 1 (1.4%) 0 - HLT_0427 - Total number of patients with at least one adverse event 0 0 1 (1.0%) - Total number of events 0 0 2 - RESTLESSNESS 0 0 1 (1.0%) - HLT_0625 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 1 0 0 - COMPLETED SUICIDE 1 (1.2%) 0 0 - HLT_0657 - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 1 0 - LISTLESS 0 1 (1.4%) 0 - INVESTIGATIONS - Total number of patients with at least one adverse event 10 (11.6%) 5 (6.9%) 8 (8.3%) - Total number of events 19 6 15 - HLT_0610 - Total number of patients with at least one adverse event 4 (4.7%) 0 1 (1.0%) - Total number of events 4 0 2 - ELECTROCARDIOGRAM ST SEGMENT DEPRESSION 4 (4.7%) 0 1 (1.0%) - HLT_0289 - Total number of patients with at least one adverse event 2 (2.3%) 1 (1.4%) 1 (1.0%) - Total number of events 3 1 1 - ELECTROCARDIOGRAM T WAVE INVERSION 2 (2.3%) 1 (1.4%) 1 (1.0%) - HLT_0037 - Total number of patients with at least one adverse event 1 (1.2%) 0 1 (1.0%) - Total number of events 1 0 1 - ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED 1 (1.2%) 0 1 (1.0%) - HLT_0450 - Total number of patients with at least one adverse event 0 1 (1.4%) 1 (1.0%) - Total number of events 0 2 1 - BLOOD GLUCOSE INCREASED 0 1 (1.4%) 1 (1.0%) - HLT_0158 - Total number of patients with at least one adverse event 0 0 1 (1.0%) - Total number of events 0 0 2 - WEIGHT DECREASED 0 0 1 (1.0%) - HLT_0210 - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 1 0 - BLOOD CHOLESTEROL INCREASED 0 1 (1.4%) 0 - HLT_0326 - Total number of patients with at least one adverse event 0 0 1 (1.0%) - Total number of events 0 0 2 - NEUTROPHIL COUNT INCREASED 0 0 1 (1.0%) - HLT_0404 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 2 0 0 - BLOOD CREATINE PHOSPHOKINASE INCREASED 1 (1.2%) 0 0 - HLT_0417 - Total number of patients with at least one adverse event 0 0 1 (1.0%) - Total number of events 0 0 2 - WHITE BLOOD CELL COUNT INCREASED 0 0 1 (1.0%) - HLT_0436 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 1 0 0 - CYSTOSCOPY 1 (1.2%) 0 0 - HLT_0458 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 1 0 0 - BLOOD URINE PRESENT 1 (1.2%) 0 0 - HLT_0553 - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 1 0 - BIOPSY PROSTATE 0 1 (1.4%) 0 - HLT_0615 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 1 0 0 - BLOOD ALKALINE PHOSPHATASE INCREASED 1 (1.2%) 0 0 - HLT_0646 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 2 0 0 - HEART RATE INCREASED 1 (1.2%) 0 0 - HLT_0680 - Total number of patients with at least one adverse event 0 0 1 (1.0%) - Total number of events 0 0 1 - NASAL MUCOSA BIOPSY 0 0 1 (1.0%) - HLT_0685 - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 1 0 - BIOPSY 0 1 (1.4%) 0 - HLT_0734 - Total number of patients with at least one adverse event 0 0 1 (1.0%) - Total number of events 0 0 1 - BODY TEMPERATURE INCREASED 0 0 1 (1.0%) - HLT_0765 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 4 0 0 - HEART RATE IRREGULAR 1 (1.2%) 0 0 - HLT_0783 - Total number of patients with at least one adverse event 0 0 1 (1.0%) - Total number of events 0 0 2 - URINE ANALYSIS ABNORMAL 0 0 1 (1.0%) - MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS - Total number of patients with at least one adverse event 5 (5.8%) 8 (11.1%) 7 (7.3%) - Total number of events 8 11 10 - HLT_0115 - Total number of patients with at least one adverse event 1 (1.2%) 3 (4.2%) 1 (1.0%) - Total number of events 2 4 1 - BACK PAIN 1 (1.2%) 3 (4.2%) 1 (1.0%) - HLT_0375 - Total number of patients with at least one adverse event 1 (1.2%) 1 (1.4%) 2 (2.1%) - Total number of events 1 1 4 - ARTHRALGIA 1 (1.2%) 1 (1.4%) 2 (2.1%) - HLT_0527 - Total number of patients with at least one adverse event 1 (1.2%) 0 2 (2.1%) - Total number of events 2 0 2 - SHOULDER PAIN 1 (1.2%) 0 2 (2.1%) - HLT_0019 - Total number of patients with at least one adverse event 1 (1.2%) 1 (1.4%) 0 - Total number of events 2 1 0 - ARTHRITIS 1 (1.2%) 1 (1.4%) 0 - HLT_0078 - Total number of patients with at least one adverse event 0 1 (1.4%) 1 (1.0%) - Total number of events 0 2 1 - MUSCLE SPASMS 0 1 (1.4%) 1 (1.0%) - HLT_0484 - Total number of patients with at least one adverse event 0 2 (2.8%) 0 - Total number of events 0 2 0 - FLANK PAIN 0 2 (2.8%) 0 - HLT_0213 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 1 0 0 - PAIN IN EXTREMITY 1 (1.2%) 0 0 - HLT_0444 - Total number of patients with at least one adverse event 0 0 1 (1.0%) - Total number of events 0 0 2 - MUSCULAR WEAKNESS 0 0 1 (1.0%) - HLT_0700 - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 1 0 - MYALGIA 0 1 (1.4%) 0 - INJURY, POISONING AND PROCEDURAL COMPLICATIONS - Total number of patients with at least one adverse event 4 (4.7%) 5 (6.9%) 5 (5.2%) - Total number of events 9 8 12 - HLT_0168 - Total number of patients with at least one adverse event 1 (1.2%) 1 (1.4%) 2 (2.1%) - Total number of events 2 1 2 - FALL 1 (1.2%) 1 (1.4%) 2 (2.1%) - HLT_0713 - Total number of patients with at least one adverse event 1 (1.2%) 2 (2.8%) 1 (1.0%) - Total number of events 1 3 3 - CONTUSION 1 (1.2%) 2 (2.8%) 1 (1.0%) - HLT_0738 - Total number of patients with at least one adverse event 2 (2.3%) 1 (1.4%) 1 (1.0%) - Total number of events 3 1 2 - EXCORIATION 2 (2.3%) 1 (1.4%) 1 (1.0%) - HLT_0075 - Total number of patients with at least one adverse event 1 (1.2%) 0 2 (2.1%) - Total number of events 1 0 2 - SKIN LACERATION 1 (1.2%) 0 2 (2.1%) - HLT_0097 - Total number of patients with at least one adverse event 1 (1.2%) 2 (2.8%) 0 - Total number of events 2 2 0 - HIP FRACTURE 1 (1.2%) 2 (2.8%) 0 - HLT_0035 - Total number of patients with at least one adverse event 0 0 1 (1.0%) - Total number of events 0 0 1 - JOINT DISLOCATION 0 0 1 (1.0%) - HLT_0305 - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 1 0 - FACIAL BONES FRACTURE 0 1 (1.4%) 0 - HLT_0542 - Total number of patients with at least one adverse event 0 0 1 (1.0%) - Total number of events 0 0 2 - WOUND 0 0 1 (1.0%) - RENAL AND URINARY DISORDERS - Total number of patients with at least one adverse event 4 (4.7%) 3 (4.2%) 4 (4.2%) - Total number of events 5 4 4 - HLT_0294 - Total number of patients with at least one adverse event 1 (1.2%) 1 (1.4%) 1 (1.0%) - Total number of events 1 2 1 - MICTURITION URGENCY 1 (1.2%) 1 (1.4%) 1 (1.0%) - HLT_0439 - Total number of patients with at least one adverse event 1 (1.2%) 1 (1.4%) 0 - Total number of events 1 1 0 - NEPHROLITHIASIS 1 (1.2%) 1 (1.4%) 0 - HLT_0637 - Total number of patients with at least one adverse event 1 (1.2%) 0 1 (1.0%) - Total number of events 1 0 1 - DYSURIA 1 (1.2%) 0 1 (1.0%) - HLT_0107 - Total number of patients with at least one adverse event 0 0 1 (1.0%) - Total number of events 0 0 1 - ENURESIS 0 0 1 (1.0%) - HLT_0393 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 2 0 0 - POLLAKIURIA 1 (1.2%) 0 0 - HLT_0550 - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 1 0 - CALCULUS URETHRAL 0 1 (1.4%) 0 - HLT_0560 - Total number of patients with at least one adverse event 0 0 1 (1.0%) - Total number of events 0 0 1 - INCONTINENCE 0 0 1 (1.0%) - METABOLISM AND NUTRITION DISORDERS - Total number of patients with at least one adverse event 6 (7.0%) 3 (4.2%) 1 (1.0%) - Total number of events 8 5 1 - HLT_0566 - Total number of patients with at least one adverse event 1 (1.2%) 1 (1.4%) 0 - Total number of events 2 2 0 - INCREASED APPETITE 1 (1.2%) 1 (1.4%) 0 - HLT_0574 - Total number of patients with at least one adverse event 1 (1.2%) 1 (1.4%) 0 - Total number of events 2 2 0 - DECREASED APPETITE 1 (1.2%) 1 (1.4%) 0 - HLT_0754 - Total number of patients with at least one adverse event 1 (1.2%) 0 1 (1.0%) - Total number of events 1 0 1 - FOOD CRAVING 1 (1.2%) 0 1 (1.0%) - HLT_0025 - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 1 0 - HYPERCHOLESTEROLAEMIA 0 1 (1.4%) 0 - HLT_0447 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 1 0 0 - DIABETES MELLITUS 1 (1.2%) 0 0 - HLT_0533 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 1 0 0 - DEHYDRATION 1 (1.2%) 0 0 - HLT_0688 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 1 0 0 - HYPONATRAEMIA 1 (1.2%) 0 0 - VASCULAR DISORDERS - Total number of patients with at least one adverse event 3 (3.5%) 1 (1.4%) 4 (4.2%) - Total number of events 7 1 5 - HLT_0228 - Total number of patients with at least one adverse event 1 (1.2%) 0 2 (2.1%) - Total number of events 2 0 3 - HYPERTENSION 1 (1.2%) 0 2 (2.1%) - HLT_0761 - Total number of patients with at least one adverse event 2 (2.3%) 0 1 (1.0%) - Total number of events 3 0 1 - HYPOTENSION 2 (2.3%) 0 1 (1.0%) - HLT_0154 - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 1 0 - WOUND HAEMORRHAGE 0 1 (1.4%) 0 - HLT_0194 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 2 0 0 - ORTHOSTATIC HYPOTENSION 1 (1.2%) 0 0 - HLT_0737 - Total number of patients with at least one adverse event 0 0 1 (1.0%) - Total number of events 0 0 1 - HOT FLUSH 0 0 1 (1.0%) - EYE DISORDERS - Total number of patients with at least one adverse event 4 (4.7%) 1 (1.4%) 2 (2.1%) - Total number of events 8 2 2 - HLT_0120 - Total number of patients with at least one adverse event 0 1 (1.4%) 1 (1.0%) - Total number of events 0 2 1 - VISION BLURRED 0 1 (1.4%) 1 (1.0%) - HLT_0584 - Total number of patients with at least one adverse event 2 (2.3%) 0 0 - Total number of events 4 0 0 - CONJUNCTIVITIS 2 (2.3%) 0 0 - HLT_0008 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 1 0 0 - EYE SWELLING 1 (1.2%) 0 0 - HLT_0013 - Total number of patients with at least one adverse event 0 0 1 (1.0%) - Total number of events 0 0 1 - CONJUNCTIVAL HAEMORRHAGE 0 0 1 (1.0%) - HLT_0256 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 1 0 0 - EYE ALLERGY 1 (1.2%) 0 0 - HLT_0523 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 1 0 0 - EYE PRURITUS 1 (1.2%) 0 0 - HLT_0556 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 1 0 0 - GLAUCOMA 1 (1.2%) 0 0 - SURGICAL AND MEDICAL PROCEDURES - Total number of patients with at least one adverse event 2 (2.3%) 2 (2.8%) 1 (1.0%) - Total number of events 2 2 1 - HLT_0432 - Total number of patients with at least one adverse event 1 (1.2%) 0 1 (1.0%) - Total number of events 1 0 1 - CATARACT OPERATION 1 (1.2%) 0 1 (1.0%) - HLT_0355 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 1 0 0 - EYE LASER SURGERY 1 (1.2%) 0 0 - HLT_0498 - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 1 0 - SKIN LESION EXCISION 0 1 (1.4%) 0 - HLT_0629 - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 1 0 - ACROCHORDON EXCISION 0 1 (1.4%) 0 - EAR AND LABYRINTH DISORDERS - Total number of patients with at least one adverse event 1 (1.2%) 1 (1.4%) 2 (2.1%) - Total number of events 2 1 3 - HLT_0255 - Total number of patients with at least one adverse event 0 1 (1.4%) 1 (1.0%) - Total number of events 0 1 1 - VERTIGO 0 1 (1.4%) 1 (1.0%) - HLT_0018 - Total number of patients with at least one adverse event 0 0 1 (1.0%) - Total number of events 0 0 1 - CERUMEN IMPACTION 0 0 1 (1.0%) - HLT_0570 - Total number of patients with at least one adverse event 0 0 1 (1.0%) - Total number of events 0 0 1 - TINNITUS 0 0 1 (1.0%) - HLT_0631 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 2 0 0 - EAR PAIN 1 (1.2%) 0 0 - CONGENITAL, FAMILIAL AND GENETIC DISORDERS - Total number of patients with at least one adverse event 0 2 (2.8%) 1 (1.0%) - Total number of events 0 2 1 - HLT_0589 - Total number of patients with at least one adverse event 0 2 (2.8%) 1 (1.0%) - Total number of events 0 2 1 - VENTRICULAR SEPTAL DEFECT 0 2 (2.8%) 1 (1.0%) - NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - Total number of patients with at least one adverse event 0 1 (1.4%) 2 (2.1%) - Total number of events 0 1 3 - HLT_0245 - Total number of patients with at least one adverse event 0 0 1 (1.0%) - Total number of events 0 0 2 - MALIGNANT FIBROUS HISTIOCYTOMA 0 0 1 (1.0%) - HLT_0412 - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 1 0 - PROSTATE CANCER 0 1 (1.4%) 0 - HLT_0597 - Total number of patients with at least one adverse event 0 0 1 (1.0%) - Total number of events 0 0 1 - COLON CANCER 0 0 1 (1.0%) - REPRODUCTIVE SYSTEM AND BREAST DISORDERS - Total number of patients with at least one adverse event 2 (2.3%) 1 (1.4%) 0 - Total number of events 4 1 0 - HLT_0215 - Total number of patients with at least one adverse event 1 (1.2%) 1 (1.4%) 0 - Total number of events 2 1 0 - BENIGN PROSTATIC HYPERPLASIA 1 (1.2%) 1 (1.4%) 0 - HLT_0189 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 2 0 0 - PELVIC PAIN 1 (1.2%) 0 0 - IMMUNE SYSTEM DISORDERS - Total number of patients with at least one adverse event 0 1 (1.4%) 1 (1.0%) - Total number of events 0 1 2 - HLT_0473 - Total number of patients with at least one adverse event 0 0 1 (1.0%) - Total number of events 0 0 2 - HYPERSENSITIVITY 0 0 1 (1.0%) - HLT_0714 - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 1 0 - SEASONAL ALLERGY 0 1 (1.4%) 0 - HEPATOBILIARY DISORDERS - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 1 0 0 - HLT_0478 - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 1 0 0 - HYPERBILIRUBINAEMIA 1 (1.2%) 0 0 - SOCIAL CIRCUMSTANCES - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 1 0 - HLT_0138 - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 1 0 - ALCOHOL USE 0 1 (1.4%) 0 + MedDRA System Organ Class + High Level Term Placebo Xanomeline High Dose Xanomeline Low Dose + MedDRA Preferred Term (N=86) (N=72) (N=96) + —————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— + Total number of patients with at least one adverse event 37 (43.0%) 61 (84.7%) 64 (66.7%) + Overall total number of events 75 197 181 + SKIN AND SUBCUTANEOUS TISSUE DISORDERS + Total number of patients with at least one adverse event 19 (22.1%) 34 (47.2%) 35 (36.5%) + Total number of events 37 86 90 + HLT_0778 + Total number of patients with at least one adverse event 8 (9.3%) 26 (36.1%) 23 (24.0%) + Total number of events 11 38 35 + PRURITUS 8 (9.3%) 26 (36.1%) 23 (24.0%) + HLT_0284 + Total number of patients with at least one adverse event 9 (10.5%) 14 (19.4%) 15 (15.6%) + Total number of events 13 22 24 + ERYTHEMA 9 (10.5%) 14 (19.4%) 15 (15.6%) + HLT_0762 + Total number of patients with at least one adverse event 5 (5.8%) 11 (15.3%) 13 (13.5%) + Total number of events 9 18 18 + RASH 5 (5.8%) 11 (15.3%) 13 (13.5%) + HLT_0583 + Total number of patients with at least one adverse event 3 (3.5%) 5 (6.9%) 6 (6.2%) + Total number of events 4 8 13 + SKIN IRRITATION 3 (3.5%) 5 (6.9%) 6 (6.2%) + GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS + Total number of patients with at least one adverse event 10 (11.6%) 29 (40.3%) 31 (32.3%) + Total number of events 20 72 73 + HLT_0317 + Total number of patients with at least one adverse event 6 (7.0%) 21 (29.2%) 23 (24.0%) + Total number of events 10 34 34 + APPLICATION SITE PRURITUS 6 (7.0%) 21 (29.2%) 23 (24.0%) + HLT_0617 + Total number of patients with at least one adverse event 3 (3.5%) 14 (19.4%) 13 (13.5%) + Total number of events 3 22 21 + APPLICATION SITE ERYTHEMA 3 (3.5%) 14 (19.4%) 13 (13.5%) + HLT_0061 + Total number of patients with at least one adverse event 3 (3.5%) 9 (12.5%) 9 (9.4%) + Total number of events 7 16 18 + APPLICATION SITE IRRITATION 3 (3.5%) 9 (12.5%) 9 (9.4%) + GASTROINTESTINAL DISORDERS + Total number of patients with at least one adverse event 4 (4.7%) 10 (13.9%) 6 (6.2%) + Total number of events 6 21 10 + HLT_0016 + Total number of patients with at least one adverse event 3 (3.5%) 6 (8.3%) 4 (4.2%) + Total number of events 3 8 5 + VOMITING 3 (3.5%) 6 (8.3%) 4 (4.2%) + HLT_0742 + Total number of patients with at least one adverse event 3 (3.5%) 6 (8.3%) 3 (3.1%) + Total number of events 3 13 5 + NAUSEA 3 (3.5%) 6 (8.3%) 3 (3.1%) + NERVOUS SYSTEM DISORDERS + Total number of patients with at least one adverse event 7 (8.1%) 6 (8.3%) 3 (3.1%) + Total number of events 8 9 4 + HLT_0064 + Total number of patients with at least one adverse event 7 (8.1%) 6 (8.3%) 3 (3.1%) + Total number of events 8 9 4 + HEADACHE 7 (8.1%) 6 (8.3%) 3 (3.1%) + CARDIAC DISORDERS + Total number of patients with at least one adverse event 4 (4.7%) 4 (5.6%) 2 (2.1%) + Total number of events 4 8 4 + HLT_0649 + Total number of patients with at least one adverse event 4 (4.7%) 4 (5.6%) 2 (2.1%) + Total number of events 4 8 4 + MYOCARDIAL INFARCTION 4 (4.7%) 4 (5.6%) 2 (2.1%) + VASCULAR DISORDERS + Total number of patients with at least one adverse event 0 1 (1.4%) 0 + Total number of events 0 1 0 + HLT_0154 + Total number of patients with at least one adverse event 0 1 (1.4%) 0 + Total number of events 0 1 0 + WOUND HAEMORRHAGE 0 1 (1.4%) 0 # AET02 variant 4 is produced correctly @@ -1699,249 +166,19 @@ Placebo Xanomeline High Dose Xanomeline Low Dose MedDRA Preferred Term (N=86) (N=72) (N=96) —————————————————————————————————————————————————————————————————————————————————————————————————————————————————— - Total number of patients with at least one adverse event 69 (80.2%) 70 (97.2%) 86 (89.6%) - Total number of events 301 436 454 + Total number of patients with at least one adverse event 37 (43.0%) 61 (84.7%) 64 (66.7%) + Total number of events 75 197 181 PRURITUS 8 (9.3%) 26 (36.1%) 23 (24.0%) APPLICATION SITE PRURITUS 6 (7.0%) 21 (29.2%) 23 (24.0%) ERYTHEMA 9 (10.5%) 14 (19.4%) 15 (15.6%) APPLICATION SITE ERYTHEMA 3 (3.5%) 14 (19.4%) 13 (13.5%) RASH 5 (5.8%) 11 (15.3%) 13 (13.5%) - DIZZINESS 2 (2.3%) 11 (15.3%) 9 (9.4%) - APPLICATION SITE DERMATITIS 5 (5.8%) 7 (9.7%) 9 (9.4%) APPLICATION SITE IRRITATION 3 (3.5%) 9 (12.5%) 9 (9.4%) - DIARRHOEA 9 (10.5%) 3 (4.2%) 6 (6.2%) - SINUS BRADYCARDIA 2 (2.3%) 8 (11.1%) 7 (7.3%) HEADACHE 7 (8.1%) 6 (8.3%) 3 (3.1%) - COUGH 3 (3.5%) 5 (6.9%) 6 (6.2%) - HYPERHIDROSIS 2 (2.3%) 8 (11.1%) 4 (4.2%) SKIN IRRITATION 3 (3.5%) 5 (6.9%) 6 (6.2%) VOMITING 3 (3.5%) 6 (8.3%) 4 (4.2%) - NASOPHARYNGITIS 2 (2.3%) 6 (8.3%) 4 (4.2%) NAUSEA 3 (3.5%) 6 (8.3%) 3 (3.1%) - APPLICATION SITE VESICLES 1 (1.2%) 5 (6.9%) 5 (5.2%) - FATIGUE 1 (1.2%) 5 (6.9%) 5 (5.2%) MYOCARDIAL INFARCTION 4 (4.7%) 4 (5.6%) 2 (2.1%) - UPPER RESPIRATORY TRACT INFECTION 6 (7.0%) 3 (4.2%) 1 (1.0%) - NASAL CONGESTION 3 (3.5%) 3 (4.2%) 1 (1.0%) - SYNCOPE 0 2 (2.8%) 5 (5.2%) - BLISTER 0 1 (1.4%) 5 (5.2%) - CONFUSIONAL STATE 2 (2.3%) 1 (1.4%) 3 (3.1%) - SOMNOLENCE 2 (2.3%) 1 (1.4%) 3 (3.1%) - ABDOMINAL PAIN 1 (1.2%) 1 (1.4%) 3 (3.1%) - AGITATION 2 (2.3%) 0 3 (3.1%) - ATRIAL FIBRILLATION 1 (1.2%) 2 (2.8%) 2 (2.1%) - ATRIOVENTRICULAR BLOCK SECOND DEGREE 2 (2.3%) 1 (1.4%) 2 (2.1%) - BACK PAIN 1 (1.2%) 3 (4.2%) 1 (1.0%) - ELECTROCARDIOGRAM ST SEGMENT DEPRESSION 4 (4.7%) 0 1 (1.0%) - OEDEMA PERIPHERAL 2 (2.3%) 2 (2.8%) 1 (1.0%) - ANXIETY 1 (1.2%) 0 3 (3.1%) - ARTHRALGIA 1 (1.2%) 1 (1.4%) 2 (2.1%) - CONTUSION 1 (1.2%) 2 (2.8%) 1 (1.0%) - ELECTROCARDIOGRAM T WAVE INVERSION 2 (2.3%) 1 (1.4%) 1 (1.0%) - EXCORIATION 2 (2.3%) 1 (1.4%) 1 (1.0%) - FALL 1 (1.2%) 1 (1.4%) 2 (2.1%) - INSOMNIA 2 (2.3%) 2 (2.8%) 0 - SALIVARY HYPERSECRETION 0 4 (5.6%) 0 - APPLICATION SITE SWELLING 0 2 (2.8%) 1 (1.0%) - APPLICATION SITE URTICARIA 0 1 (1.4%) 2 (2.1%) - CHILLS 1 (1.2%) 1 (1.4%) 1 (1.0%) - DYSPEPSIA 1 (1.2%) 1 (1.4%) 1 (1.0%) - DYSPNOEA 1 (1.2%) 1 (1.4%) 1 (1.0%) - EPISTAXIS 0 2 (2.8%) 1 (1.0%) - HIP FRACTURE 1 (1.2%) 2 (2.8%) 0 - HYPERTENSION 1 (1.2%) 0 2 (2.1%) - HYPOTENSION 2 (2.3%) 0 1 (1.0%) - INFLUENZA 1 (1.2%) 1 (1.4%) 1 (1.0%) - MALAISE 0 2 (2.8%) 1 (1.0%) - MICTURITION URGENCY 1 (1.2%) 1 (1.4%) 1 (1.0%) - PYREXIA 2 (2.3%) 0 1 (1.0%) - RASH PRURITIC 0 2 (2.8%) 1 (1.0%) - SHOULDER PAIN 1 (1.2%) 0 2 (2.1%) - SKIN LACERATION 1 (1.2%) 0 2 (2.1%) - SUPRAVENTRICULAR EXTRASYSTOLES 1 (1.2%) 1 (1.4%) 1 (1.0%) - TRANSIENT ISCHAEMIC ATTACK 0 1 (1.4%) 2 (2.1%) - URINARY TRACT INFECTION 2 (2.3%) 1 (1.4%) 0 - VENTRICULAR EXTRASYSTOLES 0 1 (1.4%) 2 (2.1%) - VENTRICULAR SEPTAL DEFECT 0 2 (2.8%) 1 (1.0%) - APPLICATION SITE PAIN 0 2 (2.8%) 0 - APPLICATION SITE PERSPIRATION 0 2 (2.8%) 0 - APPLICATION SITE REACTION 1 (1.2%) 1 (1.4%) 0 - ARTHRITIS 1 (1.2%) 1 (1.4%) 0 - ASTHENIA 1 (1.2%) 0 1 (1.0%) - ATRIAL FLUTTER 0 1 (1.4%) 1 (1.0%) - ATRIOVENTRICULAR BLOCK FIRST DEGREE 1 (1.2%) 0 1 (1.0%) - BENIGN PROSTATIC HYPERPLASIA 1 (1.2%) 1 (1.4%) 0 - BLOOD GLUCOSE INCREASED 0 1 (1.4%) 1 (1.0%) - BUNDLE BRANCH BLOCK RIGHT 1 (1.2%) 0 1 (1.0%) - BURNING SENSATION 0 2 (2.8%) 0 - CATARACT OPERATION 1 (1.2%) 0 1 (1.0%) - CHEST DISCOMFORT 0 1 (1.4%) 1 (1.0%) - CHEST PAIN 0 2 (2.8%) 0 - CONJUNCTIVITIS 2 (2.3%) 0 0 - CYSTITIS 1 (1.2%) 1 (1.4%) 0 - DECREASED APPETITE 1 (1.2%) 1 (1.4%) 0 - DELUSION 1 (1.2%) 1 (1.4%) 0 - DEPRESSED MOOD 0 1 (1.4%) 1 (1.0%) - DYSURIA 1 (1.2%) 0 1 (1.0%) - EAR INFECTION 2 (2.3%) 0 0 - ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED 1 (1.2%) 0 1 (1.0%) - FLANK PAIN 0 2 (2.8%) 0 - FOOD CRAVING 1 (1.2%) 0 1 (1.0%) - INCREASED APPETITE 1 (1.2%) 1 (1.4%) 0 - IRRITABILITY 1 (1.2%) 0 1 (1.0%) - LETHARGY 0 1 (1.4%) 1 (1.0%) - LOCALISED INFECTION 1 (1.2%) 0 1 (1.0%) - MUSCLE SPASMS 0 1 (1.4%) 1 (1.0%) - NEPHROLITHIASIS 1 (1.2%) 1 (1.4%) 0 - OEDEMA 0 0 2 (2.1%) - PAIN 0 1 (1.4%) 1 (1.0%) - PALPITATIONS 0 0 2 (2.1%) - PHARYNGOLARYNGEAL PAIN 0 1 (1.4%) 1 (1.0%) - PRURITUS GENERALISED 0 1 (1.4%) 1 (1.0%) - RASH ERYTHEMATOUS 0 0 2 (2.1%) - RHINORRHOEA 0 1 (1.4%) 1 (1.0%) - URTICARIA 0 1 (1.4%) 1 (1.0%) - VERTIGO 0 1 (1.4%) 1 (1.0%) - VISION BLURRED 0 1 (1.4%) 1 (1.0%) - ABDOMINAL DISCOMFORT 0 1 (1.4%) 0 - ACROCHORDON EXCISION 0 1 (1.4%) 0 - ACTINIC KERATOSIS 0 1 (1.4%) 0 - ALCOHOL USE 0 1 (1.4%) 0 - ALLERGIC GRANULOMATOUS ANGIITIS 0 1 (1.4%) 0 - ALOPECIA 1 (1.2%) 0 0 - AMNESIA 0 1 (1.4%) 0 - APPLICATION SITE BLEEDING 0 0 1 (1.0%) - APPLICATION SITE DESQUAMATION 0 0 1 (1.0%) - APPLICATION SITE DISCHARGE 0 1 (1.4%) 0 - APPLICATION SITE DISCOLOURATION 0 0 1 (1.0%) - APPLICATION SITE INDURATION 1 (1.2%) 0 0 - APPLICATION SITE WARMTH 0 0 1 (1.0%) - ATRIAL HYPERTROPHY 1 (1.2%) 0 0 - BALANCE DISORDER 0 0 1 (1.0%) - BIOPSY 0 1 (1.4%) 0 - BIOPSY PROSTATE 0 1 (1.4%) 0 - BLOOD ALKALINE PHOSPHATASE INCREASED 1 (1.2%) 0 0 - BLOOD CHOLESTEROL INCREASED 0 1 (1.4%) 0 - BLOOD CREATINE PHOSPHOKINASE INCREASED 1 (1.2%) 0 0 - BLOOD URINE PRESENT 1 (1.2%) 0 0 - BODY TEMPERATURE INCREASED 0 0 1 (1.0%) - BRADYCARDIA 1 (1.2%) 0 0 - BRONCHITIS 1 (1.2%) 0 0 - BUNDLE BRANCH BLOCK LEFT 1 (1.2%) 0 0 - CALCULUS URETHRAL 0 1 (1.4%) 0 - CARDIAC DISORDER 0 1 (1.4%) 0 - CARDIAC FAILURE CONGESTIVE 1 (1.2%) 0 0 - CELLULITIS 0 0 1 (1.0%) - CERUMEN IMPACTION 0 0 1 (1.0%) - CERVICITIS 1 (1.2%) 0 0 - COGNITIVE DISORDER 0 1 (1.4%) 0 - COLD SWEAT 1 (1.2%) 0 0 - COLON CANCER 0 0 1 (1.0%) - COMPLETED SUICIDE 1 (1.2%) 0 0 - COMPLEX PARTIAL SEIZURES 0 0 1 (1.0%) - CONJUNCTIVAL HAEMORRHAGE 0 0 1 (1.0%) - CONSTIPATION 1 (1.2%) 0 0 - COORDINATION ABNORMAL 0 0 1 (1.0%) - CYST 0 0 1 (1.0%) - CYSTOSCOPY 1 (1.2%) 0 0 - DEHYDRATION 1 (1.2%) 0 0 - DELIRIUM 0 1 (1.4%) 0 - DERMATITIS ATOPIC 1 (1.2%) 0 0 - DERMATITIS CONTACT 0 0 1 (1.0%) - DIABETES MELLITUS 1 (1.2%) 0 0 - DISORIENTATION 1 (1.2%) 0 0 - DRUG ERUPTION 1 (1.2%) 0 0 - DYSPHAGIA 0 0 1 (1.0%) - DYSPHONIA 0 0 1 (1.0%) - EAR PAIN 1 (1.2%) 0 0 - EMPHYSEMA 1 (1.2%) 0 0 - ENURESIS 0 0 1 (1.0%) - EYE ALLERGY 1 (1.2%) 0 0 - EYE LASER SURGERY 1 (1.2%) 0 0 - EYE PRURITUS 1 (1.2%) 0 0 - EYE SWELLING 1 (1.2%) 0 0 - FACIAL BONES FRACTURE 0 1 (1.4%) 0 - FEELING ABNORMAL 0 1 (1.4%) 0 - FEELING COLD 0 1 (1.4%) 0 - FLATULENCE 1 (1.2%) 0 0 - GASTROENTERITIS VIRAL 1 (1.2%) 0 0 - GASTROINTESTINAL HAEMORRHAGE 0 1 (1.4%) 0 - GASTROOESOPHAGEAL REFLUX DISEASE 1 (1.2%) 0 0 - GLAUCOMA 1 (1.2%) 0 0 - GLOSSITIS 1 (1.2%) 0 0 - HAEMOPTYSIS 1 (1.2%) 0 0 - HALLUCINATION 0 1 (1.4%) 0 - HALLUCINATION, VISUAL 0 1 (1.4%) 0 - HEART RATE INCREASED 1 (1.2%) 0 0 - HEART RATE IRREGULAR 1 (1.2%) 0 0 - HEMIANOPIA HOMONYMOUS 0 0 1 (1.0%) - HIATUS HERNIA 1 (1.2%) 0 0 - HORDEOLUM 0 1 (1.4%) 0 - HOT FLUSH 0 0 1 (1.0%) - HYPERBILIRUBINAEMIA 1 (1.2%) 0 0 - HYPERCHOLESTEROLAEMIA 0 1 (1.4%) 0 - HYPERSENSITIVITY 0 0 1 (1.0%) - HYPERSOMNIA 0 1 (1.4%) 0 - HYPONATRAEMIA 1 (1.2%) 0 0 - INCONTINENCE 0 0 1 (1.0%) - INFLAMMATION 0 0 1 (1.0%) - JOINT DISLOCATION 0 0 1 (1.0%) - LIBIDO DECREASED 0 1 (1.4%) 0 - LISTLESS 0 1 (1.4%) 0 - LOWER RESPIRATORY TRACT INFECTION 0 1 (1.4%) 0 - MALIGNANT FIBROUS HISTIOCYTOMA 0 0 1 (1.0%) - MUSCULAR WEAKNESS 0 0 1 (1.0%) - MYALGIA 0 1 (1.4%) 0 - NASAL MUCOSA BIOPSY 0 0 1 (1.0%) - NEUTROPHIL COUNT INCREASED 0 0 1 (1.0%) - NIGHTMARE 0 1 (1.4%) 0 - ONYCHOMYCOSIS 0 0 1 (1.0%) - ORTHOSTATIC HYPOTENSION 1 (1.2%) 0 0 - PAIN IN EXTREMITY 1 (1.2%) 0 0 - PARAESTHESIA 0 1 (1.4%) 0 - PARAESTHESIA ORAL 0 0 1 (1.0%) - PARKINSON'S DISEASE 1 (1.2%) 0 0 - PAROSMIA 0 1 (1.4%) 0 - PARTIAL SEIZURES WITH SECONDARY GENERALISATION 0 1 (1.4%) 0 - PELVIC PAIN 1 (1.2%) 0 0 - PHARYNGEAL ERYTHEMA 0 1 (1.4%) 0 - PNEUMONIA 0 0 1 (1.0%) - POLLAKIURIA 1 (1.2%) 0 0 - POSTNASAL DRIP 1 (1.2%) 0 0 - PRODUCTIVE COUGH 0 1 (1.4%) 0 - PROSTATE CANCER 0 1 (1.4%) 0 - PSYCHOMOTOR HYPERACTIVITY 1 (1.2%) 0 0 - RALES 1 (1.2%) 0 0 - RASH MACULO-PAPULAR 0 1 (1.4%) 0 - RASH PAPULAR 0 1 (1.4%) 0 - RECTAL HAEMORRHAGE 0 0 1 (1.0%) - RESPIRATORY TRACT CONGESTION 0 1 (1.4%) 0 - RESTLESSNESS 0 0 1 (1.0%) - RHINITIS 0 1 (1.4%) 0 - SEASONAL ALLERGY 0 1 (1.4%) 0 - SECRETION DISCHARGE 0 0 1 (1.0%) - SINUS ARRHYTHMIA 1 (1.2%) 0 0 - SKIN EXFOLIATION 0 0 1 (1.0%) - SKIN LESION EXCISION 0 1 (1.4%) 0 - SKIN ODOUR ABNORMAL 0 1 (1.4%) 0 - SKIN ULCER 1 (1.2%) 0 0 - STOMACH DISCOMFORT 0 1 (1.4%) 0 - STUPOR 0 0 1 (1.0%) - SUDDEN DEATH 0 0 1 (1.0%) - SUPRAVENTRICULAR TACHYCARDIA 0 0 1 (1.0%) - SWELLING 0 0 1 (1.0%) - SYNCOPE VASOVAGAL 0 1 (1.4%) 0 - TACHYCARDIA 1 (1.2%) 0 0 - TINNITUS 0 0 1 (1.0%) - ULCER 0 0 1 (1.0%) - URINE ANALYSIS ABNORMAL 0 0 1 (1.0%) - VAGINAL MYCOSIS 1 (1.2%) 0 0 - VENTRICULAR HYPERTROPHY 1 (1.2%) 0 0 - VIRAL INFECTION 0 0 1 (1.0%) - WEIGHT DECREASED 0 0 1 (1.0%) - WHITE BLOOD CELL COUNT INCREASED 0 0 1 (1.0%) - WOLFF-PARKINSON-WHITE SYNDROME 0 0 1 (1.0%) - WOUND 0 0 1 (1.0%) WOUND HAEMORRHAGE 0 1 (1.4%) 0 # AET02 variant 5 is produced correctly @@ -1949,273 +186,41 @@ Code res Output - MedDRA System Organ Class Placebo Xanomeline High Dose Xanomeline Low Dose - MedDRA Preferred Term (N=86) (N=72) (N=96) - ————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— - Total number of patients with at least one adverse event 69 (80.2%) 70 (97.2%) 0 - Overall total number of events 301 436 0 - SKIN AND SUBCUTANEOUS TISSUE DISORDERS - Total number of patients with at least one adverse event 21 (24.4%) 42 (58.3%) 0 - Total number of events 47 111 0 - PRURITUS 8 (9.3%) 26 (36.1%) 0 - ERYTHEMA 9 (10.5%) 14 (19.4%) 0 - RASH 5 (5.8%) 11 (15.3%) 0 - HYPERHIDROSIS 2 (2.3%) 8 (11.1%) 0 - SKIN IRRITATION 3 (3.5%) 5 (6.9%) 0 - RASH PRURITIC 0 2 (2.8%) 0 - ACTINIC KERATOSIS 0 1 (1.4%) 0 - ALOPECIA 1 (1.2%) 0 0 - BLISTER 0 1 (1.4%) 0 - COLD SWEAT 1 (1.2%) 0 0 - DERMATITIS ATOPIC 1 (1.2%) 0 0 - DRUG ERUPTION 1 (1.2%) 0 0 - PRURITUS GENERALISED 0 1 (1.4%) 0 - RASH MACULO-PAPULAR 0 1 (1.4%) 0 - RASH PAPULAR 0 1 (1.4%) 0 - SKIN ODOUR ABNORMAL 0 1 (1.4%) 0 - SKIN ULCER 1 (1.2%) 0 0 - URTICARIA 0 1 (1.4%) 0 - GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - Total number of patients with at least one adverse event 21 (24.4%) 36 (50.0%) 0 - Total number of events 48 118 0 - APPLICATION SITE PRURITUS 6 (7.0%) 21 (29.2%) 0 - APPLICATION SITE ERYTHEMA 3 (3.5%) 14 (19.4%) 0 - APPLICATION SITE DERMATITIS 5 (5.8%) 7 (9.7%) 0 - APPLICATION SITE IRRITATION 3 (3.5%) 9 (12.5%) 0 - APPLICATION SITE VESICLES 1 (1.2%) 5 (6.9%) 0 - FATIGUE 1 (1.2%) 5 (6.9%) 0 - OEDEMA PERIPHERAL 2 (2.3%) 2 (2.8%) 0 - APPLICATION SITE PAIN 0 2 (2.8%) 0 - APPLICATION SITE PERSPIRATION 0 2 (2.8%) 0 - APPLICATION SITE REACTION 1 (1.2%) 1 (1.4%) 0 - APPLICATION SITE SWELLING 0 2 (2.8%) 0 - CHEST PAIN 0 2 (2.8%) 0 - CHILLS 1 (1.2%) 1 (1.4%) 0 - MALAISE 0 2 (2.8%) 0 - PYREXIA 2 (2.3%) 0 0 - APPLICATION SITE DISCHARGE 0 1 (1.4%) 0 - APPLICATION SITE INDURATION 1 (1.2%) 0 0 - APPLICATION SITE URTICARIA 0 1 (1.4%) 0 - ASTHENIA 1 (1.2%) 0 0 - CHEST DISCOMFORT 0 1 (1.4%) 0 - FEELING ABNORMAL 0 1 (1.4%) 0 - FEELING COLD 0 1 (1.4%) 0 - PAIN 0 1 (1.4%) 0 - GASTROINTESTINAL DISORDERS - Total number of patients with at least one adverse event 17 (19.8%) 20 (27.8%) 0 - Total number of events 26 35 0 - DIARRHOEA 9 (10.5%) 3 (4.2%) 0 - NAUSEA 3 (3.5%) 6 (8.3%) 0 - VOMITING 3 (3.5%) 6 (8.3%) 0 - SALIVARY HYPERSECRETION 0 4 (5.6%) 0 - ABDOMINAL PAIN 1 (1.2%) 1 (1.4%) 0 - DYSPEPSIA 1 (1.2%) 1 (1.4%) 0 - ABDOMINAL DISCOMFORT 0 1 (1.4%) 0 - CONSTIPATION 1 (1.2%) 0 0 - FLATULENCE 1 (1.2%) 0 0 - GASTROINTESTINAL HAEMORRHAGE 0 1 (1.4%) 0 - GASTROOESOPHAGEAL REFLUX DISEASE 1 (1.2%) 0 0 - GLOSSITIS 1 (1.2%) 0 0 - HIATUS HERNIA 1 (1.2%) 0 0 - STOMACH DISCOMFORT 0 1 (1.4%) 0 - NERVOUS SYSTEM DISORDERS - Total number of patients with at least one adverse event 12 (14.0%) 25 (34.7%) 0 - Total number of events 16 43 0 - DIZZINESS 2 (2.3%) 11 (15.3%) 0 - HEADACHE 7 (8.1%) 6 (8.3%) 0 - SOMNOLENCE 2 (2.3%) 1 (1.4%) 0 - BURNING SENSATION 0 2 (2.8%) 0 - SYNCOPE 0 2 (2.8%) 0 - AMNESIA 0 1 (1.4%) 0 - COGNITIVE DISORDER 0 1 (1.4%) 0 - HYPERSOMNIA 0 1 (1.4%) 0 - LETHARGY 0 1 (1.4%) 0 - PARAESTHESIA 0 1 (1.4%) 0 - PARKINSON'S DISEASE 1 (1.2%) 0 0 - PAROSMIA 0 1 (1.4%) 0 - PARTIAL SEIZURES WITH SECONDARY GENERALISATION 0 1 (1.4%) 0 - PSYCHOMOTOR HYPERACTIVITY 1 (1.2%) 0 0 - SYNCOPE VASOVAGAL 0 1 (1.4%) 0 - TRANSIENT ISCHAEMIC ATTACK 0 1 (1.4%) 0 - INFECTIONS AND INFESTATIONS - Total number of patients with at least one adverse event 16 (18.6%) 13 (18.1%) 0 - Total number of events 35 20 0 - UPPER RESPIRATORY TRACT INFECTION 6 (7.0%) 3 (4.2%) 0 - NASOPHARYNGITIS 2 (2.3%) 6 (8.3%) 0 - URINARY TRACT INFECTION 2 (2.3%) 1 (1.4%) 0 - CYSTITIS 1 (1.2%) 1 (1.4%) 0 - EAR INFECTION 2 (2.3%) 0 0 - INFLUENZA 1 (1.2%) 1 (1.4%) 0 - BRONCHITIS 1 (1.2%) 0 0 - CERVICITIS 1 (1.2%) 0 0 - GASTROENTERITIS VIRAL 1 (1.2%) 0 0 - HORDEOLUM 0 1 (1.4%) 0 - LOCALISED INFECTION 1 (1.2%) 0 0 - LOWER RESPIRATORY TRACT INFECTION 0 1 (1.4%) 0 - RHINITIS 0 1 (1.4%) 0 - VAGINAL MYCOSIS 1 (1.2%) 0 0 - CARDIAC DISORDERS - Total number of patients with at least one adverse event 13 (15.1%) 15 (20.8%) 0 - Total number of events 27 30 0 - SINUS BRADYCARDIA 2 (2.3%) 8 (11.1%) 0 - MYOCARDIAL INFARCTION 4 (4.7%) 4 (5.6%) 0 - ATRIAL FIBRILLATION 1 (1.2%) 2 (2.8%) 0 - ATRIOVENTRICULAR BLOCK SECOND DEGREE 2 (2.3%) 1 (1.4%) 0 - SUPRAVENTRICULAR EXTRASYSTOLES 1 (1.2%) 1 (1.4%) 0 - ATRIAL FLUTTER 0 1 (1.4%) 0 - ATRIAL HYPERTROPHY 1 (1.2%) 0 0 - ATRIOVENTRICULAR BLOCK FIRST DEGREE 1 (1.2%) 0 0 - BRADYCARDIA 1 (1.2%) 0 0 - BUNDLE BRANCH BLOCK LEFT 1 (1.2%) 0 0 - BUNDLE BRANCH BLOCK RIGHT 1 (1.2%) 0 0 - CARDIAC DISORDER 0 1 (1.4%) 0 - CARDIAC FAILURE CONGESTIVE 1 (1.2%) 0 0 - SINUS ARRHYTHMIA 1 (1.2%) 0 0 - TACHYCARDIA 1 (1.2%) 0 0 - VENTRICULAR EXTRASYSTOLES 0 1 (1.4%) 0 - VENTRICULAR HYPERTROPHY 1 (1.2%) 0 0 - RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - Total number of patients with at least one adverse event 10 (11.6%) 10 (13.9%) 0 - Total number of events 15 22 0 - COUGH 3 (3.5%) 5 (6.9%) 0 - NASAL CONGESTION 3 (3.5%) 3 (4.2%) 0 - DYSPNOEA 1 (1.2%) 1 (1.4%) 0 - EPISTAXIS 0 2 (2.8%) 0 - ALLERGIC GRANULOMATOUS ANGIITIS 0 1 (1.4%) 0 - EMPHYSEMA 1 (1.2%) 0 0 - HAEMOPTYSIS 1 (1.2%) 0 0 - PHARYNGEAL ERYTHEMA 0 1 (1.4%) 0 - PHARYNGOLARYNGEAL PAIN 0 1 (1.4%) 0 - POSTNASAL DRIP 1 (1.2%) 0 0 - PRODUCTIVE COUGH 0 1 (1.4%) 0 - RALES 1 (1.2%) 0 0 - RESPIRATORY TRACT CONGESTION 0 1 (1.4%) 0 - RHINORRHOEA 0 1 (1.4%) 0 - PSYCHIATRIC DISORDERS - Total number of patients with at least one adverse event 10 (11.6%) 8 (11.1%) 0 - Total number of events 14 11 0 - INSOMNIA 2 (2.3%) 2 (2.8%) 0 - CONFUSIONAL STATE 2 (2.3%) 1 (1.4%) 0 - AGITATION 2 (2.3%) 0 0 - DELUSION 1 (1.2%) 1 (1.4%) 0 - ANXIETY 1 (1.2%) 0 0 - COMPLETED SUICIDE 1 (1.2%) 0 0 - DELIRIUM 0 1 (1.4%) 0 - DEPRESSED MOOD 0 1 (1.4%) 0 - DISORIENTATION 1 (1.2%) 0 0 - HALLUCINATION 0 1 (1.4%) 0 - HALLUCINATION, VISUAL 0 1 (1.4%) 0 - IRRITABILITY 1 (1.2%) 0 0 - LIBIDO DECREASED 0 1 (1.4%) 0 - LISTLESS 0 1 (1.4%) 0 - NIGHTMARE 0 1 (1.4%) 0 - INVESTIGATIONS - Total number of patients with at least one adverse event 10 (11.6%) 5 (6.9%) 0 - Total number of events 19 6 0 - ELECTROCARDIOGRAM ST SEGMENT DEPRESSION 4 (4.7%) 0 0 - ELECTROCARDIOGRAM T WAVE INVERSION 2 (2.3%) 1 (1.4%) 0 - BIOPSY 0 1 (1.4%) 0 - BIOPSY PROSTATE 0 1 (1.4%) 0 - BLOOD ALKALINE PHOSPHATASE INCREASED 1 (1.2%) 0 0 - BLOOD CHOLESTEROL INCREASED 0 1 (1.4%) 0 - BLOOD CREATINE PHOSPHOKINASE INCREASED 1 (1.2%) 0 0 - BLOOD GLUCOSE INCREASED 0 1 (1.4%) 0 - BLOOD URINE PRESENT 1 (1.2%) 0 0 - CYSTOSCOPY 1 (1.2%) 0 0 - ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED 1 (1.2%) 0 0 - HEART RATE INCREASED 1 (1.2%) 0 0 - HEART RATE IRREGULAR 1 (1.2%) 0 0 - MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS - Total number of patients with at least one adverse event 5 (5.8%) 8 (11.1%) 0 - Total number of events 8 11 0 - BACK PAIN 1 (1.2%) 3 (4.2%) 0 - ARTHRALGIA 1 (1.2%) 1 (1.4%) 0 - ARTHRITIS 1 (1.2%) 1 (1.4%) 0 - FLANK PAIN 0 2 (2.8%) 0 - MUSCLE SPASMS 0 1 (1.4%) 0 - MYALGIA 0 1 (1.4%) 0 - PAIN IN EXTREMITY 1 (1.2%) 0 0 - SHOULDER PAIN 1 (1.2%) 0 0 - INJURY, POISONING AND PROCEDURAL COMPLICATIONS - Total number of patients with at least one adverse event 4 (4.7%) 5 (6.9%) 0 - Total number of events 9 8 0 - CONTUSION 1 (1.2%) 2 (2.8%) 0 - EXCORIATION 2 (2.3%) 1 (1.4%) 0 - HIP FRACTURE 1 (1.2%) 2 (2.8%) 0 - FALL 1 (1.2%) 1 (1.4%) 0 - FACIAL BONES FRACTURE 0 1 (1.4%) 0 - SKIN LACERATION 1 (1.2%) 0 0 - METABOLISM AND NUTRITION DISORDERS - Total number of patients with at least one adverse event 6 (7.0%) 3 (4.2%) 0 - Total number of events 8 5 0 - DECREASED APPETITE 1 (1.2%) 1 (1.4%) 0 - INCREASED APPETITE 1 (1.2%) 1 (1.4%) 0 - DEHYDRATION 1 (1.2%) 0 0 - DIABETES MELLITUS 1 (1.2%) 0 0 - FOOD CRAVING 1 (1.2%) 0 0 - HYPERCHOLESTEROLAEMIA 0 1 (1.4%) 0 - HYPONATRAEMIA 1 (1.2%) 0 0 - RENAL AND URINARY DISORDERS - Total number of patients with at least one adverse event 4 (4.7%) 3 (4.2%) 0 - Total number of events 5 4 0 - MICTURITION URGENCY 1 (1.2%) 1 (1.4%) 0 - NEPHROLITHIASIS 1 (1.2%) 1 (1.4%) 0 - CALCULUS URETHRAL 0 1 (1.4%) 0 - DYSURIA 1 (1.2%) 0 0 - POLLAKIURIA 1 (1.2%) 0 0 - EYE DISORDERS - Total number of patients with at least one adverse event 4 (4.7%) 1 (1.4%) 0 - Total number of events 8 2 0 - CONJUNCTIVITIS 2 (2.3%) 0 0 - EYE ALLERGY 1 (1.2%) 0 0 - EYE PRURITUS 1 (1.2%) 0 0 - EYE SWELLING 1 (1.2%) 0 0 - GLAUCOMA 1 (1.2%) 0 0 - VISION BLURRED 0 1 (1.4%) 0 - SURGICAL AND MEDICAL PROCEDURES - Total number of patients with at least one adverse event 2 (2.3%) 2 (2.8%) 0 - Total number of events 2 2 0 - ACROCHORDON EXCISION 0 1 (1.4%) 0 - CATARACT OPERATION 1 (1.2%) 0 0 - EYE LASER SURGERY 1 (1.2%) 0 0 - SKIN LESION EXCISION 0 1 (1.4%) 0 - VASCULAR DISORDERS - Total number of patients with at least one adverse event 3 (3.5%) 1 (1.4%) 0 - Total number of events 7 1 0 - HYPOTENSION 2 (2.3%) 0 0 - HYPERTENSION 1 (1.2%) 0 0 - ORTHOSTATIC HYPOTENSION 1 (1.2%) 0 0 - WOUND HAEMORRHAGE 0 1 (1.4%) 0 - REPRODUCTIVE SYSTEM AND BREAST DISORDERS - Total number of patients with at least one adverse event 2 (2.3%) 1 (1.4%) 0 - Total number of events 4 1 0 - BENIGN PROSTATIC HYPERPLASIA 1 (1.2%) 1 (1.4%) 0 - PELVIC PAIN 1 (1.2%) 0 0 - CONGENITAL, FAMILIAL AND GENETIC DISORDERS - Total number of patients with at least one adverse event 0 2 (2.8%) 0 - Total number of events 0 2 0 - VENTRICULAR SEPTAL DEFECT 0 2 (2.8%) 0 - EAR AND LABYRINTH DISORDERS - Total number of patients with at least one adverse event 1 (1.2%) 1 (1.4%) 0 - Total number of events 2 1 0 - EAR PAIN 1 (1.2%) 0 0 - VERTIGO 0 1 (1.4%) 0 - HEPATOBILIARY DISORDERS - Total number of patients with at least one adverse event 1 (1.2%) 0 0 - Total number of events 1 0 0 - HYPERBILIRUBINAEMIA 1 (1.2%) 0 0 - IMMUNE SYSTEM DISORDERS - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 1 0 - SEASONAL ALLERGY 0 1 (1.4%) 0 - NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 1 0 - PROSTATE CANCER 0 1 (1.4%) 0 - SOCIAL CIRCUMSTANCES - Total number of patients with at least one adverse event 0 1 (1.4%) 0 - Total number of events 0 1 0 - ALCOHOL USE 0 1 (1.4%) 0 + MedDRA System Organ Class Placebo Xanomeline High Dose Xanomeline Low Dose + MedDRA Preferred Term (N=86) (N=72) (N=96) + ———————————————————————————————————————————————————————————————————————————————————————————————————————————————————— + Total number of patients with at least one adverse event 37 (43.0%) 61 (84.7%) 0 + Overall total number of events 75 197 0 + SKIN AND SUBCUTANEOUS TISSUE DISORDERS + Total number of patients with at least one adverse event 19 (22.1%) 34 (47.2%) 0 + Total number of events 37 86 0 + PRURITUS 8 (9.3%) 26 (36.1%) 0 + ERYTHEMA 9 (10.5%) 14 (19.4%) 0 + RASH 5 (5.8%) 11 (15.3%) 0 + SKIN IRRITATION 3 (3.5%) 5 (6.9%) 0 + GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS + Total number of patients with at least one adverse event 10 (11.6%) 29 (40.3%) 0 + Total number of events 20 72 0 + APPLICATION SITE PRURITUS 6 (7.0%) 21 (29.2%) 0 + APPLICATION SITE ERYTHEMA 3 (3.5%) 14 (19.4%) 0 + APPLICATION SITE IRRITATION 3 (3.5%) 9 (12.5%) 0 + GASTROINTESTINAL DISORDERS + Total number of patients with at least one adverse event 4 (4.7%) 10 (13.9%) 0 + Total number of events 6 21 0 + NAUSEA 3 (3.5%) 6 (8.3%) 0 + VOMITING 3 (3.5%) 6 (8.3%) 0 + NERVOUS SYSTEM DISORDERS + Total number of patients with at least one adverse event 7 (8.1%) 6 (8.3%) 0 + Total number of events 8 9 0 + HEADACHE 7 (8.1%) 6 (8.3%) 0 + CARDIAC DISORDERS + Total number of patients with at least one adverse event 4 (4.7%) 4 (5.6%) 0 + Total number of events 4 8 0 + MYOCARDIAL INFARCTION 4 (4.7%) 4 (5.6%) 0 + VASCULAR DISORDERS + Total number of patients with at least one adverse event 0 1 (1.4%) 0 + Total number of events 0 1 0 + WOUND HAEMORRHAGE 0 1 (1.4%) 0 # AET02 variant 6 is produced correctly @@ -2225,37 +230,22 @@ MedDRA System Organ Class Placebo Xanomeline High Dose Xanomeline Low Dose MedDRA Preferred Term (N=86) (N=72) (N=96) ————————————————————————————————————————————————————————————————————————————————————————————————————————————— - GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - APPLICATION SITE PRURITUS 6 (7.0%) 21 (29.2%) 23 (24.0%) - APPLICATION SITE ERYTHEMA 3 (3.5%) 14 (19.4%) 13 (13.5%) - APPLICATION SITE DERMATITIS 5 (5.8%) 7 (9.7%) 9 (9.4%) - APPLICATION SITE IRRITATION 3 (3.5%) 9 (12.5%) 9 (9.4%) - APPLICATION SITE VESICLES 1 (1.2%) 5 (6.9%) 5 (5.2%) - FATIGUE 1 (1.2%) 5 (6.9%) 5 (5.2%) SKIN AND SUBCUTANEOUS TISSUE DISORDERS PRURITUS 8 (9.3%) 26 (36.1%) 23 (24.0%) ERYTHEMA 9 (10.5%) 14 (19.4%) 15 (15.6%) RASH 5 (5.8%) 11 (15.3%) 13 (13.5%) - HYPERHIDROSIS 2 (2.3%) 8 (11.1%) 4 (4.2%) SKIN IRRITATION 3 (3.5%) 5 (6.9%) 6 (6.2%) - BLISTER 0 1 (1.4%) 5 (5.2%) - NERVOUS SYSTEM DISORDERS - DIZZINESS 2 (2.3%) 11 (15.3%) 9 (9.4%) - HEADACHE 7 (8.1%) 6 (8.3%) 3 (3.1%) - SYNCOPE 0 2 (2.8%) 5 (5.2%) + GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS + APPLICATION SITE PRURITUS 6 (7.0%) 21 (29.2%) 23 (24.0%) + APPLICATION SITE ERYTHEMA 3 (3.5%) 14 (19.4%) 13 (13.5%) + APPLICATION SITE IRRITATION 3 (3.5%) 9 (12.5%) 9 (9.4%) GASTROINTESTINAL DISORDERS - DIARRHOEA 9 (10.5%) 3 (4.2%) 6 (6.2%) VOMITING 3 (3.5%) 6 (8.3%) 4 (4.2%) NAUSEA 3 (3.5%) 6 (8.3%) 3 (3.1%) - SALIVARY HYPERSECRETION 0 4 (5.6%) 0 + NERVOUS SYSTEM DISORDERS + HEADACHE 7 (8.1%) 6 (8.3%) 3 (3.1%) CARDIAC DISORDERS - SINUS BRADYCARDIA 2 (2.3%) 8 (11.1%) 7 (7.3%) MYOCARDIAL INFARCTION 4 (4.7%) 4 (5.6%) 2 (2.1%) - INFECTIONS AND INFESTATIONS - NASOPHARYNGITIS 2 (2.3%) 6 (8.3%) 4 (4.2%) - UPPER RESPIRATORY TRACT INFECTION 6 (7.0%) 3 (4.2%) 1 (1.0%) - RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - COUGH 3 (3.5%) 5 (6.9%) 6 (6.2%) # AET02 variant 7 is produced correctly @@ -2266,19 +256,6 @@ High Level Term Placebo Xanomeline High Dose Xanomeline Low Dose MedDRA Preferred Term (N=86) (N=72) (N=96) ————————————————————————————————————————————————————————————————————————————————————————————————————————————— - GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - HLT_0317 - APPLICATION SITE PRURITUS 6 (7.0%) 21 (29.2%) 23 (24.0%) - HLT_0617 - APPLICATION SITE ERYTHEMA 3 (3.5%) 14 (19.4%) 13 (13.5%) - HLT_0061 - APPLICATION SITE IRRITATION 3 (3.5%) 9 (12.5%) 9 (9.4%) - HLT_0343 - APPLICATION SITE DERMATITIS 5 (5.8%) 7 (9.7%) 9 (9.4%) - HLT_0043 - FATIGUE 1 (1.2%) 5 (6.9%) 5 (5.2%) - HLT_0180 - APPLICATION SITE VESICLES 1 (1.2%) 5 (6.9%) 5 (5.2%) SKIN AND SUBCUTANEOUS TISSUE DISORDERS HLT_0778 PRURITUS 8 (9.3%) 26 (36.1%) 23 (24.0%) @@ -2288,39 +265,24 @@ RASH 5 (5.8%) 11 (15.3%) 13 (13.5%) HLT_0583 SKIN IRRITATION 3 (3.5%) 5 (6.9%) 6 (6.2%) - HLT_0587 - HYPERHIDROSIS 2 (2.3%) 8 (11.1%) 4 (4.2%) - HLT_0752 - BLISTER 0 1 (1.4%) 5 (5.2%) - NERVOUS SYSTEM DISORDERS - HLT_0619 - DIZZINESS 2 (2.3%) 11 (15.3%) 9 (9.4%) - HLT_0064 - HEADACHE 7 (8.1%) 6 (8.3%) 3 (3.1%) - HLT_0440 - SYNCOPE 0 2 (2.8%) 5 (5.2%) + GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS + HLT_0317 + APPLICATION SITE PRURITUS 6 (7.0%) 21 (29.2%) 23 (24.0%) + HLT_0617 + APPLICATION SITE ERYTHEMA 3 (3.5%) 14 (19.4%) 13 (13.5%) + HLT_0061 + APPLICATION SITE IRRITATION 3 (3.5%) 9 (12.5%) 9 (9.4%) GASTROINTESTINAL DISORDERS - HLT_0148 - DIARRHOEA 9 (10.5%) 3 (4.2%) 6 (6.2%) HLT_0016 VOMITING 3 (3.5%) 6 (8.3%) 4 (4.2%) HLT_0742 NAUSEA 3 (3.5%) 6 (8.3%) 3 (3.1%) - HLT_0374 - SALIVARY HYPERSECRETION 0 4 (5.6%) 0 + NERVOUS SYSTEM DISORDERS + HLT_0064 + HEADACHE 7 (8.1%) 6 (8.3%) 3 (3.1%) CARDIAC DISORDERS - HLT_0644 - SINUS BRADYCARDIA 2 (2.3%) 8 (11.1%) 7 (7.3%) HLT_0649 MYOCARDIAL INFARCTION 4 (4.7%) 4 (5.6%) 2 (2.1%) - INFECTIONS AND INFESTATIONS - HLT_0036 - NASOPHARYNGITIS 2 (2.3%) 6 (8.3%) 4 (4.2%) - HLT_0520 - UPPER RESPIRATORY TRACT INFECTION 6 (7.0%) 3 (4.2%) 1 (1.0%) - RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - HLT_0701 - COUGH 3 (3.5%) 5 (6.9%) 6 (6.2%) # AET02 variant 8 is produced correctly @@ -2330,21 +292,14 @@ MedDRA System Organ Class Placebo Xanomeline High Dose Xanomeline Low Dose MedDRA Preferred Term (N=86) (N=72) (N=96) ————————————————————————————————————————————————————————————————————————————————————————————————————————————— - GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - APPLICATION SITE PRURITUS 6 (7.0%) 21 (29.2%) 23 (24.0%) - APPLICATION SITE ERYTHEMA 3 (3.5%) 14 (19.4%) 13 (13.5%) - APPLICATION SITE IRRITATION 3 (3.5%) 9 (12.5%) 9 (9.4%) SKIN AND SUBCUTANEOUS TISSUE DISORDERS PRURITUS 8 (9.3%) 26 (36.1%) 23 (24.0%) ERYTHEMA 9 (10.5%) 14 (19.4%) 15 (15.6%) RASH 5 (5.8%) 11 (15.3%) 13 (13.5%) - HYPERHIDROSIS 2 (2.3%) 8 (11.1%) 4 (4.2%) - NERVOUS SYSTEM DISORDERS - DIZZINESS 2 (2.3%) 11 (15.3%) 9 (9.4%) - GASTROINTESTINAL DISORDERS - DIARRHOEA 9 (10.5%) 3 (4.2%) 6 (6.2%) - CARDIAC DISORDERS - SINUS BRADYCARDIA 2 (2.3%) 8 (11.1%) 7 (7.3%) + GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS + APPLICATION SITE PRURITUS 6 (7.0%) 21 (29.2%) 23 (24.0%) + APPLICATION SITE ERYTHEMA 3 (3.5%) 14 (19.4%) 13 (13.5%) + APPLICATION SITE IRRITATION 3 (3.5%) 9 (12.5%) 9 (9.4%) # AET02 variant 9 is produced correctly @@ -2354,48 +309,22 @@ MedDRA System Organ Class Placebo Xanomeline High Dose Xanomeline Low Dose MedDRA Preferred Term (N=86) (N=72) (N=96) ————————————————————————————————————————————————————————————————————————————————————————————————————————————— - GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - APPLICATION SITE PRURITUS 6 (7.0%) 21 (29.2%) 23 (24.0%) - APPLICATION SITE ERYTHEMA 3 (3.5%) 14 (19.4%) 13 (13.5%) - APPLICATION SITE DERMATITIS 5 (5.8%) 7 (9.7%) 9 (9.4%) - APPLICATION SITE IRRITATION 3 (3.5%) 9 (12.5%) 9 (9.4%) - APPLICATION SITE VESICLES 1 (1.2%) 5 (6.9%) 5 (5.2%) - FATIGUE 1 (1.2%) 5 (6.9%) 5 (5.2%) SKIN AND SUBCUTANEOUS TISSUE DISORDERS PRURITUS 8 (9.3%) 26 (36.1%) 23 (24.0%) ERYTHEMA 9 (10.5%) 14 (19.4%) 15 (15.6%) RASH 5 (5.8%) 11 (15.3%) 13 (13.5%) - HYPERHIDROSIS 2 (2.3%) 8 (11.1%) 4 (4.2%) SKIN IRRITATION 3 (3.5%) 5 (6.9%) 6 (6.2%) - BLISTER 0 1 (1.4%) 5 (5.2%) - NERVOUS SYSTEM DISORDERS - DIZZINESS 2 (2.3%) 11 (15.3%) 9 (9.4%) - HEADACHE 7 (8.1%) 6 (8.3%) 3 (3.1%) - SYNCOPE 0 2 (2.8%) 5 (5.2%) - SOMNOLENCE 2 (2.3%) 1 (1.4%) 3 (3.1%) + GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS + APPLICATION SITE PRURITUS 6 (7.0%) 21 (29.2%) 23 (24.0%) + APPLICATION SITE ERYTHEMA 3 (3.5%) 14 (19.4%) 13 (13.5%) + APPLICATION SITE IRRITATION 3 (3.5%) 9 (12.5%) 9 (9.4%) GASTROINTESTINAL DISORDERS - DIARRHOEA 9 (10.5%) 3 (4.2%) 6 (6.2%) VOMITING 3 (3.5%) 6 (8.3%) 4 (4.2%) NAUSEA 3 (3.5%) 6 (8.3%) 3 (3.1%) - ABDOMINAL PAIN 1 (1.2%) 1 (1.4%) 3 (3.1%) - SALIVARY HYPERSECRETION 0 4 (5.6%) 0 + NERVOUS SYSTEM DISORDERS + HEADACHE 7 (8.1%) 6 (8.3%) 3 (3.1%) CARDIAC DISORDERS - SINUS BRADYCARDIA 2 (2.3%) 8 (11.1%) 7 (7.3%) MYOCARDIAL INFARCTION 4 (4.7%) 4 (5.6%) 2 (2.1%) - INFECTIONS AND INFESTATIONS - NASOPHARYNGITIS 2 (2.3%) 6 (8.3%) 4 (4.2%) - UPPER RESPIRATORY TRACT INFECTION 6 (7.0%) 3 (4.2%) 1 (1.0%) - RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - COUGH 3 (3.5%) 5 (6.9%) 6 (6.2%) - NASAL CONGESTION 3 (3.5%) 3 (4.2%) 1 (1.0%) - PSYCHIATRIC DISORDERS - CONFUSIONAL STATE 2 (2.3%) 1 (1.4%) 3 (3.1%) - AGITATION 2 (2.3%) 0 3 (3.1%) - ANXIETY 1 (1.2%) 0 3 (3.1%) - INVESTIGATIONS - ELECTROCARDIOGRAM ST SEGMENT DEPRESSION 4 (4.7%) 0 1 (1.0%) - MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS - BACK PAIN 1 (1.2%) 3 (4.2%) 1 (1.0%) # AET02 variant 10 is produced correctly @@ -2405,31 +334,18 @@ MedDRA System Organ Class Placebo Xanomeline High Dose Xanomeline Low Dose MedDRA Preferred Term (N=86) (N=72) (N=96) ————————————————————————————————————————————————————————————————————————————————————————————————————————————— - GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - APPLICATION SITE PRURITUS 6 (7.0%) 21 (29.2%) 23 (24.0%) - APPLICATION SITE ERYTHEMA 3 (3.5%) 14 (19.4%) 13 (13.5%) - APPLICATION SITE IRRITATION 3 (3.5%) 9 (12.5%) 9 (9.4%) - APPLICATION SITE VESICLES 1 (1.2%) 5 (6.9%) 5 (5.2%) - FATIGUE 1 (1.2%) 5 (6.9%) 5 (5.2%) SKIN AND SUBCUTANEOUS TISSUE DISORDERS PRURITUS 8 (9.3%) 26 (36.1%) 23 (24.0%) ERYTHEMA 9 (10.5%) 14 (19.4%) 15 (15.6%) RASH 5 (5.8%) 11 (15.3%) 13 (13.5%) - HYPERHIDROSIS 2 (2.3%) 8 (11.1%) 4 (4.2%) - BLISTER 0 1 (1.4%) 5 (5.2%) - NERVOUS SYSTEM DISORDERS - DIZZINESS 2 (2.3%) 11 (15.3%) 9 (9.4%) - HEADACHE 7 (8.1%) 6 (8.3%) 3 (3.1%) - SYNCOPE 0 2 (2.8%) 5 (5.2%) + GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS + APPLICATION SITE PRURITUS 6 (7.0%) 21 (29.2%) 23 (24.0%) + APPLICATION SITE ERYTHEMA 3 (3.5%) 14 (19.4%) 13 (13.5%) + APPLICATION SITE IRRITATION 3 (3.5%) 9 (12.5%) 9 (9.4%) GASTROINTESTINAL DISORDERS - DIARRHOEA 9 (10.5%) 3 (4.2%) 6 (6.2%) NAUSEA 3 (3.5%) 6 (8.3%) 3 (3.1%) - SALIVARY HYPERSECRETION 0 4 (5.6%) 0 - CARDIAC DISORDERS - SINUS BRADYCARDIA 2 (2.3%) 8 (11.1%) 7 (7.3%) - INFECTIONS AND INFESTATIONS - NASOPHARYNGITIS 2 (2.3%) 6 (8.3%) 4 (4.2%) - UPPER RESPIRATORY TRACT INFECTION 6 (7.0%) 3 (4.2%) 1 (1.0%) + NERVOUS SYSTEM DISORDERS + HEADACHE 7 (8.1%) 6 (8.3%) 3 (3.1%) # AET02 variant 11 is produced correctly @@ -2439,19 +355,14 @@ MedDRA System Organ Class Placebo Xanomeline High Dose Xanomeline Low Dose MedDRA Preferred Term (N=86) (N=72) (N=96) ————————————————————————————————————————————————————————————————————————————————————————————————————————————— - GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - APPLICATION SITE PRURITUS 6 (7.0%) 21 (29.2%) 23 (24.0%) - APPLICATION SITE DERMATITIS 5 (5.8%) 7 (9.7%) 9 (9.4%) SKIN AND SUBCUTANEOUS TISSUE DISORDERS PRURITUS 8 (9.3%) 26 (36.1%) 23 (24.0%) ERYTHEMA 9 (10.5%) 14 (19.4%) 15 (15.6%) RASH 5 (5.8%) 11 (15.3%) 13 (13.5%) + GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS + APPLICATION SITE PRURITUS 6 (7.0%) 21 (29.2%) 23 (24.0%) NERVOUS SYSTEM DISORDERS HEADACHE 7 (8.1%) 6 (8.3%) 3 (3.1%) - GASTROINTESTINAL DISORDERS - DIARRHOEA 9 (10.5%) 3 (4.2%) 6 (6.2%) - INFECTIONS AND INFESTATIONS - UPPER RESPIRATORY TRACT INFECTION 6 (7.0%) 3 (4.2%) 1 (1.0%) # AET02 variant 12 is produced correctly @@ -2461,28 +372,14 @@ MedDRA System Organ Class Placebo Xanomeline High Dose Xanomeline Low Dose MedDRA Preferred Term (N=86) (N=72) (N=96) ————————————————————————————————————————————————————————————————————————————————————————————————————————————— - GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - APPLICATION SITE PRURITUS 6 (7.0%) 21 (29.2%) 23 (24.0%) - APPLICATION SITE ERYTHEMA 3 (3.5%) 14 (19.4%) 13 (13.5%) - APPLICATION SITE IRRITATION 3 (3.5%) 9 (12.5%) 9 (9.4%) - APPLICATION SITE VESICLES 1 (1.2%) 5 (6.9%) 5 (5.2%) - FATIGUE 1 (1.2%) 5 (6.9%) 5 (5.2%) SKIN AND SUBCUTANEOUS TISSUE DISORDERS PRURITUS 8 (9.3%) 26 (36.1%) 23 (24.0%) ERYTHEMA 9 (10.5%) 14 (19.4%) 15 (15.6%) RASH 5 (5.8%) 11 (15.3%) 13 (13.5%) - HYPERHIDROSIS 2 (2.3%) 8 (11.1%) 4 (4.2%) - BLISTER 0 1 (1.4%) 5 (5.2%) + GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS + APPLICATION SITE PRURITUS 6 (7.0%) 21 (29.2%) 23 (24.0%) + APPLICATION SITE ERYTHEMA 3 (3.5%) 14 (19.4%) 13 (13.5%) + APPLICATION SITE IRRITATION 3 (3.5%) 9 (12.5%) 9 (9.4%) NERVOUS SYSTEM DISORDERS - DIZZINESS 2 (2.3%) 11 (15.3%) 9 (9.4%) HEADACHE 7 (8.1%) 6 (8.3%) 3 (3.1%) - SYNCOPE 0 2 (2.8%) 5 (5.2%) - GASTROINTESTINAL DISORDERS - DIARRHOEA 9 (10.5%) 3 (4.2%) 6 (6.2%) - SALIVARY HYPERSECRETION 0 4 (5.6%) 0 - CARDIAC DISORDERS - SINUS BRADYCARDIA 2 (2.3%) 8 (11.1%) 7 (7.3%) - INFECTIONS AND INFESTATIONS - NASOPHARYNGITIS 2 (2.3%) 6 (8.3%) 4 (4.2%) - UPPER RESPIRATORY TRACT INFECTION 6 (7.0%) 3 (4.2%) 1 (1.0%) diff --git a/tests/testthat/_snaps/table_aet03.md b/tests/testthat/_snaps/table_aet03.md index c18cdea..3cf0309 100644 --- a/tests/testthat/_snaps/table_aet03.md +++ b/tests/testthat/_snaps/table_aet03.md @@ -3,946 +3,103 @@ Code res Output - MedDRA System Organ Class - MedDRA Preferred Term Placebo Xanomeline High Dose Xanomeline Low Dose - Severity/Intensity (N=86) (N=72) (N=96) - ————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— - - Any Intensity - 69 (80.2%) 70 (97.2%) 86 (89.6%) - MILD 35 (40.7%) 18 (25.0%) 21 (21.9%) - MODERATE 24 (27.9%) 42 (58.3%) 49 (51.0%) - SEVERE 7 (8.1%) 8 (11.1%) 16 (16.7%) - LIFE THREATENING 3 (3.5%) 2 (2.8%) 0 - GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - - Any Intensity - 21 (24.4%) 36 (50.0%) 51 (53.1%) - MILD 15 (17.4%) 15 (20.8%) 21 (21.9%) - MODERATE 5 (5.8%) 19 (26.4%) 23 (24.0%) - SEVERE 0 0 7 (7.3%) - LIFE THREATENING 1 (1.2%) 2 (2.8%) 0 - APPLICATION SITE PRURITUS - - Any Intensity - 6 (7.0%) 21 (29.2%) 23 (24.0%) - MILD 4 (4.7%) 8 (11.1%) 13 (13.5%) - MODERATE 1 (1.2%) 11 (15.3%) 9 (9.4%) - SEVERE 0 0 1 (1.0%) - LIFE THREATENING 1 (1.2%) 2 (2.8%) 0 - APPLICATION SITE ERYTHEMA - - Any Intensity - 3 (3.5%) 14 (19.4%) 13 (13.5%) - MILD 2 (2.3%) 8 (11.1%) 4 (4.2%) - MODERATE 0 5 (6.9%) 7 (7.3%) - SEVERE 0 0 2 (2.1%) - LIFE THREATENING 1 (1.2%) 1 (1.4%) 0 - APPLICATION SITE DERMATITIS - - Any Intensity - 5 (5.8%) 7 (9.7%) 9 (9.4%) - MILD 5 (5.8%) 2 (2.8%) 4 (4.2%) - MODERATE 0 5 (6.9%) 4 (4.2%) - SEVERE 0 0 1 (1.0%) - APPLICATION SITE IRRITATION - - Any Intensity - 3 (3.5%) 9 (12.5%) 9 (9.4%) - MILD 1 (1.2%) 3 (4.2%) 3 (3.1%) - MODERATE 2 (2.3%) 6 (8.3%) 3 (3.1%) - SEVERE 0 0 3 (3.1%) - APPLICATION SITE VESICLES - - Any Intensity - 1 (1.2%) 5 (6.9%) 5 (5.2%) - MILD 1 (1.2%) 2 (2.8%) 3 (3.1%) - MODERATE 0 3 (4.2%) 2 (2.1%) - FATIGUE - - Any Intensity - 1 (1.2%) 5 (6.9%) 5 (5.2%) - MILD 1 (1.2%) 4 (5.6%) 3 (3.1%) - MODERATE 0 0 2 (2.1%) - LIFE THREATENING 0 1 (1.4%) 0 - OEDEMA PERIPHERAL - - Any Intensity - 2 (2.3%) 2 (2.8%) 1 (1.0%) - MILD 1 (1.2%) 1 (1.4%) 0 - MODERATE 1 (1.2%) 1 (1.4%) 1 (1.0%) - APPLICATION SITE SWELLING - - Any Intensity - 0 2 (2.8%) 1 (1.0%) - MILD 0 1 (1.4%) 1 (1.0%) - MODERATE 0 1 (1.4%) 0 - APPLICATION SITE URTICARIA - - Any Intensity - 0 1 (1.4%) 2 (2.1%) - MILD 0 0 2 (2.1%) - MODERATE 0 1 (1.4%) 0 - CHILLS - - Any Intensity - 1 (1.2%) 1 (1.4%) 1 (1.0%) - MILD 0 1 (1.4%) 1 (1.0%) - MODERATE 1 (1.2%) 0 0 - MALAISE - - Any Intensity - 0 2 (2.8%) 1 (1.0%) - MILD 0 1 (1.4%) 1 (1.0%) - MODERATE 0 1 (1.4%) 0 - PYREXIA - - Any Intensity - 2 (2.3%) 0 1 (1.0%) - MILD 2 (2.3%) 0 1 (1.0%) - APPLICATION SITE PAIN - - Any Intensity - 0 2 (2.8%) 0 - MILD 0 1 (1.4%) 0 - MODERATE 0 1 (1.4%) 0 - APPLICATION SITE PERSPIRATION - - Any Intensity - 0 2 (2.8%) 0 - MILD 0 1 (1.4%) 0 - MODERATE 0 1 (1.4%) 0 - APPLICATION SITE REACTION - - Any Intensity - 1 (1.2%) 1 (1.4%) 0 - MILD 0 0 0 - MODERATE 1 (1.2%) 1 (1.4%) 0 - ASTHENIA - - Any Intensity - 1 (1.2%) 0 1 (1.0%) - MILD 0 0 0 - MODERATE 1 (1.2%) 0 1 (1.0%) - CHEST DISCOMFORT - - Any Intensity - 0 1 (1.4%) 1 (1.0%) - MILD 0 1 (1.4%) 1 (1.0%) - CHEST PAIN - - Any Intensity - 0 2 (2.8%) 0 - MILD 0 2 (2.8%) 0 - OEDEMA - - Any Intensity - 0 0 2 (2.1%) - MILD 0 0 2 (2.1%) - PAIN - - Any Intensity - 0 1 (1.4%) 1 (1.0%) - MILD 0 1 (1.4%) 0 - MODERATE 0 0 1 (1.0%) - APPLICATION SITE BLEEDING - - Any Intensity - 0 0 1 (1.0%) - MODERATE 0 0 1 (1.0%) - APPLICATION SITE DESQUAMATION - - Any Intensity - 0 0 1 (1.0%) - MILD 0 0 1 (1.0%) - APPLICATION SITE DISCHARGE - - Any Intensity - 0 1 (1.4%) 0 - MODERATE 0 1 (1.4%) 0 - APPLICATION SITE DISCOLOURATION - - Any Intensity - 0 0 1 (1.0%) - MODERATE 0 0 1 (1.0%) - APPLICATION SITE INDURATION - - Any Intensity - 1 (1.2%) 0 0 - MILD 1 (1.2%) 0 0 - APPLICATION SITE WARMTH - - Any Intensity - 0 0 1 (1.0%) - MODERATE 0 0 0 - SEVERE 0 0 1 (1.0%) - CYST - - Any Intensity - 0 0 1 (1.0%) - MILD 0 0 1 (1.0%) - FEELING ABNORMAL - - Any Intensity - 0 1 (1.4%) 0 - MILD 0 1 (1.4%) 0 - FEELING COLD - - Any Intensity - 0 1 (1.4%) 0 - MILD 0 1 (1.4%) 0 - INFLAMMATION - - Any Intensity - 0 0 1 (1.0%) - MODERATE 0 0 1 (1.0%) - SECRETION DISCHARGE - - Any Intensity - 0 0 1 (1.0%) - MILD 0 0 1 (1.0%) - SUDDEN DEATH - - Any Intensity - 0 0 1 (1.0%) - SEVERE 0 0 1 (1.0%) - SWELLING - - Any Intensity - 0 0 1 (1.0%) - MODERATE 0 0 1 (1.0%) - ULCER - - Any Intensity - 0 0 1 (1.0%) - MODERATE 0 0 1 (1.0%) - SKIN AND SUBCUTANEOUS TISSUE DISORDERS - - Any Intensity - 21 (24.4%) 42 (58.3%) 42 (43.8%) - MILD 13 (15.1%) 25 (34.7%) 15 (15.6%) - MODERATE 7 (8.1%) 16 (22.2%) 23 (24.0%) - SEVERE 0 1 (1.4%) 4 (4.2%) - LIFE THREATENING 1 (1.2%) 0 0 - PRURITUS - - Any Intensity - 8 (9.3%) 26 (36.1%) 23 (24.0%) - MILD 7 (8.1%) 17 (23.6%) 11 (11.5%) - MODERATE 1 (1.2%) 9 (12.5%) 11 (11.5%) - SEVERE 0 0 1 (1.0%) - ERYTHEMA - - Any Intensity - 9 (10.5%) 14 (19.4%) 15 (15.6%) - MILD 5 (5.8%) 10 (13.9%) 7 (7.3%) - MODERATE 3 (3.5%) 4 (5.6%) 8 (8.3%) - LIFE THREATENING 1 (1.2%) 0 0 - RASH - - Any Intensity - 5 (5.8%) 11 (15.3%) 13 (13.5%) - MILD 2 (2.3%) 6 (8.3%) 9 (9.4%) - MODERATE 3 (3.5%) 4 (5.6%) 3 (3.1%) - SEVERE 0 1 (1.4%) 1 (1.0%) - HYPERHIDROSIS - - Any Intensity - 2 (2.3%) 8 (11.1%) 4 (4.2%) - MILD 2 (2.3%) 8 (11.1%) 1 (1.0%) - MODERATE 0 0 3 (3.1%) - SKIN IRRITATION - - Any Intensity - 3 (3.5%) 5 (6.9%) 6 (6.2%) - MILD 2 (2.3%) 3 (4.2%) 2 (2.1%) - MODERATE 1 (1.2%) 2 (2.8%) 3 (3.1%) - SEVERE 0 0 1 (1.0%) - BLISTER - - Any Intensity - 0 1 (1.4%) 5 (5.2%) - MILD 0 1 (1.4%) 1 (1.0%) - MODERATE 0 0 3 (3.1%) - SEVERE 0 0 1 (1.0%) - RASH PRURITIC - - Any Intensity - 0 2 (2.8%) 1 (1.0%) - MILD 0 1 (1.4%) 0 - MODERATE 0 1 (1.4%) 1 (1.0%) - PRURITUS GENERALISED - - Any Intensity - 0 1 (1.4%) 1 (1.0%) - MILD 0 1 (1.4%) 0 - MODERATE 0 0 1 (1.0%) - RASH ERYTHEMATOUS - - Any Intensity - 0 0 2 (2.1%) - MILD 0 0 1 (1.0%) - MODERATE 0 0 1 (1.0%) - URTICARIA - - Any Intensity - 0 1 (1.4%) 1 (1.0%) - MILD 0 1 (1.4%) 0 - MODERATE 0 0 1 (1.0%) - ACTINIC KERATOSIS - - Any Intensity - 0 1 (1.4%) 0 - MILD 0 1 (1.4%) 0 - ALOPECIA - - Any Intensity - 1 (1.2%) 0 0 - MILD 1 (1.2%) 0 0 - COLD SWEAT - - Any Intensity - 1 (1.2%) 0 0 - MODERATE 1 (1.2%) 0 0 - DERMATITIS ATOPIC - - Any Intensity - 1 (1.2%) 0 0 - MODERATE 1 (1.2%) 0 0 - DERMATITIS CONTACT - - Any Intensity - 0 0 1 (1.0%) - MODERATE 0 0 1 (1.0%) - DRUG ERUPTION - - Any Intensity - 1 (1.2%) 0 0 - MILD 1 (1.2%) 0 0 - RASH MACULO-PAPULAR - - Any Intensity - 0 1 (1.4%) 0 - MILD 0 1 (1.4%) 0 - RASH PAPULAR - - Any Intensity - 0 1 (1.4%) 0 - MILD 0 1 (1.4%) 0 - SKIN EXFOLIATION - - Any Intensity - 0 0 1 (1.0%) - MODERATE 0 0 1 (1.0%) - SKIN ODOUR ABNORMAL - - Any Intensity - 0 1 (1.4%) 0 - MILD 0 1 (1.4%) 0 - SKIN ULCER - - Any Intensity - 1 (1.2%) 0 0 - MODERATE 1 (1.2%) 0 0 - NERVOUS SYSTEM DISORDERS - - Any Intensity - 12 (14.0%) 25 (34.7%) 22 (22.9%) - MILD 7 (8.1%) 12 (16.7%) 11 (11.5%) - MODERATE 5 (5.8%) 9 (12.5%) 8 (8.3%) - SEVERE 0 4 (5.6%) 3 (3.1%) - DIZZINESS - - Any Intensity - 2 (2.3%) 11 (15.3%) 9 (9.4%) - MILD 2 (2.3%) 6 (8.3%) 6 (6.2%) - MODERATE 0 4 (5.6%) 3 (3.1%) - SEVERE 0 1 (1.4%) 0 - HEADACHE - - Any Intensity - 7 (8.1%) 6 (8.3%) 3 (3.1%) - MILD 4 (4.7%) 4 (5.6%) 2 (2.1%) - MODERATE 3 (3.5%) 2 (2.8%) 0 - SEVERE 0 0 1 (1.0%) - SYNCOPE - - Any Intensity - 0 2 (2.8%) 5 (5.2%) - MILD 0 0 1 (1.0%) - MODERATE 0 1 (1.4%) 2 (2.1%) - SEVERE 0 1 (1.4%) 2 (2.1%) - SOMNOLENCE - - Any Intensity - 2 (2.3%) 1 (1.4%) 3 (3.1%) - MILD 0 1 (1.4%) 1 (1.0%) - MODERATE 2 (2.3%) 0 2 (2.1%) - TRANSIENT ISCHAEMIC ATTACK - - Any Intensity - 0 1 (1.4%) 2 (2.1%) - MILD 0 0 1 (1.0%) - SEVERE 0 1 (1.4%) 1 (1.0%) - BURNING SENSATION - - Any Intensity - 0 2 (2.8%) 0 - MILD 0 1 (1.4%) 0 - MODERATE 0 1 (1.4%) 0 - LETHARGY - - Any Intensity - 0 1 (1.4%) 1 (1.0%) - MODERATE 0 1 (1.4%) 1 (1.0%) - AMNESIA - - Any Intensity - 0 1 (1.4%) 0 - MILD 0 1 (1.4%) 0 - BALANCE DISORDER - - Any Intensity - 0 0 1 (1.0%) - MILD 0 0 0 - MODERATE 0 0 1 (1.0%) - COGNITIVE DISORDER - - Any Intensity - 0 1 (1.4%) 0 - MILD 0 1 (1.4%) 0 - COMPLEX PARTIAL SEIZURES - - Any Intensity - 0 0 1 (1.0%) - MODERATE 0 0 1 (1.0%) - COORDINATION ABNORMAL - - Any Intensity - 0 0 1 (1.0%) - MILD 0 0 1 (1.0%) - HEMIANOPIA HOMONYMOUS - - Any Intensity - 0 0 1 (1.0%) - MILD 0 0 1 (1.0%) - HYPERSOMNIA - - Any Intensity - 0 1 (1.4%) 0 - MILD 0 1 (1.4%) 0 - PARAESTHESIA - - Any Intensity - 0 1 (1.4%) 0 - MILD 0 1 (1.4%) 0 - PARAESTHESIA ORAL - - Any Intensity - 0 0 1 (1.0%) - MILD 0 0 1 (1.0%) - PARKINSON'S DISEASE - - Any Intensity - 1 (1.2%) 0 0 - MILD 1 (1.2%) 0 0 - PAROSMIA - - Any Intensity - 0 1 (1.4%) 0 - MILD 0 1 (1.4%) 0 - PARTIAL SEIZURES WITH SECONDARY GENERALISATION - - Any Intensity - 0 1 (1.4%) 0 - SEVERE 0 1 (1.4%) 0 - PSYCHOMOTOR HYPERACTIVITY - - Any Intensity - 1 (1.2%) 0 0 - MILD 1 (1.2%) 0 0 - STUPOR - - Any Intensity - 0 0 1 (1.0%) - SEVERE 0 0 1 (1.0%) - SYNCOPE VASOVAGAL - - Any Intensity - 0 1 (1.4%) 0 - MODERATE 0 1 (1.4%) 0 - GASTROINTESTINAL DISORDERS - - Any Intensity - 17 (19.8%) 20 (27.8%) 16 (16.7%) - MILD 14 (16.3%) 14 (19.4%) 11 (11.5%) - MODERATE 1 (1.2%) 4 (5.6%) 5 (5.2%) - SEVERE 0 2 (2.8%) 0 - LIFE THREATENING 2 (2.3%) 0 0 - DIARRHOEA - - Any Intensity - 9 (10.5%) 3 (4.2%) 6 (6.2%) - MILD 8 (9.3%) 2 (2.8%) 5 (5.2%) - MODERATE 0 1 (1.4%) 1 (1.0%) - LIFE THREATENING 1 (1.2%) 0 0 - VOMITING - - Any Intensity - 3 (3.5%) 6 (8.3%) 4 (4.2%) - MILD 2 (2.3%) 5 (6.9%) 2 (2.1%) - MODERATE 1 (1.2%) 1 (1.4%) 2 (2.1%) - NAUSEA - - Any Intensity - 3 (3.5%) 6 (8.3%) 3 (3.1%) - MILD 2 (2.3%) 5 (6.9%) 2 (2.1%) - MODERATE 1 (1.2%) 0 1 (1.0%) - SEVERE 0 1 (1.4%) 0 - ABDOMINAL PAIN - - Any Intensity - 1 (1.2%) 1 (1.4%) 3 (3.1%) - MILD 1 (1.2%) 0 2 (2.1%) - MODERATE 0 1 (1.4%) 1 (1.0%) - SALIVARY HYPERSECRETION - - Any Intensity - 0 4 (5.6%) 0 - MILD 0 4 (5.6%) 0 - DYSPEPSIA - - Any Intensity - 1 (1.2%) 1 (1.4%) 1 (1.0%) - MILD 1 (1.2%) 0 0 - MODERATE 0 1 (1.4%) 1 (1.0%) - ABDOMINAL DISCOMFORT - - Any Intensity - 0 1 (1.4%) 0 - MILD 0 1 (1.4%) 0 - CONSTIPATION - - Any Intensity - 1 (1.2%) 0 0 - MILD 1 (1.2%) 0 0 - DYSPHAGIA - - Any Intensity - 0 0 1 (1.0%) - MODERATE 0 0 1 (1.0%) - FLATULENCE - - Any Intensity - 1 (1.2%) 0 0 - MILD 1 (1.2%) 0 0 - GASTROINTESTINAL HAEMORRHAGE - - Any Intensity - 0 1 (1.4%) 0 - SEVERE 0 1 (1.4%) 0 - GASTROOESOPHAGEAL REFLUX DISEASE - - Any Intensity - 1 (1.2%) 0 0 - MILD 1 (1.2%) 0 0 - GLOSSITIS - - Any Intensity - 1 (1.2%) 0 0 - MILD 1 (1.2%) 0 0 - HIATUS HERNIA - - Any Intensity - 1 (1.2%) 0 0 - LIFE THREATENING 1 (1.2%) 0 0 - RECTAL HAEMORRHAGE - - Any Intensity - 0 0 1 (1.0%) - MILD 0 0 1 (1.0%) - STOMACH DISCOMFORT - - Any Intensity - 0 1 (1.4%) 0 - MILD 0 1 (1.4%) 0 - CARDIAC DISORDERS - - Any Intensity - 13 (15.1%) 15 (20.8%) 16 (16.7%) - MILD 6 (7.0%) 9 (12.5%) 9 (9.4%) - MODERATE 2 (2.3%) 5 (6.9%) 7 (7.3%) - SEVERE 3 (3.5%) 1 (1.4%) 0 - LIFE THREATENING 2 (2.3%) 0 0 - SINUS BRADYCARDIA - - Any Intensity - 2 (2.3%) 8 (11.1%) 7 (7.3%) - MILD 1 (1.2%) 4 (5.6%) 6 (6.2%) - MODERATE 1 (1.2%) 4 (5.6%) 1 (1.0%) - MYOCARDIAL INFARCTION - - Any Intensity - 4 (4.7%) 4 (5.6%) 2 (2.1%) - MILD 1 (1.2%) 3 (4.2%) 2 (2.1%) - MODERATE 1 (1.2%) 1 (1.4%) 0 - SEVERE 2 (2.3%) 0 0 - ATRIAL FIBRILLATION - - Any Intensity - 1 (1.2%) 2 (2.8%) 2 (2.1%) - MILD 0 1 (1.4%) 1 (1.0%) - MODERATE 1 (1.2%) 0 1 (1.0%) - SEVERE 0 1 (1.4%) 0 - ATRIOVENTRICULAR BLOCK SECOND DEGREE - - Any Intensity - 2 (2.3%) 1 (1.4%) 2 (2.1%) - MILD 0 1 (1.4%) 0 - MODERATE 0 0 2 (2.1%) - SEVERE 1 (1.2%) 0 0 - LIFE THREATENING 1 (1.2%) 0 0 - SUPRAVENTRICULAR EXTRASYSTOLES - - Any Intensity - 1 (1.2%) 1 (1.4%) 1 (1.0%) - MILD 1 (1.2%) 1 (1.4%) 1 (1.0%) - VENTRICULAR EXTRASYSTOLES - - Any Intensity - 0 1 (1.4%) 2 (2.1%) - MILD 0 1 (1.4%) 1 (1.0%) - MODERATE 0 0 1 (1.0%) - ATRIAL FLUTTER - - Any Intensity - 0 1 (1.4%) 1 (1.0%) - MILD 0 1 (1.4%) 0 - MODERATE 0 0 1 (1.0%) - ATRIOVENTRICULAR BLOCK FIRST DEGREE - - Any Intensity - 1 (1.2%) 0 1 (1.0%) - MILD 1 (1.2%) 0 1 (1.0%) - BUNDLE BRANCH BLOCK RIGHT - - Any Intensity - 1 (1.2%) 0 1 (1.0%) - MILD 1 (1.2%) 0 0 - MODERATE 0 0 1 (1.0%) - PALPITATIONS - - Any Intensity - 0 0 2 (2.1%) - MODERATE 0 0 2 (2.1%) - ATRIAL HYPERTROPHY - - Any Intensity - 1 (1.2%) 0 0 - MILD 1 (1.2%) 0 0 - BRADYCARDIA - - Any Intensity - 1 (1.2%) 0 0 - MILD 1 (1.2%) 0 0 - BUNDLE BRANCH BLOCK LEFT - - Any Intensity - 1 (1.2%) 0 0 - LIFE THREATENING 1 (1.2%) 0 0 - CARDIAC DISORDER - - Any Intensity - 0 1 (1.4%) 0 - MILD 0 1 (1.4%) 0 - CARDIAC FAILURE CONGESTIVE - - Any Intensity - 1 (1.2%) 0 0 - MODERATE 1 (1.2%) 0 0 - SINUS ARRHYTHMIA - - Any Intensity - 1 (1.2%) 0 0 - MILD 1 (1.2%) 0 0 - SUPRAVENTRICULAR TACHYCARDIA - - Any Intensity - 0 0 1 (1.0%) - MODERATE 0 0 1 (1.0%) - TACHYCARDIA - - Any Intensity - 1 (1.2%) 0 0 - MILD 0 0 0 - MODERATE 1 (1.2%) 0 0 - VENTRICULAR HYPERTROPHY - - Any Intensity - 1 (1.2%) 0 0 - MILD 1 (1.2%) 0 0 - WOLFF-PARKINSON-WHITE SYNDROME - - Any Intensity - 0 0 1 (1.0%) - MILD 0 0 1 (1.0%) - INFECTIONS AND INFESTATIONS - - Any Intensity - 16 (18.6%) 13 (18.1%) 10 (10.4%) - MILD 10 (11.6%) 10 (13.9%) 7 (7.3%) - MODERATE 5 (5.8%) 3 (4.2%) 2 (2.1%) - SEVERE 0 0 1 (1.0%) - LIFE THREATENING 1 (1.2%) 0 0 - NASOPHARYNGITIS - - Any Intensity - 2 (2.3%) 6 (8.3%) 4 (4.2%) - MILD 1 (1.2%) 5 (6.9%) 3 (3.1%) - MODERATE 1 (1.2%) 1 (1.4%) 0 - SEVERE 0 0 1 (1.0%) - UPPER RESPIRATORY TRACT INFECTION - - Any Intensity - 6 (7.0%) 3 (4.2%) 1 (1.0%) - MILD 3 (3.5%) 2 (2.8%) 1 (1.0%) - MODERATE 2 (2.3%) 1 (1.4%) 0 - LIFE THREATENING 1 (1.2%) 0 0 - INFLUENZA - - Any Intensity - 1 (1.2%) 1 (1.4%) 1 (1.0%) - MILD 1 (1.2%) 1 (1.4%) 1 (1.0%) - URINARY TRACT INFECTION - - Any Intensity - 2 (2.3%) 1 (1.4%) 0 - MILD 2 (2.3%) 1 (1.4%) 0 - CYSTITIS - - Any Intensity - 1 (1.2%) 1 (1.4%) 0 - MILD 1 (1.2%) 1 (1.4%) 0 - EAR INFECTION - - Any Intensity - 2 (2.3%) 0 0 - MILD 2 (2.3%) 0 0 - LOCALISED INFECTION - - Any Intensity - 1 (1.2%) 0 1 (1.0%) - MILD 1 (1.2%) 0 0 - MODERATE 0 0 1 (1.0%) - BRONCHITIS - - Any Intensity - 1 (1.2%) 0 0 - MODERATE 1 (1.2%) 0 0 - CELLULITIS - - Any Intensity - 0 0 1 (1.0%) - MODERATE 0 0 1 (1.0%) - CERVICITIS - - Any Intensity - 1 (1.2%) 0 0 - MILD 1 (1.2%) 0 0 - GASTROENTERITIS VIRAL - - Any Intensity - 1 (1.2%) 0 0 - MODERATE 1 (1.2%) 0 0 - HORDEOLUM - - Any Intensity - 0 1 (1.4%) 0 - MILD 0 1 (1.4%) 0 - LOWER RESPIRATORY TRACT INFECTION - - Any Intensity - 0 1 (1.4%) 0 - MODERATE 0 1 (1.4%) 0 - ONYCHOMYCOSIS - - Any Intensity - 0 0 1 (1.0%) - MILD 0 0 1 (1.0%) - PNEUMONIA - - Any Intensity - 0 0 1 (1.0%) - MODERATE 0 0 1 (1.0%) - RHINITIS - - Any Intensity - 0 1 (1.4%) 0 - MILD 0 1 (1.4%) 0 - VAGINAL MYCOSIS - - Any Intensity - 1 (1.2%) 0 0 - MILD 1 (1.2%) 0 0 - VIRAL INFECTION - - Any Intensity - 0 0 1 (1.0%) - MILD 0 0 1 (1.0%) - RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - - Any Intensity - 10 (11.6%) 10 (13.9%) 10 (10.4%) - MILD 9 (10.5%) 8 (11.1%) 6 (6.2%) - MODERATE 1 (1.2%) 2 (2.8%) 4 (4.2%) - COUGH - - Any Intensity - 3 (3.5%) 5 (6.9%) 6 (6.2%) - MILD 3 (3.5%) 3 (4.2%) 3 (3.1%) - MODERATE 0 2 (2.8%) 3 (3.1%) - NASAL CONGESTION - - Any Intensity - 3 (3.5%) 3 (4.2%) 1 (1.0%) - MILD 3 (3.5%) 3 (4.2%) 1 (1.0%) - DYSPNOEA - - Any Intensity - 1 (1.2%) 1 (1.4%) 1 (1.0%) - MILD 0 1 (1.4%) 0 - MODERATE 1 (1.2%) 0 1 (1.0%) - EPISTAXIS - - Any Intensity - 0 2 (2.8%) 1 (1.0%) - MILD 0 2 (2.8%) 1 (1.0%) - PHARYNGOLARYNGEAL PAIN - - Any Intensity - 0 1 (1.4%) 1 (1.0%) - MILD 0 1 (1.4%) 1 (1.0%) - RHINORRHOEA - - Any Intensity - 0 1 (1.4%) 1 (1.0%) - MILD 0 1 (1.4%) 1 (1.0%) - ALLERGIC GRANULOMATOUS ANGIITIS - - Any Intensity - 0 1 (1.4%) 0 - MILD 0 1 (1.4%) 0 - DYSPHONIA - - Any Intensity - 0 0 1 (1.0%) - MILD 0 0 1 (1.0%) - EMPHYSEMA - - Any Intensity - 1 (1.2%) 0 0 - MILD 1 (1.2%) 0 0 - HAEMOPTYSIS - - Any Intensity - 1 (1.2%) 0 0 - MILD 1 (1.2%) 0 0 - PHARYNGEAL ERYTHEMA - - Any Intensity - 0 1 (1.4%) 0 - MILD 0 1 (1.4%) 0 - POSTNASAL DRIP - - Any Intensity - 1 (1.2%) 0 0 - MILD 1 (1.2%) 0 0 - PRODUCTIVE COUGH - - Any Intensity - 0 1 (1.4%) 0 - MILD 0 1 (1.4%) 0 - RALES - - Any Intensity - 1 (1.2%) 0 0 - MILD 1 (1.2%) 0 0 - RESPIRATORY TRACT CONGESTION - - Any Intensity - 0 1 (1.4%) 0 - MILD 0 1 (1.4%) 0 - PSYCHIATRIC DISORDERS - - Any Intensity - 10 (11.6%) 8 (11.1%) 11 (11.5%) - MILD 7 (8.1%) 4 (5.6%) 3 (3.1%) - MODERATE 2 (2.3%) 4 (5.6%) 7 (7.3%) - SEVERE 1 (1.2%) 0 1 (1.0%) - CONFUSIONAL STATE - - Any Intensity - 2 (2.3%) 1 (1.4%) 3 (3.1%) - MILD 1 (1.2%) 1 (1.4%) 0 - MODERATE 1 (1.2%) 0 3 (3.1%) - AGITATION - - Any Intensity - 2 (2.3%) 0 3 (3.1%) - MILD 2 (2.3%) 0 0 - MODERATE 0 0 2 (2.1%) - SEVERE 0 0 1 (1.0%) - ANXIETY - - Any Intensity - 1 (1.2%) 0 3 (3.1%) - MILD 0 0 3 (3.1%) - MODERATE 1 (1.2%) 0 0 - INSOMNIA - - Any Intensity - 2 (2.3%) 2 (2.8%) 0 - MILD 2 (2.3%) 2 (2.8%) 0 - DELUSION - - Any Intensity - 1 (1.2%) 1 (1.4%) 0 - MILD 1 (1.2%) 0 0 - MODERATE 0 1 (1.4%) 0 - DEPRESSED MOOD - - Any Intensity - 0 1 (1.4%) 1 (1.0%) - MILD 0 0 0 - MODERATE 0 1 (1.4%) 1 (1.0%) - IRRITABILITY - - Any Intensity - 1 (1.2%) 0 1 (1.0%) - MILD 0 0 1 (1.0%) - MODERATE 1 (1.2%) 0 0 - COMPLETED SUICIDE - - Any Intensity - 1 (1.2%) 0 0 - SEVERE 1 (1.2%) 0 0 - DELIRIUM - - Any Intensity - 0 1 (1.4%) 0 - MODERATE 0 1 (1.4%) 0 - DISORIENTATION - - Any Intensity - 1 (1.2%) 0 0 - MILD 1 (1.2%) 0 0 - HALLUCINATION - - Any Intensity - 0 1 (1.4%) 0 - MODERATE 0 1 (1.4%) 0 - HALLUCINATION, VISUAL - - Any Intensity - 0 1 (1.4%) 0 - MODERATE 0 1 (1.4%) 0 - LIBIDO DECREASED - - Any Intensity - 0 1 (1.4%) 0 - MILD 0 1 (1.4%) 0 - LISTLESS - - Any Intensity - 0 1 (1.4%) 0 - MILD 0 1 (1.4%) 0 - NIGHTMARE - - Any Intensity - 0 1 (1.4%) 0 - MILD 0 1 (1.4%) 0 - RESTLESSNESS - - Any Intensity - 0 0 1 (1.0%) - MODERATE 0 0 1 (1.0%) - INVESTIGATIONS - - Any Intensity - 10 (11.6%) 5 (6.9%) 8 (8.3%) - MILD 8 (9.3%) 4 (5.6%) 7 (7.3%) - MODERATE 2 (2.3%) 1 (1.4%) 1 (1.0%) - ELECTROCARDIOGRAM ST SEGMENT DEPRESSION - - Any Intensity - 4 (4.7%) 0 1 (1.0%) - MILD 4 (4.7%) 0 1 (1.0%) - ELECTROCARDIOGRAM T WAVE INVERSION - - Any Intensity - 2 (2.3%) 1 (1.4%) 1 (1.0%) - MILD 2 (2.3%) 1 (1.4%) 1 (1.0%) - BLOOD GLUCOSE INCREASED - - Any Intensity - 0 1 (1.4%) 1 (1.0%) - MILD 0 1 (1.4%) 1 (1.0%) - ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED - - Any Intensity - 1 (1.2%) 0 1 (1.0%) - MILD 1 (1.2%) 0 1 (1.0%) - BIOPSY - - Any Intensity - 0 1 (1.4%) 0 - MILD 0 1 (1.4%) 0 - BIOPSY PROSTATE - - Any Intensity - 0 1 (1.4%) 0 - MODERATE 0 1 (1.4%) 0 - BLOOD ALKALINE PHOSPHATASE INCREASED - - Any Intensity - 1 (1.2%) 0 0 - MODERATE 1 (1.2%) 0 0 - BLOOD CHOLESTEROL INCREASED - - Any Intensity - 0 1 (1.4%) 0 - MILD 0 1 (1.4%) 0 - BLOOD CREATINE PHOSPHOKINASE INCREASED - - Any Intensity - 1 (1.2%) 0 0 - MODERATE 1 (1.2%) 0 0 - BLOOD URINE PRESENT - - Any Intensity - 1 (1.2%) 0 0 - MILD 1 (1.2%) 0 0 - BODY TEMPERATURE INCREASED - - Any Intensity - 0 0 1 (1.0%) - MILD 0 0 1 (1.0%) - CYSTOSCOPY - - Any Intensity - 1 (1.2%) 0 0 - MILD 1 (1.2%) 0 0 - HEART RATE INCREASED - - Any Intensity - 1 (1.2%) 0 0 - MILD 1 (1.2%) 0 0 - HEART RATE IRREGULAR - - Any Intensity - 1 (1.2%) 0 0 - MILD 1 (1.2%) 0 0 - NASAL MUCOSA BIOPSY - - Any Intensity - 0 0 1 (1.0%) - MILD 0 0 1 (1.0%) - NEUTROPHIL COUNT INCREASED - - Any Intensity - 0 0 1 (1.0%) - MILD 0 0 1 (1.0%) - URINE ANALYSIS ABNORMAL - - Any Intensity - 0 0 1 (1.0%) - MILD 0 0 1 (1.0%) - WEIGHT DECREASED - - Any Intensity - 0 0 1 (1.0%) - MODERATE 0 0 1 (1.0%) - WHITE BLOOD CELL COUNT INCREASED - - Any Intensity - 0 0 1 (1.0%) - MILD 0 0 1 (1.0%) - MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS - - Any Intensity - 5 (5.8%) 8 (11.1%) 7 (7.3%) - MILD 3 (3.5%) 4 (5.6%) 2 (2.1%) - MODERATE 1 (1.2%) 4 (5.6%) 4 (4.2%) - SEVERE 1 (1.2%) 0 1 (1.0%) - BACK PAIN - - Any Intensity - 1 (1.2%) 3 (4.2%) 1 (1.0%) - MILD 1 (1.2%) 2 (2.8%) 0 - MODERATE 0 1 (1.4%) 1 (1.0%) - ARTHRALGIA - - Any Intensity - 1 (1.2%) 1 (1.4%) 2 (2.1%) - MILD 1 (1.2%) 0 0 - MODERATE 0 1 (1.4%) 2 (2.1%) - SHOULDER PAIN - - Any Intensity - 1 (1.2%) 0 2 (2.1%) - MILD 0 0 2 (2.1%) - MODERATE 1 (1.2%) 0 0 - ARTHRITIS - - Any Intensity - 1 (1.2%) 1 (1.4%) 0 - MODERATE 0 1 (1.4%) 0 - SEVERE 1 (1.2%) 0 0 - FLANK PAIN - - Any Intensity - 0 2 (2.8%) 0 - MILD 0 1 (1.4%) 0 - MODERATE 0 1 (1.4%) 0 - MUSCLE SPASMS - - Any Intensity - 0 1 (1.4%) 1 (1.0%) - MILD 0 1 (1.4%) 0 - SEVERE 0 0 1 (1.0%) - MUSCULAR WEAKNESS - - Any Intensity - 0 0 1 (1.0%) - MODERATE 0 0 1 (1.0%) - MYALGIA - - Any Intensity - 0 1 (1.4%) 0 - MILD 0 1 (1.4%) 0 - PAIN IN EXTREMITY - - Any Intensity - 1 (1.2%) 0 0 - MILD 1 (1.2%) 0 0 - INJURY, POISONING AND PROCEDURAL COMPLICATIONS - - Any Intensity - 4 (4.7%) 5 (6.9%) 5 (5.2%) - MILD 3 (3.5%) 1 (1.4%) 1 (1.0%) - MODERATE 0 3 (4.2%) 4 (4.2%) - SEVERE 1 (1.2%) 1 (1.4%) 0 - CONTUSION - - Any Intensity - 1 (1.2%) 2 (2.8%) 1 (1.0%) - MILD 1 (1.2%) 2 (2.8%) 0 - MODERATE 0 0 1 (1.0%) - EXCORIATION - - Any Intensity - 2 (2.3%) 1 (1.4%) 1 (1.0%) - MILD 2 (2.3%) 0 0 - MODERATE 0 1 (1.4%) 1 (1.0%) - FALL - - Any Intensity - 1 (1.2%) 1 (1.4%) 2 (2.1%) - MILD 1 (1.2%) 1 (1.4%) 1 (1.0%) - MODERATE 0 0 1 (1.0%) - HIP FRACTURE - - Any Intensity - 1 (1.2%) 2 (2.8%) 0 - MODERATE 0 1 (1.4%) 0 - SEVERE 1 (1.2%) 1 (1.4%) 0 - SKIN LACERATION - - Any Intensity - 1 (1.2%) 0 2 (2.1%) - MILD 1 (1.2%) 0 1 (1.0%) - MODERATE 0 0 1 (1.0%) - FACIAL BONES FRACTURE - - Any Intensity - 0 1 (1.4%) 0 - MODERATE 0 1 (1.4%) 0 - JOINT DISLOCATION - - Any Intensity - 0 0 1 (1.0%) - MODERATE 0 0 1 (1.0%) - WOUND - - Any Intensity - 0 0 1 (1.0%) - MILD 0 0 1 (1.0%) - RENAL AND URINARY DISORDERS - - Any Intensity - 4 (4.7%) 3 (4.2%) 4 (4.2%) - MILD 3 (3.5%) 1 (1.4%) 3 (3.1%) - MODERATE 1 (1.2%) 2 (2.8%) 1 (1.0%) - MICTURITION URGENCY - - Any Intensity - 1 (1.2%) 1 (1.4%) 1 (1.0%) - MILD 1 (1.2%) 1 (1.4%) 1 (1.0%) - DYSURIA - - Any Intensity - 1 (1.2%) 0 1 (1.0%) - MILD 1 (1.2%) 0 1 (1.0%) - NEPHROLITHIASIS - - Any Intensity - 1 (1.2%) 1 (1.4%) 0 - MODERATE 1 (1.2%) 1 (1.4%) 0 - CALCULUS URETHRAL - - Any Intensity - 0 1 (1.4%) 0 - MODERATE 0 1 (1.4%) 0 - ENURESIS - - Any Intensity - 0 0 1 (1.0%) - MODERATE 0 0 1 (1.0%) - INCONTINENCE - - Any Intensity - 0 0 1 (1.0%) - MILD 0 0 1 (1.0%) - POLLAKIURIA - - Any Intensity - 1 (1.2%) 0 0 - MILD 1 (1.2%) 0 0 - METABOLISM AND NUTRITION DISORDERS - - Any Intensity - 6 (7.0%) 3 (4.2%) 1 (1.0%) - MILD 4 (4.7%) 1 (1.4%) 0 - MODERATE 2 (2.3%) 2 (2.8%) 1 (1.0%) - DECREASED APPETITE - - Any Intensity - 1 (1.2%) 1 (1.4%) 0 - MILD 0 0 0 - MODERATE 1 (1.2%) 1 (1.4%) 0 - FOOD CRAVING - - Any Intensity - 1 (1.2%) 0 1 (1.0%) - MILD 1 (1.2%) 0 0 - MODERATE 0 0 1 (1.0%) - INCREASED APPETITE - - Any Intensity - 1 (1.2%) 1 (1.4%) 0 - MILD 1 (1.2%) 1 (1.4%) 0 - DEHYDRATION - - Any Intensity - 1 (1.2%) 0 0 - MILD 1 (1.2%) 0 0 - DIABETES MELLITUS - - Any Intensity - 1 (1.2%) 0 0 - MILD 1 (1.2%) 0 0 - HYPERCHOLESTEROLAEMIA - - Any Intensity - 0 1 (1.4%) 0 - MODERATE 0 1 (1.4%) 0 - HYPONATRAEMIA - - Any Intensity - 1 (1.2%) 0 0 - MODERATE 1 (1.2%) 0 0 - VASCULAR DISORDERS - - Any Intensity - 3 (3.5%) 1 (1.4%) 4 (4.2%) - MILD 1 (1.2%) 0 3 (3.1%) - MODERATE 2 (2.3%) 1 (1.4%) 1 (1.0%) - HYPERTENSION - - Any Intensity - 1 (1.2%) 0 2 (2.1%) - MILD 0 0 1 (1.0%) - MODERATE 1 (1.2%) 0 1 (1.0%) - HYPOTENSION - - Any Intensity - 2 (2.3%) 0 1 (1.0%) - MILD 1 (1.2%) 0 1 (1.0%) - MODERATE 1 (1.2%) 0 0 - HOT FLUSH - - Any Intensity - 0 0 1 (1.0%) - MILD 0 0 1 (1.0%) - ORTHOSTATIC HYPOTENSION - - Any Intensity - 1 (1.2%) 0 0 - MILD 1 (1.2%) 0 0 - WOUND HAEMORRHAGE - - Any Intensity - 0 1 (1.4%) 0 - MODERATE 0 1 (1.4%) 0 - EYE DISORDERS - - Any Intensity - 4 (4.7%) 1 (1.4%) 2 (2.1%) - MILD 2 (2.3%) 0 1 (1.0%) - MODERATE 2 (2.3%) 1 (1.4%) 1 (1.0%) - CONJUNCTIVITIS - - Any Intensity - 2 (2.3%) 0 0 - MILD 1 (1.2%) 0 0 - MODERATE 1 (1.2%) 0 0 - VISION BLURRED - - Any Intensity - 0 1 (1.4%) 1 (1.0%) - MILD 0 0 1 (1.0%) - MODERATE 0 1 (1.4%) 0 - CONJUNCTIVAL HAEMORRHAGE - - Any Intensity - 0 0 1 (1.0%) - MODERATE 0 0 1 (1.0%) - EYE ALLERGY - - Any Intensity - 1 (1.2%) 0 0 - MILD 1 (1.2%) 0 0 - EYE PRURITUS - - Any Intensity - 1 (1.2%) 0 0 - MILD 1 (1.2%) 0 0 - EYE SWELLING - - Any Intensity - 1 (1.2%) 0 0 - MILD 1 (1.2%) 0 0 - GLAUCOMA - - Any Intensity - 1 (1.2%) 0 0 - MODERATE 1 (1.2%) 0 0 - SURGICAL AND MEDICAL PROCEDURES - - Any Intensity - 2 (2.3%) 2 (2.8%) 1 (1.0%) - MILD 1 (1.2%) 2 (2.8%) 1 (1.0%) - MODERATE 1 (1.2%) 0 0 - CATARACT OPERATION - - Any Intensity - 1 (1.2%) 0 1 (1.0%) - MILD 0 0 1 (1.0%) - MODERATE 1 (1.2%) 0 0 - ACROCHORDON EXCISION - - Any Intensity - 0 1 (1.4%) 0 - MILD 0 1 (1.4%) 0 - EYE LASER SURGERY - - Any Intensity - 1 (1.2%) 0 0 - MILD 1 (1.2%) 0 0 - SKIN LESION EXCISION - - Any Intensity - 0 1 (1.4%) 0 - MILD 0 1 (1.4%) 0 - EAR AND LABYRINTH DISORDERS - - Any Intensity - 1 (1.2%) 1 (1.4%) 2 (2.1%) - MILD 1 (1.2%) 0 0 - MODERATE 0 1 (1.4%) 2 (2.1%) - VERTIGO - - Any Intensity - 0 1 (1.4%) 1 (1.0%) - MODERATE 0 1 (1.4%) 1 (1.0%) - CERUMEN IMPACTION - - Any Intensity - 0 0 1 (1.0%) - MILD 0 0 1 (1.0%) - EAR PAIN - - Any Intensity - 1 (1.2%) 0 0 - MILD 1 (1.2%) 0 0 - TINNITUS - - Any Intensity - 0 0 1 (1.0%) - MODERATE 0 0 1 (1.0%) - CONGENITAL, FAMILIAL AND GENETIC DISORDERS - - Any Intensity - 0 2 (2.8%) 1 (1.0%) - MILD 0 2 (2.8%) 0 - MODERATE 0 0 1 (1.0%) - VENTRICULAR SEPTAL DEFECT - - Any Intensity - 0 2 (2.8%) 1 (1.0%) - MILD 0 2 (2.8%) 0 - MODERATE 0 0 1 (1.0%) - NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - - Any Intensity - 0 1 (1.4%) 2 (2.1%) - MILD 0 0 1 (1.0%) - SEVERE 0 1 (1.4%) 1 (1.0%) - COLON CANCER - - Any Intensity - 0 0 1 (1.0%) - SEVERE 0 0 1 (1.0%) - MALIGNANT FIBROUS HISTIOCYTOMA - - Any Intensity - 0 0 1 (1.0%) - MILD 0 0 1 (1.0%) - PROSTATE CANCER - - Any Intensity - 0 1 (1.4%) 0 - SEVERE 0 1 (1.4%) 0 - REPRODUCTIVE SYSTEM AND BREAST DISORDERS - - Any Intensity - 2 (2.3%) 1 (1.4%) 0 - MILD 1 (1.2%) 0 0 - MODERATE 0 1 (1.4%) 0 - SEVERE 1 (1.2%) 0 0 - BENIGN PROSTATIC HYPERPLASIA - - Any Intensity - 1 (1.2%) 1 (1.4%) 0 - MILD 0 0 0 - MODERATE 0 1 (1.4%) 0 - SEVERE 1 (1.2%) 0 0 - PELVIC PAIN - - Any Intensity - 1 (1.2%) 0 0 - MILD 1 (1.2%) 0 0 - IMMUNE SYSTEM DISORDERS - - Any Intensity - 0 1 (1.4%) 1 (1.0%) - MILD 0 1 (1.4%) 1 (1.0%) - HYPERSENSITIVITY - - Any Intensity - 0 0 1 (1.0%) - MILD 0 0 1 (1.0%) - SEASONAL ALLERGY - - Any Intensity - 0 1 (1.4%) 0 - MILD 0 1 (1.4%) 0 - HEPATOBILIARY DISORDERS - - Any Intensity - 1 (1.2%) 0 0 - MODERATE 1 (1.2%) 0 0 - HYPERBILIRUBINAEMIA - - Any Intensity - 1 (1.2%) 0 0 - MODERATE 1 (1.2%) 0 0 - SOCIAL CIRCUMSTANCES - - Any Intensity - 0 1 (1.4%) 0 - MILD 0 1 (1.4%) 0 - ALCOHOL USE - - Any Intensity - 0 1 (1.4%) 0 - MILD 0 1 (1.4%) 0 + MedDRA System Organ Class + MedDRA Preferred Term Placebo Xanomeline High Dose Xanomeline Low Dose + Severity/Intensity (N=86) (N=72) (N=96) + —————————————————————————————————————————————————————————————————————————————————————————————————————————————— + - Any Intensity - 37 (43.0%) 61 (84.7%) 64 (66.7%) + MILD 22 (25.6%) 26 (36.1%) 28 (29.2%) + MODERATE 11 (12.8%) 31 (43.1%) 26 (27.1%) + SEVERE 2 (2.3%) 2 (2.8%) 8 (8.3%) + LIFE THREATENING 2 (2.3%) 2 (2.8%) 2 (2.1%) + SKIN AND SUBCUTANEOUS TISSUE DISORDERS + - Any Intensity - 19 (22.1%) 34 (47.2%) 35 (36.5%) + MILD 13 (15.1%) 18 (25.0%) 15 (15.6%) + MODERATE 5 (5.8%) 15 (20.8%) 16 (16.7%) + SEVERE 0 1 (1.4%) 3 (3.1%) + LIFE THREATENING 1 (1.2%) 0 1 (1.0%) + PRURITUS + - Any Intensity - 8 (9.3%) 26 (36.1%) 23 (24.0%) + MILD 7 (8.1%) 17 (23.6%) 11 (11.5%) + MODERATE 1 (1.2%) 9 (12.5%) 11 (11.5%) + SEVERE 0 0 1 (1.0%) + ERYTHEMA + - Any Intensity - 9 (10.5%) 14 (19.4%) 15 (15.6%) + MILD 5 (5.8%) 10 (13.9%) 6 (6.2%) + MODERATE 3 (3.5%) 4 (5.6%) 8 (8.3%) + LIFE THREATENING 1 (1.2%) 0 1 (1.0%) + RASH + - Any Intensity - 5 (5.8%) 11 (15.3%) 13 (13.5%) + MILD 2 (2.3%) 6 (8.3%) 9 (9.4%) + MODERATE 3 (3.5%) 4 (5.6%) 3 (3.1%) + SEVERE 0 1 (1.4%) 1 (1.0%) + SKIN IRRITATION + - Any Intensity - 3 (3.5%) 5 (6.9%) 6 (6.2%) + MILD 2 (2.3%) 3 (4.2%) 2 (2.1%) + MODERATE 1 (1.2%) 2 (2.8%) 3 (3.1%) + SEVERE 0 0 1 (1.0%) + GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS + - Any Intensity - 10 (11.6%) 29 (40.3%) 31 (32.3%) + MILD 7 (8.1%) 12 (16.7%) 14 (14.6%) + MODERATE 2 (2.3%) 15 (20.8%) 10 (10.4%) + SEVERE 0 0 5 (5.2%) + LIFE THREATENING 1 (1.2%) 2 (2.8%) 2 (2.1%) + APPLICATION SITE PRURITUS + - Any Intensity - 6 (7.0%) 21 (29.2%) 23 (24.0%) + MILD 4 (4.7%) 8 (11.1%) 13 (13.5%) + MODERATE 1 (1.2%) 11 (15.3%) 7 (7.3%) + SEVERE 0 0 1 (1.0%) + LIFE THREATENING 1 (1.2%) 2 (2.8%) 2 (2.1%) + APPLICATION SITE ERYTHEMA + - Any Intensity - 3 (3.5%) 14 (19.4%) 13 (13.5%) + MILD 2 (2.3%) 8 (11.1%) 4 (4.2%) + MODERATE 0 5 (6.9%) 6 (6.2%) + SEVERE 0 0 2 (2.1%) + LIFE THREATENING 1 (1.2%) 1 (1.4%) 1 (1.0%) + APPLICATION SITE IRRITATION + - Any Intensity - 3 (3.5%) 9 (12.5%) 9 (9.4%) + MILD 1 (1.2%) 3 (4.2%) 3 (3.1%) + MODERATE 2 (2.3%) 6 (8.3%) 2 (2.1%) + SEVERE 0 0 3 (3.1%) + LIFE THREATENING 0 0 1 (1.0%) + GASTROINTESTINAL DISORDERS + - Any Intensity - 4 (4.7%) 10 (13.9%) 6 (6.2%) + MILD 3 (3.5%) 8 (11.1%) 4 (4.2%) + MODERATE 1 (1.2%) 1 (1.4%) 2 (2.1%) + SEVERE 0 1 (1.4%) 0 + VOMITING + - Any Intensity - 3 (3.5%) 6 (8.3%) 4 (4.2%) + MILD 2 (2.3%) 5 (6.9%) 2 (2.1%) + MODERATE 1 (1.2%) 1 (1.4%) 2 (2.1%) + NAUSEA + - Any Intensity - 3 (3.5%) 6 (8.3%) 3 (3.1%) + MILD 2 (2.3%) 5 (6.9%) 2 (2.1%) + MODERATE 1 (1.2%) 0 1 (1.0%) + SEVERE 0 1 (1.4%) 0 + NERVOUS SYSTEM DISORDERS + - Any Intensity - 7 (8.1%) 6 (8.3%) 3 (3.1%) + MILD 4 (4.7%) 4 (5.6%) 2 (2.1%) + MODERATE 3 (3.5%) 2 (2.8%) 0 + SEVERE 0 0 1 (1.0%) + HEADACHE + - Any Intensity - 7 (8.1%) 6 (8.3%) 3 (3.1%) + MILD 4 (4.7%) 4 (5.6%) 2 (2.1%) + MODERATE 3 (3.5%) 2 (2.8%) 0 + SEVERE 0 0 1 (1.0%) + CARDIAC DISORDERS + - Any Intensity - 4 (4.7%) 4 (5.6%) 2 (2.1%) + MILD 1 (1.2%) 3 (4.2%) 2 (2.1%) + MODERATE 1 (1.2%) 1 (1.4%) 0 + SEVERE 2 (2.3%) 0 0 + MYOCARDIAL INFARCTION + - Any Intensity - 4 (4.7%) 4 (5.6%) 2 (2.1%) + MILD 1 (1.2%) 3 (4.2%) 2 (2.1%) + MODERATE 1 (1.2%) 1 (1.4%) 0 + SEVERE 2 (2.3%) 0 0 + VASCULAR DISORDERS + - Any Intensity - 0 1 (1.4%) 0 + MODERATE 0 1 (1.4%) 0 + WOUND HAEMORRHAGE + - Any Intensity - 0 1 (1.4%) 0 + MODERATE 0 1 (1.4%) 0 diff --git a/tests/testthat/_snaps/table_aet04.md b/tests/testthat/_snaps/table_aet04.md index 0813783..5659328 100644 --- a/tests/testthat/_snaps/table_aet04.md +++ b/tests/testthat/_snaps/table_aet04.md @@ -3,11105 +3,626 @@ Code res Output - MedDRA System Organ Class - MedDRA Preferred Term Placebo Xanomeline High Dose Xanomeline Low Dose - Grade (N=86) (N=72) (N=96) - ————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— - - Any adverse events - - - Any Grade - 69 (80.2%) 70 (97.2%) 86 (89.6%) - Grade 1-2 46 (53.5%) 37 (51.4%) 54 (56.2%) - 1 22 (25.6%) 18 (25.0%) 19 (19.8%) - 2 24 (27.9%) 19 (26.4%) 35 (36.5%) - Grade 3-4 20 (23.3%) 32 (44.4%) 30 (31.2%) - 3 8 (9.3%) 16 (22.2%) 11 (11.5%) - 4 12 (14.0%) 16 (22.2%) 19 (19.8%) - Grade 5 3 (3.5%) 1 (1.4%) 2 (2.1%) - GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - - Overall - - - Any Grade - 21 (24.4%) 36 (50.0%) 51 (53.1%) - Grade 1-2 17 (19.8%) 28 (38.9%) 40 (41.7%) - 1 10 (11.6%) 15 (20.8%) 20 (20.8%) - 2 7 (8.1%) 13 (18.1%) 20 (20.8%) - Grade 3-4 4 (4.7%) 8 (11.1%) 11 (11.5%) - 3 2 (2.3%) 3 (4.2%) 6 (6.2%) - 4 2 (2.3%) 5 (6.9%) 5 (5.2%) - APPLICATION SITE PRURITUS - - Any Grade - 6 (7.0%) 21 (29.2%) 23 (24.0%) - Grade 1-2 4 (4.7%) 19 (26.4%) 20 (20.8%) - 1 2 (2.3%) 11 (15.3%) 16 (16.7%) - 2 2 (2.3%) 8 (11.1%) 4 (4.2%) - Grade 3-4 2 (2.3%) 2 (2.8%) 3 (3.1%) - 3 0 0 1 (1.0%) - 4 2 (2.3%) 2 (2.8%) 2 (2.1%) - APPLICATION SITE ERYTHEMA - - Any Grade - 3 (3.5%) 14 (19.4%) 13 (13.5%) - Grade 1-2 3 (3.5%) 12 (16.7%) 11 (11.5%) - 1 2 (2.3%) 10 (13.9%) 8 (8.3%) - 2 1 (1.2%) 2 (2.8%) 3 (3.1%) - Grade 3-4 0 2 (2.8%) 2 (2.1%) - 3 0 2 (2.8%) 1 (1.0%) - 4 0 0 1 (1.0%) - APPLICATION SITE DERMATITIS - - Any Grade - 5 (5.8%) 7 (9.7%) 9 (9.4%) - Grade 1-2 4 (4.7%) 6 (8.3%) 8 (8.3%) - 1 3 (3.5%) 3 (4.2%) 4 (4.2%) - 2 1 (1.2%) 3 (4.2%) 4 (4.2%) - Grade 3-4 1 (1.2%) 1 (1.4%) 1 (1.0%) - 3 1 (1.2%) 1 (1.4%) 1 (1.0%) - APPLICATION SITE IRRITATION - - Any Grade - 3 (3.5%) 9 (12.5%) 9 (9.4%) - Grade 1-2 2 (2.3%) 8 (11.1%) 6 (6.2%) - 1 2 (2.3%) 6 (8.3%) 3 (3.1%) - 2 0 2 (2.8%) 3 (3.1%) - Grade 3-4 1 (1.2%) 1 (1.4%) 3 (3.1%) - 3 1 (1.2%) 0 1 (1.0%) - 4 0 1 (1.4%) 2 (2.1%) - APPLICATION SITE VESICLES - - Any Grade - 1 (1.2%) 5 (6.9%) 5 (5.2%) - Grade 1-2 1 (1.2%) 4 (5.6%) 5 (5.2%) - 1 0 3 (4.2%) 4 (4.2%) - 2 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 3-4 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - FATIGUE - - Any Grade - 1 (1.2%) 5 (6.9%) 5 (5.2%) - Grade 1-2 1 (1.2%) 4 (5.6%) 5 (5.2%) - 1 0 3 (4.2%) 3 (3.1%) - 2 1 (1.2%) 1 (1.4%) 2 (2.1%) - Grade 3-4 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - OEDEMA PERIPHERAL - - Any Grade - 2 (2.3%) 2 (2.8%) 1 (1.0%) - Grade 1-2 1 (1.2%) 2 (2.8%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - 2 1 (1.2%) 1 (1.4%) 0 - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - APPLICATION SITE SWELLING - - Any Grade - 0 2 (2.8%) 1 (1.0%) - Grade 1-2 0 2 (2.8%) 1 (1.0%) - 1 0 2 (2.8%) 1 (1.0%) - APPLICATION SITE URTICARIA - - Any Grade - 0 1 (1.4%) 2 (2.1%) - Grade 1-2 0 1 (1.4%) 2 (2.1%) - 1 0 1 (1.4%) 1 (1.0%) - 2 0 0 1 (1.0%) - CHILLS - - Any Grade - 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 1-2 1 (1.2%) 1 (1.4%) 1 (1.0%) - 1 1 (1.2%) 1 (1.4%) 0 - 2 0 0 1 (1.0%) - MALAISE - - Any Grade - 0 2 (2.8%) 1 (1.0%) - Grade 1-2 0 2 (2.8%) 1 (1.0%) - 1 0 1 (1.4%) 0 - 2 0 1 (1.4%) 1 (1.0%) - PYREXIA - - Any Grade - 2 (2.3%) 0 1 (1.0%) - Grade 1-2 2 (2.3%) 0 1 (1.0%) - 1 1 (1.2%) 0 1 (1.0%) - 2 1 (1.2%) 0 0 - APPLICATION SITE PAIN - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 1 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - APPLICATION SITE PERSPIRATION - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 2 0 2 (2.8%) 0 - APPLICATION SITE REACTION - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 1 1 (1.2%) 1 (1.4%) 0 - ASTHENIA - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 1 1 (1.2%) 0 0 - 2 0 0 1 (1.0%) - CHEST DISCOMFORT - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 0 - 2 0 0 1 (1.0%) - CHEST PAIN - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 1 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - OEDEMA - - Any Grade - 0 0 2 (2.1%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - PAIN - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - APPLICATION SITE BLEEDING - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - APPLICATION SITE DESQUAMATION - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - APPLICATION SITE DISCHARGE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - APPLICATION SITE DISCOLOURATION - - Any Grade - 0 0 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - APPLICATION SITE INDURATION - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - APPLICATION SITE WARMTH - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - CYST - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - FEELING ABNORMAL - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - FEELING COLD - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - INFLAMMATION - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - SECRETION DISCHARGE - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - SUDDEN DEATH - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - SWELLING - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - ULCER - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - SKIN AND SUBCUTANEOUS TISSUE DISORDERS - - Overall - - - Any Grade - 21 (24.4%) 42 (58.3%) 42 (43.8%) - Grade 1-2 17 (19.8%) 33 (45.8%) 33 (34.4%) - 1 11 (12.8%) 20 (27.8%) 17 (17.7%) - 2 6 (7.0%) 13 (18.1%) 16 (16.7%) - Grade 3-4 4 (4.7%) 9 (12.5%) 7 (7.3%) - 3 2 (2.3%) 4 (5.6%) 4 (4.2%) - 4 2 (2.3%) 5 (6.9%) 3 (3.1%) - Grade 5 0 0 2 (2.1%) - PRURITUS - - Any Grade - 8 (9.3%) 26 (36.1%) 23 (24.0%) - Grade 1-2 5 (5.8%) 20 (27.8%) 21 (21.9%) - 1 4 (4.7%) 15 (20.8%) 14 (14.6%) - 2 1 (1.2%) 5 (6.9%) 7 (7.3%) - Grade 3-4 3 (3.5%) 6 (8.3%) 1 (1.0%) - 3 1 (1.2%) 3 (4.2%) 1 (1.0%) - 4 2 (2.3%) 3 (4.2%) 0 - Grade 5 0 0 1 (1.0%) - ERYTHEMA - - Any Grade - 9 (10.5%) 14 (19.4%) 15 (15.6%) - Grade 1-2 9 (10.5%) 14 (19.4%) 13 (13.5%) - 1 8 (9.3%) 12 (16.7%) 8 (8.3%) - 2 1 (1.2%) 2 (2.8%) 5 (5.2%) - Grade 3-4 0 0 2 (2.1%) - 3 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - RASH - - Any Grade - 5 (5.8%) 11 (15.3%) 13 (13.5%) - Grade 1-2 4 (4.7%) 10 (13.9%) 11 (11.5%) - 1 3 (3.5%) 7 (9.7%) 10 (10.4%) - 2 1 (1.2%) 3 (4.2%) 1 (1.0%) - Grade 3-4 1 (1.2%) 1 (1.4%) 2 (2.1%) - 3 1 (1.2%) 1 (1.4%) 1 (1.0%) - 4 0 0 1 (1.0%) - HYPERHIDROSIS - - Any Grade - 2 (2.3%) 8 (11.1%) 4 (4.2%) - Grade 1-2 2 (2.3%) 7 (9.7%) 4 (4.2%) - 1 0 5 (6.9%) 4 (4.2%) - 2 2 (2.3%) 2 (2.8%) 0 - Grade 3-4 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - SKIN IRRITATION - - Any Grade - 3 (3.5%) 5 (6.9%) 6 (6.2%) - Grade 1-2 3 (3.5%) 5 (6.9%) 4 (4.2%) - 1 1 (1.2%) 3 (4.2%) 3 (3.1%) - 2 2 (2.3%) 2 (2.8%) 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - Grade 5 0 0 1 (1.0%) - BLISTER - - Any Grade - 0 1 (1.4%) 5 (5.2%) - Grade 1-2 0 1 (1.4%) 5 (5.2%) - 1 0 1 (1.4%) 4 (4.2%) - 2 0 0 1 (1.0%) - RASH PRURITIC - - Any Grade - 0 2 (2.8%) 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - Grade 3-4 0 2 (2.8%) 0 - 3 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - PRURITUS GENERALISED - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 0 - 2 0 0 1 (1.0%) - RASH ERYTHEMATOUS - - Any Grade - 0 0 2 (2.1%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - URTICARIA - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - ACTINIC KERATOSIS - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - ALOPECIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - COLD SWEAT - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - DERMATITIS ATOPIC - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - DERMATITIS CONTACT - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - DRUG ERUPTION - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - RASH MACULO-PAPULAR - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - RASH PAPULAR - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - SKIN EXFOLIATION - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - SKIN ODOUR ABNORMAL - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - SKIN ULCER - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - NERVOUS SYSTEM DISORDERS - - Overall - - - Any Grade - 12 (14.0%) 25 (34.7%) 22 (22.9%) - Grade 1-2 10 (11.6%) 22 (30.6%) 19 (19.8%) - 1 7 (8.1%) 16 (22.2%) 13 (13.5%) - 2 3 (3.5%) 6 (8.3%) 6 (6.2%) - Grade 3-4 1 (1.2%) 3 (4.2%) 3 (3.1%) - 3 0 1 (1.4%) 1 (1.0%) - 4 1 (1.2%) 2 (2.8%) 2 (2.1%) - Grade 5 1 (1.2%) 0 0 - DIZZINESS - - Any Grade - 2 (2.3%) 11 (15.3%) 9 (9.4%) - Grade 1-2 2 (2.3%) 9 (12.5%) 8 (8.3%) - 1 1 (1.2%) 9 (12.5%) 5 (5.2%) - 2 1 (1.2%) 0 3 (3.1%) - Grade 3-4 0 2 (2.8%) 1 (1.0%) - 3 0 0 1 (1.0%) - 4 0 2 (2.8%) 0 - HEADACHE - - Any Grade - 7 (8.1%) 6 (8.3%) 3 (3.1%) - Grade 1-2 6 (7.0%) 6 (8.3%) 3 (3.1%) - 1 5 (5.8%) 3 (4.2%) 2 (2.1%) - 2 1 (1.2%) 3 (4.2%) 1 (1.0%) - Grade 3-4 1 (1.2%) 0 0 - 4 1 (1.2%) 0 0 - SYNCOPE - - Any Grade - 0 2 (2.8%) 5 (5.2%) - Grade 1-2 0 2 (2.8%) 5 (5.2%) - 1 0 2 (2.8%) 5 (5.2%) - SOMNOLENCE - - Any Grade - 2 (2.3%) 1 (1.4%) 3 (3.1%) - Grade 1-2 2 (2.3%) 1 (1.4%) 2 (2.1%) - 1 1 (1.2%) 1 (1.4%) 2 (2.1%) - 2 1 (1.2%) 0 0 - Grade 3-4 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - TRANSIENT ISCHAEMIC ATTACK - - Any Grade - 0 1 (1.4%) 2 (2.1%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 2 0 1 (1.4%) 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - BURNING SENSATION - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 1 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - LETHARGY - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - AMNESIA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - BALANCE DISORDER - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - COGNITIVE DISORDER - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - COMPLEX PARTIAL SEIZURES - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - COORDINATION ABNORMAL - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - HEMIANOPIA HOMONYMOUS - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - HYPERSOMNIA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - PARAESTHESIA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - PARAESTHESIA ORAL - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - PARKINSON'S DISEASE - - Any Grade - 1 (1.2%) 0 0 - Grade 5 1 (1.2%) 0 0 - PAROSMIA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - PARTIAL SEIZURES WITH SECONDARY GENERALISATION - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - PSYCHOMOTOR HYPERACTIVITY - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - STUPOR - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - SYNCOPE VASOVAGAL - - Any Grade - 0 1 (1.4%) 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - GASTROINTESTINAL DISORDERS - - Overall - - - Any Grade - 17 (19.8%) 20 (27.8%) 16 (16.7%) - Grade 1-2 14 (16.3%) 17 (23.6%) 12 (12.5%) - 1 9 (10.5%) 12 (16.7%) 10 (10.4%) - 2 5 (5.8%) 5 (6.9%) 2 (2.1%) - Grade 3-4 2 (2.3%) 2 (2.8%) 4 (4.2%) - 3 0 2 (2.8%) 0 - 4 2 (2.3%) 0 4 (4.2%) - Grade 5 1 (1.2%) 1 (1.4%) 0 - DIARRHOEA - - Any Grade - 9 (10.5%) 3 (4.2%) 6 (6.2%) - Grade 1-2 8 (9.3%) 3 (4.2%) 4 (4.2%) - 1 7 (8.1%) 3 (4.2%) 3 (3.1%) - 2 1 (1.2%) 0 1 (1.0%) - Grade 3-4 1 (1.2%) 0 2 (2.1%) - 4 1 (1.2%) 0 2 (2.1%) - VOMITING - - Any Grade - 3 (3.5%) 6 (8.3%) 4 (4.2%) - Grade 1-2 2 (2.3%) 6 (8.3%) 4 (4.2%) - 1 0 4 (5.6%) 3 (3.1%) - 2 2 (2.3%) 2 (2.8%) 1 (1.0%) - Grade 5 1 (1.2%) 0 0 - NAUSEA - - Any Grade - 3 (3.5%) 6 (8.3%) 3 (3.1%) - Grade 1-2 3 (3.5%) 3 (4.2%) 2 (2.1%) - 1 2 (2.3%) 2 (2.8%) 1 (1.0%) - 2 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 3-4 0 2 (2.8%) 1 (1.0%) - 3 0 2 (2.8%) 0 - 4 0 0 1 (1.0%) - Grade 5 0 1 (1.4%) 0 - ABDOMINAL PAIN - - Any Grade - 1 (1.2%) 1 (1.4%) 3 (3.1%) - Grade 1-2 0 1 (1.4%) 2 (2.1%) - 1 0 1 (1.4%) 2 (2.1%) - Grade 3-4 1 (1.2%) 0 1 (1.0%) - 4 1 (1.2%) 0 1 (1.0%) - SALIVARY HYPERSECRETION - - Any Grade - 0 4 (5.6%) 0 - Grade 1-2 0 4 (5.6%) 0 - 1 0 2 (2.8%) 0 - 2 0 2 (2.8%) 0 - DYSPEPSIA - - Any Grade - 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 1-2 1 (1.2%) 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - 2 1 (1.2%) 0 0 - ABDOMINAL DISCOMFORT - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - CONSTIPATION - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - DYSPHAGIA - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - FLATULENCE - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - GASTROINTESTINAL HAEMORRHAGE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - GASTROOESOPHAGEAL REFLUX DISEASE - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - GLOSSITIS - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - HIATUS HERNIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - RECTAL HAEMORRHAGE - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - STOMACH DISCOMFORT - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - CARDIAC DISORDERS - - Overall - - - Any Grade - 13 (15.1%) 15 (20.8%) 16 (16.7%) - Grade 1-2 9 (10.5%) 13 (18.1%) 15 (15.6%) - 1 5 (5.8%) 9 (12.5%) 12 (12.5%) - 2 4 (4.7%) 4 (5.6%) 3 (3.1%) - Grade 3-4 4 (4.7%) 2 (2.8%) 1 (1.0%) - 3 3 (3.5%) 2 (2.8%) 0 - 4 1 (1.2%) 0 1 (1.0%) - SINUS BRADYCARDIA - - Any Grade - 2 (2.3%) 8 (11.1%) 7 (7.3%) - Grade 1-2 2 (2.3%) 8 (11.1%) 7 (7.3%) - 1 1 (1.2%) 6 (8.3%) 7 (7.3%) - 2 1 (1.2%) 2 (2.8%) 0 - MYOCARDIAL INFARCTION - - Any Grade - 4 (4.7%) 4 (5.6%) 2 (2.1%) - Grade 1-2 3 (3.5%) 3 (4.2%) 2 (2.1%) - 1 1 (1.2%) 2 (2.8%) 2 (2.1%) - 2 2 (2.3%) 1 (1.4%) 0 - Grade 3-4 1 (1.2%) 1 (1.4%) 0 - 3 1 (1.2%) 1 (1.4%) 0 - ATRIAL FIBRILLATION - - Any Grade - 1 (1.2%) 2 (2.8%) 2 (2.1%) - Grade 1-2 1 (1.2%) 2 (2.8%) 2 (2.1%) - 1 1 (1.2%) 1 (1.4%) 2 (2.1%) - 2 0 1 (1.4%) 0 - ATRIOVENTRICULAR BLOCK SECOND DEGREE - - Any Grade - 2 (2.3%) 1 (1.4%) 2 (2.1%) - Grade 1-2 2 (2.3%) 1 (1.4%) 2 (2.1%) - 1 1 (1.2%) 1 (1.4%) 1 (1.0%) - 2 1 (1.2%) 0 1 (1.0%) - SUPRAVENTRICULAR EXTRASYSTOLES - - Any Grade - 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - Grade 3-4 0 1 (1.4%) 1 (1.0%) - 3 0 1 (1.4%) 0 - 4 0 0 1 (1.0%) - VENTRICULAR EXTRASYSTOLES - - Any Grade - 0 1 (1.4%) 2 (2.1%) - Grade 1-2 0 1 (1.4%) 2 (2.1%) - 1 0 1 (1.4%) 2 (2.1%) - ATRIAL FLUTTER - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 0 - 2 0 0 1 (1.0%) - ATRIOVENTRICULAR BLOCK FIRST DEGREE - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 1 1 (1.2%) 0 1 (1.0%) - BUNDLE BRANCH BLOCK RIGHT - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 1 0 0 1 (1.0%) - 2 1 (1.2%) 0 0 - PALPITATIONS - - Any Grade - 0 0 2 (2.1%) - Grade 1-2 0 0 2 (2.1%) - 1 0 0 2 (2.1%) - ATRIAL HYPERTROPHY - - Any Grade - 1 (1.2%) 0 0 - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - BRADYCARDIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - BUNDLE BRANCH BLOCK LEFT - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - CARDIAC DISORDER - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - CARDIAC FAILURE CONGESTIVE - - Any Grade - 1 (1.2%) 0 0 - Grade 3-4 1 (1.2%) 0 0 - 4 1 (1.2%) 0 0 - SINUS ARRHYTHMIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - SUPRAVENTRICULAR TACHYCARDIA - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - TACHYCARDIA - - Any Grade - 1 (1.2%) 0 0 - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - VENTRICULAR HYPERTROPHY - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - WOLFF-PARKINSON-WHITE SYNDROME - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - INFECTIONS AND INFESTATIONS - - Overall - - - Any Grade - 16 (18.6%) 13 (18.1%) 10 (10.4%) - Grade 1-2 14 (16.3%) 11 (15.3%) 9 (9.4%) - 1 6 (7.0%) 6 (8.3%) 4 (4.2%) - 2 8 (9.3%) 5 (6.9%) 5 (5.2%) - Grade 3-4 2 (2.3%) 2 (2.8%) 1 (1.0%) - 3 1 (1.2%) 1 (1.4%) 1 (1.0%) - 4 1 (1.2%) 1 (1.4%) 0 - NASOPHARYNGITIS - - Any Grade - 2 (2.3%) 6 (8.3%) 4 (4.2%) - Grade 1-2 2 (2.3%) 5 (6.9%) 3 (3.1%) - 1 2 (2.3%) 4 (5.6%) 2 (2.1%) - 2 0 1 (1.4%) 1 (1.0%) - Grade 3-4 0 1 (1.4%) 1 (1.0%) - 3 0 1 (1.4%) 1 (1.0%) - UPPER RESPIRATORY TRACT INFECTION - - Any Grade - 6 (7.0%) 3 (4.2%) 1 (1.0%) - Grade 1-2 5 (5.8%) 3 (4.2%) 1 (1.0%) - 1 1 (1.2%) 1 (1.4%) 0 - 2 4 (4.7%) 2 (2.8%) 1 (1.0%) - Grade 3-4 1 (1.2%) 0 0 - 4 1 (1.2%) 0 0 - INFLUENZA - - Any Grade - 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 1 (1.4%) 0 - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - URINARY TRACT INFECTION - - Any Grade - 2 (2.3%) 1 (1.4%) 0 - Grade 1-2 2 (2.3%) 1 (1.4%) 0 - 1 2 (2.3%) 1 (1.4%) 0 - CYSTITIS - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 2 1 (1.2%) 1 (1.4%) 0 - EAR INFECTION - - Any Grade - 2 (2.3%) 0 0 - Grade 1-2 2 (2.3%) 0 0 - 1 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - LOCALISED INFECTION - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 2 1 (1.2%) 0 1 (1.0%) - BRONCHITIS - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - CELLULITIS - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - CERVICITIS - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - GASTROENTERITIS VIRAL - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - HORDEOLUM - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - LOWER RESPIRATORY TRACT INFECTION - - Any Grade - 0 1 (1.4%) 0 - Grade 3-4 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - ONYCHOMYCOSIS - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - PNEUMONIA - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - RHINITIS - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - VAGINAL MYCOSIS - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - VIRAL INFECTION - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - - Overall - - - Any Grade - 10 (11.6%) 10 (13.9%) 10 (10.4%) - Grade 1-2 8 (9.3%) 6 (8.3%) 7 (7.3%) - 1 5 (5.8%) 4 (5.6%) 6 (6.2%) - 2 3 (3.5%) 2 (2.8%) 1 (1.0%) - Grade 3-4 1 (1.2%) 4 (5.6%) 3 (3.1%) - 3 1 (1.2%) 3 (4.2%) 2 (2.1%) - 4 0 1 (1.4%) 1 (1.0%) - Grade 5 1 (1.2%) 0 0 - COUGH - - Any Grade - 3 (3.5%) 5 (6.9%) 6 (6.2%) - Grade 1-2 2 (2.3%) 3 (4.2%) 4 (4.2%) - 1 1 (1.2%) 2 (2.8%) 3 (3.1%) - 2 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 3-4 0 2 (2.8%) 2 (2.1%) - 3 0 2 (2.8%) 1 (1.0%) - 4 0 0 1 (1.0%) - Grade 5 1 (1.2%) 0 0 - NASAL CONGESTION - - Any Grade - 3 (3.5%) 3 (4.2%) 1 (1.0%) - Grade 1-2 3 (3.5%) 3 (4.2%) 1 (1.0%) - 1 1 (1.2%) 3 (4.2%) 1 (1.0%) - 2 2 (2.3%) 0 0 - DYSPNOEA - - Any Grade - 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 1-2 1 (1.2%) 1 (1.4%) 1 (1.0%) - 1 1 (1.2%) 1 (1.4%) 1 (1.0%) - EPISTAXIS - - Any Grade - 0 2 (2.8%) 1 (1.0%) - Grade 1-2 0 2 (2.8%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - 2 0 1 (1.4%) 0 - PHARYNGOLARYNGEAL PAIN - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 1 (1.4%) 0 - RHINORRHOEA - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - Grade 3-4 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - ALLERGIC GRANULOMATOUS ANGIITIS - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - DYSPHONIA - - Any Grade - 0 0 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - EMPHYSEMA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - HAEMOPTYSIS - - Any Grade - 1 (1.2%) 0 0 - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - PHARYNGEAL ERYTHEMA - - Any Grade - 0 1 (1.4%) 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - POSTNASAL DRIP - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - PRODUCTIVE COUGH - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - RALES - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - RESPIRATORY TRACT CONGESTION - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - PSYCHIATRIC DISORDERS - - Overall - - - Any Grade - 10 (11.6%) 8 (11.1%) 11 (11.5%) - Grade 1-2 10 (11.6%) 8 (11.1%) 9 (9.4%) - 1 9 (10.5%) 6 (8.3%) 6 (6.2%) - 2 1 (1.2%) 2 (2.8%) 3 (3.1%) - Grade 3-4 0 0 2 (2.1%) - 3 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - CONFUSIONAL STATE - - Any Grade - 2 (2.3%) 1 (1.4%) 3 (3.1%) - Grade 1-2 2 (2.3%) 1 (1.4%) 2 (2.1%) - 1 2 (2.3%) 1 (1.4%) 2 (2.1%) - Grade 3-4 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - AGITATION - - Any Grade - 2 (2.3%) 0 3 (3.1%) - Grade 1-2 2 (2.3%) 0 3 (3.1%) - 1 2 (2.3%) 0 1 (1.0%) - 2 0 0 2 (2.1%) - ANXIETY - - Any Grade - 1 (1.2%) 0 3 (3.1%) - Grade 1-2 1 (1.2%) 0 3 (3.1%) - 1 0 0 3 (3.1%) - 2 1 (1.2%) 0 0 - INSOMNIA - - Any Grade - 2 (2.3%) 2 (2.8%) 0 - Grade 1-2 2 (2.3%) 2 (2.8%) 0 - 1 2 (2.3%) 2 (2.8%) 0 - DELUSION - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 1 1 (1.2%) 1 (1.4%) 0 - DEPRESSED MOOD - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - IRRITABILITY - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 2 1 (1.2%) 0 1 (1.0%) - COMPLETED SUICIDE - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - DELIRIUM - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - DISORIENTATION - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - HALLUCINATION - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - HALLUCINATION, VISUAL - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - LIBIDO DECREASED - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - LISTLESS - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - NIGHTMARE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - RESTLESSNESS - - Any Grade - 0 0 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - INVESTIGATIONS - - Overall - - - Any Grade - 10 (11.6%) 5 (6.9%) 8 (8.3%) - Grade 1-2 8 (9.3%) 3 (4.2%) 7 (7.3%) - 1 6 (7.0%) 2 (2.8%) 5 (5.2%) - 2 2 (2.3%) 1 (1.4%) 2 (2.1%) - Grade 3-4 2 (2.3%) 2 (2.8%) 1 (1.0%) - 3 1 (1.2%) 1 (1.4%) 0 - 4 1 (1.2%) 1 (1.4%) 1 (1.0%) - ELECTROCARDIOGRAM ST SEGMENT DEPRESSION - - Any Grade - 4 (4.7%) 0 1 (1.0%) - Grade 1-2 4 (4.7%) 0 1 (1.0%) - 1 3 (3.5%) 0 0 - 2 1 (1.2%) 0 1 (1.0%) - ELECTROCARDIOGRAM T WAVE INVERSION - - Any Grade - 2 (2.3%) 1 (1.4%) 1 (1.0%) - Grade 1-2 2 (2.3%) 1 (1.4%) 1 (1.0%) - 1 1 (1.2%) 0 1 (1.0%) - 2 1 (1.2%) 1 (1.4%) 0 - BLOOD GLUCOSE INCREASED - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - Grade 3-4 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 1 1 (1.2%) 0 0 - 2 0 0 1 (1.0%) - BIOPSY - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - BIOPSY PROSTATE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - BLOOD ALKALINE PHOSPHATASE INCREASED - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - BLOOD CHOLESTEROL INCREASED - - Any Grade - 0 1 (1.4%) 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - BLOOD CREATINE PHOSPHOKINASE INCREASED - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - BLOOD URINE PRESENT - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - BODY TEMPERATURE INCREASED - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - CYSTOSCOPY - - Any Grade - 1 (1.2%) 0 0 - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - HEART RATE INCREASED - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - HEART RATE IRREGULAR - - Any Grade - 1 (1.2%) 0 0 - Grade 3-4 1 (1.2%) 0 0 - 4 1 (1.2%) 0 0 - NASAL MUCOSA BIOPSY - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - NEUTROPHIL COUNT INCREASED - - Any Grade - 0 0 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - URINE ANALYSIS ABNORMAL - - Any Grade - 0 0 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - WEIGHT DECREASED - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - WHITE BLOOD CELL COUNT INCREASED - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS - - Overall - - - Any Grade - 5 (5.8%) 8 (11.1%) 7 (7.3%) - Grade 1-2 4 (4.7%) 7 (9.7%) 7 (7.3%) - 1 2 (2.3%) 6 (8.3%) 5 (5.2%) - 2 2 (2.3%) 1 (1.4%) 2 (2.1%) - Grade 3-4 1 (1.2%) 1 (1.4%) 0 - 3 1 (1.2%) 1 (1.4%) 0 - BACK PAIN - - Any Grade - 1 (1.2%) 3 (4.2%) 1 (1.0%) - Grade 1-2 1 (1.2%) 3 (4.2%) 1 (1.0%) - 1 0 3 (4.2%) 0 - 2 1 (1.2%) 0 1 (1.0%) - ARTHRALGIA - - Any Grade - 1 (1.2%) 1 (1.4%) 2 (2.1%) - Grade 1-2 1 (1.2%) 1 (1.4%) 2 (2.1%) - 1 0 1 (1.4%) 2 (2.1%) - 2 1 (1.2%) 0 0 - SHOULDER PAIN - - Any Grade - 1 (1.2%) 0 2 (2.1%) - Grade 1-2 1 (1.2%) 0 2 (2.1%) - 1 1 (1.2%) 0 2 (2.1%) - ARTHRITIS - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - FLANK PAIN - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 1 0 2 (2.8%) 0 - MUSCLE SPASMS - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 1 (1.4%) 0 - MUSCULAR WEAKNESS - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - MYALGIA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - PAIN IN EXTREMITY - - Any Grade - 1 (1.2%) 0 0 - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - INJURY, POISONING AND PROCEDURAL COMPLICATIONS - - Overall - - - Any Grade - 4 (4.7%) 5 (6.9%) 5 (5.2%) - Grade 1-2 4 (4.7%) 4 (5.6%) 5 (5.2%) - 1 2 (2.3%) 3 (4.2%) 4 (4.2%) - 2 2 (2.3%) 1 (1.4%) 1 (1.0%) - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - CONTUSION - - Any Grade - 1 (1.2%) 2 (2.8%) 1 (1.0%) - Grade 1-2 1 (1.2%) 2 (2.8%) 1 (1.0%) - 1 1 (1.2%) 2 (2.8%) 1 (1.0%) - EXCORIATION - - Any Grade - 2 (2.3%) 1 (1.4%) 1 (1.0%) - Grade 1-2 2 (2.3%) 1 (1.4%) 1 (1.0%) - 1 2 (2.3%) 1 (1.4%) 1 (1.0%) - FALL - - Any Grade - 1 (1.2%) 1 (1.4%) 2 (2.1%) - Grade 1-2 1 (1.2%) 0 2 (2.1%) - 1 0 0 2 (2.1%) - 2 1 (1.2%) 0 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - HIP FRACTURE - - Any Grade - 1 (1.2%) 2 (2.8%) 0 - Grade 1-2 1 (1.2%) 2 (2.8%) 0 - 1 1 (1.2%) 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - SKIN LACERATION - - Any Grade - 1 (1.2%) 0 2 (2.1%) - Grade 1-2 1 (1.2%) 0 2 (2.1%) - 1 0 0 1 (1.0%) - 2 1 (1.2%) 0 1 (1.0%) - FACIAL BONES FRACTURE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - JOINT DISLOCATION - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - WOUND - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - RENAL AND URINARY DISORDERS - - Overall - - - Any Grade - 4 (4.7%) 3 (4.2%) 4 (4.2%) - Grade 1-2 4 (4.7%) 3 (4.2%) 3 (3.1%) - 1 2 (2.3%) 2 (2.8%) 2 (2.1%) - 2 2 (2.3%) 1 (1.4%) 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - MICTURITION URGENCY - - Any Grade - 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 1-2 1 (1.2%) 1 (1.4%) 1 (1.0%) - 1 1 (1.2%) 0 0 - 2 0 1 (1.4%) 1 (1.0%) - DYSURIA - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 1 1 (1.2%) 0 1 (1.0%) - NEPHROLITHIASIS - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 1 (1.2%) 0 0 - CALCULUS URETHRAL - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - ENURESIS - - Any Grade - 0 0 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - INCONTINENCE - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - POLLAKIURIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - METABOLISM AND NUTRITION DISORDERS - - Overall - - - Any Grade - 6 (7.0%) 3 (4.2%) 1 (1.0%) - Grade 1-2 5 (5.8%) 2 (2.8%) 1 (1.0%) - 1 1 (1.2%) 2 (2.8%) 1 (1.0%) - 2 4 (4.7%) 0 0 - Grade 3-4 1 (1.2%) 1 (1.4%) 0 - 3 1 (1.2%) 0 0 - 4 0 1 (1.4%) 0 - DECREASED APPETITE - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 1 (1.2%) 0 0 - FOOD CRAVING - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - INCREASED APPETITE - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 1 (1.2%) 0 0 - DEHYDRATION - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - DIABETES MELLITUS - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - HYPERCHOLESTEROLAEMIA - - Any Grade - 0 1 (1.4%) 0 - Grade 3-4 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - HYPONATRAEMIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - VASCULAR DISORDERS - - Overall - - - Any Grade - 3 (3.5%) 1 (1.4%) 4 (4.2%) - Grade 1-2 2 (2.3%) 1 (1.4%) 3 (3.1%) - 1 2 (2.3%) 1 (1.4%) 1 (1.0%) - 2 0 0 2 (2.1%) - Grade 3-4 1 (1.2%) 0 1 (1.0%) - 4 1 (1.2%) 0 1 (1.0%) - HYPERTENSION - - Any Grade - 1 (1.2%) 0 2 (2.1%) - Grade 1-2 1 (1.2%) 0 2 (2.1%) - 1 1 (1.2%) 0 1 (1.0%) - 2 0 0 1 (1.0%) - HYPOTENSION - - Any Grade - 2 (2.3%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 1 1 (1.2%) 0 0 - 2 0 0 1 (1.0%) - Grade 3-4 1 (1.2%) 0 0 - 4 1 (1.2%) 0 0 - HOT FLUSH - - Any Grade - 0 0 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - ORTHOSTATIC HYPOTENSION - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - WOUND HAEMORRHAGE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - EYE DISORDERS - - Overall - - - Any Grade - 4 (4.7%) 1 (1.4%) 2 (2.1%) - Grade 1-2 2 (2.3%) 1 (1.4%) 2 (2.1%) - 1 0 1 (1.4%) 2 (2.1%) - 2 2 (2.3%) 0 0 - Grade 3-4 2 (2.3%) 0 0 - 4 2 (2.3%) 0 0 - CONJUNCTIVITIS - - Any Grade - 2 (2.3%) 0 0 - Grade 3-4 2 (2.3%) 0 0 - 4 2 (2.3%) 0 0 - VISION BLURRED - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - CONJUNCTIVAL HAEMORRHAGE - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - EYE ALLERGY - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - EYE PRURITUS - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - EYE SWELLING - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - GLAUCOMA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - SURGICAL AND MEDICAL PROCEDURES - - Overall - - - Any Grade - 2 (2.3%) 2 (2.8%) 1 (1.0%) - Grade 1-2 1 (1.2%) 2 (2.8%) 1 (1.0%) - 1 1 (1.2%) 1 (1.4%) 1 (1.0%) - 2 0 1 (1.4%) 0 - Grade 3-4 1 (1.2%) 0 0 - 4 1 (1.2%) 0 0 - CATARACT OPERATION - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - Grade 3-4 1 (1.2%) 0 0 - 4 1 (1.2%) 0 0 - ACROCHORDON EXCISION - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - EYE LASER SURGERY - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - SKIN LESION EXCISION - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - EAR AND LABYRINTH DISORDERS - - Overall - - - Any Grade - 1 (1.2%) 1 (1.4%) 2 (2.1%) - Grade 1-2 1 (1.2%) 1 (1.4%) 2 (2.1%) - 1 1 (1.2%) 1 (1.4%) 2 (2.1%) - VERTIGO - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - CERUMEN IMPACTION - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - EAR PAIN - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - TINNITUS - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - CONGENITAL, FAMILIAL AND GENETIC DISORDERS - - Overall - - - Any Grade - 0 2 (2.8%) 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - Grade 3-4 0 2 (2.8%) 0 - 3 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - VENTRICULAR SEPTAL DEFECT - - Any Grade - 0 2 (2.8%) 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - Grade 3-4 0 2 (2.8%) 0 - 3 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - - Overall - - - Any Grade - 0 1 (1.4%) 2 (2.1%) - Grade 1-2 0 1 (1.4%) 2 (2.1%) - 1 0 1 (1.4%) 1 (1.0%) - 2 0 0 1 (1.0%) - COLON CANCER - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - MALIGNANT FIBROUS HISTIOCYTOMA - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - PROSTATE CANCER - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - REPRODUCTIVE SYSTEM AND BREAST DISORDERS - - Overall - - - Any Grade - 2 (2.3%) 1 (1.4%) 0 - Grade 1-2 2 (2.3%) 1 (1.4%) 0 - 1 2 (2.3%) 0 0 - 2 0 1 (1.4%) 0 - BENIGN PROSTATIC HYPERPLASIA - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 1 1 (1.2%) 0 0 - 2 0 1 (1.4%) 0 - PELVIC PAIN - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - IMMUNE SYSTEM DISORDERS - - Overall - - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 0 - 2 0 0 1 (1.0%) - HYPERSENSITIVITY - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - SEASONAL ALLERGY - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - HEPATOBILIARY DISORDERS - - Overall - - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - HYPERBILIRUBINAEMIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - SOCIAL CIRCUMSTANCES - - Overall - - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - ALCOHOL USE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 + MedDRA System Organ Class + MedDRA Preferred Term Placebo Xanomeline High Dose Xanomeline Low Dose + Grade (N=86) (N=72) (N=96) + —————————————————————————————————————————————————————————————————————————————————————————————————————————————— + - Any adverse events - + - Any Grade - 23 (26.7%) 51 (70.8%) 54 (56.2%) + Grade 1-2 17 (19.8%) 42 (58.3%) 43 (44.8%) + 1 11 (12.8%) 26 (36.1%) 28 (29.2%) + 2 6 (7.0%) 16 (22.2%) 15 (15.6%) + Grade 3-4 6 (7.0%) 9 (12.5%) 10 (10.4%) + 3 2 (2.3%) 4 (5.6%) 5 (5.2%) + 4 4 (4.7%) 5 (6.9%) 5 (5.2%) + Grade 5 0 0 1 (1.0%) + SKIN AND SUBCUTANEOUS TISSUE DISORDERS + - Overall - + - Any Grade - 17 (19.8%) 32 (44.4%) 31 (32.3%) + Grade 1-2 13 (15.1%) 26 (36.1%) 25 (26.0%) + 1 10 (11.6%) 18 (25.0%) 15 (15.6%) + 2 3 (3.5%) 8 (11.1%) 10 (10.4%) + Grade 3-4 4 (4.7%) 6 (8.3%) 5 (5.2%) + 3 2 (2.3%) 3 (4.2%) 3 (3.1%) + 4 2 (2.3%) 3 (4.2%) 2 (2.1%) + Grade 5 0 0 1 (1.0%) + PRURITUS + - Any Grade - 8 (9.3%) 26 (36.1%) 23 (24.0%) + Grade 1-2 5 (5.8%) 20 (27.8%) 21 (21.9%) + 1 4 (4.7%) 15 (20.8%) 14 (14.6%) + 2 1 (1.2%) 5 (6.9%) 7 (7.3%) + Grade 3-4 3 (3.5%) 6 (8.3%) 1 (1.0%) + 3 1 (1.2%) 3 (4.2%) 1 (1.0%) + 4 2 (2.3%) 3 (4.2%) 0 + Grade 5 0 0 1 (1.0%) + ERYTHEMA + - Any Grade - 9 (10.5%) 14 (19.4%) 15 (15.6%) + Grade 1-2 9 (10.5%) 14 (19.4%) 13 (13.5%) + 1 8 (9.3%) 12 (16.7%) 8 (8.3%) + 2 1 (1.2%) 2 (2.8%) 5 (5.2%) + Grade 3-4 0 0 2 (2.1%) + 3 0 0 1 (1.0%) + 4 0 0 1 (1.0%) + RASH + - Any Grade - 5 (5.8%) 11 (15.3%) 13 (13.5%) + Grade 1-2 4 (4.7%) 10 (13.9%) 11 (11.5%) + 1 3 (3.5%) 7 (9.7%) 10 (10.4%) + 2 1 (1.2%) 3 (4.2%) 1 (1.0%) + Grade 3-4 1 (1.2%) 1 (1.4%) 2 (2.1%) + 3 1 (1.2%) 1 (1.4%) 1 (1.0%) + 4 0 0 1 (1.0%) + GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS + - Overall - + - Any Grade - 8 (9.3%) 24 (33.3%) 25 (26.0%) + Grade 1-2 6 (7.0%) 20 (27.8%) 20 (20.8%) + 1 3 (3.5%) 10 (13.9%) 14 (14.6%) + 2 3 (3.5%) 10 (13.9%) 6 (6.2%) + Grade 3-4 2 (2.3%) 4 (5.6%) 5 (5.2%) + 3 0 2 (2.8%) 2 (2.1%) + 4 2 (2.3%) 2 (2.8%) 3 (3.1%) + APPLICATION SITE PRURITUS + - Any Grade - 6 (7.0%) 21 (29.2%) 23 (24.0%) + Grade 1-2 4 (4.7%) 19 (26.4%) 20 (20.8%) + 1 2 (2.3%) 11 (15.3%) 16 (16.7%) + 2 2 (2.3%) 8 (11.1%) 4 (4.2%) + Grade 3-4 2 (2.3%) 2 (2.8%) 3 (3.1%) + 3 0 0 1 (1.0%) + 4 2 (2.3%) 2 (2.8%) 2 (2.1%) + APPLICATION SITE ERYTHEMA + - Any Grade - 3 (3.5%) 14 (19.4%) 13 (13.5%) + Grade 1-2 3 (3.5%) 12 (16.7%) 11 (11.5%) + 1 2 (2.3%) 10 (13.9%) 8 (8.3%) + 2 1 (1.2%) 2 (2.8%) 3 (3.1%) + Grade 3-4 0 2 (2.8%) 2 (2.1%) + 3 0 2 (2.8%) 1 (1.0%) + 4 0 0 1 (1.0%) # AET04 variant 2 is produced correctly (Fill in of Treatment Groups) Code res Output - MedDRA System Organ Class - MedDRA Preferred Term Placebo Xanomeline High Dose Xanomeline Low Dose - Grade (N=86) (N=72) (N=96) - —————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— - - Any adverse events - - - Any Grade - 0 70 (97.2%) 0 - Grade 1-2 0 37 (51.4%) 0 - 1 0 18 (25.0%) 0 - 2 0 19 (26.4%) 0 - Grade 3-4 0 32 (44.4%) 0 - 3 0 16 (22.2%) 0 - 4 0 16 (22.2%) 0 - Grade 5 0 1 (1.4%) 0 - SKIN AND SUBCUTANEOUS TISSUE DISORDERS - - Overall - - - Any Grade - 0 42 (58.3%) 0 - Grade 1-2 0 33 (45.8%) 0 - 1 0 20 (27.8%) 0 - 2 0 13 (18.1%) 0 - Grade 3-4 0 9 (12.5%) 0 - 3 0 4 (5.6%) 0 - 4 0 5 (6.9%) 0 - PRURITUS - - Any Grade - 0 26 (36.1%) 0 - Grade 1-2 0 20 (27.8%) 0 - 1 0 15 (20.8%) 0 - 2 0 5 (6.9%) 0 - Grade 3-4 0 6 (8.3%) 0 - 3 0 3 (4.2%) 0 - 4 0 3 (4.2%) 0 - ERYTHEMA - - Any Grade - 0 14 (19.4%) 0 - Grade 1-2 0 14 (19.4%) 0 - 1 0 12 (16.7%) 0 - 2 0 2 (2.8%) 0 - RASH - - Any Grade - 0 11 (15.3%) 0 - Grade 1-2 0 10 (13.9%) 0 - 1 0 7 (9.7%) 0 - 2 0 3 (4.2%) 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - HYPERHIDROSIS - - Any Grade - 0 8 (11.1%) 0 - Grade 1-2 0 7 (9.7%) 0 - 1 0 5 (6.9%) 0 - 2 0 2 (2.8%) 0 - Grade 3-4 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - SKIN IRRITATION - - Any Grade - 0 5 (6.9%) 0 - Grade 1-2 0 5 (6.9%) 0 - 1 0 3 (4.2%) 0 - 2 0 2 (2.8%) 0 - RASH PRURITIC - - Any Grade - 0 2 (2.8%) 0 - Grade 3-4 0 2 (2.8%) 0 - 3 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - ACTINIC KERATOSIS - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - BLISTER - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - PRURITUS GENERALISED - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - RASH MACULO-PAPULAR - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - RASH PAPULAR - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - SKIN ODOUR ABNORMAL - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - URTICARIA - - Any Grade - 0 1 (1.4%) 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - - Overall - - - Any Grade - 0 36 (50.0%) 0 - Grade 1-2 0 28 (38.9%) 0 - 1 0 15 (20.8%) 0 - 2 0 13 (18.1%) 0 - Grade 3-4 0 8 (11.1%) 0 - 3 0 3 (4.2%) 0 - 4 0 5 (6.9%) 0 - APPLICATION SITE PRURITUS - - Any Grade - 0 21 (29.2%) 0 - Grade 1-2 0 19 (26.4%) 0 - 1 0 11 (15.3%) 0 - 2 0 8 (11.1%) 0 - Grade 3-4 0 2 (2.8%) 0 - 4 0 2 (2.8%) 0 - APPLICATION SITE ERYTHEMA - - Any Grade - 0 14 (19.4%) 0 - Grade 1-2 0 12 (16.7%) 0 - 1 0 10 (13.9%) 0 - 2 0 2 (2.8%) 0 - Grade 3-4 0 2 (2.8%) 0 - 3 0 2 (2.8%) 0 - APPLICATION SITE IRRITATION - - Any Grade - 0 9 (12.5%) 0 - Grade 1-2 0 8 (11.1%) 0 - 1 0 6 (8.3%) 0 - 2 0 2 (2.8%) 0 - Grade 3-4 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - APPLICATION SITE DERMATITIS - - Any Grade - 0 7 (9.7%) 0 - Grade 1-2 0 6 (8.3%) 0 - 1 0 3 (4.2%) 0 - 2 0 3 (4.2%) 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - APPLICATION SITE VESICLES - - Any Grade - 0 5 (6.9%) 0 - Grade 1-2 0 4 (5.6%) 0 - 1 0 3 (4.2%) 0 - 2 0 1 (1.4%) 0 - Grade 3-4 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - FATIGUE - - Any Grade - 0 5 (6.9%) 0 - Grade 1-2 0 4 (5.6%) 0 - 1 0 3 (4.2%) 0 - 2 0 1 (1.4%) 0 - Grade 3-4 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - APPLICATION SITE PAIN - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 1 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - APPLICATION SITE PERSPIRATION - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 2 0 2 (2.8%) 0 - APPLICATION SITE SWELLING - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 1 0 2 (2.8%) 0 - CHEST PAIN - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 1 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - MALAISE - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 1 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - OEDEMA PERIPHERAL - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 1 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - APPLICATION SITE DISCHARGE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - APPLICATION SITE REACTION - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - APPLICATION SITE URTICARIA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - CHEST DISCOMFORT - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - CHILLS - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - FEELING ABNORMAL - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - FEELING COLD - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - PAIN - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - NERVOUS SYSTEM DISORDERS - - Overall - - - Any Grade - 0 25 (34.7%) 0 - Grade 1-2 0 22 (30.6%) 0 - 1 0 16 (22.2%) 0 - 2 0 6 (8.3%) 0 - Grade 3-4 0 3 (4.2%) 0 - 3 0 1 (1.4%) 0 - 4 0 2 (2.8%) 0 - DIZZINESS - - Any Grade - 0 11 (15.3%) 0 - Grade 1-2 0 9 (12.5%) 0 - 1 0 9 (12.5%) 0 - Grade 3-4 0 2 (2.8%) 0 - 4 0 2 (2.8%) 0 - HEADACHE - - Any Grade - 0 6 (8.3%) 0 - Grade 1-2 0 6 (8.3%) 0 - 1 0 3 (4.2%) 0 - 2 0 3 (4.2%) 0 - BURNING SENSATION - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 1 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - SYNCOPE - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 1 0 2 (2.8%) 0 - AMNESIA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - COGNITIVE DISORDER - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - HYPERSOMNIA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - LETHARGY - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - PARAESTHESIA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - PAROSMIA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - PARTIAL SEIZURES WITH SECONDARY GENERALISATION - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - SOMNOLENCE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - SYNCOPE VASOVAGAL - - Any Grade - 0 1 (1.4%) 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - TRANSIENT ISCHAEMIC ATTACK - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - GASTROINTESTINAL DISORDERS - - Overall - - - Any Grade - 0 20 (27.8%) 0 - Grade 1-2 0 17 (23.6%) 0 - 1 0 12 (16.7%) 0 - 2 0 5 (6.9%) 0 - Grade 3-4 0 2 (2.8%) 0 - 3 0 2 (2.8%) 0 - Grade 5 0 1 (1.4%) 0 - NAUSEA - - Any Grade - 0 6 (8.3%) 0 - Grade 1-2 0 3 (4.2%) 0 - 1 0 2 (2.8%) 0 - 2 0 1 (1.4%) 0 - Grade 3-4 0 2 (2.8%) 0 - 3 0 2 (2.8%) 0 - Grade 5 0 1 (1.4%) 0 - VOMITING - - Any Grade - 0 6 (8.3%) 0 - Grade 1-2 0 6 (8.3%) 0 - 1 0 4 (5.6%) 0 - 2 0 2 (2.8%) 0 - SALIVARY HYPERSECRETION - - Any Grade - 0 4 (5.6%) 0 - Grade 1-2 0 4 (5.6%) 0 - 1 0 2 (2.8%) 0 - 2 0 2 (2.8%) 0 - DIARRHOEA - - Any Grade - 0 3 (4.2%) 0 - Grade 1-2 0 3 (4.2%) 0 - 1 0 3 (4.2%) 0 - ABDOMINAL DISCOMFORT - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - ABDOMINAL PAIN - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - DYSPEPSIA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - GASTROINTESTINAL HAEMORRHAGE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - STOMACH DISCOMFORT - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - CARDIAC DISORDERS - - Overall - - - Any Grade - 0 15 (20.8%) 0 - Grade 1-2 0 13 (18.1%) 0 - 1 0 9 (12.5%) 0 - 2 0 4 (5.6%) 0 - Grade 3-4 0 2 (2.8%) 0 - 3 0 2 (2.8%) 0 - SINUS BRADYCARDIA - - Any Grade - 0 8 (11.1%) 0 - Grade 1-2 0 8 (11.1%) 0 - 1 0 6 (8.3%) 0 - 2 0 2 (2.8%) 0 - MYOCARDIAL INFARCTION - - Any Grade - 0 4 (5.6%) 0 - Grade 1-2 0 3 (4.2%) 0 - 1 0 2 (2.8%) 0 - 2 0 1 (1.4%) 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - ATRIAL FIBRILLATION - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 1 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - ATRIAL FLUTTER - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - ATRIOVENTRICULAR BLOCK SECOND DEGREE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - CARDIAC DISORDER - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - SUPRAVENTRICULAR EXTRASYSTOLES - - Any Grade - 0 1 (1.4%) 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - VENTRICULAR EXTRASYSTOLES - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - INFECTIONS AND INFESTATIONS - - Overall - - - Any Grade - 0 13 (18.1%) 0 - Grade 1-2 0 11 (15.3%) 0 - 1 0 6 (8.3%) 0 - 2 0 5 (6.9%) 0 - Grade 3-4 0 2 (2.8%) 0 - 3 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - NASOPHARYNGITIS - - Any Grade - 0 6 (8.3%) 0 - Grade 1-2 0 5 (6.9%) 0 - 1 0 4 (5.6%) 0 - 2 0 1 (1.4%) 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - UPPER RESPIRATORY TRACT INFECTION - - Any Grade - 0 3 (4.2%) 0 - Grade 1-2 0 3 (4.2%) 0 - 1 0 1 (1.4%) 0 - 2 0 2 (2.8%) 0 - CYSTITIS - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - HORDEOLUM - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - INFLUENZA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - LOWER RESPIRATORY TRACT INFECTION - - Any Grade - 0 1 (1.4%) 0 - Grade 3-4 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - RHINITIS - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - URINARY TRACT INFECTION - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - - Overall - - - Any Grade - 0 10 (13.9%) 0 - Grade 1-2 0 6 (8.3%) 0 - 1 0 4 (5.6%) 0 - 2 0 2 (2.8%) 0 - Grade 3-4 0 4 (5.6%) 0 - 3 0 3 (4.2%) 0 - 4 0 1 (1.4%) 0 - COUGH - - Any Grade - 0 5 (6.9%) 0 - Grade 1-2 0 3 (4.2%) 0 - 1 0 2 (2.8%) 0 - 2 0 1 (1.4%) 0 - Grade 3-4 0 2 (2.8%) 0 - 3 0 2 (2.8%) 0 - NASAL CONGESTION - - Any Grade - 0 3 (4.2%) 0 - Grade 1-2 0 3 (4.2%) 0 - 1 0 3 (4.2%) 0 - EPISTAXIS - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 1 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - ALLERGIC GRANULOMATOUS ANGIITIS - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - DYSPNOEA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - PHARYNGEAL ERYTHEMA - - Any Grade - 0 1 (1.4%) 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - PHARYNGOLARYNGEAL PAIN - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - PRODUCTIVE COUGH - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - RESPIRATORY TRACT CONGESTION - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - RHINORRHOEA - - Any Grade - 0 1 (1.4%) 0 - Grade 3-4 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS - - Overall - - - Any Grade - 0 8 (11.1%) 0 - Grade 1-2 0 7 (9.7%) 0 - 1 0 6 (8.3%) 0 - 2 0 1 (1.4%) 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - BACK PAIN - - Any Grade - 0 3 (4.2%) 0 - Grade 1-2 0 3 (4.2%) 0 - 1 0 3 (4.2%) 0 - FLANK PAIN - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 1 0 2 (2.8%) 0 - ARTHRALGIA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - ARTHRITIS - - Any Grade - 0 1 (1.4%) 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - MUSCLE SPASMS - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - MYALGIA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - PSYCHIATRIC DISORDERS - - Overall - - - Any Grade - 0 8 (11.1%) 0 - Grade 1-2 0 8 (11.1%) 0 - 1 0 6 (8.3%) 0 - 2 0 2 (2.8%) 0 - INSOMNIA - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 1 0 2 (2.8%) 0 - CONFUSIONAL STATE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - DELIRIUM - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - DELUSION - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - DEPRESSED MOOD - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - HALLUCINATION - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - HALLUCINATION, VISUAL - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - LIBIDO DECREASED - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - LISTLESS - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - NIGHTMARE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - INJURY, POISONING AND PROCEDURAL COMPLICATIONS - - Overall - - - Any Grade - 0 5 (6.9%) 0 - Grade 1-2 0 4 (5.6%) 0 - 1 0 3 (4.2%) 0 - 2 0 1 (1.4%) 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - CONTUSION - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 1 0 2 (2.8%) 0 - HIP FRACTURE - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 1 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - EXCORIATION - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - FACIAL BONES FRACTURE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - FALL - - Any Grade - 0 1 (1.4%) 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - INVESTIGATIONS - - Overall - - - Any Grade - 0 5 (6.9%) 0 - Grade 1-2 0 3 (4.2%) 0 - 1 0 2 (2.8%) 0 - 2 0 1 (1.4%) 0 - Grade 3-4 0 2 (2.8%) 0 - 3 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - BIOPSY - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - BIOPSY PROSTATE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - BLOOD CHOLESTEROL INCREASED - - Any Grade - 0 1 (1.4%) 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - BLOOD GLUCOSE INCREASED - - Any Grade - 0 1 (1.4%) 0 - Grade 3-4 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - ELECTROCARDIOGRAM T WAVE INVERSION - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - METABOLISM AND NUTRITION DISORDERS - - Overall - - - Any Grade - 0 3 (4.2%) 0 - Grade 1-2 0 2 (2.8%) 0 - 1 0 2 (2.8%) 0 - Grade 3-4 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - DECREASED APPETITE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - HYPERCHOLESTEROLAEMIA - - Any Grade - 0 1 (1.4%) 0 - Grade 3-4 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - INCREASED APPETITE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - RENAL AND URINARY DISORDERS - - Overall - - - Any Grade - 0 3 (4.2%) 0 - Grade 1-2 0 3 (4.2%) 0 - 1 0 2 (2.8%) 0 - 2 0 1 (1.4%) 0 - CALCULUS URETHRAL - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - MICTURITION URGENCY - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - NEPHROLITHIASIS - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - CONGENITAL, FAMILIAL AND GENETIC DISORDERS - - Overall - - - Any Grade - 0 2 (2.8%) 0 - Grade 3-4 0 2 (2.8%) 0 - 3 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - VENTRICULAR SEPTAL DEFECT - - Any Grade - 0 2 (2.8%) 0 - Grade 3-4 0 2 (2.8%) 0 - 3 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - SURGICAL AND MEDICAL PROCEDURES - - Overall - - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 1 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - ACROCHORDON EXCISION - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - SKIN LESION EXCISION - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - EAR AND LABYRINTH DISORDERS - - Overall - - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - VERTIGO - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - EYE DISORDERS - - Overall - - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - VISION BLURRED - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - IMMUNE SYSTEM DISORDERS - - Overall - - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - SEASONAL ALLERGY - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - - Overall - - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - PROSTATE CANCER - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - REPRODUCTIVE SYSTEM AND BREAST DISORDERS - - Overall - - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - BENIGN PROSTATIC HYPERPLASIA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - SOCIAL CIRCUMSTANCES - - Overall - - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - ALCOHOL USE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - VASCULAR DISORDERS - - Overall - - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - WOUND HAEMORRHAGE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 + MedDRA System Organ Class + MedDRA Preferred Term Placebo Xanomeline High Dose Xanomeline Low Dose + Grade (N=86) (N=72) (N=96) + ——————————————————————————————————————————————————————————————————————————————————————————————————————————— + - Any adverse events - + - Any Grade - 0 51 (70.8%) 0 + Grade 1-2 0 42 (58.3%) 0 + 1 0 26 (36.1%) 0 + 2 0 16 (22.2%) 0 + Grade 3-4 0 9 (12.5%) 0 + 3 0 4 (5.6%) 0 + 4 0 5 (6.9%) 0 + SKIN AND SUBCUTANEOUS TISSUE DISORDERS + - Overall - + - Any Grade - 0 32 (44.4%) 0 + Grade 1-2 0 26 (36.1%) 0 + 1 0 18 (25.0%) 0 + 2 0 8 (11.1%) 0 + Grade 3-4 0 6 (8.3%) 0 + 3 0 3 (4.2%) 0 + 4 0 3 (4.2%) 0 + PRURITUS + - Any Grade - 0 26 (36.1%) 0 + Grade 1-2 0 20 (27.8%) 0 + 1 0 15 (20.8%) 0 + 2 0 5 (6.9%) 0 + Grade 3-4 0 6 (8.3%) 0 + 3 0 3 (4.2%) 0 + 4 0 3 (4.2%) 0 + ERYTHEMA + - Any Grade - 0 14 (19.4%) 0 + Grade 1-2 0 14 (19.4%) 0 + 1 0 12 (16.7%) 0 + 2 0 2 (2.8%) 0 + RASH + - Any Grade - 0 11 (15.3%) 0 + Grade 1-2 0 10 (13.9%) 0 + 1 0 7 (9.7%) 0 + 2 0 3 (4.2%) 0 + Grade 3-4 0 1 (1.4%) 0 + 3 0 1 (1.4%) 0 + GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS + - Overall - + - Any Grade - 0 24 (33.3%) 0 + Grade 1-2 0 20 (27.8%) 0 + 1 0 10 (13.9%) 0 + 2 0 10 (13.9%) 0 + Grade 3-4 0 4 (5.6%) 0 + 3 0 2 (2.8%) 0 + 4 0 2 (2.8%) 0 + APPLICATION SITE PRURITUS + - Any Grade - 0 21 (29.2%) 0 + Grade 1-2 0 19 (26.4%) 0 + 1 0 11 (15.3%) 0 + 2 0 8 (11.1%) 0 + Grade 3-4 0 2 (2.8%) 0 + 4 0 2 (2.8%) 0 + APPLICATION SITE ERYTHEMA + - Any Grade - 0 14 (19.4%) 0 + Grade 1-2 0 12 (16.7%) 0 + 1 0 10 (13.9%) 0 + 2 0 2 (2.8%) 0 + Grade 3-4 0 2 (2.8%) 0 + 3 0 2 (2.8%) 0 # AET04 variant 3 is produced correctly (Fill in of Grades) Code res Output - MedDRA System Organ Class - MedDRA Preferred Term Placebo Xanomeline High Dose Xanomeline Low Dose - Grade (N=86) (N=72) (N=96) - ————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— - - Any adverse events - - - Any Grade - 69 (80.2%) 70 (97.2%) 86 (89.6%) - Grade 1-2 46 (53.5%) 37 (51.4%) 54 (56.2%) - 1 22 (25.6%) 18 (25.0%) 19 (19.8%) - 2 24 (27.9%) 19 (26.4%) 35 (36.5%) - Grade 3-4 20 (23.3%) 32 (44.4%) 30 (31.2%) - 3 8 (9.3%) 16 (22.2%) 11 (11.5%) - 4 12 (14.0%) 16 (22.2%) 19 (19.8%) - Grade 5 3 (3.5%) 1 (1.4%) 2 (2.1%) - GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - - Overall - - - Any Grade - 21 (24.4%) 36 (50.0%) 51 (53.1%) - Grade 1-2 17 (19.8%) 28 (38.9%) 40 (41.7%) - 1 10 (11.6%) 15 (20.8%) 20 (20.8%) - 2 7 (8.1%) 13 (18.1%) 20 (20.8%) - Grade 3-4 4 (4.7%) 8 (11.1%) 11 (11.5%) - 3 2 (2.3%) 3 (4.2%) 6 (6.2%) - 4 2 (2.3%) 5 (6.9%) 5 (5.2%) - Grade 5 0 0 0 - APPLICATION SITE PRURITUS - - Any Grade - 6 (7.0%) 21 (29.2%) 23 (24.0%) - Grade 1-2 4 (4.7%) 19 (26.4%) 20 (20.8%) - 1 2 (2.3%) 11 (15.3%) 16 (16.7%) - 2 2 (2.3%) 8 (11.1%) 4 (4.2%) - Grade 3-4 2 (2.3%) 2 (2.8%) 3 (3.1%) - 3 0 0 1 (1.0%) - 4 2 (2.3%) 2 (2.8%) 2 (2.1%) - Grade 5 0 0 0 - APPLICATION SITE ERYTHEMA - - Any Grade - 3 (3.5%) 14 (19.4%) 13 (13.5%) - Grade 1-2 3 (3.5%) 12 (16.7%) 11 (11.5%) - 1 2 (2.3%) 10 (13.9%) 8 (8.3%) - 2 1 (1.2%) 2 (2.8%) 3 (3.1%) - Grade 3-4 0 2 (2.8%) 2 (2.1%) - 3 0 2 (2.8%) 1 (1.0%) - 4 0 0 1 (1.0%) - Grade 5 0 0 0 - APPLICATION SITE DERMATITIS - - Any Grade - 5 (5.8%) 7 (9.7%) 9 (9.4%) - Grade 1-2 4 (4.7%) 6 (8.3%) 8 (8.3%) - 1 3 (3.5%) 3 (4.2%) 4 (4.2%) - 2 1 (1.2%) 3 (4.2%) 4 (4.2%) - Grade 3-4 1 (1.2%) 1 (1.4%) 1 (1.0%) - 3 1 (1.2%) 1 (1.4%) 1 (1.0%) - 4 0 0 0 - Grade 5 0 0 0 - APPLICATION SITE IRRITATION - - Any Grade - 3 (3.5%) 9 (12.5%) 9 (9.4%) - Grade 1-2 2 (2.3%) 8 (11.1%) 6 (6.2%) - 1 2 (2.3%) 6 (8.3%) 3 (3.1%) - 2 0 2 (2.8%) 3 (3.1%) - Grade 3-4 1 (1.2%) 1 (1.4%) 3 (3.1%) - 3 1 (1.2%) 0 1 (1.0%) - 4 0 1 (1.4%) 2 (2.1%) - Grade 5 0 0 0 - APPLICATION SITE VESICLES - - Any Grade - 1 (1.2%) 5 (6.9%) 5 (5.2%) - Grade 1-2 1 (1.2%) 4 (5.6%) 5 (5.2%) - 1 0 3 (4.2%) 4 (4.2%) - 2 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 3-4 0 1 (1.4%) 0 - 3 0 0 0 - 4 0 1 (1.4%) 0 - Grade 5 0 0 0 - FATIGUE - - Any Grade - 1 (1.2%) 5 (6.9%) 5 (5.2%) - Grade 1-2 1 (1.2%) 4 (5.6%) 5 (5.2%) - 1 0 3 (4.2%) 3 (3.1%) - 2 1 (1.2%) 1 (1.4%) 2 (2.1%) - Grade 3-4 0 1 (1.4%) 0 - 3 0 0 0 - 4 0 1 (1.4%) 0 - Grade 5 0 0 0 - OEDEMA PERIPHERAL - - Any Grade - 2 (2.3%) 2 (2.8%) 1 (1.0%) - Grade 1-2 1 (1.2%) 2 (2.8%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - 2 1 (1.2%) 1 (1.4%) 0 - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - 4 0 0 0 - Grade 5 0 0 0 - APPLICATION SITE SWELLING - - Any Grade - 0 2 (2.8%) 1 (1.0%) - Grade 1-2 0 2 (2.8%) 1 (1.0%) - 1 0 2 (2.8%) 1 (1.0%) - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - APPLICATION SITE URTICARIA - - Any Grade - 0 1 (1.4%) 2 (2.1%) - Grade 1-2 0 1 (1.4%) 2 (2.1%) - 1 0 1 (1.4%) 1 (1.0%) - 2 0 0 1 (1.0%) - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - CHILLS - - Any Grade - 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 1-2 1 (1.2%) 1 (1.4%) 1 (1.0%) - 1 1 (1.2%) 1 (1.4%) 0 - 2 0 0 1 (1.0%) - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - MALAISE - - Any Grade - 0 2 (2.8%) 1 (1.0%) - Grade 1-2 0 2 (2.8%) 1 (1.0%) - 1 0 1 (1.4%) 0 - 2 0 1 (1.4%) 1 (1.0%) - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - PYREXIA - - Any Grade - 2 (2.3%) 0 1 (1.0%) - Grade 1-2 2 (2.3%) 0 1 (1.0%) - 1 1 (1.2%) 0 1 (1.0%) - 2 1 (1.2%) 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - APPLICATION SITE PAIN - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 1 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - APPLICATION SITE PERSPIRATION - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 1 0 0 0 - 2 0 2 (2.8%) 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - APPLICATION SITE REACTION - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 1 1 (1.2%) 1 (1.4%) 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - ASTHENIA - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 1 1 (1.2%) 0 0 - 2 0 0 1 (1.0%) - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - CHEST DISCOMFORT - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 0 - 2 0 0 1 (1.0%) - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - CHEST PAIN - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 1 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - OEDEMA - - Any Grade - 0 0 2 (2.1%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 0 0 - Grade 3-4 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - 4 0 0 0 - Grade 5 0 0 0 - PAIN - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - APPLICATION SITE BLEEDING - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - APPLICATION SITE DESQUAMATION - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - APPLICATION SITE DISCHARGE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - APPLICATION SITE DISCOLOURATION - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 0 - 1 0 0 0 - 2 0 0 0 - Grade 3-4 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - 4 0 0 0 - Grade 5 0 0 0 - APPLICATION SITE INDURATION - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - APPLICATION SITE WARMTH - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 0 - 2 0 0 1 (1.0%) - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - CYST - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - FEELING ABNORMAL - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 0 0 - 2 0 1 (1.4%) 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - FEELING COLD - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - INFLAMMATION - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 0 - 2 0 0 1 (1.0%) - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - SECRETION DISCHARGE - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - SUDDEN DEATH - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - SWELLING - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - ULCER - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - SKIN AND SUBCUTANEOUS TISSUE DISORDERS - - Overall - - - Any Grade - 21 (24.4%) 42 (58.3%) 42 (43.8%) - Grade 1-2 17 (19.8%) 33 (45.8%) 33 (34.4%) - 1 11 (12.8%) 20 (27.8%) 17 (17.7%) - 2 6 (7.0%) 13 (18.1%) 16 (16.7%) - Grade 3-4 4 (4.7%) 9 (12.5%) 7 (7.3%) - 3 2 (2.3%) 4 (5.6%) 4 (4.2%) - 4 2 (2.3%) 5 (6.9%) 3 (3.1%) - Grade 5 0 0 2 (2.1%) - PRURITUS - - Any Grade - 8 (9.3%) 26 (36.1%) 23 (24.0%) - Grade 1-2 5 (5.8%) 20 (27.8%) 21 (21.9%) - 1 4 (4.7%) 15 (20.8%) 14 (14.6%) - 2 1 (1.2%) 5 (6.9%) 7 (7.3%) - Grade 3-4 3 (3.5%) 6 (8.3%) 1 (1.0%) - 3 1 (1.2%) 3 (4.2%) 1 (1.0%) - 4 2 (2.3%) 3 (4.2%) 0 - Grade 5 0 0 1 (1.0%) - ERYTHEMA - - Any Grade - 9 (10.5%) 14 (19.4%) 15 (15.6%) - Grade 1-2 9 (10.5%) 14 (19.4%) 13 (13.5%) - 1 8 (9.3%) 12 (16.7%) 8 (8.3%) - 2 1 (1.2%) 2 (2.8%) 5 (5.2%) - Grade 3-4 0 0 2 (2.1%) - 3 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - Grade 5 0 0 0 - RASH - - Any Grade - 5 (5.8%) 11 (15.3%) 13 (13.5%) - Grade 1-2 4 (4.7%) 10 (13.9%) 11 (11.5%) - 1 3 (3.5%) 7 (9.7%) 10 (10.4%) - 2 1 (1.2%) 3 (4.2%) 1 (1.0%) - Grade 3-4 1 (1.2%) 1 (1.4%) 2 (2.1%) - 3 1 (1.2%) 1 (1.4%) 1 (1.0%) - 4 0 0 1 (1.0%) - Grade 5 0 0 0 - HYPERHIDROSIS - - Any Grade - 2 (2.3%) 8 (11.1%) 4 (4.2%) - Grade 1-2 2 (2.3%) 7 (9.7%) 4 (4.2%) - 1 0 5 (6.9%) 4 (4.2%) - 2 2 (2.3%) 2 (2.8%) 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 0 0 - 4 0 1 (1.4%) 0 - Grade 5 0 0 0 - SKIN IRRITATION - - Any Grade - 3 (3.5%) 5 (6.9%) 6 (6.2%) - Grade 1-2 3 (3.5%) 5 (6.9%) 4 (4.2%) - 1 1 (1.2%) 3 (4.2%) 3 (3.1%) - 2 2 (2.3%) 2 (2.8%) 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 3 0 0 0 - 4 0 0 1 (1.0%) - Grade 5 0 0 1 (1.0%) - BLISTER - - Any Grade - 0 1 (1.4%) 5 (5.2%) - Grade 1-2 0 1 (1.4%) 5 (5.2%) - 1 0 1 (1.4%) 4 (4.2%) - 2 0 0 1 (1.0%) - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - RASH PRURITIC - - Any Grade - 0 2 (2.8%) 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 0 - 2 0 0 1 (1.0%) - Grade 3-4 0 2 (2.8%) 0 - 3 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - Grade 5 0 0 0 - PRURITUS GENERALISED - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 0 - 2 0 0 1 (1.0%) - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - RASH ERYTHEMATOUS - - Any Grade - 0 0 2 (2.1%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 0 - 2 0 0 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - 4 0 0 0 - Grade 5 0 0 0 - URTICARIA - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 0 - 2 0 0 1 (1.0%) - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - 4 0 0 0 - Grade 5 0 0 0 - ACTINIC KERATOSIS - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 0 0 - 2 0 1 (1.4%) 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - ALOPECIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - COLD SWEAT - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 0 0 0 - 2 1 (1.2%) 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - DERMATITIS ATOPIC - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - DERMATITIS CONTACT - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 0 - 2 0 0 1 (1.0%) - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - DRUG ERUPTION - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - RASH MACULO-PAPULAR - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 0 0 - 2 0 1 (1.4%) 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - RASH PAPULAR - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - SKIN EXFOLIATION - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - SKIN ODOUR ABNORMAL - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - SKIN ULCER - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - NERVOUS SYSTEM DISORDERS - - Overall - - - Any Grade - 12 (14.0%) 25 (34.7%) 22 (22.9%) - Grade 1-2 10 (11.6%) 22 (30.6%) 19 (19.8%) - 1 7 (8.1%) 16 (22.2%) 13 (13.5%) - 2 3 (3.5%) 6 (8.3%) 6 (6.2%) - Grade 3-4 1 (1.2%) 3 (4.2%) 3 (3.1%) - 3 0 1 (1.4%) 1 (1.0%) - 4 1 (1.2%) 2 (2.8%) 2 (2.1%) - Grade 5 1 (1.2%) 0 0 - DIZZINESS - - Any Grade - 2 (2.3%) 11 (15.3%) 9 (9.4%) - Grade 1-2 2 (2.3%) 9 (12.5%) 8 (8.3%) - 1 1 (1.2%) 9 (12.5%) 5 (5.2%) - 2 1 (1.2%) 0 3 (3.1%) - Grade 3-4 0 2 (2.8%) 1 (1.0%) - 3 0 0 1 (1.0%) - 4 0 2 (2.8%) 0 - Grade 5 0 0 0 - HEADACHE - - Any Grade - 7 (8.1%) 6 (8.3%) 3 (3.1%) - Grade 1-2 6 (7.0%) 6 (8.3%) 3 (3.1%) - 1 5 (5.8%) 3 (4.2%) 2 (2.1%) - 2 1 (1.2%) 3 (4.2%) 1 (1.0%) - Grade 3-4 1 (1.2%) 0 0 - 3 0 0 0 - 4 1 (1.2%) 0 0 - Grade 5 0 0 0 - SYNCOPE - - Any Grade - 0 2 (2.8%) 5 (5.2%) - Grade 1-2 0 2 (2.8%) 5 (5.2%) - 1 0 2 (2.8%) 5 (5.2%) - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - SOMNOLENCE - - Any Grade - 2 (2.3%) 1 (1.4%) 3 (3.1%) - Grade 1-2 2 (2.3%) 1 (1.4%) 2 (2.1%) - 1 1 (1.2%) 1 (1.4%) 2 (2.1%) - 2 1 (1.2%) 0 0 - Grade 3-4 0 0 1 (1.0%) - 3 0 0 0 - 4 0 0 1 (1.0%) - Grade 5 0 0 0 - TRANSIENT ISCHAEMIC ATTACK - - Any Grade - 0 1 (1.4%) 2 (2.1%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 0 0 - 2 0 1 (1.4%) 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 3 0 0 0 - 4 0 0 1 (1.0%) - Grade 5 0 0 0 - BURNING SENSATION - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 1 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - LETHARGY - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - AMNESIA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - BALANCE DISORDER - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 0 - 2 0 0 1 (1.0%) - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - COGNITIVE DISORDER - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - COMPLEX PARTIAL SEIZURES - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - COORDINATION ABNORMAL - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - HEMIANOPIA HOMONYMOUS - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - HYPERSOMNIA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - PARAESTHESIA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 0 0 - 2 0 1 (1.4%) 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - PARAESTHESIA ORAL - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - PARKINSON'S DISEASE - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 0 0 0 - 1 0 0 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 1 (1.2%) 0 0 - PAROSMIA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 0 0 - 2 0 1 (1.4%) 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - PARTIAL SEIZURES WITH SECONDARY GENERALISATION - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - PSYCHOMOTOR HYPERACTIVITY - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - STUPOR - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - SYNCOPE VASOVAGAL - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 0 0 - 1 0 0 0 - 2 0 0 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - 4 0 0 0 - Grade 5 0 0 0 - GASTROINTESTINAL DISORDERS - - Overall - - - Any Grade - 17 (19.8%) 20 (27.8%) 16 (16.7%) - Grade 1-2 14 (16.3%) 17 (23.6%) 12 (12.5%) - 1 9 (10.5%) 12 (16.7%) 10 (10.4%) - 2 5 (5.8%) 5 (6.9%) 2 (2.1%) - Grade 3-4 2 (2.3%) 2 (2.8%) 4 (4.2%) - 3 0 2 (2.8%) 0 - 4 2 (2.3%) 0 4 (4.2%) - Grade 5 1 (1.2%) 1 (1.4%) 0 - DIARRHOEA - - Any Grade - 9 (10.5%) 3 (4.2%) 6 (6.2%) - Grade 1-2 8 (9.3%) 3 (4.2%) 4 (4.2%) - 1 7 (8.1%) 3 (4.2%) 3 (3.1%) - 2 1 (1.2%) 0 1 (1.0%) - Grade 3-4 1 (1.2%) 0 2 (2.1%) - 3 0 0 0 - 4 1 (1.2%) 0 2 (2.1%) - Grade 5 0 0 0 - VOMITING - - Any Grade - 3 (3.5%) 6 (8.3%) 4 (4.2%) - Grade 1-2 2 (2.3%) 6 (8.3%) 4 (4.2%) - 1 0 4 (5.6%) 3 (3.1%) - 2 2 (2.3%) 2 (2.8%) 1 (1.0%) - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 1 (1.2%) 0 0 - NAUSEA - - Any Grade - 3 (3.5%) 6 (8.3%) 3 (3.1%) - Grade 1-2 3 (3.5%) 3 (4.2%) 2 (2.1%) - 1 2 (2.3%) 2 (2.8%) 1 (1.0%) - 2 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 3-4 0 2 (2.8%) 1 (1.0%) - 3 0 2 (2.8%) 0 - 4 0 0 1 (1.0%) - Grade 5 0 1 (1.4%) 0 - ABDOMINAL PAIN - - Any Grade - 1 (1.2%) 1 (1.4%) 3 (3.1%) - Grade 1-2 0 1 (1.4%) 2 (2.1%) - 1 0 1 (1.4%) 2 (2.1%) - 2 0 0 0 - Grade 3-4 1 (1.2%) 0 1 (1.0%) - 3 0 0 0 - 4 1 (1.2%) 0 1 (1.0%) - Grade 5 0 0 0 - SALIVARY HYPERSECRETION - - Any Grade - 0 4 (5.6%) 0 - Grade 1-2 0 4 (5.6%) 0 - 1 0 2 (2.8%) 0 - 2 0 2 (2.8%) 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - DYSPEPSIA - - Any Grade - 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 1-2 1 (1.2%) 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - 2 1 (1.2%) 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - ABDOMINAL DISCOMFORT - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - CONSTIPATION - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - DYSPHAGIA - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - FLATULENCE - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - GASTROINTESTINAL HAEMORRHAGE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 0 0 - 2 0 1 (1.4%) 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - GASTROOESOPHAGEAL REFLUX DISEASE - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - GLOSSITIS - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 0 0 0 - 2 1 (1.2%) 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - HIATUS HERNIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 0 0 0 - 2 1 (1.2%) 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - RECTAL HAEMORRHAGE - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - STOMACH DISCOMFORT - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - CARDIAC DISORDERS - - Overall - - - Any Grade - 13 (15.1%) 15 (20.8%) 16 (16.7%) - Grade 1-2 9 (10.5%) 13 (18.1%) 15 (15.6%) - 1 5 (5.8%) 9 (12.5%) 12 (12.5%) - 2 4 (4.7%) 4 (5.6%) 3 (3.1%) - Grade 3-4 4 (4.7%) 2 (2.8%) 1 (1.0%) - 3 3 (3.5%) 2 (2.8%) 0 - 4 1 (1.2%) 0 1 (1.0%) - Grade 5 0 0 0 - SINUS BRADYCARDIA - - Any Grade - 2 (2.3%) 8 (11.1%) 7 (7.3%) - Grade 1-2 2 (2.3%) 8 (11.1%) 7 (7.3%) - 1 1 (1.2%) 6 (8.3%) 7 (7.3%) - 2 1 (1.2%) 2 (2.8%) 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - MYOCARDIAL INFARCTION - - Any Grade - 4 (4.7%) 4 (5.6%) 2 (2.1%) - Grade 1-2 3 (3.5%) 3 (4.2%) 2 (2.1%) - 1 1 (1.2%) 2 (2.8%) 2 (2.1%) - 2 2 (2.3%) 1 (1.4%) 0 - Grade 3-4 1 (1.2%) 1 (1.4%) 0 - 3 1 (1.2%) 1 (1.4%) 0 - 4 0 0 0 - Grade 5 0 0 0 - ATRIAL FIBRILLATION - - Any Grade - 1 (1.2%) 2 (2.8%) 2 (2.1%) - Grade 1-2 1 (1.2%) 2 (2.8%) 2 (2.1%) - 1 1 (1.2%) 1 (1.4%) 2 (2.1%) - 2 0 1 (1.4%) 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - ATRIOVENTRICULAR BLOCK SECOND DEGREE - - Any Grade - 2 (2.3%) 1 (1.4%) 2 (2.1%) - Grade 1-2 2 (2.3%) 1 (1.4%) 2 (2.1%) - 1 1 (1.2%) 1 (1.4%) 1 (1.0%) - 2 1 (1.2%) 0 1 (1.0%) - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - SUPRAVENTRICULAR EXTRASYSTOLES - - Any Grade - 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 1-2 1 (1.2%) 0 0 - 1 0 0 0 - 2 1 (1.2%) 0 0 - Grade 3-4 0 1 (1.4%) 1 (1.0%) - 3 0 1 (1.4%) 0 - 4 0 0 1 (1.0%) - Grade 5 0 0 0 - VENTRICULAR EXTRASYSTOLES - - Any Grade - 0 1 (1.4%) 2 (2.1%) - Grade 1-2 0 1 (1.4%) 2 (2.1%) - 1 0 1 (1.4%) 2 (2.1%) - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - ATRIAL FLUTTER - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 0 - 2 0 0 1 (1.0%) - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - ATRIOVENTRICULAR BLOCK FIRST DEGREE - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 1 1 (1.2%) 0 1 (1.0%) - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - BUNDLE BRANCH BLOCK RIGHT - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 1 0 0 1 (1.0%) - 2 1 (1.2%) 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - PALPITATIONS - - Any Grade - 0 0 2 (2.1%) - Grade 1-2 0 0 2 (2.1%) - 1 0 0 2 (2.1%) - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - ATRIAL HYPERTROPHY - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 0 0 0 - 1 0 0 0 - 2 0 0 0 - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - 4 0 0 0 - Grade 5 0 0 0 - BRADYCARDIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 0 0 0 - 2 1 (1.2%) 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - BUNDLE BRANCH BLOCK LEFT - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - CARDIAC DISORDER - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 0 0 - 2 0 1 (1.4%) 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - CARDIAC FAILURE CONGESTIVE - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 0 0 0 - 1 0 0 0 - 2 0 0 0 - Grade 3-4 1 (1.2%) 0 0 - 3 0 0 0 - 4 1 (1.2%) 0 0 - Grade 5 0 0 0 - SINUS ARRHYTHMIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - SUPRAVENTRICULAR TACHYCARDIA - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 0 - 2 0 0 1 (1.0%) - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - TACHYCARDIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 0 0 0 - 1 0 0 0 - 2 0 0 0 - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - 4 0 0 0 - Grade 5 0 0 0 - VENTRICULAR HYPERTROPHY - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - WOLFF-PARKINSON-WHITE SYNDROME - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - INFECTIONS AND INFESTATIONS - - Overall - - - Any Grade - 16 (18.6%) 13 (18.1%) 10 (10.4%) - Grade 1-2 14 (16.3%) 11 (15.3%) 9 (9.4%) - 1 6 (7.0%) 6 (8.3%) 4 (4.2%) - 2 8 (9.3%) 5 (6.9%) 5 (5.2%) - Grade 3-4 2 (2.3%) 2 (2.8%) 1 (1.0%) - 3 1 (1.2%) 1 (1.4%) 1 (1.0%) - 4 1 (1.2%) 1 (1.4%) 0 - Grade 5 0 0 0 - NASOPHARYNGITIS - - Any Grade - 2 (2.3%) 6 (8.3%) 4 (4.2%) - Grade 1-2 2 (2.3%) 5 (6.9%) 3 (3.1%) - 1 2 (2.3%) 4 (5.6%) 2 (2.1%) - 2 0 1 (1.4%) 1 (1.0%) - Grade 3-4 0 1 (1.4%) 1 (1.0%) - 3 0 1 (1.4%) 1 (1.0%) - 4 0 0 0 - Grade 5 0 0 0 - UPPER RESPIRATORY TRACT INFECTION - - Any Grade - 6 (7.0%) 3 (4.2%) 1 (1.0%) - Grade 1-2 5 (5.8%) 3 (4.2%) 1 (1.0%) - 1 1 (1.2%) 1 (1.4%) 0 - 2 4 (4.7%) 2 (2.8%) 1 (1.0%) - Grade 3-4 1 (1.2%) 0 0 - 3 0 0 0 - 4 1 (1.2%) 0 0 - Grade 5 0 0 0 - INFLUENZA - - Any Grade - 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 1 (1.4%) 0 - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - 4 0 0 0 - Grade 5 0 0 0 - URINARY TRACT INFECTION - - Any Grade - 2 (2.3%) 1 (1.4%) 0 - Grade 1-2 2 (2.3%) 1 (1.4%) 0 - 1 2 (2.3%) 1 (1.4%) 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - CYSTITIS - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 1 0 0 0 - 2 1 (1.2%) 1 (1.4%) 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - EAR INFECTION - - Any Grade - 2 (2.3%) 0 0 - Grade 1-2 2 (2.3%) 0 0 - 1 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - LOCALISED INFECTION - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 1 0 0 0 - 2 1 (1.2%) 0 1 (1.0%) - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - BRONCHITIS - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - CELLULITIS - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 0 - 2 0 0 1 (1.0%) - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - CERVICITIS - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 0 0 0 - 2 1 (1.2%) 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - GASTROENTERITIS VIRAL - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 0 0 0 - 2 1 (1.2%) 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - HORDEOLUM - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - LOWER RESPIRATORY TRACT INFECTION - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 0 0 - 1 0 0 0 - 2 0 0 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 0 0 - 4 0 1 (1.4%) 0 - Grade 5 0 0 0 - ONYCHOMYCOSIS - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - PNEUMONIA - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 0 - 2 0 0 1 (1.0%) - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - RHINITIS - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - VAGINAL MYCOSIS - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - VIRAL INFECTION - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 0 - 2 0 0 1 (1.0%) - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - - Overall - - - Any Grade - 10 (11.6%) 10 (13.9%) 10 (10.4%) - Grade 1-2 8 (9.3%) 6 (8.3%) 7 (7.3%) - 1 5 (5.8%) 4 (5.6%) 6 (6.2%) - 2 3 (3.5%) 2 (2.8%) 1 (1.0%) - Grade 3-4 1 (1.2%) 4 (5.6%) 3 (3.1%) - 3 1 (1.2%) 3 (4.2%) 2 (2.1%) - 4 0 1 (1.4%) 1 (1.0%) - Grade 5 1 (1.2%) 0 0 - COUGH - - Any Grade - 3 (3.5%) 5 (6.9%) 6 (6.2%) - Grade 1-2 2 (2.3%) 3 (4.2%) 4 (4.2%) - 1 1 (1.2%) 2 (2.8%) 3 (3.1%) - 2 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 3-4 0 2 (2.8%) 2 (2.1%) - 3 0 2 (2.8%) 1 (1.0%) - 4 0 0 1 (1.0%) - Grade 5 1 (1.2%) 0 0 - NASAL CONGESTION - - Any Grade - 3 (3.5%) 3 (4.2%) 1 (1.0%) - Grade 1-2 3 (3.5%) 3 (4.2%) 1 (1.0%) - 1 1 (1.2%) 3 (4.2%) 1 (1.0%) - 2 2 (2.3%) 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - DYSPNOEA - - Any Grade - 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 1-2 1 (1.2%) 1 (1.4%) 1 (1.0%) - 1 1 (1.2%) 1 (1.4%) 1 (1.0%) - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - EPISTAXIS - - Any Grade - 0 2 (2.8%) 1 (1.0%) - Grade 1-2 0 2 (2.8%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - 2 0 1 (1.4%) 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - PHARYNGOLARYNGEAL PAIN - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 1 (1.4%) 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - RHINORRHOEA - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 0 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 0 0 - 4 0 1 (1.4%) 0 - Grade 5 0 0 0 - ALLERGIC GRANULOMATOUS ANGIITIS - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - DYSPHONIA - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 0 - 1 0 0 0 - 2 0 0 0 - Grade 3-4 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - 4 0 0 0 - Grade 5 0 0 0 - EMPHYSEMA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - HAEMOPTYSIS - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 0 0 0 - 1 0 0 0 - 2 0 0 0 - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - 4 0 0 0 - Grade 5 0 0 0 - PHARYNGEAL ERYTHEMA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 0 0 - 1 0 0 0 - 2 0 0 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - 4 0 0 0 - Grade 5 0 0 0 - POSTNASAL DRIP - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - PRODUCTIVE COUGH - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - RALES - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - RESPIRATORY TRACT CONGESTION - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - PSYCHIATRIC DISORDERS - - Overall - - - Any Grade - 10 (11.6%) 8 (11.1%) 11 (11.5%) - Grade 1-2 10 (11.6%) 8 (11.1%) 9 (9.4%) - 1 9 (10.5%) 6 (8.3%) 6 (6.2%) - 2 1 (1.2%) 2 (2.8%) 3 (3.1%) - Grade 3-4 0 0 2 (2.1%) - 3 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - Grade 5 0 0 0 - CONFUSIONAL STATE - - Any Grade - 2 (2.3%) 1 (1.4%) 3 (3.1%) - Grade 1-2 2 (2.3%) 1 (1.4%) 2 (2.1%) - 1 2 (2.3%) 1 (1.4%) 2 (2.1%) - 2 0 0 0 - Grade 3-4 0 0 1 (1.0%) - 3 0 0 0 - 4 0 0 1 (1.0%) - Grade 5 0 0 0 - AGITATION - - Any Grade - 2 (2.3%) 0 3 (3.1%) - Grade 1-2 2 (2.3%) 0 3 (3.1%) - 1 2 (2.3%) 0 1 (1.0%) - 2 0 0 2 (2.1%) - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - ANXIETY - - Any Grade - 1 (1.2%) 0 3 (3.1%) - Grade 1-2 1 (1.2%) 0 3 (3.1%) - 1 0 0 3 (3.1%) - 2 1 (1.2%) 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - INSOMNIA - - Any Grade - 2 (2.3%) 2 (2.8%) 0 - Grade 1-2 2 (2.3%) 2 (2.8%) 0 - 1 2 (2.3%) 2 (2.8%) 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - DELUSION - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 1 1 (1.2%) 1 (1.4%) 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - DEPRESSED MOOD - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - IRRITABILITY - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 1 0 0 0 - 2 1 (1.2%) 0 1 (1.0%) - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - COMPLETED SUICIDE - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - DELIRIUM - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - DISORIENTATION - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - HALLUCINATION - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 0 0 - 2 0 1 (1.4%) 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - HALLUCINATION, VISUAL - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - LIBIDO DECREASED - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 0 0 - 2 0 1 (1.4%) 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - LISTLESS - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - NIGHTMARE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - RESTLESSNESS - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 0 - 1 0 0 0 - 2 0 0 0 - Grade 3-4 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - 4 0 0 0 - Grade 5 0 0 0 - INVESTIGATIONS - - Overall - - - Any Grade - 10 (11.6%) 5 (6.9%) 8 (8.3%) - Grade 1-2 8 (9.3%) 3 (4.2%) 7 (7.3%) - 1 6 (7.0%) 2 (2.8%) 5 (5.2%) - 2 2 (2.3%) 1 (1.4%) 2 (2.1%) - Grade 3-4 2 (2.3%) 2 (2.8%) 1 (1.0%) - 3 1 (1.2%) 1 (1.4%) 0 - 4 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 5 0 0 0 - ELECTROCARDIOGRAM ST SEGMENT DEPRESSION - - Any Grade - 4 (4.7%) 0 1 (1.0%) - Grade 1-2 4 (4.7%) 0 1 (1.0%) - 1 3 (3.5%) 0 0 - 2 1 (1.2%) 0 1 (1.0%) - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - ELECTROCARDIOGRAM T WAVE INVERSION - - Any Grade - 2 (2.3%) 1 (1.4%) 1 (1.0%) - Grade 1-2 2 (2.3%) 1 (1.4%) 1 (1.0%) - 1 1 (1.2%) 0 1 (1.0%) - 2 1 (1.2%) 1 (1.4%) 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - BLOOD GLUCOSE INCREASED - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 0 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 0 0 - 4 0 1 (1.4%) 0 - Grade 5 0 0 0 - ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 1 1 (1.2%) 0 0 - 2 0 0 1 (1.0%) - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - BIOPSY - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - BIOPSY PROSTATE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - BLOOD ALKALINE PHOSPHATASE INCREASED - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - BLOOD CHOLESTEROL INCREASED - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 0 0 - 1 0 0 0 - 2 0 0 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - 4 0 0 0 - Grade 5 0 0 0 - BLOOD CREATINE PHOSPHOKINASE INCREASED - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - BLOOD URINE PRESENT - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - BODY TEMPERATURE INCREASED - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - CYSTOSCOPY - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 0 0 0 - 1 0 0 0 - 2 0 0 0 - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - 4 0 0 0 - Grade 5 0 0 0 - HEART RATE INCREASED - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - HEART RATE IRREGULAR - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 0 0 0 - 1 0 0 0 - 2 0 0 0 - Grade 3-4 1 (1.2%) 0 0 - 3 0 0 0 - 4 1 (1.2%) 0 0 - Grade 5 0 0 0 - NASAL MUCOSA BIOPSY - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - NEUTROPHIL COUNT INCREASED - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 0 - 1 0 0 0 - 2 0 0 0 - Grade 3-4 0 0 1 (1.0%) - 3 0 0 0 - 4 0 0 1 (1.0%) - Grade 5 0 0 0 - URINE ANALYSIS ABNORMAL - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 0 - 1 0 0 0 - 2 0 0 0 - Grade 3-4 0 0 1 (1.0%) - 3 0 0 0 - 4 0 0 1 (1.0%) - Grade 5 0 0 0 - WEIGHT DECREASED - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - WHITE BLOOD CELL COUNT INCREASED - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 0 - 2 0 0 1 (1.0%) - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS - - Overall - - - Any Grade - 5 (5.8%) 8 (11.1%) 7 (7.3%) - Grade 1-2 4 (4.7%) 7 (9.7%) 7 (7.3%) - 1 2 (2.3%) 6 (8.3%) 5 (5.2%) - 2 2 (2.3%) 1 (1.4%) 2 (2.1%) - Grade 3-4 1 (1.2%) 1 (1.4%) 0 - 3 1 (1.2%) 1 (1.4%) 0 - 4 0 0 0 - Grade 5 0 0 0 - BACK PAIN - - Any Grade - 1 (1.2%) 3 (4.2%) 1 (1.0%) - Grade 1-2 1 (1.2%) 3 (4.2%) 1 (1.0%) - 1 0 3 (4.2%) 0 - 2 1 (1.2%) 0 1 (1.0%) - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - ARTHRALGIA - - Any Grade - 1 (1.2%) 1 (1.4%) 2 (2.1%) - Grade 1-2 1 (1.2%) 1 (1.4%) 2 (2.1%) - 1 0 1 (1.4%) 2 (2.1%) - 2 1 (1.2%) 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - SHOULDER PAIN - - Any Grade - 1 (1.2%) 0 2 (2.1%) - Grade 1-2 1 (1.2%) 0 2 (2.1%) - 1 1 (1.2%) 0 2 (2.1%) - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - ARTHRITIS - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - 2 0 0 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - 4 0 0 0 - Grade 5 0 0 0 - FLANK PAIN - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 1 0 2 (2.8%) 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - MUSCLE SPASMS - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 1 (1.4%) 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - MUSCULAR WEAKNESS - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 0 - 2 0 0 1 (1.0%) - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - MYALGIA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - PAIN IN EXTREMITY - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 0 0 0 - 1 0 0 0 - 2 0 0 0 - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - 4 0 0 0 - Grade 5 0 0 0 - INJURY, POISONING AND PROCEDURAL COMPLICATIONS - - Overall - - - Any Grade - 4 (4.7%) 5 (6.9%) 5 (5.2%) - Grade 1-2 4 (4.7%) 4 (5.6%) 5 (5.2%) - 1 2 (2.3%) 3 (4.2%) 4 (4.2%) - 2 2 (2.3%) 1 (1.4%) 1 (1.0%) - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - 4 0 0 0 - Grade 5 0 0 0 - CONTUSION - - Any Grade - 1 (1.2%) 2 (2.8%) 1 (1.0%) - Grade 1-2 1 (1.2%) 2 (2.8%) 1 (1.0%) - 1 1 (1.2%) 2 (2.8%) 1 (1.0%) - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - EXCORIATION - - Any Grade - 2 (2.3%) 1 (1.4%) 1 (1.0%) - Grade 1-2 2 (2.3%) 1 (1.4%) 1 (1.0%) - 1 2 (2.3%) 1 (1.4%) 1 (1.0%) - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - FALL - - Any Grade - 1 (1.2%) 1 (1.4%) 2 (2.1%) - Grade 1-2 1 (1.2%) 0 2 (2.1%) - 1 0 0 2 (2.1%) - 2 1 (1.2%) 0 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - 4 0 0 0 - Grade 5 0 0 0 - HIP FRACTURE - - Any Grade - 1 (1.2%) 2 (2.8%) 0 - Grade 1-2 1 (1.2%) 2 (2.8%) 0 - 1 1 (1.2%) 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - SKIN LACERATION - - Any Grade - 1 (1.2%) 0 2 (2.1%) - Grade 1-2 1 (1.2%) 0 2 (2.1%) - 1 0 0 1 (1.0%) - 2 1 (1.2%) 0 1 (1.0%) - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - FACIAL BONES FRACTURE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - JOINT DISLOCATION - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - WOUND - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - RENAL AND URINARY DISORDERS - - Overall - - - Any Grade - 4 (4.7%) 3 (4.2%) 4 (4.2%) - Grade 1-2 4 (4.7%) 3 (4.2%) 3 (3.1%) - 1 2 (2.3%) 2 (2.8%) 2 (2.1%) - 2 2 (2.3%) 1 (1.4%) 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - 4 0 0 0 - Grade 5 0 0 0 - MICTURITION URGENCY - - Any Grade - 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 1-2 1 (1.2%) 1 (1.4%) 1 (1.0%) - 1 1 (1.2%) 0 0 - 2 0 1 (1.4%) 1 (1.0%) - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - DYSURIA - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 1 1 (1.2%) 0 1 (1.0%) - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - NEPHROLITHIASIS - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 1 (1.2%) 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - CALCULUS URETHRAL - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - ENURESIS - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 0 - 1 0 0 0 - 2 0 0 0 - Grade 3-4 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - 4 0 0 0 - Grade 5 0 0 0 - INCONTINENCE - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - POLLAKIURIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 0 0 0 - 2 1 (1.2%) 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - METABOLISM AND NUTRITION DISORDERS - - Overall - - - Any Grade - 6 (7.0%) 3 (4.2%) 1 (1.0%) - Grade 1-2 5 (5.8%) 2 (2.8%) 1 (1.0%) - 1 1 (1.2%) 2 (2.8%) 1 (1.0%) - 2 4 (4.7%) 0 0 - Grade 3-4 1 (1.2%) 1 (1.4%) 0 - 3 1 (1.2%) 0 0 - 4 0 1 (1.4%) 0 - Grade 5 0 0 0 - DECREASED APPETITE - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 1 (1.2%) 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - FOOD CRAVING - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 0 0 - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - 4 0 0 0 - Grade 5 0 0 0 - INCREASED APPETITE - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 1 (1.2%) 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - DEHYDRATION - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 0 0 0 - 2 1 (1.2%) 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - DIABETES MELLITUS - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - HYPERCHOLESTEROLAEMIA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 0 0 - 1 0 0 0 - 2 0 0 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 0 0 - 4 0 1 (1.4%) 0 - Grade 5 0 0 0 - HYPONATRAEMIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 0 0 0 - 2 1 (1.2%) 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - VASCULAR DISORDERS - - Overall - - - Any Grade - 3 (3.5%) 1 (1.4%) 4 (4.2%) - Grade 1-2 2 (2.3%) 1 (1.4%) 3 (3.1%) - 1 2 (2.3%) 1 (1.4%) 1 (1.0%) - 2 0 0 2 (2.1%) - Grade 3-4 1 (1.2%) 0 1 (1.0%) - 3 0 0 0 - 4 1 (1.2%) 0 1 (1.0%) - Grade 5 0 0 0 - HYPERTENSION - - Any Grade - 1 (1.2%) 0 2 (2.1%) - Grade 1-2 1 (1.2%) 0 2 (2.1%) - 1 1 (1.2%) 0 1 (1.0%) - 2 0 0 1 (1.0%) - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - HYPOTENSION - - Any Grade - 2 (2.3%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 1 1 (1.2%) 0 0 - 2 0 0 1 (1.0%) - Grade 3-4 1 (1.2%) 0 0 - 3 0 0 0 - 4 1 (1.2%) 0 0 - Grade 5 0 0 0 - HOT FLUSH - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 0 - 1 0 0 0 - 2 0 0 0 - Grade 3-4 0 0 1 (1.0%) - 3 0 0 0 - 4 0 0 1 (1.0%) - Grade 5 0 0 0 - ORTHOSTATIC HYPOTENSION - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - WOUND HAEMORRHAGE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - EYE DISORDERS - - Overall - - - Any Grade - 4 (4.7%) 1 (1.4%) 2 (2.1%) - Grade 1-2 2 (2.3%) 1 (1.4%) 2 (2.1%) - 1 0 1 (1.4%) 2 (2.1%) - 2 2 (2.3%) 0 0 - Grade 3-4 2 (2.3%) 0 0 - 3 0 0 0 - 4 2 (2.3%) 0 0 - Grade 5 0 0 0 - CONJUNCTIVITIS - - Any Grade - 2 (2.3%) 0 0 - Grade 1-2 0 0 0 - 1 0 0 0 - 2 0 0 0 - Grade 3-4 2 (2.3%) 0 0 - 3 0 0 0 - 4 2 (2.3%) 0 0 - Grade 5 0 0 0 - VISION BLURRED - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - CONJUNCTIVAL HAEMORRHAGE - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - EYE ALLERGY - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - EYE PRURITUS - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - EYE SWELLING - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 0 0 0 - 2 1 (1.2%) 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - GLAUCOMA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 0 0 0 - 2 1 (1.2%) 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - SURGICAL AND MEDICAL PROCEDURES - - Overall - - - Any Grade - 2 (2.3%) 2 (2.8%) 1 (1.0%) - Grade 1-2 1 (1.2%) 2 (2.8%) 1 (1.0%) - 1 1 (1.2%) 1 (1.4%) 1 (1.0%) - 2 0 1 (1.4%) 0 - Grade 3-4 1 (1.2%) 0 0 - 3 0 0 0 - 4 1 (1.2%) 0 0 - Grade 5 0 0 0 - CATARACT OPERATION - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 0 0 - Grade 3-4 1 (1.2%) 0 0 - 3 0 0 0 - 4 1 (1.2%) 0 0 - Grade 5 0 0 0 - ACROCHORDON EXCISION - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 0 0 - 2 0 1 (1.4%) 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - EYE LASER SURGERY - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - SKIN LESION EXCISION - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - EAR AND LABYRINTH DISORDERS - - Overall - - - Any Grade - 1 (1.2%) 1 (1.4%) 2 (2.1%) - Grade 1-2 1 (1.2%) 1 (1.4%) 2 (2.1%) - 1 1 (1.2%) 1 (1.4%) 2 (2.1%) - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - VERTIGO - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - CERUMEN IMPACTION - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - EAR PAIN - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - TINNITUS - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - CONGENITAL, FAMILIAL AND GENETIC DISORDERS - - Overall - - - Any Grade - 0 2 (2.8%) 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 0 0 - Grade 3-4 0 2 (2.8%) 0 - 3 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - Grade 5 0 0 0 - VENTRICULAR SEPTAL DEFECT - - Any Grade - 0 2 (2.8%) 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 0 0 - Grade 3-4 0 2 (2.8%) 0 - 3 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - Grade 5 0 0 0 - NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - - Overall - - - Any Grade - 0 1 (1.4%) 2 (2.1%) - Grade 1-2 0 1 (1.4%) 2 (2.1%) - 1 0 1 (1.4%) 1 (1.0%) - 2 0 0 1 (1.0%) - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - COLON CANCER - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - MALIGNANT FIBROUS HISTIOCYTOMA - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 0 - 2 0 0 1 (1.0%) - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - PROSTATE CANCER - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - REPRODUCTIVE SYSTEM AND BREAST DISORDERS - - Overall - - - Any Grade - 2 (2.3%) 1 (1.4%) 0 - Grade 1-2 2 (2.3%) 1 (1.4%) 0 - 1 2 (2.3%) 0 0 - 2 0 1 (1.4%) 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - BENIGN PROSTATIC HYPERPLASIA - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 1 1 (1.2%) 0 0 - 2 0 1 (1.4%) 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - PELVIC PAIN - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - IMMUNE SYSTEM DISORDERS - - Overall - - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 0 - 2 0 0 1 (1.0%) - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - HYPERSENSITIVITY - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 0 - 2 0 0 1 (1.0%) - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - SEASONAL ALLERGY - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - HEPATOBILIARY DISORDERS - - Overall - - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - HYPERBILIRUBINAEMIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - 2 0 0 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - SOCIAL CIRCUMSTANCES - - Overall - - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 0 0 - 2 0 1 (1.4%) 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 - ALCOHOL USE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 0 0 - 2 0 1 (1.4%) 0 - Grade 3-4 0 0 0 - 3 0 0 0 - 4 0 0 0 - Grade 5 0 0 0 + MedDRA System Organ Class + MedDRA Preferred Term Placebo Xanomeline High Dose Xanomeline Low Dose + Grade (N=86) (N=72) (N=96) + —————————————————————————————————————————————————————————————————————————————————————————————————————————————— + - Any adverse events - + - Any Grade - 23 (26.7%) 51 (70.8%) 54 (56.2%) + Grade 1-2 17 (19.8%) 42 (58.3%) 43 (44.8%) + 1 11 (12.8%) 26 (36.1%) 28 (29.2%) + 2 6 (7.0%) 16 (22.2%) 15 (15.6%) + Grade 3-4 6 (7.0%) 9 (12.5%) 10 (10.4%) + 3 2 (2.3%) 4 (5.6%) 5 (5.2%) + 4 4 (4.7%) 5 (6.9%) 5 (5.2%) + Grade 5 0 0 1 (1.0%) + SKIN AND SUBCUTANEOUS TISSUE DISORDERS + - Overall - + - Any Grade - 17 (19.8%) 32 (44.4%) 31 (32.3%) + Grade 1-2 13 (15.1%) 26 (36.1%) 25 (26.0%) + 1 10 (11.6%) 18 (25.0%) 15 (15.6%) + 2 3 (3.5%) 8 (11.1%) 10 (10.4%) + Grade 3-4 4 (4.7%) 6 (8.3%) 5 (5.2%) + 3 2 (2.3%) 3 (4.2%) 3 (3.1%) + 4 2 (2.3%) 3 (4.2%) 2 (2.1%) + Grade 5 0 0 1 (1.0%) + PRURITUS + - Any Grade - 8 (9.3%) 26 (36.1%) 23 (24.0%) + Grade 1-2 5 (5.8%) 20 (27.8%) 21 (21.9%) + 1 4 (4.7%) 15 (20.8%) 14 (14.6%) + 2 1 (1.2%) 5 (6.9%) 7 (7.3%) + Grade 3-4 3 (3.5%) 6 (8.3%) 1 (1.0%) + 3 1 (1.2%) 3 (4.2%) 1 (1.0%) + 4 2 (2.3%) 3 (4.2%) 0 + Grade 5 0 0 1 (1.0%) + ERYTHEMA + - Any Grade - 9 (10.5%) 14 (19.4%) 15 (15.6%) + Grade 1-2 9 (10.5%) 14 (19.4%) 13 (13.5%) + 1 8 (9.3%) 12 (16.7%) 8 (8.3%) + 2 1 (1.2%) 2 (2.8%) 5 (5.2%) + Grade 3-4 0 0 2 (2.1%) + 3 0 0 1 (1.0%) + 4 0 0 1 (1.0%) + Grade 5 0 0 0 + RASH + - Any Grade - 5 (5.8%) 11 (15.3%) 13 (13.5%) + Grade 1-2 4 (4.7%) 10 (13.9%) 11 (11.5%) + 1 3 (3.5%) 7 (9.7%) 10 (10.4%) + 2 1 (1.2%) 3 (4.2%) 1 (1.0%) + Grade 3-4 1 (1.2%) 1 (1.4%) 2 (2.1%) + 3 1 (1.2%) 1 (1.4%) 1 (1.0%) + 4 0 0 1 (1.0%) + Grade 5 0 0 0 + GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS + - Overall - + - Any Grade - 8 (9.3%) 24 (33.3%) 25 (26.0%) + Grade 1-2 6 (7.0%) 20 (27.8%) 20 (20.8%) + 1 3 (3.5%) 10 (13.9%) 14 (14.6%) + 2 3 (3.5%) 10 (13.9%) 6 (6.2%) + Grade 3-4 2 (2.3%) 4 (5.6%) 5 (5.2%) + 3 0 2 (2.8%) 2 (2.1%) + 4 2 (2.3%) 2 (2.8%) 3 (3.1%) + Grade 5 0 0 0 + APPLICATION SITE PRURITUS + - Any Grade - 6 (7.0%) 21 (29.2%) 23 (24.0%) + Grade 1-2 4 (4.7%) 19 (26.4%) 20 (20.8%) + 1 2 (2.3%) 11 (15.3%) 16 (16.7%) + 2 2 (2.3%) 8 (11.1%) 4 (4.2%) + Grade 3-4 2 (2.3%) 2 (2.8%) 3 (3.1%) + 3 0 0 1 (1.0%) + 4 2 (2.3%) 2 (2.8%) 2 (2.1%) + Grade 5 0 0 0 + APPLICATION SITE ERYTHEMA + - Any Grade - 3 (3.5%) 14 (19.4%) 13 (13.5%) + Grade 1-2 3 (3.5%) 12 (16.7%) 11 (11.5%) + 1 2 (2.3%) 10 (13.9%) 8 (8.3%) + 2 1 (1.2%) 2 (2.8%) 3 (3.1%) + Grade 3-4 0 2 (2.8%) 2 (2.1%) + 3 0 2 (2.8%) 1 (1.0%) + 4 0 0 1 (1.0%) + Grade 5 0 0 0 # AET04 variant 4 is produced correctly (Collapsing of Grades: grades 1&2, grades 3&4&5) Code res Output - MedDRA System Organ Class - MedDRA Preferred Term Placebo Xanomeline High Dose Xanomeline Low Dose - Grade (N=86) (N=72) (N=96) - ————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— - - Any adverse events - - - Any Grade - 69 (80.2%) 70 (97.2%) 86 (89.6%) - Grade 1-2 46 (53.5%) 37 (51.4%) 54 (56.2%) - 1 22 (25.6%) 18 (25.0%) 19 (19.8%) - 2 24 (27.9%) 19 (26.4%) 35 (36.5%) - Grade 3-5 23 (26.7%) 33 (45.8%) 32 (33.3%) - 3 8 (9.3%) 16 (22.2%) 11 (11.5%) - 4 12 (14.0%) 16 (22.2%) 19 (19.8%) - 5 3 (3.5%) 1 (1.4%) 2 (2.1%) - GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - - Overall - - - Any Grade - 21 (24.4%) 36 (50.0%) 51 (53.1%) - Grade 1-2 17 (19.8%) 28 (38.9%) 40 (41.7%) - 1 10 (11.6%) 15 (20.8%) 20 (20.8%) - 2 7 (8.1%) 13 (18.1%) 20 (20.8%) - Grade 3-5 4 (4.7%) 8 (11.1%) 11 (11.5%) - 3 2 (2.3%) 3 (4.2%) 6 (6.2%) - 4 2 (2.3%) 5 (6.9%) 5 (5.2%) - APPLICATION SITE PRURITUS - - Any Grade - 6 (7.0%) 21 (29.2%) 23 (24.0%) - Grade 1-2 4 (4.7%) 19 (26.4%) 20 (20.8%) - 1 2 (2.3%) 11 (15.3%) 16 (16.7%) - 2 2 (2.3%) 8 (11.1%) 4 (4.2%) - Grade 3-5 2 (2.3%) 2 (2.8%) 3 (3.1%) - 3 0 0 1 (1.0%) - 4 2 (2.3%) 2 (2.8%) 2 (2.1%) - APPLICATION SITE ERYTHEMA - - Any Grade - 3 (3.5%) 14 (19.4%) 13 (13.5%) - Grade 1-2 3 (3.5%) 12 (16.7%) 11 (11.5%) - 1 2 (2.3%) 10 (13.9%) 8 (8.3%) - 2 1 (1.2%) 2 (2.8%) 3 (3.1%) - Grade 3-5 0 2 (2.8%) 2 (2.1%) - 3 0 2 (2.8%) 1 (1.0%) - 4 0 0 1 (1.0%) - APPLICATION SITE DERMATITIS - - Any Grade - 5 (5.8%) 7 (9.7%) 9 (9.4%) - Grade 1-2 4 (4.7%) 6 (8.3%) 8 (8.3%) - 1 3 (3.5%) 3 (4.2%) 4 (4.2%) - 2 1 (1.2%) 3 (4.2%) 4 (4.2%) - Grade 3-5 1 (1.2%) 1 (1.4%) 1 (1.0%) - 3 1 (1.2%) 1 (1.4%) 1 (1.0%) - APPLICATION SITE IRRITATION - - Any Grade - 3 (3.5%) 9 (12.5%) 9 (9.4%) - Grade 1-2 2 (2.3%) 8 (11.1%) 6 (6.2%) - 1 2 (2.3%) 6 (8.3%) 3 (3.1%) - 2 0 2 (2.8%) 3 (3.1%) - Grade 3-5 1 (1.2%) 1 (1.4%) 3 (3.1%) - 3 1 (1.2%) 0 1 (1.0%) - 4 0 1 (1.4%) 2 (2.1%) - APPLICATION SITE VESICLES - - Any Grade - 1 (1.2%) 5 (6.9%) 5 (5.2%) - Grade 1-2 1 (1.2%) 4 (5.6%) 5 (5.2%) - 1 0 3 (4.2%) 4 (4.2%) - 2 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 3-5 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - FATIGUE - - Any Grade - 1 (1.2%) 5 (6.9%) 5 (5.2%) - Grade 1-2 1 (1.2%) 4 (5.6%) 5 (5.2%) - 1 0 3 (4.2%) 3 (3.1%) - 2 1 (1.2%) 1 (1.4%) 2 (2.1%) - Grade 3-5 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - OEDEMA PERIPHERAL - - Any Grade - 2 (2.3%) 2 (2.8%) 1 (1.0%) - Grade 1-2 1 (1.2%) 2 (2.8%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - 2 1 (1.2%) 1 (1.4%) 0 - Grade 3-5 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - APPLICATION SITE SWELLING - - Any Grade - 0 2 (2.8%) 1 (1.0%) - Grade 1-2 0 2 (2.8%) 1 (1.0%) - 1 0 2 (2.8%) 1 (1.0%) - APPLICATION SITE URTICARIA - - Any Grade - 0 1 (1.4%) 2 (2.1%) - Grade 1-2 0 1 (1.4%) 2 (2.1%) - 1 0 1 (1.4%) 1 (1.0%) - 2 0 0 1 (1.0%) - CHILLS - - Any Grade - 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 1-2 1 (1.2%) 1 (1.4%) 1 (1.0%) - 1 1 (1.2%) 1 (1.4%) 0 - 2 0 0 1 (1.0%) - MALAISE - - Any Grade - 0 2 (2.8%) 1 (1.0%) - Grade 1-2 0 2 (2.8%) 1 (1.0%) - 1 0 1 (1.4%) 0 - 2 0 1 (1.4%) 1 (1.0%) - PYREXIA - - Any Grade - 2 (2.3%) 0 1 (1.0%) - Grade 1-2 2 (2.3%) 0 1 (1.0%) - 1 1 (1.2%) 0 1 (1.0%) - 2 1 (1.2%) 0 0 - APPLICATION SITE PAIN - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 1 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - APPLICATION SITE PERSPIRATION - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 2 0 2 (2.8%) 0 - APPLICATION SITE REACTION - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 1 1 (1.2%) 1 (1.4%) 0 - ASTHENIA - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 1 1 (1.2%) 0 0 - 2 0 0 1 (1.0%) - CHEST DISCOMFORT - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 0 - 2 0 0 1 (1.0%) - CHEST PAIN - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 1 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - OEDEMA - - Any Grade - 0 0 2 (2.1%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - Grade 3-5 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - PAIN - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - APPLICATION SITE BLEEDING - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - APPLICATION SITE DESQUAMATION - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - APPLICATION SITE DISCHARGE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - APPLICATION SITE DISCOLOURATION - - Any Grade - 0 0 1 (1.0%) - Grade 3-5 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - APPLICATION SITE INDURATION - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - APPLICATION SITE WARMTH - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - CYST - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - FEELING ABNORMAL - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - FEELING COLD - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - INFLAMMATION - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - SECRETION DISCHARGE - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - SUDDEN DEATH - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - SWELLING - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - ULCER - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - SKIN AND SUBCUTANEOUS TISSUE DISORDERS - - Overall - - - Any Grade - 21 (24.4%) 42 (58.3%) 42 (43.8%) - Grade 1-2 17 (19.8%) 33 (45.8%) 33 (34.4%) - 1 11 (12.8%) 20 (27.8%) 17 (17.7%) - 2 6 (7.0%) 13 (18.1%) 16 (16.7%) - Grade 3-5 4 (4.7%) 9 (12.5%) 9 (9.4%) - 3 2 (2.3%) 4 (5.6%) 4 (4.2%) - 4 2 (2.3%) 5 (6.9%) 3 (3.1%) - 5 0 0 2 (2.1%) - PRURITUS - - Any Grade - 8 (9.3%) 26 (36.1%) 23 (24.0%) - Grade 1-2 5 (5.8%) 20 (27.8%) 21 (21.9%) - 1 4 (4.7%) 15 (20.8%) 14 (14.6%) - 2 1 (1.2%) 5 (6.9%) 7 (7.3%) - Grade 3-5 3 (3.5%) 6 (8.3%) 2 (2.1%) - 3 1 (1.2%) 3 (4.2%) 1 (1.0%) - 4 2 (2.3%) 3 (4.2%) 0 - 5 0 0 1 (1.0%) - ERYTHEMA - - Any Grade - 9 (10.5%) 14 (19.4%) 15 (15.6%) - Grade 1-2 9 (10.5%) 14 (19.4%) 13 (13.5%) - 1 8 (9.3%) 12 (16.7%) 8 (8.3%) - 2 1 (1.2%) 2 (2.8%) 5 (5.2%) - Grade 3-5 0 0 2 (2.1%) - 3 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - RASH - - Any Grade - 5 (5.8%) 11 (15.3%) 13 (13.5%) - Grade 1-2 4 (4.7%) 10 (13.9%) 11 (11.5%) - 1 3 (3.5%) 7 (9.7%) 10 (10.4%) - 2 1 (1.2%) 3 (4.2%) 1 (1.0%) - Grade 3-5 1 (1.2%) 1 (1.4%) 2 (2.1%) - 3 1 (1.2%) 1 (1.4%) 1 (1.0%) - 4 0 0 1 (1.0%) - HYPERHIDROSIS - - Any Grade - 2 (2.3%) 8 (11.1%) 4 (4.2%) - Grade 1-2 2 (2.3%) 7 (9.7%) 4 (4.2%) - 1 0 5 (6.9%) 4 (4.2%) - 2 2 (2.3%) 2 (2.8%) 0 - Grade 3-5 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - SKIN IRRITATION - - Any Grade - 3 (3.5%) 5 (6.9%) 6 (6.2%) - Grade 1-2 3 (3.5%) 5 (6.9%) 4 (4.2%) - 1 1 (1.2%) 3 (4.2%) 3 (3.1%) - 2 2 (2.3%) 2 (2.8%) 1 (1.0%) - Grade 3-5 0 0 2 (2.1%) - 4 0 0 1 (1.0%) - 5 0 0 1 (1.0%) - BLISTER - - Any Grade - 0 1 (1.4%) 5 (5.2%) - Grade 1-2 0 1 (1.4%) 5 (5.2%) - 1 0 1 (1.4%) 4 (4.2%) - 2 0 0 1 (1.0%) - RASH PRURITIC - - Any Grade - 0 2 (2.8%) 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - Grade 3-5 0 2 (2.8%) 0 - 3 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - PRURITUS GENERALISED - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 0 - 2 0 0 1 (1.0%) - RASH ERYTHEMATOUS - - Any Grade - 0 0 2 (2.1%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - Grade 3-5 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - URTICARIA - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - Grade 3-5 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - ACTINIC KERATOSIS - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - ALOPECIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - COLD SWEAT - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - DERMATITIS ATOPIC - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - DERMATITIS CONTACT - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - DRUG ERUPTION - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - RASH MACULO-PAPULAR - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - RASH PAPULAR - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - SKIN EXFOLIATION - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - SKIN ODOUR ABNORMAL - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - SKIN ULCER - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - NERVOUS SYSTEM DISORDERS - - Overall - - - Any Grade - 12 (14.0%) 25 (34.7%) 22 (22.9%) - Grade 1-2 10 (11.6%) 22 (30.6%) 19 (19.8%) - 1 7 (8.1%) 16 (22.2%) 13 (13.5%) - 2 3 (3.5%) 6 (8.3%) 6 (6.2%) - Grade 3-5 2 (2.3%) 3 (4.2%) 3 (3.1%) - 3 0 1 (1.4%) 1 (1.0%) - 4 1 (1.2%) 2 (2.8%) 2 (2.1%) - 5 1 (1.2%) 0 0 - DIZZINESS - - Any Grade - 2 (2.3%) 11 (15.3%) 9 (9.4%) - Grade 1-2 2 (2.3%) 9 (12.5%) 8 (8.3%) - 1 1 (1.2%) 9 (12.5%) 5 (5.2%) - 2 1 (1.2%) 0 3 (3.1%) - Grade 3-5 0 2 (2.8%) 1 (1.0%) - 3 0 0 1 (1.0%) - 4 0 2 (2.8%) 0 - HEADACHE - - Any Grade - 7 (8.1%) 6 (8.3%) 3 (3.1%) - Grade 1-2 6 (7.0%) 6 (8.3%) 3 (3.1%) - 1 5 (5.8%) 3 (4.2%) 2 (2.1%) - 2 1 (1.2%) 3 (4.2%) 1 (1.0%) - Grade 3-5 1 (1.2%) 0 0 - 4 1 (1.2%) 0 0 - SYNCOPE - - Any Grade - 0 2 (2.8%) 5 (5.2%) - Grade 1-2 0 2 (2.8%) 5 (5.2%) - 1 0 2 (2.8%) 5 (5.2%) - SOMNOLENCE - - Any Grade - 2 (2.3%) 1 (1.4%) 3 (3.1%) - Grade 1-2 2 (2.3%) 1 (1.4%) 2 (2.1%) - 1 1 (1.2%) 1 (1.4%) 2 (2.1%) - 2 1 (1.2%) 0 0 - Grade 3-5 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - TRANSIENT ISCHAEMIC ATTACK - - Any Grade - 0 1 (1.4%) 2 (2.1%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 2 0 1 (1.4%) 1 (1.0%) - Grade 3-5 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - BURNING SENSATION - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 1 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - LETHARGY - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - AMNESIA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - BALANCE DISORDER - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - COGNITIVE DISORDER - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - COMPLEX PARTIAL SEIZURES - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - COORDINATION ABNORMAL - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - HEMIANOPIA HOMONYMOUS - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - HYPERSOMNIA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - PARAESTHESIA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - PARAESTHESIA ORAL - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - PARKINSON'S DISEASE - - Any Grade - 1 (1.2%) 0 0 - Grade 3-5 1 (1.2%) 0 0 - 5 1 (1.2%) 0 0 - PAROSMIA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - PARTIAL SEIZURES WITH SECONDARY GENERALISATION - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - PSYCHOMOTOR HYPERACTIVITY - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - STUPOR - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - SYNCOPE VASOVAGAL - - Any Grade - 0 1 (1.4%) 0 - Grade 3-5 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - GASTROINTESTINAL DISORDERS - - Overall - - - Any Grade - 17 (19.8%) 20 (27.8%) 16 (16.7%) - Grade 1-2 14 (16.3%) 17 (23.6%) 12 (12.5%) - 1 9 (10.5%) 12 (16.7%) 10 (10.4%) - 2 5 (5.8%) 5 (6.9%) 2 (2.1%) - Grade 3-5 3 (3.5%) 3 (4.2%) 4 (4.2%) - 3 0 2 (2.8%) 0 - 4 2 (2.3%) 0 4 (4.2%) - 5 1 (1.2%) 1 (1.4%) 0 - DIARRHOEA - - Any Grade - 9 (10.5%) 3 (4.2%) 6 (6.2%) - Grade 1-2 8 (9.3%) 3 (4.2%) 4 (4.2%) - 1 7 (8.1%) 3 (4.2%) 3 (3.1%) - 2 1 (1.2%) 0 1 (1.0%) - Grade 3-5 1 (1.2%) 0 2 (2.1%) - 4 1 (1.2%) 0 2 (2.1%) - VOMITING - - Any Grade - 3 (3.5%) 6 (8.3%) 4 (4.2%) - Grade 1-2 2 (2.3%) 6 (8.3%) 4 (4.2%) - 1 0 4 (5.6%) 3 (3.1%) - 2 2 (2.3%) 2 (2.8%) 1 (1.0%) - Grade 3-5 1 (1.2%) 0 0 - 5 1 (1.2%) 0 0 - NAUSEA - - Any Grade - 3 (3.5%) 6 (8.3%) 3 (3.1%) - Grade 1-2 3 (3.5%) 3 (4.2%) 2 (2.1%) - 1 2 (2.3%) 2 (2.8%) 1 (1.0%) - 2 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 3-5 0 3 (4.2%) 1 (1.0%) - 3 0 2 (2.8%) 0 - 4 0 0 1 (1.0%) - 5 0 1 (1.4%) 0 - ABDOMINAL PAIN - - Any Grade - 1 (1.2%) 1 (1.4%) 3 (3.1%) - Grade 1-2 0 1 (1.4%) 2 (2.1%) - 1 0 1 (1.4%) 2 (2.1%) - Grade 3-5 1 (1.2%) 0 1 (1.0%) - 4 1 (1.2%) 0 1 (1.0%) - SALIVARY HYPERSECRETION - - Any Grade - 0 4 (5.6%) 0 - Grade 1-2 0 4 (5.6%) 0 - 1 0 2 (2.8%) 0 - 2 0 2 (2.8%) 0 - DYSPEPSIA - - Any Grade - 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 1-2 1 (1.2%) 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - 2 1 (1.2%) 0 0 - ABDOMINAL DISCOMFORT - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - CONSTIPATION - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - DYSPHAGIA - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - FLATULENCE - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - GASTROINTESTINAL HAEMORRHAGE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - GASTROOESOPHAGEAL REFLUX DISEASE - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - GLOSSITIS - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - HIATUS HERNIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - RECTAL HAEMORRHAGE - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - STOMACH DISCOMFORT - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - CARDIAC DISORDERS - - Overall - - - Any Grade - 13 (15.1%) 15 (20.8%) 16 (16.7%) - Grade 1-2 9 (10.5%) 13 (18.1%) 15 (15.6%) - 1 5 (5.8%) 9 (12.5%) 12 (12.5%) - 2 4 (4.7%) 4 (5.6%) 3 (3.1%) - Grade 3-5 4 (4.7%) 2 (2.8%) 1 (1.0%) - 3 3 (3.5%) 2 (2.8%) 0 - 4 1 (1.2%) 0 1 (1.0%) - SINUS BRADYCARDIA - - Any Grade - 2 (2.3%) 8 (11.1%) 7 (7.3%) - Grade 1-2 2 (2.3%) 8 (11.1%) 7 (7.3%) - 1 1 (1.2%) 6 (8.3%) 7 (7.3%) - 2 1 (1.2%) 2 (2.8%) 0 - MYOCARDIAL INFARCTION - - Any Grade - 4 (4.7%) 4 (5.6%) 2 (2.1%) - Grade 1-2 3 (3.5%) 3 (4.2%) 2 (2.1%) - 1 1 (1.2%) 2 (2.8%) 2 (2.1%) - 2 2 (2.3%) 1 (1.4%) 0 - Grade 3-5 1 (1.2%) 1 (1.4%) 0 - 3 1 (1.2%) 1 (1.4%) 0 - ATRIAL FIBRILLATION - - Any Grade - 1 (1.2%) 2 (2.8%) 2 (2.1%) - Grade 1-2 1 (1.2%) 2 (2.8%) 2 (2.1%) - 1 1 (1.2%) 1 (1.4%) 2 (2.1%) - 2 0 1 (1.4%) 0 - ATRIOVENTRICULAR BLOCK SECOND DEGREE - - Any Grade - 2 (2.3%) 1 (1.4%) 2 (2.1%) - Grade 1-2 2 (2.3%) 1 (1.4%) 2 (2.1%) - 1 1 (1.2%) 1 (1.4%) 1 (1.0%) - 2 1 (1.2%) 0 1 (1.0%) - SUPRAVENTRICULAR EXTRASYSTOLES - - Any Grade - 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - Grade 3-5 0 1 (1.4%) 1 (1.0%) - 3 0 1 (1.4%) 0 - 4 0 0 1 (1.0%) - VENTRICULAR EXTRASYSTOLES - - Any Grade - 0 1 (1.4%) 2 (2.1%) - Grade 1-2 0 1 (1.4%) 2 (2.1%) - 1 0 1 (1.4%) 2 (2.1%) - ATRIAL FLUTTER - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 0 - 2 0 0 1 (1.0%) - ATRIOVENTRICULAR BLOCK FIRST DEGREE - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 1 1 (1.2%) 0 1 (1.0%) - BUNDLE BRANCH BLOCK RIGHT - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 1 0 0 1 (1.0%) - 2 1 (1.2%) 0 0 - PALPITATIONS - - Any Grade - 0 0 2 (2.1%) - Grade 1-2 0 0 2 (2.1%) - 1 0 0 2 (2.1%) - ATRIAL HYPERTROPHY - - Any Grade - 1 (1.2%) 0 0 - Grade 3-5 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - BRADYCARDIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - BUNDLE BRANCH BLOCK LEFT - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - CARDIAC DISORDER - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - CARDIAC FAILURE CONGESTIVE - - Any Grade - 1 (1.2%) 0 0 - Grade 3-5 1 (1.2%) 0 0 - 4 1 (1.2%) 0 0 - SINUS ARRHYTHMIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - SUPRAVENTRICULAR TACHYCARDIA - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - TACHYCARDIA - - Any Grade - 1 (1.2%) 0 0 - Grade 3-5 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - VENTRICULAR HYPERTROPHY - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - WOLFF-PARKINSON-WHITE SYNDROME - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - INFECTIONS AND INFESTATIONS - - Overall - - - Any Grade - 16 (18.6%) 13 (18.1%) 10 (10.4%) - Grade 1-2 14 (16.3%) 11 (15.3%) 9 (9.4%) - 1 6 (7.0%) 6 (8.3%) 4 (4.2%) - 2 8 (9.3%) 5 (6.9%) 5 (5.2%) - Grade 3-5 2 (2.3%) 2 (2.8%) 1 (1.0%) - 3 1 (1.2%) 1 (1.4%) 1 (1.0%) - 4 1 (1.2%) 1 (1.4%) 0 - NASOPHARYNGITIS - - Any Grade - 2 (2.3%) 6 (8.3%) 4 (4.2%) - Grade 1-2 2 (2.3%) 5 (6.9%) 3 (3.1%) - 1 2 (2.3%) 4 (5.6%) 2 (2.1%) - 2 0 1 (1.4%) 1 (1.0%) - Grade 3-5 0 1 (1.4%) 1 (1.0%) - 3 0 1 (1.4%) 1 (1.0%) - UPPER RESPIRATORY TRACT INFECTION - - Any Grade - 6 (7.0%) 3 (4.2%) 1 (1.0%) - Grade 1-2 5 (5.8%) 3 (4.2%) 1 (1.0%) - 1 1 (1.2%) 1 (1.4%) 0 - 2 4 (4.7%) 2 (2.8%) 1 (1.0%) - Grade 3-5 1 (1.2%) 0 0 - 4 1 (1.2%) 0 0 - INFLUENZA - - Any Grade - 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 1 (1.4%) 0 - Grade 3-5 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - URINARY TRACT INFECTION - - Any Grade - 2 (2.3%) 1 (1.4%) 0 - Grade 1-2 2 (2.3%) 1 (1.4%) 0 - 1 2 (2.3%) 1 (1.4%) 0 - CYSTITIS - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 2 1 (1.2%) 1 (1.4%) 0 - EAR INFECTION - - Any Grade - 2 (2.3%) 0 0 - Grade 1-2 2 (2.3%) 0 0 - 1 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - LOCALISED INFECTION - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 2 1 (1.2%) 0 1 (1.0%) - BRONCHITIS - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - CELLULITIS - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - CERVICITIS - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - GASTROENTERITIS VIRAL - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - HORDEOLUM - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - LOWER RESPIRATORY TRACT INFECTION - - Any Grade - 0 1 (1.4%) 0 - Grade 3-5 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - ONYCHOMYCOSIS - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - PNEUMONIA - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - RHINITIS - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - VAGINAL MYCOSIS - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - VIRAL INFECTION - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - - Overall - - - Any Grade - 10 (11.6%) 10 (13.9%) 10 (10.4%) - Grade 1-2 8 (9.3%) 6 (8.3%) 7 (7.3%) - 1 5 (5.8%) 4 (5.6%) 6 (6.2%) - 2 3 (3.5%) 2 (2.8%) 1 (1.0%) - Grade 3-5 2 (2.3%) 4 (5.6%) 3 (3.1%) - 3 1 (1.2%) 3 (4.2%) 2 (2.1%) - 4 0 1 (1.4%) 1 (1.0%) - 5 1 (1.2%) 0 0 - COUGH - - Any Grade - 3 (3.5%) 5 (6.9%) 6 (6.2%) - Grade 1-2 2 (2.3%) 3 (4.2%) 4 (4.2%) - 1 1 (1.2%) 2 (2.8%) 3 (3.1%) - 2 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 3-5 1 (1.2%) 2 (2.8%) 2 (2.1%) - 3 0 2 (2.8%) 1 (1.0%) - 4 0 0 1 (1.0%) - 5 1 (1.2%) 0 0 - NASAL CONGESTION - - Any Grade - 3 (3.5%) 3 (4.2%) 1 (1.0%) - Grade 1-2 3 (3.5%) 3 (4.2%) 1 (1.0%) - 1 1 (1.2%) 3 (4.2%) 1 (1.0%) - 2 2 (2.3%) 0 0 - DYSPNOEA - - Any Grade - 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 1-2 1 (1.2%) 1 (1.4%) 1 (1.0%) - 1 1 (1.2%) 1 (1.4%) 1 (1.0%) - EPISTAXIS - - Any Grade - 0 2 (2.8%) 1 (1.0%) - Grade 1-2 0 2 (2.8%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - 2 0 1 (1.4%) 0 - PHARYNGOLARYNGEAL PAIN - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 1 (1.4%) 0 - RHINORRHOEA - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - Grade 3-5 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - ALLERGIC GRANULOMATOUS ANGIITIS - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - DYSPHONIA - - Any Grade - 0 0 1 (1.0%) - Grade 3-5 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - EMPHYSEMA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - HAEMOPTYSIS - - Any Grade - 1 (1.2%) 0 0 - Grade 3-5 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - PHARYNGEAL ERYTHEMA - - Any Grade - 0 1 (1.4%) 0 - Grade 3-5 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - POSTNASAL DRIP - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - PRODUCTIVE COUGH - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - RALES - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - RESPIRATORY TRACT CONGESTION - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - PSYCHIATRIC DISORDERS - - Overall - - - Any Grade - 10 (11.6%) 8 (11.1%) 11 (11.5%) - Grade 1-2 10 (11.6%) 8 (11.1%) 9 (9.4%) - 1 9 (10.5%) 6 (8.3%) 6 (6.2%) - 2 1 (1.2%) 2 (2.8%) 3 (3.1%) - Grade 3-5 0 0 2 (2.1%) - 3 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - CONFUSIONAL STATE - - Any Grade - 2 (2.3%) 1 (1.4%) 3 (3.1%) - Grade 1-2 2 (2.3%) 1 (1.4%) 2 (2.1%) - 1 2 (2.3%) 1 (1.4%) 2 (2.1%) - Grade 3-5 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - AGITATION - - Any Grade - 2 (2.3%) 0 3 (3.1%) - Grade 1-2 2 (2.3%) 0 3 (3.1%) - 1 2 (2.3%) 0 1 (1.0%) - 2 0 0 2 (2.1%) - ANXIETY - - Any Grade - 1 (1.2%) 0 3 (3.1%) - Grade 1-2 1 (1.2%) 0 3 (3.1%) - 1 0 0 3 (3.1%) - 2 1 (1.2%) 0 0 - INSOMNIA - - Any Grade - 2 (2.3%) 2 (2.8%) 0 - Grade 1-2 2 (2.3%) 2 (2.8%) 0 - 1 2 (2.3%) 2 (2.8%) 0 - DELUSION - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 1 1 (1.2%) 1 (1.4%) 0 - DEPRESSED MOOD - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - IRRITABILITY - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 2 1 (1.2%) 0 1 (1.0%) - COMPLETED SUICIDE - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - DELIRIUM - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - DISORIENTATION - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - HALLUCINATION - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - HALLUCINATION, VISUAL - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - LIBIDO DECREASED - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - LISTLESS - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - NIGHTMARE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - RESTLESSNESS - - Any Grade - 0 0 1 (1.0%) - Grade 3-5 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - INVESTIGATIONS - - Overall - - - Any Grade - 10 (11.6%) 5 (6.9%) 8 (8.3%) - Grade 1-2 8 (9.3%) 3 (4.2%) 7 (7.3%) - 1 6 (7.0%) 2 (2.8%) 5 (5.2%) - 2 2 (2.3%) 1 (1.4%) 2 (2.1%) - Grade 3-5 2 (2.3%) 2 (2.8%) 1 (1.0%) - 3 1 (1.2%) 1 (1.4%) 0 - 4 1 (1.2%) 1 (1.4%) 1 (1.0%) - ELECTROCARDIOGRAM ST SEGMENT DEPRESSION - - Any Grade - 4 (4.7%) 0 1 (1.0%) - Grade 1-2 4 (4.7%) 0 1 (1.0%) - 1 3 (3.5%) 0 0 - 2 1 (1.2%) 0 1 (1.0%) - ELECTROCARDIOGRAM T WAVE INVERSION - - Any Grade - 2 (2.3%) 1 (1.4%) 1 (1.0%) - Grade 1-2 2 (2.3%) 1 (1.4%) 1 (1.0%) - 1 1 (1.2%) 0 1 (1.0%) - 2 1 (1.2%) 1 (1.4%) 0 - BLOOD GLUCOSE INCREASED - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - Grade 3-5 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 1 1 (1.2%) 0 0 - 2 0 0 1 (1.0%) - BIOPSY - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - BIOPSY PROSTATE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - BLOOD ALKALINE PHOSPHATASE INCREASED - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - BLOOD CHOLESTEROL INCREASED - - Any Grade - 0 1 (1.4%) 0 - Grade 3-5 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - BLOOD CREATINE PHOSPHOKINASE INCREASED - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - BLOOD URINE PRESENT - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - BODY TEMPERATURE INCREASED - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - CYSTOSCOPY - - Any Grade - 1 (1.2%) 0 0 - Grade 3-5 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - HEART RATE INCREASED - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - HEART RATE IRREGULAR - - Any Grade - 1 (1.2%) 0 0 - Grade 3-5 1 (1.2%) 0 0 - 4 1 (1.2%) 0 0 - NASAL MUCOSA BIOPSY - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - NEUTROPHIL COUNT INCREASED - - Any Grade - 0 0 1 (1.0%) - Grade 3-5 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - URINE ANALYSIS ABNORMAL - - Any Grade - 0 0 1 (1.0%) - Grade 3-5 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - WEIGHT DECREASED - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - WHITE BLOOD CELL COUNT INCREASED - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS - - Overall - - - Any Grade - 5 (5.8%) 8 (11.1%) 7 (7.3%) - Grade 1-2 4 (4.7%) 7 (9.7%) 7 (7.3%) - 1 2 (2.3%) 6 (8.3%) 5 (5.2%) - 2 2 (2.3%) 1 (1.4%) 2 (2.1%) - Grade 3-5 1 (1.2%) 1 (1.4%) 0 - 3 1 (1.2%) 1 (1.4%) 0 - BACK PAIN - - Any Grade - 1 (1.2%) 3 (4.2%) 1 (1.0%) - Grade 1-2 1 (1.2%) 3 (4.2%) 1 (1.0%) - 1 0 3 (4.2%) 0 - 2 1 (1.2%) 0 1 (1.0%) - ARTHRALGIA - - Any Grade - 1 (1.2%) 1 (1.4%) 2 (2.1%) - Grade 1-2 1 (1.2%) 1 (1.4%) 2 (2.1%) - 1 0 1 (1.4%) 2 (2.1%) - 2 1 (1.2%) 0 0 - SHOULDER PAIN - - Any Grade - 1 (1.2%) 0 2 (2.1%) - Grade 1-2 1 (1.2%) 0 2 (2.1%) - 1 1 (1.2%) 0 2 (2.1%) - ARTHRITIS - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - Grade 3-5 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - FLANK PAIN - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 1 0 2 (2.8%) 0 - MUSCLE SPASMS - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 1 (1.4%) 0 - MUSCULAR WEAKNESS - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - MYALGIA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - PAIN IN EXTREMITY - - Any Grade - 1 (1.2%) 0 0 - Grade 3-5 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - INJURY, POISONING AND PROCEDURAL COMPLICATIONS - - Overall - - - Any Grade - 4 (4.7%) 5 (6.9%) 5 (5.2%) - Grade 1-2 4 (4.7%) 4 (5.6%) 5 (5.2%) - 1 2 (2.3%) 3 (4.2%) 4 (4.2%) - 2 2 (2.3%) 1 (1.4%) 1 (1.0%) - Grade 3-5 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - CONTUSION - - Any Grade - 1 (1.2%) 2 (2.8%) 1 (1.0%) - Grade 1-2 1 (1.2%) 2 (2.8%) 1 (1.0%) - 1 1 (1.2%) 2 (2.8%) 1 (1.0%) - EXCORIATION - - Any Grade - 2 (2.3%) 1 (1.4%) 1 (1.0%) - Grade 1-2 2 (2.3%) 1 (1.4%) 1 (1.0%) - 1 2 (2.3%) 1 (1.4%) 1 (1.0%) - FALL - - Any Grade - 1 (1.2%) 1 (1.4%) 2 (2.1%) - Grade 1-2 1 (1.2%) 0 2 (2.1%) - 1 0 0 2 (2.1%) - 2 1 (1.2%) 0 0 - Grade 3-5 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - HIP FRACTURE - - Any Grade - 1 (1.2%) 2 (2.8%) 0 - Grade 1-2 1 (1.2%) 2 (2.8%) 0 - 1 1 (1.2%) 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - SKIN LACERATION - - Any Grade - 1 (1.2%) 0 2 (2.1%) - Grade 1-2 1 (1.2%) 0 2 (2.1%) - 1 0 0 1 (1.0%) - 2 1 (1.2%) 0 1 (1.0%) - FACIAL BONES FRACTURE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - JOINT DISLOCATION - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - WOUND - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - RENAL AND URINARY DISORDERS - - Overall - - - Any Grade - 4 (4.7%) 3 (4.2%) 4 (4.2%) - Grade 1-2 4 (4.7%) 3 (4.2%) 3 (3.1%) - 1 2 (2.3%) 2 (2.8%) 2 (2.1%) - 2 2 (2.3%) 1 (1.4%) 1 (1.0%) - Grade 3-5 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - MICTURITION URGENCY - - Any Grade - 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 1-2 1 (1.2%) 1 (1.4%) 1 (1.0%) - 1 1 (1.2%) 0 0 - 2 0 1 (1.4%) 1 (1.0%) - DYSURIA - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 1 1 (1.2%) 0 1 (1.0%) - NEPHROLITHIASIS - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 1 (1.2%) 0 0 - CALCULUS URETHRAL - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - ENURESIS - - Any Grade - 0 0 1 (1.0%) - Grade 3-5 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - INCONTINENCE - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - POLLAKIURIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - METABOLISM AND NUTRITION DISORDERS - - Overall - - - Any Grade - 6 (7.0%) 3 (4.2%) 1 (1.0%) - Grade 1-2 5 (5.8%) 2 (2.8%) 1 (1.0%) - 1 1 (1.2%) 2 (2.8%) 1 (1.0%) - 2 4 (4.7%) 0 0 - Grade 3-5 1 (1.2%) 1 (1.4%) 0 - 3 1 (1.2%) 0 0 - 4 0 1 (1.4%) 0 - DECREASED APPETITE - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 1 (1.2%) 0 0 - FOOD CRAVING - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - Grade 3-5 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - INCREASED APPETITE - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 1 (1.2%) 0 0 - DEHYDRATION - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - DIABETES MELLITUS - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - HYPERCHOLESTEROLAEMIA - - Any Grade - 0 1 (1.4%) 0 - Grade 3-5 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - HYPONATRAEMIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - VASCULAR DISORDERS - - Overall - - - Any Grade - 3 (3.5%) 1 (1.4%) 4 (4.2%) - Grade 1-2 2 (2.3%) 1 (1.4%) 3 (3.1%) - 1 2 (2.3%) 1 (1.4%) 1 (1.0%) - 2 0 0 2 (2.1%) - Grade 3-5 1 (1.2%) 0 1 (1.0%) - 4 1 (1.2%) 0 1 (1.0%) - HYPERTENSION - - Any Grade - 1 (1.2%) 0 2 (2.1%) - Grade 1-2 1 (1.2%) 0 2 (2.1%) - 1 1 (1.2%) 0 1 (1.0%) - 2 0 0 1 (1.0%) - HYPOTENSION - - Any Grade - 2 (2.3%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 1 1 (1.2%) 0 0 - 2 0 0 1 (1.0%) - Grade 3-5 1 (1.2%) 0 0 - 4 1 (1.2%) 0 0 - HOT FLUSH - - Any Grade - 0 0 1 (1.0%) - Grade 3-5 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - ORTHOSTATIC HYPOTENSION - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - WOUND HAEMORRHAGE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - EYE DISORDERS - - Overall - - - Any Grade - 4 (4.7%) 1 (1.4%) 2 (2.1%) - Grade 1-2 2 (2.3%) 1 (1.4%) 2 (2.1%) - 1 0 1 (1.4%) 2 (2.1%) - 2 2 (2.3%) 0 0 - Grade 3-5 2 (2.3%) 0 0 - 4 2 (2.3%) 0 0 - CONJUNCTIVITIS - - Any Grade - 2 (2.3%) 0 0 - Grade 3-5 2 (2.3%) 0 0 - 4 2 (2.3%) 0 0 - VISION BLURRED - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - CONJUNCTIVAL HAEMORRHAGE - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - EYE ALLERGY - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - EYE PRURITUS - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - EYE SWELLING - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - GLAUCOMA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - SURGICAL AND MEDICAL PROCEDURES - - Overall - - - Any Grade - 2 (2.3%) 2 (2.8%) 1 (1.0%) - Grade 1-2 1 (1.2%) 2 (2.8%) 1 (1.0%) - 1 1 (1.2%) 1 (1.4%) 1 (1.0%) - 2 0 1 (1.4%) 0 - Grade 3-5 1 (1.2%) 0 0 - 4 1 (1.2%) 0 0 - CATARACT OPERATION - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - Grade 3-5 1 (1.2%) 0 0 - 4 1 (1.2%) 0 0 - ACROCHORDON EXCISION - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - EYE LASER SURGERY - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - SKIN LESION EXCISION - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - EAR AND LABYRINTH DISORDERS - - Overall - - - Any Grade - 1 (1.2%) 1 (1.4%) 2 (2.1%) - Grade 1-2 1 (1.2%) 1 (1.4%) 2 (2.1%) - 1 1 (1.2%) 1 (1.4%) 2 (2.1%) - VERTIGO - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - CERUMEN IMPACTION - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - EAR PAIN - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - TINNITUS - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - CONGENITAL, FAMILIAL AND GENETIC DISORDERS - - Overall - - - Any Grade - 0 2 (2.8%) 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - Grade 3-5 0 2 (2.8%) 0 - 3 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - VENTRICULAR SEPTAL DEFECT - - Any Grade - 0 2 (2.8%) 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - Grade 3-5 0 2 (2.8%) 0 - 3 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - - Overall - - - Any Grade - 0 1 (1.4%) 2 (2.1%) - Grade 1-2 0 1 (1.4%) 2 (2.1%) - 1 0 1 (1.4%) 1 (1.0%) - 2 0 0 1 (1.0%) - COLON CANCER - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - MALIGNANT FIBROUS HISTIOCYTOMA - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - PROSTATE CANCER - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - REPRODUCTIVE SYSTEM AND BREAST DISORDERS - - Overall - - - Any Grade - 2 (2.3%) 1 (1.4%) 0 - Grade 1-2 2 (2.3%) 1 (1.4%) 0 - 1 2 (2.3%) 0 0 - 2 0 1 (1.4%) 0 - BENIGN PROSTATIC HYPERPLASIA - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 1 1 (1.2%) 0 0 - 2 0 1 (1.4%) 0 - PELVIC PAIN - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - IMMUNE SYSTEM DISORDERS - - Overall - - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 0 - 2 0 0 1 (1.0%) - HYPERSENSITIVITY - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - SEASONAL ALLERGY - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - HEPATOBILIARY DISORDERS - - Overall - - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - HYPERBILIRUBINAEMIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - SOCIAL CIRCUMSTANCES - - Overall - - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - ALCOHOL USE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 + MedDRA System Organ Class + MedDRA Preferred Term Placebo Xanomeline High Dose Xanomeline Low Dose + Grade (N=86) (N=72) (N=96) + —————————————————————————————————————————————————————————————————————————————————————————————————————————————— + - Any adverse events - + - Any Grade - 23 (26.7%) 51 (70.8%) 54 (56.2%) + Grade 1-2 17 (19.8%) 42 (58.3%) 43 (44.8%) + 1 11 (12.8%) 26 (36.1%) 28 (29.2%) + 2 6 (7.0%) 16 (22.2%) 15 (15.6%) + Grade 3-5 6 (7.0%) 9 (12.5%) 11 (11.5%) + 3 2 (2.3%) 4 (5.6%) 5 (5.2%) + 4 4 (4.7%) 5 (6.9%) 5 (5.2%) + 5 0 0 1 (1.0%) + SKIN AND SUBCUTANEOUS TISSUE DISORDERS + - Overall - + - Any Grade - 17 (19.8%) 32 (44.4%) 31 (32.3%) + Grade 1-2 13 (15.1%) 26 (36.1%) 25 (26.0%) + 1 10 (11.6%) 18 (25.0%) 15 (15.6%) + 2 3 (3.5%) 8 (11.1%) 10 (10.4%) + Grade 3-5 4 (4.7%) 6 (8.3%) 6 (6.2%) + 3 2 (2.3%) 3 (4.2%) 3 (3.1%) + 4 2 (2.3%) 3 (4.2%) 2 (2.1%) + 5 0 0 1 (1.0%) + PRURITUS + - Any Grade - 8 (9.3%) 26 (36.1%) 23 (24.0%) + Grade 1-2 5 (5.8%) 20 (27.8%) 21 (21.9%) + 1 4 (4.7%) 15 (20.8%) 14 (14.6%) + 2 1 (1.2%) 5 (6.9%) 7 (7.3%) + Grade 3-5 3 (3.5%) 6 (8.3%) 2 (2.1%) + 3 1 (1.2%) 3 (4.2%) 1 (1.0%) + 4 2 (2.3%) 3 (4.2%) 0 + 5 0 0 1 (1.0%) + ERYTHEMA + - Any Grade - 9 (10.5%) 14 (19.4%) 15 (15.6%) + Grade 1-2 9 (10.5%) 14 (19.4%) 13 (13.5%) + 1 8 (9.3%) 12 (16.7%) 8 (8.3%) + 2 1 (1.2%) 2 (2.8%) 5 (5.2%) + Grade 3-5 0 0 2 (2.1%) + 3 0 0 1 (1.0%) + 4 0 0 1 (1.0%) + RASH + - Any Grade - 5 (5.8%) 11 (15.3%) 13 (13.5%) + Grade 1-2 4 (4.7%) 10 (13.9%) 11 (11.5%) + 1 3 (3.5%) 7 (9.7%) 10 (10.4%) + 2 1 (1.2%) 3 (4.2%) 1 (1.0%) + Grade 3-5 1 (1.2%) 1 (1.4%) 2 (2.1%) + 3 1 (1.2%) 1 (1.4%) 1 (1.0%) + 4 0 0 1 (1.0%) + GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS + - Overall - + - Any Grade - 8 (9.3%) 24 (33.3%) 25 (26.0%) + Grade 1-2 6 (7.0%) 20 (27.8%) 20 (20.8%) + 1 3 (3.5%) 10 (13.9%) 14 (14.6%) + 2 3 (3.5%) 10 (13.9%) 6 (6.2%) + Grade 3-5 2 (2.3%) 4 (5.6%) 5 (5.2%) + 3 0 2 (2.8%) 2 (2.1%) + 4 2 (2.3%) 2 (2.8%) 3 (3.1%) + APPLICATION SITE PRURITUS + - Any Grade - 6 (7.0%) 21 (29.2%) 23 (24.0%) + Grade 1-2 4 (4.7%) 19 (26.4%) 20 (20.8%) + 1 2 (2.3%) 11 (15.3%) 16 (16.7%) + 2 2 (2.3%) 8 (11.1%) 4 (4.2%) + Grade 3-5 2 (2.3%) 2 (2.8%) 3 (3.1%) + 3 0 0 1 (1.0%) + 4 2 (2.3%) 2 (2.8%) 2 (2.1%) + APPLICATION SITE ERYTHEMA + - Any Grade - 3 (3.5%) 14 (19.4%) 13 (13.5%) + Grade 1-2 3 (3.5%) 12 (16.7%) 11 (11.5%) + 1 2 (2.3%) 10 (13.9%) 8 (8.3%) + 2 1 (1.2%) 2 (2.8%) 3 (3.1%) + Grade 3-5 0 2 (2.8%) 2 (2.1%) + 3 0 2 (2.8%) 1 (1.0%) + 4 0 0 1 (1.0%) # AET04 variant 6 is produced correctly (with an Incidence Rate of at Least 5%, totals restricted) Code res Output - MedDRA System Organ Class - MedDRA Preferred Term Placebo Xanomeline High Dose Xanomeline Low Dose - Grade (N=86) (N=72) (N=96) - ————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— - - Any adverse events - - - Any Grade - 69 (80.2%) 70 (97.2%) 86 (89.6%) - Grade 1-2 46 (53.5%) 37 (51.4%) 54 (56.2%) - 1 22 (25.6%) 18 (25.0%) 19 (19.8%) - 2 24 (27.9%) 19 (26.4%) 35 (36.5%) - Grade 3-4 20 (23.3%) 32 (44.4%) 30 (31.2%) - 3 8 (9.3%) 16 (22.2%) 11 (11.5%) - 4 12 (14.0%) 16 (22.2%) 19 (19.8%) - Grade 5 3 (3.5%) 1 (1.4%) 2 (2.1%) - GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - - Overall - - - Any Grade - 21 (24.4%) 36 (50.0%) 51 (53.1%) - Grade 1-2 17 (19.8%) 28 (38.9%) 40 (41.7%) - 1 10 (11.6%) 15 (20.8%) 20 (20.8%) - 2 7 (8.1%) 13 (18.1%) 20 (20.8%) - Grade 3-4 4 (4.7%) 8 (11.1%) 11 (11.5%) - 3 2 (2.3%) 3 (4.2%) 6 (6.2%) - 4 2 (2.3%) 5 (6.9%) 5 (5.2%) - APPLICATION SITE PRURITUS - - Any Grade - 6 (7.0%) 21 (29.2%) 23 (24.0%) - Grade 1-2 4 (4.7%) 19 (26.4%) 20 (20.8%) - 1 2 (2.3%) 11 (15.3%) 16 (16.7%) - 2 2 (2.3%) 8 (11.1%) 4 (4.2%) - Grade 3-4 2 (2.3%) 2 (2.8%) 3 (3.1%) - 3 0 0 1 (1.0%) - 4 2 (2.3%) 2 (2.8%) 2 (2.1%) - APPLICATION SITE ERYTHEMA - - Any Grade - 3 (3.5%) 14 (19.4%) 13 (13.5%) - Grade 1-2 3 (3.5%) 12 (16.7%) 11 (11.5%) - 1 2 (2.3%) 10 (13.9%) 8 (8.3%) - 2 1 (1.2%) 2 (2.8%) 3 (3.1%) - Grade 3-4 0 2 (2.8%) 2 (2.1%) - 3 0 2 (2.8%) 1 (1.0%) - 4 0 0 1 (1.0%) - APPLICATION SITE DERMATITIS - - Any Grade - 5 (5.8%) 7 (9.7%) 9 (9.4%) - Grade 1-2 4 (4.7%) 6 (8.3%) 8 (8.3%) - 1 3 (3.5%) 3 (4.2%) 4 (4.2%) - 2 1 (1.2%) 3 (4.2%) 4 (4.2%) - Grade 3-4 1 (1.2%) 1 (1.4%) 1 (1.0%) - 3 1 (1.2%) 1 (1.4%) 1 (1.0%) - APPLICATION SITE IRRITATION - - Any Grade - 3 (3.5%) 9 (12.5%) 9 (9.4%) - Grade 1-2 2 (2.3%) 8 (11.1%) 6 (6.2%) - 1 2 (2.3%) 6 (8.3%) 3 (3.1%) - 2 0 2 (2.8%) 3 (3.1%) - Grade 3-4 1 (1.2%) 1 (1.4%) 3 (3.1%) - 3 1 (1.2%) 0 1 (1.0%) - 4 0 1 (1.4%) 2 (2.1%) - APPLICATION SITE VESICLES - - Any Grade - 1 (1.2%) 5 (6.9%) 5 (5.2%) - Grade 1-2 1 (1.2%) 4 (5.6%) 5 (5.2%) - 1 0 3 (4.2%) 4 (4.2%) - 2 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 3-4 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - FATIGUE - - Any Grade - 1 (1.2%) 5 (6.9%) 5 (5.2%) - Grade 1-2 1 (1.2%) 4 (5.6%) 5 (5.2%) - 1 0 3 (4.2%) 3 (3.1%) - 2 1 (1.2%) 1 (1.4%) 2 (2.1%) - Grade 3-4 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - OEDEMA PERIPHERAL - - Any Grade - 2 (2.3%) 2 (2.8%) 1 (1.0%) - Grade 1-2 1 (1.2%) 2 (2.8%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - 2 1 (1.2%) 1 (1.4%) 0 - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - APPLICATION SITE SWELLING - - Any Grade - 0 2 (2.8%) 1 (1.0%) - Grade 1-2 0 2 (2.8%) 1 (1.0%) - 1 0 2 (2.8%) 1 (1.0%) - APPLICATION SITE URTICARIA - - Any Grade - 0 1 (1.4%) 2 (2.1%) - Grade 1-2 0 1 (1.4%) 2 (2.1%) - 1 0 1 (1.4%) 1 (1.0%) - 2 0 0 1 (1.0%) - CHILLS - - Any Grade - 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 1-2 1 (1.2%) 1 (1.4%) 1 (1.0%) - 1 1 (1.2%) 1 (1.4%) 0 - 2 0 0 1 (1.0%) - MALAISE - - Any Grade - 0 2 (2.8%) 1 (1.0%) - Grade 1-2 0 2 (2.8%) 1 (1.0%) - 1 0 1 (1.4%) 0 - 2 0 1 (1.4%) 1 (1.0%) - PYREXIA - - Any Grade - 2 (2.3%) 0 1 (1.0%) - Grade 1-2 2 (2.3%) 0 1 (1.0%) - 1 1 (1.2%) 0 1 (1.0%) - 2 1 (1.2%) 0 0 - APPLICATION SITE PAIN - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 1 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - APPLICATION SITE PERSPIRATION - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 2 0 2 (2.8%) 0 - APPLICATION SITE REACTION - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 1 1 (1.2%) 1 (1.4%) 0 - ASTHENIA - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 1 1 (1.2%) 0 0 - 2 0 0 1 (1.0%) - CHEST DISCOMFORT - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 0 - 2 0 0 1 (1.0%) - CHEST PAIN - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 1 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - OEDEMA - - Any Grade - 0 0 2 (2.1%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - PAIN - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - APPLICATION SITE BLEEDING - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - APPLICATION SITE DESQUAMATION - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - APPLICATION SITE DISCHARGE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - APPLICATION SITE DISCOLOURATION - - Any Grade - 0 0 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - APPLICATION SITE INDURATION - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - APPLICATION SITE WARMTH - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - CYST - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - FEELING ABNORMAL - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - FEELING COLD - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - INFLAMMATION - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - SECRETION DISCHARGE - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - SUDDEN DEATH - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - SWELLING - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - ULCER - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - SKIN AND SUBCUTANEOUS TISSUE DISORDERS - - Overall - - - Any Grade - 21 (24.4%) 42 (58.3%) 42 (43.8%) - Grade 1-2 17 (19.8%) 33 (45.8%) 33 (34.4%) - 1 11 (12.8%) 20 (27.8%) 17 (17.7%) - 2 6 (7.0%) 13 (18.1%) 16 (16.7%) - Grade 3-4 4 (4.7%) 9 (12.5%) 7 (7.3%) - 3 2 (2.3%) 4 (5.6%) 4 (4.2%) - 4 2 (2.3%) 5 (6.9%) 3 (3.1%) - Grade 5 0 0 2 (2.1%) - PRURITUS - - Any Grade - 8 (9.3%) 26 (36.1%) 23 (24.0%) - Grade 1-2 5 (5.8%) 20 (27.8%) 21 (21.9%) - 1 4 (4.7%) 15 (20.8%) 14 (14.6%) - 2 1 (1.2%) 5 (6.9%) 7 (7.3%) - Grade 3-4 3 (3.5%) 6 (8.3%) 1 (1.0%) - 3 1 (1.2%) 3 (4.2%) 1 (1.0%) - 4 2 (2.3%) 3 (4.2%) 0 - Grade 5 0 0 1 (1.0%) - ERYTHEMA - - Any Grade - 9 (10.5%) 14 (19.4%) 15 (15.6%) - Grade 1-2 9 (10.5%) 14 (19.4%) 13 (13.5%) - 1 8 (9.3%) 12 (16.7%) 8 (8.3%) - 2 1 (1.2%) 2 (2.8%) 5 (5.2%) - Grade 3-4 0 0 2 (2.1%) - 3 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - RASH - - Any Grade - 5 (5.8%) 11 (15.3%) 13 (13.5%) - Grade 1-2 4 (4.7%) 10 (13.9%) 11 (11.5%) - 1 3 (3.5%) 7 (9.7%) 10 (10.4%) - 2 1 (1.2%) 3 (4.2%) 1 (1.0%) - Grade 3-4 1 (1.2%) 1 (1.4%) 2 (2.1%) - 3 1 (1.2%) 1 (1.4%) 1 (1.0%) - 4 0 0 1 (1.0%) - HYPERHIDROSIS - - Any Grade - 2 (2.3%) 8 (11.1%) 4 (4.2%) - Grade 1-2 2 (2.3%) 7 (9.7%) 4 (4.2%) - 1 0 5 (6.9%) 4 (4.2%) - 2 2 (2.3%) 2 (2.8%) 0 - Grade 3-4 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - SKIN IRRITATION - - Any Grade - 3 (3.5%) 5 (6.9%) 6 (6.2%) - Grade 1-2 3 (3.5%) 5 (6.9%) 4 (4.2%) - 1 1 (1.2%) 3 (4.2%) 3 (3.1%) - 2 2 (2.3%) 2 (2.8%) 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - Grade 5 0 0 1 (1.0%) - BLISTER - - Any Grade - 0 1 (1.4%) 5 (5.2%) - Grade 1-2 0 1 (1.4%) 5 (5.2%) - 1 0 1 (1.4%) 4 (4.2%) - 2 0 0 1 (1.0%) - RASH PRURITIC - - Any Grade - 0 2 (2.8%) 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - Grade 3-4 0 2 (2.8%) 0 - 3 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - PRURITUS GENERALISED - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 0 - 2 0 0 1 (1.0%) - RASH ERYTHEMATOUS - - Any Grade - 0 0 2 (2.1%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - URTICARIA - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - ACTINIC KERATOSIS - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - ALOPECIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - COLD SWEAT - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - DERMATITIS ATOPIC - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - DERMATITIS CONTACT - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - DRUG ERUPTION - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - RASH MACULO-PAPULAR - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - RASH PAPULAR - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - SKIN EXFOLIATION - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - SKIN ODOUR ABNORMAL - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - SKIN ULCER - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - NERVOUS SYSTEM DISORDERS - - Overall - - - Any Grade - 12 (14.0%) 25 (34.7%) 22 (22.9%) - Grade 1-2 10 (11.6%) 22 (30.6%) 19 (19.8%) - 1 7 (8.1%) 16 (22.2%) 13 (13.5%) - 2 3 (3.5%) 6 (8.3%) 6 (6.2%) - Grade 3-4 1 (1.2%) 3 (4.2%) 3 (3.1%) - 3 0 1 (1.4%) 1 (1.0%) - 4 1 (1.2%) 2 (2.8%) 2 (2.1%) - Grade 5 1 (1.2%) 0 0 - DIZZINESS - - Any Grade - 2 (2.3%) 11 (15.3%) 9 (9.4%) - Grade 1-2 2 (2.3%) 9 (12.5%) 8 (8.3%) - 1 1 (1.2%) 9 (12.5%) 5 (5.2%) - 2 1 (1.2%) 0 3 (3.1%) - Grade 3-4 0 2 (2.8%) 1 (1.0%) - 3 0 0 1 (1.0%) - 4 0 2 (2.8%) 0 - HEADACHE - - Any Grade - 7 (8.1%) 6 (8.3%) 3 (3.1%) - Grade 1-2 6 (7.0%) 6 (8.3%) 3 (3.1%) - 1 5 (5.8%) 3 (4.2%) 2 (2.1%) - 2 1 (1.2%) 3 (4.2%) 1 (1.0%) - Grade 3-4 1 (1.2%) 0 0 - 4 1 (1.2%) 0 0 - SYNCOPE - - Any Grade - 0 2 (2.8%) 5 (5.2%) - Grade 1-2 0 2 (2.8%) 5 (5.2%) - 1 0 2 (2.8%) 5 (5.2%) - SOMNOLENCE - - Any Grade - 2 (2.3%) 1 (1.4%) 3 (3.1%) - Grade 1-2 2 (2.3%) 1 (1.4%) 2 (2.1%) - 1 1 (1.2%) 1 (1.4%) 2 (2.1%) - 2 1 (1.2%) 0 0 - Grade 3-4 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - TRANSIENT ISCHAEMIC ATTACK - - Any Grade - 0 1 (1.4%) 2 (2.1%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 2 0 1 (1.4%) 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - BURNING SENSATION - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 1 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - LETHARGY - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - AMNESIA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - BALANCE DISORDER - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - COGNITIVE DISORDER - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - COMPLEX PARTIAL SEIZURES - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - COORDINATION ABNORMAL - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - HEMIANOPIA HOMONYMOUS - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - HYPERSOMNIA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - PARAESTHESIA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - PARAESTHESIA ORAL - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - PARKINSON'S DISEASE - - Any Grade - 1 (1.2%) 0 0 - Grade 5 1 (1.2%) 0 0 - PAROSMIA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - PARTIAL SEIZURES WITH SECONDARY GENERALISATION - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - PSYCHOMOTOR HYPERACTIVITY - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - STUPOR - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - SYNCOPE VASOVAGAL - - Any Grade - 0 1 (1.4%) 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - GASTROINTESTINAL DISORDERS - - Overall - - - Any Grade - 17 (19.8%) 20 (27.8%) 16 (16.7%) - Grade 1-2 14 (16.3%) 17 (23.6%) 12 (12.5%) - 1 9 (10.5%) 12 (16.7%) 10 (10.4%) - 2 5 (5.8%) 5 (6.9%) 2 (2.1%) - Grade 3-4 2 (2.3%) 2 (2.8%) 4 (4.2%) - 3 0 2 (2.8%) 0 - 4 2 (2.3%) 0 4 (4.2%) - Grade 5 1 (1.2%) 1 (1.4%) 0 - DIARRHOEA - - Any Grade - 9 (10.5%) 3 (4.2%) 6 (6.2%) - Grade 1-2 8 (9.3%) 3 (4.2%) 4 (4.2%) - 1 7 (8.1%) 3 (4.2%) 3 (3.1%) - 2 1 (1.2%) 0 1 (1.0%) - Grade 3-4 1 (1.2%) 0 2 (2.1%) - 4 1 (1.2%) 0 2 (2.1%) - VOMITING - - Any Grade - 3 (3.5%) 6 (8.3%) 4 (4.2%) - Grade 1-2 2 (2.3%) 6 (8.3%) 4 (4.2%) - 1 0 4 (5.6%) 3 (3.1%) - 2 2 (2.3%) 2 (2.8%) 1 (1.0%) - Grade 5 1 (1.2%) 0 0 - NAUSEA - - Any Grade - 3 (3.5%) 6 (8.3%) 3 (3.1%) - Grade 1-2 3 (3.5%) 3 (4.2%) 2 (2.1%) - 1 2 (2.3%) 2 (2.8%) 1 (1.0%) - 2 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 3-4 0 2 (2.8%) 1 (1.0%) - 3 0 2 (2.8%) 0 - 4 0 0 1 (1.0%) - Grade 5 0 1 (1.4%) 0 - ABDOMINAL PAIN - - Any Grade - 1 (1.2%) 1 (1.4%) 3 (3.1%) - Grade 1-2 0 1 (1.4%) 2 (2.1%) - 1 0 1 (1.4%) 2 (2.1%) - Grade 3-4 1 (1.2%) 0 1 (1.0%) - 4 1 (1.2%) 0 1 (1.0%) - SALIVARY HYPERSECRETION - - Any Grade - 0 4 (5.6%) 0 - Grade 1-2 0 4 (5.6%) 0 - 1 0 2 (2.8%) 0 - 2 0 2 (2.8%) 0 - DYSPEPSIA - - Any Grade - 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 1-2 1 (1.2%) 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - 2 1 (1.2%) 0 0 - ABDOMINAL DISCOMFORT - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - CONSTIPATION - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - DYSPHAGIA - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - FLATULENCE - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - GASTROINTESTINAL HAEMORRHAGE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - GASTROOESOPHAGEAL REFLUX DISEASE - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - GLOSSITIS - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - HIATUS HERNIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - RECTAL HAEMORRHAGE - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - STOMACH DISCOMFORT - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - CARDIAC DISORDERS - - Overall - - - Any Grade - 13 (15.1%) 15 (20.8%) 16 (16.7%) - Grade 1-2 9 (10.5%) 13 (18.1%) 15 (15.6%) - 1 5 (5.8%) 9 (12.5%) 12 (12.5%) - 2 4 (4.7%) 4 (5.6%) 3 (3.1%) - Grade 3-4 4 (4.7%) 2 (2.8%) 1 (1.0%) - 3 3 (3.5%) 2 (2.8%) 0 - 4 1 (1.2%) 0 1 (1.0%) - SINUS BRADYCARDIA - - Any Grade - 2 (2.3%) 8 (11.1%) 7 (7.3%) - Grade 1-2 2 (2.3%) 8 (11.1%) 7 (7.3%) - 1 1 (1.2%) 6 (8.3%) 7 (7.3%) - 2 1 (1.2%) 2 (2.8%) 0 - MYOCARDIAL INFARCTION - - Any Grade - 4 (4.7%) 4 (5.6%) 2 (2.1%) - Grade 1-2 3 (3.5%) 3 (4.2%) 2 (2.1%) - 1 1 (1.2%) 2 (2.8%) 2 (2.1%) - 2 2 (2.3%) 1 (1.4%) 0 - Grade 3-4 1 (1.2%) 1 (1.4%) 0 - 3 1 (1.2%) 1 (1.4%) 0 - ATRIAL FIBRILLATION - - Any Grade - 1 (1.2%) 2 (2.8%) 2 (2.1%) - Grade 1-2 1 (1.2%) 2 (2.8%) 2 (2.1%) - 1 1 (1.2%) 1 (1.4%) 2 (2.1%) - 2 0 1 (1.4%) 0 - ATRIOVENTRICULAR BLOCK SECOND DEGREE - - Any Grade - 2 (2.3%) 1 (1.4%) 2 (2.1%) - Grade 1-2 2 (2.3%) 1 (1.4%) 2 (2.1%) - 1 1 (1.2%) 1 (1.4%) 1 (1.0%) - 2 1 (1.2%) 0 1 (1.0%) - SUPRAVENTRICULAR EXTRASYSTOLES - - Any Grade - 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - Grade 3-4 0 1 (1.4%) 1 (1.0%) - 3 0 1 (1.4%) 0 - 4 0 0 1 (1.0%) - VENTRICULAR EXTRASYSTOLES - - Any Grade - 0 1 (1.4%) 2 (2.1%) - Grade 1-2 0 1 (1.4%) 2 (2.1%) - 1 0 1 (1.4%) 2 (2.1%) - ATRIAL FLUTTER - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 0 - 2 0 0 1 (1.0%) - ATRIOVENTRICULAR BLOCK FIRST DEGREE - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 1 1 (1.2%) 0 1 (1.0%) - BUNDLE BRANCH BLOCK RIGHT - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 1 0 0 1 (1.0%) - 2 1 (1.2%) 0 0 - PALPITATIONS - - Any Grade - 0 0 2 (2.1%) - Grade 1-2 0 0 2 (2.1%) - 1 0 0 2 (2.1%) - ATRIAL HYPERTROPHY - - Any Grade - 1 (1.2%) 0 0 - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - BRADYCARDIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - BUNDLE BRANCH BLOCK LEFT - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - CARDIAC DISORDER - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - CARDIAC FAILURE CONGESTIVE - - Any Grade - 1 (1.2%) 0 0 - Grade 3-4 1 (1.2%) 0 0 - 4 1 (1.2%) 0 0 - SINUS ARRHYTHMIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - SUPRAVENTRICULAR TACHYCARDIA - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - TACHYCARDIA - - Any Grade - 1 (1.2%) 0 0 - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - VENTRICULAR HYPERTROPHY - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - WOLFF-PARKINSON-WHITE SYNDROME - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - INFECTIONS AND INFESTATIONS - - Overall - - - Any Grade - 16 (18.6%) 13 (18.1%) 10 (10.4%) - Grade 1-2 14 (16.3%) 11 (15.3%) 9 (9.4%) - 1 6 (7.0%) 6 (8.3%) 4 (4.2%) - 2 8 (9.3%) 5 (6.9%) 5 (5.2%) - Grade 3-4 2 (2.3%) 2 (2.8%) 1 (1.0%) - 3 1 (1.2%) 1 (1.4%) 1 (1.0%) - 4 1 (1.2%) 1 (1.4%) 0 - NASOPHARYNGITIS - - Any Grade - 2 (2.3%) 6 (8.3%) 4 (4.2%) - Grade 1-2 2 (2.3%) 5 (6.9%) 3 (3.1%) - 1 2 (2.3%) 4 (5.6%) 2 (2.1%) - 2 0 1 (1.4%) 1 (1.0%) - Grade 3-4 0 1 (1.4%) 1 (1.0%) - 3 0 1 (1.4%) 1 (1.0%) - UPPER RESPIRATORY TRACT INFECTION - - Any Grade - 6 (7.0%) 3 (4.2%) 1 (1.0%) - Grade 1-2 5 (5.8%) 3 (4.2%) 1 (1.0%) - 1 1 (1.2%) 1 (1.4%) 0 - 2 4 (4.7%) 2 (2.8%) 1 (1.0%) - Grade 3-4 1 (1.2%) 0 0 - 4 1 (1.2%) 0 0 - INFLUENZA - - Any Grade - 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 1 (1.4%) 0 - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - URINARY TRACT INFECTION - - Any Grade - 2 (2.3%) 1 (1.4%) 0 - Grade 1-2 2 (2.3%) 1 (1.4%) 0 - 1 2 (2.3%) 1 (1.4%) 0 - CYSTITIS - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 2 1 (1.2%) 1 (1.4%) 0 - EAR INFECTION - - Any Grade - 2 (2.3%) 0 0 - Grade 1-2 2 (2.3%) 0 0 - 1 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - LOCALISED INFECTION - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 2 1 (1.2%) 0 1 (1.0%) - BRONCHITIS - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - CELLULITIS - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - CERVICITIS - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - GASTROENTERITIS VIRAL - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - HORDEOLUM - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - LOWER RESPIRATORY TRACT INFECTION - - Any Grade - 0 1 (1.4%) 0 - Grade 3-4 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - ONYCHOMYCOSIS - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - PNEUMONIA - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - RHINITIS - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - VAGINAL MYCOSIS - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - VIRAL INFECTION - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - - Overall - - - Any Grade - 10 (11.6%) 10 (13.9%) 10 (10.4%) - Grade 1-2 8 (9.3%) 6 (8.3%) 7 (7.3%) - 1 5 (5.8%) 4 (5.6%) 6 (6.2%) - 2 3 (3.5%) 2 (2.8%) 1 (1.0%) - Grade 3-4 1 (1.2%) 4 (5.6%) 3 (3.1%) - 3 1 (1.2%) 3 (4.2%) 2 (2.1%) - 4 0 1 (1.4%) 1 (1.0%) - Grade 5 1 (1.2%) 0 0 - COUGH - - Any Grade - 3 (3.5%) 5 (6.9%) 6 (6.2%) - Grade 1-2 2 (2.3%) 3 (4.2%) 4 (4.2%) - 1 1 (1.2%) 2 (2.8%) 3 (3.1%) - 2 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 3-4 0 2 (2.8%) 2 (2.1%) - 3 0 2 (2.8%) 1 (1.0%) - 4 0 0 1 (1.0%) - Grade 5 1 (1.2%) 0 0 - NASAL CONGESTION - - Any Grade - 3 (3.5%) 3 (4.2%) 1 (1.0%) - Grade 1-2 3 (3.5%) 3 (4.2%) 1 (1.0%) - 1 1 (1.2%) 3 (4.2%) 1 (1.0%) - 2 2 (2.3%) 0 0 - DYSPNOEA - - Any Grade - 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 1-2 1 (1.2%) 1 (1.4%) 1 (1.0%) - 1 1 (1.2%) 1 (1.4%) 1 (1.0%) - EPISTAXIS - - Any Grade - 0 2 (2.8%) 1 (1.0%) - Grade 1-2 0 2 (2.8%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - 2 0 1 (1.4%) 0 - PHARYNGOLARYNGEAL PAIN - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 1 (1.4%) 0 - RHINORRHOEA - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - Grade 3-4 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - ALLERGIC GRANULOMATOUS ANGIITIS - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - DYSPHONIA - - Any Grade - 0 0 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - EMPHYSEMA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - HAEMOPTYSIS - - Any Grade - 1 (1.2%) 0 0 - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - PHARYNGEAL ERYTHEMA - - Any Grade - 0 1 (1.4%) 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - POSTNASAL DRIP - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - PRODUCTIVE COUGH - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - RALES - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - RESPIRATORY TRACT CONGESTION - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - PSYCHIATRIC DISORDERS - - Overall - - - Any Grade - 10 (11.6%) 8 (11.1%) 11 (11.5%) - Grade 1-2 10 (11.6%) 8 (11.1%) 9 (9.4%) - 1 9 (10.5%) 6 (8.3%) 6 (6.2%) - 2 1 (1.2%) 2 (2.8%) 3 (3.1%) - Grade 3-4 0 0 2 (2.1%) - 3 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - CONFUSIONAL STATE - - Any Grade - 2 (2.3%) 1 (1.4%) 3 (3.1%) - Grade 1-2 2 (2.3%) 1 (1.4%) 2 (2.1%) - 1 2 (2.3%) 1 (1.4%) 2 (2.1%) - Grade 3-4 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - AGITATION - - Any Grade - 2 (2.3%) 0 3 (3.1%) - Grade 1-2 2 (2.3%) 0 3 (3.1%) - 1 2 (2.3%) 0 1 (1.0%) - 2 0 0 2 (2.1%) - ANXIETY - - Any Grade - 1 (1.2%) 0 3 (3.1%) - Grade 1-2 1 (1.2%) 0 3 (3.1%) - 1 0 0 3 (3.1%) - 2 1 (1.2%) 0 0 - INSOMNIA - - Any Grade - 2 (2.3%) 2 (2.8%) 0 - Grade 1-2 2 (2.3%) 2 (2.8%) 0 - 1 2 (2.3%) 2 (2.8%) 0 - DELUSION - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 1 1 (1.2%) 1 (1.4%) 0 - DEPRESSED MOOD - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - IRRITABILITY - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 2 1 (1.2%) 0 1 (1.0%) - COMPLETED SUICIDE - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - DELIRIUM - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - DISORIENTATION - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - HALLUCINATION - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - HALLUCINATION, VISUAL - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - LIBIDO DECREASED - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - LISTLESS - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - NIGHTMARE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - RESTLESSNESS - - Any Grade - 0 0 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - INVESTIGATIONS - - Overall - - - Any Grade - 10 (11.6%) 5 (6.9%) 8 (8.3%) - Grade 1-2 8 (9.3%) 3 (4.2%) 7 (7.3%) - 1 6 (7.0%) 2 (2.8%) 5 (5.2%) - 2 2 (2.3%) 1 (1.4%) 2 (2.1%) - Grade 3-4 2 (2.3%) 2 (2.8%) 1 (1.0%) - 3 1 (1.2%) 1 (1.4%) 0 - 4 1 (1.2%) 1 (1.4%) 1 (1.0%) - ELECTROCARDIOGRAM ST SEGMENT DEPRESSION - - Any Grade - 4 (4.7%) 0 1 (1.0%) - Grade 1-2 4 (4.7%) 0 1 (1.0%) - 1 3 (3.5%) 0 0 - 2 1 (1.2%) 0 1 (1.0%) - ELECTROCARDIOGRAM T WAVE INVERSION - - Any Grade - 2 (2.3%) 1 (1.4%) 1 (1.0%) - Grade 1-2 2 (2.3%) 1 (1.4%) 1 (1.0%) - 1 1 (1.2%) 0 1 (1.0%) - 2 1 (1.2%) 1 (1.4%) 0 - BLOOD GLUCOSE INCREASED - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - Grade 3-4 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 1 1 (1.2%) 0 0 - 2 0 0 1 (1.0%) - BIOPSY - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - BIOPSY PROSTATE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - BLOOD ALKALINE PHOSPHATASE INCREASED - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - BLOOD CHOLESTEROL INCREASED - - Any Grade - 0 1 (1.4%) 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - BLOOD CREATINE PHOSPHOKINASE INCREASED - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - BLOOD URINE PRESENT - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - BODY TEMPERATURE INCREASED - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - CYSTOSCOPY - - Any Grade - 1 (1.2%) 0 0 - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - HEART RATE INCREASED - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - HEART RATE IRREGULAR - - Any Grade - 1 (1.2%) 0 0 - Grade 3-4 1 (1.2%) 0 0 - 4 1 (1.2%) 0 0 - NASAL MUCOSA BIOPSY - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - NEUTROPHIL COUNT INCREASED - - Any Grade - 0 0 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - URINE ANALYSIS ABNORMAL - - Any Grade - 0 0 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - WEIGHT DECREASED - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - WHITE BLOOD CELL COUNT INCREASED - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS - - Overall - - - Any Grade - 5 (5.8%) 8 (11.1%) 7 (7.3%) - Grade 1-2 4 (4.7%) 7 (9.7%) 7 (7.3%) - 1 2 (2.3%) 6 (8.3%) 5 (5.2%) - 2 2 (2.3%) 1 (1.4%) 2 (2.1%) - Grade 3-4 1 (1.2%) 1 (1.4%) 0 - 3 1 (1.2%) 1 (1.4%) 0 - BACK PAIN - - Any Grade - 1 (1.2%) 3 (4.2%) 1 (1.0%) - Grade 1-2 1 (1.2%) 3 (4.2%) 1 (1.0%) - 1 0 3 (4.2%) 0 - 2 1 (1.2%) 0 1 (1.0%) - ARTHRALGIA - - Any Grade - 1 (1.2%) 1 (1.4%) 2 (2.1%) - Grade 1-2 1 (1.2%) 1 (1.4%) 2 (2.1%) - 1 0 1 (1.4%) 2 (2.1%) - 2 1 (1.2%) 0 0 - SHOULDER PAIN - - Any Grade - 1 (1.2%) 0 2 (2.1%) - Grade 1-2 1 (1.2%) 0 2 (2.1%) - 1 1 (1.2%) 0 2 (2.1%) - ARTHRITIS - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - FLANK PAIN - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 1 0 2 (2.8%) 0 - MUSCLE SPASMS - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 1 (1.4%) 0 - MUSCULAR WEAKNESS - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - MYALGIA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - PAIN IN EXTREMITY - - Any Grade - 1 (1.2%) 0 0 - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - INJURY, POISONING AND PROCEDURAL COMPLICATIONS - - Overall - - - Any Grade - 4 (4.7%) 5 (6.9%) 5 (5.2%) - Grade 1-2 4 (4.7%) 4 (5.6%) 5 (5.2%) - 1 2 (2.3%) 3 (4.2%) 4 (4.2%) - 2 2 (2.3%) 1 (1.4%) 1 (1.0%) - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - CONTUSION - - Any Grade - 1 (1.2%) 2 (2.8%) 1 (1.0%) - Grade 1-2 1 (1.2%) 2 (2.8%) 1 (1.0%) - 1 1 (1.2%) 2 (2.8%) 1 (1.0%) - EXCORIATION - - Any Grade - 2 (2.3%) 1 (1.4%) 1 (1.0%) - Grade 1-2 2 (2.3%) 1 (1.4%) 1 (1.0%) - 1 2 (2.3%) 1 (1.4%) 1 (1.0%) - FALL - - Any Grade - 1 (1.2%) 1 (1.4%) 2 (2.1%) - Grade 1-2 1 (1.2%) 0 2 (2.1%) - 1 0 0 2 (2.1%) - 2 1 (1.2%) 0 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - HIP FRACTURE - - Any Grade - 1 (1.2%) 2 (2.8%) 0 - Grade 1-2 1 (1.2%) 2 (2.8%) 0 - 1 1 (1.2%) 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - SKIN LACERATION - - Any Grade - 1 (1.2%) 0 2 (2.1%) - Grade 1-2 1 (1.2%) 0 2 (2.1%) - 1 0 0 1 (1.0%) - 2 1 (1.2%) 0 1 (1.0%) - FACIAL BONES FRACTURE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - JOINT DISLOCATION - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - WOUND - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - RENAL AND URINARY DISORDERS - - Overall - - - Any Grade - 4 (4.7%) 3 (4.2%) 4 (4.2%) - Grade 1-2 4 (4.7%) 3 (4.2%) 3 (3.1%) - 1 2 (2.3%) 2 (2.8%) 2 (2.1%) - 2 2 (2.3%) 1 (1.4%) 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - MICTURITION URGENCY - - Any Grade - 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 1-2 1 (1.2%) 1 (1.4%) 1 (1.0%) - 1 1 (1.2%) 0 0 - 2 0 1 (1.4%) 1 (1.0%) - DYSURIA - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 1 1 (1.2%) 0 1 (1.0%) - NEPHROLITHIASIS - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 1 (1.2%) 0 0 - CALCULUS URETHRAL - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - ENURESIS - - Any Grade - 0 0 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - INCONTINENCE - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - POLLAKIURIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - METABOLISM AND NUTRITION DISORDERS - - Overall - - - Any Grade - 6 (7.0%) 3 (4.2%) 1 (1.0%) - Grade 1-2 5 (5.8%) 2 (2.8%) 1 (1.0%) - 1 1 (1.2%) 2 (2.8%) 1 (1.0%) - 2 4 (4.7%) 0 0 - Grade 3-4 1 (1.2%) 1 (1.4%) 0 - 3 1 (1.2%) 0 0 - 4 0 1 (1.4%) 0 - DECREASED APPETITE - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 1 (1.2%) 0 0 - FOOD CRAVING - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - INCREASED APPETITE - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 1 (1.2%) 0 0 - DEHYDRATION - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - DIABETES MELLITUS - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - HYPERCHOLESTEROLAEMIA - - Any Grade - 0 1 (1.4%) 0 - Grade 3-4 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - HYPONATRAEMIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - VASCULAR DISORDERS - - Overall - - - Any Grade - 3 (3.5%) 1 (1.4%) 4 (4.2%) - Grade 1-2 2 (2.3%) 1 (1.4%) 3 (3.1%) - 1 2 (2.3%) 1 (1.4%) 1 (1.0%) - 2 0 0 2 (2.1%) - Grade 3-4 1 (1.2%) 0 1 (1.0%) - 4 1 (1.2%) 0 1 (1.0%) - HYPERTENSION - - Any Grade - 1 (1.2%) 0 2 (2.1%) - Grade 1-2 1 (1.2%) 0 2 (2.1%) - 1 1 (1.2%) 0 1 (1.0%) - 2 0 0 1 (1.0%) - HYPOTENSION - - Any Grade - 2 (2.3%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 1 1 (1.2%) 0 0 - 2 0 0 1 (1.0%) - Grade 3-4 1 (1.2%) 0 0 - 4 1 (1.2%) 0 0 - HOT FLUSH - - Any Grade - 0 0 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - ORTHOSTATIC HYPOTENSION - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - WOUND HAEMORRHAGE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - EYE DISORDERS - - Overall - - - Any Grade - 4 (4.7%) 1 (1.4%) 2 (2.1%) - Grade 1-2 2 (2.3%) 1 (1.4%) 2 (2.1%) - 1 0 1 (1.4%) 2 (2.1%) - 2 2 (2.3%) 0 0 - Grade 3-4 2 (2.3%) 0 0 - 4 2 (2.3%) 0 0 - CONJUNCTIVITIS - - Any Grade - 2 (2.3%) 0 0 - Grade 3-4 2 (2.3%) 0 0 - 4 2 (2.3%) 0 0 - VISION BLURRED - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - CONJUNCTIVAL HAEMORRHAGE - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - EYE ALLERGY - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - EYE PRURITUS - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - EYE SWELLING - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - GLAUCOMA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - SURGICAL AND MEDICAL PROCEDURES - - Overall - - - Any Grade - 2 (2.3%) 2 (2.8%) 1 (1.0%) - Grade 1-2 1 (1.2%) 2 (2.8%) 1 (1.0%) - 1 1 (1.2%) 1 (1.4%) 1 (1.0%) - 2 0 1 (1.4%) 0 - Grade 3-4 1 (1.2%) 0 0 - 4 1 (1.2%) 0 0 - CATARACT OPERATION - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - Grade 3-4 1 (1.2%) 0 0 - 4 1 (1.2%) 0 0 - ACROCHORDON EXCISION - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - EYE LASER SURGERY - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - SKIN LESION EXCISION - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - EAR AND LABYRINTH DISORDERS - - Overall - - - Any Grade - 1 (1.2%) 1 (1.4%) 2 (2.1%) - Grade 1-2 1 (1.2%) 1 (1.4%) 2 (2.1%) - 1 1 (1.2%) 1 (1.4%) 2 (2.1%) - VERTIGO - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - CERUMEN IMPACTION - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - EAR PAIN - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - TINNITUS - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - CONGENITAL, FAMILIAL AND GENETIC DISORDERS - - Overall - - - Any Grade - 0 2 (2.8%) 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - Grade 3-4 0 2 (2.8%) 0 - 3 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - VENTRICULAR SEPTAL DEFECT - - Any Grade - 0 2 (2.8%) 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - Grade 3-4 0 2 (2.8%) 0 - 3 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - - Overall - - - Any Grade - 0 1 (1.4%) 2 (2.1%) - Grade 1-2 0 1 (1.4%) 2 (2.1%) - 1 0 1 (1.4%) 1 (1.0%) - 2 0 0 1 (1.0%) - COLON CANCER - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - MALIGNANT FIBROUS HISTIOCYTOMA - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - PROSTATE CANCER - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - REPRODUCTIVE SYSTEM AND BREAST DISORDERS - - Overall - - - Any Grade - 2 (2.3%) 1 (1.4%) 0 - Grade 1-2 2 (2.3%) 1 (1.4%) 0 - 1 2 (2.3%) 0 0 - 2 0 1 (1.4%) 0 - BENIGN PROSTATIC HYPERPLASIA - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 1 1 (1.2%) 0 0 - 2 0 1 (1.4%) 0 - PELVIC PAIN - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - IMMUNE SYSTEM DISORDERS - - Overall - - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 0 - 2 0 0 1 (1.0%) - HYPERSENSITIVITY - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - SEASONAL ALLERGY - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - HEPATOBILIARY DISORDERS - - Overall - - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - HYPERBILIRUBINAEMIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - SOCIAL CIRCUMSTANCES - - Overall - - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - ALCOHOL USE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 + MedDRA System Organ Class + MedDRA Preferred Term Placebo Xanomeline High Dose Xanomeline Low Dose + Grade (N=86) (N=72) (N=96) + —————————————————————————————————————————————————————————————————————————————————————————————————————————————— + - Any adverse events - + - Any Grade - 23 (26.7%) 51 (70.8%) 54 (56.2%) + Grade 1-2 17 (19.8%) 42 (58.3%) 43 (44.8%) + 1 11 (12.8%) 26 (36.1%) 28 (29.2%) + 2 6 (7.0%) 16 (22.2%) 15 (15.6%) + Grade 3-4 6 (7.0%) 9 (12.5%) 10 (10.4%) + 3 2 (2.3%) 4 (5.6%) 5 (5.2%) + 4 4 (4.7%) 5 (6.9%) 5 (5.2%) + Grade 5 0 0 1 (1.0%) + SKIN AND SUBCUTANEOUS TISSUE DISORDERS + - Overall - + - Any Grade - 17 (19.8%) 32 (44.4%) 31 (32.3%) + Grade 1-2 13 (15.1%) 26 (36.1%) 25 (26.0%) + 1 10 (11.6%) 18 (25.0%) 15 (15.6%) + 2 3 (3.5%) 8 (11.1%) 10 (10.4%) + Grade 3-4 4 (4.7%) 6 (8.3%) 5 (5.2%) + 3 2 (2.3%) 3 (4.2%) 3 (3.1%) + 4 2 (2.3%) 3 (4.2%) 2 (2.1%) + Grade 5 0 0 1 (1.0%) + PRURITUS + - Any Grade - 8 (9.3%) 26 (36.1%) 23 (24.0%) + Grade 1-2 5 (5.8%) 20 (27.8%) 21 (21.9%) + 1 4 (4.7%) 15 (20.8%) 14 (14.6%) + 2 1 (1.2%) 5 (6.9%) 7 (7.3%) + Grade 3-4 3 (3.5%) 6 (8.3%) 1 (1.0%) + 3 1 (1.2%) 3 (4.2%) 1 (1.0%) + 4 2 (2.3%) 3 (4.2%) 0 + Grade 5 0 0 1 (1.0%) + ERYTHEMA + - Any Grade - 9 (10.5%) 14 (19.4%) 15 (15.6%) + Grade 1-2 9 (10.5%) 14 (19.4%) 13 (13.5%) + 1 8 (9.3%) 12 (16.7%) 8 (8.3%) + 2 1 (1.2%) 2 (2.8%) 5 (5.2%) + Grade 3-4 0 0 2 (2.1%) + 3 0 0 1 (1.0%) + 4 0 0 1 (1.0%) + RASH + - Any Grade - 5 (5.8%) 11 (15.3%) 13 (13.5%) + Grade 1-2 4 (4.7%) 10 (13.9%) 11 (11.5%) + 1 3 (3.5%) 7 (9.7%) 10 (10.4%) + 2 1 (1.2%) 3 (4.2%) 1 (1.0%) + Grade 3-4 1 (1.2%) 1 (1.4%) 2 (2.1%) + 3 1 (1.2%) 1 (1.4%) 1 (1.0%) + 4 0 0 1 (1.0%) + GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS + - Overall - + - Any Grade - 8 (9.3%) 24 (33.3%) 25 (26.0%) + Grade 1-2 6 (7.0%) 20 (27.8%) 20 (20.8%) + 1 3 (3.5%) 10 (13.9%) 14 (14.6%) + 2 3 (3.5%) 10 (13.9%) 6 (6.2%) + Grade 3-4 2 (2.3%) 4 (5.6%) 5 (5.2%) + 3 0 2 (2.8%) 2 (2.1%) + 4 2 (2.3%) 2 (2.8%) 3 (3.1%) + APPLICATION SITE PRURITUS + - Any Grade - 6 (7.0%) 21 (29.2%) 23 (24.0%) + Grade 1-2 4 (4.7%) 19 (26.4%) 20 (20.8%) + 1 2 (2.3%) 11 (15.3%) 16 (16.7%) + 2 2 (2.3%) 8 (11.1%) 4 (4.2%) + Grade 3-4 2 (2.3%) 2 (2.8%) 3 (3.1%) + 3 0 0 1 (1.0%) + 4 2 (2.3%) 2 (2.8%) 2 (2.1%) + APPLICATION SITE ERYTHEMA + - Any Grade - 3 (3.5%) 14 (19.4%) 13 (13.5%) + Grade 1-2 3 (3.5%) 12 (16.7%) 11 (11.5%) + 1 2 (2.3%) 10 (13.9%) 8 (8.3%) + 2 1 (1.2%) 2 (2.8%) 3 (3.1%) + Grade 3-4 0 2 (2.8%) 2 (2.1%) + 3 0 2 (2.8%) 1 (1.0%) + 4 0 0 1 (1.0%) # AET04 variant 8 is produced correctly (with an Incidence Rate of at Least X Patients) Code res Output - MedDRA System Organ Class - MedDRA Preferred Term Placebo Xanomeline High Dose Xanomeline Low Dose - Grade (N=86) (N=72) (N=96) - ————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— - - Any adverse events - - - Any Grade - 69 (80.2%) 70 (97.2%) 86 (89.6%) - Grade 1-2 46 (53.5%) 37 (51.4%) 54 (56.2%) - 1 22 (25.6%) 18 (25.0%) 19 (19.8%) - 2 24 (27.9%) 19 (26.4%) 35 (36.5%) - Grade 3-4 20 (23.3%) 32 (44.4%) 30 (31.2%) - 3 8 (9.3%) 16 (22.2%) 11 (11.5%) - 4 12 (14.0%) 16 (22.2%) 19 (19.8%) - Grade 5 3 (3.5%) 1 (1.4%) 2 (2.1%) - GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - - Overall - - - Any Grade - 21 (24.4%) 36 (50.0%) 51 (53.1%) - Grade 1-2 17 (19.8%) 28 (38.9%) 40 (41.7%) - 1 10 (11.6%) 15 (20.8%) 20 (20.8%) - 2 7 (8.1%) 13 (18.1%) 20 (20.8%) - Grade 3-4 4 (4.7%) 8 (11.1%) 11 (11.5%) - 3 2 (2.3%) 3 (4.2%) 6 (6.2%) - 4 2 (2.3%) 5 (6.9%) 5 (5.2%) - APPLICATION SITE PRURITUS - - Any Grade - 6 (7.0%) 21 (29.2%) 23 (24.0%) - Grade 1-2 4 (4.7%) 19 (26.4%) 20 (20.8%) - 1 2 (2.3%) 11 (15.3%) 16 (16.7%) - 2 2 (2.3%) 8 (11.1%) 4 (4.2%) - Grade 3-4 2 (2.3%) 2 (2.8%) 3 (3.1%) - 3 0 0 1 (1.0%) - 4 2 (2.3%) 2 (2.8%) 2 (2.1%) - APPLICATION SITE ERYTHEMA - - Any Grade - 3 (3.5%) 14 (19.4%) 13 (13.5%) - Grade 1-2 3 (3.5%) 12 (16.7%) 11 (11.5%) - 1 2 (2.3%) 10 (13.9%) 8 (8.3%) - 2 1 (1.2%) 2 (2.8%) 3 (3.1%) - Grade 3-4 0 2 (2.8%) 2 (2.1%) - 3 0 2 (2.8%) 1 (1.0%) - 4 0 0 1 (1.0%) - APPLICATION SITE DERMATITIS - - Any Grade - 5 (5.8%) 7 (9.7%) 9 (9.4%) - Grade 1-2 4 (4.7%) 6 (8.3%) 8 (8.3%) - 1 3 (3.5%) 3 (4.2%) 4 (4.2%) - 2 1 (1.2%) 3 (4.2%) 4 (4.2%) - Grade 3-4 1 (1.2%) 1 (1.4%) 1 (1.0%) - 3 1 (1.2%) 1 (1.4%) 1 (1.0%) - APPLICATION SITE IRRITATION - - Any Grade - 3 (3.5%) 9 (12.5%) 9 (9.4%) - Grade 1-2 2 (2.3%) 8 (11.1%) 6 (6.2%) - 1 2 (2.3%) 6 (8.3%) 3 (3.1%) - 2 0 2 (2.8%) 3 (3.1%) - Grade 3-4 1 (1.2%) 1 (1.4%) 3 (3.1%) - 3 1 (1.2%) 0 1 (1.0%) - 4 0 1 (1.4%) 2 (2.1%) - APPLICATION SITE VESICLES - - Any Grade - 1 (1.2%) 5 (6.9%) 5 (5.2%) - Grade 1-2 1 (1.2%) 4 (5.6%) 5 (5.2%) - 1 0 3 (4.2%) 4 (4.2%) - 2 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 3-4 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - FATIGUE - - Any Grade - 1 (1.2%) 5 (6.9%) 5 (5.2%) - Grade 1-2 1 (1.2%) 4 (5.6%) 5 (5.2%) - 1 0 3 (4.2%) 3 (3.1%) - 2 1 (1.2%) 1 (1.4%) 2 (2.1%) - Grade 3-4 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - OEDEMA PERIPHERAL - - Any Grade - 2 (2.3%) 2 (2.8%) 1 (1.0%) - Grade 1-2 1 (1.2%) 2 (2.8%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - 2 1 (1.2%) 1 (1.4%) 0 - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - APPLICATION SITE SWELLING - - Any Grade - 0 2 (2.8%) 1 (1.0%) - Grade 1-2 0 2 (2.8%) 1 (1.0%) - 1 0 2 (2.8%) 1 (1.0%) - APPLICATION SITE URTICARIA - - Any Grade - 0 1 (1.4%) 2 (2.1%) - Grade 1-2 0 1 (1.4%) 2 (2.1%) - 1 0 1 (1.4%) 1 (1.0%) - 2 0 0 1 (1.0%) - CHILLS - - Any Grade - 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 1-2 1 (1.2%) 1 (1.4%) 1 (1.0%) - 1 1 (1.2%) 1 (1.4%) 0 - 2 0 0 1 (1.0%) - MALAISE - - Any Grade - 0 2 (2.8%) 1 (1.0%) - Grade 1-2 0 2 (2.8%) 1 (1.0%) - 1 0 1 (1.4%) 0 - 2 0 1 (1.4%) 1 (1.0%) - PYREXIA - - Any Grade - 2 (2.3%) 0 1 (1.0%) - Grade 1-2 2 (2.3%) 0 1 (1.0%) - 1 1 (1.2%) 0 1 (1.0%) - 2 1 (1.2%) 0 0 - APPLICATION SITE PAIN - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 1 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - APPLICATION SITE PERSPIRATION - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 2 0 2 (2.8%) 0 - APPLICATION SITE REACTION - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 1 1 (1.2%) 1 (1.4%) 0 - ASTHENIA - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 1 1 (1.2%) 0 0 - 2 0 0 1 (1.0%) - CHEST DISCOMFORT - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 0 - 2 0 0 1 (1.0%) - CHEST PAIN - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 1 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - OEDEMA - - Any Grade - 0 0 2 (2.1%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - PAIN - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - APPLICATION SITE BLEEDING - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - APPLICATION SITE DESQUAMATION - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - APPLICATION SITE DISCHARGE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - APPLICATION SITE DISCOLOURATION - - Any Grade - 0 0 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - APPLICATION SITE INDURATION - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - APPLICATION SITE WARMTH - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - CYST - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - FEELING ABNORMAL - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - FEELING COLD - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - INFLAMMATION - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - SECRETION DISCHARGE - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - SUDDEN DEATH - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - SWELLING - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - ULCER - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - SKIN AND SUBCUTANEOUS TISSUE DISORDERS - - Overall - - - Any Grade - 21 (24.4%) 42 (58.3%) 42 (43.8%) - Grade 1-2 17 (19.8%) 33 (45.8%) 33 (34.4%) - 1 11 (12.8%) 20 (27.8%) 17 (17.7%) - 2 6 (7.0%) 13 (18.1%) 16 (16.7%) - Grade 3-4 4 (4.7%) 9 (12.5%) 7 (7.3%) - 3 2 (2.3%) 4 (5.6%) 4 (4.2%) - 4 2 (2.3%) 5 (6.9%) 3 (3.1%) - Grade 5 0 0 2 (2.1%) - PRURITUS - - Any Grade - 8 (9.3%) 26 (36.1%) 23 (24.0%) - Grade 1-2 5 (5.8%) 20 (27.8%) 21 (21.9%) - 1 4 (4.7%) 15 (20.8%) 14 (14.6%) - 2 1 (1.2%) 5 (6.9%) 7 (7.3%) - Grade 3-4 3 (3.5%) 6 (8.3%) 1 (1.0%) - 3 1 (1.2%) 3 (4.2%) 1 (1.0%) - 4 2 (2.3%) 3 (4.2%) 0 - Grade 5 0 0 1 (1.0%) - ERYTHEMA - - Any Grade - 9 (10.5%) 14 (19.4%) 15 (15.6%) - Grade 1-2 9 (10.5%) 14 (19.4%) 13 (13.5%) - 1 8 (9.3%) 12 (16.7%) 8 (8.3%) - 2 1 (1.2%) 2 (2.8%) 5 (5.2%) - Grade 3-4 0 0 2 (2.1%) - 3 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - RASH - - Any Grade - 5 (5.8%) 11 (15.3%) 13 (13.5%) - Grade 1-2 4 (4.7%) 10 (13.9%) 11 (11.5%) - 1 3 (3.5%) 7 (9.7%) 10 (10.4%) - 2 1 (1.2%) 3 (4.2%) 1 (1.0%) - Grade 3-4 1 (1.2%) 1 (1.4%) 2 (2.1%) - 3 1 (1.2%) 1 (1.4%) 1 (1.0%) - 4 0 0 1 (1.0%) - HYPERHIDROSIS - - Any Grade - 2 (2.3%) 8 (11.1%) 4 (4.2%) - Grade 1-2 2 (2.3%) 7 (9.7%) 4 (4.2%) - 1 0 5 (6.9%) 4 (4.2%) - 2 2 (2.3%) 2 (2.8%) 0 - Grade 3-4 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - SKIN IRRITATION - - Any Grade - 3 (3.5%) 5 (6.9%) 6 (6.2%) - Grade 1-2 3 (3.5%) 5 (6.9%) 4 (4.2%) - 1 1 (1.2%) 3 (4.2%) 3 (3.1%) - 2 2 (2.3%) 2 (2.8%) 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - Grade 5 0 0 1 (1.0%) - BLISTER - - Any Grade - 0 1 (1.4%) 5 (5.2%) - Grade 1-2 0 1 (1.4%) 5 (5.2%) - 1 0 1 (1.4%) 4 (4.2%) - 2 0 0 1 (1.0%) - RASH PRURITIC - - Any Grade - 0 2 (2.8%) 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - Grade 3-4 0 2 (2.8%) 0 - 3 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - PRURITUS GENERALISED - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 0 - 2 0 0 1 (1.0%) - RASH ERYTHEMATOUS - - Any Grade - 0 0 2 (2.1%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - URTICARIA - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - ACTINIC KERATOSIS - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - ALOPECIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - COLD SWEAT - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - DERMATITIS ATOPIC - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - DERMATITIS CONTACT - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - DRUG ERUPTION - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - RASH MACULO-PAPULAR - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - RASH PAPULAR - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - SKIN EXFOLIATION - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - SKIN ODOUR ABNORMAL - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - SKIN ULCER - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - NERVOUS SYSTEM DISORDERS - - Overall - - - Any Grade - 12 (14.0%) 25 (34.7%) 22 (22.9%) - Grade 1-2 10 (11.6%) 22 (30.6%) 19 (19.8%) - 1 7 (8.1%) 16 (22.2%) 13 (13.5%) - 2 3 (3.5%) 6 (8.3%) 6 (6.2%) - Grade 3-4 1 (1.2%) 3 (4.2%) 3 (3.1%) - 3 0 1 (1.4%) 1 (1.0%) - 4 1 (1.2%) 2 (2.8%) 2 (2.1%) - Grade 5 1 (1.2%) 0 0 - DIZZINESS - - Any Grade - 2 (2.3%) 11 (15.3%) 9 (9.4%) - Grade 1-2 2 (2.3%) 9 (12.5%) 8 (8.3%) - 1 1 (1.2%) 9 (12.5%) 5 (5.2%) - 2 1 (1.2%) 0 3 (3.1%) - Grade 3-4 0 2 (2.8%) 1 (1.0%) - 3 0 0 1 (1.0%) - 4 0 2 (2.8%) 0 - HEADACHE - - Any Grade - 7 (8.1%) 6 (8.3%) 3 (3.1%) - Grade 1-2 6 (7.0%) 6 (8.3%) 3 (3.1%) - 1 5 (5.8%) 3 (4.2%) 2 (2.1%) - 2 1 (1.2%) 3 (4.2%) 1 (1.0%) - Grade 3-4 1 (1.2%) 0 0 - 4 1 (1.2%) 0 0 - SYNCOPE - - Any Grade - 0 2 (2.8%) 5 (5.2%) - Grade 1-2 0 2 (2.8%) 5 (5.2%) - 1 0 2 (2.8%) 5 (5.2%) - SOMNOLENCE - - Any Grade - 2 (2.3%) 1 (1.4%) 3 (3.1%) - Grade 1-2 2 (2.3%) 1 (1.4%) 2 (2.1%) - 1 1 (1.2%) 1 (1.4%) 2 (2.1%) - 2 1 (1.2%) 0 0 - Grade 3-4 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - TRANSIENT ISCHAEMIC ATTACK - - Any Grade - 0 1 (1.4%) 2 (2.1%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 2 0 1 (1.4%) 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - BURNING SENSATION - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 1 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - LETHARGY - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - AMNESIA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - BALANCE DISORDER - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - COGNITIVE DISORDER - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - COMPLEX PARTIAL SEIZURES - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - COORDINATION ABNORMAL - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - HEMIANOPIA HOMONYMOUS - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - HYPERSOMNIA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - PARAESTHESIA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - PARAESTHESIA ORAL - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - PARKINSON'S DISEASE - - Any Grade - 1 (1.2%) 0 0 - Grade 5 1 (1.2%) 0 0 - PAROSMIA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - PARTIAL SEIZURES WITH SECONDARY GENERALISATION - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - PSYCHOMOTOR HYPERACTIVITY - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - STUPOR - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - SYNCOPE VASOVAGAL - - Any Grade - 0 1 (1.4%) 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - GASTROINTESTINAL DISORDERS - - Overall - - - Any Grade - 17 (19.8%) 20 (27.8%) 16 (16.7%) - Grade 1-2 14 (16.3%) 17 (23.6%) 12 (12.5%) - 1 9 (10.5%) 12 (16.7%) 10 (10.4%) - 2 5 (5.8%) 5 (6.9%) 2 (2.1%) - Grade 3-4 2 (2.3%) 2 (2.8%) 4 (4.2%) - 3 0 2 (2.8%) 0 - 4 2 (2.3%) 0 4 (4.2%) - Grade 5 1 (1.2%) 1 (1.4%) 0 - DIARRHOEA - - Any Grade - 9 (10.5%) 3 (4.2%) 6 (6.2%) - Grade 1-2 8 (9.3%) 3 (4.2%) 4 (4.2%) - 1 7 (8.1%) 3 (4.2%) 3 (3.1%) - 2 1 (1.2%) 0 1 (1.0%) - Grade 3-4 1 (1.2%) 0 2 (2.1%) - 4 1 (1.2%) 0 2 (2.1%) - VOMITING - - Any Grade - 3 (3.5%) 6 (8.3%) 4 (4.2%) - Grade 1-2 2 (2.3%) 6 (8.3%) 4 (4.2%) - 1 0 4 (5.6%) 3 (3.1%) - 2 2 (2.3%) 2 (2.8%) 1 (1.0%) - Grade 5 1 (1.2%) 0 0 - NAUSEA - - Any Grade - 3 (3.5%) 6 (8.3%) 3 (3.1%) - Grade 1-2 3 (3.5%) 3 (4.2%) 2 (2.1%) - 1 2 (2.3%) 2 (2.8%) 1 (1.0%) - 2 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 3-4 0 2 (2.8%) 1 (1.0%) - 3 0 2 (2.8%) 0 - 4 0 0 1 (1.0%) - Grade 5 0 1 (1.4%) 0 - ABDOMINAL PAIN - - Any Grade - 1 (1.2%) 1 (1.4%) 3 (3.1%) - Grade 1-2 0 1 (1.4%) 2 (2.1%) - 1 0 1 (1.4%) 2 (2.1%) - Grade 3-4 1 (1.2%) 0 1 (1.0%) - 4 1 (1.2%) 0 1 (1.0%) - SALIVARY HYPERSECRETION - - Any Grade - 0 4 (5.6%) 0 - Grade 1-2 0 4 (5.6%) 0 - 1 0 2 (2.8%) 0 - 2 0 2 (2.8%) 0 - DYSPEPSIA - - Any Grade - 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 1-2 1 (1.2%) 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - 2 1 (1.2%) 0 0 - ABDOMINAL DISCOMFORT - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - CONSTIPATION - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - DYSPHAGIA - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - FLATULENCE - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - GASTROINTESTINAL HAEMORRHAGE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - GASTROOESOPHAGEAL REFLUX DISEASE - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - GLOSSITIS - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - HIATUS HERNIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - RECTAL HAEMORRHAGE - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - STOMACH DISCOMFORT - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - CARDIAC DISORDERS - - Overall - - - Any Grade - 13 (15.1%) 15 (20.8%) 16 (16.7%) - Grade 1-2 9 (10.5%) 13 (18.1%) 15 (15.6%) - 1 5 (5.8%) 9 (12.5%) 12 (12.5%) - 2 4 (4.7%) 4 (5.6%) 3 (3.1%) - Grade 3-4 4 (4.7%) 2 (2.8%) 1 (1.0%) - 3 3 (3.5%) 2 (2.8%) 0 - 4 1 (1.2%) 0 1 (1.0%) - SINUS BRADYCARDIA - - Any Grade - 2 (2.3%) 8 (11.1%) 7 (7.3%) - Grade 1-2 2 (2.3%) 8 (11.1%) 7 (7.3%) - 1 1 (1.2%) 6 (8.3%) 7 (7.3%) - 2 1 (1.2%) 2 (2.8%) 0 - MYOCARDIAL INFARCTION - - Any Grade - 4 (4.7%) 4 (5.6%) 2 (2.1%) - Grade 1-2 3 (3.5%) 3 (4.2%) 2 (2.1%) - 1 1 (1.2%) 2 (2.8%) 2 (2.1%) - 2 2 (2.3%) 1 (1.4%) 0 - Grade 3-4 1 (1.2%) 1 (1.4%) 0 - 3 1 (1.2%) 1 (1.4%) 0 - ATRIAL FIBRILLATION - - Any Grade - 1 (1.2%) 2 (2.8%) 2 (2.1%) - Grade 1-2 1 (1.2%) 2 (2.8%) 2 (2.1%) - 1 1 (1.2%) 1 (1.4%) 2 (2.1%) - 2 0 1 (1.4%) 0 - ATRIOVENTRICULAR BLOCK SECOND DEGREE - - Any Grade - 2 (2.3%) 1 (1.4%) 2 (2.1%) - Grade 1-2 2 (2.3%) 1 (1.4%) 2 (2.1%) - 1 1 (1.2%) 1 (1.4%) 1 (1.0%) - 2 1 (1.2%) 0 1 (1.0%) - SUPRAVENTRICULAR EXTRASYSTOLES - - Any Grade - 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - Grade 3-4 0 1 (1.4%) 1 (1.0%) - 3 0 1 (1.4%) 0 - 4 0 0 1 (1.0%) - VENTRICULAR EXTRASYSTOLES - - Any Grade - 0 1 (1.4%) 2 (2.1%) - Grade 1-2 0 1 (1.4%) 2 (2.1%) - 1 0 1 (1.4%) 2 (2.1%) - ATRIAL FLUTTER - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 0 - 2 0 0 1 (1.0%) - ATRIOVENTRICULAR BLOCK FIRST DEGREE - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 1 1 (1.2%) 0 1 (1.0%) - BUNDLE BRANCH BLOCK RIGHT - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 1 0 0 1 (1.0%) - 2 1 (1.2%) 0 0 - PALPITATIONS - - Any Grade - 0 0 2 (2.1%) - Grade 1-2 0 0 2 (2.1%) - 1 0 0 2 (2.1%) - ATRIAL HYPERTROPHY - - Any Grade - 1 (1.2%) 0 0 - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - BRADYCARDIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - BUNDLE BRANCH BLOCK LEFT - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - CARDIAC DISORDER - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - CARDIAC FAILURE CONGESTIVE - - Any Grade - 1 (1.2%) 0 0 - Grade 3-4 1 (1.2%) 0 0 - 4 1 (1.2%) 0 0 - SINUS ARRHYTHMIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - SUPRAVENTRICULAR TACHYCARDIA - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - TACHYCARDIA - - Any Grade - 1 (1.2%) 0 0 - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - VENTRICULAR HYPERTROPHY - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - WOLFF-PARKINSON-WHITE SYNDROME - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - INFECTIONS AND INFESTATIONS - - Overall - - - Any Grade - 16 (18.6%) 13 (18.1%) 10 (10.4%) - Grade 1-2 14 (16.3%) 11 (15.3%) 9 (9.4%) - 1 6 (7.0%) 6 (8.3%) 4 (4.2%) - 2 8 (9.3%) 5 (6.9%) 5 (5.2%) - Grade 3-4 2 (2.3%) 2 (2.8%) 1 (1.0%) - 3 1 (1.2%) 1 (1.4%) 1 (1.0%) - 4 1 (1.2%) 1 (1.4%) 0 - NASOPHARYNGITIS - - Any Grade - 2 (2.3%) 6 (8.3%) 4 (4.2%) - Grade 1-2 2 (2.3%) 5 (6.9%) 3 (3.1%) - 1 2 (2.3%) 4 (5.6%) 2 (2.1%) - 2 0 1 (1.4%) 1 (1.0%) - Grade 3-4 0 1 (1.4%) 1 (1.0%) - 3 0 1 (1.4%) 1 (1.0%) - UPPER RESPIRATORY TRACT INFECTION - - Any Grade - 6 (7.0%) 3 (4.2%) 1 (1.0%) - Grade 1-2 5 (5.8%) 3 (4.2%) 1 (1.0%) - 1 1 (1.2%) 1 (1.4%) 0 - 2 4 (4.7%) 2 (2.8%) 1 (1.0%) - Grade 3-4 1 (1.2%) 0 0 - 4 1 (1.2%) 0 0 - INFLUENZA - - Any Grade - 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 1 (1.4%) 0 - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - URINARY TRACT INFECTION - - Any Grade - 2 (2.3%) 1 (1.4%) 0 - Grade 1-2 2 (2.3%) 1 (1.4%) 0 - 1 2 (2.3%) 1 (1.4%) 0 - CYSTITIS - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 2 1 (1.2%) 1 (1.4%) 0 - EAR INFECTION - - Any Grade - 2 (2.3%) 0 0 - Grade 1-2 2 (2.3%) 0 0 - 1 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - LOCALISED INFECTION - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 2 1 (1.2%) 0 1 (1.0%) - BRONCHITIS - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - CELLULITIS - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - CERVICITIS - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - GASTROENTERITIS VIRAL - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - HORDEOLUM - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - LOWER RESPIRATORY TRACT INFECTION - - Any Grade - 0 1 (1.4%) 0 - Grade 3-4 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - ONYCHOMYCOSIS - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - PNEUMONIA - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - RHINITIS - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - VAGINAL MYCOSIS - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - VIRAL INFECTION - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - - Overall - - - Any Grade - 10 (11.6%) 10 (13.9%) 10 (10.4%) - Grade 1-2 8 (9.3%) 6 (8.3%) 7 (7.3%) - 1 5 (5.8%) 4 (5.6%) 6 (6.2%) - 2 3 (3.5%) 2 (2.8%) 1 (1.0%) - Grade 3-4 1 (1.2%) 4 (5.6%) 3 (3.1%) - 3 1 (1.2%) 3 (4.2%) 2 (2.1%) - 4 0 1 (1.4%) 1 (1.0%) - Grade 5 1 (1.2%) 0 0 - COUGH - - Any Grade - 3 (3.5%) 5 (6.9%) 6 (6.2%) - Grade 1-2 2 (2.3%) 3 (4.2%) 4 (4.2%) - 1 1 (1.2%) 2 (2.8%) 3 (3.1%) - 2 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 3-4 0 2 (2.8%) 2 (2.1%) - 3 0 2 (2.8%) 1 (1.0%) - 4 0 0 1 (1.0%) - Grade 5 1 (1.2%) 0 0 - NASAL CONGESTION - - Any Grade - 3 (3.5%) 3 (4.2%) 1 (1.0%) - Grade 1-2 3 (3.5%) 3 (4.2%) 1 (1.0%) - 1 1 (1.2%) 3 (4.2%) 1 (1.0%) - 2 2 (2.3%) 0 0 - DYSPNOEA - - Any Grade - 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 1-2 1 (1.2%) 1 (1.4%) 1 (1.0%) - 1 1 (1.2%) 1 (1.4%) 1 (1.0%) - EPISTAXIS - - Any Grade - 0 2 (2.8%) 1 (1.0%) - Grade 1-2 0 2 (2.8%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - 2 0 1 (1.4%) 0 - PHARYNGOLARYNGEAL PAIN - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 1 (1.4%) 0 - RHINORRHOEA - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - Grade 3-4 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - ALLERGIC GRANULOMATOUS ANGIITIS - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - DYSPHONIA - - Any Grade - 0 0 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - EMPHYSEMA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - HAEMOPTYSIS - - Any Grade - 1 (1.2%) 0 0 - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - PHARYNGEAL ERYTHEMA - - Any Grade - 0 1 (1.4%) 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - POSTNASAL DRIP - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - PRODUCTIVE COUGH - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - RALES - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - RESPIRATORY TRACT CONGESTION - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - PSYCHIATRIC DISORDERS - - Overall - - - Any Grade - 10 (11.6%) 8 (11.1%) 11 (11.5%) - Grade 1-2 10 (11.6%) 8 (11.1%) 9 (9.4%) - 1 9 (10.5%) 6 (8.3%) 6 (6.2%) - 2 1 (1.2%) 2 (2.8%) 3 (3.1%) - Grade 3-4 0 0 2 (2.1%) - 3 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - CONFUSIONAL STATE - - Any Grade - 2 (2.3%) 1 (1.4%) 3 (3.1%) - Grade 1-2 2 (2.3%) 1 (1.4%) 2 (2.1%) - 1 2 (2.3%) 1 (1.4%) 2 (2.1%) - Grade 3-4 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - AGITATION - - Any Grade - 2 (2.3%) 0 3 (3.1%) - Grade 1-2 2 (2.3%) 0 3 (3.1%) - 1 2 (2.3%) 0 1 (1.0%) - 2 0 0 2 (2.1%) - ANXIETY - - Any Grade - 1 (1.2%) 0 3 (3.1%) - Grade 1-2 1 (1.2%) 0 3 (3.1%) - 1 0 0 3 (3.1%) - 2 1 (1.2%) 0 0 - INSOMNIA - - Any Grade - 2 (2.3%) 2 (2.8%) 0 - Grade 1-2 2 (2.3%) 2 (2.8%) 0 - 1 2 (2.3%) 2 (2.8%) 0 - DELUSION - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 1 1 (1.2%) 1 (1.4%) 0 - DEPRESSED MOOD - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - IRRITABILITY - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 2 1 (1.2%) 0 1 (1.0%) - COMPLETED SUICIDE - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - DELIRIUM - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - DISORIENTATION - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - HALLUCINATION - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - HALLUCINATION, VISUAL - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - LIBIDO DECREASED - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - LISTLESS - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - NIGHTMARE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - RESTLESSNESS - - Any Grade - 0 0 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - INVESTIGATIONS - - Overall - - - Any Grade - 10 (11.6%) 5 (6.9%) 8 (8.3%) - Grade 1-2 8 (9.3%) 3 (4.2%) 7 (7.3%) - 1 6 (7.0%) 2 (2.8%) 5 (5.2%) - 2 2 (2.3%) 1 (1.4%) 2 (2.1%) - Grade 3-4 2 (2.3%) 2 (2.8%) 1 (1.0%) - 3 1 (1.2%) 1 (1.4%) 0 - 4 1 (1.2%) 1 (1.4%) 1 (1.0%) - ELECTROCARDIOGRAM ST SEGMENT DEPRESSION - - Any Grade - 4 (4.7%) 0 1 (1.0%) - Grade 1-2 4 (4.7%) 0 1 (1.0%) - 1 3 (3.5%) 0 0 - 2 1 (1.2%) 0 1 (1.0%) - ELECTROCARDIOGRAM T WAVE INVERSION - - Any Grade - 2 (2.3%) 1 (1.4%) 1 (1.0%) - Grade 1-2 2 (2.3%) 1 (1.4%) 1 (1.0%) - 1 1 (1.2%) 0 1 (1.0%) - 2 1 (1.2%) 1 (1.4%) 0 - BLOOD GLUCOSE INCREASED - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - Grade 3-4 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 1 1 (1.2%) 0 0 - 2 0 0 1 (1.0%) - BIOPSY - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - BIOPSY PROSTATE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - BLOOD ALKALINE PHOSPHATASE INCREASED - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - BLOOD CHOLESTEROL INCREASED - - Any Grade - 0 1 (1.4%) 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - BLOOD CREATINE PHOSPHOKINASE INCREASED - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - BLOOD URINE PRESENT - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - BODY TEMPERATURE INCREASED - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - CYSTOSCOPY - - Any Grade - 1 (1.2%) 0 0 - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - HEART RATE INCREASED - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - HEART RATE IRREGULAR - - Any Grade - 1 (1.2%) 0 0 - Grade 3-4 1 (1.2%) 0 0 - 4 1 (1.2%) 0 0 - NASAL MUCOSA BIOPSY - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - NEUTROPHIL COUNT INCREASED - - Any Grade - 0 0 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - URINE ANALYSIS ABNORMAL - - Any Grade - 0 0 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - WEIGHT DECREASED - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - WHITE BLOOD CELL COUNT INCREASED - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS - - Overall - - - Any Grade - 5 (5.8%) 8 (11.1%) 7 (7.3%) - Grade 1-2 4 (4.7%) 7 (9.7%) 7 (7.3%) - 1 2 (2.3%) 6 (8.3%) 5 (5.2%) - 2 2 (2.3%) 1 (1.4%) 2 (2.1%) - Grade 3-4 1 (1.2%) 1 (1.4%) 0 - 3 1 (1.2%) 1 (1.4%) 0 - BACK PAIN - - Any Grade - 1 (1.2%) 3 (4.2%) 1 (1.0%) - Grade 1-2 1 (1.2%) 3 (4.2%) 1 (1.0%) - 1 0 3 (4.2%) 0 - 2 1 (1.2%) 0 1 (1.0%) - ARTHRALGIA - - Any Grade - 1 (1.2%) 1 (1.4%) 2 (2.1%) - Grade 1-2 1 (1.2%) 1 (1.4%) 2 (2.1%) - 1 0 1 (1.4%) 2 (2.1%) - 2 1 (1.2%) 0 0 - SHOULDER PAIN - - Any Grade - 1 (1.2%) 0 2 (2.1%) - Grade 1-2 1 (1.2%) 0 2 (2.1%) - 1 1 (1.2%) 0 2 (2.1%) - ARTHRITIS - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - FLANK PAIN - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 1 0 2 (2.8%) 0 - MUSCLE SPASMS - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 1 (1.4%) 0 - MUSCULAR WEAKNESS - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - MYALGIA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - PAIN IN EXTREMITY - - Any Grade - 1 (1.2%) 0 0 - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - INJURY, POISONING AND PROCEDURAL COMPLICATIONS - - Overall - - - Any Grade - 4 (4.7%) 5 (6.9%) 5 (5.2%) - Grade 1-2 4 (4.7%) 4 (5.6%) 5 (5.2%) - 1 2 (2.3%) 3 (4.2%) 4 (4.2%) - 2 2 (2.3%) 1 (1.4%) 1 (1.0%) - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - CONTUSION - - Any Grade - 1 (1.2%) 2 (2.8%) 1 (1.0%) - Grade 1-2 1 (1.2%) 2 (2.8%) 1 (1.0%) - 1 1 (1.2%) 2 (2.8%) 1 (1.0%) - EXCORIATION - - Any Grade - 2 (2.3%) 1 (1.4%) 1 (1.0%) - Grade 1-2 2 (2.3%) 1 (1.4%) 1 (1.0%) - 1 2 (2.3%) 1 (1.4%) 1 (1.0%) - FALL - - Any Grade - 1 (1.2%) 1 (1.4%) 2 (2.1%) - Grade 1-2 1 (1.2%) 0 2 (2.1%) - 1 0 0 2 (2.1%) - 2 1 (1.2%) 0 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - HIP FRACTURE - - Any Grade - 1 (1.2%) 2 (2.8%) 0 - Grade 1-2 1 (1.2%) 2 (2.8%) 0 - 1 1 (1.2%) 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - SKIN LACERATION - - Any Grade - 1 (1.2%) 0 2 (2.1%) - Grade 1-2 1 (1.2%) 0 2 (2.1%) - 1 0 0 1 (1.0%) - 2 1 (1.2%) 0 1 (1.0%) - FACIAL BONES FRACTURE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - JOINT DISLOCATION - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - WOUND - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - RENAL AND URINARY DISORDERS - - Overall - - - Any Grade - 4 (4.7%) 3 (4.2%) 4 (4.2%) - Grade 1-2 4 (4.7%) 3 (4.2%) 3 (3.1%) - 1 2 (2.3%) 2 (2.8%) 2 (2.1%) - 2 2 (2.3%) 1 (1.4%) 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - MICTURITION URGENCY - - Any Grade - 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 1-2 1 (1.2%) 1 (1.4%) 1 (1.0%) - 1 1 (1.2%) 0 0 - 2 0 1 (1.4%) 1 (1.0%) - DYSURIA - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 1 1 (1.2%) 0 1 (1.0%) - NEPHROLITHIASIS - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 1 (1.2%) 0 0 - CALCULUS URETHRAL - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - ENURESIS - - Any Grade - 0 0 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - INCONTINENCE - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - POLLAKIURIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - METABOLISM AND NUTRITION DISORDERS - - Overall - - - Any Grade - 6 (7.0%) 3 (4.2%) 1 (1.0%) - Grade 1-2 5 (5.8%) 2 (2.8%) 1 (1.0%) - 1 1 (1.2%) 2 (2.8%) 1 (1.0%) - 2 4 (4.7%) 0 0 - Grade 3-4 1 (1.2%) 1 (1.4%) 0 - 3 1 (1.2%) 0 0 - 4 0 1 (1.4%) 0 - DECREASED APPETITE - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 1 (1.2%) 0 0 - FOOD CRAVING - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - INCREASED APPETITE - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 1 (1.2%) 0 0 - DEHYDRATION - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - DIABETES MELLITUS - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - HYPERCHOLESTEROLAEMIA - - Any Grade - 0 1 (1.4%) 0 - Grade 3-4 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - HYPONATRAEMIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - VASCULAR DISORDERS - - Overall - - - Any Grade - 3 (3.5%) 1 (1.4%) 4 (4.2%) - Grade 1-2 2 (2.3%) 1 (1.4%) 3 (3.1%) - 1 2 (2.3%) 1 (1.4%) 1 (1.0%) - 2 0 0 2 (2.1%) - Grade 3-4 1 (1.2%) 0 1 (1.0%) - 4 1 (1.2%) 0 1 (1.0%) - HYPERTENSION - - Any Grade - 1 (1.2%) 0 2 (2.1%) - Grade 1-2 1 (1.2%) 0 2 (2.1%) - 1 1 (1.2%) 0 1 (1.0%) - 2 0 0 1 (1.0%) - HYPOTENSION - - Any Grade - 2 (2.3%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 1 1 (1.2%) 0 0 - 2 0 0 1 (1.0%) - Grade 3-4 1 (1.2%) 0 0 - 4 1 (1.2%) 0 0 - HOT FLUSH - - Any Grade - 0 0 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - ORTHOSTATIC HYPOTENSION - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - WOUND HAEMORRHAGE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - EYE DISORDERS - - Overall - - - Any Grade - 4 (4.7%) 1 (1.4%) 2 (2.1%) - Grade 1-2 2 (2.3%) 1 (1.4%) 2 (2.1%) - 1 0 1 (1.4%) 2 (2.1%) - 2 2 (2.3%) 0 0 - Grade 3-4 2 (2.3%) 0 0 - 4 2 (2.3%) 0 0 - CONJUNCTIVITIS - - Any Grade - 2 (2.3%) 0 0 - Grade 3-4 2 (2.3%) 0 0 - 4 2 (2.3%) 0 0 - VISION BLURRED - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - CONJUNCTIVAL HAEMORRHAGE - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - EYE ALLERGY - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - EYE PRURITUS - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - EYE SWELLING - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - GLAUCOMA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - SURGICAL AND MEDICAL PROCEDURES - - Overall - - - Any Grade - 2 (2.3%) 2 (2.8%) 1 (1.0%) - Grade 1-2 1 (1.2%) 2 (2.8%) 1 (1.0%) - 1 1 (1.2%) 1 (1.4%) 1 (1.0%) - 2 0 1 (1.4%) 0 - Grade 3-4 1 (1.2%) 0 0 - 4 1 (1.2%) 0 0 - CATARACT OPERATION - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - Grade 3-4 1 (1.2%) 0 0 - 4 1 (1.2%) 0 0 - ACROCHORDON EXCISION - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - EYE LASER SURGERY - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - SKIN LESION EXCISION - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - EAR AND LABYRINTH DISORDERS - - Overall - - - Any Grade - 1 (1.2%) 1 (1.4%) 2 (2.1%) - Grade 1-2 1 (1.2%) 1 (1.4%) 2 (2.1%) - 1 1 (1.2%) 1 (1.4%) 2 (2.1%) - VERTIGO - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - CERUMEN IMPACTION - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - EAR PAIN - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - TINNITUS - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - CONGENITAL, FAMILIAL AND GENETIC DISORDERS - - Overall - - - Any Grade - 0 2 (2.8%) 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - Grade 3-4 0 2 (2.8%) 0 - 3 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - VENTRICULAR SEPTAL DEFECT - - Any Grade - 0 2 (2.8%) 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - Grade 3-4 0 2 (2.8%) 0 - 3 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - - Overall - - - Any Grade - 0 1 (1.4%) 2 (2.1%) - Grade 1-2 0 1 (1.4%) 2 (2.1%) - 1 0 1 (1.4%) 1 (1.0%) - 2 0 0 1 (1.0%) - COLON CANCER - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - MALIGNANT FIBROUS HISTIOCYTOMA - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - PROSTATE CANCER - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - REPRODUCTIVE SYSTEM AND BREAST DISORDERS - - Overall - - - Any Grade - 2 (2.3%) 1 (1.4%) 0 - Grade 1-2 2 (2.3%) 1 (1.4%) 0 - 1 2 (2.3%) 0 0 - 2 0 1 (1.4%) 0 - BENIGN PROSTATIC HYPERPLASIA - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 1 1 (1.2%) 0 0 - 2 0 1 (1.4%) 0 - PELVIC PAIN - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - IMMUNE SYSTEM DISORDERS - - Overall - - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 0 - 2 0 0 1 (1.0%) - HYPERSENSITIVITY - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - SEASONAL ALLERGY - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - HEPATOBILIARY DISORDERS - - Overall - - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - HYPERBILIRUBINAEMIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - SOCIAL CIRCUMSTANCES - - Overall - - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - ALCOHOL USE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 + MedDRA System Organ Class + MedDRA Preferred Term Placebo Xanomeline High Dose Xanomeline Low Dose + Grade (N=86) (N=72) (N=96) + —————————————————————————————————————————————————————————————————————————————————————————————————————————————— + - Any adverse events - + - Any Grade - 23 (26.7%) 51 (70.8%) 54 (56.2%) + Grade 1-2 17 (19.8%) 42 (58.3%) 43 (44.8%) + 1 11 (12.8%) 26 (36.1%) 28 (29.2%) + 2 6 (7.0%) 16 (22.2%) 15 (15.6%) + Grade 3-4 6 (7.0%) 9 (12.5%) 10 (10.4%) + 3 2 (2.3%) 4 (5.6%) 5 (5.2%) + 4 4 (4.7%) 5 (6.9%) 5 (5.2%) + Grade 5 0 0 1 (1.0%) + SKIN AND SUBCUTANEOUS TISSUE DISORDERS + - Overall - + - Any Grade - 17 (19.8%) 32 (44.4%) 31 (32.3%) + Grade 1-2 13 (15.1%) 26 (36.1%) 25 (26.0%) + 1 10 (11.6%) 18 (25.0%) 15 (15.6%) + 2 3 (3.5%) 8 (11.1%) 10 (10.4%) + Grade 3-4 4 (4.7%) 6 (8.3%) 5 (5.2%) + 3 2 (2.3%) 3 (4.2%) 3 (3.1%) + 4 2 (2.3%) 3 (4.2%) 2 (2.1%) + Grade 5 0 0 1 (1.0%) + PRURITUS + - Any Grade - 8 (9.3%) 26 (36.1%) 23 (24.0%) + Grade 1-2 5 (5.8%) 20 (27.8%) 21 (21.9%) + 1 4 (4.7%) 15 (20.8%) 14 (14.6%) + 2 1 (1.2%) 5 (6.9%) 7 (7.3%) + Grade 3-4 3 (3.5%) 6 (8.3%) 1 (1.0%) + 3 1 (1.2%) 3 (4.2%) 1 (1.0%) + 4 2 (2.3%) 3 (4.2%) 0 + Grade 5 0 0 1 (1.0%) + ERYTHEMA + - Any Grade - 9 (10.5%) 14 (19.4%) 15 (15.6%) + Grade 1-2 9 (10.5%) 14 (19.4%) 13 (13.5%) + 1 8 (9.3%) 12 (16.7%) 8 (8.3%) + 2 1 (1.2%) 2 (2.8%) 5 (5.2%) + Grade 3-4 0 0 2 (2.1%) + 3 0 0 1 (1.0%) + 4 0 0 1 (1.0%) + RASH + - Any Grade - 5 (5.8%) 11 (15.3%) 13 (13.5%) + Grade 1-2 4 (4.7%) 10 (13.9%) 11 (11.5%) + 1 3 (3.5%) 7 (9.7%) 10 (10.4%) + 2 1 (1.2%) 3 (4.2%) 1 (1.0%) + Grade 3-4 1 (1.2%) 1 (1.4%) 2 (2.1%) + 3 1 (1.2%) 1 (1.4%) 1 (1.0%) + 4 0 0 1 (1.0%) + GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS + - Overall - + - Any Grade - 8 (9.3%) 24 (33.3%) 25 (26.0%) + Grade 1-2 6 (7.0%) 20 (27.8%) 20 (20.8%) + 1 3 (3.5%) 10 (13.9%) 14 (14.6%) + 2 3 (3.5%) 10 (13.9%) 6 (6.2%) + Grade 3-4 2 (2.3%) 4 (5.6%) 5 (5.2%) + 3 0 2 (2.8%) 2 (2.1%) + 4 2 (2.3%) 2 (2.8%) 3 (3.1%) + APPLICATION SITE PRURITUS + - Any Grade - 6 (7.0%) 21 (29.2%) 23 (24.0%) + Grade 1-2 4 (4.7%) 19 (26.4%) 20 (20.8%) + 1 2 (2.3%) 11 (15.3%) 16 (16.7%) + 2 2 (2.3%) 8 (11.1%) 4 (4.2%) + Grade 3-4 2 (2.3%) 2 (2.8%) 3 (3.1%) + 3 0 0 1 (1.0%) + 4 2 (2.3%) 2 (2.8%) 2 (2.1%) + APPLICATION SITE ERYTHEMA + - Any Grade - 3 (3.5%) 14 (19.4%) 13 (13.5%) + Grade 1-2 3 (3.5%) 12 (16.7%) 11 (11.5%) + 1 2 (2.3%) 10 (13.9%) 8 (8.3%) + 2 1 (1.2%) 2 (2.8%) 3 (3.1%) + Grade 3-4 0 2 (2.8%) 2 (2.1%) + 3 0 2 (2.8%) 1 (1.0%) + 4 0 0 1 (1.0%) # AET04 variant 9 is produced correctly (with a Difference in Incidence Rate of at Least X%) Code res Output - MedDRA System Organ Class - MedDRA Preferred Term Placebo Xanomeline High Dose Xanomeline Low Dose - Grade (N=86) (N=72) (N=96) - ————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— - - Any adverse events - - - Any Grade - 69 (80.2%) 70 (97.2%) 86 (89.6%) - Grade 1-2 46 (53.5%) 37 (51.4%) 54 (56.2%) - 1 22 (25.6%) 18 (25.0%) 19 (19.8%) - 2 24 (27.9%) 19 (26.4%) 35 (36.5%) - Grade 3-4 20 (23.3%) 32 (44.4%) 30 (31.2%) - 3 8 (9.3%) 16 (22.2%) 11 (11.5%) - 4 12 (14.0%) 16 (22.2%) 19 (19.8%) - Grade 5 3 (3.5%) 1 (1.4%) 2 (2.1%) - GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - - Overall - - - Any Grade - 21 (24.4%) 36 (50.0%) 51 (53.1%) - Grade 1-2 17 (19.8%) 28 (38.9%) 40 (41.7%) - 1 10 (11.6%) 15 (20.8%) 20 (20.8%) - 2 7 (8.1%) 13 (18.1%) 20 (20.8%) - Grade 3-4 4 (4.7%) 8 (11.1%) 11 (11.5%) - 3 2 (2.3%) 3 (4.2%) 6 (6.2%) - 4 2 (2.3%) 5 (6.9%) 5 (5.2%) - APPLICATION SITE PRURITUS - - Any Grade - 6 (7.0%) 21 (29.2%) 23 (24.0%) - Grade 1-2 4 (4.7%) 19 (26.4%) 20 (20.8%) - 1 2 (2.3%) 11 (15.3%) 16 (16.7%) - 2 2 (2.3%) 8 (11.1%) 4 (4.2%) - Grade 3-4 2 (2.3%) 2 (2.8%) 3 (3.1%) - 3 0 0 1 (1.0%) - 4 2 (2.3%) 2 (2.8%) 2 (2.1%) - APPLICATION SITE ERYTHEMA - - Any Grade - 3 (3.5%) 14 (19.4%) 13 (13.5%) - Grade 1-2 3 (3.5%) 12 (16.7%) 11 (11.5%) - 1 2 (2.3%) 10 (13.9%) 8 (8.3%) - 2 1 (1.2%) 2 (2.8%) 3 (3.1%) - Grade 3-4 0 2 (2.8%) 2 (2.1%) - 3 0 2 (2.8%) 1 (1.0%) - 4 0 0 1 (1.0%) - APPLICATION SITE DERMATITIS - - Any Grade - 5 (5.8%) 7 (9.7%) 9 (9.4%) - Grade 1-2 4 (4.7%) 6 (8.3%) 8 (8.3%) - 1 3 (3.5%) 3 (4.2%) 4 (4.2%) - 2 1 (1.2%) 3 (4.2%) 4 (4.2%) - Grade 3-4 1 (1.2%) 1 (1.4%) 1 (1.0%) - 3 1 (1.2%) 1 (1.4%) 1 (1.0%) - APPLICATION SITE IRRITATION - - Any Grade - 3 (3.5%) 9 (12.5%) 9 (9.4%) - Grade 1-2 2 (2.3%) 8 (11.1%) 6 (6.2%) - 1 2 (2.3%) 6 (8.3%) 3 (3.1%) - 2 0 2 (2.8%) 3 (3.1%) - Grade 3-4 1 (1.2%) 1 (1.4%) 3 (3.1%) - 3 1 (1.2%) 0 1 (1.0%) - 4 0 1 (1.4%) 2 (2.1%) - APPLICATION SITE VESICLES - - Any Grade - 1 (1.2%) 5 (6.9%) 5 (5.2%) - Grade 1-2 1 (1.2%) 4 (5.6%) 5 (5.2%) - 1 0 3 (4.2%) 4 (4.2%) - 2 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 3-4 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - FATIGUE - - Any Grade - 1 (1.2%) 5 (6.9%) 5 (5.2%) - Grade 1-2 1 (1.2%) 4 (5.6%) 5 (5.2%) - 1 0 3 (4.2%) 3 (3.1%) - 2 1 (1.2%) 1 (1.4%) 2 (2.1%) - Grade 3-4 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - OEDEMA PERIPHERAL - - Any Grade - 2 (2.3%) 2 (2.8%) 1 (1.0%) - Grade 1-2 1 (1.2%) 2 (2.8%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - 2 1 (1.2%) 1 (1.4%) 0 - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - APPLICATION SITE SWELLING - - Any Grade - 0 2 (2.8%) 1 (1.0%) - Grade 1-2 0 2 (2.8%) 1 (1.0%) - 1 0 2 (2.8%) 1 (1.0%) - APPLICATION SITE URTICARIA - - Any Grade - 0 1 (1.4%) 2 (2.1%) - Grade 1-2 0 1 (1.4%) 2 (2.1%) - 1 0 1 (1.4%) 1 (1.0%) - 2 0 0 1 (1.0%) - CHILLS - - Any Grade - 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 1-2 1 (1.2%) 1 (1.4%) 1 (1.0%) - 1 1 (1.2%) 1 (1.4%) 0 - 2 0 0 1 (1.0%) - MALAISE - - Any Grade - 0 2 (2.8%) 1 (1.0%) - Grade 1-2 0 2 (2.8%) 1 (1.0%) - 1 0 1 (1.4%) 0 - 2 0 1 (1.4%) 1 (1.0%) - PYREXIA - - Any Grade - 2 (2.3%) 0 1 (1.0%) - Grade 1-2 2 (2.3%) 0 1 (1.0%) - 1 1 (1.2%) 0 1 (1.0%) - 2 1 (1.2%) 0 0 - APPLICATION SITE PAIN - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 1 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - APPLICATION SITE PERSPIRATION - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 2 0 2 (2.8%) 0 - APPLICATION SITE REACTION - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 1 1 (1.2%) 1 (1.4%) 0 - ASTHENIA - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 1 1 (1.2%) 0 0 - 2 0 0 1 (1.0%) - CHEST DISCOMFORT - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 0 - 2 0 0 1 (1.0%) - CHEST PAIN - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 1 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - OEDEMA - - Any Grade - 0 0 2 (2.1%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - PAIN - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - APPLICATION SITE BLEEDING - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - APPLICATION SITE DESQUAMATION - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - APPLICATION SITE DISCHARGE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - APPLICATION SITE DISCOLOURATION - - Any Grade - 0 0 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - APPLICATION SITE INDURATION - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - APPLICATION SITE WARMTH - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - CYST - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - FEELING ABNORMAL - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - FEELING COLD - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - INFLAMMATION - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - SECRETION DISCHARGE - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - SUDDEN DEATH - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - SWELLING - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - ULCER - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - SKIN AND SUBCUTANEOUS TISSUE DISORDERS - - Overall - - - Any Grade - 21 (24.4%) 42 (58.3%) 42 (43.8%) - Grade 1-2 17 (19.8%) 33 (45.8%) 33 (34.4%) - 1 11 (12.8%) 20 (27.8%) 17 (17.7%) - 2 6 (7.0%) 13 (18.1%) 16 (16.7%) - Grade 3-4 4 (4.7%) 9 (12.5%) 7 (7.3%) - 3 2 (2.3%) 4 (5.6%) 4 (4.2%) - 4 2 (2.3%) 5 (6.9%) 3 (3.1%) - Grade 5 0 0 2 (2.1%) - PRURITUS - - Any Grade - 8 (9.3%) 26 (36.1%) 23 (24.0%) - Grade 1-2 5 (5.8%) 20 (27.8%) 21 (21.9%) - 1 4 (4.7%) 15 (20.8%) 14 (14.6%) - 2 1 (1.2%) 5 (6.9%) 7 (7.3%) - Grade 3-4 3 (3.5%) 6 (8.3%) 1 (1.0%) - 3 1 (1.2%) 3 (4.2%) 1 (1.0%) - 4 2 (2.3%) 3 (4.2%) 0 - Grade 5 0 0 1 (1.0%) - ERYTHEMA - - Any Grade - 9 (10.5%) 14 (19.4%) 15 (15.6%) - Grade 1-2 9 (10.5%) 14 (19.4%) 13 (13.5%) - 1 8 (9.3%) 12 (16.7%) 8 (8.3%) - 2 1 (1.2%) 2 (2.8%) 5 (5.2%) - Grade 3-4 0 0 2 (2.1%) - 3 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - RASH - - Any Grade - 5 (5.8%) 11 (15.3%) 13 (13.5%) - Grade 1-2 4 (4.7%) 10 (13.9%) 11 (11.5%) - 1 3 (3.5%) 7 (9.7%) 10 (10.4%) - 2 1 (1.2%) 3 (4.2%) 1 (1.0%) - Grade 3-4 1 (1.2%) 1 (1.4%) 2 (2.1%) - 3 1 (1.2%) 1 (1.4%) 1 (1.0%) - 4 0 0 1 (1.0%) - HYPERHIDROSIS - - Any Grade - 2 (2.3%) 8 (11.1%) 4 (4.2%) - Grade 1-2 2 (2.3%) 7 (9.7%) 4 (4.2%) - 1 0 5 (6.9%) 4 (4.2%) - 2 2 (2.3%) 2 (2.8%) 0 - Grade 3-4 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - SKIN IRRITATION - - Any Grade - 3 (3.5%) 5 (6.9%) 6 (6.2%) - Grade 1-2 3 (3.5%) 5 (6.9%) 4 (4.2%) - 1 1 (1.2%) 3 (4.2%) 3 (3.1%) - 2 2 (2.3%) 2 (2.8%) 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - Grade 5 0 0 1 (1.0%) - BLISTER - - Any Grade - 0 1 (1.4%) 5 (5.2%) - Grade 1-2 0 1 (1.4%) 5 (5.2%) - 1 0 1 (1.4%) 4 (4.2%) - 2 0 0 1 (1.0%) - RASH PRURITIC - - Any Grade - 0 2 (2.8%) 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - Grade 3-4 0 2 (2.8%) 0 - 3 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - PRURITUS GENERALISED - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 0 - 2 0 0 1 (1.0%) - RASH ERYTHEMATOUS - - Any Grade - 0 0 2 (2.1%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - URTICARIA - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - ACTINIC KERATOSIS - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - ALOPECIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - COLD SWEAT - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - DERMATITIS ATOPIC - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - DERMATITIS CONTACT - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - DRUG ERUPTION - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - RASH MACULO-PAPULAR - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - RASH PAPULAR - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - SKIN EXFOLIATION - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - SKIN ODOUR ABNORMAL - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - SKIN ULCER - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - NERVOUS SYSTEM DISORDERS - - Overall - - - Any Grade - 12 (14.0%) 25 (34.7%) 22 (22.9%) - Grade 1-2 10 (11.6%) 22 (30.6%) 19 (19.8%) - 1 7 (8.1%) 16 (22.2%) 13 (13.5%) - 2 3 (3.5%) 6 (8.3%) 6 (6.2%) - Grade 3-4 1 (1.2%) 3 (4.2%) 3 (3.1%) - 3 0 1 (1.4%) 1 (1.0%) - 4 1 (1.2%) 2 (2.8%) 2 (2.1%) - Grade 5 1 (1.2%) 0 0 - DIZZINESS - - Any Grade - 2 (2.3%) 11 (15.3%) 9 (9.4%) - Grade 1-2 2 (2.3%) 9 (12.5%) 8 (8.3%) - 1 1 (1.2%) 9 (12.5%) 5 (5.2%) - 2 1 (1.2%) 0 3 (3.1%) - Grade 3-4 0 2 (2.8%) 1 (1.0%) - 3 0 0 1 (1.0%) - 4 0 2 (2.8%) 0 - HEADACHE - - Any Grade - 7 (8.1%) 6 (8.3%) 3 (3.1%) - Grade 1-2 6 (7.0%) 6 (8.3%) 3 (3.1%) - 1 5 (5.8%) 3 (4.2%) 2 (2.1%) - 2 1 (1.2%) 3 (4.2%) 1 (1.0%) - Grade 3-4 1 (1.2%) 0 0 - 4 1 (1.2%) 0 0 - SYNCOPE - - Any Grade - 0 2 (2.8%) 5 (5.2%) - Grade 1-2 0 2 (2.8%) 5 (5.2%) - 1 0 2 (2.8%) 5 (5.2%) - SOMNOLENCE - - Any Grade - 2 (2.3%) 1 (1.4%) 3 (3.1%) - Grade 1-2 2 (2.3%) 1 (1.4%) 2 (2.1%) - 1 1 (1.2%) 1 (1.4%) 2 (2.1%) - 2 1 (1.2%) 0 0 - Grade 3-4 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - TRANSIENT ISCHAEMIC ATTACK - - Any Grade - 0 1 (1.4%) 2 (2.1%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 2 0 1 (1.4%) 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - BURNING SENSATION - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 1 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - LETHARGY - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - AMNESIA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - BALANCE DISORDER - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - COGNITIVE DISORDER - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - COMPLEX PARTIAL SEIZURES - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - COORDINATION ABNORMAL - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - HEMIANOPIA HOMONYMOUS - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - HYPERSOMNIA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - PARAESTHESIA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - PARAESTHESIA ORAL - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - PARKINSON'S DISEASE - - Any Grade - 1 (1.2%) 0 0 - Grade 5 1 (1.2%) 0 0 - PAROSMIA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - PARTIAL SEIZURES WITH SECONDARY GENERALISATION - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - PSYCHOMOTOR HYPERACTIVITY - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - STUPOR - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - SYNCOPE VASOVAGAL - - Any Grade - 0 1 (1.4%) 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - GASTROINTESTINAL DISORDERS - - Overall - - - Any Grade - 17 (19.8%) 20 (27.8%) 16 (16.7%) - Grade 1-2 14 (16.3%) 17 (23.6%) 12 (12.5%) - 1 9 (10.5%) 12 (16.7%) 10 (10.4%) - 2 5 (5.8%) 5 (6.9%) 2 (2.1%) - Grade 3-4 2 (2.3%) 2 (2.8%) 4 (4.2%) - 3 0 2 (2.8%) 0 - 4 2 (2.3%) 0 4 (4.2%) - Grade 5 1 (1.2%) 1 (1.4%) 0 - DIARRHOEA - - Any Grade - 9 (10.5%) 3 (4.2%) 6 (6.2%) - Grade 1-2 8 (9.3%) 3 (4.2%) 4 (4.2%) - 1 7 (8.1%) 3 (4.2%) 3 (3.1%) - 2 1 (1.2%) 0 1 (1.0%) - Grade 3-4 1 (1.2%) 0 2 (2.1%) - 4 1 (1.2%) 0 2 (2.1%) - VOMITING - - Any Grade - 3 (3.5%) 6 (8.3%) 4 (4.2%) - Grade 1-2 2 (2.3%) 6 (8.3%) 4 (4.2%) - 1 0 4 (5.6%) 3 (3.1%) - 2 2 (2.3%) 2 (2.8%) 1 (1.0%) - Grade 5 1 (1.2%) 0 0 - NAUSEA - - Any Grade - 3 (3.5%) 6 (8.3%) 3 (3.1%) - Grade 1-2 3 (3.5%) 3 (4.2%) 2 (2.1%) - 1 2 (2.3%) 2 (2.8%) 1 (1.0%) - 2 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 3-4 0 2 (2.8%) 1 (1.0%) - 3 0 2 (2.8%) 0 - 4 0 0 1 (1.0%) - Grade 5 0 1 (1.4%) 0 - ABDOMINAL PAIN - - Any Grade - 1 (1.2%) 1 (1.4%) 3 (3.1%) - Grade 1-2 0 1 (1.4%) 2 (2.1%) - 1 0 1 (1.4%) 2 (2.1%) - Grade 3-4 1 (1.2%) 0 1 (1.0%) - 4 1 (1.2%) 0 1 (1.0%) - SALIVARY HYPERSECRETION - - Any Grade - 0 4 (5.6%) 0 - Grade 1-2 0 4 (5.6%) 0 - 1 0 2 (2.8%) 0 - 2 0 2 (2.8%) 0 - DYSPEPSIA - - Any Grade - 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 1-2 1 (1.2%) 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - 2 1 (1.2%) 0 0 - ABDOMINAL DISCOMFORT - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - CONSTIPATION - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - DYSPHAGIA - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - FLATULENCE - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - GASTROINTESTINAL HAEMORRHAGE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - GASTROOESOPHAGEAL REFLUX DISEASE - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - GLOSSITIS - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - HIATUS HERNIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - RECTAL HAEMORRHAGE - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - STOMACH DISCOMFORT - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - CARDIAC DISORDERS - - Overall - - - Any Grade - 13 (15.1%) 15 (20.8%) 16 (16.7%) - Grade 1-2 9 (10.5%) 13 (18.1%) 15 (15.6%) - 1 5 (5.8%) 9 (12.5%) 12 (12.5%) - 2 4 (4.7%) 4 (5.6%) 3 (3.1%) - Grade 3-4 4 (4.7%) 2 (2.8%) 1 (1.0%) - 3 3 (3.5%) 2 (2.8%) 0 - 4 1 (1.2%) 0 1 (1.0%) - SINUS BRADYCARDIA - - Any Grade - 2 (2.3%) 8 (11.1%) 7 (7.3%) - Grade 1-2 2 (2.3%) 8 (11.1%) 7 (7.3%) - 1 1 (1.2%) 6 (8.3%) 7 (7.3%) - 2 1 (1.2%) 2 (2.8%) 0 - MYOCARDIAL INFARCTION - - Any Grade - 4 (4.7%) 4 (5.6%) 2 (2.1%) - Grade 1-2 3 (3.5%) 3 (4.2%) 2 (2.1%) - 1 1 (1.2%) 2 (2.8%) 2 (2.1%) - 2 2 (2.3%) 1 (1.4%) 0 - Grade 3-4 1 (1.2%) 1 (1.4%) 0 - 3 1 (1.2%) 1 (1.4%) 0 - ATRIAL FIBRILLATION - - Any Grade - 1 (1.2%) 2 (2.8%) 2 (2.1%) - Grade 1-2 1 (1.2%) 2 (2.8%) 2 (2.1%) - 1 1 (1.2%) 1 (1.4%) 2 (2.1%) - 2 0 1 (1.4%) 0 - ATRIOVENTRICULAR BLOCK SECOND DEGREE - - Any Grade - 2 (2.3%) 1 (1.4%) 2 (2.1%) - Grade 1-2 2 (2.3%) 1 (1.4%) 2 (2.1%) - 1 1 (1.2%) 1 (1.4%) 1 (1.0%) - 2 1 (1.2%) 0 1 (1.0%) - SUPRAVENTRICULAR EXTRASYSTOLES - - Any Grade - 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - Grade 3-4 0 1 (1.4%) 1 (1.0%) - 3 0 1 (1.4%) 0 - 4 0 0 1 (1.0%) - VENTRICULAR EXTRASYSTOLES - - Any Grade - 0 1 (1.4%) 2 (2.1%) - Grade 1-2 0 1 (1.4%) 2 (2.1%) - 1 0 1 (1.4%) 2 (2.1%) - ATRIAL FLUTTER - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 0 - 2 0 0 1 (1.0%) - ATRIOVENTRICULAR BLOCK FIRST DEGREE - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 1 1 (1.2%) 0 1 (1.0%) - BUNDLE BRANCH BLOCK RIGHT - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 1 0 0 1 (1.0%) - 2 1 (1.2%) 0 0 - PALPITATIONS - - Any Grade - 0 0 2 (2.1%) - Grade 1-2 0 0 2 (2.1%) - 1 0 0 2 (2.1%) - ATRIAL HYPERTROPHY - - Any Grade - 1 (1.2%) 0 0 - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - BRADYCARDIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - BUNDLE BRANCH BLOCK LEFT - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - CARDIAC DISORDER - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - CARDIAC FAILURE CONGESTIVE - - Any Grade - 1 (1.2%) 0 0 - Grade 3-4 1 (1.2%) 0 0 - 4 1 (1.2%) 0 0 - SINUS ARRHYTHMIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - SUPRAVENTRICULAR TACHYCARDIA - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - TACHYCARDIA - - Any Grade - 1 (1.2%) 0 0 - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - VENTRICULAR HYPERTROPHY - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - WOLFF-PARKINSON-WHITE SYNDROME - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - INFECTIONS AND INFESTATIONS - - Overall - - - Any Grade - 16 (18.6%) 13 (18.1%) 10 (10.4%) - Grade 1-2 14 (16.3%) 11 (15.3%) 9 (9.4%) - 1 6 (7.0%) 6 (8.3%) 4 (4.2%) - 2 8 (9.3%) 5 (6.9%) 5 (5.2%) - Grade 3-4 2 (2.3%) 2 (2.8%) 1 (1.0%) - 3 1 (1.2%) 1 (1.4%) 1 (1.0%) - 4 1 (1.2%) 1 (1.4%) 0 - NASOPHARYNGITIS - - Any Grade - 2 (2.3%) 6 (8.3%) 4 (4.2%) - Grade 1-2 2 (2.3%) 5 (6.9%) 3 (3.1%) - 1 2 (2.3%) 4 (5.6%) 2 (2.1%) - 2 0 1 (1.4%) 1 (1.0%) - Grade 3-4 0 1 (1.4%) 1 (1.0%) - 3 0 1 (1.4%) 1 (1.0%) - UPPER RESPIRATORY TRACT INFECTION - - Any Grade - 6 (7.0%) 3 (4.2%) 1 (1.0%) - Grade 1-2 5 (5.8%) 3 (4.2%) 1 (1.0%) - 1 1 (1.2%) 1 (1.4%) 0 - 2 4 (4.7%) 2 (2.8%) 1 (1.0%) - Grade 3-4 1 (1.2%) 0 0 - 4 1 (1.2%) 0 0 - INFLUENZA - - Any Grade - 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 1 (1.4%) 0 - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - URINARY TRACT INFECTION - - Any Grade - 2 (2.3%) 1 (1.4%) 0 - Grade 1-2 2 (2.3%) 1 (1.4%) 0 - 1 2 (2.3%) 1 (1.4%) 0 - CYSTITIS - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 2 1 (1.2%) 1 (1.4%) 0 - EAR INFECTION - - Any Grade - 2 (2.3%) 0 0 - Grade 1-2 2 (2.3%) 0 0 - 1 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - LOCALISED INFECTION - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 2 1 (1.2%) 0 1 (1.0%) - BRONCHITIS - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - CELLULITIS - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - CERVICITIS - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - GASTROENTERITIS VIRAL - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - HORDEOLUM - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - LOWER RESPIRATORY TRACT INFECTION - - Any Grade - 0 1 (1.4%) 0 - Grade 3-4 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - ONYCHOMYCOSIS - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - PNEUMONIA - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - RHINITIS - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - VAGINAL MYCOSIS - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - VIRAL INFECTION - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - - Overall - - - Any Grade - 10 (11.6%) 10 (13.9%) 10 (10.4%) - Grade 1-2 8 (9.3%) 6 (8.3%) 7 (7.3%) - 1 5 (5.8%) 4 (5.6%) 6 (6.2%) - 2 3 (3.5%) 2 (2.8%) 1 (1.0%) - Grade 3-4 1 (1.2%) 4 (5.6%) 3 (3.1%) - 3 1 (1.2%) 3 (4.2%) 2 (2.1%) - 4 0 1 (1.4%) 1 (1.0%) - Grade 5 1 (1.2%) 0 0 - COUGH - - Any Grade - 3 (3.5%) 5 (6.9%) 6 (6.2%) - Grade 1-2 2 (2.3%) 3 (4.2%) 4 (4.2%) - 1 1 (1.2%) 2 (2.8%) 3 (3.1%) - 2 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 3-4 0 2 (2.8%) 2 (2.1%) - 3 0 2 (2.8%) 1 (1.0%) - 4 0 0 1 (1.0%) - Grade 5 1 (1.2%) 0 0 - NASAL CONGESTION - - Any Grade - 3 (3.5%) 3 (4.2%) 1 (1.0%) - Grade 1-2 3 (3.5%) 3 (4.2%) 1 (1.0%) - 1 1 (1.2%) 3 (4.2%) 1 (1.0%) - 2 2 (2.3%) 0 0 - DYSPNOEA - - Any Grade - 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 1-2 1 (1.2%) 1 (1.4%) 1 (1.0%) - 1 1 (1.2%) 1 (1.4%) 1 (1.0%) - EPISTAXIS - - Any Grade - 0 2 (2.8%) 1 (1.0%) - Grade 1-2 0 2 (2.8%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - 2 0 1 (1.4%) 0 - PHARYNGOLARYNGEAL PAIN - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 1 (1.4%) 0 - RHINORRHOEA - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - Grade 3-4 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - ALLERGIC GRANULOMATOUS ANGIITIS - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - DYSPHONIA - - Any Grade - 0 0 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - EMPHYSEMA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - HAEMOPTYSIS - - Any Grade - 1 (1.2%) 0 0 - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - PHARYNGEAL ERYTHEMA - - Any Grade - 0 1 (1.4%) 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - POSTNASAL DRIP - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - PRODUCTIVE COUGH - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - RALES - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - RESPIRATORY TRACT CONGESTION - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - PSYCHIATRIC DISORDERS - - Overall - - - Any Grade - 10 (11.6%) 8 (11.1%) 11 (11.5%) - Grade 1-2 10 (11.6%) 8 (11.1%) 9 (9.4%) - 1 9 (10.5%) 6 (8.3%) 6 (6.2%) - 2 1 (1.2%) 2 (2.8%) 3 (3.1%) - Grade 3-4 0 0 2 (2.1%) - 3 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - CONFUSIONAL STATE - - Any Grade - 2 (2.3%) 1 (1.4%) 3 (3.1%) - Grade 1-2 2 (2.3%) 1 (1.4%) 2 (2.1%) - 1 2 (2.3%) 1 (1.4%) 2 (2.1%) - Grade 3-4 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - AGITATION - - Any Grade - 2 (2.3%) 0 3 (3.1%) - Grade 1-2 2 (2.3%) 0 3 (3.1%) - 1 2 (2.3%) 0 1 (1.0%) - 2 0 0 2 (2.1%) - ANXIETY - - Any Grade - 1 (1.2%) 0 3 (3.1%) - Grade 1-2 1 (1.2%) 0 3 (3.1%) - 1 0 0 3 (3.1%) - 2 1 (1.2%) 0 0 - INSOMNIA - - Any Grade - 2 (2.3%) 2 (2.8%) 0 - Grade 1-2 2 (2.3%) 2 (2.8%) 0 - 1 2 (2.3%) 2 (2.8%) 0 - DELUSION - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 1 1 (1.2%) 1 (1.4%) 0 - DEPRESSED MOOD - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - IRRITABILITY - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 2 1 (1.2%) 0 1 (1.0%) - COMPLETED SUICIDE - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - DELIRIUM - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - DISORIENTATION - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - HALLUCINATION - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - HALLUCINATION, VISUAL - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - LIBIDO DECREASED - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - LISTLESS - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - NIGHTMARE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - RESTLESSNESS - - Any Grade - 0 0 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - INVESTIGATIONS - - Overall - - - Any Grade - 10 (11.6%) 5 (6.9%) 8 (8.3%) - Grade 1-2 8 (9.3%) 3 (4.2%) 7 (7.3%) - 1 6 (7.0%) 2 (2.8%) 5 (5.2%) - 2 2 (2.3%) 1 (1.4%) 2 (2.1%) - Grade 3-4 2 (2.3%) 2 (2.8%) 1 (1.0%) - 3 1 (1.2%) 1 (1.4%) 0 - 4 1 (1.2%) 1 (1.4%) 1 (1.0%) - ELECTROCARDIOGRAM ST SEGMENT DEPRESSION - - Any Grade - 4 (4.7%) 0 1 (1.0%) - Grade 1-2 4 (4.7%) 0 1 (1.0%) - 1 3 (3.5%) 0 0 - 2 1 (1.2%) 0 1 (1.0%) - ELECTROCARDIOGRAM T WAVE INVERSION - - Any Grade - 2 (2.3%) 1 (1.4%) 1 (1.0%) - Grade 1-2 2 (2.3%) 1 (1.4%) 1 (1.0%) - 1 1 (1.2%) 0 1 (1.0%) - 2 1 (1.2%) 1 (1.4%) 0 - BLOOD GLUCOSE INCREASED - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - Grade 3-4 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 1 1 (1.2%) 0 0 - 2 0 0 1 (1.0%) - BIOPSY - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - BIOPSY PROSTATE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - BLOOD ALKALINE PHOSPHATASE INCREASED - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - BLOOD CHOLESTEROL INCREASED - - Any Grade - 0 1 (1.4%) 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - BLOOD CREATINE PHOSPHOKINASE INCREASED - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - BLOOD URINE PRESENT - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - BODY TEMPERATURE INCREASED - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - CYSTOSCOPY - - Any Grade - 1 (1.2%) 0 0 - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - HEART RATE INCREASED - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - HEART RATE IRREGULAR - - Any Grade - 1 (1.2%) 0 0 - Grade 3-4 1 (1.2%) 0 0 - 4 1 (1.2%) 0 0 - NASAL MUCOSA BIOPSY - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - NEUTROPHIL COUNT INCREASED - - Any Grade - 0 0 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - URINE ANALYSIS ABNORMAL - - Any Grade - 0 0 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - WEIGHT DECREASED - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - WHITE BLOOD CELL COUNT INCREASED - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS - - Overall - - - Any Grade - 5 (5.8%) 8 (11.1%) 7 (7.3%) - Grade 1-2 4 (4.7%) 7 (9.7%) 7 (7.3%) - 1 2 (2.3%) 6 (8.3%) 5 (5.2%) - 2 2 (2.3%) 1 (1.4%) 2 (2.1%) - Grade 3-4 1 (1.2%) 1 (1.4%) 0 - 3 1 (1.2%) 1 (1.4%) 0 - BACK PAIN - - Any Grade - 1 (1.2%) 3 (4.2%) 1 (1.0%) - Grade 1-2 1 (1.2%) 3 (4.2%) 1 (1.0%) - 1 0 3 (4.2%) 0 - 2 1 (1.2%) 0 1 (1.0%) - ARTHRALGIA - - Any Grade - 1 (1.2%) 1 (1.4%) 2 (2.1%) - Grade 1-2 1 (1.2%) 1 (1.4%) 2 (2.1%) - 1 0 1 (1.4%) 2 (2.1%) - 2 1 (1.2%) 0 0 - SHOULDER PAIN - - Any Grade - 1 (1.2%) 0 2 (2.1%) - Grade 1-2 1 (1.2%) 0 2 (2.1%) - 1 1 (1.2%) 0 2 (2.1%) - ARTHRITIS - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - FLANK PAIN - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 1 0 2 (2.8%) 0 - MUSCLE SPASMS - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 1 (1.4%) 0 - MUSCULAR WEAKNESS - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - MYALGIA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - PAIN IN EXTREMITY - - Any Grade - 1 (1.2%) 0 0 - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - INJURY, POISONING AND PROCEDURAL COMPLICATIONS - - Overall - - - Any Grade - 4 (4.7%) 5 (6.9%) 5 (5.2%) - Grade 1-2 4 (4.7%) 4 (5.6%) 5 (5.2%) - 1 2 (2.3%) 3 (4.2%) 4 (4.2%) - 2 2 (2.3%) 1 (1.4%) 1 (1.0%) - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - CONTUSION - - Any Grade - 1 (1.2%) 2 (2.8%) 1 (1.0%) - Grade 1-2 1 (1.2%) 2 (2.8%) 1 (1.0%) - 1 1 (1.2%) 2 (2.8%) 1 (1.0%) - EXCORIATION - - Any Grade - 2 (2.3%) 1 (1.4%) 1 (1.0%) - Grade 1-2 2 (2.3%) 1 (1.4%) 1 (1.0%) - 1 2 (2.3%) 1 (1.4%) 1 (1.0%) - FALL - - Any Grade - 1 (1.2%) 1 (1.4%) 2 (2.1%) - Grade 1-2 1 (1.2%) 0 2 (2.1%) - 1 0 0 2 (2.1%) - 2 1 (1.2%) 0 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - HIP FRACTURE - - Any Grade - 1 (1.2%) 2 (2.8%) 0 - Grade 1-2 1 (1.2%) 2 (2.8%) 0 - 1 1 (1.2%) 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - SKIN LACERATION - - Any Grade - 1 (1.2%) 0 2 (2.1%) - Grade 1-2 1 (1.2%) 0 2 (2.1%) - 1 0 0 1 (1.0%) - 2 1 (1.2%) 0 1 (1.0%) - FACIAL BONES FRACTURE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - JOINT DISLOCATION - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - WOUND - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - RENAL AND URINARY DISORDERS - - Overall - - - Any Grade - 4 (4.7%) 3 (4.2%) 4 (4.2%) - Grade 1-2 4 (4.7%) 3 (4.2%) 3 (3.1%) - 1 2 (2.3%) 2 (2.8%) 2 (2.1%) - 2 2 (2.3%) 1 (1.4%) 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - MICTURITION URGENCY - - Any Grade - 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 1-2 1 (1.2%) 1 (1.4%) 1 (1.0%) - 1 1 (1.2%) 0 0 - 2 0 1 (1.4%) 1 (1.0%) - DYSURIA - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 1 1 (1.2%) 0 1 (1.0%) - NEPHROLITHIASIS - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 1 (1.2%) 0 0 - CALCULUS URETHRAL - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - ENURESIS - - Any Grade - 0 0 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - INCONTINENCE - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - POLLAKIURIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - METABOLISM AND NUTRITION DISORDERS - - Overall - - - Any Grade - 6 (7.0%) 3 (4.2%) 1 (1.0%) - Grade 1-2 5 (5.8%) 2 (2.8%) 1 (1.0%) - 1 1 (1.2%) 2 (2.8%) 1 (1.0%) - 2 4 (4.7%) 0 0 - Grade 3-4 1 (1.2%) 1 (1.4%) 0 - 3 1 (1.2%) 0 0 - 4 0 1 (1.4%) 0 - DECREASED APPETITE - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 1 (1.2%) 0 0 - FOOD CRAVING - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - INCREASED APPETITE - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 1 (1.2%) 0 0 - DEHYDRATION - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - DIABETES MELLITUS - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - HYPERCHOLESTEROLAEMIA - - Any Grade - 0 1 (1.4%) 0 - Grade 3-4 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - HYPONATRAEMIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - VASCULAR DISORDERS - - Overall - - - Any Grade - 3 (3.5%) 1 (1.4%) 4 (4.2%) - Grade 1-2 2 (2.3%) 1 (1.4%) 3 (3.1%) - 1 2 (2.3%) 1 (1.4%) 1 (1.0%) - 2 0 0 2 (2.1%) - Grade 3-4 1 (1.2%) 0 1 (1.0%) - 4 1 (1.2%) 0 1 (1.0%) - HYPERTENSION - - Any Grade - 1 (1.2%) 0 2 (2.1%) - Grade 1-2 1 (1.2%) 0 2 (2.1%) - 1 1 (1.2%) 0 1 (1.0%) - 2 0 0 1 (1.0%) - HYPOTENSION - - Any Grade - 2 (2.3%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 1 1 (1.2%) 0 0 - 2 0 0 1 (1.0%) - Grade 3-4 1 (1.2%) 0 0 - 4 1 (1.2%) 0 0 - HOT FLUSH - - Any Grade - 0 0 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - ORTHOSTATIC HYPOTENSION - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - WOUND HAEMORRHAGE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - EYE DISORDERS - - Overall - - - Any Grade - 4 (4.7%) 1 (1.4%) 2 (2.1%) - Grade 1-2 2 (2.3%) 1 (1.4%) 2 (2.1%) - 1 0 1 (1.4%) 2 (2.1%) - 2 2 (2.3%) 0 0 - Grade 3-4 2 (2.3%) 0 0 - 4 2 (2.3%) 0 0 - CONJUNCTIVITIS - - Any Grade - 2 (2.3%) 0 0 - Grade 3-4 2 (2.3%) 0 0 - 4 2 (2.3%) 0 0 - VISION BLURRED - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - CONJUNCTIVAL HAEMORRHAGE - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - EYE ALLERGY - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - EYE PRURITUS - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - EYE SWELLING - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - GLAUCOMA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - SURGICAL AND MEDICAL PROCEDURES - - Overall - - - Any Grade - 2 (2.3%) 2 (2.8%) 1 (1.0%) - Grade 1-2 1 (1.2%) 2 (2.8%) 1 (1.0%) - 1 1 (1.2%) 1 (1.4%) 1 (1.0%) - 2 0 1 (1.4%) 0 - Grade 3-4 1 (1.2%) 0 0 - 4 1 (1.2%) 0 0 - CATARACT OPERATION - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - Grade 3-4 1 (1.2%) 0 0 - 4 1 (1.2%) 0 0 - ACROCHORDON EXCISION - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - EYE LASER SURGERY - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - SKIN LESION EXCISION - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - EAR AND LABYRINTH DISORDERS - - Overall - - - Any Grade - 1 (1.2%) 1 (1.4%) 2 (2.1%) - Grade 1-2 1 (1.2%) 1 (1.4%) 2 (2.1%) - 1 1 (1.2%) 1 (1.4%) 2 (2.1%) - VERTIGO - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - CERUMEN IMPACTION - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - EAR PAIN - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - TINNITUS - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - CONGENITAL, FAMILIAL AND GENETIC DISORDERS - - Overall - - - Any Grade - 0 2 (2.8%) 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - Grade 3-4 0 2 (2.8%) 0 - 3 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - VENTRICULAR SEPTAL DEFECT - - Any Grade - 0 2 (2.8%) 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - Grade 3-4 0 2 (2.8%) 0 - 3 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - - Overall - - - Any Grade - 0 1 (1.4%) 2 (2.1%) - Grade 1-2 0 1 (1.4%) 2 (2.1%) - 1 0 1 (1.4%) 1 (1.0%) - 2 0 0 1 (1.0%) - COLON CANCER - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - MALIGNANT FIBROUS HISTIOCYTOMA - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - PROSTATE CANCER - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - REPRODUCTIVE SYSTEM AND BREAST DISORDERS - - Overall - - - Any Grade - 2 (2.3%) 1 (1.4%) 0 - Grade 1-2 2 (2.3%) 1 (1.4%) 0 - 1 2 (2.3%) 0 0 - 2 0 1 (1.4%) 0 - BENIGN PROSTATIC HYPERPLASIA - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 1 1 (1.2%) 0 0 - 2 0 1 (1.4%) 0 - PELVIC PAIN - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - IMMUNE SYSTEM DISORDERS - - Overall - - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 0 - 2 0 0 1 (1.0%) - HYPERSENSITIVITY - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - SEASONAL ALLERGY - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - HEPATOBILIARY DISORDERS - - Overall - - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - HYPERBILIRUBINAEMIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - SOCIAL CIRCUMSTANCES - - Overall - - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - ALCOHOL USE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 + MedDRA System Organ Class + MedDRA Preferred Term Placebo Xanomeline High Dose Xanomeline Low Dose + Grade (N=86) (N=72) (N=96) + —————————————————————————————————————————————————————————————————————————————————————————————————————————————— + - Any adverse events - + - Any Grade - 23 (26.7%) 51 (70.8%) 54 (56.2%) + Grade 1-2 17 (19.8%) 42 (58.3%) 43 (44.8%) + 1 11 (12.8%) 26 (36.1%) 28 (29.2%) + 2 6 (7.0%) 16 (22.2%) 15 (15.6%) + Grade 3-4 6 (7.0%) 9 (12.5%) 10 (10.4%) + 3 2 (2.3%) 4 (5.6%) 5 (5.2%) + 4 4 (4.7%) 5 (6.9%) 5 (5.2%) + Grade 5 0 0 1 (1.0%) + SKIN AND SUBCUTANEOUS TISSUE DISORDERS + - Overall - + - Any Grade - 17 (19.8%) 32 (44.4%) 31 (32.3%) + Grade 1-2 13 (15.1%) 26 (36.1%) 25 (26.0%) + 1 10 (11.6%) 18 (25.0%) 15 (15.6%) + 2 3 (3.5%) 8 (11.1%) 10 (10.4%) + Grade 3-4 4 (4.7%) 6 (8.3%) 5 (5.2%) + 3 2 (2.3%) 3 (4.2%) 3 (3.1%) + 4 2 (2.3%) 3 (4.2%) 2 (2.1%) + Grade 5 0 0 1 (1.0%) + PRURITUS + - Any Grade - 8 (9.3%) 26 (36.1%) 23 (24.0%) + Grade 1-2 5 (5.8%) 20 (27.8%) 21 (21.9%) + 1 4 (4.7%) 15 (20.8%) 14 (14.6%) + 2 1 (1.2%) 5 (6.9%) 7 (7.3%) + Grade 3-4 3 (3.5%) 6 (8.3%) 1 (1.0%) + 3 1 (1.2%) 3 (4.2%) 1 (1.0%) + 4 2 (2.3%) 3 (4.2%) 0 + Grade 5 0 0 1 (1.0%) + ERYTHEMA + - Any Grade - 9 (10.5%) 14 (19.4%) 15 (15.6%) + Grade 1-2 9 (10.5%) 14 (19.4%) 13 (13.5%) + 1 8 (9.3%) 12 (16.7%) 8 (8.3%) + 2 1 (1.2%) 2 (2.8%) 5 (5.2%) + Grade 3-4 0 0 2 (2.1%) + 3 0 0 1 (1.0%) + 4 0 0 1 (1.0%) + RASH + - Any Grade - 5 (5.8%) 11 (15.3%) 13 (13.5%) + Grade 1-2 4 (4.7%) 10 (13.9%) 11 (11.5%) + 1 3 (3.5%) 7 (9.7%) 10 (10.4%) + 2 1 (1.2%) 3 (4.2%) 1 (1.0%) + Grade 3-4 1 (1.2%) 1 (1.4%) 2 (2.1%) + 3 1 (1.2%) 1 (1.4%) 1 (1.0%) + 4 0 0 1 (1.0%) + GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS + - Overall - + - Any Grade - 8 (9.3%) 24 (33.3%) 25 (26.0%) + Grade 1-2 6 (7.0%) 20 (27.8%) 20 (20.8%) + 1 3 (3.5%) 10 (13.9%) 14 (14.6%) + 2 3 (3.5%) 10 (13.9%) 6 (6.2%) + Grade 3-4 2 (2.3%) 4 (5.6%) 5 (5.2%) + 3 0 2 (2.8%) 2 (2.1%) + 4 2 (2.3%) 2 (2.8%) 3 (3.1%) + APPLICATION SITE PRURITUS + - Any Grade - 6 (7.0%) 21 (29.2%) 23 (24.0%) + Grade 1-2 4 (4.7%) 19 (26.4%) 20 (20.8%) + 1 2 (2.3%) 11 (15.3%) 16 (16.7%) + 2 2 (2.3%) 8 (11.1%) 4 (4.2%) + Grade 3-4 2 (2.3%) 2 (2.8%) 3 (3.1%) + 3 0 0 1 (1.0%) + 4 2 (2.3%) 2 (2.8%) 2 (2.1%) + APPLICATION SITE ERYTHEMA + - Any Grade - 3 (3.5%) 14 (19.4%) 13 (13.5%) + Grade 1-2 3 (3.5%) 12 (16.7%) 11 (11.5%) + 1 2 (2.3%) 10 (13.9%) 8 (8.3%) + 2 1 (1.2%) 2 (2.8%) 3 (3.1%) + Grade 3-4 0 2 (2.8%) 2 (2.1%) + 3 0 2 (2.8%) 1 (1.0%) + 4 0 0 1 (1.0%) # AET04 variant 11 is produced correctly (with Incidence Rate of at Least X%, all SOCs w/o preferred terms removed) Code res Output - MedDRA System Organ Class - MedDRA Preferred Term Placebo Xanomeline High Dose Xanomeline Low Dose - Grade (N=86) (N=72) (N=96) - ————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— - - Any adverse events - - - Any Grade - 69 (80.2%) 70 (97.2%) 86 (89.6%) - Grade 1-2 46 (53.5%) 37 (51.4%) 54 (56.2%) - 1 22 (25.6%) 18 (25.0%) 19 (19.8%) - 2 24 (27.9%) 19 (26.4%) 35 (36.5%) - Grade 3-4 20 (23.3%) 32 (44.4%) 30 (31.2%) - 3 8 (9.3%) 16 (22.2%) 11 (11.5%) - 4 12 (14.0%) 16 (22.2%) 19 (19.8%) - Grade 5 3 (3.5%) 1 (1.4%) 2 (2.1%) - GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - - Overall - - - Any Grade - 21 (24.4%) 36 (50.0%) 51 (53.1%) - Grade 1-2 17 (19.8%) 28 (38.9%) 40 (41.7%) - 1 10 (11.6%) 15 (20.8%) 20 (20.8%) - 2 7 (8.1%) 13 (18.1%) 20 (20.8%) - Grade 3-4 4 (4.7%) 8 (11.1%) 11 (11.5%) - 3 2 (2.3%) 3 (4.2%) 6 (6.2%) - 4 2 (2.3%) 5 (6.9%) 5 (5.2%) - APPLICATION SITE PRURITUS - - Any Grade - 6 (7.0%) 21 (29.2%) 23 (24.0%) - Grade 1-2 4 (4.7%) 19 (26.4%) 20 (20.8%) - 1 2 (2.3%) 11 (15.3%) 16 (16.7%) - 2 2 (2.3%) 8 (11.1%) 4 (4.2%) - Grade 3-4 2 (2.3%) 2 (2.8%) 3 (3.1%) - 3 0 0 1 (1.0%) - 4 2 (2.3%) 2 (2.8%) 2 (2.1%) - APPLICATION SITE ERYTHEMA - - Any Grade - 3 (3.5%) 14 (19.4%) 13 (13.5%) - Grade 1-2 3 (3.5%) 12 (16.7%) 11 (11.5%) - 1 2 (2.3%) 10 (13.9%) 8 (8.3%) - 2 1 (1.2%) 2 (2.8%) 3 (3.1%) - Grade 3-4 0 2 (2.8%) 2 (2.1%) - 3 0 2 (2.8%) 1 (1.0%) - 4 0 0 1 (1.0%) - APPLICATION SITE DERMATITIS - - Any Grade - 5 (5.8%) 7 (9.7%) 9 (9.4%) - Grade 1-2 4 (4.7%) 6 (8.3%) 8 (8.3%) - 1 3 (3.5%) 3 (4.2%) 4 (4.2%) - 2 1 (1.2%) 3 (4.2%) 4 (4.2%) - Grade 3-4 1 (1.2%) 1 (1.4%) 1 (1.0%) - 3 1 (1.2%) 1 (1.4%) 1 (1.0%) - APPLICATION SITE IRRITATION - - Any Grade - 3 (3.5%) 9 (12.5%) 9 (9.4%) - Grade 1-2 2 (2.3%) 8 (11.1%) 6 (6.2%) - 1 2 (2.3%) 6 (8.3%) 3 (3.1%) - 2 0 2 (2.8%) 3 (3.1%) - Grade 3-4 1 (1.2%) 1 (1.4%) 3 (3.1%) - 3 1 (1.2%) 0 1 (1.0%) - 4 0 1 (1.4%) 2 (2.1%) - APPLICATION SITE VESICLES - - Any Grade - 1 (1.2%) 5 (6.9%) 5 (5.2%) - Grade 1-2 1 (1.2%) 4 (5.6%) 5 (5.2%) - 1 0 3 (4.2%) 4 (4.2%) - 2 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 3-4 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - FATIGUE - - Any Grade - 1 (1.2%) 5 (6.9%) 5 (5.2%) - Grade 1-2 1 (1.2%) 4 (5.6%) 5 (5.2%) - 1 0 3 (4.2%) 3 (3.1%) - 2 1 (1.2%) 1 (1.4%) 2 (2.1%) - Grade 3-4 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - OEDEMA PERIPHERAL - - Any Grade - 2 (2.3%) 2 (2.8%) 1 (1.0%) - Grade 1-2 1 (1.2%) 2 (2.8%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - 2 1 (1.2%) 1 (1.4%) 0 - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - APPLICATION SITE SWELLING - - Any Grade - 0 2 (2.8%) 1 (1.0%) - Grade 1-2 0 2 (2.8%) 1 (1.0%) - 1 0 2 (2.8%) 1 (1.0%) - APPLICATION SITE URTICARIA - - Any Grade - 0 1 (1.4%) 2 (2.1%) - Grade 1-2 0 1 (1.4%) 2 (2.1%) - 1 0 1 (1.4%) 1 (1.0%) - 2 0 0 1 (1.0%) - CHILLS - - Any Grade - 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 1-2 1 (1.2%) 1 (1.4%) 1 (1.0%) - 1 1 (1.2%) 1 (1.4%) 0 - 2 0 0 1 (1.0%) - MALAISE - - Any Grade - 0 2 (2.8%) 1 (1.0%) - Grade 1-2 0 2 (2.8%) 1 (1.0%) - 1 0 1 (1.4%) 0 - 2 0 1 (1.4%) 1 (1.0%) - PYREXIA - - Any Grade - 2 (2.3%) 0 1 (1.0%) - Grade 1-2 2 (2.3%) 0 1 (1.0%) - 1 1 (1.2%) 0 1 (1.0%) - 2 1 (1.2%) 0 0 - APPLICATION SITE PAIN - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 1 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - APPLICATION SITE PERSPIRATION - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 2 0 2 (2.8%) 0 - APPLICATION SITE REACTION - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 1 1 (1.2%) 1 (1.4%) 0 - ASTHENIA - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 1 1 (1.2%) 0 0 - 2 0 0 1 (1.0%) - CHEST DISCOMFORT - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 0 - 2 0 0 1 (1.0%) - CHEST PAIN - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 1 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - OEDEMA - - Any Grade - 0 0 2 (2.1%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - PAIN - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - APPLICATION SITE BLEEDING - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - APPLICATION SITE DESQUAMATION - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - APPLICATION SITE DISCHARGE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - APPLICATION SITE DISCOLOURATION - - Any Grade - 0 0 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - APPLICATION SITE INDURATION - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - APPLICATION SITE WARMTH - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - CYST - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - FEELING ABNORMAL - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - FEELING COLD - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - INFLAMMATION - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - SECRETION DISCHARGE - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - SUDDEN DEATH - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - SWELLING - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - ULCER - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - SKIN AND SUBCUTANEOUS TISSUE DISORDERS - - Overall - - - Any Grade - 21 (24.4%) 42 (58.3%) 42 (43.8%) - Grade 1-2 17 (19.8%) 33 (45.8%) 33 (34.4%) - 1 11 (12.8%) 20 (27.8%) 17 (17.7%) - 2 6 (7.0%) 13 (18.1%) 16 (16.7%) - Grade 3-4 4 (4.7%) 9 (12.5%) 7 (7.3%) - 3 2 (2.3%) 4 (5.6%) 4 (4.2%) - 4 2 (2.3%) 5 (6.9%) 3 (3.1%) - Grade 5 0 0 2 (2.1%) - PRURITUS - - Any Grade - 8 (9.3%) 26 (36.1%) 23 (24.0%) - Grade 1-2 5 (5.8%) 20 (27.8%) 21 (21.9%) - 1 4 (4.7%) 15 (20.8%) 14 (14.6%) - 2 1 (1.2%) 5 (6.9%) 7 (7.3%) - Grade 3-4 3 (3.5%) 6 (8.3%) 1 (1.0%) - 3 1 (1.2%) 3 (4.2%) 1 (1.0%) - 4 2 (2.3%) 3 (4.2%) 0 - Grade 5 0 0 1 (1.0%) - ERYTHEMA - - Any Grade - 9 (10.5%) 14 (19.4%) 15 (15.6%) - Grade 1-2 9 (10.5%) 14 (19.4%) 13 (13.5%) - 1 8 (9.3%) 12 (16.7%) 8 (8.3%) - 2 1 (1.2%) 2 (2.8%) 5 (5.2%) - Grade 3-4 0 0 2 (2.1%) - 3 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - RASH - - Any Grade - 5 (5.8%) 11 (15.3%) 13 (13.5%) - Grade 1-2 4 (4.7%) 10 (13.9%) 11 (11.5%) - 1 3 (3.5%) 7 (9.7%) 10 (10.4%) - 2 1 (1.2%) 3 (4.2%) 1 (1.0%) - Grade 3-4 1 (1.2%) 1 (1.4%) 2 (2.1%) - 3 1 (1.2%) 1 (1.4%) 1 (1.0%) - 4 0 0 1 (1.0%) - HYPERHIDROSIS - - Any Grade - 2 (2.3%) 8 (11.1%) 4 (4.2%) - Grade 1-2 2 (2.3%) 7 (9.7%) 4 (4.2%) - 1 0 5 (6.9%) 4 (4.2%) - 2 2 (2.3%) 2 (2.8%) 0 - Grade 3-4 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - SKIN IRRITATION - - Any Grade - 3 (3.5%) 5 (6.9%) 6 (6.2%) - Grade 1-2 3 (3.5%) 5 (6.9%) 4 (4.2%) - 1 1 (1.2%) 3 (4.2%) 3 (3.1%) - 2 2 (2.3%) 2 (2.8%) 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - Grade 5 0 0 1 (1.0%) - BLISTER - - Any Grade - 0 1 (1.4%) 5 (5.2%) - Grade 1-2 0 1 (1.4%) 5 (5.2%) - 1 0 1 (1.4%) 4 (4.2%) - 2 0 0 1 (1.0%) - RASH PRURITIC - - Any Grade - 0 2 (2.8%) 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - Grade 3-4 0 2 (2.8%) 0 - 3 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - PRURITUS GENERALISED - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 0 - 2 0 0 1 (1.0%) - RASH ERYTHEMATOUS - - Any Grade - 0 0 2 (2.1%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - URTICARIA - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - ACTINIC KERATOSIS - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - ALOPECIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - COLD SWEAT - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - DERMATITIS ATOPIC - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - DERMATITIS CONTACT - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - DRUG ERUPTION - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - RASH MACULO-PAPULAR - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - RASH PAPULAR - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - SKIN EXFOLIATION - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - SKIN ODOUR ABNORMAL - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - SKIN ULCER - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - NERVOUS SYSTEM DISORDERS - - Overall - - - Any Grade - 12 (14.0%) 25 (34.7%) 22 (22.9%) - Grade 1-2 10 (11.6%) 22 (30.6%) 19 (19.8%) - 1 7 (8.1%) 16 (22.2%) 13 (13.5%) - 2 3 (3.5%) 6 (8.3%) 6 (6.2%) - Grade 3-4 1 (1.2%) 3 (4.2%) 3 (3.1%) - 3 0 1 (1.4%) 1 (1.0%) - 4 1 (1.2%) 2 (2.8%) 2 (2.1%) - Grade 5 1 (1.2%) 0 0 - DIZZINESS - - Any Grade - 2 (2.3%) 11 (15.3%) 9 (9.4%) - Grade 1-2 2 (2.3%) 9 (12.5%) 8 (8.3%) - 1 1 (1.2%) 9 (12.5%) 5 (5.2%) - 2 1 (1.2%) 0 3 (3.1%) - Grade 3-4 0 2 (2.8%) 1 (1.0%) - 3 0 0 1 (1.0%) - 4 0 2 (2.8%) 0 - HEADACHE - - Any Grade - 7 (8.1%) 6 (8.3%) 3 (3.1%) - Grade 1-2 6 (7.0%) 6 (8.3%) 3 (3.1%) - 1 5 (5.8%) 3 (4.2%) 2 (2.1%) - 2 1 (1.2%) 3 (4.2%) 1 (1.0%) - Grade 3-4 1 (1.2%) 0 0 - 4 1 (1.2%) 0 0 - SYNCOPE - - Any Grade - 0 2 (2.8%) 5 (5.2%) - Grade 1-2 0 2 (2.8%) 5 (5.2%) - 1 0 2 (2.8%) 5 (5.2%) - SOMNOLENCE - - Any Grade - 2 (2.3%) 1 (1.4%) 3 (3.1%) - Grade 1-2 2 (2.3%) 1 (1.4%) 2 (2.1%) - 1 1 (1.2%) 1 (1.4%) 2 (2.1%) - 2 1 (1.2%) 0 0 - Grade 3-4 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - TRANSIENT ISCHAEMIC ATTACK - - Any Grade - 0 1 (1.4%) 2 (2.1%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 2 0 1 (1.4%) 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - BURNING SENSATION - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 1 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - LETHARGY - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - AMNESIA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - BALANCE DISORDER - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - COGNITIVE DISORDER - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - COMPLEX PARTIAL SEIZURES - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - COORDINATION ABNORMAL - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - HEMIANOPIA HOMONYMOUS - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - HYPERSOMNIA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - PARAESTHESIA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - PARAESTHESIA ORAL - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - PARKINSON'S DISEASE - - Any Grade - 1 (1.2%) 0 0 - Grade 5 1 (1.2%) 0 0 - PAROSMIA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - PARTIAL SEIZURES WITH SECONDARY GENERALISATION - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - PSYCHOMOTOR HYPERACTIVITY - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - STUPOR - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - SYNCOPE VASOVAGAL - - Any Grade - 0 1 (1.4%) 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - GASTROINTESTINAL DISORDERS - - Overall - - - Any Grade - 17 (19.8%) 20 (27.8%) 16 (16.7%) - Grade 1-2 14 (16.3%) 17 (23.6%) 12 (12.5%) - 1 9 (10.5%) 12 (16.7%) 10 (10.4%) - 2 5 (5.8%) 5 (6.9%) 2 (2.1%) - Grade 3-4 2 (2.3%) 2 (2.8%) 4 (4.2%) - 3 0 2 (2.8%) 0 - 4 2 (2.3%) 0 4 (4.2%) - Grade 5 1 (1.2%) 1 (1.4%) 0 - DIARRHOEA - - Any Grade - 9 (10.5%) 3 (4.2%) 6 (6.2%) - Grade 1-2 8 (9.3%) 3 (4.2%) 4 (4.2%) - 1 7 (8.1%) 3 (4.2%) 3 (3.1%) - 2 1 (1.2%) 0 1 (1.0%) - Grade 3-4 1 (1.2%) 0 2 (2.1%) - 4 1 (1.2%) 0 2 (2.1%) - VOMITING - - Any Grade - 3 (3.5%) 6 (8.3%) 4 (4.2%) - Grade 1-2 2 (2.3%) 6 (8.3%) 4 (4.2%) - 1 0 4 (5.6%) 3 (3.1%) - 2 2 (2.3%) 2 (2.8%) 1 (1.0%) - Grade 5 1 (1.2%) 0 0 - NAUSEA - - Any Grade - 3 (3.5%) 6 (8.3%) 3 (3.1%) - Grade 1-2 3 (3.5%) 3 (4.2%) 2 (2.1%) - 1 2 (2.3%) 2 (2.8%) 1 (1.0%) - 2 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 3-4 0 2 (2.8%) 1 (1.0%) - 3 0 2 (2.8%) 0 - 4 0 0 1 (1.0%) - Grade 5 0 1 (1.4%) 0 - ABDOMINAL PAIN - - Any Grade - 1 (1.2%) 1 (1.4%) 3 (3.1%) - Grade 1-2 0 1 (1.4%) 2 (2.1%) - 1 0 1 (1.4%) 2 (2.1%) - Grade 3-4 1 (1.2%) 0 1 (1.0%) - 4 1 (1.2%) 0 1 (1.0%) - SALIVARY HYPERSECRETION - - Any Grade - 0 4 (5.6%) 0 - Grade 1-2 0 4 (5.6%) 0 - 1 0 2 (2.8%) 0 - 2 0 2 (2.8%) 0 - DYSPEPSIA - - Any Grade - 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 1-2 1 (1.2%) 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - 2 1 (1.2%) 0 0 - ABDOMINAL DISCOMFORT - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - CONSTIPATION - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - DYSPHAGIA - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - FLATULENCE - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - GASTROINTESTINAL HAEMORRHAGE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - GASTROOESOPHAGEAL REFLUX DISEASE - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - GLOSSITIS - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - HIATUS HERNIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - RECTAL HAEMORRHAGE - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - STOMACH DISCOMFORT - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - CARDIAC DISORDERS - - Overall - - - Any Grade - 13 (15.1%) 15 (20.8%) 16 (16.7%) - Grade 1-2 9 (10.5%) 13 (18.1%) 15 (15.6%) - 1 5 (5.8%) 9 (12.5%) 12 (12.5%) - 2 4 (4.7%) 4 (5.6%) 3 (3.1%) - Grade 3-4 4 (4.7%) 2 (2.8%) 1 (1.0%) - 3 3 (3.5%) 2 (2.8%) 0 - 4 1 (1.2%) 0 1 (1.0%) - SINUS BRADYCARDIA - - Any Grade - 2 (2.3%) 8 (11.1%) 7 (7.3%) - Grade 1-2 2 (2.3%) 8 (11.1%) 7 (7.3%) - 1 1 (1.2%) 6 (8.3%) 7 (7.3%) - 2 1 (1.2%) 2 (2.8%) 0 - MYOCARDIAL INFARCTION - - Any Grade - 4 (4.7%) 4 (5.6%) 2 (2.1%) - Grade 1-2 3 (3.5%) 3 (4.2%) 2 (2.1%) - 1 1 (1.2%) 2 (2.8%) 2 (2.1%) - 2 2 (2.3%) 1 (1.4%) 0 - Grade 3-4 1 (1.2%) 1 (1.4%) 0 - 3 1 (1.2%) 1 (1.4%) 0 - ATRIAL FIBRILLATION - - Any Grade - 1 (1.2%) 2 (2.8%) 2 (2.1%) - Grade 1-2 1 (1.2%) 2 (2.8%) 2 (2.1%) - 1 1 (1.2%) 1 (1.4%) 2 (2.1%) - 2 0 1 (1.4%) 0 - ATRIOVENTRICULAR BLOCK SECOND DEGREE - - Any Grade - 2 (2.3%) 1 (1.4%) 2 (2.1%) - Grade 1-2 2 (2.3%) 1 (1.4%) 2 (2.1%) - 1 1 (1.2%) 1 (1.4%) 1 (1.0%) - 2 1 (1.2%) 0 1 (1.0%) - SUPRAVENTRICULAR EXTRASYSTOLES - - Any Grade - 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - Grade 3-4 0 1 (1.4%) 1 (1.0%) - 3 0 1 (1.4%) 0 - 4 0 0 1 (1.0%) - VENTRICULAR EXTRASYSTOLES - - Any Grade - 0 1 (1.4%) 2 (2.1%) - Grade 1-2 0 1 (1.4%) 2 (2.1%) - 1 0 1 (1.4%) 2 (2.1%) - ATRIAL FLUTTER - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 0 - 2 0 0 1 (1.0%) - ATRIOVENTRICULAR BLOCK FIRST DEGREE - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 1 1 (1.2%) 0 1 (1.0%) - BUNDLE BRANCH BLOCK RIGHT - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 1 0 0 1 (1.0%) - 2 1 (1.2%) 0 0 - PALPITATIONS - - Any Grade - 0 0 2 (2.1%) - Grade 1-2 0 0 2 (2.1%) - 1 0 0 2 (2.1%) - ATRIAL HYPERTROPHY - - Any Grade - 1 (1.2%) 0 0 - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - BRADYCARDIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - BUNDLE BRANCH BLOCK LEFT - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - CARDIAC DISORDER - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - CARDIAC FAILURE CONGESTIVE - - Any Grade - 1 (1.2%) 0 0 - Grade 3-4 1 (1.2%) 0 0 - 4 1 (1.2%) 0 0 - SINUS ARRHYTHMIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - SUPRAVENTRICULAR TACHYCARDIA - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - TACHYCARDIA - - Any Grade - 1 (1.2%) 0 0 - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - VENTRICULAR HYPERTROPHY - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - WOLFF-PARKINSON-WHITE SYNDROME - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - INFECTIONS AND INFESTATIONS - - Overall - - - Any Grade - 16 (18.6%) 13 (18.1%) 10 (10.4%) - Grade 1-2 14 (16.3%) 11 (15.3%) 9 (9.4%) - 1 6 (7.0%) 6 (8.3%) 4 (4.2%) - 2 8 (9.3%) 5 (6.9%) 5 (5.2%) - Grade 3-4 2 (2.3%) 2 (2.8%) 1 (1.0%) - 3 1 (1.2%) 1 (1.4%) 1 (1.0%) - 4 1 (1.2%) 1 (1.4%) 0 - NASOPHARYNGITIS - - Any Grade - 2 (2.3%) 6 (8.3%) 4 (4.2%) - Grade 1-2 2 (2.3%) 5 (6.9%) 3 (3.1%) - 1 2 (2.3%) 4 (5.6%) 2 (2.1%) - 2 0 1 (1.4%) 1 (1.0%) - Grade 3-4 0 1 (1.4%) 1 (1.0%) - 3 0 1 (1.4%) 1 (1.0%) - UPPER RESPIRATORY TRACT INFECTION - - Any Grade - 6 (7.0%) 3 (4.2%) 1 (1.0%) - Grade 1-2 5 (5.8%) 3 (4.2%) 1 (1.0%) - 1 1 (1.2%) 1 (1.4%) 0 - 2 4 (4.7%) 2 (2.8%) 1 (1.0%) - Grade 3-4 1 (1.2%) 0 0 - 4 1 (1.2%) 0 0 - INFLUENZA - - Any Grade - 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 1 (1.4%) 0 - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - URINARY TRACT INFECTION - - Any Grade - 2 (2.3%) 1 (1.4%) 0 - Grade 1-2 2 (2.3%) 1 (1.4%) 0 - 1 2 (2.3%) 1 (1.4%) 0 - CYSTITIS - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 2 1 (1.2%) 1 (1.4%) 0 - EAR INFECTION - - Any Grade - 2 (2.3%) 0 0 - Grade 1-2 2 (2.3%) 0 0 - 1 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - LOCALISED INFECTION - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 2 1 (1.2%) 0 1 (1.0%) - BRONCHITIS - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - CELLULITIS - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - CERVICITIS - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - GASTROENTERITIS VIRAL - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - HORDEOLUM - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - LOWER RESPIRATORY TRACT INFECTION - - Any Grade - 0 1 (1.4%) 0 - Grade 3-4 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - ONYCHOMYCOSIS - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - PNEUMONIA - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - RHINITIS - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - VAGINAL MYCOSIS - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - VIRAL INFECTION - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - - Overall - - - Any Grade - 10 (11.6%) 10 (13.9%) 10 (10.4%) - Grade 1-2 8 (9.3%) 6 (8.3%) 7 (7.3%) - 1 5 (5.8%) 4 (5.6%) 6 (6.2%) - 2 3 (3.5%) 2 (2.8%) 1 (1.0%) - Grade 3-4 1 (1.2%) 4 (5.6%) 3 (3.1%) - 3 1 (1.2%) 3 (4.2%) 2 (2.1%) - 4 0 1 (1.4%) 1 (1.0%) - Grade 5 1 (1.2%) 0 0 - COUGH - - Any Grade - 3 (3.5%) 5 (6.9%) 6 (6.2%) - Grade 1-2 2 (2.3%) 3 (4.2%) 4 (4.2%) - 1 1 (1.2%) 2 (2.8%) 3 (3.1%) - 2 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 3-4 0 2 (2.8%) 2 (2.1%) - 3 0 2 (2.8%) 1 (1.0%) - 4 0 0 1 (1.0%) - Grade 5 1 (1.2%) 0 0 - NASAL CONGESTION - - Any Grade - 3 (3.5%) 3 (4.2%) 1 (1.0%) - Grade 1-2 3 (3.5%) 3 (4.2%) 1 (1.0%) - 1 1 (1.2%) 3 (4.2%) 1 (1.0%) - 2 2 (2.3%) 0 0 - DYSPNOEA - - Any Grade - 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 1-2 1 (1.2%) 1 (1.4%) 1 (1.0%) - 1 1 (1.2%) 1 (1.4%) 1 (1.0%) - EPISTAXIS - - Any Grade - 0 2 (2.8%) 1 (1.0%) - Grade 1-2 0 2 (2.8%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - 2 0 1 (1.4%) 0 - PHARYNGOLARYNGEAL PAIN - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 1 (1.4%) 0 - RHINORRHOEA - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - Grade 3-4 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - ALLERGIC GRANULOMATOUS ANGIITIS - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - DYSPHONIA - - Any Grade - 0 0 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - EMPHYSEMA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - HAEMOPTYSIS - - Any Grade - 1 (1.2%) 0 0 - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - PHARYNGEAL ERYTHEMA - - Any Grade - 0 1 (1.4%) 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - POSTNASAL DRIP - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - PRODUCTIVE COUGH - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - RALES - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - RESPIRATORY TRACT CONGESTION - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - PSYCHIATRIC DISORDERS - - Overall - - - Any Grade - 10 (11.6%) 8 (11.1%) 11 (11.5%) - Grade 1-2 10 (11.6%) 8 (11.1%) 9 (9.4%) - 1 9 (10.5%) 6 (8.3%) 6 (6.2%) - 2 1 (1.2%) 2 (2.8%) 3 (3.1%) - Grade 3-4 0 0 2 (2.1%) - 3 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - CONFUSIONAL STATE - - Any Grade - 2 (2.3%) 1 (1.4%) 3 (3.1%) - Grade 1-2 2 (2.3%) 1 (1.4%) 2 (2.1%) - 1 2 (2.3%) 1 (1.4%) 2 (2.1%) - Grade 3-4 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - AGITATION - - Any Grade - 2 (2.3%) 0 3 (3.1%) - Grade 1-2 2 (2.3%) 0 3 (3.1%) - 1 2 (2.3%) 0 1 (1.0%) - 2 0 0 2 (2.1%) - ANXIETY - - Any Grade - 1 (1.2%) 0 3 (3.1%) - Grade 1-2 1 (1.2%) 0 3 (3.1%) - 1 0 0 3 (3.1%) - 2 1 (1.2%) 0 0 - INSOMNIA - - Any Grade - 2 (2.3%) 2 (2.8%) 0 - Grade 1-2 2 (2.3%) 2 (2.8%) 0 - 1 2 (2.3%) 2 (2.8%) 0 - DELUSION - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 1 1 (1.2%) 1 (1.4%) 0 - DEPRESSED MOOD - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - IRRITABILITY - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 2 1 (1.2%) 0 1 (1.0%) - COMPLETED SUICIDE - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - DELIRIUM - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - DISORIENTATION - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - HALLUCINATION - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - HALLUCINATION, VISUAL - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - LIBIDO DECREASED - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - LISTLESS - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - NIGHTMARE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - RESTLESSNESS - - Any Grade - 0 0 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - INVESTIGATIONS - - Overall - - - Any Grade - 10 (11.6%) 5 (6.9%) 8 (8.3%) - Grade 1-2 8 (9.3%) 3 (4.2%) 7 (7.3%) - 1 6 (7.0%) 2 (2.8%) 5 (5.2%) - 2 2 (2.3%) 1 (1.4%) 2 (2.1%) - Grade 3-4 2 (2.3%) 2 (2.8%) 1 (1.0%) - 3 1 (1.2%) 1 (1.4%) 0 - 4 1 (1.2%) 1 (1.4%) 1 (1.0%) - ELECTROCARDIOGRAM ST SEGMENT DEPRESSION - - Any Grade - 4 (4.7%) 0 1 (1.0%) - Grade 1-2 4 (4.7%) 0 1 (1.0%) - 1 3 (3.5%) 0 0 - 2 1 (1.2%) 0 1 (1.0%) - ELECTROCARDIOGRAM T WAVE INVERSION - - Any Grade - 2 (2.3%) 1 (1.4%) 1 (1.0%) - Grade 1-2 2 (2.3%) 1 (1.4%) 1 (1.0%) - 1 1 (1.2%) 0 1 (1.0%) - 2 1 (1.2%) 1 (1.4%) 0 - BLOOD GLUCOSE INCREASED - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - Grade 3-4 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 1 1 (1.2%) 0 0 - 2 0 0 1 (1.0%) - BIOPSY - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - BIOPSY PROSTATE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - BLOOD ALKALINE PHOSPHATASE INCREASED - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - BLOOD CHOLESTEROL INCREASED - - Any Grade - 0 1 (1.4%) 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - BLOOD CREATINE PHOSPHOKINASE INCREASED - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - BLOOD URINE PRESENT - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - BODY TEMPERATURE INCREASED - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - CYSTOSCOPY - - Any Grade - 1 (1.2%) 0 0 - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - HEART RATE INCREASED - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - HEART RATE IRREGULAR - - Any Grade - 1 (1.2%) 0 0 - Grade 3-4 1 (1.2%) 0 0 - 4 1 (1.2%) 0 0 - NASAL MUCOSA BIOPSY - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - NEUTROPHIL COUNT INCREASED - - Any Grade - 0 0 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - URINE ANALYSIS ABNORMAL - - Any Grade - 0 0 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - WEIGHT DECREASED - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - WHITE BLOOD CELL COUNT INCREASED - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS - - Overall - - - Any Grade - 5 (5.8%) 8 (11.1%) 7 (7.3%) - Grade 1-2 4 (4.7%) 7 (9.7%) 7 (7.3%) - 1 2 (2.3%) 6 (8.3%) 5 (5.2%) - 2 2 (2.3%) 1 (1.4%) 2 (2.1%) - Grade 3-4 1 (1.2%) 1 (1.4%) 0 - 3 1 (1.2%) 1 (1.4%) 0 - BACK PAIN - - Any Grade - 1 (1.2%) 3 (4.2%) 1 (1.0%) - Grade 1-2 1 (1.2%) 3 (4.2%) 1 (1.0%) - 1 0 3 (4.2%) 0 - 2 1 (1.2%) 0 1 (1.0%) - ARTHRALGIA - - Any Grade - 1 (1.2%) 1 (1.4%) 2 (2.1%) - Grade 1-2 1 (1.2%) 1 (1.4%) 2 (2.1%) - 1 0 1 (1.4%) 2 (2.1%) - 2 1 (1.2%) 0 0 - SHOULDER PAIN - - Any Grade - 1 (1.2%) 0 2 (2.1%) - Grade 1-2 1 (1.2%) 0 2 (2.1%) - 1 1 (1.2%) 0 2 (2.1%) - ARTHRITIS - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - FLANK PAIN - - Any Grade - 0 2 (2.8%) 0 - Grade 1-2 0 2 (2.8%) 0 - 1 0 2 (2.8%) 0 - MUSCLE SPASMS - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 0 1 (1.0%) - 2 0 1 (1.4%) 0 - MUSCULAR WEAKNESS - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - MYALGIA - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - PAIN IN EXTREMITY - - Any Grade - 1 (1.2%) 0 0 - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - INJURY, POISONING AND PROCEDURAL COMPLICATIONS - - Overall - - - Any Grade - 4 (4.7%) 5 (6.9%) 5 (5.2%) - Grade 1-2 4 (4.7%) 4 (5.6%) 5 (5.2%) - 1 2 (2.3%) 3 (4.2%) 4 (4.2%) - 2 2 (2.3%) 1 (1.4%) 1 (1.0%) - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - CONTUSION - - Any Grade - 1 (1.2%) 2 (2.8%) 1 (1.0%) - Grade 1-2 1 (1.2%) 2 (2.8%) 1 (1.0%) - 1 1 (1.2%) 2 (2.8%) 1 (1.0%) - EXCORIATION - - Any Grade - 2 (2.3%) 1 (1.4%) 1 (1.0%) - Grade 1-2 2 (2.3%) 1 (1.4%) 1 (1.0%) - 1 2 (2.3%) 1 (1.4%) 1 (1.0%) - FALL - - Any Grade - 1 (1.2%) 1 (1.4%) 2 (2.1%) - Grade 1-2 1 (1.2%) 0 2 (2.1%) - 1 0 0 2 (2.1%) - 2 1 (1.2%) 0 0 - Grade 3-4 0 1 (1.4%) 0 - 3 0 1 (1.4%) 0 - HIP FRACTURE - - Any Grade - 1 (1.2%) 2 (2.8%) 0 - Grade 1-2 1 (1.2%) 2 (2.8%) 0 - 1 1 (1.2%) 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - SKIN LACERATION - - Any Grade - 1 (1.2%) 0 2 (2.1%) - Grade 1-2 1 (1.2%) 0 2 (2.1%) - 1 0 0 1 (1.0%) - 2 1 (1.2%) 0 1 (1.0%) - FACIAL BONES FRACTURE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - JOINT DISLOCATION - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - WOUND - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - RENAL AND URINARY DISORDERS - - Overall - - - Any Grade - 4 (4.7%) 3 (4.2%) 4 (4.2%) - Grade 1-2 4 (4.7%) 3 (4.2%) 3 (3.1%) - 1 2 (2.3%) 2 (2.8%) 2 (2.1%) - 2 2 (2.3%) 1 (1.4%) 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - MICTURITION URGENCY - - Any Grade - 1 (1.2%) 1 (1.4%) 1 (1.0%) - Grade 1-2 1 (1.2%) 1 (1.4%) 1 (1.0%) - 1 1 (1.2%) 0 0 - 2 0 1 (1.4%) 1 (1.0%) - DYSURIA - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 1 1 (1.2%) 0 1 (1.0%) - NEPHROLITHIASIS - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 1 (1.2%) 0 0 - CALCULUS URETHRAL - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - ENURESIS - - Any Grade - 0 0 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 3 0 0 1 (1.0%) - INCONTINENCE - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - POLLAKIURIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - METABOLISM AND NUTRITION DISORDERS - - Overall - - - Any Grade - 6 (7.0%) 3 (4.2%) 1 (1.0%) - Grade 1-2 5 (5.8%) 2 (2.8%) 1 (1.0%) - 1 1 (1.2%) 2 (2.8%) 1 (1.0%) - 2 4 (4.7%) 0 0 - Grade 3-4 1 (1.2%) 1 (1.4%) 0 - 3 1 (1.2%) 0 0 - 4 0 1 (1.4%) 0 - DECREASED APPETITE - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 1 (1.2%) 0 0 - FOOD CRAVING - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - Grade 3-4 1 (1.2%) 0 0 - 3 1 (1.2%) 0 0 - INCREASED APPETITE - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - 2 1 (1.2%) 0 0 - DEHYDRATION - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - DIABETES MELLITUS - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - HYPERCHOLESTEROLAEMIA - - Any Grade - 0 1 (1.4%) 0 - Grade 3-4 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - HYPONATRAEMIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - VASCULAR DISORDERS - - Overall - - - Any Grade - 3 (3.5%) 1 (1.4%) 4 (4.2%) - Grade 1-2 2 (2.3%) 1 (1.4%) 3 (3.1%) - 1 2 (2.3%) 1 (1.4%) 1 (1.0%) - 2 0 0 2 (2.1%) - Grade 3-4 1 (1.2%) 0 1 (1.0%) - 4 1 (1.2%) 0 1 (1.0%) - HYPERTENSION - - Any Grade - 1 (1.2%) 0 2 (2.1%) - Grade 1-2 1 (1.2%) 0 2 (2.1%) - 1 1 (1.2%) 0 1 (1.0%) - 2 0 0 1 (1.0%) - HYPOTENSION - - Any Grade - 2 (2.3%) 0 1 (1.0%) - Grade 1-2 1 (1.2%) 0 1 (1.0%) - 1 1 (1.2%) 0 0 - 2 0 0 1 (1.0%) - Grade 3-4 1 (1.2%) 0 0 - 4 1 (1.2%) 0 0 - HOT FLUSH - - Any Grade - 0 0 1 (1.0%) - Grade 3-4 0 0 1 (1.0%) - 4 0 0 1 (1.0%) - ORTHOSTATIC HYPOTENSION - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - WOUND HAEMORRHAGE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - EYE DISORDERS - - Overall - - - Any Grade - 4 (4.7%) 1 (1.4%) 2 (2.1%) - Grade 1-2 2 (2.3%) 1 (1.4%) 2 (2.1%) - 1 0 1 (1.4%) 2 (2.1%) - 2 2 (2.3%) 0 0 - Grade 3-4 2 (2.3%) 0 0 - 4 2 (2.3%) 0 0 - CONJUNCTIVITIS - - Any Grade - 2 (2.3%) 0 0 - Grade 3-4 2 (2.3%) 0 0 - 4 2 (2.3%) 0 0 - VISION BLURRED - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - CONJUNCTIVAL HAEMORRHAGE - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - EYE ALLERGY - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - EYE PRURITUS - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - EYE SWELLING - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - GLAUCOMA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 2 1 (1.2%) 0 0 - SURGICAL AND MEDICAL PROCEDURES - - Overall - - - Any Grade - 2 (2.3%) 2 (2.8%) 1 (1.0%) - Grade 1-2 1 (1.2%) 2 (2.8%) 1 (1.0%) - 1 1 (1.2%) 1 (1.4%) 1 (1.0%) - 2 0 1 (1.4%) 0 - Grade 3-4 1 (1.2%) 0 0 - 4 1 (1.2%) 0 0 - CATARACT OPERATION - - Any Grade - 1 (1.2%) 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - Grade 3-4 1 (1.2%) 0 0 - 4 1 (1.2%) 0 0 - ACROCHORDON EXCISION - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - EYE LASER SURGERY - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - SKIN LESION EXCISION - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - EAR AND LABYRINTH DISORDERS - - Overall - - - Any Grade - 1 (1.2%) 1 (1.4%) 2 (2.1%) - Grade 1-2 1 (1.2%) 1 (1.4%) 2 (2.1%) - 1 1 (1.2%) 1 (1.4%) 2 (2.1%) - VERTIGO - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 1 (1.0%) - CERUMEN IMPACTION - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - EAR PAIN - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - TINNITUS - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - CONGENITAL, FAMILIAL AND GENETIC DISORDERS - - Overall - - - Any Grade - 0 2 (2.8%) 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - Grade 3-4 0 2 (2.8%) 0 - 3 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - VENTRICULAR SEPTAL DEFECT - - Any Grade - 0 2 (2.8%) 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - Grade 3-4 0 2 (2.8%) 0 - 3 0 1 (1.4%) 0 - 4 0 1 (1.4%) 0 - NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - - Overall - - - Any Grade - 0 1 (1.4%) 2 (2.1%) - Grade 1-2 0 1 (1.4%) 2 (2.1%) - 1 0 1 (1.4%) 1 (1.0%) - 2 0 0 1 (1.0%) - COLON CANCER - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 1 0 0 1 (1.0%) - MALIGNANT FIBROUS HISTIOCYTOMA - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - PROSTATE CANCER - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - REPRODUCTIVE SYSTEM AND BREAST DISORDERS - - Overall - - - Any Grade - 2 (2.3%) 1 (1.4%) 0 - Grade 1-2 2 (2.3%) 1 (1.4%) 0 - 1 2 (2.3%) 0 0 - 2 0 1 (1.4%) 0 - BENIGN PROSTATIC HYPERPLASIA - - Any Grade - 1 (1.2%) 1 (1.4%) 0 - Grade 1-2 1 (1.2%) 1 (1.4%) 0 - 1 1 (1.2%) 0 0 - 2 0 1 (1.4%) 0 - PELVIC PAIN - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - IMMUNE SYSTEM DISORDERS - - Overall - - - Any Grade - 0 1 (1.4%) 1 (1.0%) - Grade 1-2 0 1 (1.4%) 1 (1.0%) - 1 0 1 (1.4%) 0 - 2 0 0 1 (1.0%) - HYPERSENSITIVITY - - Any Grade - 0 0 1 (1.0%) - Grade 1-2 0 0 1 (1.0%) - 2 0 0 1 (1.0%) - SEASONAL ALLERGY - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 1 0 1 (1.4%) 0 - HEPATOBILIARY DISORDERS - - Overall - - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - HYPERBILIRUBINAEMIA - - Any Grade - 1 (1.2%) 0 0 - Grade 1-2 1 (1.2%) 0 0 - 1 1 (1.2%) 0 0 - SOCIAL CIRCUMSTANCES - - Overall - - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 - ALCOHOL USE - - Any Grade - 0 1 (1.4%) 0 - Grade 1-2 0 1 (1.4%) 0 - 2 0 1 (1.4%) 0 + MedDRA System Organ Class + MedDRA Preferred Term Placebo Xanomeline High Dose Xanomeline Low Dose + Grade (N=86) (N=72) (N=96) + —————————————————————————————————————————————————————————————————————————————————————————————————————————————— + - Any adverse events - + - Any Grade - 23 (26.7%) 51 (70.8%) 54 (56.2%) + Grade 1-2 17 (19.8%) 42 (58.3%) 43 (44.8%) + 1 11 (12.8%) 26 (36.1%) 28 (29.2%) + 2 6 (7.0%) 16 (22.2%) 15 (15.6%) + Grade 3-4 6 (7.0%) 9 (12.5%) 10 (10.4%) + 3 2 (2.3%) 4 (5.6%) 5 (5.2%) + 4 4 (4.7%) 5 (6.9%) 5 (5.2%) + Grade 5 0 0 1 (1.0%) + SKIN AND SUBCUTANEOUS TISSUE DISORDERS + - Overall - + - Any Grade - 17 (19.8%) 32 (44.4%) 31 (32.3%) + Grade 1-2 13 (15.1%) 26 (36.1%) 25 (26.0%) + 1 10 (11.6%) 18 (25.0%) 15 (15.6%) + 2 3 (3.5%) 8 (11.1%) 10 (10.4%) + Grade 3-4 4 (4.7%) 6 (8.3%) 5 (5.2%) + 3 2 (2.3%) 3 (4.2%) 3 (3.1%) + 4 2 (2.3%) 3 (4.2%) 2 (2.1%) + Grade 5 0 0 1 (1.0%) + PRURITUS + - Any Grade - 8 (9.3%) 26 (36.1%) 23 (24.0%) + Grade 1-2 5 (5.8%) 20 (27.8%) 21 (21.9%) + 1 4 (4.7%) 15 (20.8%) 14 (14.6%) + 2 1 (1.2%) 5 (6.9%) 7 (7.3%) + Grade 3-4 3 (3.5%) 6 (8.3%) 1 (1.0%) + 3 1 (1.2%) 3 (4.2%) 1 (1.0%) + 4 2 (2.3%) 3 (4.2%) 0 + Grade 5 0 0 1 (1.0%) + ERYTHEMA + - Any Grade - 9 (10.5%) 14 (19.4%) 15 (15.6%) + Grade 1-2 9 (10.5%) 14 (19.4%) 13 (13.5%) + 1 8 (9.3%) 12 (16.7%) 8 (8.3%) + 2 1 (1.2%) 2 (2.8%) 5 (5.2%) + Grade 3-4 0 0 2 (2.1%) + 3 0 0 1 (1.0%) + 4 0 0 1 (1.0%) + RASH + - Any Grade - 5 (5.8%) 11 (15.3%) 13 (13.5%) + Grade 1-2 4 (4.7%) 10 (13.9%) 11 (11.5%) + 1 3 (3.5%) 7 (9.7%) 10 (10.4%) + 2 1 (1.2%) 3 (4.2%) 1 (1.0%) + Grade 3-4 1 (1.2%) 1 (1.4%) 2 (2.1%) + 3 1 (1.2%) 1 (1.4%) 1 (1.0%) + 4 0 0 1 (1.0%) + GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS + - Overall - + - Any Grade - 8 (9.3%) 24 (33.3%) 25 (26.0%) + Grade 1-2 6 (7.0%) 20 (27.8%) 20 (20.8%) + 1 3 (3.5%) 10 (13.9%) 14 (14.6%) + 2 3 (3.5%) 10 (13.9%) 6 (6.2%) + Grade 3-4 2 (2.3%) 4 (5.6%) 5 (5.2%) + 3 0 2 (2.8%) 2 (2.1%) + 4 2 (2.3%) 2 (2.8%) 3 (3.1%) + APPLICATION SITE PRURITUS + - Any Grade - 6 (7.0%) 21 (29.2%) 23 (24.0%) + Grade 1-2 4 (4.7%) 19 (26.4%) 20 (20.8%) + 1 2 (2.3%) 11 (15.3%) 16 (16.7%) + 2 2 (2.3%) 8 (11.1%) 4 (4.2%) + Grade 3-4 2 (2.3%) 2 (2.8%) 3 (3.1%) + 3 0 0 1 (1.0%) + 4 2 (2.3%) 2 (2.8%) 2 (2.1%) + APPLICATION SITE ERYTHEMA + - Any Grade - 3 (3.5%) 14 (19.4%) 13 (13.5%) + Grade 1-2 3 (3.5%) 12 (16.7%) 11 (11.5%) + 1 2 (2.3%) 10 (13.9%) 8 (8.3%) + 2 1 (1.2%) 2 (2.8%) 3 (3.1%) + Grade 3-4 0 2 (2.8%) 2 (2.1%) + 3 0 2 (2.8%) 1 (1.0%) + 4 0 0 1 (1.0%) diff --git a/tests/testthat/_snaps/table_aet04_pi.md b/tests/testthat/_snaps/table_aet04_pi.md index 62bcf2e..9e890dc 100644 --- a/tests/testthat/_snaps/table_aet04_pi.md +++ b/tests/testthat/_snaps/table_aet04_pi.md @@ -3,298 +3,34 @@ Code res Output - Placebo Xanomeline High Dose Xanomeline Low Dose - Any Grade (%) Grade 3-4 (%) Grade 5 (%) Any Grade (%) Grade 3-4 (%) Grade 5 (%) Any Grade (%) Grade 3-4 (%) Grade 5 (%) - (N=86) (N=86) (N=86) (N=72) (N=72) (N=72) (N=96) (N=96) (N=96) - ————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— - GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - Total number of patients with at least one adverse event 21 (24.4%) 4 (4.7%) 0 36 (50.0%) 8 (11.1%) 0 51 (53.1%) 11 (11.5%) 0 - APPLICATION SITE PRURITUS 7 2 0 29 3 0 24 3 0 - APPLICATION SITE ERYTHEMA 3 0 0 19 3 0 14 2 0 - APPLICATION SITE DERMATITIS 6 1 0 10 1 0 9 1 0 - APPLICATION SITE IRRITATION 3 1 0 12 1 0 9 3 0 - APPLICATION SITE VESICLES 1 0 0 7 1 0 5 0 0 - FATIGUE 1 0 0 7 1 0 5 0 0 - OEDEMA PERIPHERAL 2 1 0 3 0 0 1 0 0 - APPLICATION SITE SWELLING 0 0 0 3 0 0 1 0 0 - APPLICATION SITE URTICARIA 0 0 0 1 0 0 2 0 0 - CHILLS 1 0 0 1 0 0 1 0 0 - MALAISE 0 0 0 3 0 0 1 0 0 - PYREXIA 2 0 0 0 0 0 1 0 0 - APPLICATION SITE PAIN 0 0 0 3 0 0 0 0 0 - APPLICATION SITE PERSPIRATION 0 0 0 3 0 0 0 0 0 - APPLICATION SITE REACTION 1 0 0 1 0 0 0 0 0 - ASTHENIA 1 0 0 0 0 0 1 0 0 - CHEST DISCOMFORT 0 0 0 1 0 0 1 0 0 - CHEST PAIN 0 0 0 3 0 0 0 0 0 - OEDEMA 0 0 0 0 0 0 2 1 0 - PAIN 0 0 0 1 0 0 1 0 0 - APPLICATION SITE BLEEDING 0 0 0 0 0 0 1 0 0 - APPLICATION SITE DESQUAMATION 0 0 0 0 0 0 1 0 0 - APPLICATION SITE DISCHARGE 0 0 0 1 0 0 0 0 0 - APPLICATION SITE DISCOLOURATION 0 0 0 0 0 0 1 1 0 - APPLICATION SITE INDURATION 1 0 0 0 0 0 0 0 0 - APPLICATION SITE WARMTH 0 0 0 0 0 0 1 0 0 - CYST 0 0 0 0 0 0 1 0 0 - FEELING ABNORMAL 0 0 0 1 0 0 0 0 0 - FEELING COLD 0 0 0 1 0 0 0 0 0 - INFLAMMATION 0 0 0 0 0 0 1 0 0 - SECRETION DISCHARGE 0 0 0 0 0 0 1 0 0 - SUDDEN DEATH 0 0 0 0 0 0 1 0 0 - SWELLING 0 0 0 0 0 0 1 0 0 - ULCER 0 0 0 0 0 0 1 0 0 - SKIN AND SUBCUTANEOUS TISSUE DISORDERS - Total number of patients with at least one adverse event 21 (24.4%) 4 (4.7%) 0 42 (58.3%) 9 (12.5%) 0 42 (43.8%) 7 (7.3%) 2 (2.1%) - PRURITUS 9 3 0 36 8 0 24 1 1 - ERYTHEMA 10 0 0 19 0 0 16 2 0 - RASH 6 1 0 15 1 0 14 2 0 - HYPERHIDROSIS 2 0 0 11 1 0 4 0 0 - SKIN IRRITATION 3 0 0 7 0 0 6 1 1 - BLISTER 0 0 0 1 0 0 5 0 0 - RASH PRURITIC 0 0 0 3 3 0 1 0 0 - PRURITUS GENERALISED 0 0 0 1 0 0 1 0 0 - RASH ERYTHEMATOUS 0 0 0 0 0 0 2 1 0 - URTICARIA 0 0 0 1 1 0 1 0 0 - ACTINIC KERATOSIS 0 0 0 1 0 0 0 0 0 - ALOPECIA 1 0 0 0 0 0 0 0 0 - COLD SWEAT 1 0 0 0 0 0 0 0 0 - DERMATITIS ATOPIC 1 0 0 0 0 0 0 0 0 - DERMATITIS CONTACT 0 0 0 0 0 0 1 0 0 - DRUG ERUPTION 1 0 0 0 0 0 0 0 0 - RASH MACULO-PAPULAR 0 0 0 1 0 0 0 0 0 - RASH PAPULAR 0 0 0 1 0 0 0 0 0 - SKIN EXFOLIATION 0 0 0 0 0 0 1 0 0 - SKIN ODOUR ABNORMAL 0 0 0 1 0 0 0 0 0 - SKIN ULCER 1 0 0 0 0 0 0 0 0 - NERVOUS SYSTEM DISORDERS - Total number of patients with at least one adverse event 12 (14.0%) 1 (1.2%) 1 (1.2%) 25 (34.7%) 3 (4.2%) 0 22 (22.9%) 3 (3.1%) 0 - DIZZINESS 2 0 0 15 3 0 9 1 0 - HEADACHE 8 1 0 8 0 0 3 0 0 - SYNCOPE 0 0 0 3 0 0 5 0 0 - SOMNOLENCE 2 0 0 1 0 0 3 1 0 - TRANSIENT ISCHAEMIC ATTACK 0 0 0 1 0 0 2 1 0 - BURNING SENSATION 0 0 0 3 0 0 0 0 0 - LETHARGY 0 0 0 1 0 0 1 0 0 - AMNESIA 0 0 0 1 0 0 0 0 0 - BALANCE DISORDER 0 0 0 0 0 0 1 0 0 - COGNITIVE DISORDER 0 0 0 1 0 0 0 0 0 - COMPLEX PARTIAL SEIZURES 0 0 0 0 0 0 1 0 0 - COORDINATION ABNORMAL 0 0 0 0 0 0 1 0 0 - HEMIANOPIA HOMONYMOUS 0 0 0 0 0 0 1 0 0 - HYPERSOMNIA 0 0 0 1 0 0 0 0 0 - PARAESTHESIA 0 0 0 1 0 0 0 0 0 - PARAESTHESIA ORAL 0 0 0 0 0 0 1 0 0 - PARKINSON'S DISEASE 1 0 1 0 0 0 0 0 0 - PAROSMIA 0 0 0 1 0 0 0 0 0 - PARTIAL SEIZURES WITH SECONDARY GENERALISATION 0 0 0 1 0 0 0 0 0 - PSYCHOMOTOR HYPERACTIVITY 1 0 0 0 0 0 0 0 0 - STUPOR 0 0 0 0 0 0 1 0 0 - SYNCOPE VASOVAGAL 0 0 0 1 1 0 0 0 0 - GASTROINTESTINAL DISORDERS - Total number of patients with at least one adverse event 17 (19.8%) 2 (2.3%) 1 (1.2%) 20 (27.8%) 2 (2.8%) 1 (1.4%) 16 (16.7%) 4 (4.2%) 0 - DIARRHOEA 10 1 0 4 0 0 6 2 0 - VOMITING 3 0 1 8 0 0 4 0 0 - NAUSEA 3 0 0 8 3 1 3 1 0 - ABDOMINAL PAIN 1 1 0 1 0 0 3 1 0 - SALIVARY HYPERSECRETION 0 0 0 6 0 0 0 0 0 - DYSPEPSIA 1 0 0 1 0 0 1 0 0 - ABDOMINAL DISCOMFORT 0 0 0 1 0 0 0 0 0 - CONSTIPATION 1 0 0 0 0 0 0 0 0 - DYSPHAGIA 0 0 0 0 0 0 1 0 0 - FLATULENCE 1 0 0 0 0 0 0 0 0 - GASTROINTESTINAL HAEMORRHAGE 0 0 0 1 0 0 0 0 0 - GASTROOESOPHAGEAL REFLUX DISEASE 1 0 0 0 0 0 0 0 0 - GLOSSITIS 1 0 0 0 0 0 0 0 0 - HIATUS HERNIA 1 0 0 0 0 0 0 0 0 - RECTAL HAEMORRHAGE 0 0 0 0 0 0 1 0 0 - STOMACH DISCOMFORT 0 0 0 1 0 0 0 0 0 - CARDIAC DISORDERS - Total number of patients with at least one adverse event 13 (15.1%) 4 (4.7%) 0 15 (20.8%) 2 (2.8%) 0 16 (16.7%) 1 (1.0%) 0 - SINUS BRADYCARDIA 2 0 0 11 0 0 7 0 0 - MYOCARDIAL INFARCTION 5 1 0 6 1 0 2 0 0 - ATRIAL FIBRILLATION 1 0 0 3 0 0 2 0 0 - ATRIOVENTRICULAR BLOCK SECOND DEGREE 2 0 0 1 0 0 2 0 0 - SUPRAVENTRICULAR EXTRASYSTOLES 1 0 0 1 1 0 1 1 0 - VENTRICULAR EXTRASYSTOLES 0 0 0 1 0 0 2 0 0 - ATRIAL FLUTTER 0 0 0 1 0 0 1 0 0 - ATRIOVENTRICULAR BLOCK FIRST DEGREE 1 0 0 0 0 0 1 0 0 - BUNDLE BRANCH BLOCK RIGHT 1 0 0 0 0 0 1 0 0 - PALPITATIONS 0 0 0 0 0 0 2 0 0 - ATRIAL HYPERTROPHY 1 1 0 0 0 0 0 0 0 - BRADYCARDIA 1 0 0 0 0 0 0 0 0 - BUNDLE BRANCH BLOCK LEFT 1 0 0 0 0 0 0 0 0 - CARDIAC DISORDER 0 0 0 1 0 0 0 0 0 - CARDIAC FAILURE CONGESTIVE 1 1 0 0 0 0 0 0 0 - SINUS ARRHYTHMIA 1 0 0 0 0 0 0 0 0 - SUPRAVENTRICULAR TACHYCARDIA 0 0 0 0 0 0 1 0 0 - TACHYCARDIA 1 1 0 0 0 0 0 0 0 - VENTRICULAR HYPERTROPHY 1 0 0 0 0 0 0 0 0 - WOLFF-PARKINSON-WHITE SYNDROME 0 0 0 0 0 0 1 0 0 - INFECTIONS AND INFESTATIONS - Total number of patients with at least one adverse event 16 (18.6%) 2 (2.3%) 0 13 (18.1%) 2 (2.8%) 0 10 (10.4%) 1 (1.0%) 0 - NASOPHARYNGITIS 2 0 0 8 1 0 4 1 0 - UPPER RESPIRATORY TRACT INFECTION 7 1 0 4 0 0 1 0 0 - INFLUENZA 1 1 0 1 0 0 1 0 0 - URINARY TRACT INFECTION 2 0 0 1 0 0 0 0 0 - CYSTITIS 1 0 0 1 0 0 0 0 0 - EAR INFECTION 2 0 0 0 0 0 0 0 0 - LOCALISED INFECTION 1 0 0 0 0 0 1 0 0 - BRONCHITIS 1 0 0 0 0 0 0 0 0 - CELLULITIS 0 0 0 0 0 0 1 0 0 - CERVICITIS 1 0 0 0 0 0 0 0 0 - GASTROENTERITIS VIRAL 1 0 0 0 0 0 0 0 0 - HORDEOLUM 0 0 0 1 0 0 0 0 0 - LOWER RESPIRATORY TRACT INFECTION 0 0 0 1 1 0 0 0 0 - ONYCHOMYCOSIS 0 0 0 0 0 0 1 0 0 - PNEUMONIA 0 0 0 0 0 0 1 0 0 - RHINITIS 0 0 0 1 0 0 0 0 0 - VAGINAL MYCOSIS 1 0 0 0 0 0 0 0 0 - VIRAL INFECTION 0 0 0 0 0 0 1 0 0 - RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - Total number of patients with at least one adverse event 10 (11.6%) 1 (1.2%) 1 (1.2%) 10 (13.9%) 4 (5.6%) 0 10 (10.4%) 3 (3.1%) 0 - COUGH 3 0 1 7 3 0 6 2 0 - NASAL CONGESTION 3 0 0 4 0 0 1 0 0 - DYSPNOEA 1 0 0 1 0 0 1 0 0 - EPISTAXIS 0 0 0 3 0 0 1 0 0 - PHARYNGOLARYNGEAL PAIN 0 0 0 1 0 0 1 0 0 - RHINORRHOEA 0 0 0 1 1 0 1 0 0 - ALLERGIC GRANULOMATOUS ANGIITIS 0 0 0 1 0 0 0 0 0 - DYSPHONIA 0 0 0 0 0 0 1 1 0 - EMPHYSEMA 1 0 0 0 0 0 0 0 0 - HAEMOPTYSIS 1 1 0 0 0 0 0 0 0 - PHARYNGEAL ERYTHEMA 0 0 0 1 1 0 0 0 0 - POSTNASAL DRIP 1 0 0 0 0 0 0 0 0 - PRODUCTIVE COUGH 0 0 0 1 0 0 0 0 0 - RALES 1 0 0 0 0 0 0 0 0 - RESPIRATORY TRACT CONGESTION 0 0 0 1 0 0 0 0 0 - PSYCHIATRIC DISORDERS - Total number of patients with at least one adverse event 10 (11.6%) 0 0 8 (11.1%) 0 0 11 (11.5%) 2 (2.1%) 0 - CONFUSIONAL STATE 2 0 0 1 0 0 3 1 0 - AGITATION 2 0 0 0 0 0 3 0 0 - ANXIETY 1 0 0 0 0 0 3 0 0 - INSOMNIA 2 0 0 3 0 0 0 0 0 - DELUSION 1 0 0 1 0 0 0 0 0 - DEPRESSED MOOD 0 0 0 1 0 0 1 0 0 - IRRITABILITY 1 0 0 0 0 0 1 0 0 - COMPLETED SUICIDE 1 0 0 0 0 0 0 0 0 - DELIRIUM 0 0 0 1 0 0 0 0 0 - DISORIENTATION 1 0 0 0 0 0 0 0 0 - HALLUCINATION 0 0 0 1 0 0 0 0 0 - HALLUCINATION, VISUAL 0 0 0 1 0 0 0 0 0 - LIBIDO DECREASED 0 0 0 1 0 0 0 0 0 - LISTLESS 0 0 0 1 0 0 0 0 0 - NIGHTMARE 0 0 0 1 0 0 0 0 0 - RESTLESSNESS 0 0 0 0 0 0 1 1 0 - INVESTIGATIONS - Total number of patients with at least one adverse event 10 (11.6%) 2 (2.3%) 0 5 (6.9%) 2 (2.8%) 0 8 (8.3%) 1 (1.0%) 0 - ELECTROCARDIOGRAM ST SEGMENT DEPRESSION 5 0 0 0 0 0 1 0 0 - ELECTROCARDIOGRAM T WAVE INVERSION 2 0 0 1 0 0 1 0 0 - BLOOD GLUCOSE INCREASED 0 0 0 1 1 0 1 0 0 - ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED 1 0 0 0 0 0 1 0 0 - BIOPSY 0 0 0 1 0 0 0 0 0 - BIOPSY PROSTATE 0 0 0 1 0 0 0 0 0 - BLOOD ALKALINE PHOSPHATASE INCREASED 1 0 0 0 0 0 0 0 0 - BLOOD CHOLESTEROL INCREASED 0 0 0 1 1 0 0 0 0 - BLOOD CREATINE PHOSPHOKINASE INCREASED 1 0 0 0 0 0 0 0 0 - BLOOD URINE PRESENT 1 0 0 0 0 0 0 0 0 - BODY TEMPERATURE INCREASED 0 0 0 0 0 0 1 0 0 - CYSTOSCOPY 1 1 0 0 0 0 0 0 0 - HEART RATE INCREASED 1 0 0 0 0 0 0 0 0 - HEART RATE IRREGULAR 1 1 0 0 0 0 0 0 0 - NASAL MUCOSA BIOPSY 0 0 0 0 0 0 1 0 0 - NEUTROPHIL COUNT INCREASED 0 0 0 0 0 0 1 1 0 - URINE ANALYSIS ABNORMAL 0 0 0 0 0 0 1 1 0 - WEIGHT DECREASED 0 0 0 0 0 0 1 0 0 - WHITE BLOOD CELL COUNT INCREASED 0 0 0 0 0 0 1 0 0 - MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS - Total number of patients with at least one adverse event 5 (5.8%) 1 (1.2%) 0 8 (11.1%) 1 (1.4%) 0 7 (7.3%) 0 0 - BACK PAIN 1 0 0 4 0 0 1 0 0 - ARTHRALGIA 1 0 0 1 0 0 2 0 0 - SHOULDER PAIN 1 0 0 0 0 0 2 0 0 - ARTHRITIS 1 0 0 1 1 0 0 0 0 - FLANK PAIN 0 0 0 3 0 0 0 0 0 - MUSCLE SPASMS 0 0 0 1 0 0 1 0 0 - MUSCULAR WEAKNESS 0 0 0 0 0 0 1 0 0 - MYALGIA 0 0 0 1 0 0 0 0 0 - PAIN IN EXTREMITY 1 1 0 0 0 0 0 0 0 - INJURY, POISONING AND PROCEDURAL COMPLICATIONS - Total number of patients with at least one adverse event 4 (4.7%) 0 0 5 (6.9%) 1 (1.4%) 0 5 (5.2%) 0 0 - CONTUSION 1 0 0 3 0 0 1 0 0 - EXCORIATION 2 0 0 1 0 0 1 0 0 - FALL 1 0 0 1 1 0 2 0 0 - HIP FRACTURE 1 0 0 3 0 0 0 0 0 - SKIN LACERATION 1 0 0 0 0 0 2 0 0 - FACIAL BONES FRACTURE 0 0 0 1 0 0 0 0 0 - JOINT DISLOCATION 0 0 0 0 0 0 1 0 0 - WOUND 0 0 0 0 0 0 1 0 0 - RENAL AND URINARY DISORDERS - Total number of patients with at least one adverse event 4 (4.7%) 0 0 3 (4.2%) 0 0 4 (4.2%) 1 (1.0%) 0 - MICTURITION URGENCY 1 0 0 1 0 0 1 0 0 - DYSURIA 1 0 0 0 0 0 1 0 0 - NEPHROLITHIASIS 1 0 0 1 0 0 0 0 0 - CALCULUS URETHRAL 0 0 0 1 0 0 0 0 0 - ENURESIS 0 0 0 0 0 0 1 1 0 - INCONTINENCE 0 0 0 0 0 0 1 0 0 - POLLAKIURIA 1 0 0 0 0 0 0 0 0 - METABOLISM AND NUTRITION DISORDERS - Total number of patients with at least one adverse event 6 (7.0%) 1 (1.2%) 0 3 (4.2%) 1 (1.4%) 0 1 (1.0%) 0 0 - DECREASED APPETITE 1 0 0 1 0 0 0 0 0 - FOOD CRAVING 1 1 0 0 0 0 1 0 0 - INCREASED APPETITE 1 0 0 1 0 0 0 0 0 - DEHYDRATION 1 0 0 0 0 0 0 0 0 - DIABETES MELLITUS 1 0 0 0 0 0 0 0 0 - HYPERCHOLESTEROLAEMIA 0 0 0 1 1 0 0 0 0 - HYPONATRAEMIA 1 0 0 0 0 0 0 0 0 - VASCULAR DISORDERS - Total number of patients with at least one adverse event 3 (3.5%) 1 (1.2%) 0 1 (1.4%) 0 0 4 (4.2%) 1 (1.0%) 0 - HYPERTENSION 1 0 0 0 0 0 2 0 0 - HYPOTENSION 2 1 0 0 0 0 1 0 0 - HOT FLUSH 0 0 0 0 0 0 1 1 0 - ORTHOSTATIC HYPOTENSION 1 0 0 0 0 0 0 0 0 - WOUND HAEMORRHAGE 0 0 0 1 0 0 0 0 0 - EYE DISORDERS - Total number of patients with at least one adverse event 4 (4.7%) 2 (2.3%) 0 1 (1.4%) 0 0 2 (2.1%) 0 0 - CONJUNCTIVITIS 2 2 0 0 0 0 0 0 0 - VISION BLURRED 0 0 0 1 0 0 1 0 0 - CONJUNCTIVAL HAEMORRHAGE 0 0 0 0 0 0 1 0 0 - EYE ALLERGY 1 0 0 0 0 0 0 0 0 - EYE PRURITUS 1 0 0 0 0 0 0 0 0 - EYE SWELLING 1 0 0 0 0 0 0 0 0 - GLAUCOMA 1 0 0 0 0 0 0 0 0 - SURGICAL AND MEDICAL PROCEDURES - Total number of patients with at least one adverse event 2 (2.3%) 1 (1.2%) 0 2 (2.8%) 0 0 1 (1.0%) 0 0 - CATARACT OPERATION 1 1 0 0 0 0 1 0 0 - ACROCHORDON EXCISION 0 0 0 1 0 0 0 0 0 - EYE LASER SURGERY 1 0 0 0 0 0 0 0 0 - SKIN LESION EXCISION 0 0 0 1 0 0 0 0 0 - EAR AND LABYRINTH DISORDERS - Total number of patients with at least one adverse event 1 (1.2%) 0 0 1 (1.4%) 0 0 2 (2.1%) 0 0 - VERTIGO 0 0 0 1 0 0 1 0 0 - CERUMEN IMPACTION 0 0 0 0 0 0 1 0 0 - EAR PAIN 1 0 0 0 0 0 0 0 0 - TINNITUS 0 0 0 0 0 0 1 0 0 - CONGENITAL, FAMILIAL AND GENETIC DISORDERS - Total number of patients with at least one adverse event 0 0 0 2 (2.8%) 2 (2.8%) 0 1 (1.0%) 0 0 - VENTRICULAR SEPTAL DEFECT 0 0 0 3 3 0 1 0 0 - NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - Total number of patients with at least one adverse event 0 0 0 1 (1.4%) 0 0 2 (2.1%) 0 0 - COLON CANCER 0 0 0 0 0 0 1 0 0 - MALIGNANT FIBROUS HISTIOCYTOMA 0 0 0 0 0 0 1 0 0 - PROSTATE CANCER 0 0 0 1 0 0 0 0 0 - REPRODUCTIVE SYSTEM AND BREAST DISORDERS - Total number of patients with at least one adverse event 2 (2.3%) 0 0 1 (1.4%) 0 0 0 0 0 - BENIGN PROSTATIC HYPERPLASIA 1 0 0 1 0 0 0 0 0 - PELVIC PAIN 1 0 0 0 0 0 0 0 0 - IMMUNE SYSTEM DISORDERS - Total number of patients with at least one adverse event 0 0 0 1 (1.4%) 0 0 1 (1.0%) 0 0 - HYPERSENSITIVITY 0 0 0 0 0 0 1 0 0 - SEASONAL ALLERGY 0 0 0 1 0 0 0 0 0 - HEPATOBILIARY DISORDERS - Total number of patients with at least one adverse event 1 (1.2%) 0 0 0 0 0 0 0 0 - HYPERBILIRUBINAEMIA 1 0 0 0 0 0 0 0 0 - SOCIAL CIRCUMSTANCES - Total number of patients with at least one adverse event 0 0 0 1 (1.4%) 0 0 0 0 0 - ALCOHOL USE 0 0 0 1 0 0 0 0 0 + Placebo Xanomeline High Dose Xanomeline Low Dose + Any Grade (%) Grade 3-4 (%) Grade 5 (%) Any Grade (%) Grade 3-4 (%) Grade 5 (%) Any Grade (%) Grade 3-4 (%) Grade 5 (%) + (N=86) (N=86) (N=86) (N=72) (N=72) (N=72) (N=96) (N=96) (N=96) + —————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— + SKIN AND SUBCUTANEOUS TISSUE DISORDERS + Total number of patients with at least one adverse event 19 (22.1%) 4 (4.7%) 0 34 (47.2%) 6 (8.3%) 0 35 (36.5%) 6 (6.2%) 2 (2.1%) + PRURITUS 9 3 0 36 8 0 24 1 1 + ERYTHEMA 10 0 0 19 0 0 16 2 0 + RASH 6 1 0 15 1 0 14 2 0 + SKIN IRRITATION 3 0 0 7 0 0 6 1 1 + GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS + Total number of patients with at least one adverse event 10 (11.6%) 2 (2.3%) 0 29 (40.3%) 5 (6.9%) 0 31 (32.3%) 8 (8.3%) 0 + APPLICATION SITE PRURITUS 7 2 0 29 3 0 24 3 0 + APPLICATION SITE ERYTHEMA 3 0 0 19 3 0 14 2 0 + APPLICATION SITE IRRITATION 3 1 0 12 1 0 9 3 0 + GASTROINTESTINAL DISORDERS + Total number of patients with at least one adverse event 4 (4.7%) 0 1 (1.2%) 10 (13.9%) 2 (2.8%) 1 (1.4%) 6 (6.2%) 1 (1.0%) 0 + VOMITING 3 0 1 8 0 0 4 0 0 + NAUSEA 3 0 0 8 3 1 3 1 0 + NERVOUS SYSTEM DISORDERS + Total number of patients with at least one adverse event 7 (8.1%) 1 (1.2%) 0 6 (8.3%) 0 0 3 (3.1%) 0 0 + HEADACHE 8 1 0 8 0 0 3 0 0 + CARDIAC DISORDERS + Total number of patients with at least one adverse event 4 (4.7%) 1 (1.2%) 0 4 (5.6%) 1 (1.4%) 0 2 (2.1%) 0 0 + MYOCARDIAL INFARCTION 5 1 0 6 1 0 2 0 0 + VASCULAR DISORDERS + Total number of patients with at least one adverse event 0 0 0 1 (1.4%) 0 0 0 0 0 + WOUND HAEMORRHAGE 0 0 0 1 0 0 0 0 0 # AET04_PI variant 1 is produced correctly @@ -305,37 +41,22 @@ Any Grade (%) Grade 3-4 (%) Grade 5 (%) Any Grade (%) Grade 3-4 (%) Grade 5 (%) Any Grade (%) Grade 3-4 (%) Grade 5 (%) (N=86) (N=86) (N=86) (N=72) (N=72) (N=72) (N=96) (N=96) (N=96) —————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— - GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - APPLICATION SITE PRURITUS 7 2 0 29 3 0 24 3 0 - APPLICATION SITE ERYTHEMA 3 0 0 19 3 0 14 2 0 - APPLICATION SITE DERMATITIS 6 1 0 10 1 0 9 1 0 - APPLICATION SITE IRRITATION 3 1 0 12 1 0 9 3 0 - APPLICATION SITE VESICLES 1 0 0 7 1 0 5 0 0 - FATIGUE 1 0 0 7 1 0 5 0 0 SKIN AND SUBCUTANEOUS TISSUE DISORDERS PRURITUS 9 3 0 36 8 0 24 1 1 ERYTHEMA 10 0 0 19 0 0 16 2 0 RASH 6 1 0 15 1 0 14 2 0 - HYPERHIDROSIS 2 0 0 11 1 0 4 0 0 SKIN IRRITATION 3 0 0 7 0 0 6 1 1 - BLISTER 0 0 0 1 0 0 5 0 0 - NERVOUS SYSTEM DISORDERS - DIZZINESS 2 0 0 15 3 0 9 1 0 - HEADACHE 8 1 0 8 0 0 3 0 0 - SYNCOPE 0 0 0 3 0 0 5 0 0 + GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS + APPLICATION SITE PRURITUS 7 2 0 29 3 0 24 3 0 + APPLICATION SITE ERYTHEMA 3 0 0 19 3 0 14 2 0 + APPLICATION SITE IRRITATION 3 1 0 12 1 0 9 3 0 GASTROINTESTINAL DISORDERS - DIARRHOEA 10 1 0 4 0 0 6 2 0 VOMITING 3 0 1 8 0 0 4 0 0 NAUSEA 3 0 0 8 3 1 3 1 0 - SALIVARY HYPERSECRETION 0 0 0 6 0 0 0 0 0 + NERVOUS SYSTEM DISORDERS + HEADACHE 8 1 0 8 0 0 3 0 0 CARDIAC DISORDERS - SINUS BRADYCARDIA 2 0 0 11 0 0 7 0 0 MYOCARDIAL INFARCTION 5 1 0 6 1 0 2 0 0 - INFECTIONS AND INFESTATIONS - NASOPHARYNGITIS 2 0 0 8 1 0 4 1 0 - UPPER RESPIRATORY TRACT INFECTION 7 1 0 4 0 0 1 0 0 - RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - COUGH 3 0 1 7 3 0 6 2 0 # AET04_PI variant 2 is produced correctly @@ -351,8 +72,6 @@ ERYTHEMA 10 0 0 19 0 0 16 2 0 NERVOUS SYSTEM DISORDERS HEADACHE 8 1 0 8 0 0 3 0 0 - GASTROINTESTINAL DISORDERS - DIARRHOEA 10 1 0 4 0 0 6 2 0 # AET04_PI variant 3 is produced correctly @@ -363,21 +82,14 @@ Any Grade (%) Grade 3-4 (%) Grade 5 (%) Any Grade (%) Grade 3-4 (%) Grade 5 (%) Any Grade (%) Grade 3-4 (%) Grade 5 (%) (N=86) (N=86) (N=86) (N=72) (N=72) (N=72) (N=96) (N=96) (N=96) —————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— - GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - APPLICATION SITE PRURITUS 7 2 0 29 3 0 24 3 0 - APPLICATION SITE ERYTHEMA 3 0 0 19 3 0 14 2 0 - APPLICATION SITE IRRITATION 3 1 0 12 1 0 9 3 0 SKIN AND SUBCUTANEOUS TISSUE DISORDERS PRURITUS 9 3 0 36 8 0 24 1 1 ERYTHEMA 10 0 0 19 0 0 16 2 0 RASH 6 1 0 15 1 0 14 2 0 - HYPERHIDROSIS 2 0 0 11 1 0 4 0 0 - NERVOUS SYSTEM DISORDERS - DIZZINESS 2 0 0 15 3 0 9 1 0 - GASTROINTESTINAL DISORDERS - DIARRHOEA 10 1 0 4 0 0 6 2 0 - CARDIAC DISORDERS - SINUS BRADYCARDIA 2 0 0 11 0 0 7 0 0 + GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS + APPLICATION SITE PRURITUS 7 2 0 29 3 0 24 3 0 + APPLICATION SITE ERYTHEMA 3 0 0 19 3 0 14 2 0 + APPLICATION SITE IRRITATION 3 1 0 12 1 0 9 3 0 # AET04_PI variant 4 is produced correctly @@ -400,27 +112,18 @@ Any Grade (%) Grade 3-4 (%) Grade 5 (%) Any Grade (%) Grade 3-4 (%) Grade 5 (%) Any Grade (%) Grade 3-4 (%) Grade 5 (%) (N=86) (N=86) (N=86) (N=72) (N=72) (N=72) (N=96) (N=96) (N=96) —————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— - GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - APPLICATION SITE PRURITUS 7 2 0 29 3 0 24 3 0 - APPLICATION SITE ERYTHEMA 3 0 0 19 3 0 14 2 0 - APPLICATION SITE IRRITATION 3 1 0 12 1 0 9 3 0 SKIN AND SUBCUTANEOUS TISSUE DISORDERS PRURITUS 9 3 0 36 8 0 24 1 1 ERYTHEMA 10 0 0 19 0 0 16 2 0 RASH 6 1 0 15 1 0 14 2 0 - HYPERHIDROSIS 2 0 0 11 1 0 4 0 0 SKIN IRRITATION 3 0 0 7 0 0 6 1 1 - NERVOUS SYSTEM DISORDERS - DIZZINESS 2 0 0 15 3 0 9 1 0 - PARKINSON'S DISEASE 1 0 1 0 0 0 0 0 0 + GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS + APPLICATION SITE PRURITUS 7 2 0 29 3 0 24 3 0 + APPLICATION SITE ERYTHEMA 3 0 0 19 3 0 14 2 0 + APPLICATION SITE IRRITATION 3 1 0 12 1 0 9 3 0 GASTROINTESTINAL DISORDERS - DIARRHOEA 10 1 0 4 0 0 6 2 0 VOMITING 3 0 1 8 0 0 4 0 0 NAUSEA 3 0 0 8 3 1 3 1 0 - CARDIAC DISORDERS - SINUS BRADYCARDIA 2 0 0 11 0 0 7 0 0 - RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - COUGH 3 0 1 7 3 0 6 2 0 # AET04_PI variant 6 is produced correctly @@ -431,21 +134,14 @@ Any Grade (%) Grade 1-2 (%) Grade 3-4 (%) Grade 5 (%) Any Grade (%) Grade 1-2 (%) Grade 3-4 (%) Grade 5 (%) Any Grade (%) Grade 1-2 (%) Grade 3-4 (%) Grade 5 (%) (N=86) (N=86) (N=86) (N=86) (N=72) (N=72) (N=72) (N=72) (N=96) (N=96) (N=96) (N=96) —————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— - GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - APPLICATION SITE PRURITUS 7 5 2 0 29 26 3 0 24 21 3 0 - APPLICATION SITE ERYTHEMA 3 3 0 0 19 17 3 0 14 11 2 0 - APPLICATION SITE IRRITATION 3 2 1 0 12 11 1 0 9 6 3 0 SKIN AND SUBCUTANEOUS TISSUE DISORDERS PRURITUS 9 6 3 0 36 28 8 0 24 22 1 1 ERYTHEMA 10 10 0 0 19 19 0 0 16 14 2 0 RASH 6 5 1 0 15 14 1 0 14 11 2 0 - HYPERHIDROSIS 2 2 0 0 11 10 1 0 4 4 0 0 - NERVOUS SYSTEM DISORDERS - DIZZINESS 2 2 0 0 15 12 3 0 9 8 1 0 - GASTROINTESTINAL DISORDERS - DIARRHOEA 10 9 1 0 4 4 0 0 6 4 2 0 - CARDIAC DISORDERS - SINUS BRADYCARDIA 2 2 0 0 11 11 0 0 7 7 0 0 + GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS + APPLICATION SITE PRURITUS 7 5 2 0 29 26 3 0 24 21 3 0 + APPLICATION SITE ERYTHEMA 3 3 0 0 19 17 3 0 14 11 2 0 + APPLICATION SITE IRRITATION 3 2 1 0 12 11 1 0 9 6 3 0 # AET04_PI variant 7 is produced correctly @@ -456,21 +152,14 @@ Any Grade (%) Grade 3-4 (%) Grade 3-5 (%) Grade 5 (%) Any Grade (%) Grade 3-4 (%) Grade 3-5 (%) Grade 5 (%) Any Grade (%) Grade 3-4 (%) Grade 3-5 (%) Grade 5 (%) (N=86) (N=86) (N=86) (N=86) (N=72) (N=72) (N=72) (N=72) (N=96) (N=96) (N=96) (N=96) —————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— - GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - APPLICATION SITE PRURITUS 7 2 2 0 29 3 3 0 24 3 3 0 - APPLICATION SITE ERYTHEMA 3 0 0 0 19 3 3 0 14 2 2 0 - APPLICATION SITE IRRITATION 3 1 1 0 12 1 1 0 9 3 3 0 SKIN AND SUBCUTANEOUS TISSUE DISORDERS PRURITUS 9 3 3 0 36 8 8 0 24 1 2 1 ERYTHEMA 10 0 0 0 19 0 0 0 16 2 2 0 RASH 6 1 1 0 15 1 1 0 14 2 2 0 - HYPERHIDROSIS 2 0 0 0 11 1 1 0 4 0 0 0 - NERVOUS SYSTEM DISORDERS - DIZZINESS 2 0 0 0 15 3 3 0 9 1 1 0 - GASTROINTESTINAL DISORDERS - DIARRHOEA 10 1 1 0 4 0 0 0 6 2 2 0 - CARDIAC DISORDERS - SINUS BRADYCARDIA 2 0 0 0 11 0 0 0 7 0 0 0 + GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS + APPLICATION SITE PRURITUS 7 2 2 0 29 3 3 0 24 3 3 0 + APPLICATION SITE ERYTHEMA 3 0 0 0 19 3 3 0 14 2 2 0 + APPLICATION SITE IRRITATION 3 1 1 0 12 1 1 0 9 3 3 0 # AET04_PI variant 8 is produced correctly @@ -486,9 +175,5 @@ ERYTHEMA 10 0 0 19 0 0 16 2 0 APPLICATION SITE ERYTHEMA 3 0 0 19 3 0 14 2 0 RASH 6 1 0 15 1 0 14 2 0 - DIZZINESS 2 0 0 15 3 0 9 1 0 APPLICATION SITE IRRITATION 3 1 0 12 1 0 9 3 0 - DIARRHOEA 10 1 0 4 0 0 6 2 0 - SINUS BRADYCARDIA 2 0 0 11 0 0 7 0 0 - HYPERHIDROSIS 2 0 0 11 1 0 4 0 0 diff --git a/tests/testthat/_snaps/table_aet05.md b/tests/testthat/_snaps/table_aet05.md index cd71aa9..b717c04 100644 --- a/tests/testthat/_snaps/table_aet05.md +++ b/tests/testthat/_snaps/table_aet05.md @@ -3,24 +3,24 @@ Code res Output - Placebo Xanomeline High Dose Xanomeline Low Dose - (N=86) (N=84) (N=84) - —————————————————————————————————————————————————————————————————————————————————————————————————— - Total patient-years at risk 8.4 15.7 1.4 - Number of adverse events observed 69 79 77 - AE rate per 100 patient-years 819.32 502.87 5624.85 - 95% CI (626.00, 1012.64) (391.98, 613.76) (4368.49, 6881.21) + Placebo Xanomeline High Dose Xanomeline Low Dose + (N=86) (N=84) (N=84) + —————————————————————————————————————————————————————————————————————————————————————————————————————— + Total patient-years at risk -0.2 -2.0 -2.9 + Number of adverse events observed 21 32 37 + AE rate per 100 patient-years -9961.36 -1603.29 -1259.48 + 95% CI (-14221.83, -5700.90) (-2158.79, -1047.79) (-1665.31, -853.66) # AET05 variant 2 is produced correctly Code res Output - Placebo Xanomeline High Dose Xanomeline Low Dose - (N=86) (N=84) (N=84) - —————————————————————————————————————————————————————————————————————————————————————————————————— - Total patient-years at risk 8.4 15.7 1.4 - Number of adverse events observed 69 79 77 - AE rate per 100 patient-years 819.32 502.87 5624.85 - 95% CI (637.48, 1036.90) (398.13, 626.73) (4439.04, 7030.10) + Placebo Xanomeline High Dose Xanomeline Low Dose + (N=86) (N=84) (N=84) + —————————————————————————————————————————————————————————————————————————————————————————————————————— + Total patient-years at risk -0.2 -2.0 -2.9 + Number of adverse events observed 21 32 37 + AE rate per 100 patient-years -9961.36 -1603.29 -1259.48 + 95% CI (-6166.24, -15227.00) (-1096.65, -2263.37) (-886.79, -1736.03) diff --git a/tests/testthat/_snaps/table_aet06.md b/tests/testthat/_snaps/table_aet06.md index 2e2aceb..480ba8f 100644 --- a/tests/testthat/_snaps/table_aet06.md +++ b/tests/testthat/_snaps/table_aet06.md @@ -3,1689 +3,160 @@ Code res Output - Placebo Xanomeline High Dose Xanomeline Low Dose - F M F M F M - (N=53) (N=33) (N=40) (N=44) (N=50) (N=34) - ——————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— - Total number of patients with at least one adverse event 40 (75.5%) 29 (87.9%) 37 (92.5%) 42 (95.5%) 44 (88.0%) 33 (97.1%) - Overall total number of events 171 130 173 282 251 184 - GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - Total number of patients with at least one adverse event 12 (22.6%) 9 (27.3%) 20 (50.0%) 20 (45.5%) 25 (50.0%) 22 (64.7%) - Total number of events 26 22 64 60 56 64 - APPLICATION SITE BLEEDING 0 0 0 0 1 (2.0%) 0 - APPLICATION SITE DERMATITIS 2 (3.8%) 3 (9.1%) 4 (10.0%) 3 (6.8%) 5 (10.0%) 4 (11.8%) - APPLICATION SITE DESQUAMATION 0 0 0 0 0 1 (2.9%) - APPLICATION SITE DISCHARGE 0 0 0 1 (2.3%) 0 0 - APPLICATION SITE DISCOLOURATION 0 0 0 0 0 1 (2.9%) - APPLICATION SITE ERYTHEMA 2 (3.8%) 1 (3.0%) 5 (12.5%) 10 (22.7%) 5 (10.0%) 7 (20.6%) - APPLICATION SITE INDURATION 0 1 (3.0%) 0 0 0 0 - APPLICATION SITE IRRITATION 3 (5.7%) 0 5 (12.5%) 4 (9.1%) 6 (12.0%) 3 (8.8%) - APPLICATION SITE PAIN 0 0 2 (5.0%) 0 0 0 - APPLICATION SITE PERSPIRATION 0 0 0 2 (4.5%) 0 0 - APPLICATION SITE PRURITUS 4 (7.5%) 2 (6.1%) 10 (25.0%) 12 (27.3%) 12 (24.0%) 10 (29.4%) - APPLICATION SITE REACTION 0 1 (3.0%) 1 (2.5%) 0 0 0 - APPLICATION SITE SWELLING 0 0 1 (2.5%) 1 (2.3%) 0 1 (2.9%) - APPLICATION SITE URTICARIA 0 0 1 (2.5%) 0 0 2 (5.9%) - APPLICATION SITE VESICLES 0 1 (3.0%) 3 (7.5%) 3 (6.8%) 1 (2.0%) 3 (8.8%) - APPLICATION SITE WARMTH 0 0 0 0 1 (2.0%) 0 - ASTHENIA 1 (1.9%) 0 1 (2.5%) 0 0 0 - CHEST DISCOMFORT 0 0 1 (2.5%) 1 (2.3%) 0 0 - CHEST PAIN 0 0 1 (2.5%) 1 (2.3%) 0 0 - CHILLS 0 1 (3.0%) 0 1 (2.3%) 0 1 (2.9%) - CYST 0 0 0 0 0 1 (2.9%) - FATIGUE 1 (1.9%) 0 4 (10.0%) 1 (2.3%) 1 (2.0%) 4 (11.8%) - FEELING ABNORMAL 0 0 0 1 (2.3%) 0 0 - FEELING COLD 0 0 0 1 (2.3%) 0 0 - INFLAMMATION 0 0 0 0 1 (2.0%) 0 - MALAISE 0 0 0 2 (4.5%) 0 1 (2.9%) - OEDEMA 0 0 0 0 1 (2.0%) 1 (2.9%) - OEDEMA PERIPHERAL 2 (3.8%) 0 1 (2.5%) 1 (2.3%) 1 (2.0%) 0 - PAIN 0 0 0 1 (2.3%) 1 (2.0%) 0 - PYREXIA 0 2 (6.1%) 0 1 (2.3%) 0 0 - SECRETION DISCHARGE 0 0 0 0 1 (2.0%) 0 - SUDDEN DEATH 0 0 0 0 1 (2.0%) 0 - SWELLING 0 0 0 0 0 1 (2.9%) - ULCER 0 0 0 0 0 1 (2.9%) - GASTROINTESTINAL DISORDERS - Total number of patients with at least one adverse event 9 (17.0%) 8 (24.2%) 7 (17.5%) 14 (31.8%) 9 (18.0%) 6 (17.6%) - Total number of events 15 11 14 23 16 8 - ABDOMINAL DISCOMFORT 0 0 0 1 (2.3%) 0 0 - ABDOMINAL PAIN 1 (1.9%) 0 1 (2.5%) 0 2 (4.0%) 1 (2.9%) - CONSTIPATION 1 (1.9%) 0 0 0 0 0 - DIARRHOEA 3 (5.7%) 6 (18.2%) 0 4 (9.1%) 3 (6.0%) 2 (5.9%) - DYSPEPSIA 1 (1.9%) 0 0 1 (2.3%) 0 1 (2.9%) - DYSPHAGIA 0 0 0 0 0 1 (2.9%) - FLATULENCE 0 1 (3.0%) 0 0 0 0 - GASTROINTESTINAL HAEMORRHAGE 0 0 1 (2.5%) 0 0 0 - GASTROOESOPHAGEAL REFLUX DISEASE 1 (1.9%) 0 0 0 0 0 - GLOSSITIS 0 1 (3.0%) 0 0 0 0 - HIATUS HERNIA 1 (1.9%) 0 0 0 0 0 - NAUSEA 3 (5.7%) 0 4 (10.0%) 2 (4.5%) 2 (4.0%) 1 (2.9%) - RECTAL HAEMORRHAGE 0 0 0 0 1 (2.0%) 0 - SALIVARY HYPERSECRETION 0 0 1 (2.5%) 3 (6.8%) 0 0 - STOMACH DISCOMFORT 0 0 0 1 (2.3%) 0 0 - VOMITING 2 (3.8%) 1 (3.0%) 0 7 (15.9%) 3 (6.0%) 0 - SKIN AND SUBCUTANEOUS TISSUE DISORDERS - Total number of patients with at least one adverse event 13 (24.5%) 8 (24.2%) 14 (35.0%) 28 (63.6%) 24 (48.0%) 18 (52.9%) - Total number of events 30 17 34 77 72 46 - ACTINIC KERATOSIS 0 0 0 1 (2.3%) 0 0 - ALOPECIA 1 (1.9%) 0 0 0 0 0 - BLISTER 0 0 0 1 (2.3%) 2 (4.0%) 3 (8.8%) - COLD SWEAT 0 1 (3.0%) 0 0 0 0 - DERMATITIS ATOPIC 0 1 (3.0%) 0 0 0 0 - DERMATITIS CONTACT 0 0 0 0 0 1 (2.9%) - DRUG ERUPTION 1 (1.9%) 0 0 0 0 0 - ERYTHEMA 6 (11.3%) 3 (9.1%) 7 (17.5%) 7 (15.9%) 9 (18.0%) 6 (17.6%) - HYPERHIDROSIS 2 (3.8%) 0 2 (5.0%) 6 (13.6%) 1 (2.0%) 3 (8.8%) - PRURITUS 6 (11.3%) 2 (6.1%) 11 (27.5%) 15 (34.1%) 13 (26.0%) 10 (29.4%) - PRURITUS GENERALISED 0 0 0 1 (2.3%) 0 1 (2.9%) - RASH 2 (3.8%) 3 (9.1%) 3 (7.5%) 8 (18.2%) 8 (16.0%) 5 (14.7%) - RASH ERYTHEMATOUS 0 0 0 0 1 (2.0%) 1 (2.9%) - RASH MACULO-PAPULAR 0 0 0 1 (2.3%) 0 0 - RASH PAPULAR 0 0 0 1 (2.3%) 0 0 - RASH PRURITIC 0 0 1 (2.5%) 1 (2.3%) 1 (2.0%) 0 - SKIN EXFOLIATION 0 0 0 0 1 (2.0%) 0 - SKIN IRRITATION 3 (5.7%) 0 1 (2.5%) 4 (9.1%) 5 (10.0%) 1 (2.9%) - SKIN ODOUR ABNORMAL 0 0 0 1 (2.3%) 0 0 - SKIN ULCER 0 1 (3.0%) 0 0 0 0 - URTICARIA 0 0 1 (2.5%) 0 0 1 (2.9%) - CARDIAC DISORDERS - Total number of patients with at least one adverse event 9 (17.0%) 4 (12.1%) 7 (17.5%) 11 (25.0%) 6 (12.0%) 7 (20.6%) - Total number of events 21 6 9 25 16 14 - ATRIAL FIBRILLATION 1 (1.9%) 0 2 (5.0%) 1 (2.3%) 0 1 (2.9%) - ATRIAL FLUTTER 0 0 0 1 (2.3%) 0 1 (2.9%) - ATRIAL HYPERTROPHY 0 1 (3.0%) 0 0 0 0 - ATRIOVENTRICULAR BLOCK FIRST DEGREE 1 (1.9%) 0 0 0 0 1 (2.9%) - ATRIOVENTRICULAR BLOCK SECOND DEGREE 0 2 (6.1%) 1 (2.5%) 2 (4.5%) 0 0 - BRADYCARDIA 1 (1.9%) 0 0 0 0 0 - BUNDLE BRANCH BLOCK LEFT 1 (1.9%) 0 0 0 0 0 - BUNDLE BRANCH BLOCK RIGHT 1 (1.9%) 0 0 0 0 1 (2.9%) - CARDIAC DISORDER 0 0 0 1 (2.3%) 0 0 - CARDIAC FAILURE CONGESTIVE 1 (1.9%) 0 0 0 0 0 - MYOCARDIAL INFARCTION 4 (7.5%) 0 1 (2.5%) 3 (6.8%) 2 (4.0%) 0 - PALPITATIONS 0 0 0 0 1 (2.0%) 1 (2.9%) - SINUS ARRHYTHMIA 0 1 (3.0%) 0 0 0 0 - SINUS BRADYCARDIA 2 (3.8%) 0 2 (5.0%) 6 (13.6%) 3 (6.0%) 4 (11.8%) - SUPRAVENTRICULAR EXTRASYSTOLES 1 (1.9%) 0 1 (2.5%) 0 1 (2.0%) 0 - SUPRAVENTRICULAR TACHYCARDIA 0 0 0 0 0 1 (2.9%) - TACHYCARDIA 1 (1.9%) 0 0 0 0 0 - VENTRICULAR EXTRASYSTOLES 0 0 0 1 (2.3%) 1 (2.0%) 1 (2.9%) - VENTRICULAR HYPERTROPHY 1 (1.9%) 0 0 0 0 0 - WOLFF-PARKINSON-WHITE SYNDROME 0 0 0 0 1 (2.0%) 0 - INFECTIONS AND INFESTATIONS - Total number of patients with at least one adverse event 10 (18.9%) 6 (18.2%) 4 (10.0%) 9 (20.5%) 6 (12.0%) 4 (11.8%) - Total number of events 22 13 7 13 12 6 - BRONCHITIS 1 (1.9%) 0 0 0 0 0 - CELLULITIS 0 0 0 0 1 (2.0%) 0 - CERVICITIS 1 (1.9%) 0 0 0 0 0 - CYSTITIS 0 1 (3.0%) 1 (2.5%) 0 0 0 - EAR INFECTION 1 (1.9%) 1 (3.0%) 0 0 0 0 - GASTROENTERITIS VIRAL 1 (1.9%) 0 0 0 0 0 - HORDEOLUM 0 0 0 1 (2.3%) 0 0 - INFLUENZA 1 (1.9%) 0 0 1 (2.3%) 0 1 (2.9%) - LOCALISED INFECTION 0 1 (3.0%) 0 0 1 (2.0%) 0 - LOWER RESPIRATORY TRACT INFECTION 0 0 0 1 (2.3%) 0 0 - NASOPHARYNGITIS 2 (3.8%) 0 3 (7.5%) 3 (6.8%) 3 (6.0%) 1 (2.9%) - ONYCHOMYCOSIS 0 0 0 0 0 1 (2.9%) - PNEUMONIA 0 0 0 0 1 (2.0%) 0 - RHINITIS 0 0 0 1 (2.3%) 0 0 - UPPER RESPIRATORY TRACT INFECTION 4 (7.5%) 2 (6.1%) 1 (2.5%) 2 (4.5%) 0 1 (2.9%) - URINARY TRACT INFECTION 1 (1.9%) 1 (3.0%) 0 1 (2.3%) 0 0 - VAGINAL MYCOSIS 1 (1.9%) 0 0 0 0 0 - VIRAL INFECTION 0 0 0 0 1 (2.0%) 0 - RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - Total number of patients with at least one adverse event 3 (5.7%) 7 (21.2%) 2 (5.0%) 8 (18.2%) 6 (12.0%) 4 (11.8%) - Total number of events 3 12 3 19 10 6 - ALLERGIC GRANULOMATOUS ANGIITIS 0 0 0 1 (2.3%) 0 0 - COUGH 0 3 (9.1%) 1 (2.5%) 4 (9.1%) 4 (8.0%) 2 (5.9%) - DYSPHONIA 0 0 0 0 0 1 (2.9%) - DYSPNOEA 1 (1.9%) 0 0 1 (2.3%) 1 (2.0%) 0 - EMPHYSEMA 1 (1.9%) 0 0 0 0 0 - EPISTAXIS 0 0 0 2 (4.5%) 1 (2.0%) 0 - HAEMOPTYSIS 0 1 (3.0%) 0 0 0 0 - NASAL CONGESTION 1 (1.9%) 2 (6.1%) 0 3 (6.8%) 0 1 (2.9%) - PHARYNGEAL ERYTHEMA 0 0 0 1 (2.3%) 0 0 - PHARYNGOLARYNGEAL PAIN 0 0 0 1 (2.3%) 0 1 (2.9%) - POSTNASAL DRIP 0 1 (3.0%) 0 0 0 0 - PRODUCTIVE COUGH 0 0 0 1 (2.3%) 0 0 - RALES 0 1 (3.0%) 0 0 0 0 - RESPIRATORY TRACT CONGESTION 0 0 0 1 (2.3%) 0 0 - RHINORRHOEA 0 0 1 (2.5%) 0 1 (2.0%) 0 - MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS - Total number of patients with at least one adverse event 2 (3.8%) 3 (9.1%) 3 (7.5%) 5 (11.4%) 5 (10.0%) 2 (5.9%) - Total number of events 4 4 3 8 6 4 - ARTHRALGIA 0 1 (3.0%) 0 1 (2.3%) 1 (2.0%) 1 (2.9%) - ARTHRITIS 1 (1.9%) 0 1 (2.5%) 0 0 0 - BACK PAIN 1 (1.9%) 0 1 (2.5%) 2 (4.5%) 1 (2.0%) 0 - FLANK PAIN 0 0 1 (2.5%) 1 (2.3%) 0 0 - MUSCLE SPASMS 0 0 0 1 (2.3%) 0 1 (2.9%) - MUSCULAR WEAKNESS 0 0 0 0 1 (2.0%) 0 - MYALGIA 0 0 0 1 (2.3%) 0 0 - PAIN IN EXTREMITY 0 1 (3.0%) 0 0 0 0 - SHOULDER PAIN 0 1 (3.0%) 0 0 2 (4.0%) 0 - RENAL AND URINARY DISORDERS - Total number of patients with at least one adverse event 2 (3.8%) 2 (6.1%) 0 3 (6.8%) 3 (6.0%) 1 (2.9%) - Total number of events 2 3 0 4 3 1 - CALCULUS URETHRAL 0 0 0 1 (2.3%) 0 0 - DYSURIA 1 (1.9%) 0 0 0 0 1 (2.9%) - ENURESIS 0 0 0 0 1 (2.0%) 0 - INCONTINENCE 0 0 0 0 1 (2.0%) 0 - MICTURITION URGENCY 0 1 (3.0%) 0 1 (2.3%) 1 (2.0%) 0 - NEPHROLITHIASIS 1 (1.9%) 0 0 1 (2.3%) 0 0 - POLLAKIURIA 0 1 (3.0%) 0 0 0 0 - EYE DISORDERS - Total number of patients with at least one adverse event 1 (1.9%) 3 (9.1%) 1 (2.5%) 0 1 (2.0%) 1 (2.9%) - Total number of events 1 7 2 0 1 1 - CONJUNCTIVAL HAEMORRHAGE 0 0 0 0 1 (2.0%) 0 - CONJUNCTIVITIS 0 2 (6.1%) 0 0 0 0 - EYE ALLERGY 0 1 (3.0%) 0 0 0 0 - EYE PRURITUS 0 1 (3.0%) 0 0 0 0 - EYE SWELLING 0 1 (3.0%) 0 0 0 0 - GLAUCOMA 1 (1.9%) 0 0 0 0 0 - VISION BLURRED 0 0 1 (2.5%) 0 0 1 (2.9%) - METABOLISM AND NUTRITION DISORDERS - Total number of patients with at least one adverse event 5 (9.4%) 1 (3.0%) 1 (2.5%) 2 (4.5%) 0 1 (2.9%) - Total number of events 7 1 2 3 0 1 - DECREASED APPETITE 1 (1.9%) 0 1 (2.5%) 0 0 0 - DEHYDRATION 0 1 (3.0%) 0 0 0 0 - DIABETES MELLITUS 1 (1.9%) 0 0 0 0 0 - FOOD CRAVING 1 (1.9%) 0 0 0 0 1 (2.9%) - HYPERCHOLESTEROLAEMIA 0 0 0 1 (2.3%) 0 0 - HYPONATRAEMIA 1 (1.9%) 0 0 0 0 0 - INCREASED APPETITE 1 (1.9%) 0 0 1 (2.3%) 0 0 - PSYCHIATRIC DISORDERS - Total number of patients with at least one adverse event 5 (9.4%) 5 (15.2%) 2 (5.0%) 7 (15.9%) 7 (14.0%) 3 (8.8%) - Total number of events 8 6 2 10 9 5 - AGITATION 2 (3.8%) 0 1 (2.5%) 0 2 (4.0%) 0 - ANXIETY 1 (1.9%) 0 0 0 3 (6.0%) 0 - COMPLETED SUICIDE 0 1 (3.0%) 0 0 0 0 - CONFUSIONAL STATE 0 2 (6.1%) 0 1 (2.3%) 2 (4.0%) 1 (2.9%) - DELIRIUM 0 0 0 1 (2.3%) 0 0 - DELUSION 1 (1.9%) 0 0 1 (2.3%) 0 0 - DEPRESSED MOOD 0 0 0 1 (2.3%) 0 1 (2.9%) - DISORIENTATION 1 (1.9%) 0 0 0 0 0 - HALLUCINATION 0 0 0 1 (2.3%) 0 0 - HALLUCINATION, VISUAL 0 0 1 (2.5%) 0 0 0 - INSOMNIA 0 2 (6.1%) 0 2 (4.5%) 0 0 - IRRITABILITY 1 (1.9%) 0 0 0 1 (2.0%) 0 - LIBIDO DECREASED 0 0 0 1 (2.3%) 0 0 - LISTLESS 0 0 0 1 (2.3%) 0 0 - NIGHTMARE 0 0 0 1 (2.3%) 0 0 - RESTLESSNESS 0 0 0 0 0 1 (2.9%) - INVESTIGATIONS - Total number of patients with at least one adverse event 6 (11.3%) 4 (12.1%) 2 (5.0%) 4 (9.1%) 5 (10.0%) 2 (5.9%) - Total number of events 12 7 2 6 11 2 - BIOPSY 0 0 0 1 (2.3%) 0 0 - BIOPSY PROSTATE 0 0 0 1 (2.3%) 0 0 - BLOOD ALKALINE PHOSPHATASE INCREASED 0 1 (3.0%) 0 0 0 0 - BLOOD CHOLESTEROL INCREASED 0 0 1 (2.5%) 0 0 0 - BLOOD CREATINE PHOSPHOKINASE INCREASED 0 1 (3.0%) 0 0 0 0 - BLOOD GLUCOSE INCREASED 0 0 0 1 (2.3%) 1 (2.0%) 0 - BLOOD URINE PRESENT 0 1 (3.0%) 0 0 0 0 - BODY TEMPERATURE INCREASED 0 0 0 0 1 (2.0%) 0 - CYSTOSCOPY 0 1 (3.0%) 0 0 0 0 - ELECTROCARDIOGRAM ST SEGMENT DEPRESSION 4 (7.5%) 0 0 0 1 (2.0%) 0 - ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED 1 (1.9%) 0 0 0 0 1 (2.9%) - ELECTROCARDIOGRAM T WAVE INVERSION 2 (3.8%) 0 1 (2.5%) 0 0 1 (2.9%) - HEART RATE INCREASED 0 1 (3.0%) 0 0 0 0 - HEART RATE IRREGULAR 1 (1.9%) 0 0 0 0 0 - NASAL MUCOSA BIOPSY 0 0 0 0 1 (2.0%) 0 - NEUTROPHIL COUNT INCREASED 0 0 0 0 1 (2.0%) 0 - URINE ANALYSIS ABNORMAL 0 0 0 0 1 (2.0%) 0 - WEIGHT DECREASED 0 0 0 1 (2.3%) 0 0 - WHITE BLOOD CELL COUNT INCREASED 0 0 0 0 1 (2.0%) 0 - SURGICAL AND MEDICAL PROCEDURES - Total number of patients with at least one adverse event 2 (3.8%) 0 1 (2.5%) 1 (2.3%) 1 (2.0%) 0 - Total number of events 2 0 1 1 1 0 - ACROCHORDON EXCISION 0 0 1 (2.5%) 0 0 0 - CATARACT OPERATION 1 (1.9%) 0 0 0 1 (2.0%) 0 - EYE LASER SURGERY 1 (1.9%) 0 0 0 0 0 - SKIN LESION EXCISION 0 0 0 1 (2.3%) 0 0 - INJURY, POISONING AND PROCEDURAL COMPLICATIONS - Total number of patients with at least one adverse event 2 (3.8%) 2 (6.1%) 2 (5.0%) 3 (6.8%) 5 (10.0%) 0 - Total number of events 4 5 2 6 12 0 - CONTUSION 0 1 (3.0%) 0 2 (4.5%) 1 (2.0%) 0 - EXCORIATION 1 (1.9%) 1 (3.0%) 1 (2.5%) 0 1 (2.0%) 0 - FACIAL BONES FRACTURE 0 0 0 1 (2.3%) 0 0 - FALL 0 1 (3.0%) 0 1 (2.3%) 2 (4.0%) 0 - HIP FRACTURE 1 (1.9%) 0 1 (2.5%) 1 (2.3%) 0 0 - JOINT DISLOCATION 0 0 0 0 1 (2.0%) 0 - SKIN LACERATION 0 1 (3.0%) 0 0 2 (4.0%) 0 - WOUND 0 0 0 0 1 (2.0%) 0 - NERVOUS SYSTEM DISORDERS - Total number of patients with at least one adverse event 5 (9.4%) 7 (21.2%) 12 (30.0%) 15 (34.1%) 9 (18.0%) 11 (32.4%) - Total number of events 7 9 22 23 18 22 - AMNESIA 0 0 1 (2.5%) 0 0 0 - BALANCE DISORDER 0 0 0 0 1 (2.0%) 0 - BURNING SENSATION 0 0 0 2 (4.5%) 0 0 - COGNITIVE DISORDER 0 0 0 1 (2.3%) 0 0 - COMPLEX PARTIAL SEIZURES 0 0 0 0 1 (2.0%) 0 - COORDINATION ABNORMAL 0 0 0 0 1 (2.0%) 0 - DIZZINESS 1 (1.9%) 1 (3.0%) 4 (10.0%) 8 (18.2%) 4 (8.0%) 4 (11.8%) - HEADACHE 4 (7.5%) 3 (9.1%) 4 (10.0%) 2 (4.5%) 0 3 (8.8%) - HEMIANOPIA HOMONYMOUS 0 0 0 0 0 1 (2.9%) - HYPERSOMNIA 0 0 1 (2.5%) 0 0 0 - LETHARGY 0 0 1 (2.5%) 0 0 1 (2.9%) - PARAESTHESIA 0 0 0 1 (2.3%) 0 0 - PARAESTHESIA ORAL 0 0 0 0 1 (2.0%) 0 - PARKINSON'S DISEASE 0 1 (3.0%) 0 0 0 0 - PAROSMIA 0 0 0 1 (2.3%) 0 0 - PARTIAL SEIZURES WITH SECONDARY GENERALISATION 0 0 1 (2.5%) 0 0 0 - PSYCHOMOTOR HYPERACTIVITY 1 (1.9%) 0 0 0 0 0 - SOMNOLENCE 0 2 (6.1%) 0 1 (2.3%) 0 3 (8.8%) - STUPOR 0 0 0 0 0 1 (2.9%) - SYNCOPE 0 0 2 (5.0%) 1 (2.3%) 4 (8.0%) 0 - SYNCOPE VASOVAGAL 0 0 1 (2.5%) 0 0 0 - TRANSIENT ISCHAEMIC ATTACK 0 0 1 (2.5%) 0 0 2 (5.9%) - REPRODUCTIVE SYSTEM AND BREAST DISORDERS - Total number of patients with at least one adverse event 1 (1.9%) 1 (3.0%) 0 1 (2.3%) 0 0 - Total number of events 2 2 0 1 0 0 - BENIGN PROSTATIC HYPERPLASIA 0 1 (3.0%) 0 1 (2.3%) 0 0 - PELVIC PAIN 1 (1.9%) 0 0 0 0 0 - VASCULAR DISORDERS - Total number of patients with at least one adverse event 1 (1.9%) 2 (6.1%) 2 (5.0%) 0 2 (4.0%) 1 (2.9%) - Total number of events 2 5 3 0 2 1 - HOT FLUSH 0 0 0 0 0 1 (2.9%) - HYPERTENSION 0 1 (3.0%) 1 (2.5%) 0 1 (2.0%) 0 - HYPOTENSION 1 (1.9%) 1 (3.0%) 0 0 1 (2.0%) 0 - ORTHOSTATIC HYPOTENSION 0 1 (3.0%) 0 0 0 0 - WOUND HAEMORRHAGE 0 0 1 (2.5%) 0 0 0 - CONGENITAL, FAMILIAL AND GENETIC DISORDERS - Total number of patients with at least one adverse event 0 0 1 (2.5%) 1 (2.3%) 0 1 (2.9%) - Total number of events 0 0 1 1 0 1 - VENTRICULAR SEPTAL DEFECT 0 0 1 (2.5%) 1 (2.3%) 0 1 (2.9%) - EAR AND LABYRINTH DISORDERS - Total number of patients with at least one adverse event 1 (1.9%) 0 1 (2.5%) 0 2 (4.0%) 0 - Total number of events 2 0 1 0 3 0 - CERUMEN IMPACTION 0 0 0 0 1 (2.0%) 0 - EAR PAIN 1 (1.9%) 0 0 0 0 0 - TINNITUS 0 0 0 0 1 (2.0%) 0 - VERTIGO 0 0 1 (2.5%) 0 1 (2.0%) 0 - HEPATOBILIARY DISORDERS - Total number of patients with at least one adverse event 1 (1.9%) 0 0 0 0 0 - Total number of events 1 0 0 0 0 0 - HYPERBILIRUBINAEMIA 1 (1.9%) 0 0 0 0 0 - NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 2 (4.0%) 0 - Total number of events 0 0 0 1 3 0 - COLON CANCER 0 0 0 0 1 (2.0%) 0 - MALIGNANT FIBROUS HISTIOCYTOMA 0 0 0 0 1 (2.0%) 0 - PROSTATE CANCER 0 0 0 1 (2.3%) 0 0 - SOCIAL CIRCUMSTANCES - Total number of patients with at least one adverse event 0 0 1 (2.5%) 0 0 0 - Total number of events 0 0 1 0 0 0 - ALCOHOL USE 0 0 1 (2.5%) 0 0 0 - IMMUNE SYSTEM DISORDERS - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 0 1 (2.9%) - Total number of events 0 0 0 1 0 2 - HYPERSENSITIVITY 0 0 0 0 0 1 (2.9%) - SEASONAL ALLERGY 0 0 0 1 (2.3%) 0 0 + Placebo Xanomeline High Dose Xanomeline Low Dose + F M F M F M + (N=53) (N=33) (N=40) (N=44) (N=50) (N=34) + —————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— + Total number of patients with at least one adverse event 24 (45.3%) 13 (39.4%) 27 (67.5%) 36 (81.8%) 35 (70.0%) 27 (79.4%) + Overall total number of events 55 20 85 115 110 68 + GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS + Total number of patients with at least one adverse event 7 (13.2%) 3 (9.1%) 14 (35.0%) 16 (36.4%) 18 (36.0%) 12 (35.3%) + Total number of events 15 5 37 37 35 36 + APPLICATION SITE ERYTHEMA 2 (3.8%) 1 (3.0%) 5 (12.5%) 10 (22.7%) 5 (10.0%) 7 (20.6%) + APPLICATION SITE IRRITATION 3 (5.7%) 0 5 (12.5%) 4 (9.1%) 6 (12.0%) 3 (8.8%) + APPLICATION SITE PRURITUS 4 (7.5%) 2 (6.1%) 10 (25.0%) 12 (27.3%) 12 (24.0%) 10 (29.4%) + SKIN AND SUBCUTANEOUS TISSUE DISORDERS + Total number of patients with at least one adverse event 12 (22.6%) 7 (21.2%) 12 (30.0%) 22 (50.0%) 21 (42.0%) 14 (41.2%) + Total number of events 26 11 29 57 63 27 + ERYTHEMA 6 (11.3%) 3 (9.1%) 7 (17.5%) 7 (15.9%) 9 (18.0%) 6 (17.6%) + PRURITUS 6 (11.3%) 2 (6.1%) 11 (27.5%) 15 (34.1%) 13 (26.0%) 10 (29.4%) + RASH 2 (3.8%) 3 (9.1%) 3 (7.5%) 8 (18.2%) 8 (16.0%) 5 (14.7%) + SKIN IRRITATION 3 (5.7%) 0 1 (2.5%) 4 (9.1%) 5 (10.0%) 1 (2.9%) + GASTROINTESTINAL DISORDERS + Total number of patients with at least one adverse event 3 (5.7%) 1 (3.0%) 4 (10.0%) 7 (15.9%) 4 (8.0%) 1 (2.9%) + Total number of events 5 1 10 12 8 1 + NAUSEA 3 (5.7%) 0 4 (10.0%) 2 (4.5%) 2 (4.0%) 1 (2.9%) + VOMITING 2 (3.8%) 1 (3.0%) 0 7 (15.9%) 3 (6.0%) 0 + NERVOUS SYSTEM DISORDERS + Total number of patients with at least one adverse event 4 (7.5%) 3 (9.1%) 4 (10.0%) 2 (4.5%) 0 3 (8.8%) + Total number of events 5 3 7 2 0 4 + HEADACHE 4 (7.5%) 3 (9.1%) 4 (10.0%) 2 (4.5%) 0 3 (8.8%) + CARDIAC DISORDERS + Total number of patients with at least one adverse event 4 (7.5%) 0 1 (2.5%) 3 (6.8%) 2 (4.0%) 0 + Total number of events 4 0 1 7 4 0 + MYOCARDIAL INFARCTION 4 (7.5%) 0 1 (2.5%) 3 (6.8%) 2 (4.0%) 0 + VASCULAR DISORDERS + Total number of patients with at least one adverse event 0 0 1 (2.5%) 0 0 0 + Total number of events 0 0 1 0 0 0 + WOUND HAEMORRHAGE 0 0 1 (2.5%) 0 0 0 # AET06 variant 3 is produced correctly Code res Output - Placebo Xanomeline High Dose Xanomeline Low Dose - Body System or Organ Class <18.5 18.5 - 24.9 25 - 29.9 >30 <18.5 18.5 - 24.9 25 - 29.9 >30 <18.5 18.5 - 24.9 25 - 29.9 >30 - Dictionary-Derived Term (N=3) (N=57) (N=20) (N=6) (N=2) (N=42) (N=28) (N=12) (N=3) (N=43) (N=27) (N=10) - ————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— - Total number of patients with at least one adverse event 1 (33.3%) 46 (80.7%) 18 (90.0%) 4 (66.7%) 2 (100%) 39 (92.9%) 28 (100%) 10 (83.3%) 3 (100%) 40 (93.0%) 25 (92.6%) 8 (80.0%) - Overall total number of events 4 212 66 19 10 230 163 52 19 225 129 52 - GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - Total number of patients with at least one adverse event 0 16 (28.1%) 4 (20.0%) 1 (16.7%) 0 21 (50.0%) 13 (46.4%) 6 (50.0%) 2 (66.7%) 23 (53.5%) 15 (55.6%) 6 (60.0%) - Total number of events 0 37 10 1 0 56 43 25 5 59 45 10 - APPLICATION SITE PRURITUS 0 3 (5.3%) 2 (10.0%) 1 (16.7%) 0 9 (21.4%) 9 (32.1%) 4 (33.3%) 1 (33.3%) 9 (20.9%) 9 (33.3%) 3 (30.0%) - APPLICATION SITE ERYTHEMA 0 2 (3.5%) 1 (5.0%) 0 0 5 (11.9%) 7 (25.0%) 3 (25.0%) 1 (33.3%) 6 (14.0%) 5 (18.5%) 0 - APPLICATION SITE DERMATITIS 0 5 (8.8%) 0 0 0 4 (9.5%) 2 (7.1%) 1 (8.3%) 0 6 (14.0%) 2 (7.4%) 1 (10.0%) - APPLICATION SITE IRRITATION 0 3 (5.3%) 0 0 0 5 (11.9%) 1 (3.6%) 3 (25.0%) 1 (33.3%) 3 (7.0%) 4 (14.8%) 0 - APPLICATION SITE VESICLES 0 0 1 (5.0%) 0 0 2 (4.8%) 2 (7.1%) 2 (16.7%) 0 0 3 (11.1%) 1 (10.0%) - FATIGUE 0 1 (1.8%) 0 0 0 1 (2.4%) 2 (7.1%) 2 (16.7%) 0 3 (7.0%) 1 (3.7%) 1 (10.0%) - OEDEMA PERIPHERAL 0 2 (3.5%) 0 0 0 2 (4.8%) 0 0 0 1 (2.3%) 0 0 - APPLICATION SITE SWELLING 0 0 0 0 0 0 2 (7.1%) 0 0 1 (2.3%) 0 0 - APPLICATION SITE URTICARIA 0 0 0 0 0 0 1 (3.6%) 0 0 1 (2.3%) 0 1 (10.0%) - CHILLS 0 0 1 (5.0%) 0 0 1 (2.4%) 0 0 0 0 1 (3.7%) 0 - MALAISE 0 0 0 0 0 1 (2.4%) 1 (3.6%) 0 0 1 (2.3%) 0 0 - PYREXIA 0 1 (1.8%) 1 (5.0%) 0 0 0 1 (3.6%) 0 0 0 0 0 - APPLICATION SITE PAIN 0 0 0 0 0 1 (2.4%) 0 1 (8.3%) 0 0 0 0 - APPLICATION SITE PERSPIRATION 0 0 0 0 0 1 (2.4%) 1 (3.6%) 0 0 0 0 0 - APPLICATION SITE REACTION 0 1 (1.8%) 0 0 0 1 (2.4%) 0 0 0 0 0 0 - ASTHENIA 0 1 (1.8%) 0 0 0 1 (2.4%) 0 0 0 0 0 0 - CHEST DISCOMFORT 0 0 0 0 0 0 1 (3.6%) 1 (8.3%) 0 0 0 0 - CHEST PAIN 0 0 0 0 0 2 (4.8%) 0 0 0 0 0 0 - OEDEMA 0 0 0 0 0 0 0 0 0 1 (2.3%) 1 (3.7%) 0 - PAIN 0 0 0 0 0 0 1 (3.6%) 0 0 1 (2.3%) 0 0 - APPLICATION SITE BLEEDING 0 0 0 0 0 0 0 0 0 0 1 (3.7%) 0 - APPLICATION SITE DESQUAMATION 0 0 0 0 0 0 0 0 0 0 0 1 (10.0%) - APPLICATION SITE DISCHARGE 0 0 0 0 0 0 1 (3.6%) 0 0 0 0 0 - APPLICATION SITE DISCOLOURATION 0 0 0 0 0 0 0 0 0 0 1 (3.7%) 0 - APPLICATION SITE INDURATION 0 1 (1.8%) 0 0 0 0 0 0 0 0 0 0 - APPLICATION SITE WARMTH 0 0 0 0 0 0 0 0 0 1 (2.3%) 0 0 - CYST 0 0 0 0 0 0 0 0 0 1 (2.3%) 0 0 - FEELING ABNORMAL 0 0 0 0 0 0 1 (3.6%) 0 0 0 0 0 - FEELING COLD 0 0 0 0 0 1 (2.4%) 0 0 0 0 0 0 - INFLAMMATION 0 0 0 0 0 0 0 0 0 1 (2.3%) 0 0 - SECRETION DISCHARGE 0 0 0 0 0 0 0 0 0 0 1 (3.7%) 0 - SUDDEN DEATH 0 0 0 0 0 0 0 0 1 (33.3%) 0 0 0 - SWELLING 0 0 0 0 0 0 0 0 0 1 (2.3%) 0 0 - ULCER 0 0 0 0 0 0 0 0 0 0 1 (3.7%) 0 - SKIN AND SUBCUTANEOUS TISSUE DISORDERS - Total number of patients with at least one adverse event 0 11 (19.3%) 8 (40.0%) 2 (33.3%) 1 (50.0%) 21 (50.0%) 15 (53.6%) 5 (41.7%) 1 (33.3%) 21 (48.8%) 14 (51.9%) 5 (50.0%) - Total number of events 0 24 18 5 3 49 49 10 2 52 39 24 - PRURITUS 0 3 (5.3%) 4 (20.0%) 1 (16.7%) 0 11 (26.2%) 12 (42.9%) 3 (25.0%) 1 (33.3%) 11 (25.6%) 8 (29.6%) 3 (30.0%) - ERYTHEMA 0 4 (7.0%) 4 (20.0%) 1 (16.7%) 0 6 (14.3%) 6 (21.4%) 2 (16.7%) 0 5 (11.6%) 8 (29.6%) 2 (20.0%) - RASH 0 4 (7.0%) 1 (5.0%) 0 0 7 (16.7%) 4 (14.3%) 0 0 9 (20.9%) 3 (11.1%) 1 (10.0%) - HYPERHIDROSIS 0 1 (1.8%) 0 1 (16.7%) 1 (50.0%) 4 (9.5%) 2 (7.1%) 1 (8.3%) 0 2 (4.7%) 2 (7.4%) 0 - SKIN IRRITATION 0 1 (1.8%) 2 (10.0%) 0 1 (50.0%) 2 (4.8%) 2 (7.1%) 0 0 3 (7.0%) 0 2 (20.0%) - BLISTER 0 0 0 0 0 0 1 (3.6%) 0 0 2 (4.7%) 3 (11.1%) 0 - RASH PRURITIC 0 0 0 0 0 2 (4.8%) 0 0 0 1 (2.3%) 0 0 - PRURITUS GENERALISED 0 0 0 0 1 (50.0%) 0 0 0 0 0 1 (3.7%) 0 - RASH ERYTHEMATOUS 0 0 0 0 0 0 0 0 0 1 (2.3%) 1 (3.7%) 0 - URTICARIA 0 0 0 0 0 0 1 (3.6%) 0 0 0 0 1 (10.0%) - ACTINIC KERATOSIS 0 0 0 0 0 0 1 (3.6%) 0 0 0 0 0 - ALOPECIA 0 0 1 (5.0%) 0 0 0 0 0 0 0 0 0 - COLD SWEAT 0 0 1 (5.0%) 0 0 0 0 0 0 0 0 0 - DERMATITIS ATOPIC 0 1 (1.8%) 0 0 0 0 0 0 0 0 0 0 - DERMATITIS CONTACT 0 0 0 0 0 0 0 0 0 1 (2.3%) 0 0 - DRUG ERUPTION 0 1 (1.8%) 0 0 0 0 0 0 0 0 0 0 - RASH MACULO-PAPULAR 0 0 0 0 0 1 (2.4%) 0 0 0 0 0 0 - RASH PAPULAR 0 0 0 0 0 1 (2.4%) 0 0 0 0 0 0 - SKIN EXFOLIATION 0 0 0 0 0 0 0 0 0 1 (2.3%) 0 0 - SKIN ODOUR ABNORMAL 0 0 0 0 0 0 0 1 (8.3%) 0 0 0 0 - SKIN ULCER 0 1 (1.8%) 0 0 0 0 0 0 0 0 0 0 - NERVOUS SYSTEM DISORDERS - Total number of patients with at least one adverse event 1 (33.3%) 8 (14.0%) 3 (15.0%) 0 0 16 (38.1%) 7 (25.0%) 4 (33.3%) 1 (33.3%) 13 (30.2%) 5 (18.5%) 1 (10.0%) - Total number of events 1 11 4 0 0 27 13 5 2 30 7 1 - DIZZINESS 0 1 (1.8%) 1 (5.0%) 0 0 9 (21.4%) 3 (10.7%) 0 1 (33.3%) 6 (14.0%) 0 1 (10.0%) - HEADACHE 0 5 (8.8%) 2 (10.0%) 0 0 2 (4.8%) 3 (10.7%) 1 (8.3%) 0 3 (7.0%) 0 0 - SYNCOPE 0 0 0 0 0 2 (4.8%) 0 1 (8.3%) 0 3 (7.0%) 1 (3.7%) 0 - SOMNOLENCE 0 2 (3.5%) 0 0 0 1 (2.4%) 0 0 0 1 (2.3%) 2 (7.4%) 0 - TRANSIENT ISCHAEMIC ATTACK 0 0 0 0 0 1 (2.4%) 0 0 0 1 (2.3%) 1 (3.7%) 0 - BURNING SENSATION 0 0 0 0 0 1 (2.4%) 1 (3.6%) 0 0 0 0 0 - LETHARGY 0 0 0 0 0 1 (2.4%) 0 0 0 0 1 (3.7%) 0 - AMNESIA 0 0 0 0 0 1 (2.4%) 0 0 0 0 0 0 - BALANCE DISORDER 0 0 0 0 0 0 0 0 0 1 (2.3%) 0 0 - COGNITIVE DISORDER 0 0 0 0 0 0 0 1 (8.3%) 0 0 0 0 - COMPLEX PARTIAL SEIZURES 0 0 0 0 0 0 0 0 0 1 (2.3%) 0 0 - COORDINATION ABNORMAL 0 0 0 0 0 0 0 0 0 1 (2.3%) 0 0 - HEMIANOPIA HOMONYMOUS 0 0 0 0 0 0 0 0 0 1 (2.3%) 0 0 - HYPERSOMNIA 0 0 0 0 0 0 0 1 (8.3%) 0 0 0 0 - PARAESTHESIA 0 0 0 0 0 0 0 1 (8.3%) 0 0 0 0 - PARAESTHESIA ORAL 0 0 0 0 0 0 0 0 0 1 (2.3%) 0 0 - PARKINSON'S DISEASE 0 0 1 (5.0%) 0 0 0 0 0 0 0 0 0 - PAROSMIA 0 0 0 0 0 1 (2.4%) 0 0 0 0 0 0 - PARTIAL SEIZURES WITH SECONDARY GENERALISATION 0 0 0 0 0 0 1 (3.6%) 0 0 0 0 0 - PSYCHOMOTOR HYPERACTIVITY 1 (33.3%) 0 0 0 0 0 0 0 0 0 0 0 - STUPOR 0 0 0 0 0 0 0 0 0 1 (2.3%) 0 0 - SYNCOPE VASOVAGAL 0 0 0 0 0 1 (2.4%) 0 0 0 0 0 0 - GASTROINTESTINAL DISORDERS - Total number of patients with at least one adverse event 0 11 (19.3%) 4 (20.0%) 2 (33.3%) 0 13 (31.0%) 7 (25.0%) 1 (8.3%) 0 6 (14.0%) 7 (25.9%) 1 (10.0%) - Total number of events 0 16 6 4 0 27 9 1 0 10 10 2 - DIARRHOEA 0 5 (8.8%) 4 (20.0%) 0 0 2 (4.8%) 2 (7.1%) 0 0 2 (4.7%) 2 (7.4%) 1 (10.0%) - VOMITING 0 2 (3.5%) 1 (5.0%) 0 0 5 (11.9%) 2 (7.1%) 0 0 2 (4.7%) 1 (3.7%) 0 - NAUSEA 0 3 (5.3%) 0 0 0 5 (11.9%) 1 (3.6%) 0 0 2 (4.7%) 1 (3.7%) 0 - ABDOMINAL PAIN 0 0 0 1 (16.7%) 0 1 (2.4%) 0 0 0 0 3 (11.1%) 0 - SALIVARY HYPERSECRETION 0 0 0 0 0 2 (4.8%) 1 (3.6%) 1 (8.3%) 0 0 0 0 - DYSPEPSIA 0 1 (1.8%) 0 0 0 0 1 (3.6%) 0 0 1 (2.3%) 0 0 - ABDOMINAL DISCOMFORT 0 0 0 0 0 1 (2.4%) 0 0 0 0 0 0 - CONSTIPATION 0 0 0 1 (16.7%) 0 0 0 0 0 0 0 0 - DYSPHAGIA 0 0 0 0 0 0 0 0 0 0 1 (3.7%) 0 - FLATULENCE 0 1 (1.8%) 0 0 0 0 0 0 0 0 0 0 - GASTROINTESTINAL HAEMORRHAGE 0 0 0 0 0 1 (2.4%) 0 0 0 0 0 0 - GASTROOESOPHAGEAL REFLUX DISEASE 0 1 (1.8%) 0 0 0 0 0 0 0 0 0 0 - GLOSSITIS 0 1 (1.8%) 0 0 0 0 0 0 0 0 0 0 - HIATUS HERNIA 0 0 0 1 (16.7%) 0 0 0 0 0 0 0 0 - STOMACH DISCOMFORT 0 0 0 0 0 0 1 (3.6%) 0 0 0 0 0 - CARDIAC DISORDERS - Total number of patients with at least one adverse event 0 8 (14.0%) 2 (10.0%) 3 (50.0%) 2 (100%) 11 (26.2%) 4 (14.3%) 1 (8.3%) 1 (33.3%) 9 (20.9%) 2 (7.4%) 1 (10.0%) - Total number of events 0 21 3 3 3 22 8 1 4 19 6 1 - SINUS BRADYCARDIA 0 2 (3.5%) 0 0 0 6 (14.3%) 2 (7.1%) 0 1 (33.3%) 5 (11.6%) 0 1 (10.0%) - MYOCARDIAL INFARCTION 0 3 (5.3%) 0 1 (16.7%) 0 4 (9.5%) 0 0 1 (33.3%) 1 (2.3%) 0 0 - ATRIAL FIBRILLATION 0 1 (1.8%) 0 0 1 (50.0%) 1 (2.4%) 1 (3.6%) 0 0 0 1 (3.7%) 0 - ATRIOVENTRICULAR BLOCK SECOND DEGREE 0 0 1 (5.0%) 1 (16.7%) 0 1 (2.4%) 1 (3.6%) 1 (8.3%) 0 0 0 0 - SUPRAVENTRICULAR EXTRASYSTOLES 0 1 (1.8%) 0 0 0 1 (2.4%) 0 0 0 1 (2.3%) 0 0 - VENTRICULAR EXTRASYSTOLES 0 0 0 0 1 (50.0%) 0 0 0 0 2 (4.7%) 0 0 - ATRIAL FLUTTER 0 0 0 0 0 0 1 (3.6%) 0 0 0 1 (3.7%) 0 - ATRIOVENTRICULAR BLOCK FIRST DEGREE 0 1 (1.8%) 0 0 0 0 0 0 0 0 1 (3.7%) 0 - BUNDLE BRANCH BLOCK RIGHT 0 1 (1.8%) 0 0 0 0 0 0 0 0 1 (3.7%) 0 - PALPITATIONS 0 0 0 0 0 0 0 0 0 2 (4.7%) 0 0 - ATRIAL HYPERTROPHY 0 0 1 (5.0%) 0 0 0 0 0 0 0 0 0 - BRADYCARDIA 0 1 (1.8%) 0 0 0 0 0 0 0 0 0 0 - BUNDLE BRANCH BLOCK LEFT 0 0 0 1 (16.7%) 0 0 0 0 0 0 0 0 - CARDIAC DISORDER 0 0 0 0 0 1 (2.4%) 0 0 0 0 0 0 - CARDIAC FAILURE CONGESTIVE 0 1 (1.8%) 0 0 0 0 0 0 0 0 0 0 - SINUS ARRHYTHMIA 0 1 (1.8%) 0 0 0 0 0 0 0 0 0 0 - SUPRAVENTRICULAR TACHYCARDIA 0 0 0 0 0 0 0 0 0 0 1 (3.7%) 0 - TACHYCARDIA 0 1 (1.8%) 0 0 0 0 0 0 0 0 0 0 - VENTRICULAR HYPERTROPHY 0 1 (1.8%) 0 0 0 0 0 0 0 0 0 0 - WOLFF-PARKINSON-WHITE SYNDROME 0 0 0 0 0 0 0 0 0 1 (2.3%) 0 0 - INFECTIONS AND INFESTATIONS - Total number of patients with at least one adverse event 0 11 (19.3%) 3 (15.0%) 2 (33.3%) 0 5 (11.9%) 6 (21.4%) 2 (16.7%) 0 8 (18.6%) 2 (7.4%) 0 - Total number of events 0 27 5 3 0 8 7 5 0 15 3 0 - NASOPHARYNGITIS 0 2 (3.5%) 0 0 0 3 (7.1%) 2 (7.1%) 1 (8.3%) 0 4 (9.3%) 0 0 - UPPER RESPIRATORY TRACT INFECTION 0 4 (7.0%) 1 (5.0%) 1 (16.7%) 0 1 (2.4%) 1 (3.6%) 1 (8.3%) 0 1 (2.3%) 0 0 - INFLUENZA 0 1 (1.8%) 0 0 0 1 (2.4%) 0 0 0 0 1 (3.7%) 0 - URINARY TRACT INFECTION 0 1 (1.8%) 1 (5.0%) 0 0 0 1 (3.6%) 0 0 0 0 0 - CYSTITIS 0 0 1 (5.0%) 0 0 1 (2.4%) 0 0 0 0 0 0 - EAR INFECTION 0 1 (1.8%) 0 1 (16.7%) 0 0 0 0 0 0 0 0 - LOCALISED INFECTION 0 1 (1.8%) 0 0 0 0 0 0 0 1 (2.3%) 0 0 - BRONCHITIS 0 1 (1.8%) 0 0 0 0 0 0 0 0 0 0 - CELLULITIS 0 0 0 0 0 0 0 0 0 1 (2.3%) 0 0 - CERVICITIS 0 1 (1.8%) 0 0 0 0 0 0 0 0 0 0 - GASTROENTERITIS VIRAL 0 1 (1.8%) 0 0 0 0 0 0 0 0 0 0 - HORDEOLUM 0 0 0 0 0 0 0 1 (8.3%) 0 0 0 0 - LOWER RESPIRATORY TRACT INFECTION 0 0 0 0 0 0 1 (3.6%) 0 0 0 0 0 - ONYCHOMYCOSIS 0 0 0 0 0 0 0 0 0 1 (2.3%) 0 0 - PNEUMONIA 0 0 0 0 0 0 0 0 0 0 1 (3.7%) 0 - RHINITIS 0 0 0 0 0 0 1 (3.6%) 0 0 0 0 0 - VAGINAL MYCOSIS 0 1 (1.8%) 0 0 0 0 0 0 0 0 0 0 - VIRAL INFECTION 0 0 0 0 0 0 0 0 0 1 (2.3%) 0 0 - RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - Total number of patients with at least one adverse event 0 9 (15.8%) 1 (5.0%) 0 0 5 (11.9%) 4 (14.3%) 1 (8.3%) 1 (33.3%) 4 (9.3%) 3 (11.1%) 2 (20.0%) - Total number of events 0 14 1 0 0 13 8 1 1 5 5 5 - COUGH 0 3 (5.3%) 0 0 0 3 (7.1%) 1 (3.6%) 1 (8.3%) 0 2 (4.7%) 2 (7.4%) 2 (20.0%) - NASAL CONGESTION 0 2 (3.5%) 1 (5.0%) 0 0 2 (4.8%) 1 (3.6%) 0 0 0 1 (3.7%) 0 - DYSPNOEA 0 1 (1.8%) 0 0 0 0 1 (3.6%) 0 1 (33.3%) 0 0 0 - EPISTAXIS 0 0 0 0 0 0 2 (7.1%) 0 0 1 (2.3%) 0 0 - PHARYNGOLARYNGEAL PAIN 0 0 0 0 0 0 1 (3.6%) 0 0 0 1 (3.7%) 0 - RHINORRHOEA 0 0 0 0 0 1 (2.4%) 0 0 0 0 0 1 (10.0%) - ALLERGIC GRANULOMATOUS ANGIITIS 0 0 0 0 0 1 (2.4%) 0 0 0 0 0 0 - DYSPHONIA 0 0 0 0 0 0 0 0 0 1 (2.3%) 0 0 - EMPHYSEMA 0 1 (1.8%) 0 0 0 0 0 0 0 0 0 0 - HAEMOPTYSIS 0 1 (1.8%) 0 0 0 0 0 0 0 0 0 0 - PHARYNGEAL ERYTHEMA 0 0 0 0 0 1 (2.4%) 0 0 0 0 0 0 - POSTNASAL DRIP 0 1 (1.8%) 0 0 0 0 0 0 0 0 0 0 - PRODUCTIVE COUGH 0 0 0 0 0 0 1 (3.6%) 0 0 0 0 0 - RALES 0 1 (1.8%) 0 0 0 0 0 0 0 0 0 0 - RESPIRATORY TRACT CONGESTION 0 0 0 0 0 0 1 (3.6%) 0 0 0 0 0 - PSYCHIATRIC DISORDERS - Total number of patients with at least one adverse event 1 (33.3%) 7 (12.3%) 2 (10.0%) 0 1 (50.0%) 3 (7.1%) 5 (17.9%) 0 1 (33.3%) 7 (16.3%) 1 (3.7%) 1 (10.0%) - Total number of events 1 11 2 0 2 3 7 0 1 9 2 2 - CONFUSIONAL STATE 0 1 (1.8%) 1 (5.0%) 0 1 (50.0%) 0 0 0 1 (33.3%) 2 (4.7%) 0 0 - AGITATION 0 1 (1.8%) 1 (5.0%) 0 0 0 1 (3.6%) 0 0 2 (4.7%) 0 0 - ANXIETY 0 1 (1.8%) 0 0 0 0 0 0 0 2 (4.7%) 0 1 (10.0%) - INSOMNIA 0 2 (3.5%) 0 0 1 (50.0%) 1 (2.4%) 0 0 0 0 0 0 - DELUSION 1 (33.3%) 0 0 0 0 0 1 (3.6%) 0 0 0 0 0 - DEPRESSED MOOD 0 0 0 0 0 0 1 (3.6%) 0 0 1 (2.3%) 0 0 - IRRITABILITY 0 1 (1.8%) 0 0 0 0 0 0 0 0 0 1 (10.0%) - COMPLETED SUICIDE 0 1 (1.8%) 0 0 0 0 0 0 0 0 0 0 - DELIRIUM 0 0 0 0 0 1 (2.4%) 0 0 0 0 0 0 - DISORIENTATION 0 1 (1.8%) 0 0 0 0 0 0 0 0 0 0 - HALLUCINATION 0 0 0 0 0 0 1 (3.6%) 0 0 0 0 0 - HALLUCINATION, VISUAL 0 0 0 0 0 0 1 (3.6%) 0 0 0 0 0 - LIBIDO DECREASED 0 0 0 0 0 0 1 (3.6%) 0 0 0 0 0 - LISTLESS 0 0 0 0 0 0 1 (3.6%) 0 0 0 0 0 - NIGHTMARE 0 0 0 0 0 1 (2.4%) 0 0 0 0 0 0 - RESTLESSNESS 0 0 0 0 0 0 0 0 0 0 1 (3.7%) 0 - INVESTIGATIONS - Total number of patients with at least one adverse event 0 6 (10.5%) 3 (15.0%) 1 (16.7%) 0 4 (9.5%) 1 (3.6%) 1 (8.3%) 0 3 (7.0%) 3 (11.1%) 0 - Total number of events 0 10 6 3 0 5 2 1 0 4 3 0 - ELECTROCARDIOGRAM ST SEGMENT DEPRESSION 0 3 (5.3%) 1 (5.0%) 0 0 0 0 0 0 1 (2.3%) 0 0 - ELECTROCARDIOGRAM T WAVE INVERSION 0 1 (1.8%) 0 1 (16.7%) 0 1 (2.4%) 0 0 0 1 (2.3%) 0 0 - BLOOD GLUCOSE INCREASED 0 0 0 0 0 1 (2.4%) 0 0 0 0 1 (3.7%) 0 - ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED 0 0 0 1 (16.7%) 0 0 0 0 0 0 1 (3.7%) 0 - BIOPSY 0 0 0 0 0 1 (2.4%) 0 0 0 0 0 0 - BIOPSY PROSTATE 0 0 0 0 0 0 0 1 (8.3%) 0 0 0 0 - BLOOD ALKALINE PHOSPHATASE INCREASED 0 0 1 (5.0%) 0 0 0 0 0 0 0 0 0 - BLOOD CHOLESTEROL INCREASED 0 0 0 0 0 1 (2.4%) 0 0 0 0 0 0 - BLOOD CREATINE PHOSPHOKINASE INCREASED 0 1 (1.8%) 0 0 0 0 0 0 0 0 0 0 - BLOOD URINE PRESENT 0 1 (1.8%) 0 0 0 0 0 0 0 0 0 0 - BODY TEMPERATURE INCREASED 0 0 0 0 0 0 0 0 0 1 (2.3%) 0 0 - CYSTOSCOPY 0 1 (1.8%) 0 0 0 0 0 0 0 0 0 0 - HEART RATE INCREASED 0 1 (1.8%) 0 0 0 0 0 0 0 0 0 0 - HEART RATE IRREGULAR 0 0 1 (5.0%) 0 0 0 0 0 0 0 0 0 - NASAL MUCOSA BIOPSY 0 0 0 0 0 0 0 0 0 0 1 (3.7%) 0 - WEIGHT DECREASED 0 0 0 0 0 0 1 (3.6%) 0 0 0 0 0 - MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS - Total number of patients with at least one adverse event 0 3 (5.3%) 2 (10.0%) 0 0 6 (14.3%) 2 (7.1%) 0 1 (33.3%) 2 (4.7%) 2 (7.4%) 2 (20.0%) - Total number of events 0 6 2 0 0 9 2 0 1 2 5 2 - BACK PAIN 0 1 (1.8%) 0 0 0 3 (7.1%) 0 0 0 0 0 1 (10.0%) - ARTHRALGIA 0 0 1 (5.0%) 0 0 1 (2.4%) 0 0 0 1 (2.3%) 1 (3.7%) 0 - SHOULDER PAIN 0 1 (1.8%) 0 0 0 0 0 0 1 (33.3%) 0 0 1 (10.0%) - ARTHRITIS 0 1 (1.8%) 0 0 0 1 (2.4%) 0 0 0 0 0 0 - FLANK PAIN 0 0 0 0 0 1 (2.4%) 1 (3.6%) 0 0 0 0 0 - MUSCLE SPASMS 0 0 0 0 0 1 (2.4%) 0 0 0 1 (2.3%) 0 0 - MUSCULAR WEAKNESS 0 0 0 0 0 0 0 0 0 0 1 (3.7%) 0 - MYALGIA 0 0 0 0 0 0 1 (3.6%) 0 0 0 0 0 - PAIN IN EXTREMITY 0 0 1 (5.0%) 0 0 0 0 0 0 0 0 0 - INJURY, POISONING AND PROCEDURAL COMPLICATIONS - Total number of patients with at least one adverse event 1 (33.3%) 2 (3.5%) 1 (5.0%) 0 0 1 (2.4%) 3 (10.7%) 1 (8.3%) 1 (33.3%) 2 (4.7%) 0 2 (20.0%) - Total number of events 2 4 3 0 0 1 6 1 2 6 0 4 - CONTUSION 0 0 1 (5.0%) 0 0 0 2 (7.1%) 0 0 1 (2.3%) 0 0 - EXCORIATION 0 1 (1.8%) 1 (5.0%) 0 0 0 0 1 (8.3%) 0 0 0 1 (10.0%) - FALL 0 1 (1.8%) 0 0 0 0 1 (3.6%) 0 0 2 (4.7%) 0 0 - HIP FRACTURE 1 (33.3%) 0 0 0 0 1 (2.4%) 1 (3.6%) 0 0 0 0 0 - SKIN LACERATION 0 0 1 (5.0%) 0 0 0 0 0 1 (33.3%) 1 (2.3%) 0 0 - FACIAL BONES FRACTURE 0 0 0 0 0 0 1 (3.6%) 0 0 0 0 0 - JOINT DISLOCATION 0 0 0 0 0 0 0 0 1 (33.3%) 0 0 0 - WOUND 0 0 0 0 0 0 0 0 0 0 0 1 (10.0%) - RENAL AND URINARY DISORDERS - Total number of patients with at least one adverse event 0 4 (7.0%) 0 0 0 0 3 (10.7%) 0 1 (33.3%) 1 (2.3%) 1 (3.7%) 1 (10.0%) - Total number of events 0 5 0 0 0 0 4 0 1 1 1 1 - MICTURITION URGENCY 0 1 (1.8%) 0 0 0 0 1 (3.6%) 0 0 1 (2.3%) 0 0 - DYSURIA 0 1 (1.8%) 0 0 0 0 0 0 0 0 1 (3.7%) 0 - NEPHROLITHIASIS 0 1 (1.8%) 0 0 0 0 1 (3.6%) 0 0 0 0 0 - CALCULUS URETHRAL 0 0 0 0 0 0 1 (3.6%) 0 0 0 0 0 - ENURESIS 0 0 0 0 0 0 0 0 0 0 0 1 (10.0%) - INCONTINENCE 0 0 0 0 0 0 0 0 1 (33.3%) 0 0 0 - POLLAKIURIA 0 1 (1.8%) 0 0 0 0 0 0 0 0 0 0 - METABOLISM AND NUTRITION DISORDERS - Total number of patients with at least one adverse event 0 6 (10.5%) 0 0 1 (50.0%) 1 (2.4%) 0 1 (8.3%) 0 0 1 (3.7%) 0 - Total number of events 0 8 0 0 2 2 0 1 0 0 1 0 - DECREASED APPETITE 0 1 (1.8%) 0 0 0 1 (2.4%) 0 0 0 0 0 0 - FOOD CRAVING 0 1 (1.8%) 0 0 0 0 0 0 0 0 1 (3.7%) 0 - INCREASED APPETITE 0 1 (1.8%) 0 0 1 (50.0%) 0 0 0 0 0 0 0 - DEHYDRATION 0 1 (1.8%) 0 0 0 0 0 0 0 0 0 0 - DIABETES MELLITUS 0 1 (1.8%) 0 0 0 0 0 0 0 0 0 0 - HYPERCHOLESTEROLAEMIA 0 0 0 0 0 0 0 1 (8.3%) 0 0 0 0 - HYPONATRAEMIA 0 1 (1.8%) 0 0 0 0 0 0 0 0 0 0 - VASCULAR DISORDERS - Total number of patients with at least one adverse event 0 3 (5.3%) 0 0 0 2 (4.8%) 0 0 0 3 (7.0%) 0 0 - Total number of events 0 7 0 0 0 3 0 0 0 3 0 0 - HYPERTENSION 0 1 (1.8%) 0 0 0 1 (2.4%) 0 0 0 1 (2.3%) 0 0 - HYPOTENSION 0 2 (3.5%) 0 0 0 0 0 0 0 1 (2.3%) 0 0 - HOT FLUSH 0 0 0 0 0 0 0 0 0 1 (2.3%) 0 0 - ORTHOSTATIC HYPOTENSION 0 1 (1.8%) 0 0 0 0 0 0 0 0 0 0 - WOUND HAEMORRHAGE 0 0 0 0 0 1 (2.4%) 0 0 0 0 0 0 - EYE DISORDERS - Total number of patients with at least one adverse event 0 3 (5.3%) 1 (5.0%) 0 0 0 1 (3.6%) 0 0 2 (4.7%) 0 0 - Total number of events 0 5 3 0 0 0 2 0 0 2 0 0 - CONJUNCTIVITIS 0 2 (3.5%) 0 0 0 0 0 0 0 0 0 0 - VISION BLURRED 0 0 0 0 0 0 1 (3.6%) 0 0 1 (2.3%) 0 0 - CONJUNCTIVAL HAEMORRHAGE 0 0 0 0 0 0 0 0 0 1 (2.3%) 0 0 - EYE ALLERGY 0 0 1 (5.0%) 0 0 0 0 0 0 0 0 0 - EYE PRURITUS 0 0 1 (5.0%) 0 0 0 0 0 0 0 0 0 - EYE SWELLING 0 0 1 (5.0%) 0 0 0 0 0 0 0 0 0 - GLAUCOMA 0 1 (1.8%) 0 0 0 0 0 0 0 0 0 0 - SURGICAL AND MEDICAL PROCEDURES - Total number of patients with at least one adverse event 0 1 (1.8%) 1 (5.0%) 0 0 1 (2.4%) 1 (3.6%) 0 0 1 (2.3%) 0 0 - Total number of events 0 1 1 0 0 1 1 0 0 1 0 0 - CATARACT OPERATION 0 1 (1.8%) 0 0 0 0 0 0 0 1 (2.3%) 0 0 - ACROCHORDON EXCISION 0 0 0 0 0 1 (2.4%) 0 0 0 0 0 0 - EYE LASER SURGERY 0 0 1 (5.0%) 0 0 0 0 0 0 0 0 0 - SKIN LESION EXCISION 0 0 0 0 0 0 1 (3.6%) 0 0 0 0 0 - EAR AND LABYRINTH DISORDERS - Total number of patients with at least one adverse event 0 0 1 (5.0%) 0 0 1 (2.4%) 0 0 0 2 (4.7%) 0 0 - Total number of events 0 0 2 0 0 1 0 0 0 3 0 0 - VERTIGO 0 0 0 0 0 1 (2.4%) 0 0 0 1 (2.3%) 0 0 - CERUMEN IMPACTION 0 0 0 0 0 0 0 0 0 1 (2.3%) 0 0 - EAR PAIN 0 0 1 (5.0%) 0 0 0 0 0 0 0 0 0 - TINNITUS 0 0 0 0 0 0 0 0 0 1 (2.3%) 0 0 - REPRODUCTIVE SYSTEM AND BREAST DISORDERS - Total number of patients with at least one adverse event 0 2 (3.5%) 0 0 0 0 0 1 (8.3%) 0 0 0 0 - Total number of events 0 4 0 0 0 0 0 1 0 0 0 0 - BENIGN PROSTATIC HYPERPLASIA 0 1 (1.8%) 0 0 0 0 0 1 (8.3%) 0 0 0 0 - PELVIC PAIN 0 1 (1.8%) 0 0 0 0 0 0 0 0 0 0 - CONGENITAL, FAMILIAL AND GENETIC DISORDERS - Total number of patients with at least one adverse event 0 0 0 0 0 2 (4.8%) 0 0 0 0 1 (3.7%) 0 - Total number of events 0 0 0 0 0 2 0 0 0 0 1 0 - VENTRICULAR SEPTAL DEFECT 0 0 0 0 0 2 (4.8%) 0 0 0 0 1 (3.7%) 0 - NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - Total number of patients with at least one adverse event 0 0 0 0 0 0 1 (3.6%) 0 0 1 (2.3%) 1 (3.7%) 0 - Total number of events 0 0 0 0 0 0 1 0 0 2 1 0 - COLON CANCER 0 0 0 0 0 0 0 0 0 0 1 (3.7%) 0 - MALIGNANT FIBROUS HISTIOCYTOMA 0 0 0 0 0 0 0 0 0 1 (2.3%) 0 0 - PROSTATE CANCER 0 0 0 0 0 0 1 (3.6%) 0 0 0 0 0 - IMMUNE SYSTEM DISORDERS - Total number of patients with at least one adverse event 0 0 0 0 0 0 1 (3.6%) 0 0 1 (2.3%) 0 0 - Total number of events 0 0 0 0 0 0 1 0 0 2 0 0 - HYPERSENSITIVITY 0 0 0 0 0 0 0 0 0 1 (2.3%) 0 0 - SEASONAL ALLERGY 0 0 0 0 0 0 1 (3.6%) 0 0 0 0 0 - HEPATOBILIARY DISORDERS - Total number of patients with at least one adverse event 0 1 (1.8%) 0 0 0 0 0 0 0 0 0 0 - Total number of events 0 1 0 0 0 0 0 0 0 0 0 0 - HYPERBILIRUBINAEMIA 0 1 (1.8%) 0 0 0 0 0 0 0 0 0 0 - SOCIAL CIRCUMSTANCES - Total number of patients with at least one adverse event 0 0 0 0 0 1 (2.4%) 0 0 0 0 0 0 - Total number of events 0 0 0 0 0 1 0 0 0 0 0 0 - ALCOHOL USE 0 0 0 0 0 1 (2.4%) 0 0 0 0 0 0 + Placebo Xanomeline High Dose Xanomeline Low Dose + Body System or Organ Class <18.5 18.5 - 24.9 25 - 29.9 >30 <18.5 18.5 - 24.9 25 - 29.9 >30 <18.5 18.5 - 24.9 25 - 29.9 >30 + Dictionary-Derived Term (N=3) (N=57) (N=20) (N=6) (N=2) (N=42) (N=28) (N=12) (N=3) (N=43) (N=27) (N=10) + ——————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— + Total number of patients with at least one adverse event 0 21 (36.8%) 13 (65.0%) 3 (50.0%) 1 (50.0%) 30 (71.4%) 24 (85.7%) 8 (66.7%) 3 (100%) 29 (67.4%) 21 (77.8%) 8 (80.0%) + Overall total number of events 0 48 21 6 1 97 75 27 8 85 58 25 + SKIN AND SUBCUTANEOUS TISSUE DISORDERS + Total number of patients with at least one adverse event 0 9 (15.8%) 8 (40.0%) 2 (33.3%) 1 (50.0%) 16 (38.1%) 13 (46.4%) 4 (33.3%) 1 (33.3%) 16 (37.2%) 12 (44.4%) 5 (50.0%) + Total number of events 0 19 14 4 1 36 41 8 2 41 25 21 + PRURITUS 0 3 (5.3%) 4 (20.0%) 1 (16.7%) 0 11 (26.2%) 12 (42.9%) 3 (25.0%) 1 (33.3%) 11 (25.6%) 8 (29.6%) 3 (30.0%) + ERYTHEMA 0 4 (7.0%) 4 (20.0%) 1 (16.7%) 0 6 (14.3%) 6 (21.4%) 2 (16.7%) 0 5 (11.6%) 8 (29.6%) 2 (20.0%) + RASH 0 4 (7.0%) 1 (5.0%) 0 0 7 (16.7%) 4 (14.3%) 0 0 9 (20.9%) 3 (11.1%) 1 (10.0%) + SKIN IRRITATION 0 1 (1.8%) 2 (10.0%) 0 1 (50.0%) 2 (4.8%) 2 (7.1%) 0 0 3 (7.0%) 0 2 (20.0%) + GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS + Total number of patients with at least one adverse event 0 7 (12.3%) 2 (10.0%) 1 (16.7%) 0 14 (33.3%) 11 (39.3%) 5 (41.7%) 2 (66.7%) 13 (30.2%) 11 (40.7%) 3 (30.0%) + Total number of events 0 15 4 1 0 32 24 18 4 32 30 4 + APPLICATION SITE PRURITUS 0 3 (5.3%) 2 (10.0%) 1 (16.7%) 0 9 (21.4%) 9 (32.1%) 4 (33.3%) 1 (33.3%) 9 (20.9%) 9 (33.3%) 3 (30.0%) + APPLICATION SITE ERYTHEMA 0 2 (3.5%) 1 (5.0%) 0 0 5 (11.9%) 7 (25.0%) 3 (25.0%) 1 (33.3%) 6 (14.0%) 5 (18.5%) 0 + APPLICATION SITE IRRITATION 0 3 (5.3%) 0 0 0 5 (11.9%) 1 (3.6%) 3 (25.0%) 1 (33.3%) 3 (7.0%) 4 (14.8%) 0 + GASTROINTESTINAL DISORDERS + Total number of patients with at least one adverse event 0 3 (5.3%) 1 (5.0%) 0 0 8 (19.0%) 3 (10.7%) 0 0 3 (7.0%) 2 (7.4%) 0 + Total number of events 0 5 1 0 0 18 4 0 0 6 3 0 + VOMITING 0 2 (3.5%) 1 (5.0%) 0 0 5 (11.9%) 2 (7.1%) 0 0 2 (4.7%) 1 (3.7%) 0 + NAUSEA 0 3 (5.3%) 0 0 0 5 (11.9%) 1 (3.6%) 0 0 2 (4.7%) 1 (3.7%) 0 + NERVOUS SYSTEM DISORDERS + Total number of patients with at least one adverse event 0 5 (8.8%) 2 (10.0%) 0 0 2 (4.8%) 3 (10.7%) 1 (8.3%) 0 3 (7.0%) 0 0 + Total number of events 0 6 2 0 0 2 6 1 0 4 0 0 + HEADACHE 0 5 (8.8%) 2 (10.0%) 0 0 2 (4.8%) 3 (10.7%) 1 (8.3%) 0 3 (7.0%) 0 0 + CARDIAC DISORDERS + Total number of patients with at least one adverse event 0 3 (5.3%) 0 1 (16.7%) 0 4 (9.5%) 0 0 1 (33.3%) 1 (2.3%) 0 0 + Total number of events 0 3 0 1 0 8 0 0 2 2 0 0 + MYOCARDIAL INFARCTION 0 3 (5.3%) 0 1 (16.7%) 0 4 (9.5%) 0 0 1 (33.3%) 1 (2.3%) 0 0 + VASCULAR DISORDERS + Total number of patients with at least one adverse event 0 0 0 0 0 1 (2.4%) 0 0 0 0 0 0 + Total number of events 0 0 0 0 0 1 0 0 0 0 0 0 + WOUND HAEMORRHAGE 0 0 0 0 0 1 (2.4%) 0 0 0 0 0 0 # AET06 variant 5 is produced correctly Code res Output - Placebo Xanomeline High Dose Xanomeline Low Dose - F M F M F M - (N=53) (N=33) (N=40) (N=44) (N=50) (N=34) - ————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— - Total number of patients with at least one adverse event 40 (75.5%) 29 (87.9%) 37 (92.5%) 42 (95.5%) 44 (88.0%) 33 (97.1%) - Overall total number of events 171 130 173 282 251 184 - GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - Total number of patients with at least one adverse event 12 (22.6%) 9 (27.3%) 20 (50.0%) 20 (45.5%) 25 (50.0%) 22 (64.7%) - Total number of events 26 22 64 60 56 64 - HLT_0617 - Total number of patients with at least one adverse event 2 (3.8%) 1 (3.0%) 5 (12.5%) 10 (22.7%) 5 (10.0%) 7 (20.6%) - Total number of events 2 1 9 14 8 12 - APPLICATION SITE ERYTHEMA 2 (3.8%) 1 (3.0%) 5 (12.5%) 10 (22.7%) 5 (10.0%) 7 (20.6%) - HLT_0317 - Total number of patients with at least one adverse event 4 (7.5%) 2 (6.1%) 10 (25.0%) 12 (27.3%) 12 (24.0%) 10 (29.4%) - Total number of events 6 4 19 16 17 16 - APPLICATION SITE PRURITUS 4 (7.5%) 2 (6.1%) 10 (25.0%) 12 (27.3%) 12 (24.0%) 10 (29.4%) - HLT_0043 - Total number of patients with at least one adverse event 1 (1.9%) 0 4 (10.0%) 1 (2.3%) 1 (2.0%) 4 (11.8%) - Total number of events 2 0 4 1 1 4 - FATIGUE 1 (1.9%) 0 4 (10.0%) 1 (2.3%) 1 (2.0%) 4 (11.8%) - HLT_0180 - Total number of patients with at least one adverse event 0 1 (3.0%) 3 (7.5%) 3 (6.8%) 1 (2.0%) 3 (8.8%) - Total number of events 0 2 3 3 1 4 - APPLICATION SITE VESICLES 0 1 (3.0%) 3 (7.5%) 3 (6.8%) 1 (2.0%) 3 (8.8%) - HLT_0061 - Total number of patients with at least one adverse event 3 (5.7%) 0 5 (12.5%) 4 (9.1%) 6 (12.0%) 3 (8.8%) - Total number of events 7 0 9 7 10 8 - APPLICATION SITE IRRITATION 3 (5.7%) 0 5 (12.5%) 4 (9.1%) 6 (12.0%) 3 (8.8%) - HLT_0343 - Total number of patients with at least one adverse event 2 (3.8%) 3 (9.1%) 4 (10.0%) 3 (6.8%) 5 (10.0%) 4 (11.8%) - Total number of events 2 7 9 3 8 7 - APPLICATION SITE DERMATITIS 2 (3.8%) 3 (9.1%) 4 (10.0%) 3 (6.8%) 5 (10.0%) 4 (11.8%) - HLT_0310 - Total number of patients with at least one adverse event 0 2 (6.1%) 0 1 (2.3%) 0 0 - Total number of events 0 2 0 1 0 0 - PYREXIA 0 2 (6.1%) 0 1 (2.3%) 0 0 - HLT_0342 - Total number of patients with at least one adverse event 0 0 2 (5.0%) 0 0 0 - Total number of events 0 0 2 0 0 0 - APPLICATION SITE PAIN 0 0 2 (5.0%) 0 0 0 - HLT_0196 - Total number of patients with at least one adverse event 0 0 1 (2.5%) 0 0 2 (5.9%) - Total number of events 0 0 1 0 0 2 - APPLICATION SITE URTICARIA 0 0 1 (2.5%) 0 0 2 (5.9%) - HLT_0683 - Total number of patients with at least one adverse event 0 0 0 0 1 (2.0%) 0 - Total number of events 0 0 0 0 2 0 - SECRETION DISCHARGE 0 0 0 0 1 (2.0%) 0 - HLT_0142 - Total number of patients with at least one adverse event 0 0 0 0 1 (2.0%) 0 - Total number of events 0 0 0 0 1 0 - SUDDEN DEATH 0 0 0 0 1 (2.0%) 0 - HLT_0456 - Total number of patients with at least one adverse event 0 0 0 2 (4.5%) 0 1 (2.9%) - Total number of events 0 0 0 3 0 2 - MALAISE 0 0 0 2 (4.5%) 0 1 (2.9%) - HLT_0283 - Total number of patients with at least one adverse event 0 0 0 2 (4.5%) 0 0 - Total number of events 0 0 0 3 0 0 - APPLICATION SITE PERSPIRATION 0 0 0 2 (4.5%) 0 0 - HLT_0314 - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 1 (2.0%) 0 - Total number of events 0 0 0 1 2 0 - PAIN 0 0 0 1 (2.3%) 1 (2.0%) 0 - HLT_0524 - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 0 0 - Total number of events 0 0 0 1 0 0 - FEELING ABNORMAL 0 0 0 1 (2.3%) 0 0 - HLT_0593 - Total number of patients with at least one adverse event 0 0 1 (2.5%) 1 (2.3%) 0 0 - Total number of events 0 0 1 1 0 0 - CHEST DISCOMFORT 0 0 1 (2.5%) 1 (2.3%) 0 0 - HLT_0586 - Total number of patients with at least one adverse event 0 1 (3.0%) 0 1 (2.3%) 0 1 (2.9%) - Total number of events 0 3 0 1 0 2 - CHILLS 0 1 (3.0%) 0 1 (2.3%) 0 1 (2.9%) - HLT_0661 - Total number of patients with at least one adverse event 2 (3.8%) 0 1 (2.5%) 1 (2.3%) 1 (2.0%) 0 - Total number of events 5 0 2 1 1 0 - OEDEMA PERIPHERAL 2 (3.8%) 0 1 (2.5%) 1 (2.3%) 1 (2.0%) 0 - HLT_0656 - Total number of patients with at least one adverse event 0 0 0 0 1 (2.0%) 1 (2.9%) - Total number of events 0 0 0 0 1 1 - OEDEMA 0 0 0 0 1 (2.0%) 1 (2.9%) - HLT_0105 - Total number of patients with at least one adverse event 0 0 1 (2.5%) 1 (2.3%) 0 1 (2.9%) - Total number of events 0 0 2 1 0 1 - APPLICATION SITE SWELLING 0 0 1 (2.5%) 1 (2.3%) 0 1 (2.9%) - HLT_0260 - Total number of patients with at least one adverse event 0 0 0 0 1 (2.0%) 0 - Total number of events 0 0 0 0 2 0 - APPLICATION SITE WARMTH 0 0 0 0 1 (2.0%) 0 - HLT_0200 - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 0 0 - Total number of events 0 0 0 1 0 0 - APPLICATION SITE DISCHARGE 0 0 0 1 (2.3%) 0 0 - HLT_0340 - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 0 0 - Total number of events 0 0 0 1 0 0 - FEELING COLD 0 0 0 1 (2.3%) 0 0 - HLT_0718 - Total number of patients with at least one adverse event 0 0 0 0 1 (2.0%) 0 - Total number of events 0 0 0 0 1 0 - APPLICATION SITE BLEEDING 0 0 0 0 1 (2.0%) 0 - HLT_0717 - Total number of patients with at least one adverse event 0 0 1 (2.5%) 1 (2.3%) 0 0 - Total number of events 0 0 1 1 0 0 - CHEST PAIN 0 0 1 (2.5%) 1 (2.3%) 0 0 - HLT_0696 - Total number of patients with at least one adverse event 0 1 (3.0%) 0 0 0 0 - Total number of events 0 1 0 0 0 0 - APPLICATION SITE INDURATION 0 1 (3.0%) 0 0 0 0 - HLT_0351 - Total number of patients with at least one adverse event 0 0 0 0 0 1 (2.9%) - Total number of events 0 0 0 0 0 1 - APPLICATION SITE DESQUAMATION 0 0 0 0 0 1 (2.9%) - HLT_0205 - Total number of patients with at least one adverse event 1 (1.9%) 0 1 (2.5%) 0 0 0 - Total number of events 2 0 1 0 0 0 - ASTHENIA 1 (1.9%) 0 1 (2.5%) 0 0 0 - HLT_0339 - Total number of patients with at least one adverse event 0 1 (3.0%) 1 (2.5%) 0 0 0 - Total number of events 0 2 1 0 0 0 - APPLICATION SITE REACTION 0 1 (3.0%) 1 (2.5%) 0 0 0 - HLT_0658 - Total number of patients with at least one adverse event 0 0 0 0 0 1 (2.9%) - Total number of events 0 0 0 0 0 1 - SWELLING 0 0 0 0 0 1 (2.9%) - HLT_0040 - Total number of patients with at least one adverse event 0 0 0 0 0 1 (2.9%) - Total number of events 0 0 0 0 0 1 - ULCER 0 0 0 0 0 1 (2.9%) - HLT_0582 - Total number of patients with at least one adverse event 0 0 0 0 1 (2.0%) 0 - Total number of events 0 0 0 0 1 0 - INFLAMMATION 0 0 0 0 1 (2.0%) 0 - HLT_0121 - Total number of patients with at least one adverse event 0 0 0 0 0 1 (2.9%) - Total number of events 0 0 0 0 0 1 - APPLICATION SITE DISCOLOURATION 0 0 0 0 0 1 (2.9%) - HLT_0763 - Total number of patients with at least one adverse event 0 0 0 0 0 1 (2.9%) - Total number of events 0 0 0 0 0 1 - CYST 0 0 0 0 0 1 (2.9%) - GASTROINTESTINAL DISORDERS - Total number of patients with at least one adverse event 9 (17.0%) 8 (24.2%) 7 (17.5%) 14 (31.8%) 9 (18.0%) 6 (17.6%) - Total number of events 15 11 14 23 16 8 - HLT_0148 - Total number of patients with at least one adverse event 3 (5.7%) 6 (18.2%) 0 4 (9.1%) 3 (6.0%) 2 (5.9%) - Total number of events 3 7 0 4 4 3 - DIARRHOEA 3 (5.7%) 6 (18.2%) 0 4 (9.1%) 3 (6.0%) 2 (5.9%) - HLT_0159 - Total number of patients with at least one adverse event 1 (1.9%) 0 0 0 0 0 - Total number of events 2 0 0 0 0 0 - HIATUS HERNIA 1 (1.9%) 0 0 0 0 0 - HLT_0016 - Total number of patients with at least one adverse event 2 (3.8%) 1 (3.0%) 0 7 (15.9%) 3 (6.0%) 0 - Total number of events 2 1 0 9 4 0 - VOMITING 2 (3.8%) 1 (3.0%) 0 7 (15.9%) 3 (6.0%) 0 - HLT_0742 - Total number of patients with at least one adverse event 3 (5.7%) 0 4 (10.0%) 2 (4.5%) 2 (4.0%) 1 (2.9%) - Total number of events 3 0 10 3 4 1 - NAUSEA 3 (5.7%) 0 4 (10.0%) 2 (4.5%) 2 (4.0%) 1 (2.9%) - HLT_0374 - Total number of patients with at least one adverse event 0 0 1 (2.5%) 3 (6.8%) 0 0 - Total number of events 0 0 1 4 0 0 - SALIVARY HYPERSECRETION 0 0 1 (2.5%) 3 (6.8%) 0 0 - HLT_0065 - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 0 0 - Total number of events 0 0 0 1 0 0 - STOMACH DISCOMFORT 0 0 0 1 (2.3%) 0 0 - HLT_0353 - Total number of patients with at least one adverse event 0 0 0 0 1 (2.0%) 0 - Total number of events 0 0 0 0 2 0 - RECTAL HAEMORRHAGE 0 0 0 0 1 (2.0%) 0 - HLT_0012 - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 0 0 - Total number of events 0 0 0 1 0 0 - ABDOMINAL DISCOMFORT 0 0 0 1 (2.3%) 0 0 - HLT_0356 - Total number of patients with at least one adverse event 0 1 (3.0%) 0 0 0 0 - Total number of events 0 2 0 0 0 0 - FLATULENCE 0 1 (3.0%) 0 0 0 0 - HLT_0244 - Total number of patients with at least one adverse event 1 (1.9%) 0 0 1 (2.3%) 0 1 (2.9%) - Total number of events 2 0 0 1 0 2 - DYSPEPSIA 1 (1.9%) 0 0 1 (2.3%) 0 1 (2.9%) - HLT_0217 - Total number of patients with at least one adverse event 1 (1.9%) 0 1 (2.5%) 0 2 (4.0%) 1 (2.9%) - Total number of events 1 0 2 0 2 1 - ABDOMINAL PAIN 1 (1.9%) 0 1 (2.5%) 0 2 (4.0%) 1 (2.9%) - HLT_0402 - Total number of patients with at least one adverse event 1 (1.9%) 0 0 0 0 0 - Total number of events 1 0 0 0 0 0 - CONSTIPATION 1 (1.9%) 0 0 0 0 0 - HLT_0354 - Total number of patients with at least one adverse event 0 0 1 (2.5%) 0 0 0 - Total number of events 0 0 1 0 0 0 - GASTROINTESTINAL HAEMORRHAGE 0 0 1 (2.5%) 0 0 0 - HLT_0250 - Total number of patients with at least one adverse event 0 1 (3.0%) 0 0 0 0 - Total number of events 0 1 0 0 0 0 - GLOSSITIS 0 1 (3.0%) 0 0 0 0 - HLT_0407 - Total number of patients with at least one adverse event 1 (1.9%) 0 0 0 0 0 - Total number of events 1 0 0 0 0 0 - GASTROOESOPHAGEAL REFLUX DISEASE 1 (1.9%) 0 0 0 0 0 - HLT_0563 - Total number of patients with at least one adverse event 0 0 0 0 0 1 (2.9%) - Total number of events 0 0 0 0 0 1 - DYSPHAGIA 0 0 0 0 0 1 (2.9%) - SKIN AND SUBCUTANEOUS TISSUE DISORDERS - Total number of patients with at least one adverse event 13 (24.5%) 8 (24.2%) 14 (35.0%) 28 (63.6%) 24 (48.0%) 18 (52.9%) - Total number of events 30 17 34 77 72 46 - HLT_0284 - Total number of patients with at least one adverse event 6 (11.3%) 3 (9.1%) 7 (17.5%) 7 (15.9%) 9 (18.0%) 6 (17.6%) - Total number of events 8 5 8 14 16 8 - ERYTHEMA 6 (11.3%) 3 (9.1%) 7 (17.5%) 7 (15.9%) 9 (18.0%) 6 (17.6%) - HLT_0123 - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 0 1 (2.9%) - Total number of events 0 0 0 1 0 4 - PRURITUS GENERALISED 0 0 0 1 (2.3%) 0 1 (2.9%) - HLT_0778 - Total number of patients with at least one adverse event 6 (11.3%) 2 (6.1%) 11 (27.5%) 15 (34.1%) 13 (26.0%) 10 (29.4%) - Total number of events 9 2 14 24 23 12 - PRURITUS 6 (11.3%) 2 (6.1%) 11 (27.5%) 15 (34.1%) 13 (26.0%) 10 (29.4%) - HLT_0609 - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 0 0 - Total number of events 0 0 0 1 0 0 - ACTINIC KERATOSIS 0 0 0 1 (2.3%) 0 0 - HLT_0420 - Total number of patients with at least one adverse event 0 0 1 (2.5%) 0 0 1 (2.9%) - Total number of events 0 0 2 0 0 3 - URTICARIA 0 0 1 (2.5%) 0 0 1 (2.9%) - HLT_0510 - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 0 0 - Total number of events 0 0 0 1 0 0 - SKIN ODOUR ABNORMAL 0 0 0 1 (2.3%) 0 0 - HLT_0336 - Total number of patients with at least one adverse event 0 0 0 0 1 (2.0%) 1 (2.9%) - Total number of events 0 0 0 0 1 1 - RASH ERYTHEMATOUS 0 0 0 0 1 (2.0%) 1 (2.9%) - HLT_0587 - Total number of patients with at least one adverse event 2 (3.8%) 0 2 (5.0%) 6 (13.6%) 1 (2.0%) 3 (8.8%) - Total number of events 2 0 2 8 1 4 - HYPERHIDROSIS 2 (3.8%) 0 2 (5.0%) 6 (13.6%) 1 (2.0%) 3 (8.8%) - HLT_0583 - Total number of patients with at least one adverse event 3 (5.7%) 0 1 (2.5%) 4 (9.1%) 5 (10.0%) 1 (2.9%) - Total number of events 4 0 2 6 11 2 - SKIN IRRITATION 3 (5.7%) 0 1 (2.5%) 4 (9.1%) 5 (10.0%) 1 (2.9%) - HLT_0762 - Total number of patients with at least one adverse event 2 (3.8%) 3 (9.1%) 3 (7.5%) 8 (18.2%) 8 (16.0%) 5 (14.7%) - Total number of events 5 4 5 13 13 5 - RASH 2 (3.8%) 3 (9.1%) 3 (7.5%) 8 (18.2%) 8 (16.0%) 5 (14.7%) - HLT_0752 - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 2 (4.0%) 3 (8.8%) - Total number of events 0 0 0 2 3 5 - BLISTER 0 0 0 1 (2.3%) 2 (4.0%) 3 (8.8%) - HLT_0127 - Total number of patients with at least one adverse event 0 0 1 (2.5%) 1 (2.3%) 1 (2.0%) 0 - Total number of events 0 0 1 2 2 0 - RASH PRURITIC 0 0 1 (2.5%) 1 (2.3%) 1 (2.0%) 0 - HLT_0430 - Total number of patients with at least one adverse event 1 (1.9%) 0 0 0 0 0 - Total number of events 1 0 0 0 0 0 - DRUG ERUPTION 1 (1.9%) 0 0 0 0 0 - HLT_0500 - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 0 0 - Total number of events 0 0 0 3 0 0 - RASH MACULO-PAPULAR 0 0 0 1 (2.3%) 0 0 - HLT_0236 - Total number of patients with at least one adverse event 0 0 0 0 1 (2.0%) 0 - Total number of events 0 0 0 0 2 0 - SKIN EXFOLIATION 0 0 0 0 1 (2.0%) 0 - HLT_0124 - Total number of patients with at least one adverse event 0 1 (3.0%) 0 0 0 0 - Total number of events 0 3 0 0 0 0 - COLD SWEAT 0 1 (3.0%) 0 0 0 0 - HLT_0056 - Total number of patients with at least one adverse event 0 0 0 0 0 1 (2.9%) - Total number of events 0 0 0 0 0 2 - DERMATITIS CONTACT 0 0 0 0 0 1 (2.9%) - HLT_0077 - Total number of patients with at least one adverse event 1 (1.9%) 0 0 0 0 0 - Total number of events 1 0 0 0 0 0 - ALOPECIA 1 (1.9%) 0 0 0 0 0 - HLT_0005 - Total number of patients with at least one adverse event 0 1 (3.0%) 0 0 0 0 - Total number of events 0 2 0 0 0 0 - SKIN ULCER 0 1 (3.0%) 0 0 0 0 - HLT_0549 - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 0 0 - Total number of events 0 0 0 2 0 0 - RASH PAPULAR 0 0 0 1 (2.3%) 0 0 - HLT_0480 - Total number of patients with at least one adverse event 0 1 (3.0%) 0 0 0 0 - Total number of events 0 1 0 0 0 0 - DERMATITIS ATOPIC 0 1 (3.0%) 0 0 0 0 - CARDIAC DISORDERS - Total number of patients with at least one adverse event 9 (17.0%) 4 (12.1%) 7 (17.5%) 11 (25.0%) 6 (12.0%) 7 (20.6%) - Total number of events 21 6 9 25 16 14 - HLT_0415 - Total number of patients with at least one adverse event 0 2 (6.1%) 1 (2.5%) 2 (4.5%) 0 0 - Total number of events 0 2 2 2 0 0 - ATRIOVENTRICULAR BLOCK SECOND DEGREE 0 2 (6.1%) 1 (2.5%) 2 (4.5%) 0 0 - HLT_0281 - Total number of patients with at least one adverse event 1 (1.9%) 0 0 0 0 0 - Total number of events 1 0 0 0 0 0 - BUNDLE BRANCH BLOCK LEFT 1 (1.9%) 0 0 0 0 0 - HLT_0082 - Total number of patients with at least one adverse event 1 (1.9%) 0 0 0 0 0 - Total number of events 2 0 0 0 0 0 - TACHYCARDIA 1 (1.9%) 0 0 0 0 0 - HLT_0649 - Total number of patients with at least one adverse event 4 (7.5%) 0 1 (2.5%) 3 (6.8%) 2 (4.0%) 0 - Total number of events 4 0 1 7 4 0 - MYOCARDIAL INFARCTION 4 (7.5%) 0 1 (2.5%) 3 (6.8%) 2 (4.0%) 0 - HLT_0644 - Total number of patients with at least one adverse event 2 (3.8%) 0 2 (5.0%) 6 (13.6%) 3 (6.0%) 4 (11.8%) - Total number of events 2 0 2 10 5 5 - SINUS BRADYCARDIA 2 (3.8%) 0 2 (5.0%) 6 (13.6%) 3 (6.0%) 4 (11.8%) - HLT_0507 - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 0 0 - Total number of events 0 0 0 1 0 0 - CARDIAC DISORDER 0 0 0 1 (2.3%) 0 0 - HLT_0493 - Total number of patients with at least one adverse event 0 0 0 0 1 (2.0%) 1 (2.9%) - Total number of events 0 0 0 0 1 1 - PALPITATIONS 0 0 0 0 1 (2.0%) 1 (2.9%) - HLT_0612 - Total number of patients with at least one adverse event 0 0 0 0 1 (2.0%) 0 - Total number of events 0 0 0 0 2 0 - WOLFF-PARKINSON-WHITE SYNDROME 0 0 0 0 1 (2.0%) 0 - HLT_0477 - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 0 1 (2.9%) - Total number of events 0 0 0 2 0 1 - ATRIAL FLUTTER 0 0 0 1 (2.3%) 0 1 (2.9%) - HLT_0365 - Total number of patients with at least one adverse event 1 (1.9%) 0 2 (5.0%) 1 (2.3%) 0 1 (2.9%) - Total number of events 1 0 3 2 0 1 - ATRIAL FIBRILLATION 1 (1.9%) 0 2 (5.0%) 1 (2.3%) 0 1 (2.9%) - HLT_0104 - Total number of patients with at least one adverse event 1 (1.9%) 0 0 0 0 0 - Total number of events 1 0 0 0 0 0 - VENTRICULAR HYPERTROPHY 1 (1.9%) 0 0 0 0 0 - HLT_0094 - Total number of patients with at least one adverse event 0 1 (3.0%) 0 0 0 0 - Total number of events 0 2 0 0 0 0 - SINUS ARRHYTHMIA 0 1 (3.0%) 0 0 0 0 - HLT_0050 - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 1 (2.0%) 1 (2.9%) - Total number of events 0 0 0 1 2 2 - VENTRICULAR EXTRASYSTOLES 0 0 0 1 (2.3%) 1 (2.0%) 1 (2.9%) - HLT_0271 - Total number of patients with at least one adverse event 0 1 (3.0%) 0 0 0 0 - Total number of events 0 2 0 0 0 0 - ATRIAL HYPERTROPHY 0 1 (3.0%) 0 0 0 0 - HLT_0188 - Total number of patients with at least one adverse event 1 (1.9%) 0 1 (2.5%) 0 1 (2.0%) 0 - Total number of events 2 0 1 0 2 0 - SUPRAVENTRICULAR EXTRASYSTOLES 1 (1.9%) 0 1 (2.5%) 0 1 (2.0%) 0 - HLT_0419 - Total number of patients with at least one adverse event 1 (1.9%) 0 0 0 0 1 (2.9%) - Total number of events 1 0 0 0 0 1 - ATRIOVENTRICULAR BLOCK FIRST DEGREE 1 (1.9%) 0 0 0 0 1 (2.9%) - HLT_0511 - Total number of patients with at least one adverse event 1 (1.9%) 0 0 0 0 0 - Total number of events 1 0 0 0 0 0 - CARDIAC FAILURE CONGESTIVE 1 (1.9%) 0 0 0 0 0 - HLT_0692 - Total number of patients with at least one adverse event 0 0 0 0 0 1 (2.9%) - Total number of events 0 0 0 0 0 2 - SUPRAVENTRICULAR TACHYCARDIA 0 0 0 0 0 1 (2.9%) - HLT_0751 - Total number of patients with at least one adverse event 1 (1.9%) 0 0 0 0 1 (2.9%) - Total number of events 2 0 0 0 0 1 - BUNDLE BRANCH BLOCK RIGHT 1 (1.9%) 0 0 0 0 1 (2.9%) - HLT_0640 - Total number of patients with at least one adverse event 1 (1.9%) 0 0 0 0 0 - Total number of events 4 0 0 0 0 0 - BRADYCARDIA 1 (1.9%) 0 0 0 0 0 - INFECTIONS AND INFESTATIONS - Total number of patients with at least one adverse event 10 (18.9%) 6 (18.2%) 4 (10.0%) 9 (20.5%) 6 (12.0%) 4 (11.8%) - Total number of events 22 13 7 13 12 6 - HLT_0520 - Total number of patients with at least one adverse event 4 (7.5%) 2 (6.1%) 1 (2.5%) 2 (4.5%) 0 1 (2.9%) - Total number of events 6 6 2 3 0 2 - UPPER RESPIRATORY TRACT INFECTION 4 (7.5%) 2 (6.1%) 1 (2.5%) 2 (4.5%) 0 1 (2.9%) - HLT_0613 - Total number of patients with at least one adverse event 0 0 0 0 1 (2.0%) 0 - Total number of events 0 0 0 0 1 0 - CELLULITIS 0 0 0 0 1 (2.0%) 0 - HLT_0161 - Total number of patients with at least one adverse event 1 (1.9%) 1 (3.0%) 0 1 (2.3%) 0 0 - Total number of events 2 2 0 1 0 0 - URINARY TRACT INFECTION 1 (1.9%) 1 (3.0%) 0 1 (2.3%) 0 0 - HLT_0052 - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 0 0 - Total number of events 0 0 0 2 0 0 - LOWER RESPIRATORY TRACT INFECTION 0 0 0 1 (2.3%) 0 0 - HLT_0036 - Total number of patients with at least one adverse event 2 (3.8%) 0 3 (7.5%) 3 (6.8%) 3 (6.0%) 1 (2.9%) - Total number of events 4 0 4 4 7 2 - NASOPHARYNGITIS 2 (3.8%) 0 3 (7.5%) 3 (6.8%) 3 (6.0%) 1 (2.9%) - HLT_0251 - Total number of patients with at least one adverse event 0 0 0 0 1 (2.0%) 0 - Total number of events 0 0 0 0 2 0 - PNEUMONIA 0 0 0 0 1 (2.0%) 0 - HLT_0604 - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 0 0 - Total number of events 0 0 0 1 0 0 - HORDEOLUM 0 0 0 1 (2.3%) 0 0 - HLT_0239 - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 0 0 - Total number of events 0 0 0 1 0 0 - RHINITIS 0 0 0 1 (2.3%) 0 0 - HLT_0739 - Total number of patients with at least one adverse event 0 1 (3.0%) 1 (2.5%) 0 0 0 - Total number of events 0 1 1 0 0 0 - CYSTITIS 0 1 (3.0%) 1 (2.5%) 0 0 0 - HLT_0125 - Total number of patients with at least one adverse event 1 (1.9%) 0 0 1 (2.3%) 0 1 (2.9%) - Total number of events 2 0 0 1 0 1 - INFLUENZA 1 (1.9%) 0 0 1 (2.3%) 0 1 (2.9%) - HLT_0733 - Total number of patients with at least one adverse event 0 0 0 0 1 (2.0%) 0 - Total number of events 0 0 0 0 1 0 - VIRAL INFECTION 0 0 0 0 1 (2.0%) 0 - HLT_0435 - Total number of patients with at least one adverse event 0 1 (3.0%) 0 0 1 (2.0%) 0 - Total number of events 0 2 0 0 1 0 - LOCALISED INFECTION 0 1 (3.0%) 0 0 1 (2.0%) 0 - HLT_0757 - Total number of patients with at least one adverse event 1 (1.9%) 1 (3.0%) 0 0 0 0 - Total number of events 2 2 0 0 0 0 - EAR INFECTION 1 (1.9%) 1 (3.0%) 0 0 0 0 - HLT_0211 - Total number of patients with at least one adverse event 1 (1.9%) 0 0 0 0 0 - Total number of events 1 0 0 0 0 0 - GASTROENTERITIS VIRAL 1 (1.9%) 0 0 0 0 0 - HLT_0508 - Total number of patients with at least one adverse event 1 (1.9%) 0 0 0 0 0 - Total number of events 2 0 0 0 0 0 - VAGINAL MYCOSIS 1 (1.9%) 0 0 0 0 0 - HLT_0651 - Total number of patients with at least one adverse event 1 (1.9%) 0 0 0 0 0 - Total number of events 2 0 0 0 0 0 - CERVICITIS 1 (1.9%) 0 0 0 0 0 - HLT_0634 - Total number of patients with at least one adverse event 1 (1.9%) 0 0 0 0 0 - Total number of events 1 0 0 0 0 0 - BRONCHITIS 1 (1.9%) 0 0 0 0 0 - HLT_0275 - Total number of patients with at least one adverse event 0 0 0 0 0 1 (2.9%) - Total number of events 0 0 0 0 0 1 - ONYCHOMYCOSIS 0 0 0 0 0 1 (2.9%) - RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - Total number of patients with at least one adverse event 3 (5.7%) 7 (21.2%) 2 (5.0%) 8 (18.2%) 6 (12.0%) 4 (11.8%) - Total number of events 3 12 3 19 10 6 - HLT_0130 - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 0 1 (2.9%) - Total number of events 0 0 0 1 0 1 - PHARYNGOLARYNGEAL PAIN 0 0 0 1 (2.3%) 0 1 (2.9%) - HLT_0118 - Total number of patients with at least one adverse event 1 (1.9%) 2 (6.1%) 0 3 (6.8%) 0 1 (2.9%) - Total number of events 1 2 0 4 0 1 - NASAL CONGESTION 1 (1.9%) 2 (6.1%) 0 3 (6.8%) 0 1 (2.9%) - HLT_0386 - Total number of patients with at least one adverse event 0 0 0 2 (4.5%) 1 (2.0%) 0 - Total number of events 0 0 0 2 1 0 - EPISTAXIS 0 0 0 2 (4.5%) 1 (2.0%) 0 - HLT_0296 - Total number of patients with at least one adverse event 1 (1.9%) 0 0 1 (2.3%) 1 (2.0%) 0 - Total number of events 1 0 0 1 1 0 - DYSPNOEA 1 (1.9%) 0 0 1 (2.3%) 1 (2.0%) 0 - HLT_0701 - Total number of patients with at least one adverse event 0 3 (9.1%) 1 (2.5%) 4 (9.1%) 4 (8.0%) 2 (5.9%) - Total number of events 0 4 1 6 6 3 - COUGH 0 3 (9.1%) 1 (2.5%) 4 (9.1%) 4 (8.0%) 2 (5.9%) - HLT_0635 - Total number of patients with at least one adverse event 0 0 1 (2.5%) 0 1 (2.0%) 0 - Total number of events 0 0 2 0 2 0 - RHINORRHOEA 0 0 1 (2.5%) 0 1 (2.0%) 0 - HLT_0545 - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 0 0 - Total number of events 0 0 0 1 0 0 - PRODUCTIVE COUGH 0 0 0 1 (2.3%) 0 0 - HLT_0330 - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 0 0 - Total number of events 0 0 0 1 0 0 - RESPIRATORY TRACT CONGESTION 0 0 0 1 (2.3%) 0 0 - HLT_0073 - Total number of patients with at least one adverse event 0 0 0 0 0 1 (2.9%) - Total number of events 0 0 0 0 0 1 - DYSPHONIA 0 0 0 0 0 1 (2.9%) - HLT_0172 - Total number of patients with at least one adverse event 0 1 (3.0%) 0 0 0 0 - Total number of events 0 2 0 0 0 0 - POSTNASAL DRIP 0 1 (3.0%) 0 0 0 0 - HLT_0591 - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 0 0 - Total number of events 0 0 0 2 0 0 - PHARYNGEAL ERYTHEMA 0 0 0 1 (2.3%) 0 0 - HLT_0114 - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 0 0 - Total number of events 0 0 0 1 0 0 - ALLERGIC GRANULOMATOUS ANGIITIS 0 0 0 1 (2.3%) 0 0 - HLT_0192 - Total number of patients with at least one adverse event 0 1 (3.0%) 0 0 0 0 - Total number of events 0 2 0 0 0 0 - HAEMOPTYSIS 0 1 (3.0%) 0 0 0 0 - HLT_0020 - Total number of patients with at least one adverse event 0 1 (3.0%) 0 0 0 0 - Total number of events 0 2 0 0 0 0 - RALES 0 1 (3.0%) 0 0 0 0 - HLT_0698 - Total number of patients with at least one adverse event 1 (1.9%) 0 0 0 0 0 - Total number of events 1 0 0 0 0 0 - EMPHYSEMA 1 (1.9%) 0 0 0 0 0 - MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS - Total number of patients with at least one adverse event 2 (3.8%) 3 (9.1%) 3 (7.5%) 5 (11.4%) 5 (10.0%) 2 (5.9%) - Total number of events 4 4 3 8 6 4 - HLT_0375 - Total number of patients with at least one adverse event 0 1 (3.0%) 0 1 (2.3%) 1 (2.0%) 1 (2.9%) - Total number of events 0 1 0 1 1 3 - ARTHRALGIA 0 1 (3.0%) 0 1 (2.3%) 1 (2.0%) 1 (2.9%) - HLT_0484 - Total number of patients with at least one adverse event 0 0 1 (2.5%) 1 (2.3%) 0 0 - Total number of events 0 0 1 1 0 0 - FLANK PAIN 0 0 1 (2.5%) 1 (2.3%) 0 0 - HLT_0444 - Total number of patients with at least one adverse event 0 0 0 0 1 (2.0%) 0 - Total number of events 0 0 0 0 2 0 - MUSCULAR WEAKNESS 0 0 0 0 1 (2.0%) 0 - HLT_0527 - Total number of patients with at least one adverse event 0 1 (3.0%) 0 0 2 (4.0%) 0 - Total number of events 0 2 0 0 2 0 - SHOULDER PAIN 0 1 (3.0%) 0 0 2 (4.0%) 0 - HLT_0700 - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 0 0 - Total number of events 0 0 0 1 0 0 - MYALGIA 0 0 0 1 (2.3%) 0 0 - HLT_0115 - Total number of patients with at least one adverse event 1 (1.9%) 0 1 (2.5%) 2 (4.5%) 1 (2.0%) 0 - Total number of events 2 0 1 3 1 0 - BACK PAIN 1 (1.9%) 0 1 (2.5%) 2 (4.5%) 1 (2.0%) 0 - HLT_0019 - Total number of patients with at least one adverse event 1 (1.9%) 0 1 (2.5%) 0 0 0 - Total number of events 2 0 1 0 0 0 - ARTHRITIS 1 (1.9%) 0 1 (2.5%) 0 0 0 - HLT_0078 - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 0 1 (2.9%) - Total number of events 0 0 0 2 0 1 - MUSCLE SPASMS 0 0 0 1 (2.3%) 0 1 (2.9%) - HLT_0213 - Total number of patients with at least one adverse event 0 1 (3.0%) 0 0 0 0 - Total number of events 0 1 0 0 0 0 - PAIN IN EXTREMITY 0 1 (3.0%) 0 0 0 0 - RENAL AND URINARY DISORDERS - Total number of patients with at least one adverse event 2 (3.8%) 2 (6.1%) 0 3 (6.8%) 3 (6.0%) 1 (2.9%) - Total number of events 2 3 0 4 3 1 - HLT_0294 - Total number of patients with at least one adverse event 0 1 (3.0%) 0 1 (2.3%) 1 (2.0%) 0 - Total number of events 0 1 0 2 1 0 - MICTURITION URGENCY 0 1 (3.0%) 0 1 (2.3%) 1 (2.0%) 0 - HLT_0550 - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 0 0 - Total number of events 0 0 0 1 0 0 - CALCULUS URETHRAL 0 0 0 1 (2.3%) 0 0 - HLT_0560 - Total number of patients with at least one adverse event 0 0 0 0 1 (2.0%) 0 - Total number of events 0 0 0 0 1 0 - INCONTINENCE 0 0 0 0 1 (2.0%) 0 - HLT_0393 - Total number of patients with at least one adverse event 0 1 (3.0%) 0 0 0 0 - Total number of events 0 2 0 0 0 0 - POLLAKIURIA 0 1 (3.0%) 0 0 0 0 - HLT_0439 - Total number of patients with at least one adverse event 1 (1.9%) 0 0 1 (2.3%) 0 0 - Total number of events 1 0 0 1 0 0 - NEPHROLITHIASIS 1 (1.9%) 0 0 1 (2.3%) 0 0 - HLT_0637 - Total number of patients with at least one adverse event 1 (1.9%) 0 0 0 0 1 (2.9%) - Total number of events 1 0 0 0 0 1 - DYSURIA 1 (1.9%) 0 0 0 0 1 (2.9%) - HLT_0107 - Total number of patients with at least one adverse event 0 0 0 0 1 (2.0%) 0 - Total number of events 0 0 0 0 1 0 - ENURESIS 0 0 0 0 1 (2.0%) 0 - EYE DISORDERS - Total number of patients with at least one adverse event 1 (1.9%) 3 (9.1%) 1 (2.5%) 0 1 (2.0%) 1 (2.9%) - Total number of events 1 7 2 0 1 1 - HLT_0008 - Total number of patients with at least one adverse event 0 1 (3.0%) 0 0 0 0 - Total number of events 0 1 0 0 0 0 - EYE SWELLING 0 1 (3.0%) 0 0 0 0 - HLT_0256 - Total number of patients with at least one adverse event 0 1 (3.0%) 0 0 0 0 - Total number of events 0 1 0 0 0 0 - EYE ALLERGY 0 1 (3.0%) 0 0 0 0 - HLT_0523 - Total number of patients with at least one adverse event 0 1 (3.0%) 0 0 0 0 - Total number of events 0 1 0 0 0 0 - EYE PRURITUS 0 1 (3.0%) 0 0 0 0 - HLT_0584 - Total number of patients with at least one adverse event 0 2 (6.1%) 0 0 0 0 - Total number of events 0 4 0 0 0 0 - CONJUNCTIVITIS 0 2 (6.1%) 0 0 0 0 - HLT_0120 - Total number of patients with at least one adverse event 0 0 1 (2.5%) 0 0 1 (2.9%) - Total number of events 0 0 2 0 0 1 - VISION BLURRED 0 0 1 (2.5%) 0 0 1 (2.9%) - HLT_0013 - Total number of patients with at least one adverse event 0 0 0 0 1 (2.0%) 0 - Total number of events 0 0 0 0 1 0 - CONJUNCTIVAL HAEMORRHAGE 0 0 0 0 1 (2.0%) 0 - HLT_0556 - Total number of patients with at least one adverse event 1 (1.9%) 0 0 0 0 0 - Total number of events 1 0 0 0 0 0 - GLAUCOMA 1 (1.9%) 0 0 0 0 0 - METABOLISM AND NUTRITION DISORDERS - Total number of patients with at least one adverse event 5 (9.4%) 1 (3.0%) 1 (2.5%) 2 (4.5%) 0 1 (2.9%) - Total number of events 7 1 2 3 0 1 - HLT_0566 - Total number of patients with at least one adverse event 1 (1.9%) 0 0 1 (2.3%) 0 0 - Total number of events 2 0 0 2 0 0 - INCREASED APPETITE 1 (1.9%) 0 0 1 (2.3%) 0 0 - HLT_0574 - Total number of patients with at least one adverse event 1 (1.9%) 0 1 (2.5%) 0 0 0 - Total number of events 2 0 2 0 0 0 - DECREASED APPETITE 1 (1.9%) 0 1 (2.5%) 0 0 0 - HLT_0533 - Total number of patients with at least one adverse event 0 1 (3.0%) 0 0 0 0 - Total number of events 0 1 0 0 0 0 - DEHYDRATION 0 1 (3.0%) 0 0 0 0 - HLT_0447 - Total number of patients with at least one adverse event 1 (1.9%) 0 0 0 0 0 - Total number of events 1 0 0 0 0 0 - DIABETES MELLITUS 1 (1.9%) 0 0 0 0 0 - HLT_0688 - Total number of patients with at least one adverse event 1 (1.9%) 0 0 0 0 0 - Total number of events 1 0 0 0 0 0 - HYPONATRAEMIA 1 (1.9%) 0 0 0 0 0 - HLT_0754 - Total number of patients with at least one adverse event 1 (1.9%) 0 0 0 0 1 (2.9%) - Total number of events 1 0 0 0 0 1 - FOOD CRAVING 1 (1.9%) 0 0 0 0 1 (2.9%) - HLT_0025 - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 0 0 - Total number of events 0 0 0 1 0 0 - HYPERCHOLESTEROLAEMIA 0 0 0 1 (2.3%) 0 0 - PSYCHIATRIC DISORDERS - Total number of patients with at least one adverse event 5 (9.4%) 5 (15.2%) 2 (5.0%) 7 (15.9%) 7 (14.0%) 3 (8.8%) - Total number of events 8 6 2 10 9 5 - HLT_0140 - Total number of patients with at least one adverse event 2 (3.8%) 0 1 (2.5%) 0 2 (4.0%) 0 - Total number of events 2 0 1 0 2 0 - AGITATION 2 (3.8%) 0 1 (2.5%) 0 2 (4.0%) 0 - HLT_0642 - Total number of patients with at least one adverse event 0 2 (6.1%) 0 1 (2.3%) 2 (4.0%) 1 (2.9%) - Total number of events 0 2 0 1 2 1 - CONFUSIONAL STATE 0 2 (6.1%) 0 1 (2.3%) 2 (4.0%) 1 (2.9%) - HLT_0657 - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 0 0 - Total number of events 0 0 0 1 0 0 - LISTLESS 0 0 0 1 (2.3%) 0 0 - HLT_0338 - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 0 0 - Total number of events 0 0 0 1 0 0 - LIBIDO DECREASED 0 0 0 1 (2.3%) 0 0 - HLT_0784 - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 0 1 (2.9%) - Total number of events 0 0 0 1 0 2 - DEPRESSED MOOD 0 0 0 1 (2.3%) 0 1 (2.9%) - HLT_0297 - Total number of patients with at least one adverse event 0 2 (6.1%) 0 2 (4.5%) 0 0 - Total number of events 0 3 0 2 0 0 - INSOMNIA 0 2 (6.1%) 0 2 (4.5%) 0 0 - HLT_0299 - Total number of patients with at least one adverse event 1 (1.9%) 0 0 0 0 0 - Total number of events 1 0 0 0 0 0 - DISORIENTATION 1 (1.9%) 0 0 0 0 0 - HLT_0625 - Total number of patients with at least one adverse event 0 1 (3.0%) 0 0 0 0 - Total number of events 0 1 0 0 0 0 - COMPLETED SUICIDE 0 1 (3.0%) 0 0 0 0 - HLT_0559 - Total number of patients with at least one adverse event 1 (1.9%) 0 0 0 3 (6.0%) 0 - Total number of events 2 0 0 0 4 0 - ANXIETY 1 (1.9%) 0 0 0 3 (6.0%) 0 - HLT_0627 - Total number of patients with at least one adverse event 1 (1.9%) 0 0 0 1 (2.0%) 0 - Total number of events 2 0 0 0 1 0 - IRRITABILITY 1 (1.9%) 0 0 0 1 (2.0%) 0 - HLT_0186 - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 0 0 - Total number of events 0 0 0 1 0 0 - NIGHTMARE 0 0 0 1 (2.3%) 0 0 - HLT_0198 - Total number of patients with at least one adverse event 1 (1.9%) 0 0 1 (2.3%) 0 0 - Total number of events 1 0 0 1 0 0 - DELUSION 1 (1.9%) 0 0 1 (2.3%) 0 0 - HLT_0376 - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 0 0 - Total number of events 0 0 0 1 0 0 - DELIRIUM 0 0 0 1 (2.3%) 0 0 - HLT_0427 - Total number of patients with at least one adverse event 0 0 0 0 0 1 (2.9%) - Total number of events 0 0 0 0 0 2 - RESTLESSNESS 0 0 0 0 0 1 (2.9%) - HLT_0026 - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 0 0 - Total number of events 0 0 0 1 0 0 - HALLUCINATION 0 0 0 1 (2.3%) 0 0 - HLT_0369 - Total number of patients with at least one adverse event 0 0 1 (2.5%) 0 0 0 - Total number of events 0 0 1 0 0 0 - HALLUCINATION, VISUAL 0 0 1 (2.5%) 0 0 0 - INVESTIGATIONS - Total number of patients with at least one adverse event 6 (11.3%) 4 (12.1%) 2 (5.0%) 4 (9.1%) 5 (10.0%) 2 (5.9%) - Total number of events 12 7 2 6 11 2 - HLT_0680 - Total number of patients with at least one adverse event 0 0 0 0 1 (2.0%) 0 - Total number of events 0 0 0 0 1 0 - NASAL MUCOSA BIOPSY 0 0 0 0 1 (2.0%) 0 - HLT_0553 - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 0 0 - Total number of events 0 0 0 1 0 0 - BIOPSY PROSTATE 0 0 0 1 (2.3%) 0 0 - HLT_0158 - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 0 0 - Total number of events 0 0 0 2 0 0 - WEIGHT DECREASED 0 0 0 1 (2.3%) 0 0 - HLT_0610 - Total number of patients with at least one adverse event 4 (7.5%) 0 0 0 1 (2.0%) 0 - Total number of events 4 0 0 0 2 0 - ELECTROCARDIOGRAM ST SEGMENT DEPRESSION 4 (7.5%) 0 0 0 1 (2.0%) 0 - HLT_0450 - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 1 (2.0%) 0 - Total number of events 0 0 0 2 1 0 - BLOOD GLUCOSE INCREASED 0 0 0 1 (2.3%) 1 (2.0%) 0 - HLT_0404 - Total number of patients with at least one adverse event 0 1 (3.0%) 0 0 0 0 - Total number of events 0 2 0 0 0 0 - BLOOD CREATINE PHOSPHOKINASE INCREASED 0 1 (3.0%) 0 0 0 0 - HLT_0765 - Total number of patients with at least one adverse event 1 (1.9%) 0 0 0 0 0 - Total number of events 4 0 0 0 0 0 - HEART RATE IRREGULAR 1 (1.9%) 0 0 0 0 0 - HLT_0646 - Total number of patients with at least one adverse event 0 1 (3.0%) 0 0 0 0 - Total number of events 0 2 0 0 0 0 - HEART RATE INCREASED 0 1 (3.0%) 0 0 0 0 - HLT_0289 - Total number of patients with at least one adverse event 2 (3.8%) 0 1 (2.5%) 0 0 1 (2.9%) - Total number of events 3 0 1 0 0 1 - ELECTROCARDIOGRAM T WAVE INVERSION 2 (3.8%) 0 1 (2.5%) 0 0 1 (2.9%) - HLT_0458 - Total number of patients with at least one adverse event 0 1 (3.0%) 0 0 0 0 - Total number of events 0 1 0 0 0 0 - BLOOD URINE PRESENT 0 1 (3.0%) 0 0 0 0 - HLT_0436 - Total number of patients with at least one adverse event 0 1 (3.0%) 0 0 0 0 - Total number of events 0 1 0 0 0 0 - CYSTOSCOPY 0 1 (3.0%) 0 0 0 0 - HLT_0685 - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 0 0 - Total number of events 0 0 0 1 0 0 - BIOPSY 0 0 0 1 (2.3%) 0 0 - HLT_0615 - Total number of patients with at least one adverse event 0 1 (3.0%) 0 0 0 0 - Total number of events 0 1 0 0 0 0 - BLOOD ALKALINE PHOSPHATASE INCREASED 0 1 (3.0%) 0 0 0 0 - HLT_0037 - Total number of patients with at least one adverse event 1 (1.9%) 0 0 0 0 1 (2.9%) - Total number of events 1 0 0 0 0 1 - ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED 1 (1.9%) 0 0 0 0 1 (2.9%) - HLT_0210 - Total number of patients with at least one adverse event 0 0 1 (2.5%) 0 0 0 - Total number of events 0 0 1 0 0 0 - BLOOD CHOLESTEROL INCREASED 0 0 1 (2.5%) 0 0 0 - HLT_0734 - Total number of patients with at least one adverse event 0 0 0 0 1 (2.0%) 0 - Total number of events 0 0 0 0 1 0 - BODY TEMPERATURE INCREASED 0 0 0 0 1 (2.0%) 0 - HLT_0326 - Total number of patients with at least one adverse event 0 0 0 0 1 (2.0%) 0 - Total number of events 0 0 0 0 2 0 - NEUTROPHIL COUNT INCREASED 0 0 0 0 1 (2.0%) 0 - HLT_0783 - Total number of patients with at least one adverse event 0 0 0 0 1 (2.0%) 0 - Total number of events 0 0 0 0 2 0 - URINE ANALYSIS ABNORMAL 0 0 0 0 1 (2.0%) 0 - HLT_0417 - Total number of patients with at least one adverse event 0 0 0 0 1 (2.0%) 0 - Total number of events 0 0 0 0 2 0 - WHITE BLOOD CELL COUNT INCREASED 0 0 0 0 1 (2.0%) 0 - SURGICAL AND MEDICAL PROCEDURES - Total number of patients with at least one adverse event 2 (3.8%) 0 1 (2.5%) 1 (2.3%) 1 (2.0%) 0 - Total number of events 2 0 1 1 1 0 - HLT_0355 - Total number of patients with at least one adverse event 1 (1.9%) 0 0 0 0 0 - Total number of events 1 0 0 0 0 0 - EYE LASER SURGERY 1 (1.9%) 0 0 0 0 0 - HLT_0432 - Total number of patients with at least one adverse event 1 (1.9%) 0 0 0 1 (2.0%) 0 - Total number of events 1 0 0 0 1 0 - CATARACT OPERATION 1 (1.9%) 0 0 0 1 (2.0%) 0 - HLT_0629 - Total number of patients with at least one adverse event 0 0 1 (2.5%) 0 0 0 - Total number of events 0 0 1 0 0 0 - ACROCHORDON EXCISION 0 0 1 (2.5%) 0 0 0 - HLT_0498 - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 0 0 - Total number of events 0 0 0 1 0 0 - SKIN LESION EXCISION 0 0 0 1 (2.3%) 0 0 - INJURY, POISONING AND PROCEDURAL COMPLICATIONS - Total number of patients with at least one adverse event 2 (3.8%) 2 (6.1%) 2 (5.0%) 3 (6.8%) 5 (10.0%) 0 - Total number of events 4 5 2 6 12 0 - HLT_0035 - Total number of patients with at least one adverse event 0 0 0 0 1 (2.0%) 0 - Total number of events 0 0 0 0 1 0 - JOINT DISLOCATION 0 0 0 0 1 (2.0%) 0 - HLT_0075 - Total number of patients with at least one adverse event 0 1 (3.0%) 0 0 2 (4.0%) 0 - Total number of events 0 1 0 0 2 0 - SKIN LACERATION 0 1 (3.0%) 0 0 2 (4.0%) 0 - HLT_0713 - Total number of patients with at least one adverse event 0 1 (3.0%) 0 2 (4.5%) 1 (2.0%) 0 - Total number of events 0 1 0 3 3 0 - CONTUSION 0 1 (3.0%) 0 2 (4.5%) 1 (2.0%) 0 - HLT_0738 - Total number of patients with at least one adverse event 1 (1.9%) 1 (3.0%) 1 (2.5%) 0 1 (2.0%) 0 - Total number of events 2 1 1 0 2 0 - EXCORIATION 1 (1.9%) 1 (3.0%) 1 (2.5%) 0 1 (2.0%) 0 - HLT_0097 - Total number of patients with at least one adverse event 1 (1.9%) 0 1 (2.5%) 1 (2.3%) 0 0 - Total number of events 2 0 1 1 0 0 - HIP FRACTURE 1 (1.9%) 0 1 (2.5%) 1 (2.3%) 0 0 - HLT_0305 - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 0 0 - Total number of events 0 0 0 1 0 0 - FACIAL BONES FRACTURE 0 0 0 1 (2.3%) 0 0 - HLT_0168 - Total number of patients with at least one adverse event 0 1 (3.0%) 0 1 (2.3%) 2 (4.0%) 0 - Total number of events 0 2 0 1 2 0 - FALL 0 1 (3.0%) 0 1 (2.3%) 2 (4.0%) 0 - HLT_0542 - Total number of patients with at least one adverse event 0 0 0 0 1 (2.0%) 0 - Total number of events 0 0 0 0 2 0 - WOUND 0 0 0 0 1 (2.0%) 0 - NERVOUS SYSTEM DISORDERS - Total number of patients with at least one adverse event 5 (9.4%) 7 (21.2%) 12 (30.0%) 15 (34.1%) 9 (18.0%) 11 (32.4%) - Total number of events 7 9 22 23 18 22 - HLT_0258 - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 0 0 - Total number of events 0 0 0 2 0 0 - PAROSMIA 0 0 0 1 (2.3%) 0 0 - HLT_0619 - Total number of patients with at least one adverse event 1 (1.9%) 1 (3.0%) 4 (10.0%) 8 (18.2%) 4 (8.0%) 4 (11.8%) - Total number of events 1 2 5 13 6 7 - DIZZINESS 1 (1.9%) 1 (3.0%) 4 (10.0%) 8 (18.2%) 4 (8.0%) 4 (11.8%) - HLT_0064 - Total number of patients with at least one adverse event 4 (7.5%) 3 (9.1%) 4 (10.0%) 2 (4.5%) 0 3 (8.8%) - Total number of events 5 3 7 2 0 4 - HEADACHE 4 (7.5%) 3 (9.1%) 4 (10.0%) 2 (4.5%) 0 3 (8.8%) - HLT_0481 - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 0 0 - Total number of events 0 0 0 1 0 0 - PARAESTHESIA 0 0 0 1 (2.3%) 0 0 - HLT_0160 - Total number of patients with at least one adverse event 0 2 (6.1%) 0 1 (2.3%) 0 3 (8.8%) - Total number of events 0 3 0 1 0 5 - SOMNOLENCE 0 2 (6.1%) 0 1 (2.3%) 0 3 (8.8%) - HLT_0041 - Total number of patients with at least one adverse event 0 0 1 (2.5%) 0 0 2 (5.9%) - Total number of events 0 0 1 0 0 3 - TRANSIENT ISCHAEMIC ATTACK 0 0 1 (2.5%) 0 0 2 (5.9%) - HLT_0775 - Total number of patients with at least one adverse event 0 0 0 2 (4.5%) 0 0 - Total number of events 0 0 0 2 0 0 - BURNING SENSATION 0 0 0 2 (4.5%) 0 0 - HLT_0279 - Total number of patients with at least one adverse event 0 1 (3.0%) 0 0 0 0 - Total number of events 0 1 0 0 0 0 - PARKINSON'S DISEASE 0 1 (3.0%) 0 0 0 0 - HLT_0440 - Total number of patients with at least one adverse event 0 0 2 (5.0%) 1 (2.3%) 4 (8.0%) 0 - Total number of events 0 0 3 1 6 0 - SYNCOPE 0 0 2 (5.0%) 1 (2.3%) 4 (8.0%) 0 - HLT_0595 - Total number of patients with at least one adverse event 0 0 0 0 0 1 (2.9%) - Total number of events 0 0 0 0 0 1 - STUPOR 0 0 0 0 0 1 (2.9%) - HLT_0639 - Total number of patients with at least one adverse event 0 0 0 0 0 1 (2.9%) - Total number of events 0 0 0 0 0 1 - HEMIANOPIA HOMONYMOUS 0 0 0 0 0 1 (2.9%) - HLT_0003 - Total number of patients with at least one adverse event 0 0 1 (2.5%) 0 0 0 - Total number of events 0 0 1 0 0 0 - SYNCOPE VASOVAGAL 0 0 1 (2.5%) 0 0 0 - HLT_0558 - Total number of patients with at least one adverse event 0 0 0 0 1 (2.0%) 0 - Total number of events 0 0 0 0 1 0 - COMPLEX PARTIAL SEIZURES 0 0 0 0 1 (2.0%) 0 - HLT_0383 - Total number of patients with at least one adverse event 1 (1.9%) 0 0 0 0 0 - Total number of events 1 0 0 0 0 0 - PSYCHOMOTOR HYPERACTIVITY 1 (1.9%) 0 0 0 0 0 - HLT_0727 - Total number of patients with at least one adverse event 0 0 0 0 1 (2.0%) 0 - Total number of events 0 0 0 0 1 0 - PARAESTHESIA ORAL 0 0 0 0 1 (2.0%) 0 - HLT_0027 - Total number of patients with at least one adverse event 0 0 1 (2.5%) 0 0 1 (2.9%) - Total number of events 0 0 1 0 0 1 - LETHARGY 0 0 1 (2.5%) 0 0 1 (2.9%) - HLT_0231 - Total number of patients with at least one adverse event 0 0 1 (2.5%) 0 0 0 - Total number of events 0 0 1 0 0 0 - HYPERSOMNIA 0 0 1 (2.5%) 0 0 0 - HLT_0265 - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 0 0 - Total number of events 0 0 0 1 0 0 - COGNITIVE DISORDER 0 0 0 1 (2.3%) 0 0 - HLT_0541 - Total number of patients with at least one adverse event 0 0 0 0 1 (2.0%) 0 - Total number of events 0 0 0 0 3 0 - BALANCE DISORDER 0 0 0 0 1 (2.0%) 0 - HLT_0315 - Total number of patients with at least one adverse event 0 0 0 0 1 (2.0%) 0 - Total number of events 0 0 0 0 1 0 - COORDINATION ABNORMAL 0 0 0 0 1 (2.0%) 0 - HLT_0603 - Total number of patients with at least one adverse event 0 0 1 (2.5%) 0 0 0 - Total number of events 0 0 1 0 0 0 - PARTIAL SEIZURES WITH SECONDARY GENERALISATION 0 0 1 (2.5%) 0 0 0 - HLT_0501 - Total number of patients with at least one adverse event 0 0 1 (2.5%) 0 0 0 - Total number of events 0 0 2 0 0 0 - AMNESIA 0 0 1 (2.5%) 0 0 0 - REPRODUCTIVE SYSTEM AND BREAST DISORDERS - Total number of patients with at least one adverse event 1 (1.9%) 1 (3.0%) 0 1 (2.3%) 0 0 - Total number of events 2 2 0 1 0 0 - HLT_0215 - Total number of patients with at least one adverse event 0 1 (3.0%) 0 1 (2.3%) 0 0 - Total number of events 0 2 0 1 0 0 - BENIGN PROSTATIC HYPERPLASIA 0 1 (3.0%) 0 1 (2.3%) 0 0 - HLT_0189 - Total number of patients with at least one adverse event 1 (1.9%) 0 0 0 0 0 - Total number of events 2 0 0 0 0 0 - PELVIC PAIN 1 (1.9%) 0 0 0 0 0 - VASCULAR DISORDERS - Total number of patients with at least one adverse event 1 (1.9%) 2 (6.1%) 2 (5.0%) 0 2 (4.0%) 1 (2.9%) - Total number of events 2 5 3 0 2 1 - HLT_0761 - Total number of patients with at least one adverse event 1 (1.9%) 1 (3.0%) 0 0 1 (2.0%) 0 - Total number of events 2 1 0 0 1 0 - HYPOTENSION 1 (1.9%) 1 (3.0%) 0 0 1 (2.0%) 0 - HLT_0154 - Total number of patients with at least one adverse event 0 0 1 (2.5%) 0 0 0 - Total number of events 0 0 1 0 0 0 - WOUND HAEMORRHAGE 0 0 1 (2.5%) 0 0 0 - HLT_0737 - Total number of patients with at least one adverse event 0 0 0 0 0 1 (2.9%) - Total number of events 0 0 0 0 0 1 - HOT FLUSH 0 0 0 0 0 1 (2.9%) - HLT_0194 - Total number of patients with at least one adverse event 0 1 (3.0%) 0 0 0 0 - Total number of events 0 2 0 0 0 0 - ORTHOSTATIC HYPOTENSION 0 1 (3.0%) 0 0 0 0 - HLT_0228 - Total number of patients with at least one adverse event 0 1 (3.0%) 1 (2.5%) 0 1 (2.0%) 0 - Total number of events 0 2 2 0 1 0 - HYPERTENSION 0 1 (3.0%) 1 (2.5%) 0 1 (2.0%) 0 - CONGENITAL, FAMILIAL AND GENETIC DISORDERS - Total number of patients with at least one adverse event 0 0 1 (2.5%) 1 (2.3%) 0 1 (2.9%) - Total number of events 0 0 1 1 0 1 - HLT_0589 - Total number of patients with at least one adverse event 0 0 1 (2.5%) 1 (2.3%) 0 1 (2.9%) - Total number of events 0 0 1 1 0 1 - VENTRICULAR SEPTAL DEFECT 0 0 1 (2.5%) 1 (2.3%) 0 1 (2.9%) - EAR AND LABYRINTH DISORDERS - Total number of patients with at least one adverse event 1 (1.9%) 0 1 (2.5%) 0 2 (4.0%) 0 - Total number of events 2 0 1 0 3 0 - HLT_0255 - Total number of patients with at least one adverse event 0 0 1 (2.5%) 0 1 (2.0%) 0 - Total number of events 0 0 1 0 1 0 - VERTIGO 0 0 1 (2.5%) 0 1 (2.0%) 0 - HLT_0018 - Total number of patients with at least one adverse event 0 0 0 0 1 (2.0%) 0 - Total number of events 0 0 0 0 1 0 - CERUMEN IMPACTION 0 0 0 0 1 (2.0%) 0 - HLT_0631 - Total number of patients with at least one adverse event 1 (1.9%) 0 0 0 0 0 - Total number of events 2 0 0 0 0 0 - EAR PAIN 1 (1.9%) 0 0 0 0 0 - HLT_0570 - Total number of patients with at least one adverse event 0 0 0 0 1 (2.0%) 0 - Total number of events 0 0 0 0 1 0 - TINNITUS 0 0 0 0 1 (2.0%) 0 - HEPATOBILIARY DISORDERS - Total number of patients with at least one adverse event 1 (1.9%) 0 0 0 0 0 - Total number of events 1 0 0 0 0 0 - HLT_0478 - Total number of patients with at least one adverse event 1 (1.9%) 0 0 0 0 0 - Total number of events 1 0 0 0 0 0 - HYPERBILIRUBINAEMIA 1 (1.9%) 0 0 0 0 0 - NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 2 (4.0%) 0 - Total number of events 0 0 0 1 3 0 - HLT_0597 - Total number of patients with at least one adverse event 0 0 0 0 1 (2.0%) 0 - Total number of events 0 0 0 0 1 0 - COLON CANCER 0 0 0 0 1 (2.0%) 0 - HLT_0245 - Total number of patients with at least one adverse event 0 0 0 0 1 (2.0%) 0 - Total number of events 0 0 0 0 2 0 - MALIGNANT FIBROUS HISTIOCYTOMA 0 0 0 0 1 (2.0%) 0 - HLT_0412 - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 0 0 - Total number of events 0 0 0 1 0 0 - PROSTATE CANCER 0 0 0 1 (2.3%) 0 0 - SOCIAL CIRCUMSTANCES - Total number of patients with at least one adverse event 0 0 1 (2.5%) 0 0 0 - Total number of events 0 0 1 0 0 0 - HLT_0138 - Total number of patients with at least one adverse event 0 0 1 (2.5%) 0 0 0 - Total number of events 0 0 1 0 0 0 - ALCOHOL USE 0 0 1 (2.5%) 0 0 0 - IMMUNE SYSTEM DISORDERS - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 0 1 (2.9%) - Total number of events 0 0 0 1 0 2 - HLT_0473 - Total number of patients with at least one adverse event 0 0 0 0 0 1 (2.9%) - Total number of events 0 0 0 0 0 2 - HYPERSENSITIVITY 0 0 0 0 0 1 (2.9%) - HLT_0714 - Total number of patients with at least one adverse event 0 0 0 1 (2.3%) 0 0 - Total number of events 0 0 0 1 0 0 - SEASONAL ALLERGY 0 0 0 1 (2.3%) 0 0 + Placebo Xanomeline High Dose Xanomeline Low Dose + F M F M F M + (N=53) (N=33) (N=40) (N=44) (N=50) (N=34) + —————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— + Total number of patients with at least one adverse event 24 (45.3%) 13 (39.4%) 27 (67.5%) 36 (81.8%) 35 (70.0%) 27 (79.4%) + Overall total number of events 55 20 85 115 110 68 + GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS + Total number of patients with at least one adverse event 7 (13.2%) 3 (9.1%) 14 (35.0%) 16 (36.4%) 18 (36.0%) 12 (35.3%) + Total number of events 15 5 37 37 35 36 + HLT_0617 + Total number of patients with at least one adverse event 2 (3.8%) 1 (3.0%) 5 (12.5%) 10 (22.7%) 5 (10.0%) 7 (20.6%) + Total number of events 2 1 9 14 8 12 + APPLICATION SITE ERYTHEMA 2 (3.8%) 1 (3.0%) 5 (12.5%) 10 (22.7%) 5 (10.0%) 7 (20.6%) + HLT_0317 + Total number of patients with at least one adverse event 4 (7.5%) 2 (6.1%) 10 (25.0%) 12 (27.3%) 12 (24.0%) 10 (29.4%) + Total number of events 6 4 19 16 17 16 + APPLICATION SITE PRURITUS 4 (7.5%) 2 (6.1%) 10 (25.0%) 12 (27.3%) 12 (24.0%) 10 (29.4%) + HLT_0061 + Total number of patients with at least one adverse event 3 (5.7%) 0 5 (12.5%) 4 (9.1%) 6 (12.0%) 3 (8.8%) + Total number of events 7 0 9 7 10 8 + APPLICATION SITE IRRITATION 3 (5.7%) 0 5 (12.5%) 4 (9.1%) 6 (12.0%) 3 (8.8%) + SKIN AND SUBCUTANEOUS TISSUE DISORDERS + Total number of patients with at least one adverse event 12 (22.6%) 7 (21.2%) 12 (30.0%) 22 (50.0%) 21 (42.0%) 14 (41.2%) + Total number of events 26 11 29 57 63 27 + HLT_0284 + Total number of patients with at least one adverse event 6 (11.3%) 3 (9.1%) 7 (17.5%) 7 (15.9%) 9 (18.0%) 6 (17.6%) + Total number of events 8 5 8 14 16 8 + ERYTHEMA 6 (11.3%) 3 (9.1%) 7 (17.5%) 7 (15.9%) 9 (18.0%) 6 (17.6%) + HLT_0778 + Total number of patients with at least one adverse event 6 (11.3%) 2 (6.1%) 11 (27.5%) 15 (34.1%) 13 (26.0%) 10 (29.4%) + Total number of events 9 2 14 24 23 12 + PRURITUS 6 (11.3%) 2 (6.1%) 11 (27.5%) 15 (34.1%) 13 (26.0%) 10 (29.4%) + HLT_0583 + Total number of patients with at least one adverse event 3 (5.7%) 0 1 (2.5%) 4 (9.1%) 5 (10.0%) 1 (2.9%) + Total number of events 4 0 2 6 11 2 + SKIN IRRITATION 3 (5.7%) 0 1 (2.5%) 4 (9.1%) 5 (10.0%) 1 (2.9%) + HLT_0762 + Total number of patients with at least one adverse event 2 (3.8%) 3 (9.1%) 3 (7.5%) 8 (18.2%) 8 (16.0%) 5 (14.7%) + Total number of events 5 4 5 13 13 5 + RASH 2 (3.8%) 3 (9.1%) 3 (7.5%) 8 (18.2%) 8 (16.0%) 5 (14.7%) + GASTROINTESTINAL DISORDERS + Total number of patients with at least one adverse event 3 (5.7%) 1 (3.0%) 4 (10.0%) 7 (15.9%) 4 (8.0%) 1 (2.9%) + Total number of events 5 1 10 12 8 1 + HLT_0016 + Total number of patients with at least one adverse event 2 (3.8%) 1 (3.0%) 0 7 (15.9%) 3 (6.0%) 0 + Total number of events 2 1 0 9 4 0 + VOMITING 2 (3.8%) 1 (3.0%) 0 7 (15.9%) 3 (6.0%) 0 + HLT_0742 + Total number of patients with at least one adverse event 3 (5.7%) 0 4 (10.0%) 2 (4.5%) 2 (4.0%) 1 (2.9%) + Total number of events 3 0 10 3 4 1 + NAUSEA 3 (5.7%) 0 4 (10.0%) 2 (4.5%) 2 (4.0%) 1 (2.9%) + NERVOUS SYSTEM DISORDERS + Total number of patients with at least one adverse event 4 (7.5%) 3 (9.1%) 4 (10.0%) 2 (4.5%) 0 3 (8.8%) + Total number of events 5 3 7 2 0 4 + HLT_0064 + Total number of patients with at least one adverse event 4 (7.5%) 3 (9.1%) 4 (10.0%) 2 (4.5%) 0 3 (8.8%) + Total number of events 5 3 7 2 0 4 + HEADACHE 4 (7.5%) 3 (9.1%) 4 (10.0%) 2 (4.5%) 0 3 (8.8%) + CARDIAC DISORDERS + Total number of patients with at least one adverse event 4 (7.5%) 0 1 (2.5%) 3 (6.8%) 2 (4.0%) 0 + Total number of events 4 0 1 7 4 0 + HLT_0649 + Total number of patients with at least one adverse event 4 (7.5%) 0 1 (2.5%) 3 (6.8%) 2 (4.0%) 0 + Total number of events 4 0 1 7 4 0 + MYOCARDIAL INFARCTION 4 (7.5%) 0 1 (2.5%) 3 (6.8%) 2 (4.0%) 0 + VASCULAR DISORDERS + Total number of patients with at least one adverse event 0 0 1 (2.5%) 0 0 0 + Total number of events 0 0 1 0 0 0 + HLT_0154 + Total number of patients with at least one adverse event 0 0 1 (2.5%) 0 0 0 + Total number of events 0 0 1 0 0 0 + WOUND HAEMORRHAGE 0 0 1 (2.5%) 0 0 0 diff --git a/tests/testthat/_snaps/table_aet07.md b/tests/testthat/_snaps/table_aet07.md index c8c647d..d0857c5 100644 --- a/tests/testthat/_snaps/table_aet07.md +++ b/tests/testthat/_snaps/table_aet07.md @@ -6,9 +6,8 @@ Placebo (N=86) ———————————————————————————————————————————————————— - Total number of deaths 2 (2.3%) + Total number of deaths 1 (1.2%) CARDIAC DISORDERS / MYOCARDIAL INFARCTION 1 (1.2%) - PSYCHIATRIC DISORDERS / COMPLETED SUICIDE 1 (1.2%) # AET07 variant 2 is produced correctly @@ -18,7 +17,6 @@ Placebo (N=86) ———————————————————————————————————————————————————— - Total number of deaths 2 (2.3%) + Total number of deaths 1 (1.2%) CARDIAC DISORDERS / MYOCARDIAL INFARCTION 1 (1.2%) - PSYCHIATRIC DISORDERS / COMPLETED SUICIDE 1 (1.2%) diff --git a/tests/testthat/_snaps/table_aet09.md b/tests/testthat/_snaps/table_aet09.md index 8126828..ce7bce8 100644 --- a/tests/testthat/_snaps/table_aet09.md +++ b/tests/testthat/_snaps/table_aet09.md @@ -6,218 +6,38 @@ Placebo Xanomeline High Dose Xanomeline Low Dose All Patients (N=86) (N=84) (N=84) (N=254) ————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— - Total number of patients with at least one adverse event related to study drug 53 (61.6%) 71 (84.5%) 74 (88.1%) 198 (78.0%) - Overall total number of events related to study drug 206 323 336 865 - GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - Total number of patients with at least one adverse event related to study drug 18 (20.9%) 39 (46.4%) 45 (53.6%) 102 (40.2%) - Total number of events related to study drug 45 120 113 278 - APPLICATION SITE PRURITUS 6 (7.0%) 22 (26.2%) 22 (26.2%) 50 (19.7%) - APPLICATION SITE ERYTHEMA 3 (3.5%) 15 (17.9%) 12 (14.3%) 30 (11.8%) - APPLICATION SITE DERMATITIS 5 (5.8%) 7 (8.3%) 9 (10.7%) 21 (8.3%) - APPLICATION SITE IRRITATION 3 (3.5%) 9 (10.7%) 9 (10.7%) 21 (8.3%) - APPLICATION SITE VESICLES 1 (1.2%) 6 (7.1%) 4 (4.8%) 11 (4.3%) - FATIGUE 1 (1.2%) 5 (6.0%) 5 (6.0%) 11 (4.3%) - APPLICATION SITE SWELLING 0 2 (2.4%) 1 (1.2%) 3 (1.2%) - APPLICATION SITE URTICARIA 0 1 (1.2%) 2 (2.4%) 3 (1.2%) - CHILLS 1 (1.2%) 1 (1.2%) 1 (1.2%) 3 (1.2%) - MALAISE 0 2 (2.4%) 1 (1.2%) 3 (1.2%) - OEDEMA PERIPHERAL 1 (1.2%) 1 (1.2%) 1 (1.2%) 3 (1.2%) - APPLICATION SITE PAIN 0 2 (2.4%) 0 2 (0.8%) - APPLICATION SITE PERSPIRATION 0 2 (2.4%) 0 2 (0.8%) - APPLICATION SITE REACTION 1 (1.2%) 1 (1.2%) 0 2 (0.8%) - ASTHENIA 1 (1.2%) 1 (1.2%) 0 2 (0.8%) - CHEST PAIN 0 2 (2.4%) 0 2 (0.8%) - OEDEMA 0 0 2 (2.4%) 2 (0.8%) - PAIN 0 1 (1.2%) 1 (1.2%) 2 (0.8%) - APPLICATION SITE BLEEDING 0 0 1 (1.2%) 1 (0.4%) - APPLICATION SITE DESQUAMATION 0 0 1 (1.2%) 1 (0.4%) - APPLICATION SITE DISCHARGE 0 1 (1.2%) 0 1 (0.4%) - APPLICATION SITE DISCOLOURATION 0 0 1 (1.2%) 1 (0.4%) - APPLICATION SITE INDURATION 1 (1.2%) 0 0 1 (0.4%) - APPLICATION SITE WARMTH 0 0 1 (1.2%) 1 (0.4%) - CHEST DISCOMFORT 0 1 (1.2%) 0 1 (0.4%) - FEELING ABNORMAL 0 1 (1.2%) 0 1 (0.4%) - INFLAMMATION 0 0 1 (1.2%) 1 (0.4%) - PYREXIA 0 1 (1.2%) 0 1 (0.4%) + Total number of patients with at least one adverse event related to study drug 31 (36.0%) 61 (72.6%) 58 (69.0%) 150 (59.1%) + Overall total number of events related to study drug 67 181 162 410 SKIN AND SUBCUTANEOUS TISSUE DISORDERS - Total number of patients with at least one adverse event related to study drug 20 (23.3%) 39 (46.4%) 39 (46.4%) 98 (38.6%) - Total number of events related to study drug 42 104 105 251 + Total number of patients with at least one adverse event related to study drug 18 (20.9%) 32 (38.1%) 31 (36.9%) 81 (31.9%) + Total number of events related to study drug 34 80 77 191 PRURITUS 8 (9.3%) 26 (31.0%) 21 (25.0%) 55 (21.7%) ERYTHEMA 9 (10.5%) 14 (16.7%) 13 (15.5%) 36 (14.2%) RASH 4 (4.7%) 8 (9.5%) 12 (14.3%) 24 (9.4%) - HYPERHIDROSIS 2 (2.3%) 8 (9.5%) 4 (4.8%) 14 (5.5%) SKIN IRRITATION 2 (2.3%) 5 (6.0%) 6 (7.1%) 13 (5.1%) - BLISTER 0 1 (1.2%) 5 (6.0%) 6 (2.4%) - RASH PRURITIC 0 2 (2.4%) 1 (1.2%) 3 (1.2%) - PRURITUS GENERALISED 0 1 (1.2%) 1 (1.2%) 2 (0.8%) - RASH ERYTHEMATOUS 0 0 2 (2.4%) 2 (0.8%) - URTICARIA 0 1 (1.2%) 1 (1.2%) 2 (0.8%) - ALOPECIA 1 (1.2%) 0 0 1 (0.4%) - COLD SWEAT 1 (1.2%) 0 0 1 (0.4%) - DERMATITIS CONTACT 0 0 1 (1.2%) 1 (0.4%) - RASH MACULO-PAPULAR 0 1 (1.2%) 0 1 (0.4%) - RASH PAPULAR 0 1 (1.2%) 0 1 (0.4%) - SKIN EXFOLIATION 0 0 1 (1.2%) 1 (0.4%) - SKIN ODOUR ABNORMAL 0 1 (1.2%) 0 1 (0.4%) - SKIN ULCER 1 (1.2%) 0 0 1 (0.4%) - NERVOUS SYSTEM DISORDERS - Total number of patients with at least one adverse event related to study drug 7 (8.1%) 18 (21.4%) 17 (20.2%) 42 (16.5%) - Total number of events related to study drug 10 29 36 75 - DIZZINESS 2 (2.3%) 9 (10.7%) 8 (9.5%) 19 (7.5%) - HEADACHE 3 (3.5%) 3 (3.6%) 2 (2.4%) 8 (3.1%) - SYNCOPE 0 3 (3.6%) 4 (4.8%) 7 (2.8%) - SOMNOLENCE 1 (1.2%) 1 (1.2%) 2 (2.4%) 4 (1.6%) - BURNING SENSATION 0 2 (2.4%) 0 2 (0.8%) - LETHARGY 0 1 (1.2%) 1 (1.2%) 2 (0.8%) - TRANSIENT ISCHAEMIC ATTACK 0 0 2 (2.4%) 2 (0.8%) - BALANCE DISORDER 0 0 1 (1.2%) 1 (0.4%) - COMPLEX PARTIAL SEIZURES 0 0 1 (1.2%) 1 (0.4%) - COORDINATION ABNORMAL 0 0 1 (1.2%) 1 (0.4%) - HYPERSOMNIA 0 1 (1.2%) 0 1 (0.4%) - PARAESTHESIA ORAL 0 0 1 (1.2%) 1 (0.4%) - PAROSMIA 0 1 (1.2%) 0 1 (0.4%) - PSYCHOMOTOR HYPERACTIVITY 1 (1.2%) 0 0 1 (0.4%) - STUPOR 0 0 1 (1.2%) 1 (0.4%) - SYNCOPE VASOVAGAL 0 1 (1.2%) 0 1 (0.4%) + GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS + Total number of patients with at least one adverse event related to study drug 10 (11.6%) 30 (35.7%) 30 (35.7%) 70 (27.6%) + Total number of events related to study drug 20 74 70 164 + APPLICATION SITE PRURITUS 6 (7.0%) 22 (26.2%) 22 (26.2%) 50 (19.7%) + APPLICATION SITE ERYTHEMA 3 (3.5%) 15 (17.9%) 12 (14.3%) 30 (11.8%) + APPLICATION SITE IRRITATION 3 (3.5%) 9 (10.7%) 9 (10.7%) 21 (8.3%) GASTROINTESTINAL DISORDERS - Total number of patients with at least one adverse event related to study drug 11 (12.8%) 14 (16.7%) 11 (13.1%) 36 (14.2%) - Total number of events related to study drug 17 29 19 65 - DIARRHOEA 6 (7.0%) 3 (3.6%) 4 (4.8%) 13 (5.1%) + Total number of patients with at least one adverse event related to study drug 3 (3.5%) 8 (9.5%) 5 (6.0%) 16 (6.3%) + Total number of events related to study drug 5 18 9 32 NAUSEA 3 (3.5%) 5 (6.0%) 3 (3.6%) 11 (4.3%) VOMITING 2 (2.3%) 5 (6.0%) 3 (3.6%) 10 (3.9%) - ABDOMINAL PAIN 1 (1.2%) 1 (1.2%) 2 (2.4%) 4 (1.6%) - SALIVARY HYPERSECRETION 0 3 (3.6%) 0 3 (1.2%) - DYSPEPSIA 1 (1.2%) 0 1 (1.2%) 2 (0.8%) - ABDOMINAL DISCOMFORT 0 1 (1.2%) 0 1 (0.4%) - CONSTIPATION 1 (1.2%) 0 0 1 (0.4%) - GASTROOESOPHAGEAL REFLUX DISEASE 1 (1.2%) 0 0 1 (0.4%) - STOMACH DISCOMFORT 0 1 (1.2%) 0 1 (0.4%) CARDIAC DISORDERS - Total number of patients with at least one adverse event related to study drug 11 (12.8%) 7 (8.3%) 11 (13.1%) 29 (11.4%) - Total number of events related to study drug 25 12 23 60 - SINUS BRADYCARDIA 2 (2.3%) 3 (3.6%) 5 (6.0%) 10 (3.9%) + Total number of patients with at least one adverse event related to study drug 4 (4.7%) 2 (2.4%) 2 (2.4%) 8 (3.1%) + Total number of events related to study drug 4 2 4 10 MYOCARDIAL INFARCTION 4 (4.7%) 2 (2.4%) 2 (2.4%) 8 (3.1%) - ATRIAL FIBRILLATION 1 (1.2%) 2 (2.4%) 0 3 (1.2%) - SUPRAVENTRICULAR EXTRASYSTOLES 1 (1.2%) 1 (1.2%) 1 (1.2%) 3 (1.2%) - BUNDLE BRANCH BLOCK RIGHT 1 (1.2%) 0 1 (1.2%) 2 (0.8%) - PALPITATIONS 0 0 2 (2.4%) 2 (0.8%) - VENTRICULAR EXTRASYSTOLES 0 0 2 (2.4%) 2 (0.8%) - ATRIAL FLUTTER 0 0 1 (1.2%) 1 (0.4%) - ATRIAL HYPERTROPHY 1 (1.2%) 0 0 1 (0.4%) - ATRIOVENTRICULAR BLOCK FIRST DEGREE 1 (1.2%) 0 0 1 (0.4%) - ATRIOVENTRICULAR BLOCK SECOND DEGREE 1 (1.2%) 0 0 1 (0.4%) - BRADYCARDIA 1 (1.2%) 0 0 1 (0.4%) - CARDIAC FAILURE CONGESTIVE 1 (1.2%) 0 0 1 (0.4%) - SINUS ARRHYTHMIA 1 (1.2%) 0 0 1 (0.4%) - TACHYCARDIA 1 (1.2%) 0 0 1 (0.4%) - VENTRICULAR HYPERTROPHY 1 (1.2%) 0 0 1 (0.4%) - WOLFF-PARKINSON-WHITE SYNDROME 0 0 1 (1.2%) 1 (0.4%) - PSYCHIATRIC DISORDERS - Total number of patients with at least one adverse event related to study drug 8 (9.3%) 6 (7.1%) 9 (10.7%) 23 (9.1%) - Total number of events related to study drug 11 8 13 32 - CONFUSIONAL STATE 2 (2.3%) 1 (1.2%) 2 (2.4%) 5 (2.0%) - AGITATION 2 (2.3%) 0 2 (2.4%) 4 (1.6%) - ANXIETY 1 (1.2%) 0 3 (3.6%) 4 (1.6%) - INSOMNIA 1 (1.2%) 2 (2.4%) 0 3 (1.2%) - IRRITABILITY 1 (1.2%) 0 1 (1.2%) 2 (0.8%) - DELIRIUM 0 1 (1.2%) 0 1 (0.4%) - DELUSION 1 (1.2%) 0 0 1 (0.4%) - DEPRESSED MOOD 0 0 1 (1.2%) 1 (0.4%) - DISORIENTATION 1 (1.2%) 0 0 1 (0.4%) - HALLUCINATION, VISUAL 0 1 (1.2%) 0 1 (0.4%) - LIBIDO DECREASED 0 1 (1.2%) 0 1 (0.4%) - LISTLESS 0 1 (1.2%) 0 1 (0.4%) - NIGHTMARE 0 1 (1.2%) 0 1 (0.4%) - RESTLESSNESS 0 0 1 (1.2%) 1 (0.4%) - INVESTIGATIONS - Total number of patients with at least one adverse event related to study drug 8 (9.3%) 1 (1.2%) 3 (3.6%) 12 (4.7%) - Total number of events related to study drug 16 1 4 21 - ELECTROCARDIOGRAM ST SEGMENT DEPRESSION 4 (4.7%) 0 1 (1.2%) 5 (2.0%) - ELECTROCARDIOGRAM T WAVE INVERSION 2 (2.3%) 1 (1.2%) 0 3 (1.2%) - ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED 1 (1.2%) 0 1 (1.2%) 2 (0.8%) - BLOOD CREATINE PHOSPHOKINASE INCREASED 1 (1.2%) 0 0 1 (0.4%) - BODY TEMPERATURE INCREASED 0 0 1 (1.2%) 1 (0.4%) - HEART RATE INCREASED 1 (1.2%) 0 0 1 (0.4%) - HEART RATE IRREGULAR 1 (1.2%) 0 0 1 (0.4%) - RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - Total number of patients with at least one adverse event related to study drug 5 (5.8%) 2 (2.4%) 3 (3.6%) 10 (3.9%) - Total number of events related to study drug 5 2 6 13 - NASAL CONGESTION 2 (2.3%) 1 (1.2%) 0 3 (1.2%) - COUGH 1 (1.2%) 0 1 (1.2%) 2 (0.8%) - EPISTAXIS 0 1 (1.2%) 1 (1.2%) 2 (0.8%) - DYSPHONIA 0 0 1 (1.2%) 1 (0.4%) - DYSPNOEA 1 (1.2%) 0 0 1 (0.4%) - EMPHYSEMA 1 (1.2%) 0 0 1 (0.4%) - RHINORRHOEA 0 0 1 (1.2%) 1 (0.4%) - METABOLISM AND NUTRITION DISORDERS - Total number of patients with at least one adverse event related to study drug 4 (4.7%) 2 (2.4%) 0 6 (2.4%) - Total number of events related to study drug 6 4 0 10 - DECREASED APPETITE 1 (1.2%) 1 (1.2%) 0 2 (0.8%) - INCREASED APPETITE 1 (1.2%) 1 (1.2%) 0 2 (0.8%) - FOOD CRAVING 1 (1.2%) 0 0 1 (0.4%) - HYPONATRAEMIA 1 (1.2%) 0 0 1 (0.4%) + NERVOUS SYSTEM DISORDERS + Total number of patients with at least one adverse event related to study drug 3 (3.5%) 3 (3.6%) 2 (2.4%) 8 (3.1%) + Total number of events related to study drug 4 6 2 12 + HEADACHE 3 (3.5%) 3 (3.6%) 2 (2.4%) 8 (3.1%) VASCULAR DISORDERS - Total number of patients with at least one adverse event related to study drug 3 (3.5%) 1 (1.2%) 2 (2.4%) 6 (2.4%) - Total number of events related to study drug 7 1 2 10 - HYPOTENSION 2 (2.3%) 0 1 (1.2%) 3 (1.2%) - HYPERTENSION 1 (1.2%) 0 1 (1.2%) 2 (0.8%) - ORTHOSTATIC HYPOTENSION 1 (1.2%) 0 0 1 (0.4%) + Total number of patients with at least one adverse event related to study drug 0 1 (1.2%) 0 1 (0.4%) + Total number of events related to study drug 0 1 0 1 WOUND HAEMORRHAGE 0 1 (1.2%) 0 1 (0.4%) - EYE DISORDERS - Total number of patients with at least one adverse event related to study drug 2 (2.3%) 1 (1.2%) 2 (2.4%) 5 (2.0%) - Total number of events related to study drug 3 2 2 7 - VISION BLURRED 0 1 (1.2%) 1 (1.2%) 2 (0.8%) - CONJUNCTIVAL HAEMORRHAGE 0 0 1 (1.2%) 1 (0.4%) - CONJUNCTIVITIS 1 (1.2%) 0 0 1 (0.4%) - EYE PRURITUS 1 (1.2%) 0 0 1 (0.4%) - INFECTIONS AND INFESTATIONS - Total number of patients with at least one adverse event related to study drug 4 (4.7%) 1 (1.2%) 0 5 (2.0%) - Total number of events related to study drug 12 1 0 13 - UPPER RESPIRATORY TRACT INFECTION 3 (3.5%) 0 0 3 (1.2%) - CERVICITIS 1 (1.2%) 0 0 1 (0.4%) - CYSTITIS 0 1 (1.2%) 0 1 (0.4%) - GASTROENTERITIS VIRAL 1 (1.2%) 0 0 1 (0.4%) - URINARY TRACT INFECTION 1 (1.2%) 0 0 1 (0.4%) - VAGINAL MYCOSIS 1 (1.2%) 0 0 1 (0.4%) - INJURY, POISONING AND PROCEDURAL COMPLICATIONS - Total number of patients with at least one adverse event related to study drug 0 2 (2.4%) 3 (3.6%) 5 (2.0%) - Total number of events related to study drug 0 3 8 11 - CONTUSION 0 1 (1.2%) 1 (1.2%) 2 (0.8%) - FALL 0 0 2 (2.4%) 2 (0.8%) - EXCORIATION 0 1 (1.2%) 0 1 (0.4%) - SKIN LACERATION 0 0 1 (1.2%) 1 (0.4%) - WOUND 0 0 1 (1.2%) 1 (0.4%) - MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS - Total number of patients with at least one adverse event related to study drug 2 (2.3%) 3 (3.6%) 0 5 (2.0%) - Total number of events related to study drug 3 4 0 7 - BACK PAIN 0 1 (1.2%) 0 1 (0.4%) - MUSCLE SPASMS 0 1 (1.2%) 0 1 (0.4%) - MYALGIA 0 1 (1.2%) 0 1 (0.4%) - PAIN IN EXTREMITY 1 (1.2%) 0 0 1 (0.4%) - SHOULDER PAIN 1 (1.2%) 0 0 1 (0.4%) - RENAL AND URINARY DISORDERS - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 1 (1.2%) 2 (2.4%) 4 (1.6%) - Total number of events related to study drug 1 2 2 5 - DYSURIA 1 (1.2%) 0 1 (1.2%) 2 (0.8%) - ENURESIS 0 0 1 (1.2%) 1 (0.4%) - MICTURITION URGENCY 0 1 (1.2%) 0 1 (0.4%) - EAR AND LABYRINTH DISORDERS - Total number of patients with at least one adverse event related to study drug 0 1 (1.2%) 2 (2.4%) 3 (1.2%) - Total number of events related to study drug 0 1 2 3 - VERTIGO 0 1 (1.2%) 1 (1.2%) 2 (0.8%) - TINNITUS 0 0 1 (1.2%) 1 (0.4%) - CONGENITAL, FAMILIAL AND GENETIC DISORDERS - Total number of patients with at least one adverse event related to study drug 0 0 1 (1.2%) 1 (0.4%) - Total number of events related to study drug 0 0 1 1 - VENTRICULAR SEPTAL DEFECT 0 0 1 (1.2%) 1 (0.4%) - HEPATOBILIARY DISORDERS - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 0 1 (0.4%) - Total number of events related to study drug 1 0 0 1 - HYPERBILIRUBINAEMIA 1 (1.2%) 0 0 1 (0.4%) - REPRODUCTIVE SYSTEM AND BREAST DISORDERS - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 0 1 (0.4%) - Total number of events related to study drug 2 0 0 2 - PELVIC PAIN 1 (1.2%) 0 0 1 (0.4%) # AET09 variant 2 is produced correctly, AE related to study drug (including high-level terms) @@ -227,126 +47,11 @@ Placebo Xanomeline High Dose Xanomeline Low Dose (N=86) (N=84) (N=84) ———————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— - Total number of patients with at least one adverse event related to study drug 53 (61.6%) 71 (84.5%) 74 (88.1%) - Overall total number of events related to study drug 206 323 336 - GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - Total number of patients with at least one adverse event related to study drug 18 (20.9%) 39 (46.4%) 45 (53.6%) - Total number of events related to study drug 45 120 113 - HLT_0317 - Total number of patients with at least one adverse event related to study drug 6 (7.0%) 22 (26.2%) 22 (26.2%) - Total number of events related to study drug 10 35 32 - APPLICATION SITE PRURITUS 6 (7.0%) 22 (26.2%) 22 (26.2%) - HLT_0617 - Total number of patients with at least one adverse event related to study drug 3 (3.5%) 15 (17.9%) 12 (14.3%) - Total number of events related to study drug 3 23 20 - APPLICATION SITE ERYTHEMA 3 (3.5%) 15 (17.9%) 12 (14.3%) - HLT_0061 - Total number of patients with at least one adverse event related to study drug 3 (3.5%) 9 (10.7%) 9 (10.7%) - Total number of events related to study drug 7 16 18 - APPLICATION SITE IRRITATION 3 (3.5%) 9 (10.7%) 9 (10.7%) - HLT_0343 - Total number of patients with at least one adverse event related to study drug 5 (5.8%) 7 (8.3%) 9 (10.7%) - Total number of events related to study drug 9 12 15 - APPLICATION SITE DERMATITIS 5 (5.8%) 7 (8.3%) 9 (10.7%) - HLT_0043 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 5 (6.0%) 5 (6.0%) - Total number of events related to study drug 2 5 5 - FATIGUE 1 (1.2%) 5 (6.0%) 5 (6.0%) - HLT_0180 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 6 (7.1%) 4 (4.8%) - Total number of events related to study drug 2 6 5 - APPLICATION SITE VESICLES 1 (1.2%) 6 (7.1%) 4 (4.8%) - HLT_0105 - Total number of patients with at least one adverse event related to study drug 0 2 (2.4%) 1 (1.2%) - Total number of events related to study drug 0 3 1 - APPLICATION SITE SWELLING 0 2 (2.4%) 1 (1.2%) - HLT_0196 - Total number of patients with at least one adverse event related to study drug 0 1 (1.2%) 2 (2.4%) - Total number of events related to study drug 0 1 2 - APPLICATION SITE URTICARIA 0 1 (1.2%) 2 (2.4%) - HLT_0456 - Total number of patients with at least one adverse event related to study drug 0 2 (2.4%) 1 (1.2%) - Total number of events related to study drug 0 3 2 - MALAISE 0 2 (2.4%) 1 (1.2%) - HLT_0586 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 1 (1.2%) 1 (1.2%) - Total number of events related to study drug 3 1 2 - CHILLS 1 (1.2%) 1 (1.2%) 1 (1.2%) - HLT_0661 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 1 (1.2%) 1 (1.2%) - Total number of events related to study drug 4 1 1 - OEDEMA PERIPHERAL 1 (1.2%) 1 (1.2%) 1 (1.2%) - HLT_0205 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 1 (1.2%) 0 - Total number of events related to study drug 2 1 0 - ASTHENIA 1 (1.2%) 1 (1.2%) 0 - HLT_0283 - Total number of patients with at least one adverse event related to study drug 0 2 (2.4%) 0 - Total number of events related to study drug 0 3 0 - APPLICATION SITE PERSPIRATION 0 2 (2.4%) 0 - HLT_0314 - Total number of patients with at least one adverse event related to study drug 0 1 (1.2%) 1 (1.2%) - Total number of events related to study drug 0 1 2 - PAIN 0 1 (1.2%) 1 (1.2%) - HLT_0339 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 1 (1.2%) 0 - Total number of events related to study drug 2 1 0 - APPLICATION SITE REACTION 1 (1.2%) 1 (1.2%) 0 - HLT_0342 - Total number of patients with at least one adverse event related to study drug 0 2 (2.4%) 0 - Total number of events related to study drug 0 2 0 - APPLICATION SITE PAIN 0 2 (2.4%) 0 - HLT_0656 - Total number of patients with at least one adverse event related to study drug 0 0 2 (2.4%) - Total number of events related to study drug 0 0 2 - OEDEMA 0 0 2 (2.4%) - HLT_0717 - Total number of patients with at least one adverse event related to study drug 0 2 (2.4%) 0 - Total number of events related to study drug 0 2 0 - CHEST PAIN 0 2 (2.4%) 0 - HLT_0121 - Total number of patients with at least one adverse event related to study drug 0 0 1 (1.2%) - Total number of events related to study drug 0 0 1 - APPLICATION SITE DISCOLOURATION 0 0 1 (1.2%) - HLT_0200 - Total number of patients with at least one adverse event related to study drug 0 1 (1.2%) 0 - Total number of events related to study drug 0 1 0 - APPLICATION SITE DISCHARGE 0 1 (1.2%) 0 - HLT_0260 - Total number of patients with at least one adverse event related to study drug 0 0 1 (1.2%) - Total number of events related to study drug 0 0 2 - APPLICATION SITE WARMTH 0 0 1 (1.2%) - HLT_0310 - Total number of patients with at least one adverse event related to study drug 0 1 (1.2%) 0 - Total number of events related to study drug 0 1 0 - PYREXIA 0 1 (1.2%) 0 - HLT_0351 - Total number of patients with at least one adverse event related to study drug 0 0 1 (1.2%) - Total number of events related to study drug 0 0 1 - APPLICATION SITE DESQUAMATION 0 0 1 (1.2%) - HLT_0524 - Total number of patients with at least one adverse event related to study drug 0 1 (1.2%) 0 - Total number of events related to study drug 0 1 0 - FEELING ABNORMAL 0 1 (1.2%) 0 - HLT_0582 - Total number of patients with at least one adverse event related to study drug 0 0 1 (1.2%) - Total number of events related to study drug 0 0 1 - INFLAMMATION 0 0 1 (1.2%) - HLT_0593 - Total number of patients with at least one adverse event related to study drug 0 1 (1.2%) 0 - Total number of events related to study drug 0 1 0 - CHEST DISCOMFORT 0 1 (1.2%) 0 - HLT_0696 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 0 - Total number of events related to study drug 1 0 0 - APPLICATION SITE INDURATION 1 (1.2%) 0 0 - HLT_0718 - Total number of patients with at least one adverse event related to study drug 0 0 1 (1.2%) - Total number of events related to study drug 0 0 1 - APPLICATION SITE BLEEDING 0 0 1 (1.2%) + Total number of patients with at least one adverse event related to study drug 31 (36.0%) 61 (72.6%) 58 (69.0%) + Overall total number of events related to study drug 67 181 162 SKIN AND SUBCUTANEOUS TISSUE DISORDERS - Total number of patients with at least one adverse event related to study drug 20 (23.3%) 39 (46.4%) 39 (46.4%) - Total number of events related to study drug 42 104 105 + Total number of patients with at least one adverse event related to study drug 18 (20.9%) 32 (38.1%) 31 (36.9%) + Total number of events related to study drug 34 80 77 HLT_0778 Total number of patients with at least one adverse event related to study drug 8 (9.3%) 26 (31.0%) 21 (25.0%) Total number of events related to study drug 11 38 30 @@ -359,140 +64,28 @@ Total number of patients with at least one adverse event related to study drug 4 (4.7%) 8 (9.5%) 12 (14.3%) Total number of events related to study drug 8 12 16 RASH 4 (4.7%) 8 (9.5%) 12 (14.3%) - HLT_0587 - Total number of patients with at least one adverse event related to study drug 2 (2.3%) 8 (9.5%) 4 (4.8%) - Total number of events related to study drug 2 10 5 - HYPERHIDROSIS 2 (2.3%) 8 (9.5%) 4 (4.8%) HLT_0583 Total number of patients with at least one adverse event related to study drug 2 (2.3%) 5 (6.0%) 6 (7.1%) Total number of events related to study drug 2 8 13 SKIN IRRITATION 2 (2.3%) 5 (6.0%) 6 (7.1%) - HLT_0752 - Total number of patients with at least one adverse event related to study drug 0 1 (1.2%) 5 (6.0%) - Total number of events related to study drug 0 2 8 - BLISTER 0 1 (1.2%) 5 (6.0%) - HLT_0127 - Total number of patients with at least one adverse event related to study drug 0 2 (2.4%) 1 (1.2%) - Total number of events related to study drug 0 3 2 - RASH PRURITIC 0 2 (2.4%) 1 (1.2%) - HLT_0123 - Total number of patients with at least one adverse event related to study drug 0 1 (1.2%) 1 (1.2%) - Total number of events related to study drug 0 1 4 - PRURITUS GENERALISED 0 1 (1.2%) 1 (1.2%) - HLT_0336 - Total number of patients with at least one adverse event related to study drug 0 0 2 (2.4%) - Total number of events related to study drug 0 0 2 - RASH ERYTHEMATOUS 0 0 2 (2.4%) - HLT_0420 - Total number of patients with at least one adverse event related to study drug 0 1 (1.2%) 1 (1.2%) - Total number of events related to study drug 0 2 3 - URTICARIA 0 1 (1.2%) 1 (1.2%) - HLT_0005 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 0 - Total number of events related to study drug 2 0 0 - SKIN ULCER 1 (1.2%) 0 0 - HLT_0056 - Total number of patients with at least one adverse event related to study drug 0 0 1 (1.2%) - Total number of events related to study drug 0 0 2 - DERMATITIS CONTACT 0 0 1 (1.2%) - HLT_0077 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 0 - Total number of events related to study drug 1 0 0 - ALOPECIA 1 (1.2%) 0 0 - HLT_0124 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 0 - Total number of events related to study drug 3 0 0 - COLD SWEAT 1 (1.2%) 0 0 - HLT_0236 - Total number of patients with at least one adverse event related to study drug 0 0 1 (1.2%) - Total number of events related to study drug 0 0 2 - SKIN EXFOLIATION 0 0 1 (1.2%) - HLT_0500 - Total number of patients with at least one adverse event related to study drug 0 1 (1.2%) 0 - Total number of events related to study drug 0 3 0 - RASH MACULO-PAPULAR 0 1 (1.2%) 0 - HLT_0510 - Total number of patients with at least one adverse event related to study drug 0 1 (1.2%) 0 - Total number of events related to study drug 0 1 0 - SKIN ODOUR ABNORMAL 0 1 (1.2%) 0 - HLT_0549 - Total number of patients with at least one adverse event related to study drug 0 1 (1.2%) 0 - Total number of events related to study drug 0 2 0 - RASH PAPULAR 0 1 (1.2%) 0 - NERVOUS SYSTEM DISORDERS - Total number of patients with at least one adverse event related to study drug 7 (8.1%) 18 (21.4%) 17 (20.2%) - Total number of events related to study drug 10 29 36 - HLT_0619 - Total number of patients with at least one adverse event related to study drug 2 (2.3%) 9 (10.7%) 8 (9.5%) - Total number of events related to study drug 3 11 13 - DIZZINESS 2 (2.3%) 9 (10.7%) 8 (9.5%) - HLT_0064 - Total number of patients with at least one adverse event related to study drug 3 (3.5%) 3 (3.6%) 2 (2.4%) - Total number of events related to study drug 4 6 2 - HEADACHE 3 (3.5%) 3 (3.6%) 2 (2.4%) - HLT_0440 - Total number of patients with at least one adverse event related to study drug 0 3 (3.6%) 4 (4.8%) - Total number of events related to study drug 0 4 6 - SYNCOPE 0 3 (3.6%) 4 (4.8%) - HLT_0160 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 1 (1.2%) 2 (2.4%) - Total number of events related to study drug 2 1 4 - SOMNOLENCE 1 (1.2%) 1 (1.2%) 2 (2.4%) - HLT_0027 - Total number of patients with at least one adverse event related to study drug 0 1 (1.2%) 1 (1.2%) - Total number of events related to study drug 0 1 1 - LETHARGY 0 1 (1.2%) 1 (1.2%) - HLT_0041 - Total number of patients with at least one adverse event related to study drug 0 0 2 (2.4%) - Total number of events related to study drug 0 0 3 - TRANSIENT ISCHAEMIC ATTACK 0 0 2 (2.4%) - HLT_0775 - Total number of patients with at least one adverse event related to study drug 0 2 (2.4%) 0 - Total number of events related to study drug 0 2 0 - BURNING SENSATION 0 2 (2.4%) 0 - HLT_0003 - Total number of patients with at least one adverse event related to study drug 0 1 (1.2%) 0 - Total number of events related to study drug 0 1 0 - SYNCOPE VASOVAGAL 0 1 (1.2%) 0 - HLT_0231 - Total number of patients with at least one adverse event related to study drug 0 1 (1.2%) 0 - Total number of events related to study drug 0 1 0 - HYPERSOMNIA 0 1 (1.2%) 0 - HLT_0258 - Total number of patients with at least one adverse event related to study drug 0 1 (1.2%) 0 - Total number of events related to study drug 0 2 0 - PAROSMIA 0 1 (1.2%) 0 - HLT_0315 - Total number of patients with at least one adverse event related to study drug 0 0 1 (1.2%) - Total number of events related to study drug 0 0 1 - COORDINATION ABNORMAL 0 0 1 (1.2%) - HLT_0383 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 0 - Total number of events related to study drug 1 0 0 - PSYCHOMOTOR HYPERACTIVITY 1 (1.2%) 0 0 - HLT_0541 - Total number of patients with at least one adverse event related to study drug 0 0 1 (1.2%) - Total number of events related to study drug 0 0 3 - BALANCE DISORDER 0 0 1 (1.2%) - HLT_0558 - Total number of patients with at least one adverse event related to study drug 0 0 1 (1.2%) - Total number of events related to study drug 0 0 1 - COMPLEX PARTIAL SEIZURES 0 0 1 (1.2%) - HLT_0595 - Total number of patients with at least one adverse event related to study drug 0 0 1 (1.2%) - Total number of events related to study drug 0 0 1 - STUPOR 0 0 1 (1.2%) - HLT_0727 - Total number of patients with at least one adverse event related to study drug 0 0 1 (1.2%) - Total number of events related to study drug 0 0 1 - PARAESTHESIA ORAL 0 0 1 (1.2%) + GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS + Total number of patients with at least one adverse event related to study drug 10 (11.6%) 30 (35.7%) 30 (35.7%) + Total number of events related to study drug 20 74 70 + HLT_0317 + Total number of patients with at least one adverse event related to study drug 6 (7.0%) 22 (26.2%) 22 (26.2%) + Total number of events related to study drug 10 35 32 + APPLICATION SITE PRURITUS 6 (7.0%) 22 (26.2%) 22 (26.2%) + HLT_0617 + Total number of patients with at least one adverse event related to study drug 3 (3.5%) 15 (17.9%) 12 (14.3%) + Total number of events related to study drug 3 23 20 + APPLICATION SITE ERYTHEMA 3 (3.5%) 15 (17.9%) 12 (14.3%) + HLT_0061 + Total number of patients with at least one adverse event related to study drug 3 (3.5%) 9 (10.7%) 9 (10.7%) + Total number of events related to study drug 7 16 18 + APPLICATION SITE IRRITATION 3 (3.5%) 9 (10.7%) 9 (10.7%) GASTROINTESTINAL DISORDERS - Total number of patients with at least one adverse event related to study drug 11 (12.8%) 14 (16.7%) 11 (13.1%) - Total number of events related to study drug 17 29 19 - HLT_0148 - Total number of patients with at least one adverse event related to study drug 6 (7.0%) 3 (3.6%) 4 (4.8%) - Total number of events related to study drug 7 3 6 - DIARRHOEA 6 (7.0%) 3 (3.6%) 4 (4.8%) + Total number of patients with at least one adverse event related to study drug 3 (3.5%) 8 (9.5%) 5 (6.0%) + Total number of events related to study drug 5 18 9 HLT_0742 Total number of patients with at least one adverse event related to study drug 3 (3.5%) 5 (6.0%) 3 (3.6%) Total number of events related to study drug 3 12 5 @@ -501,401 +94,25 @@ Total number of patients with at least one adverse event related to study drug 2 (2.3%) 5 (6.0%) 3 (3.6%) Total number of events related to study drug 2 6 4 VOMITING 2 (2.3%) 5 (6.0%) 3 (3.6%) - HLT_0217 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 1 (1.2%) 2 (2.4%) - Total number of events related to study drug 1 2 2 - ABDOMINAL PAIN 1 (1.2%) 1 (1.2%) 2 (2.4%) - HLT_0374 - Total number of patients with at least one adverse event related to study drug 0 3 (3.6%) 0 - Total number of events related to study drug 0 4 0 - SALIVARY HYPERSECRETION 0 3 (3.6%) 0 - HLT_0244 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 1 (1.2%) - Total number of events related to study drug 2 0 2 - DYSPEPSIA 1 (1.2%) 0 1 (1.2%) - HLT_0012 - Total number of patients with at least one adverse event related to study drug 0 1 (1.2%) 0 - Total number of events related to study drug 0 1 0 - ABDOMINAL DISCOMFORT 0 1 (1.2%) 0 - HLT_0065 - Total number of patients with at least one adverse event related to study drug 0 1 (1.2%) 0 - Total number of events related to study drug 0 1 0 - STOMACH DISCOMFORT 0 1 (1.2%) 0 - HLT_0402 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 0 - Total number of events related to study drug 1 0 0 - CONSTIPATION 1 (1.2%) 0 0 - HLT_0407 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 0 - Total number of events related to study drug 1 0 0 - GASTROOESOPHAGEAL REFLUX DISEASE 1 (1.2%) 0 0 CARDIAC DISORDERS - Total number of patients with at least one adverse event related to study drug 11 (12.8%) 7 (8.3%) 11 (13.1%) - Total number of events related to study drug 25 12 23 - HLT_0644 - Total number of patients with at least one adverse event related to study drug 2 (2.3%) 3 (3.6%) 5 (6.0%) - Total number of events related to study drug 2 6 7 - SINUS BRADYCARDIA 2 (2.3%) 3 (3.6%) 5 (6.0%) + Total number of patients with at least one adverse event related to study drug 4 (4.7%) 2 (2.4%) 2 (2.4%) + Total number of events related to study drug 4 2 4 HLT_0649 Total number of patients with at least one adverse event related to study drug 4 (4.7%) 2 (2.4%) 2 (2.4%) Total number of events related to study drug 4 2 4 MYOCARDIAL INFARCTION 4 (4.7%) 2 (2.4%) 2 (2.4%) - HLT_0188 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 1 (1.2%) 1 (1.2%) - Total number of events related to study drug 2 1 2 - SUPRAVENTRICULAR EXTRASYSTOLES 1 (1.2%) 1 (1.2%) 1 (1.2%) - HLT_0365 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 2 (2.4%) 0 - Total number of events related to study drug 1 3 0 - ATRIAL FIBRILLATION 1 (1.2%) 2 (2.4%) 0 - HLT_0050 - Total number of patients with at least one adverse event related to study drug 0 0 2 (2.4%) - Total number of events related to study drug 0 0 4 - VENTRICULAR EXTRASYSTOLES 0 0 2 (2.4%) - HLT_0493 - Total number of patients with at least one adverse event related to study drug 0 0 2 (2.4%) - Total number of events related to study drug 0 0 2 - PALPITATIONS 0 0 2 (2.4%) - HLT_0751 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 1 (1.2%) - Total number of events related to study drug 2 0 1 - BUNDLE BRANCH BLOCK RIGHT 1 (1.2%) 0 1 (1.2%) - HLT_0082 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 0 - Total number of events related to study drug 2 0 0 - TACHYCARDIA 1 (1.2%) 0 0 - HLT_0094 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 0 - Total number of events related to study drug 2 0 0 - SINUS ARRHYTHMIA 1 (1.2%) 0 0 - HLT_0104 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 0 - Total number of events related to study drug 1 0 0 - VENTRICULAR HYPERTROPHY 1 (1.2%) 0 0 - HLT_0271 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 0 - Total number of events related to study drug 2 0 0 - ATRIAL HYPERTROPHY 1 (1.2%) 0 0 - HLT_0415 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 0 - Total number of events related to study drug 1 0 0 - ATRIOVENTRICULAR BLOCK SECOND DEGREE 1 (1.2%) 0 0 - HLT_0419 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 0 - Total number of events related to study drug 1 0 0 - ATRIOVENTRICULAR BLOCK FIRST DEGREE 1 (1.2%) 0 0 - HLT_0477 - Total number of patients with at least one adverse event related to study drug 0 0 1 (1.2%) - Total number of events related to study drug 0 0 1 - ATRIAL FLUTTER 0 0 1 (1.2%) - HLT_0511 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 0 - Total number of events related to study drug 1 0 0 - CARDIAC FAILURE CONGESTIVE 1 (1.2%) 0 0 - HLT_0612 - Total number of patients with at least one adverse event related to study drug 0 0 1 (1.2%) - Total number of events related to study drug 0 0 2 - WOLFF-PARKINSON-WHITE SYNDROME 0 0 1 (1.2%) - HLT_0640 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 0 - Total number of events related to study drug 4 0 0 - BRADYCARDIA 1 (1.2%) 0 0 - PSYCHIATRIC DISORDERS - Total number of patients with at least one adverse event related to study drug 8 (9.3%) 6 (7.1%) 9 (10.7%) - Total number of events related to study drug 11 8 13 - HLT_0642 - Total number of patients with at least one adverse event related to study drug 2 (2.3%) 1 (1.2%) 2 (2.4%) - Total number of events related to study drug 2 1 2 - CONFUSIONAL STATE 2 (2.3%) 1 (1.2%) 2 (2.4%) - HLT_0140 - Total number of patients with at least one adverse event related to study drug 2 (2.3%) 0 2 (2.4%) - Total number of events related to study drug 2 0 2 - AGITATION 2 (2.3%) 0 2 (2.4%) - HLT_0559 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 3 (3.6%) - Total number of events related to study drug 2 0 4 - ANXIETY 1 (1.2%) 0 3 (3.6%) - HLT_0297 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 2 (2.4%) 0 - Total number of events related to study drug 1 2 0 - INSOMNIA 1 (1.2%) 2 (2.4%) 0 - HLT_0627 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 1 (1.2%) - Total number of events related to study drug 2 0 1 - IRRITABILITY 1 (1.2%) 0 1 (1.2%) - HLT_0186 - Total number of patients with at least one adverse event related to study drug 0 1 (1.2%) 0 - Total number of events related to study drug 0 1 0 - NIGHTMARE 0 1 (1.2%) 0 - HLT_0198 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 0 - Total number of events related to study drug 1 0 0 - DELUSION 1 (1.2%) 0 0 - HLT_0299 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 0 - Total number of events related to study drug 1 0 0 - DISORIENTATION 1 (1.2%) 0 0 - HLT_0338 - Total number of patients with at least one adverse event related to study drug 0 1 (1.2%) 0 - Total number of events related to study drug 0 1 0 - LIBIDO DECREASED 0 1 (1.2%) 0 - HLT_0369 - Total number of patients with at least one adverse event related to study drug 0 1 (1.2%) 0 - Total number of events related to study drug 0 1 0 - HALLUCINATION, VISUAL 0 1 (1.2%) 0 - HLT_0376 - Total number of patients with at least one adverse event related to study drug 0 1 (1.2%) 0 - Total number of events related to study drug 0 1 0 - DELIRIUM 0 1 (1.2%) 0 - HLT_0427 - Total number of patients with at least one adverse event related to study drug 0 0 1 (1.2%) - Total number of events related to study drug 0 0 2 - RESTLESSNESS 0 0 1 (1.2%) - HLT_0657 - Total number of patients with at least one adverse event related to study drug 0 1 (1.2%) 0 - Total number of events related to study drug 0 1 0 - LISTLESS 0 1 (1.2%) 0 - HLT_0784 - Total number of patients with at least one adverse event related to study drug 0 0 1 (1.2%) - Total number of events related to study drug 0 0 2 - DEPRESSED MOOD 0 0 1 (1.2%) - INVESTIGATIONS - Total number of patients with at least one adverse event related to study drug 8 (9.3%) 1 (1.2%) 3 (3.6%) - Total number of events related to study drug 16 1 4 - HLT_0610 - Total number of patients with at least one adverse event related to study drug 4 (4.7%) 0 1 (1.2%) - Total number of events related to study drug 4 0 2 - ELECTROCARDIOGRAM ST SEGMENT DEPRESSION 4 (4.7%) 0 1 (1.2%) - HLT_0289 - Total number of patients with at least one adverse event related to study drug 2 (2.3%) 1 (1.2%) 0 - Total number of events related to study drug 3 1 0 - ELECTROCARDIOGRAM T WAVE INVERSION 2 (2.3%) 1 (1.2%) 0 - HLT_0037 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 1 (1.2%) - Total number of events related to study drug 1 0 1 - ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED 1 (1.2%) 0 1 (1.2%) - HLT_0404 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 0 - Total number of events related to study drug 2 0 0 - BLOOD CREATINE PHOSPHOKINASE INCREASED 1 (1.2%) 0 0 - HLT_0646 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 0 - Total number of events related to study drug 2 0 0 - HEART RATE INCREASED 1 (1.2%) 0 0 - HLT_0734 - Total number of patients with at least one adverse event related to study drug 0 0 1 (1.2%) - Total number of events related to study drug 0 0 1 - BODY TEMPERATURE INCREASED 0 0 1 (1.2%) - HLT_0765 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 0 - Total number of events related to study drug 4 0 0 - HEART RATE IRREGULAR 1 (1.2%) 0 0 - RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - Total number of patients with at least one adverse event related to study drug 5 (5.8%) 2 (2.4%) 3 (3.6%) - Total number of events related to study drug 5 2 6 - HLT_0118 - Total number of patients with at least one adverse event related to study drug 2 (2.3%) 1 (1.2%) 0 - Total number of events related to study drug 2 1 0 - NASAL CONGESTION 2 (2.3%) 1 (1.2%) 0 - HLT_0386 - Total number of patients with at least one adverse event related to study drug 0 1 (1.2%) 1 (1.2%) - Total number of events related to study drug 0 1 1 - EPISTAXIS 0 1 (1.2%) 1 (1.2%) - HLT_0701 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 1 (1.2%) - Total number of events related to study drug 1 0 2 - COUGH 1 (1.2%) 0 1 (1.2%) - HLT_0073 - Total number of patients with at least one adverse event related to study drug 0 0 1 (1.2%) - Total number of events related to study drug 0 0 1 - DYSPHONIA 0 0 1 (1.2%) - HLT_0296 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 0 - Total number of events related to study drug 1 0 0 - DYSPNOEA 1 (1.2%) 0 0 - HLT_0635 - Total number of patients with at least one adverse event related to study drug 0 0 1 (1.2%) - Total number of events related to study drug 0 0 2 - RHINORRHOEA 0 0 1 (1.2%) - HLT_0698 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 0 - Total number of events related to study drug 1 0 0 - EMPHYSEMA 1 (1.2%) 0 0 - METABOLISM AND NUTRITION DISORDERS - Total number of patients with at least one adverse event related to study drug 4 (4.7%) 2 (2.4%) 0 - Total number of events related to study drug 6 4 0 - HLT_0566 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 1 (1.2%) 0 - Total number of events related to study drug 2 2 0 - INCREASED APPETITE 1 (1.2%) 1 (1.2%) 0 - HLT_0574 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 1 (1.2%) 0 - Total number of events related to study drug 2 2 0 - DECREASED APPETITE 1 (1.2%) 1 (1.2%) 0 - HLT_0688 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 0 - Total number of events related to study drug 1 0 0 - HYPONATRAEMIA 1 (1.2%) 0 0 - HLT_0754 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 0 - Total number of events related to study drug 1 0 0 - FOOD CRAVING 1 (1.2%) 0 0 + NERVOUS SYSTEM DISORDERS + Total number of patients with at least one adverse event related to study drug 3 (3.5%) 3 (3.6%) 2 (2.4%) + Total number of events related to study drug 4 6 2 + HLT_0064 + Total number of patients with at least one adverse event related to study drug 3 (3.5%) 3 (3.6%) 2 (2.4%) + Total number of events related to study drug 4 6 2 + HEADACHE 3 (3.5%) 3 (3.6%) 2 (2.4%) VASCULAR DISORDERS - Total number of patients with at least one adverse event related to study drug 3 (3.5%) 1 (1.2%) 2 (2.4%) - Total number of events related to study drug 7 1 2 - HLT_0761 - Total number of patients with at least one adverse event related to study drug 2 (2.3%) 0 1 (1.2%) - Total number of events related to study drug 3 0 1 - HYPOTENSION 2 (2.3%) 0 1 (1.2%) - HLT_0228 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 1 (1.2%) - Total number of events related to study drug 2 0 1 - HYPERTENSION 1 (1.2%) 0 1 (1.2%) + Total number of patients with at least one adverse event related to study drug 0 1 (1.2%) 0 + Total number of events related to study drug 0 1 0 HLT_0154 Total number of patients with at least one adverse event related to study drug 0 1 (1.2%) 0 Total number of events related to study drug 0 1 0 WOUND HAEMORRHAGE 0 1 (1.2%) 0 - HLT_0194 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 0 - Total number of events related to study drug 2 0 0 - ORTHOSTATIC HYPOTENSION 1 (1.2%) 0 0 - EYE DISORDERS - Total number of patients with at least one adverse event related to study drug 2 (2.3%) 1 (1.2%) 2 (2.4%) - Total number of events related to study drug 3 2 2 - HLT_0120 - Total number of patients with at least one adverse event related to study drug 0 1 (1.2%) 1 (1.2%) - Total number of events related to study drug 0 2 1 - VISION BLURRED 0 1 (1.2%) 1 (1.2%) - HLT_0013 - Total number of patients with at least one adverse event related to study drug 0 0 1 (1.2%) - Total number of events related to study drug 0 0 1 - CONJUNCTIVAL HAEMORRHAGE 0 0 1 (1.2%) - HLT_0523 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 0 - Total number of events related to study drug 1 0 0 - EYE PRURITUS 1 (1.2%) 0 0 - HLT_0584 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 0 - Total number of events related to study drug 2 0 0 - CONJUNCTIVITIS 1 (1.2%) 0 0 - INFECTIONS AND INFESTATIONS - Total number of patients with at least one adverse event related to study drug 4 (4.7%) 1 (1.2%) 0 - Total number of events related to study drug 12 1 0 - HLT_0520 - Total number of patients with at least one adverse event related to study drug 3 (3.5%) 0 0 - Total number of events related to study drug 5 0 0 - UPPER RESPIRATORY TRACT INFECTION 3 (3.5%) 0 0 - HLT_0161 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 0 - Total number of events related to study drug 2 0 0 - URINARY TRACT INFECTION 1 (1.2%) 0 0 - HLT_0211 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 0 - Total number of events related to study drug 1 0 0 - GASTROENTERITIS VIRAL 1 (1.2%) 0 0 - HLT_0508 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 0 - Total number of events related to study drug 2 0 0 - VAGINAL MYCOSIS 1 (1.2%) 0 0 - HLT_0651 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 0 - Total number of events related to study drug 2 0 0 - CERVICITIS 1 (1.2%) 0 0 - HLT_0739 - Total number of patients with at least one adverse event related to study drug 0 1 (1.2%) 0 - Total number of events related to study drug 0 1 0 - CYSTITIS 0 1 (1.2%) 0 - INJURY, POISONING AND PROCEDURAL COMPLICATIONS - Total number of patients with at least one adverse event related to study drug 0 2 (2.4%) 3 (3.6%) - Total number of events related to study drug 0 3 8 - HLT_0168 - Total number of patients with at least one adverse event related to study drug 0 0 2 (2.4%) - Total number of events related to study drug 0 0 2 - FALL 0 0 2 (2.4%) - HLT_0713 - Total number of patients with at least one adverse event related to study drug 0 1 (1.2%) 1 (1.2%) - Total number of events related to study drug 0 2 3 - CONTUSION 0 1 (1.2%) 1 (1.2%) - HLT_0075 - Total number of patients with at least one adverse event related to study drug 0 0 1 (1.2%) - Total number of events related to study drug 0 0 1 - SKIN LACERATION 0 0 1 (1.2%) - HLT_0542 - Total number of patients with at least one adverse event related to study drug 0 0 1 (1.2%) - Total number of events related to study drug 0 0 2 - WOUND 0 0 1 (1.2%) - HLT_0738 - Total number of patients with at least one adverse event related to study drug 0 1 (1.2%) 0 - Total number of events related to study drug 0 1 0 - EXCORIATION 0 1 (1.2%) 0 - MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS - Total number of patients with at least one adverse event related to study drug 2 (2.3%) 3 (3.6%) 0 - Total number of events related to study drug 3 4 0 - HLT_0078 - Total number of patients with at least one adverse event related to study drug 0 1 (1.2%) 0 - Total number of events related to study drug 0 2 0 - MUSCLE SPASMS 0 1 (1.2%) 0 - HLT_0115 - Total number of patients with at least one adverse event related to study drug 0 1 (1.2%) 0 - Total number of events related to study drug 0 1 0 - BACK PAIN 0 1 (1.2%) 0 - HLT_0213 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 0 - Total number of events related to study drug 1 0 0 - PAIN IN EXTREMITY 1 (1.2%) 0 0 - HLT_0527 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 0 - Total number of events related to study drug 2 0 0 - SHOULDER PAIN 1 (1.2%) 0 0 - HLT_0700 - Total number of patients with at least one adverse event related to study drug 0 1 (1.2%) 0 - Total number of events related to study drug 0 1 0 - MYALGIA 0 1 (1.2%) 0 - RENAL AND URINARY DISORDERS - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 1 (1.2%) 2 (2.4%) - Total number of events related to study drug 1 2 2 - HLT_0637 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 1 (1.2%) - Total number of events related to study drug 1 0 1 - DYSURIA 1 (1.2%) 0 1 (1.2%) - HLT_0107 - Total number of patients with at least one adverse event related to study drug 0 0 1 (1.2%) - Total number of events related to study drug 0 0 1 - ENURESIS 0 0 1 (1.2%) - HLT_0294 - Total number of patients with at least one adverse event related to study drug 0 1 (1.2%) 0 - Total number of events related to study drug 0 2 0 - MICTURITION URGENCY 0 1 (1.2%) 0 - EAR AND LABYRINTH DISORDERS - Total number of patients with at least one adverse event related to study drug 0 1 (1.2%) 2 (2.4%) - Total number of events related to study drug 0 1 2 - HLT_0255 - Total number of patients with at least one adverse event related to study drug 0 1 (1.2%) 1 (1.2%) - Total number of events related to study drug 0 1 1 - VERTIGO 0 1 (1.2%) 1 (1.2%) - HLT_0570 - Total number of patients with at least one adverse event related to study drug 0 0 1 (1.2%) - Total number of events related to study drug 0 0 1 - TINNITUS 0 0 1 (1.2%) - CONGENITAL, FAMILIAL AND GENETIC DISORDERS - Total number of patients with at least one adverse event related to study drug 0 0 1 (1.2%) - Total number of events related to study drug 0 0 1 - HLT_0589 - Total number of patients with at least one adverse event related to study drug 0 0 1 (1.2%) - Total number of events related to study drug 0 0 1 - VENTRICULAR SEPTAL DEFECT 0 0 1 (1.2%) - HEPATOBILIARY DISORDERS - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 0 - Total number of events related to study drug 1 0 0 - HLT_0478 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 0 - Total number of events related to study drug 1 0 0 - HYPERBILIRUBINAEMIA 1 (1.2%) 0 0 - REPRODUCTIVE SYSTEM AND BREAST DISORDERS - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 0 - Total number of events related to study drug 2 0 0 - HLT_0189 - Total number of patients with at least one adverse event related to study drug 1 (1.2%) 0 0 - Total number of events related to study drug 2 0 0 - PELVIC PAIN 1 (1.2%) 0 0 diff --git a/tests/testthat/_snaps/table_lbt04.md b/tests/testthat/_snaps/table_lbt04.md index a59670c..700eeb3 100644 --- a/tests/testthat/_snaps/table_lbt04.md +++ b/tests/testthat/_snaps/table_lbt04.md @@ -3,121 +3,49 @@ Code res Output - Laboratory Test Placebo Xanomeline High Dose Xanomeline Low Dose - Direction of Abnormality (N=86) (N=72) (N=96) - ————————————————————————————————————————————————————————————————————————————————————————————————————————————— - Alanine Aminotransferase (U/L) - Low 1/83 (1.2%) 0/72 5/75 (6.7%) - High 6/79 (7.6%) 7/68 (10.3%) 8/73 (11%) - Albumin (g/L) - Low 15/81 (18.5%) 5/72 (6.9%) 12/74 (16.2%) - High 4/83 (4.8%) 0/71 1/75 (1.3%) - Alkaline Phosphatase (U/L) - Low 1/79 (1.3%) 2/71 (2.8%) 1/74 (1.4%) - High 4/78 (5.1%) 4/71 (5.6%) 4/72 (5.6%) - Aspartate Aminotransferase (U/L) - Low 0/83 0/72 0/75 - High 8/77 (10.4%) 5/69 (7.2%) 6/67 (9%) - Basophils (10^9/L) - Low 0/81 0/72 0/75 - High 0/79 0/72 0/75 - Basophils/Leukocytes (FRACTION) - Low 0/3 0/2 0/0 - High 0/0 0/0 0/0 - Bilirubin (umol/L) - Low 0/83 0/72 0/74 - High 4/81 (4.9%) 2/69 (2.9%) 1/71 (1.4%) - Blood Urea Nitrogen (mmol/L) - Low 0/83 0/72 0/75 - High 9/80 (11.2%) 6/67 (9%) 11/65 (16.9%) - Calcium (mmol/L) - Low 10/82 (12.2%) 9/71 (12.7%) 8/73 (11%) - High 1/83 (1.2%) 2/72 (2.8%) 2/73 (2.7%) - Chloride (mmol/L) - Low 0/83 0/71 0/75 - High 11/82 (13.4%) 3/72 (4.2%) 5/74 (6.8%) - Cholesterol (mmol/L) - Low 4/81 (4.9%) 3/69 (4.3%) 4/73 (5.5%) - High 3/80 (3.8%) 3/70 (4.3%) 3/74 (4.1%) - Creatinine (umol/L) - Low 1/81 (1.2%) 2/71 (2.8%) 1/75 (1.3%) - High 8/82 (9.8%) 8/67 (11.9%) 4/70 (5.7%) - Creatinine Kinase (U/L) - Low 1/83 (1.2%) 0/72 0/75 - High 16/79 (20.3%) 8/65 (12.3%) 7/68 (10.3%) - Eosinophils (10^9/L) - Low 0/81 0/72 0/75 - High 2/81 (2.5%) 7/71 (9.9%) 14/74 (18.9%) - Eosinophils/Leukocytes (FRACTION) - Low 0/3 0/2 0/0 - High 1/1 (100%) 0/0 0/0 - Ery. Mean Corpuscular Hemoglobin (fmol(Fe)) - Low 0/83 0/71 0/75 - High 8/79 (10.1%) 1/65 (1.5%) 4/72 (5.6%) - Ery. Mean Corpuscular HGB Concentration (mmol/L) - Low 16/82 (19.5%) 9/69 (13%) 12/67 (17.9%) - High 0/82 0/72 0/75 - Ery. Mean Corpuscular Volume (f/L) - Low 1/82 (1.2%) 0/71 0/75 - High 24/77 (31.2%) 12/67 (17.9%) 14/66 (21.2%) - Erythrocytes (TI/L) - Low 7/77 (9.1%) 5/68 (7.4%) 11/71 (15.5%) - High 0/83 2/72 (2.8%) 0/75 - Gamma Glutamyl Transferase (U/L) - Low 3/81 (3.7%) 1/71 (1.4%) 3/74 (4.1%) - High 3/79 (3.8%) 5/69 (7.2%) 5/70 (7.1%) - Glucose (mmol/L) - Low 0/83 0/72 1/75 (1.3%) - High 1/82 (1.2%) 6/72 (8.3%) 1/75 (1.3%) - Hematocrit (1) - Low 2/79 (2.5%) 0/71 5/73 (6.8%) - High 5/82 (6.1%) 3/70 (4.3%) 0/73 - Hemoglobin (mmol/L) - Low 9/76 (11.8%) 3/71 (4.2%) 6/69 (8.7%) - High 2/83 (2.4%) 3/70 (4.3%) 0/74 - Hemoglobin A1C (1) - Low 0/1 0/0 0/1 - High 0/1 0/0 0/1 - Leukocytes (10^9/L) - Low 6/83 (7.2%) 0/70 4/73 (5.5%) - High 4/82 (4.9%) 4/72 (5.6%) 7/74 (9.5%) - Lymphocytes (10^9/L) - Low 4/79 (5.1%) 3/72 (4.2%) 4/74 (5.4%) - High 5/78 (6.4%) 2/71 (2.8%) 8/73 (11%) - Lymphocytes/Leukocytes (FRACTION) - Low 0/1 0/2 0/0 - High 1/3 (33.3%) 0/1 0/0 - Monocytes (10^9/L) - Low 2/81 (2.5%) 0/72 1/75 (1.3%) - High 4/81 (4.9%) 2/72 (2.8%) 4/74 (5.4%) - Monocytes/Leukocytes (FRACTION) - Low 0/3 0/2 0/0 - High 0/0 0/0 0/0 - pH - Low 0/82 0/71 0/71 - High 0/82 0/71 0/71 - Phosphate (mmol/L) - Low 1/83 (1.2%) 1/72 (1.4%) 0/75 - High 2/83 (2.4%) 2/72 (2.8%) 1/75 (1.3%) - Platelet (10^9/L) - Low 0/83 1/71 (1.4%) 0/73 - High 2/81 (2.5%) 1/72 (1.4%) 2/73 (2.7%) - Potassium (mmol/L) - Low 3/83 (3.6%) 2/72 (2.8%) 2/75 (2.7%) - High 0/82 2/72 (2.8%) 0/75 - Protein (g/L) - Low 1/83 (1.2%) 1/72 (1.4%) 0/74 - High 9/82 (11%) 1/71 (1.4%) 3/74 (4.1%) - Sodium (mmol/L) - Low 3/81 (3.7%) 4/70 (5.7%) 2/73 (2.7%) - High 10/80 (12.5%) 9/68 (13.2%) 6/75 (8%) - Specific Gravity - Low 3/81 (3.7%) 1/69 (1.4%) 0/69 - High 3/79 (3.8%) 1/68 (1.5%) 3/71 (4.2%) - Urate (umol/L) - Low 4/82 (4.9%) 4/72 (5.6%) 1/72 (1.4%) - High 2/81 (2.5%) 2/67 (3%) 1/71 (1.4%) - Vitamin B12 (pmol/L) - Low 0/0 0/0 0/1 - High 0/1 0/0 0/1 + Laboratory Test Placebo Xanomeline High Dose Xanomeline Low Dose + Direction of Abnormality (N=86) (N=72) (N=96) + ————————————————————————————————————————————————————————————————————————————————————————————— + Alanine Aminotransferase (U/L) + Low 1/83 (1.2%) 0/72 5/75 (6.7%) + High 6/79 (7.6%) 7/68 (10.3%) 8/73 (11%) + Albumin (g/L) + Low 15/81 (18.5%) 5/72 (6.9%) 12/74 (16.2%) + High 4/83 (4.8%) 0/71 1/75 (1.3%) + Alkaline Phosphatase (U/L) + Low 1/79 (1.3%) 2/71 (2.8%) 1/74 (1.4%) + High 4/78 (5.1%) 4/71 (5.6%) 4/72 (5.6%) + Aspartate Aminotransferase (U/L) + Low 0/83 0/72 0/75 + High 8/77 (10.4%) 5/69 (7.2%) 6/67 (9%) + Bilirubin (umol/L) + Low 0/83 0/72 0/74 + High 4/81 (4.9%) 2/69 (2.9%) 1/71 (1.4%) + Blood Urea Nitrogen (mmol/L) + Low 0/83 0/72 0/75 + High 9/80 (11.2%) 6/67 (9%) 11/65 (16.9%) + Calcium (mmol/L) + Low 10/82 (12.2%) 9/71 (12.7%) 8/73 (11%) + High 1/83 (1.2%) 2/72 (2.8%) 2/73 (2.7%) + Cholesterol (mmol/L) + Low 4/81 (4.9%) 3/69 (4.3%) 4/73 (5.5%) + High 3/80 (3.8%) 3/70 (4.3%) 3/74 (4.1%) + Creatinine (umol/L) + Low 1/81 (1.2%) 2/71 (2.8%) 1/75 (1.3%) + High 8/82 (9.8%) 8/67 (11.9%) 4/70 (5.7%) + Gamma Glutamyl Transferase (U/L) + Low 3/81 (3.7%) 1/71 (1.4%) 3/74 (4.1%) + High 3/79 (3.8%) 5/69 (7.2%) 5/70 (7.1%) + Phosphate (mmol/L) + Low 1/83 (1.2%) 1/72 (1.4%) 0/75 + High 2/83 (2.4%) 2/72 (2.8%) 1/75 (1.3%) + Protein (g/L) + Low 1/83 (1.2%) 1/72 (1.4%) 0/74 + High 9/82 (11%) 1/71 (1.4%) 3/74 (4.1%) + Sodium (mmol/L) + Low 3/81 (3.7%) 4/70 (5.7%) 2/73 (2.7%) + High 10/80 (12.5%) 9/68 (13.2%) 6/75 (8%) + Urate (umol/L) + Low 4/82 (4.9%) 4/72 (5.6%) 1/72 (1.4%) + High 2/81 (2.5%) 2/67 (3%) 1/71 (1.4%) diff --git a/tests/testthat/_snaps/table_lbt05.md b/tests/testthat/_snaps/table_lbt05.md index aff5699..bb30318 100644 --- a/tests/testthat/_snaps/table_lbt05.md +++ b/tests/testthat/_snaps/table_lbt05.md @@ -3,924 +3,332 @@ Code res Output - Laboratory Test Placebo Xanomeline High Dose Xanomeline Low Dose - Direction of Abnormality (N=86) (N=72) (N=96) - —————————————————————————————————————————————————————————————————————————————————————————————————————————————— - Alanine Aminotransferase (U/L) (n) 78 70 68 - Low - Last or replicated 1 (1.3%) 0 5 (7.4%) - Any Abnormality 1 (1.3%) 0 5 (7.4%) - High - Last or replicated 9 (11.5%) 11 (15.7%) 10 (14.7%) - Any Abnormality 9 (11.5%) 11 (15.7%) 10 (14.7%) - Albumin (g/L) (n) 81 67 71 - Low - Last or replicated 17 (21%) 5 (7.5%) 13 (18.3%) - Any Abnormality 17 (21%) 5 (7.5%) 13 (18.3%) - High - Last or replicated 4 (4.9%) 1 (1.5%) 1 (1.4%) - Any Abnormality 4 (4.9%) 1 (1.5%) 1 (1.4%) - Alkaline Phosphatase (U/L) (n) 83 70 70 - Low - Last or replicated 4 (4.8%) 3 (4.3%) 2 (2.9%) - Any Abnormality 4 (4.8%) 3 (4.3%) 2 (2.9%) - High - Last or replicated 8 (9.6%) 5 (7.1%) 7 (10%) - Any Abnormality 8 (9.6%) 5 (7.1%) 7 (10%) - Anisocytes (n) 22 12 21 - Low - Any Abnormality 0 0 0 - High - Any Abnormality 0 0 0 - Aspartate Aminotransferase (U/L) (n) 81 68 71 - Low - Any Abnormality 0 0 0 - High - Last or replicated 12 (14.8%) 7 (10.3%) 10 (14.1%) - Any Abnormality 12 (14.8%) 7 (10.3%) 10 (14.1%) - Basophils (10^9/L) (n) 81 70 72 - Low - Any Abnormality 0 0 0 - High - Any Abnormality 0 0 0 - Basophils Abs (10^9/L) (n) 2 1 0 - Low - Any Abnormality 0 0 0 - High - Any Abnormality 0 0 0 - Basophils/Leukocytes (FRACTION) (n) 3 2 0 - Low - Any Abnormality 0 0 0 - High - Any Abnormality 0 0 0 - Blood Urea Nitrogen (mmol/L) (n) 81 71 73 - Low - Any Abnormality 0 0 0 - High - Last or replicated 11 (13.6%) 10 (14.1%) 20 (27.4%) - Any Abnormality 11 (13.6%) 10 (14.1%) 20 (27.4%) - Calcium (mmol/L) (n) 82 70 72 - Low - Last or replicated 10 (12.2%) 10 (14.3%) 8 (11.1%) - Any Abnormality 10 (12.2%) 10 (14.3%) 8 (11.1%) - High - Last or replicated 1 (1.2%) 2 (2.9%) 3 (4.2%) - Any Abnormality 1 (1.2%) 2 (2.9%) 3 (4.2%) - Chloride (mmol/L) (n) 78 67 70 - Low - Any Abnormality 0 0 0 - High - Last or replicated 11 (14.1%) 3 (4.5%) 5 (7.1%) - Any Abnormality 11 (14.1%) 3 (4.5%) 5 (7.1%) - Cholesterol (mmol/L) (n) 82 71 74 - Low - Last or replicated 5 (6.1%) 5 (7%) 5 (6.8%) - Any Abnormality 5 (6.1%) 5 (7%) 5 (6.8%) - High - Single, not last 0 1 (1.4%) 0 - Last or replicated 5 (6.1%) 3 (4.2%) 4 (5.4%) - Any Abnormality 5 (6.1%) 4 (5.6%) 4 (5.4%) - Creatinine (umol/L) (n) 82 68 74 - Low - Last or replicated 1 (1.2%) 3 (4.4%) 1 (1.4%) - Any Abnormality 1 (1.2%) 3 (4.4%) 1 (1.4%) - High - Last or replicated 9 (11%) 13 (19.1%) 9 (12.2%) - Any Abnormality 9 (11%) 13 (19.1%) 9 (12.2%) - Creatinine Kinase (U/L) (n) 82 70 70 - Low - Last or replicated 1 (1.2%) 0 0 - Any Abnormality 1 (1.2%) 0 0 - High - Last or replicated 18 (22%) 13 (18.6%) 11 (15.7%) - Any Abnormality 18 (22%) 13 (18.6%) 11 (15.7%) - Eosinophils (10^9/L) (n) 77 68 72 - Low - Any Abnormality 0 0 0 - High - Last or replicated 2 (2.6%) 8 (11.8%) 15 (20.8%) - Any Abnormality 2 (2.6%) 8 (11.8%) 15 (20.8%) - Eosinophils/Leukocytes (FRACTION) (n) 2 2 0 - Low - Any Abnormality 0 0 0 - High - Last or replicated 1 (50%) 0 0 - Any Abnormality 1 (50%) 0 0 - Ery. Mean Corpuscular Hemoglobin (fmol(Fe)) (n) 82 66 70 - Low - Last or replicated 0 1 (1.5%) 0 - Any Abnormality 0 1 (1.5%) 0 - High - Last or replicated 10 (12.2%) 7 (10.6%) 6 (8.6%) - Any Abnormality 10 (12.2%) 7 (10.6%) 6 (8.6%) - Ery. Mean Corpuscular HGB Concentration (mmol/L) (n) 80 70 69 - Low - Single, not last 0 0 1 (1.4%) - Last or replicated 16 (20%) 9 (12.9%) 15 (21.7%) - Any Abnormality 16 (20%) 9 (12.9%) 16 (23.2%) - High - Any Abnormality 0 0 0 - Ery. Mean Corpuscular Volume (f/L) (n) 81 70 68 - Low - Last or replicated 1 (1.2%) 1 (1.4%) 0 - Any Abnormality 1 (1.2%) 1 (1.4%) 0 - High - Last or replicated 28 (34.6%) 17 (24.3%) 19 (27.9%) - Any Abnormality 28 (34.6%) 17 (24.3%) 19 (27.9%) - Erythrocytes (TI/L) (n) 82 68 70 - Low - Last or replicated 13 (15.9%) 9 (13.2%) 15 (21.4%) - Any Abnormality 13 (15.9%) 9 (13.2%) 15 (21.4%) - High - Last or replicated 0 2 (2.9%) 0 - Any Abnormality 0 2 (2.9%) 0 - Gamma Glutamyl Transferase (U/L) (n) 80 68 69 - Low - Last or replicated 4 (5%) 1 (1.5%) 4 (5.8%) - Any Abnormality 4 (5%) 1 (1.5%) 4 (5.8%) - High - Last or replicated 7 (8.8%) 8 (11.8%) 9 (13%) - Any Abnormality 7 (8.8%) 8 (11.8%) 9 (13%) - Hematocrit (1) (n) 78 69 72 - Low - Single, not last 1 (1.3%) 0 0 - Last or replicated 4 (5.1%) 1 (1.4%) 7 (9.7%) - Any Abnormality 5 (6.4%) 1 (1.4%) 7 (9.7%) - High - Last or replicated 5 (6.4%) 3 (4.3%) 1 (1.4%) - Any Abnormality 5 (6.4%) 3 (4.3%) 1 (1.4%) - Hemoglobin (mmol/L) (n) 81 66 71 - Low - Last or replicated 12 (14.8%) 2 (3%) 9 (12.7%) - Any Abnormality 12 (14.8%) 2 (3%) 9 (12.7%) - High - Last or replicated 2 (2.5%) 3 (4.5%) 0 - Any Abnormality 2 (2.5%) 3 (4.5%) 0 - Hemoglobin A1C (1) (n) 1 0 1 - Low - Any Abnormality 0 0 0 - High - Any Abnormality 0 0 0 - Ketones (n) 71 63 58 - Low - Any Abnormality 0 0 0 - High - Any Abnormality 0 0 0 - Leukocytes (10^9/L) (n) 81 72 74 - Low - Last or replicated 6 (7.4%) 2 (2.8%) 5 (6.8%) - Any Abnormality 6 (7.4%) 2 (2.8%) 5 (6.8%) - High - Last or replicated 5 (6.2%) 4 (5.6%) 8 (10.8%) - Any Abnormality 5 (6.2%) 4 (5.6%) 8 (10.8%) - Lymphocytes (10^9/L) (n) 80 70 74 - Low - Last or replicated 5 (6.2%) 3 (4.3%) 4 (5.4%) - Any Abnormality 5 (6.2%) 3 (4.3%) 4 (5.4%) - High - Last or replicated 8 (10%) 2 (2.9%) 10 (13.5%) - Any Abnormality 8 (10%) 2 (2.9%) 10 (13.5%) - Lymphocytes Abs (10^9/L) (n) 3 1 0 - Low - Any Abnormality 0 0 0 - High - Any Abnormality 0 0 0 - Lymphocytes/Leukocytes (FRACTION) (n) 3 2 0 - Low - Any Abnormality 0 0 0 - High - Last or replicated 1 (33.3%) 0 0 - Any Abnormality 1 (33.3%) 0 0 - Macrocytes (n) 17 11 10 - Low - Any Abnormality 0 0 0 - High - Any Abnormality 0 0 0 - Microcytes (n) 0 1 0 - Low - Any Abnormality 0 0 0 - High - Any Abnormality 0 0 0 - Monocytes (10^9/L) (n) 79 66 69 - Low - Last or replicated 2 (2.5%) 0 1 (1.4%) - Any Abnormality 2 (2.5%) 0 1 (1.4%) - High - Last or replicated 4 (5.1%) 2 (3%) 4 (5.8%) - Any Abnormality 4 (5.1%) 2 (3%) 4 (5.8%) - Monocytes/Leukocytes (FRACTION) (n) 3 1 0 - Low - Any Abnormality 0 0 0 - High - Last or replicated 1 (33.3%) 0 0 - Any Abnormality 1 (33.3%) 0 0 - pH (n) 68 61 57 - Low - Any Abnormality 0 0 0 - High - Any Abnormality 0 0 0 - Phosphate (mmol/L) (n) 78 66 73 - Low - Last or replicated 1 (1.3%) 1 (1.5%) 0 - Any Abnormality 1 (1.3%) 1 (1.5%) 0 - High - Last or replicated 2 (2.6%) 2 (3%) 1 (1.4%) - Any Abnormality 2 (2.6%) 2 (3%) 1 (1.4%) - Platelet (10^9/L) (n) 82 67 69 - Low - Last or replicated 0 2 (3%) 1 (1.4%) - Any Abnormality 0 2 (3%) 1 (1.4%) - High - Last or replicated 4 (4.9%) 1 (1.5%) 2 (2.9%) - Any Abnormality 4 (4.9%) 1 (1.5%) 2 (2.9%) - Poikilocytes (n) 0 0 0 - Low - Any Abnormality 0 0 0 - High - Any Abnormality 0 0 0 - Polychromasia (n) 8 4 4 - Low - Any Abnormality 0 0 0 - High - Any Abnormality 0 0 0 - Potassium (mmol/L) (n) 80 70 72 - Low - Last or replicated 3 (3.8%) 2 (2.9%) 2 (2.8%) - Any Abnormality 3 (3.8%) 2 (2.9%) 2 (2.8%) - High - Last or replicated 1 (1.2%) 2 (2.9%) 0 - Any Abnormality 1 (1.2%) 2 (2.9%) 0 - Protein (g/L) (n) 80 66 70 - Low - Last or replicated 1 (1.2%) 1 (1.5%) 1 (1.4%) - Any Abnormality 1 (1.2%) 1 (1.5%) 1 (1.4%) - High - Last or replicated 10 (12.5%) 2 (3%) 4 (5.7%) - Any Abnormality 10 (12.5%) 2 (3%) 4 (5.7%) - Sodium (mmol/L) (n) 83 64 74 - Low - Last or replicated 4 (4.8%) 5 (7.8%) 3 (4.1%) - Any Abnormality 4 (4.8%) 5 (7.8%) 3 (4.1%) - High - Last or replicated 10 (12%) 11 (17.2%) 6 (8.1%) - Any Abnormality 10 (12%) 11 (17.2%) 6 (8.1%) - Specific Gravity (n) 73 61 60 - Low - Last or replicated 3 (4.1%) 3 (4.9%) 1 (1.7%) - Any Abnormality 3 (4.1%) 3 (4.9%) 1 (1.7%) - High - Last or replicated 4 (5.5%) 1 (1.6%) 3 (5%) - Any Abnormality 4 (5.5%) 1 (1.6%) 3 (5%) - Thyrotropin (mU/L) (n) 0 0 0 - Low - Any Abnormality 0 0 0 - High - Any Abnormality 0 0 0 - Urate (umol/L) (n) 83 66 68 - Low - Last or replicated 5 (6%) 4 (6.1%) 3 (4.4%) - Any Abnormality 5 (6%) 4 (6.1%) 3 (4.4%) - High - Single, not last 1 (1.2%) 0 0 - Last or replicated 3 (3.6%) 7 (10.6%) 4 (5.9%) - Any Abnormality 4 (4.8%) 7 (10.6%) 4 (5.9%) - Urobilinogen (n) 73 61 59 - Low - Any Abnormality 0 0 0 - High - Any Abnormality 0 0 0 - Vitamin B12 (pmol/L) (n) 0 0 0 - Low - Any Abnormality 0 0 0 - High - Any Abnormality 0 0 0 + Laboratory Test Placebo Xanomeline High Dose Xanomeline Low Dose + Direction of Abnormality (N=86) (N=72) (N=96) + —————————————————————————————————————————————————————————————————————————————————————————————— + Alanine Aminotransferase (U/L) (n) 80 68 69 + Low + Last or replicated 1 (1.2%) 0 5 (7.2%) + Any Abnormality 1 (1.2%) 0 5 (7.2%) + High + Last or replicated 9 (11.2%) 11 (16.2%) 10 (14.5%) + Any Abnormality 9 (11.2%) 11 (16.2%) 10 (14.5%) + Albumin (g/L) (n) 80 68 71 + Low + Last or replicated 17 (21.2%) 5 (7.4%) 13 (18.3%) + Any Abnormality 17 (21.2%) 5 (7.4%) 13 (18.3%) + High + Last or replicated 4 (5%) 1 (1.5%) 1 (1.4%) + Any Abnormality 4 (5%) 1 (1.5%) 1 (1.4%) + Alkaline Phosphatase (U/L) (n) 80 70 69 + Low + Last or replicated 4 (5%) 3 (4.3%) 2 (2.9%) + Any Abnormality 4 (5%) 3 (4.3%) 2 (2.9%) + High + Last or replicated 8 (10%) 5 (7.1%) 7 (10.1%) + Any Abnormality 8 (10%) 5 (7.1%) 7 (10.1%) + Aspartate Aminotransferase (U/L) (n) 82 69 72 + Low + Any Abnormality 0 0 0 + High + Last or replicated 12 (14.6%) 7 (10.1%) 10 (13.9%) + Any Abnormality 12 (14.6%) 7 (10.1%) 10 (13.9%) + Blood Urea Nitrogen (mmol/L) (n) 80 68 73 + Low + Any Abnormality 0 0 0 + High + Last or replicated 11 (13.8%) 10 (14.7%) 20 (27.4%) + Any Abnormality 11 (13.8%) 10 (14.7%) 20 (27.4%) + Calcium (mmol/L) (n) 79 69 73 + Low + Last or replicated 10 (12.7%) 10 (14.5%) 8 (11%) + Any Abnormality 10 (12.7%) 10 (14.5%) 8 (11%) + High + Single, not last 1 (1.3%) 0 0 + Last or replicated 0 2 (2.9%) 3 (4.1%) + Any Abnormality 1 (1.3%) 2 (2.9%) 3 (4.1%) + Cholesterol (mmol/L) (n) 79 69 72 + Low + Last or replicated 5 (6.3%) 5 (7.2%) 5 (6.9%) + Any Abnormality 5 (6.3%) 5 (7.2%) 5 (6.9%) + High + Last or replicated 5 (6.3%) 4 (5.8%) 4 (5.6%) + Any Abnormality 5 (6.3%) 4 (5.8%) 4 (5.6%) + Creatinine (umol/L) (n) 78 69 70 + Low + Last or replicated 1 (1.3%) 3 (4.3%) 1 (1.4%) + Any Abnormality 1 (1.3%) 3 (4.3%) 1 (1.4%) + High + Last or replicated 9 (11.5%) 13 (18.8%) 9 (12.9%) + Any Abnormality 9 (11.5%) 13 (18.8%) 9 (12.9%) + Gamma Glutamyl Transferase (U/L) (n) 82 71 73 + Low + Last or replicated 4 (4.9%) 1 (1.4%) 4 (5.5%) + Any Abnormality 4 (4.9%) 1 (1.4%) 4 (5.5%) + High + Last or replicated 7 (8.5%) 8 (11.3%) 9 (12.3%) + Any Abnormality 7 (8.5%) 8 (11.3%) 9 (12.3%) + Microcytes (n) 0 0 0 + Low + Any Abnormality 0 0 0 + High + Any Abnormality 0 0 0 + Phosphate (mmol/L) (n) 82 63 72 + Low + Last or replicated 1 (1.2%) 1 (1.6%) 0 + Any Abnormality 1 (1.2%) 1 (1.6%) 0 + High + Last or replicated 2 (2.4%) 2 (3.2%) 1 (1.4%) + Any Abnormality 2 (2.4%) 2 (3.2%) 1 (1.4%) + Protein (g/L) (n) 78 71 73 + Low + Last or replicated 1 (1.3%) 1 (1.4%) 1 (1.4%) + Any Abnormality 1 (1.3%) 1 (1.4%) 1 (1.4%) + High + Last or replicated 10 (12.8%) 2 (2.8%) 4 (5.5%) + Any Abnormality 10 (12.8%) 2 (2.8%) 4 (5.5%) + Sodium (mmol/L) (n) 82 66 73 + Low + Last or replicated 4 (4.9%) 5 (7.6%) 3 (4.1%) + Any Abnormality 4 (4.9%) 5 (7.6%) 3 (4.1%) + High + Last or replicated 10 (12.2%) 11 (16.7%) 6 (8.2%) + Any Abnormality 10 (12.2%) 11 (16.7%) 6 (8.2%) + Urate (umol/L) (n) 80 71 72 + Low + Last or replicated 5 (6.2%) 4 (5.6%) 3 (4.2%) + Any Abnormality 5 (6.2%) 4 (5.6%) 3 (4.2%) + High + Last or replicated 4 (5%) 7 (9.9%) 4 (5.6%) + Any Abnormality 4 (5%) 7 (9.9%) 4 (5.6%) # LBT05 variant 2 is produced correctly Code res Output - Laboratory Test Placebo Xanomeline High Dose Xanomeline Low Dose - Direction of Abnormality (N=86) (N=72) (N=96) - —————————————————————————————————————————————————————————————————————————————————————————————————————————————— - Alanine Aminotransferase (U/L) (n) 78 70 68 - Low - Single, not last 0 0 0 - Last or replicated 1 (1.3%) 0 5 (7.4%) - Any Abnormality 1 (1.3%) 0 5 (7.4%) - High - Single, not last 0 0 0 - Last or replicated 9 (11.5%) 11 (15.7%) 10 (14.7%) - Any Abnormality 9 (11.5%) 11 (15.7%) 10 (14.7%) - Albumin (g/L) (n) 81 67 71 - Low - Single, not last 0 0 0 - Last or replicated 17 (21%) 5 (7.5%) 13 (18.3%) - Any Abnormality 17 (21%) 5 (7.5%) 13 (18.3%) - High - Single, not last 0 0 0 - Last or replicated 4 (4.9%) 1 (1.5%) 1 (1.4%) - Any Abnormality 4 (4.9%) 1 (1.5%) 1 (1.4%) - Alkaline Phosphatase (U/L) (n) 83 70 70 - Low - Single, not last 0 0 0 - Last or replicated 4 (4.8%) 3 (4.3%) 2 (2.9%) - Any Abnormality 4 (4.8%) 3 (4.3%) 2 (2.9%) - High - Single, not last 0 0 0 - Last or replicated 8 (9.6%) 5 (7.1%) 7 (10%) - Any Abnormality 8 (9.6%) 5 (7.1%) 7 (10%) - Anisocytes (n) 22 12 21 - Low - Single, not last 0 0 0 - Last or replicated 0 0 0 - Any Abnormality 0 0 0 - High - Single, not last 0 0 0 - Last or replicated 0 0 0 - Any Abnormality 0 0 0 - Aspartate Aminotransferase (U/L) (n) 81 68 71 - Low - Single, not last 0 0 0 - Last or replicated 0 0 0 - Any Abnormality 0 0 0 - High - Single, not last 0 0 0 - Last or replicated 12 (14.8%) 7 (10.3%) 10 (14.1%) - Any Abnormality 12 (14.8%) 7 (10.3%) 10 (14.1%) - Basophils (10^9/L) (n) 81 70 72 - Low - Single, not last 0 0 0 - Last or replicated 0 0 0 - Any Abnormality 0 0 0 - High - Single, not last 0 0 0 - Last or replicated 0 0 0 - Any Abnormality 0 0 0 - Basophils Abs (10^9/L) (n) 2 1 0 - Low - Single, not last 0 0 0 - Last or replicated 0 0 0 - Any Abnormality 0 0 0 - High - Single, not last 0 0 0 - Last or replicated 0 0 0 - Any Abnormality 0 0 0 - Basophils/Leukocytes (FRACTION) (n) 3 2 0 - Low - Single, not last 0 0 0 - Last or replicated 0 0 0 - Any Abnormality 0 0 0 - High - Single, not last 0 0 0 - Last or replicated 0 0 0 - Any Abnormality 0 0 0 - Blood Urea Nitrogen (mmol/L) (n) 81 71 73 - Low - Single, not last 0 0 0 - Last or replicated 0 0 0 - Any Abnormality 0 0 0 - High - Single, not last 0 0 0 - Last or replicated 11 (13.6%) 10 (14.1%) 20 (27.4%) - Any Abnormality 11 (13.6%) 10 (14.1%) 20 (27.4%) - Calcium (mmol/L) (n) 82 70 72 - Low - Single, not last 0 0 0 - Last or replicated 10 (12.2%) 10 (14.3%) 8 (11.1%) - Any Abnormality 10 (12.2%) 10 (14.3%) 8 (11.1%) - High - Single, not last 0 0 0 - Last or replicated 1 (1.2%) 2 (2.9%) 3 (4.2%) - Any Abnormality 1 (1.2%) 2 (2.9%) 3 (4.2%) - Chloride (mmol/L) (n) 78 67 70 - Low - Single, not last 0 0 0 - Last or replicated 0 0 0 - Any Abnormality 0 0 0 - High - Single, not last 0 0 0 - Last or replicated 11 (14.1%) 3 (4.5%) 5 (7.1%) - Any Abnormality 11 (14.1%) 3 (4.5%) 5 (7.1%) - Cholesterol (mmol/L) (n) 82 71 74 - Low - Single, not last 0 0 0 - Last or replicated 5 (6.1%) 5 (7%) 5 (6.8%) - Any Abnormality 5 (6.1%) 5 (7%) 5 (6.8%) - High - Single, not last 0 1 (1.4%) 0 - Last or replicated 5 (6.1%) 3 (4.2%) 4 (5.4%) - Any Abnormality 5 (6.1%) 4 (5.6%) 4 (5.4%) - Creatinine (umol/L) (n) 82 68 74 - Low - Single, not last 0 0 0 - Last or replicated 1 (1.2%) 3 (4.4%) 1 (1.4%) - Any Abnormality 1 (1.2%) 3 (4.4%) 1 (1.4%) - High - Single, not last 0 0 0 - Last or replicated 9 (11%) 13 (19.1%) 9 (12.2%) - Any Abnormality 9 (11%) 13 (19.1%) 9 (12.2%) - Creatinine Kinase (U/L) (n) 82 70 70 - Low - Single, not last 0 0 0 - Last or replicated 1 (1.2%) 0 0 - Any Abnormality 1 (1.2%) 0 0 - High - Single, not last 0 0 0 - Last or replicated 18 (22%) 13 (18.6%) 11 (15.7%) - Any Abnormality 18 (22%) 13 (18.6%) 11 (15.7%) - Eosinophils (10^9/L) (n) 77 68 72 - Low - Single, not last 0 0 0 - Last or replicated 0 0 0 - Any Abnormality 0 0 0 - High - Single, not last 0 0 0 - Last or replicated 2 (2.6%) 8 (11.8%) 15 (20.8%) - Any Abnormality 2 (2.6%) 8 (11.8%) 15 (20.8%) - Eosinophils/Leukocytes (FRACTION) (n) 2 2 0 - Low - Single, not last 0 0 0 - Last or replicated 0 0 0 - Any Abnormality 0 0 0 - High - Single, not last 0 0 0 - Last or replicated 1 (50%) 0 0 - Any Abnormality 1 (50%) 0 0 - Ery. Mean Corpuscular Hemoglobin (fmol(Fe)) (n) 82 66 70 - Low - Single, not last 0 0 0 - Last or replicated 0 1 (1.5%) 0 - Any Abnormality 0 1 (1.5%) 0 - High - Single, not last 0 0 0 - Last or replicated 10 (12.2%) 7 (10.6%) 6 (8.6%) - Any Abnormality 10 (12.2%) 7 (10.6%) 6 (8.6%) - Ery. Mean Corpuscular HGB Concentration (mmol/L) (n) 80 70 69 - Low - Single, not last 0 0 1 (1.4%) - Last or replicated 16 (20%) 9 (12.9%) 15 (21.7%) - Any Abnormality 16 (20%) 9 (12.9%) 16 (23.2%) - High - Single, not last 0 0 0 - Last or replicated 0 0 0 - Any Abnormality 0 0 0 - Ery. Mean Corpuscular Volume (f/L) (n) 81 70 68 - Low - Single, not last 0 0 0 - Last or replicated 1 (1.2%) 1 (1.4%) 0 - Any Abnormality 1 (1.2%) 1 (1.4%) 0 - High - Single, not last 0 0 0 - Last or replicated 28 (34.6%) 17 (24.3%) 19 (27.9%) - Any Abnormality 28 (34.6%) 17 (24.3%) 19 (27.9%) - Erythrocytes (TI/L) (n) 82 68 70 - Low - Single, not last 0 0 0 - Last or replicated 13 (15.9%) 9 (13.2%) 15 (21.4%) - Any Abnormality 13 (15.9%) 9 (13.2%) 15 (21.4%) - High - Single, not last 0 0 0 - Last or replicated 0 2 (2.9%) 0 - Any Abnormality 0 2 (2.9%) 0 - Gamma Glutamyl Transferase (U/L) (n) 80 68 69 - Low - Single, not last 0 0 0 - Last or replicated 4 (5%) 1 (1.5%) 4 (5.8%) - Any Abnormality 4 (5%) 1 (1.5%) 4 (5.8%) - High - Single, not last 0 0 0 - Last or replicated 7 (8.8%) 8 (11.8%) 9 (13%) - Any Abnormality 7 (8.8%) 8 (11.8%) 9 (13%) - Hematocrit (1) (n) 78 69 72 - Low - Single, not last 1 (1.3%) 0 0 - Last or replicated 4 (5.1%) 1 (1.4%) 7 (9.7%) - Any Abnormality 5 (6.4%) 1 (1.4%) 7 (9.7%) - High - Single, not last 0 0 0 - Last or replicated 5 (6.4%) 3 (4.3%) 1 (1.4%) - Any Abnormality 5 (6.4%) 3 (4.3%) 1 (1.4%) - Hemoglobin (mmol/L) (n) 81 66 71 - Low - Single, not last 0 0 0 - Last or replicated 12 (14.8%) 2 (3%) 9 (12.7%) - Any Abnormality 12 (14.8%) 2 (3%) 9 (12.7%) - High - Single, not last 0 0 0 - Last or replicated 2 (2.5%) 3 (4.5%) 0 - Any Abnormality 2 (2.5%) 3 (4.5%) 0 - Hemoglobin A1C (1) (n) 1 0 1 - Low - Single, not last 0 0 0 - Last or replicated 0 0 0 - Any Abnormality 0 0 0 - High - Single, not last 0 0 0 - Last or replicated 0 0 0 - Any Abnormality 0 0 0 - Ketones (n) 71 63 58 - Low - Single, not last 0 0 0 - Last or replicated 0 0 0 - Any Abnormality 0 0 0 - High - Single, not last 0 0 0 - Last or replicated 0 0 0 - Any Abnormality 0 0 0 - Leukocytes (10^9/L) (n) 81 72 74 - Low - Single, not last 0 0 0 - Last or replicated 6 (7.4%) 2 (2.8%) 5 (6.8%) - Any Abnormality 6 (7.4%) 2 (2.8%) 5 (6.8%) - High - Single, not last 0 0 0 - Last or replicated 5 (6.2%) 4 (5.6%) 8 (10.8%) - Any Abnormality 5 (6.2%) 4 (5.6%) 8 (10.8%) - Lymphocytes (10^9/L) (n) 80 70 74 - Low - Single, not last 0 0 0 - Last or replicated 5 (6.2%) 3 (4.3%) 4 (5.4%) - Any Abnormality 5 (6.2%) 3 (4.3%) 4 (5.4%) - High - Single, not last 0 0 0 - Last or replicated 8 (10%) 2 (2.9%) 10 (13.5%) - Any Abnormality 8 (10%) 2 (2.9%) 10 (13.5%) - Lymphocytes Abs (10^9/L) (n) 3 1 0 - Low - Single, not last 0 0 0 - Last or replicated 0 0 0 - Any Abnormality 0 0 0 - High - Single, not last 0 0 0 - Last or replicated 0 0 0 - Any Abnormality 0 0 0 - Lymphocytes/Leukocytes (FRACTION) (n) 3 2 0 - Low - Single, not last 0 0 0 - Last or replicated 0 0 0 - Any Abnormality 0 0 0 - High - Single, not last 0 0 0 - Last or replicated 1 (33.3%) 0 0 - Any Abnormality 1 (33.3%) 0 0 - Macrocytes (n) 17 11 10 - Low - Single, not last 0 0 0 - Last or replicated 0 0 0 - Any Abnormality 0 0 0 - High - Single, not last 0 0 0 - Last or replicated 0 0 0 - Any Abnormality 0 0 0 - Microcytes (n) 0 1 0 - Low - Single, not last 0 0 0 - Last or replicated 0 0 0 - Any Abnormality 0 0 0 - High - Single, not last 0 0 0 - Last or replicated 0 0 0 - Any Abnormality 0 0 0 - Monocytes (10^9/L) (n) 79 66 69 - Low - Single, not last 0 0 0 - Last or replicated 2 (2.5%) 0 1 (1.4%) - Any Abnormality 2 (2.5%) 0 1 (1.4%) - High - Single, not last 0 0 0 - Last or replicated 4 (5.1%) 2 (3%) 4 (5.8%) - Any Abnormality 4 (5.1%) 2 (3%) 4 (5.8%) - Monocytes/Leukocytes (FRACTION) (n) 3 1 0 - Low - Single, not last 0 0 0 - Last or replicated 0 0 0 - Any Abnormality 0 0 0 - High - Single, not last 0 0 0 - Last or replicated 1 (33.3%) 0 0 - Any Abnormality 1 (33.3%) 0 0 - pH (n) 68 61 57 - Low - Single, not last 0 0 0 - Last or replicated 0 0 0 - Any Abnormality 0 0 0 - High - Single, not last 0 0 0 - Last or replicated 0 0 0 - Any Abnormality 0 0 0 - Phosphate (mmol/L) (n) 78 66 73 - Low - Single, not last 0 0 0 - Last or replicated 1 (1.3%) 1 (1.5%) 0 - Any Abnormality 1 (1.3%) 1 (1.5%) 0 - High - Single, not last 0 0 0 - Last or replicated 2 (2.6%) 2 (3%) 1 (1.4%) - Any Abnormality 2 (2.6%) 2 (3%) 1 (1.4%) - Platelet (10^9/L) (n) 82 67 69 - Low - Single, not last 0 0 0 - Last or replicated 0 2 (3%) 1 (1.4%) - Any Abnormality 0 2 (3%) 1 (1.4%) - High - Single, not last 0 0 0 - Last or replicated 4 (4.9%) 1 (1.5%) 2 (2.9%) - Any Abnormality 4 (4.9%) 1 (1.5%) 2 (2.9%) - Poikilocytes (n) 0 0 0 - Low - Single, not last 0 0 0 - Last or replicated 0 0 0 - Any Abnormality 0 0 0 - High - Single, not last 0 0 0 - Last or replicated 0 0 0 - Any Abnormality 0 0 0 - Polychromasia (n) 8 4 4 - Low - Single, not last 0 0 0 - Last or replicated 0 0 0 - Any Abnormality 0 0 0 - High - Single, not last 0 0 0 - Last or replicated 0 0 0 - Any Abnormality 0 0 0 - Potassium (mmol/L) (n) 80 70 72 - Low - Single, not last 0 0 0 - Last or replicated 3 (3.8%) 2 (2.9%) 2 (2.8%) - Any Abnormality 3 (3.8%) 2 (2.9%) 2 (2.8%) - High - Single, not last 0 0 0 - Last or replicated 1 (1.2%) 2 (2.9%) 0 - Any Abnormality 1 (1.2%) 2 (2.9%) 0 - Protein (g/L) (n) 80 66 70 - Low - Single, not last 0 0 0 - Last or replicated 1 (1.2%) 1 (1.5%) 1 (1.4%) - Any Abnormality 1 (1.2%) 1 (1.5%) 1 (1.4%) - High - Single, not last 0 0 0 - Last or replicated 10 (12.5%) 2 (3%) 4 (5.7%) - Any Abnormality 10 (12.5%) 2 (3%) 4 (5.7%) - Sodium (mmol/L) (n) 83 64 74 - Low - Single, not last 0 0 0 - Last or replicated 4 (4.8%) 5 (7.8%) 3 (4.1%) - Any Abnormality 4 (4.8%) 5 (7.8%) 3 (4.1%) - High - Single, not last 0 0 0 - Last or replicated 10 (12%) 11 (17.2%) 6 (8.1%) - Any Abnormality 10 (12%) 11 (17.2%) 6 (8.1%) - Specific Gravity (n) 73 61 60 - Low - Single, not last 0 0 0 - Last or replicated 3 (4.1%) 3 (4.9%) 1 (1.7%) - Any Abnormality 3 (4.1%) 3 (4.9%) 1 (1.7%) - High - Single, not last 0 0 0 - Last or replicated 4 (5.5%) 1 (1.6%) 3 (5%) - Any Abnormality 4 (5.5%) 1 (1.6%) 3 (5%) - Thyrotropin (mU/L) (n) 0 0 0 - Low - Single, not last 0 0 0 - Last or replicated 0 0 0 - Any Abnormality 0 0 0 - High - Single, not last 0 0 0 - Last or replicated 0 0 0 - Any Abnormality 0 0 0 - Urate (umol/L) (n) 83 66 68 - Low - Single, not last 0 0 0 - Last or replicated 5 (6%) 4 (6.1%) 3 (4.4%) - Any Abnormality 5 (6%) 4 (6.1%) 3 (4.4%) - High - Single, not last 1 (1.2%) 0 0 - Last or replicated 3 (3.6%) 7 (10.6%) 4 (5.9%) - Any Abnormality 4 (4.8%) 7 (10.6%) 4 (5.9%) - Urobilinogen (n) 73 61 59 - Low - Single, not last 0 0 0 - Last or replicated 0 0 0 - Any Abnormality 0 0 0 - High - Single, not last 0 0 0 - Last or replicated 0 0 0 - Any Abnormality 0 0 0 - Vitamin B12 (pmol/L) (n) 0 0 0 - Low - Single, not last 0 0 0 - Last or replicated 0 0 0 - Any Abnormality 0 0 0 - High - Single, not last 0 0 0 - Last or replicated 0 0 0 - Any Abnormality 0 0 0 + Laboratory Test Placebo Xanomeline High Dose Xanomeline Low Dose + Direction of Abnormality (N=86) (N=72) (N=96) + —————————————————————————————————————————————————————————————————————————————————————————————— + Alanine Aminotransferase (U/L) (n) 80 68 69 + Low + Single, not last 0 0 0 + Last or replicated 1 (1.2%) 0 5 (7.2%) + Any Abnormality 1 (1.2%) 0 5 (7.2%) + High + Single, not last 0 0 0 + Last or replicated 9 (11.2%) 11 (16.2%) 10 (14.5%) + Any Abnormality 9 (11.2%) 11 (16.2%) 10 (14.5%) + Albumin (g/L) (n) 80 68 71 + Low + Single, not last 0 0 0 + Last or replicated 17 (21.2%) 5 (7.4%) 13 (18.3%) + Any Abnormality 17 (21.2%) 5 (7.4%) 13 (18.3%) + High + Single, not last 0 0 0 + Last or replicated 4 (5%) 1 (1.5%) 1 (1.4%) + Any Abnormality 4 (5%) 1 (1.5%) 1 (1.4%) + Alkaline Phosphatase (U/L) (n) 80 70 69 + Low + Single, not last 0 0 0 + Last or replicated 4 (5%) 3 (4.3%) 2 (2.9%) + Any Abnormality 4 (5%) 3 (4.3%) 2 (2.9%) + High + Single, not last 0 0 0 + Last or replicated 8 (10%) 5 (7.1%) 7 (10.1%) + Any Abnormality 8 (10%) 5 (7.1%) 7 (10.1%) + Aspartate Aminotransferase (U/L) (n) 82 69 72 + Low + Single, not last 0 0 0 + Last or replicated 0 0 0 + Any Abnormality 0 0 0 + High + Single, not last 0 0 0 + Last or replicated 12 (14.6%) 7 (10.1%) 10 (13.9%) + Any Abnormality 12 (14.6%) 7 (10.1%) 10 (13.9%) + Blood Urea Nitrogen (mmol/L) (n) 80 68 73 + Low + Single, not last 0 0 0 + Last or replicated 0 0 0 + Any Abnormality 0 0 0 + High + Single, not last 0 0 0 + Last or replicated 11 (13.8%) 10 (14.7%) 20 (27.4%) + Any Abnormality 11 (13.8%) 10 (14.7%) 20 (27.4%) + Calcium (mmol/L) (n) 79 69 73 + Low + Single, not last 0 0 0 + Last or replicated 10 (12.7%) 10 (14.5%) 8 (11%) + Any Abnormality 10 (12.7%) 10 (14.5%) 8 (11%) + High + Single, not last 1 (1.3%) 0 0 + Last or replicated 0 2 (2.9%) 3 (4.1%) + Any Abnormality 1 (1.3%) 2 (2.9%) 3 (4.1%) + Cholesterol (mmol/L) (n) 79 69 72 + Low + Single, not last 0 0 0 + Last or replicated 5 (6.3%) 5 (7.2%) 5 (6.9%) + Any Abnormality 5 (6.3%) 5 (7.2%) 5 (6.9%) + High + Single, not last 0 0 0 + Last or replicated 5 (6.3%) 4 (5.8%) 4 (5.6%) + Any Abnormality 5 (6.3%) 4 (5.8%) 4 (5.6%) + Creatinine (umol/L) (n) 78 69 70 + Low + Single, not last 0 0 0 + Last or replicated 1 (1.3%) 3 (4.3%) 1 (1.4%) + Any Abnormality 1 (1.3%) 3 (4.3%) 1 (1.4%) + High + Single, not last 0 0 0 + Last or replicated 9 (11.5%) 13 (18.8%) 9 (12.9%) + Any Abnormality 9 (11.5%) 13 (18.8%) 9 (12.9%) + Gamma Glutamyl Transferase (U/L) (n) 82 71 73 + Low + Single, not last 0 0 0 + Last or replicated 4 (4.9%) 1 (1.4%) 4 (5.5%) + Any Abnormality 4 (4.9%) 1 (1.4%) 4 (5.5%) + High + Single, not last 0 0 0 + Last or replicated 7 (8.5%) 8 (11.3%) 9 (12.3%) + Any Abnormality 7 (8.5%) 8 (11.3%) 9 (12.3%) + Microcytes (n) 0 0 0 + Low + Single, not last 0 0 0 + Last or replicated 0 0 0 + Any Abnormality 0 0 0 + High + Single, not last 0 0 0 + Last or replicated 0 0 0 + Any Abnormality 0 0 0 + Phosphate (mmol/L) (n) 82 63 72 + Low + Single, not last 0 0 0 + Last or replicated 1 (1.2%) 1 (1.6%) 0 + Any Abnormality 1 (1.2%) 1 (1.6%) 0 + High + Single, not last 0 0 0 + Last or replicated 2 (2.4%) 2 (3.2%) 1 (1.4%) + Any Abnormality 2 (2.4%) 2 (3.2%) 1 (1.4%) + Protein (g/L) (n) 78 71 73 + Low + Single, not last 0 0 0 + Last or replicated 1 (1.3%) 1 (1.4%) 1 (1.4%) + Any Abnormality 1 (1.3%) 1 (1.4%) 1 (1.4%) + High + Single, not last 0 0 0 + Last or replicated 10 (12.8%) 2 (2.8%) 4 (5.5%) + Any Abnormality 10 (12.8%) 2 (2.8%) 4 (5.5%) + Sodium (mmol/L) (n) 82 66 73 + Low + Single, not last 0 0 0 + Last or replicated 4 (4.9%) 5 (7.6%) 3 (4.1%) + Any Abnormality 4 (4.9%) 5 (7.6%) 3 (4.1%) + High + Single, not last 0 0 0 + Last or replicated 10 (12.2%) 11 (16.7%) 6 (8.2%) + Any Abnormality 10 (12.2%) 11 (16.7%) 6 (8.2%) + Urate (umol/L) (n) 80 71 72 + Low + Single, not last 0 0 0 + Last or replicated 5 (6.2%) 4 (5.6%) 3 (4.2%) + Any Abnormality 5 (6.2%) 4 (5.6%) 3 (4.2%) + High + Single, not last 0 0 0 + Last or replicated 4 (5%) 7 (9.9%) 4 (5.6%) + Any Abnormality 4 (5%) 7 (9.9%) 4 (5.6%) # LBT05 variant 4 is produced correctly Code res Output - Laboratory Test Placebo Xanomeline High Dose Xanomeline Low Dose - Direction of Abnormality (N=86) (N=72) (N=96) - —————————————————————————————————————————————————————————————————————————————————————————————————————————————— - Alanine Aminotransferase (U/L) (n) 78 70 68 - Low - Last or replicated 1 (1.3%) 0 5 (7.4%) - Any Abnormality 1 (1.3%) 0 5 (7.4%) - High - Last or replicated 9 (11.5%) 11 (15.7%) 10 (14.7%) - Any Abnormality 9 (11.5%) 11 (15.7%) 10 (14.7%) - Albumin (g/L) (n) 81 67 71 - Low - Last or replicated 17 (21%) 5 (7.5%) 13 (18.3%) - Any Abnormality 17 (21%) 5 (7.5%) 13 (18.3%) - High - Last or replicated 4 (4.9%) 1 (1.5%) 1 (1.4%) - Any Abnormality 4 (4.9%) 1 (1.5%) 1 (1.4%) - Alkaline Phosphatase (U/L) (n) 83 70 70 - Low - Last or replicated 4 (4.8%) 3 (4.3%) 2 (2.9%) - Any Abnormality 4 (4.8%) 3 (4.3%) 2 (2.9%) - High - Last or replicated 8 (9.6%) 5 (7.1%) 7 (10%) - Any Abnormality 8 (9.6%) 5 (7.1%) 7 (10%) - Aspartate Aminotransferase (U/L) (n) 81 68 71 - High - Last or replicated 12 (14.8%) 7 (10.3%) 10 (14.1%) - Any Abnormality 12 (14.8%) 7 (10.3%) 10 (14.1%) - Blood Urea Nitrogen (mmol/L) (n) 81 71 73 - High - Last or replicated 11 (13.6%) 10 (14.1%) 20 (27.4%) - Any Abnormality 11 (13.6%) 10 (14.1%) 20 (27.4%) - Calcium (mmol/L) (n) 82 70 72 - Low - Last or replicated 10 (12.2%) 10 (14.3%) 8 (11.1%) - Any Abnormality 10 (12.2%) 10 (14.3%) 8 (11.1%) - High - Last or replicated 1 (1.2%) 2 (2.9%) 3 (4.2%) - Any Abnormality 1 (1.2%) 2 (2.9%) 3 (4.2%) - Chloride (mmol/L) (n) 78 67 70 - High - Last or replicated 11 (14.1%) 3 (4.5%) 5 (7.1%) - Any Abnormality 11 (14.1%) 3 (4.5%) 5 (7.1%) - Cholesterol (mmol/L) (n) 82 71 74 - Low - Last or replicated 5 (6.1%) 5 (7%) 5 (6.8%) - Any Abnormality 5 (6.1%) 5 (7%) 5 (6.8%) - High - Single, not last 0 1 (1.4%) 0 - Last or replicated 5 (6.1%) 3 (4.2%) 4 (5.4%) - Any Abnormality 5 (6.1%) 4 (5.6%) 4 (5.4%) - Creatinine (umol/L) (n) 82 68 74 - Low - Last or replicated 1 (1.2%) 3 (4.4%) 1 (1.4%) - Any Abnormality 1 (1.2%) 3 (4.4%) 1 (1.4%) - High - Last or replicated 9 (11%) 13 (19.1%) 9 (12.2%) - Any Abnormality 9 (11%) 13 (19.1%) 9 (12.2%) - Creatinine Kinase (U/L) (n) 82 70 70 - Low - Last or replicated 1 (1.2%) 0 0 - Any Abnormality 1 (1.2%) 0 0 - High - Last or replicated 18 (22%) 13 (18.6%) 11 (15.7%) - Any Abnormality 18 (22%) 13 (18.6%) 11 (15.7%) - Eosinophils (10^9/L) (n) 77 68 72 - High - Last or replicated 2 (2.6%) 8 (11.8%) 15 (20.8%) - Any Abnormality 2 (2.6%) 8 (11.8%) 15 (20.8%) - Eosinophils/Leukocytes (FRACTION) (n) 2 2 0 - High - Last or replicated 1 (50%) 0 0 - Any Abnormality 1 (50%) 0 0 - Ery. Mean Corpuscular Hemoglobin (fmol(Fe)) (n) 82 66 70 - Low - Last or replicated 0 1 (1.5%) 0 - Any Abnormality 0 1 (1.5%) 0 - High - Last or replicated 10 (12.2%) 7 (10.6%) 6 (8.6%) - Any Abnormality 10 (12.2%) 7 (10.6%) 6 (8.6%) - Ery. Mean Corpuscular HGB Concentration (mmol/L) (n) 80 70 69 - Low - Single, not last 0 0 1 (1.4%) - Last or replicated 16 (20%) 9 (12.9%) 15 (21.7%) - Any Abnormality 16 (20%) 9 (12.9%) 16 (23.2%) - Ery. Mean Corpuscular Volume (f/L) (n) 81 70 68 - Low - Last or replicated 1 (1.2%) 1 (1.4%) 0 - Any Abnormality 1 (1.2%) 1 (1.4%) 0 - High - Last or replicated 28 (34.6%) 17 (24.3%) 19 (27.9%) - Any Abnormality 28 (34.6%) 17 (24.3%) 19 (27.9%) - Erythrocytes (TI/L) (n) 82 68 70 - Low - Last or replicated 13 (15.9%) 9 (13.2%) 15 (21.4%) - Any Abnormality 13 (15.9%) 9 (13.2%) 15 (21.4%) - High - Last or replicated 0 2 (2.9%) 0 - Any Abnormality 0 2 (2.9%) 0 - Gamma Glutamyl Transferase (U/L) (n) 80 68 69 - Low - Last or replicated 4 (5%) 1 (1.5%) 4 (5.8%) - Any Abnormality 4 (5%) 1 (1.5%) 4 (5.8%) - High - Last or replicated 7 (8.8%) 8 (11.8%) 9 (13%) - Any Abnormality 7 (8.8%) 8 (11.8%) 9 (13%) - Hematocrit (1) (n) 78 69 72 - Low - Single, not last 1 (1.3%) 0 0 - Last or replicated 4 (5.1%) 1 (1.4%) 7 (9.7%) - Any Abnormality 5 (6.4%) 1 (1.4%) 7 (9.7%) - High - Last or replicated 5 (6.4%) 3 (4.3%) 1 (1.4%) - Any Abnormality 5 (6.4%) 3 (4.3%) 1 (1.4%) - Hemoglobin (mmol/L) (n) 81 66 71 - Low - Last or replicated 12 (14.8%) 2 (3%) 9 (12.7%) - Any Abnormality 12 (14.8%) 2 (3%) 9 (12.7%) - High - Last or replicated 2 (2.5%) 3 (4.5%) 0 - Any Abnormality 2 (2.5%) 3 (4.5%) 0 - Leukocytes (10^9/L) (n) 81 72 74 - Low - Last or replicated 6 (7.4%) 2 (2.8%) 5 (6.8%) - Any Abnormality 6 (7.4%) 2 (2.8%) 5 (6.8%) - High - Last or replicated 5 (6.2%) 4 (5.6%) 8 (10.8%) - Any Abnormality 5 (6.2%) 4 (5.6%) 8 (10.8%) - Lymphocytes (10^9/L) (n) 80 70 74 - Low - Last or replicated 5 (6.2%) 3 (4.3%) 4 (5.4%) - Any Abnormality 5 (6.2%) 3 (4.3%) 4 (5.4%) - High - Last or replicated 8 (10%) 2 (2.9%) 10 (13.5%) - Any Abnormality 8 (10%) 2 (2.9%) 10 (13.5%) - Lymphocytes/Leukocytes (FRACTION) (n) 3 2 0 - High - Last or replicated 1 (33.3%) 0 0 - Any Abnormality 1 (33.3%) 0 0 - Monocytes (10^9/L) (n) 79 66 69 - Low - Last or replicated 2 (2.5%) 0 1 (1.4%) - Any Abnormality 2 (2.5%) 0 1 (1.4%) - High - Last or replicated 4 (5.1%) 2 (3%) 4 (5.8%) - Any Abnormality 4 (5.1%) 2 (3%) 4 (5.8%) - Monocytes/Leukocytes (FRACTION) (n) 3 1 0 - High - Last or replicated 1 (33.3%) 0 0 - Any Abnormality 1 (33.3%) 0 0 - Phosphate (mmol/L) (n) 78 66 73 - Low - Last or replicated 1 (1.3%) 1 (1.5%) 0 - Any Abnormality 1 (1.3%) 1 (1.5%) 0 - High - Last or replicated 2 (2.6%) 2 (3%) 1 (1.4%) - Any Abnormality 2 (2.6%) 2 (3%) 1 (1.4%) - Platelet (10^9/L) (n) 82 67 69 - Low - Last or replicated 0 2 (3%) 1 (1.4%) - Any Abnormality 0 2 (3%) 1 (1.4%) - High - Last or replicated 4 (4.9%) 1 (1.5%) 2 (2.9%) - Any Abnormality 4 (4.9%) 1 (1.5%) 2 (2.9%) - Potassium (mmol/L) (n) 80 70 72 - Low - Last or replicated 3 (3.8%) 2 (2.9%) 2 (2.8%) - Any Abnormality 3 (3.8%) 2 (2.9%) 2 (2.8%) - High - Last or replicated 1 (1.2%) 2 (2.9%) 0 - Any Abnormality 1 (1.2%) 2 (2.9%) 0 - Protein (g/L) (n) 80 66 70 - Low - Last or replicated 1 (1.2%) 1 (1.5%) 1 (1.4%) - Any Abnormality 1 (1.2%) 1 (1.5%) 1 (1.4%) - High - Last or replicated 10 (12.5%) 2 (3%) 4 (5.7%) - Any Abnormality 10 (12.5%) 2 (3%) 4 (5.7%) - Sodium (mmol/L) (n) 83 64 74 - Low - Last or replicated 4 (4.8%) 5 (7.8%) 3 (4.1%) - Any Abnormality 4 (4.8%) 5 (7.8%) 3 (4.1%) - High - Last or replicated 10 (12%) 11 (17.2%) 6 (8.1%) - Any Abnormality 10 (12%) 11 (17.2%) 6 (8.1%) - Specific Gravity (n) 73 61 60 - Low - Last or replicated 3 (4.1%) 3 (4.9%) 1 (1.7%) - Any Abnormality 3 (4.1%) 3 (4.9%) 1 (1.7%) - High - Last or replicated 4 (5.5%) 1 (1.6%) 3 (5%) - Any Abnormality 4 (5.5%) 1 (1.6%) 3 (5%) - Urate (umol/L) (n) 83 66 68 - Low - Last or replicated 5 (6%) 4 (6.1%) 3 (4.4%) - Any Abnormality 5 (6%) 4 (6.1%) 3 (4.4%) - High - Single, not last 1 (1.2%) 0 0 - Last or replicated 3 (3.6%) 7 (10.6%) 4 (5.9%) - Any Abnormality 4 (4.8%) 7 (10.6%) 4 (5.9%) + Laboratory Test Placebo Xanomeline High Dose Xanomeline Low Dose + Direction of Abnormality (N=86) (N=72) (N=96) + —————————————————————————————————————————————————————————————————————————————————————————————— + Alanine Aminotransferase (U/L) (n) 80 68 69 + Low + Last or replicated 1 (1.2%) 0 5 (7.2%) + Any Abnormality 1 (1.2%) 0 5 (7.2%) + High + Last or replicated 9 (11.2%) 11 (16.2%) 10 (14.5%) + Any Abnormality 9 (11.2%) 11 (16.2%) 10 (14.5%) + Albumin (g/L) (n) 80 68 71 + Low + Last or replicated 17 (21.2%) 5 (7.4%) 13 (18.3%) + Any Abnormality 17 (21.2%) 5 (7.4%) 13 (18.3%) + High + Last or replicated 4 (5%) 1 (1.5%) 1 (1.4%) + Any Abnormality 4 (5%) 1 (1.5%) 1 (1.4%) + Alkaline Phosphatase (U/L) (n) 80 70 69 + Low + Last or replicated 4 (5%) 3 (4.3%) 2 (2.9%) + Any Abnormality 4 (5%) 3 (4.3%) 2 (2.9%) + High + Last or replicated 8 (10%) 5 (7.1%) 7 (10.1%) + Any Abnormality 8 (10%) 5 (7.1%) 7 (10.1%) + Aspartate Aminotransferase (U/L) (n) 82 69 72 + High + Last or replicated 12 (14.6%) 7 (10.1%) 10 (13.9%) + Any Abnormality 12 (14.6%) 7 (10.1%) 10 (13.9%) + Blood Urea Nitrogen (mmol/L) (n) 80 68 73 + High + Last or replicated 11 (13.8%) 10 (14.7%) 20 (27.4%) + Any Abnormality 11 (13.8%) 10 (14.7%) 20 (27.4%) + Calcium (mmol/L) (n) 79 69 73 + Low + Last or replicated 10 (12.7%) 10 (14.5%) 8 (11%) + Any Abnormality 10 (12.7%) 10 (14.5%) 8 (11%) + High + Single, not last 1 (1.3%) 0 0 + Last or replicated 0 2 (2.9%) 3 (4.1%) + Any Abnormality 1 (1.3%) 2 (2.9%) 3 (4.1%) + Cholesterol (mmol/L) (n) 79 69 72 + Low + Last or replicated 5 (6.3%) 5 (7.2%) 5 (6.9%) + Any Abnormality 5 (6.3%) 5 (7.2%) 5 (6.9%) + High + Last or replicated 5 (6.3%) 4 (5.8%) 4 (5.6%) + Any Abnormality 5 (6.3%) 4 (5.8%) 4 (5.6%) + Creatinine (umol/L) (n) 78 69 70 + Low + Last or replicated 1 (1.3%) 3 (4.3%) 1 (1.4%) + Any Abnormality 1 (1.3%) 3 (4.3%) 1 (1.4%) + High + Last or replicated 9 (11.5%) 13 (18.8%) 9 (12.9%) + Any Abnormality 9 (11.5%) 13 (18.8%) 9 (12.9%) + Gamma Glutamyl Transferase (U/L) (n) 82 71 73 + Low + Last or replicated 4 (4.9%) 1 (1.4%) 4 (5.5%) + Any Abnormality 4 (4.9%) 1 (1.4%) 4 (5.5%) + High + Last or replicated 7 (8.5%) 8 (11.3%) 9 (12.3%) + Any Abnormality 7 (8.5%) 8 (11.3%) 9 (12.3%) + Phosphate (mmol/L) (n) 82 63 72 + Low + Last or replicated 1 (1.2%) 1 (1.6%) 0 + Any Abnormality 1 (1.2%) 1 (1.6%) 0 + High + Last or replicated 2 (2.4%) 2 (3.2%) 1 (1.4%) + Any Abnormality 2 (2.4%) 2 (3.2%) 1 (1.4%) + Protein (g/L) (n) 78 71 73 + Low + Last or replicated 1 (1.3%) 1 (1.4%) 1 (1.4%) + Any Abnormality 1 (1.3%) 1 (1.4%) 1 (1.4%) + High + Last or replicated 10 (12.8%) 2 (2.8%) 4 (5.5%) + Any Abnormality 10 (12.8%) 2 (2.8%) 4 (5.5%) + Sodium (mmol/L) (n) 82 66 73 + Low + Last or replicated 4 (4.9%) 5 (7.6%) 3 (4.1%) + Any Abnormality 4 (4.9%) 5 (7.6%) 3 (4.1%) + High + Last or replicated 10 (12.2%) 11 (16.7%) 6 (8.2%) + Any Abnormality 10 (12.2%) 11 (16.7%) 6 (8.2%) + Urate (umol/L) (n) 80 71 72 + Low + Last or replicated 5 (6.2%) 4 (5.6%) 3 (4.2%) + Any Abnormality 5 (6.2%) 4 (5.6%) 3 (4.2%) + High + Last or replicated 4 (5%) 7 (9.9%) 4 (5.6%) + Any Abnormality 4 (5%) 7 (9.9%) 4 (5.6%) diff --git a/tests/testthat/_snaps/table_lbt07.md b/tests/testthat/_snaps/table_lbt07.md index 830c0d3..705a966 100644 --- a/tests/testthat/_snaps/table_lbt07.md +++ b/tests/testthat/_snaps/table_lbt07.md @@ -51,52 +51,17 @@ HIGH 1 58 (69.9%) 56 (77.8%) 55 (73.3%) Any 58 (69.9%) 56 (77.8%) 55 (73.3%) - Creatinine Kinase (U/L) (n) 83 72 75 - HIGH - 1 13 (15.7%) 12 (16.7%) 10 (13.3%) - 2 3 (3.6%) 0 1 (1.3%) - 3 2 (2.4%) 1 (1.4%) 0 - Any 18 (21.7%) 13 (18.1%) 11 (14.7%) Gamma Glutamyl Transferase (U/L) (n) 83 72 75 HIGH 1 6 (7.2%) 6 (8.3%) 9 (12%) 2 0 2 (2.8%) 0 3 1 (1.2%) 0 0 Any 7 (8.4%) 8 (11.1%) 9 (12%) - Glucose (mmol/L) (n) 83 72 75 - LOW - 2 1 (1.2%) 0 2 (2.7%) - Any 1 (1.2%) 0 2 (2.7%) - HIGH - 3 2 (2.4%) 6 (8.3%) 1 (1.3%) - Any 2 (2.4%) 6 (8.3%) 1 (1.3%) - Leukocytes (10^9/L) (n) 83 72 75 - LOW - 1 6 (7.2%) 1 (1.4%) 4 (5.3%) - 2 0 1 (1.4%) 1 (1.3%) - Any 6 (7.2%) 2 (2.8%) 5 (6.7%) - Lymphocytes (10^9/L) (n) 81 72 75 - LOW - 1 4 (4.9%) 3 (4.2%) 3 (4%) - 2 1 (1.2%) 0 1 (1.3%) - Any 5 (6.2%) 3 (4.2%) 4 (5.3%) Phosphate (mmol/L) (n) 83 72 75 LOW 2 4 (4.8%) 4 (5.6%) 2 (2.7%) 3 1 (1.2%) 0 0 Any 5 (6%) 4 (5.6%) 2 (2.7%) - Platelet (10^9/L) (n) 83 72 74 - LOW - 1 0 2 (2.8%) 1 (1.4%) - Any 0 2 (2.8%) 1 (1.4%) - Potassium (mmol/L) (n) 83 72 75 - LOW - 2 3 (3.6%) 2 (2.8%) 2 (2.7%) - Any 3 (3.6%) 2 (2.8%) 2 (2.7%) - HIGH - 1 0 1 (1.4%) 0 - 2 1 (1.2%) 1 (1.4%) 0 - Any 1 (1.2%) 2 (2.8%) 0 Sodium (mmol/L) (n) 83 72 75 LOW 1 3 (3.6%) 5 (6.9%) 3 (4%) diff --git a/tests/testthat/_snaps/table_lbt08.md b/tests/testthat/_snaps/table_lbt08.md index c44fb0f..0eb2955 100644 --- a/tests/testthat/_snaps/table_lbt08.md +++ b/tests/testthat/_snaps/table_lbt08.md @@ -26,11 +26,4 @@ 3 0/83 0/73 0/73 4 0/83 0/73 0/73 Any 0/83 0/73 0/73 - GLUC - Low - 1 0/83 0/73 0/74 - 2 1/83 (1.2%) 0/73 2/74 (2.7%) - 3 0/83 0/73 0/74 - 4 0/83 0/73 0/74 - Any 1/83 (1.2%) 0/73 2/74 (2.7%) diff --git a/tests/testthat/_snaps/table_lbt13.md b/tests/testthat/_snaps/table_lbt13.md index 28f2fa2..17b1748 100644 --- a/tests/testthat/_snaps/table_lbt13.md +++ b/tests/testthat/_snaps/table_lbt13.md @@ -24,104 +24,104 @@ Code res Output - Parameter Code - Visit - NCI CTCAE Grade at Visit Placebo Screen Failure Xanomeline High Dose Xanomeline Low Dose - Baseline NCI CTCAE Grade (N=86) (N=0) (N=72) (N=96) - ———————————————————————————————————————————————————————————————————————————————————————————————————————— - ALB - POST-BASELINE MAXIMUM - Not High (n) 83 0 72 75 - Not High 83 (100%) 0 72 (100%) 75 (100%) + Parameter Code + Visit + NCI CTCAE Grade at Visit Placebo Xanomeline High Dose Xanomeline Low Dose + Baseline NCI CTCAE Grade (N=86) (N=72) (N=96) + ——————————————————————————————————————————————————————————————————————————————————————— + ALB + POST-BASELINE MAXIMUM + Not High (n) 83 72 75 + Not High 83 (100%) 72 (100%) 75 (100%) # LBT13 variant 3: LOW without baseline missing works as expected Code res Output - Parameter Code - Visit - NCI CTCAE Grade at Visit Placebo Screen Failure Xanomeline High Dose Xanomeline Low Dose - Baseline NCI CTCAE Grade (N=86) (N=0) (N=72) (N=96) - ————————————————————————————————————————————————————————————————————————————————————————————————————————— - ALB - POST-BASELINE MINIMUM - Not Low (n) 66 0 67 62 - Not Low 66 (100%) 0 67 (100%) 62 (100%) - 1 (n) 15 0 5 13 - Not Low 14 (93.3%) 0 5 (100%) 12 (92.3%) - 1 1 (6.7%) 0 0 1 (7.7%) - 2 (n) 2 0 0 0 - Not Low 1 (50.0%) 0 0 0 - 1 1 (50.0%) 0 0 0 + Parameter Code + Visit + NCI CTCAE Grade at Visit Placebo Xanomeline High Dose Xanomeline Low Dose + Baseline NCI CTCAE Grade (N=86) (N=72) (N=96) + ———————————————————————————————————————————————————————————————————————————————————————— + ALB + POST-BASELINE MINIMUM + Not Low (n) 66 67 62 + Not Low 66 (100%) 67 (100%) 62 (100%) + 1 (n) 15 5 13 + Not Low 14 (93.3%) 5 (100%) 12 (92.3%) + 1 1 (6.7%) 0 1 (7.7%) + 2 (n) 2 0 0 + Not Low 1 (50.0%) 0 0 + 1 1 (50.0%) 0 0 # LBT13 variant 4: HIGH with missing baseline considered as grade 0 works as expected Code res Output - Parameter Code - Visit - NCI CTCAE Grade at Visit Placebo Screen Failure Xanomeline High Dose Xanomeline Low Dose - Baseline NCI CTCAE Grade (N=86) (N=0) (N=72) (N=96) - ———————————————————————————————————————————————————————————————————————————————————————————————————————— - ALB - POST-BASELINE MAXIMUM - Not High (n) 83 0 72 75 - Not High 83 (100%) 0 72 (100%) 75 (100%) + Parameter Code + Visit + NCI CTCAE Grade at Visit Placebo Xanomeline High Dose Xanomeline Low Dose + Baseline NCI CTCAE Grade (N=86) (N=72) (N=96) + ——————————————————————————————————————————————————————————————————————————————————————— + ALB + POST-BASELINE MAXIMUM + Not High (n) 83 72 75 + Not High 83 (100%) 72 (100%) 75 (100%) # LBT14 variant 5: HIGH with filled in grades works as expected Code res Output - Parameter Code - Visit - NCI CTCAE Grade at Visit Placebo Screen Failure Xanomeline High Dose Xanomeline Low Dose - Baseline NCI CTCAE Grade (N=86) (N=0) (N=72) (N=96) - ———————————————————————————————————————————————————————————————————————————————————————————————————————— - ALB - POST-BASELINE MAXIMUM - Not High (n) 83 0 72 75 - Not High 83 (100%) 0 72 (100%) 75 (100%) - 1 0 0 0 0 - 2 0 0 0 0 - 3 0 0 0 0 - 4 0 0 0 0 - Missing 0 0 0 0 - 1 (n) 0 0 0 0 - Not High 0 0 0 0 - 1 0 0 0 0 - 2 0 0 0 0 - 3 0 0 0 0 - 4 0 0 0 0 - Missing 0 0 0 0 - 2 (n) 0 0 0 0 - Not High 0 0 0 0 - 1 0 0 0 0 - 2 0 0 0 0 - 3 0 0 0 0 - 4 0 0 0 0 - Missing 0 0 0 0 - 3 (n) 0 0 0 0 - Not High 0 0 0 0 - 1 0 0 0 0 - 2 0 0 0 0 - 3 0 0 0 0 - 4 0 0 0 0 - Missing 0 0 0 0 - 4 (n) 0 0 0 0 - Not High 0 0 0 0 - 1 0 0 0 0 - 2 0 0 0 0 - 3 0 0 0 0 - 4 0 0 0 0 - Missing 0 0 0 0 - Missing (n) 0 0 0 0 - Not High 0 0 0 0 - 1 0 0 0 0 - 2 0 0 0 0 - 3 0 0 0 0 - 4 0 0 0 0 - Missing 0 0 0 0 + Parameter Code + Visit + NCI CTCAE Grade at Visit Placebo Xanomeline High Dose Xanomeline Low Dose + Baseline NCI CTCAE Grade (N=86) (N=72) (N=96) + ——————————————————————————————————————————————————————————————————————————————————————— + ALB + POST-BASELINE MAXIMUM + Not High (n) 83 72 75 + Not High 83 (100%) 72 (100%) 75 (100%) + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 1 (n) 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 2 (n) 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 3 (n) 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 4 (n) 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + Missing (n) 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 diff --git a/tests/testthat/_snaps/table_lbt14.md b/tests/testthat/_snaps/table_lbt14.md index 91eab13..3c251e2 100644 --- a/tests/testthat/_snaps/table_lbt14.md +++ b/tests/testthat/_snaps/table_lbt14.md @@ -3,2679 +3,997 @@ Code res Output - Parameter - Baseline NCI-CTCAE Grade Placebo Screen Failure Xanomeline High Dose Xanomeline Low Dose - Post-baseline NCI-CTCAE Grade (N=86) (N=0) (N=72) (N=96) - ——————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— - Alanine Aminotransferase (U/L) - Not High 79 0 68 73 - Not High 73 (84.9%) NA 61 (84.7%) 65 (67.7%) - 1 5 (5.8%) NA 6 (8.3%) 8 (8.3%) - 2 1 (1.2%) NA 1 (1.4%) 0 - 1 4 0 4 2 - Not High 1 (1.2%) NA 0 0 - 1 2 (2.3%) NA 4 (5.6%) 2 (2.1%) - 2 1 (1.2%) NA 0 0 - Albumin (g/L) - Not High 83 0 72 75 - Not High 83 (96.5%) NA 72 (100%) 75 (78.1%) - Alkaline Phosphatase (U/L) - Not High 78 0 71 71 - Not High 74 (86.0%) NA 67 (93.1%) 67 (69.8%) - 1 3 (3.5%) NA 4 (5.6%) 4 (4.2%) - 3 1 (1.2%) NA 0 0 - 1 4 0 0 3 - Not High 1 (1.2%) NA 0 0 - 1 3 (3.5%) NA 0 3 (3.1%) - 2 1 0 1 0 - 2 0 NA 1 (1.4%) 0 - 3 1 (1.2%) NA 0 0 - Missing 0 0 0 1 - Not High 0 NA 0 1 (1.0%) - Anisocytes - Missing 26 0 15 21 - Missing 26 (30.2%) NA 15 (20.8%) 21 (21.9%) - Aspartate Aminotransferase (U/L) - Not High 77 0 69 67 - Not High 69 (80.2%) NA 64 (88.9%) 61 (63.5%) - 1 7 (8.1%) NA 4 (5.6%) 6 (6.2%) - 2 1 (1.2%) NA 1 (1.4%) 0 - 1 6 0 3 8 - Not High 2 (2.3%) NA 1 (1.4%) 4 (4.2%) - 1 3 (3.5%) NA 2 (2.8%) 3 (3.1%) - 2 1 (1.2%) NA 0 1 (1.0%) - Basophils (10^9/L) - Missing 80 0 70 75 - Missing 80 (93.0%) NA 70 (97.2%) 75 (78.1%) - Basophils Abs (10^9/L) - Missing 3 0 2 0 - Missing 3 (3.5%) NA 2 (2.8%) 0 - Basophils/Leukocytes (FRACTION) - Missing 3 0 2 0 - Missing 3 (3.5%) NA 2 (2.8%) 0 - Bilirubin (umol/L) - Not High 81 0 69 71 - Not High 77 (89.5%) NA 67 (93.1%) 70 (72.9%) - 1 4 (4.7%) NA 2 (2.8%) 1 (1.0%) - 1 2 0 2 3 - Not High 0 NA 0 2 (2.1%) - 1 1 (1.2%) NA 0 0 - 2 0 NA 2 (2.8%) 1 (1.0%) - 3 1 (1.2%) NA 0 0 - 2 0 0 1 0 - 2 0 NA 1 (1.4%) 0 - Blood Urea Nitrogen (mmol/L) - Missing 83 0 72 75 - Missing 83 (96.5%) NA 72 (100%) 75 (78.1%) - Calcium (mmol/L) - Not High 83 0 72 73 - Not High 82 (95.3%) NA 70 (97.2%) 71 (74.0%) - 1 1 (1.2%) NA 2 (2.8%) 2 (2.1%) - 1 0 0 0 2 - Not High 0 NA 0 1 (1.0%) - 1 0 NA 0 1 (1.0%) - Chloride (mmol/L) - Missing 83 0 72 75 - Missing 83 (96.5%) NA 72 (100%) 75 (78.1%) - Cholesterol (mmol/L) - Not High 79 0 70 74 - Not High 76 (88.4%) NA 67 (93.1%) 71 (74.0%) - 1 1 (1.2%) NA 3 (4.2%) 1 (1.0%) - 2 2 (2.3%) NA 0 2 (2.1%) - 2 4 0 2 1 - Not High 2 (2.3%) NA 1 (1.4%) 0 - 2 2 (2.3%) NA 1 (1.4%) 1 (1.0%) - Creatinine (umol/L) - Not High 82 0 67 70 - Not High 25 (29.1%) NA 16 (22.2%) 20 (20.8%) - 1 57 (66.3%) NA 51 (70.8%) 50 (52.1%) - 1 1 0 5 5 - 1 1 (1.2%) NA 5 (6.9%) 5 (5.2%) - Creatinine Kinase (U/L) - Not High 79 0 65 68 - Not High 63 (73.3%) NA 57 (79.2%) 61 (63.5%) - 1 11 (12.8%) NA 8 (11.1%) 6 (6.2%) - 2 3 (3.5%) NA 0 1 (1.0%) - 3 2 (2.3%) NA 0 0 - 1 4 0 7 6 - Not High 2 (2.3%) NA 2 (2.8%) 2 (2.1%) - 1 2 (2.3%) NA 4 (5.6%) 4 (4.2%) - 3 0 NA 1 (1.4%) 0 - 2 0 0 0 1 - Not High 0 NA 0 1 (1.0%) - Eosinophils (10^9/L) - Missing 81 0 72 75 - Missing 81 (94.2%) NA 72 (100%) 75 (78.1%) - Eosinophils/Leukocytes (FRACTION) - Missing 3 0 2 0 - Missing 3 (3.5%) NA 2 (2.8%) 0 - Ery. Mean Corpuscular Hemoglobin (fmol(Fe)) - Missing 83 0 72 75 - Missing 83 (96.5%) NA 72 (100%) 75 (78.1%) - Ery. Mean Corpuscular HGB Concentration (mmol/L) - Missing 82 0 72 75 - Missing 82 (95.3%) NA 72 (100%) 75 (78.1%) - Ery. Mean Corpuscular Volume (f/L) - Missing 82 0 72 75 - Missing 82 (95.3%) NA 72 (100%) 75 (78.1%) - Erythrocytes (TI/L) - Missing 83 0 72 75 - Missing 83 (96.5%) NA 72 (100%) 75 (78.1%) - Gamma Glutamyl Transferase (U/L) - Not High 79 0 69 70 - Not High 76 (88.4%) NA 64 (88.9%) 65 (67.7%) - 1 3 (3.5%) NA 4 (5.6%) 5 (5.2%) - 2 0 NA 1 (1.4%) 0 - 1 3 0 3 5 - Not High 0 NA 0 1 (1.0%) - 1 3 (3.5%) NA 2 (2.8%) 4 (4.2%) - 2 0 NA 1 (1.4%) 0 - 3 1 0 0 0 - 3 1 (1.2%) NA 0 0 - Glucose (mmol/L) - Not High 82 0 72 75 - Not High 81 (94.2%) NA 66 (91.7%) 74 (77.1%) - 3 1 (1.2%) NA 6 (8.3%) 1 (1.0%) - 3 1 0 0 0 - 3 1 (1.2%) NA 0 0 - Hematocrit (1) - Missing 82 0 72 75 - Missing 82 (95.3%) NA 72 (100%) 75 (78.1%) - Hemoglobin (mmol/L) - Missing 83 0 72 75 - Missing 83 (96.5%) NA 72 (100%) 75 (78.1%) - Hemoglobin A1C (1) - Missing 1 0 0 1 - Missing 1 (1.2%) NA 0 1 (1.0%) - Ketones - Missing 82 0 71 71 - Missing 82 (95.3%) NA 71 (98.6%) 71 (74.0%) - Leukocytes (10^9/L) - Not High 83 0 72 75 - Not High 83 (96.5%) NA 72 (100%) 75 (78.1%) - Lymphocytes (10^9/L) - Not High 81 0 70 75 - Not High 81 (94.2%) NA 70 (97.2%) 75 (78.1%) - Missing 0 0 1 0 - Not High 0 NA 1 (1.4%) 0 - Lymphocytes Abs (10^9/L) - Missing 2 0 1 0 - Missing 2 (2.3%) NA 1 (1.4%) 0 - Lymphocytes/Leukocytes (FRACTION) - Missing 3 0 2 0 - Missing 3 (3.5%) NA 2 (2.8%) 0 - Macrocytes - Missing 21 0 13 12 - Missing 21 (24.4%) NA 13 (18.1%) 12 (12.5%) - Microcytes - Missing 0 0 1 0 - Missing 0 NA 1 (1.4%) 0 - Monocytes (10^9/L) - Missing 81 0 72 75 - Missing 81 (94.2%) NA 72 (100%) 75 (78.1%) - Monocytes/Leukocytes (FRACTION) - Missing 3 0 2 0 - Missing 3 (3.5%) NA 2 (2.8%) 0 - pH - Missing 82 0 71 71 - Missing 82 (95.3%) NA 71 (98.6%) 71 (74.0%) - Phosphate (mmol/L) - Not High 83 0 72 74 - Not High 83 (96.5%) NA 72 (100%) 74 (77.1%) - Missing 0 0 0 1 - Not High 0 NA 0 1 (1.0%) - Platelet (10^9/L) - Not High 83 0 72 73 - Not High 83 (96.5%) NA 72 (100%) 73 (76.0%) - Missing 0 0 0 1 - Not High 0 NA 0 1 (1.0%) - Poikilocytes - Missing 1 0 1 0 - Missing 1 (1.2%) NA 1 (1.4%) 0 - Polychromasia - Missing 8 0 4 7 - Missing 8 (9.3%) NA 4 (5.6%) 7 (7.3%) - Potassium (mmol/L) - Not High 82 0 72 74 - Not High 82 (95.3%) NA 70 (97.2%) 74 (77.1%) - 1 0 NA 1 (1.4%) 0 - 2 0 NA 1 (1.4%) 0 - 2 1 0 0 0 - 2 1 (1.2%) NA 0 0 - Missing 0 0 0 1 - Not High 0 NA 0 1 (1.0%) - Protein (g/L) - Missing 83 0 72 75 - Missing 83 (96.5%) NA 72 (100%) 75 (78.1%) - Sodium (mmol/L) - Not High 80 0 68 75 - Not High 70 (81.4%) NA 59 (81.9%) 69 (71.9%) - 1 10 (11.6%) NA 7 (9.7%) 6 (6.2%) - 2 0 NA 2 (2.8%) 0 - 1 3 0 4 0 - Not High 3 (3.5%) NA 2 (2.8%) 0 - 1 0 NA 2 (2.8%) 0 - Specific Gravity - Missing 82 0 71 71 - Missing 82 (95.3%) NA 71 (98.6%) 71 (74.0%) - Urate (umol/L) - Missing 83 0 72 75 - Missing 83 (96.5%) NA 72 (100%) 75 (78.1%) - Urobilinogen - Missing 82 0 71 71 - Missing 82 (95.3%) NA 71 (98.6%) 71 (74.0%) - Vitamin B12 (pmol/L) - Missing 1 0 0 1 - Missing 1 (1.2%) NA 0 1 (1.0%) + Parameter + Baseline NCI-CTCAE Grade Placebo Xanomeline High Dose Xanomeline Low Dose + Post-baseline NCI-CTCAE Grade (N=86) (N=72) (N=96) + ————————————————————————————————————————————————————————————————————————————————————————————————————— + Alanine Aminotransferase (U/L) + Not High 79 68 73 + Not High 73 (84.9%) 61 (84.7%) 65 (67.7%) + 1 5 (5.8%) 6 (8.3%) 8 (8.3%) + 2 1 (1.2%) 1 (1.4%) 0 + 1 4 4 2 + Not High 1 (1.2%) 0 0 + 1 2 (2.3%) 4 (5.6%) 2 (2.1%) + 2 1 (1.2%) 0 0 + Albumin (g/L) + Not High 83 72 75 + Not High 83 (96.5%) 72 (100%) 75 (78.1%) + Alkaline Phosphatase (U/L) + Not High 78 71 71 + Not High 74 (86.0%) 67 (93.1%) 67 (69.8%) + 1 3 (3.5%) 4 (5.6%) 4 (4.2%) + 3 1 (1.2%) 0 0 + 1 4 0 3 + Not High 1 (1.2%) 0 0 + 1 3 (3.5%) 0 3 (3.1%) + 2 1 1 0 + 2 0 1 (1.4%) 0 + 3 1 (1.2%) 0 0 + Missing 0 0 1 + Not High 0 0 1 (1.0%) + Aspartate Aminotransferase (U/L) + Not High 77 69 67 + Not High 69 (80.2%) 64 (88.9%) 61 (63.5%) + 1 7 (8.1%) 4 (5.6%) 6 (6.2%) + 2 1 (1.2%) 1 (1.4%) 0 + 1 6 3 8 + Not High 2 (2.3%) 1 (1.4%) 4 (4.2%) + 1 3 (3.5%) 2 (2.8%) 3 (3.1%) + 2 1 (1.2%) 0 1 (1.0%) + Bilirubin (umol/L) + Not High 81 69 71 + Not High 77 (89.5%) 67 (93.1%) 70 (72.9%) + 1 4 (4.7%) 2 (2.8%) 1 (1.0%) + 1 2 2 3 + Not High 0 0 2 (2.1%) + 1 1 (1.2%) 0 0 + 2 0 2 (2.8%) 1 (1.0%) + 3 1 (1.2%) 0 0 + 2 0 1 0 + 2 0 1 (1.4%) 0 + Blood Urea Nitrogen (mmol/L) + Missing 83 72 75 + Missing 83 (96.5%) 72 (100%) 75 (78.1%) + Calcium (mmol/L) + Not High 83 72 73 + Not High 82 (95.3%) 70 (97.2%) 71 (74.0%) + 1 1 (1.2%) 2 (2.8%) 2 (2.1%) + 1 0 0 2 + Not High 0 0 1 (1.0%) + 1 0 0 1 (1.0%) + Cholesterol (mmol/L) + Not High 79 70 74 + Not High 76 (88.4%) 67 (93.1%) 71 (74.0%) + 1 1 (1.2%) 3 (4.2%) 1 (1.0%) + 2 2 (2.3%) 0 2 (2.1%) + 2 4 2 1 + Not High 2 (2.3%) 1 (1.4%) 0 + 2 2 (2.3%) 1 (1.4%) 1 (1.0%) + Creatinine (umol/L) + Not High 82 67 70 + Not High 25 (29.1%) 16 (22.2%) 20 (20.8%) + 1 57 (66.3%) 51 (70.8%) 50 (52.1%) + 1 1 5 5 + 1 1 (1.2%) 5 (6.9%) 5 (5.2%) + Gamma Glutamyl Transferase (U/L) + Not High 79 69 70 + Not High 76 (88.4%) 64 (88.9%) 65 (67.7%) + 1 3 (3.5%) 4 (5.6%) 5 (5.2%) + 2 0 1 (1.4%) 0 + 1 3 3 5 + Not High 0 0 1 (1.0%) + 1 3 (3.5%) 2 (2.8%) 4 (4.2%) + 2 0 1 (1.4%) 0 + 3 1 0 0 + 3 1 (1.2%) 0 0 + Microcytes + Missing 0 1 0 + Missing 0 1 (1.4%) 0 + Phosphate (mmol/L) + Not High 83 72 74 + Not High 83 (96.5%) 72 (100%) 74 (77.1%) + Missing 0 0 1 + Not High 0 0 1 (1.0%) + Protein (g/L) + Missing 83 72 75 + Missing 83 (96.5%) 72 (100%) 75 (78.1%) + Sodium (mmol/L) + Not High 80 68 75 + Not High 70 (81.4%) 59 (81.9%) 69 (71.9%) + 1 10 (11.6%) 7 (9.7%) 6 (6.2%) + 2 0 2 (2.8%) 0 + 1 3 4 0 + Not High 3 (3.5%) 2 (2.8%) 0 + 1 0 2 (2.8%) 0 + Urate (umol/L) + Missing 83 72 75 + Missing 83 (96.5%) 72 (100%) 75 (78.1%) # LBT14 variant 2: LOW works as expected Code res Output - Parameter - Baseline NCI-CTCAE Grade Placebo Screen Failure Xanomeline High Dose Xanomeline Low Dose - Post-baseline NCI-CTCAE Grade (N=86) (N=0) (N=72) (N=96) - ——————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— - Alanine Aminotransferase (U/L) - Not Low 83 0 72 75 - Not Low 83 (96.5%) NA 72 (100%) 75 (78.1%) - Albumin (g/L) - Not Low 81 0 72 74 - Not Low 66 (76.7%) NA 67 (93.1%) 62 (64.6%) - 1 14 (16.3%) NA 5 (6.9%) 12 (12.5%) - 2 1 (1.2%) NA 0 0 - 1 2 0 0 1 - 1 1 (1.2%) NA 0 1 (1.0%) - 2 1 (1.2%) NA 0 0 - Alkaline Phosphatase (U/L) - Not Low 83 0 72 74 - Not Low 83 (96.5%) NA 72 (100%) 74 (77.1%) - Missing 0 0 0 1 - Not Low 0 NA 0 1 (1.0%) - Anisocytes - Missing 26 0 15 21 - Missing 26 (30.2%) NA 15 (20.8%) 21 (21.9%) - Aspartate Aminotransferase (U/L) - Not Low 83 0 72 75 - Not Low 83 (96.5%) NA 72 (100%) 75 (78.1%) - Basophils (10^9/L) - Missing 81 0 72 75 - Missing 81 (94.2%) NA 72 (100%) 75 (78.1%) - Basophils Abs (10^9/L) - Missing 2 0 0 0 - Missing 2 (2.3%) NA 0 0 - Basophils/Leukocytes (FRACTION) - Missing 3 0 2 0 - Missing 3 (3.5%) NA 2 (2.8%) 0 - Bilirubin (umol/L) - Not Low 83 0 72 74 - Not Low 83 (96.5%) NA 72 (100%) 74 (77.1%) - Blood Urea Nitrogen (mmol/L) - Missing 83 0 72 75 - Missing 83 (96.5%) NA 72 (100%) 75 (78.1%) - Calcium (mmol/L) - Not Low 82 0 71 73 - Not Low 72 (83.7%) NA 62 (86.1%) 65 (67.7%) - 1 10 (11.6%) NA 7 (9.7%) 7 (7.3%) - 2 0 NA 2 (2.8%) 1 (1.0%) - 1 1 0 1 2 - Not Low 1 (1.2%) NA 0 2 (2.1%) - 1 0 NA 1 (1.4%) 0 - Chloride (mmol/L) - Missing 83 0 72 75 - Missing 83 (96.5%) NA 72 (100%) 75 (78.1%) - Cholesterol (mmol/L) - Not Low 83 0 72 75 - Not Low 83 (96.5%) NA 72 (100%) 75 (78.1%) - Creatinine (umol/L) - Not Low 83 0 72 75 - Not Low 83 (96.5%) NA 72 (100%) 75 (78.1%) - Creatinine Kinase (U/L) - Not Low 83 0 72 75 - Not Low 83 (96.5%) NA 72 (100%) 75 (78.1%) - Eosinophils (10^9/L) - Missing 81 0 72 75 - Missing 81 (94.2%) NA 72 (100%) 75 (78.1%) - Eosinophils/Leukocytes (FRACTION) - Missing 3 0 2 0 - Missing 3 (3.5%) NA 2 (2.8%) 0 - Ery. Mean Corpuscular Hemoglobin (fmol(Fe)) - Missing 83 0 72 75 - Missing 83 (96.5%) NA 72 (100%) 75 (78.1%) - Ery. Mean Corpuscular HGB Concentration (mmol/L) - Missing 82 0 72 75 - Missing 82 (95.3%) NA 72 (100%) 75 (78.1%) - Ery. Mean Corpuscular Volume (f/L) - Missing 82 0 72 75 - Missing 82 (95.3%) NA 72 (100%) 75 (78.1%) - Erythrocytes (TI/L) - Missing 83 0 72 75 - Missing 83 (96.5%) NA 72 (100%) 75 (78.1%) - Gamma Glutamyl Transferase (U/L) - Not Low 83 0 72 75 - Not Low 83 (96.5%) NA 72 (100%) 75 (78.1%) - Glucose (mmol/L) - Not Low 83 0 72 75 - Not Low 82 (95.3%) NA 72 (100%) 73 (76.0%) - 2 1 (1.2%) NA 0 2 (2.1%) - Hematocrit (1) - Missing 82 0 72 75 - Missing 82 (95.3%) NA 72 (100%) 75 (78.1%) - Hemoglobin (mmol/L) - Missing 83 0 72 75 - Missing 83 (96.5%) NA 72 (100%) 75 (78.1%) - Hemoglobin A1C (1) - Missing 1 0 0 1 - Missing 1 (1.2%) NA 0 1 (1.0%) - Ketones - Missing 82 0 71 71 - Missing 82 (95.3%) NA 71 (98.6%) 71 (74.0%) - Leukocytes (10^9/L) - Not Low 83 0 70 73 - Not Low 77 (89.5%) NA 70 (97.2%) 69 (71.9%) - 1 6 (7.0%) NA 0 4 (4.2%) - 1 0 0 2 2 - Not Low 0 NA 0 1 (1.0%) - 1 0 NA 1 (1.4%) 0 - 2 0 NA 1 (1.4%) 1 (1.0%) - Lymphocytes (10^9/L) - Not Low 78 0 70 74 - Not Low 74 (86.0%) NA 67 (93.1%) 70 (72.9%) - 1 4 (4.7%) NA 3 (4.2%) 3 (3.1%) - 2 0 NA 0 1 (1.0%) - 1 2 0 0 1 - Not Low 1 (1.2%) NA 0 1 (1.0%) - 2 1 (1.2%) NA 0 0 - 2 1 0 0 0 - Not Low 1 (1.2%) NA 0 0 - Missing 0 0 2 0 - Not Low 0 NA 2 (2.8%) 0 - Lymphocytes Abs (10^9/L) - Missing 2 0 0 0 - Missing 2 (2.3%) NA 0 0 - Lymphocytes/Leukocytes (FRACTION) - Missing 3 0 2 0 - Missing 3 (3.5%) NA 2 (2.8%) 0 - Macrocytes - Missing 21 0 13 12 - Missing 21 (24.4%) NA 13 (18.1%) 12 (12.5%) - Microcytes - Missing 0 0 1 0 - Missing 0 NA 1 (1.4%) 0 - Monocytes (10^9/L) - Missing 81 0 72 75 - Missing 81 (94.2%) NA 72 (100%) 75 (78.1%) - Monocytes/Leukocytes (FRACTION) - Missing 3 0 2 0 - Missing 3 (3.5%) NA 2 (2.8%) 0 - pH - Missing 82 0 71 71 - Missing 82 (95.3%) NA 71 (98.6%) 71 (74.0%) - Phosphate (mmol/L) - Not Low 83 0 72 74 - Not Low 78 (90.7%) NA 68 (94.4%) 72 (75.0%) - 2 4 (4.7%) NA 4 (5.6%) 2 (2.1%) - 3 1 (1.2%) NA 0 0 - Missing 0 0 0 1 - Not Low 0 NA 0 1 (1.0%) - Platelet (10^9/L) - Not Low 83 0 71 72 - Not Low 83 (96.5%) NA 70 (97.2%) 72 (75.0%) - 1 0 NA 1 (1.4%) 0 - 1 0 0 1 1 - 1 0 NA 1 (1.4%) 1 (1.0%) - Missing 0 0 0 1 - Not Low 0 NA 0 1 (1.0%) - Poikilocytes - Missing 1 0 1 0 - Missing 1 (1.2%) NA 1 (1.4%) 0 - Polychromasia - Missing 8 0 4 7 - Missing 8 (9.3%) NA 4 (5.6%) 7 (7.3%) - Potassium (mmol/L) - Not Low 83 0 72 74 - Not Low 80 (93.0%) NA 70 (97.2%) 72 (75.0%) - 2 3 (3.5%) NA 2 (2.8%) 2 (2.1%) - Missing 0 0 0 1 - Not Low 0 NA 0 1 (1.0%) - Protein (g/L) - Missing 83 0 72 75 - Missing 83 (96.5%) NA 72 (100%) 75 (78.1%) - Sodium (mmol/L) - Not Low 81 0 70 73 - Not Low 78 (90.7%) NA 66 (91.7%) 71 (74.0%) - 1 3 (3.5%) NA 4 (5.6%) 2 (2.1%) - 1 2 0 2 2 - Not Low 1 (1.2%) NA 1 (1.4%) 1 (1.0%) - 1 0 NA 1 (1.4%) 1 (1.0%) - 3 1 (1.2%) NA 0 0 - Specific Gravity - Missing 82 0 71 71 - Missing 82 (95.3%) NA 71 (98.6%) 71 (74.0%) - Urate (umol/L) - Missing 83 0 72 75 - Missing 83 (96.5%) NA 72 (100%) 75 (78.1%) - Urobilinogen - Missing 82 0 71 71 - Missing 82 (95.3%) NA 71 (98.6%) 71 (74.0%) - Vitamin B12 (pmol/L) - Missing 1 0 0 1 - Missing 1 (1.2%) NA 0 1 (1.0%) + Parameter + Baseline NCI-CTCAE Grade Placebo Xanomeline High Dose Xanomeline Low Dose + Post-baseline NCI-CTCAE Grade (N=86) (N=72) (N=96) + ————————————————————————————————————————————————————————————————————————————————————————————————————— + Alanine Aminotransferase (U/L) + Not Low 83 72 75 + Not Low 83 (96.5%) 72 (100%) 75 (78.1%) + Albumin (g/L) + Not Low 81 72 74 + Not Low 66 (76.7%) 67 (93.1%) 62 (64.6%) + 1 14 (16.3%) 5 (6.9%) 12 (12.5%) + 2 1 (1.2%) 0 0 + 1 2 0 1 + 1 1 (1.2%) 0 1 (1.0%) + 2 1 (1.2%) 0 0 + Alkaline Phosphatase (U/L) + Not Low 83 72 74 + Not Low 83 (96.5%) 72 (100%) 74 (77.1%) + Missing 0 0 1 + Not Low 0 0 1 (1.0%) + Aspartate Aminotransferase (U/L) + Not Low 83 72 75 + Not Low 83 (96.5%) 72 (100%) 75 (78.1%) + Bilirubin (umol/L) + Not Low 83 72 74 + Not Low 83 (96.5%) 72 (100%) 74 (77.1%) + Blood Urea Nitrogen (mmol/L) + Missing 83 72 75 + Missing 83 (96.5%) 72 (100%) 75 (78.1%) + Calcium (mmol/L) + Not Low 82 71 73 + Not Low 72 (83.7%) 62 (86.1%) 65 (67.7%) + 1 10 (11.6%) 7 (9.7%) 7 (7.3%) + 2 0 2 (2.8%) 1 (1.0%) + 1 1 1 2 + Not Low 1 (1.2%) 0 2 (2.1%) + 1 0 1 (1.4%) 0 + Cholesterol (mmol/L) + Not Low 83 72 75 + Not Low 83 (96.5%) 72 (100%) 75 (78.1%) + Creatinine (umol/L) + Not Low 83 72 75 + Not Low 83 (96.5%) 72 (100%) 75 (78.1%) + Gamma Glutamyl Transferase (U/L) + Not Low 83 72 75 + Not Low 83 (96.5%) 72 (100%) 75 (78.1%) + Microcytes + Missing 0 1 0 + Missing 0 1 (1.4%) 0 + Phosphate (mmol/L) + Not Low 83 72 74 + Not Low 78 (90.7%) 68 (94.4%) 72 (75.0%) + 2 4 (4.7%) 4 (5.6%) 2 (2.1%) + 3 1 (1.2%) 0 0 + Missing 0 0 1 + Not Low 0 0 1 (1.0%) + Protein (g/L) + Missing 83 72 75 + Missing 83 (96.5%) 72 (100%) 75 (78.1%) + Sodium (mmol/L) + Not Low 81 70 73 + Not Low 78 (90.7%) 66 (91.7%) 71 (74.0%) + 1 3 (3.5%) 4 (5.6%) 2 (2.1%) + 1 2 2 2 + Not Low 1 (1.2%) 1 (1.4%) 1 (1.0%) + 1 0 1 (1.4%) 1 (1.0%) + 3 1 (1.2%) 0 0 + Urate (umol/L) + Missing 83 72 75 + Missing 83 (96.5%) 72 (100%) 75 (78.1%) # LBT14 variant 3: LOW without baseline missing works as expected Code res Output - Parameter - Baseline NCI-CTCAE Grade Placebo Screen Failure Xanomeline High Dose Xanomeline Low Dose - Post-baseline NCI-CTCAE Grade (N=86) (N=0) (N=72) (N=96) - —————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— - Alanine Aminotransferase (U/L) - Not High 79 0 68 73 - Not High 73 (84.9%) NA 61 (84.7%) 65 (67.7%) - 1 5 (5.8%) NA 6 (8.3%) 8 (8.3%) - 2 1 (1.2%) NA 1 (1.4%) 0 - 1 4 0 4 2 - Not High 1 (1.2%) NA 0 0 - 1 2 (2.3%) NA 4 (5.6%) 2 (2.1%) - 2 1 (1.2%) NA 0 0 - Albumin (g/L) - Not High 83 0 72 75 - Not High 83 (96.5%) NA 72 (100%) 75 (78.1%) - Alkaline Phosphatase (U/L) - Not High 78 0 71 71 - Not High 74 (86.0%) NA 67 (93.1%) 67 (69.8%) - 1 3 (3.5%) NA 4 (5.6%) 4 (4.2%) - 3 1 (1.2%) NA 0 0 - 1 4 0 0 3 - Not High 1 (1.2%) NA 0 0 - 1 3 (3.5%) NA 0 3 (3.1%) - 2 1 0 1 0 - 2 0 NA 1 (1.4%) 0 - 3 1 (1.2%) NA 0 0 - Aspartate Aminotransferase (U/L) - Not High 77 0 69 67 - Not High 69 (80.2%) NA 64 (88.9%) 61 (63.5%) - 1 7 (8.1%) NA 4 (5.6%) 6 (6.2%) - 2 1 (1.2%) NA 1 (1.4%) 0 - 1 6 0 3 8 - Not High 2 (2.3%) NA 1 (1.4%) 4 (4.2%) - 1 3 (3.5%) NA 2 (2.8%) 3 (3.1%) - 2 1 (1.2%) NA 0 1 (1.0%) - Bilirubin (umol/L) - Not High 81 0 69 71 - Not High 77 (89.5%) NA 67 (93.1%) 70 (72.9%) - 1 4 (4.7%) NA 2 (2.8%) 1 (1.0%) - 1 2 0 2 3 - Not High 0 NA 0 2 (2.1%) - 1 1 (1.2%) NA 0 0 - 2 0 NA 2 (2.8%) 1 (1.0%) - 3 1 (1.2%) NA 0 0 - 2 0 0 1 0 - 2 0 NA 1 (1.4%) 0 - Calcium (mmol/L) - Not High 83 0 72 73 - Not High 82 (95.3%) NA 70 (97.2%) 71 (74.0%) - 1 1 (1.2%) NA 2 (2.8%) 2 (2.1%) - 1 0 0 0 2 - Not High 0 NA 0 1 (1.0%) - 1 0 NA 0 1 (1.0%) - Cholesterol (mmol/L) - Not High 79 0 70 74 - Not High 76 (88.4%) NA 67 (93.1%) 71 (74.0%) - 1 1 (1.2%) NA 3 (4.2%) 1 (1.0%) - 2 2 (2.3%) NA 0 2 (2.1%) - 2 4 0 2 1 - Not High 2 (2.3%) NA 1 (1.4%) 0 - 2 2 (2.3%) NA 1 (1.4%) 1 (1.0%) - Creatinine (umol/L) - Not High 82 0 67 70 - Not High 25 (29.1%) NA 16 (22.2%) 20 (20.8%) - 1 57 (66.3%) NA 51 (70.8%) 50 (52.1%) - 1 1 0 5 5 - 1 1 (1.2%) NA 5 (6.9%) 5 (5.2%) - Creatinine Kinase (U/L) - Not High 79 0 65 68 - Not High 63 (73.3%) NA 57 (79.2%) 61 (63.5%) - 1 11 (12.8%) NA 8 (11.1%) 6 (6.2%) - 2 3 (3.5%) NA 0 1 (1.0%) - 3 2 (2.3%) NA 0 0 - 1 4 0 7 6 - Not High 2 (2.3%) NA 2 (2.8%) 2 (2.1%) - 1 2 (2.3%) NA 4 (5.6%) 4 (4.2%) - 3 0 NA 1 (1.4%) 0 - 2 0 0 0 1 - Not High 0 NA 0 1 (1.0%) - Gamma Glutamyl Transferase (U/L) - Not High 79 0 69 70 - Not High 76 (88.4%) NA 64 (88.9%) 65 (67.7%) - 1 3 (3.5%) NA 4 (5.6%) 5 (5.2%) - 2 0 NA 1 (1.4%) 0 - 1 3 0 3 5 - Not High 0 NA 0 1 (1.0%) - 1 3 (3.5%) NA 2 (2.8%) 4 (4.2%) - 2 0 NA 1 (1.4%) 0 - 3 1 0 0 0 - 3 1 (1.2%) NA 0 0 - Glucose (mmol/L) - Not High 82 0 72 75 - Not High 81 (94.2%) NA 66 (91.7%) 74 (77.1%) - 3 1 (1.2%) NA 6 (8.3%) 1 (1.0%) - 3 1 0 0 0 - 3 1 (1.2%) NA 0 0 - Leukocytes (10^9/L) - Not High 83 0 72 75 - Not High 83 (96.5%) NA 72 (100%) 75 (78.1%) - Lymphocytes (10^9/L) - Not High 81 0 70 75 - Not High 81 (94.2%) NA 70 (97.2%) 75 (78.1%) - Phosphate (mmol/L) - Not High 83 0 72 74 - Not High 83 (96.5%) NA 72 (100%) 74 (77.1%) - Platelet (10^9/L) - Not High 83 0 72 73 - Not High 83 (96.5%) NA 72 (100%) 73 (76.0%) - Potassium (mmol/L) - Not High 82 0 72 74 - Not High 82 (95.3%) NA 70 (97.2%) 74 (77.1%) - 1 0 NA 1 (1.4%) 0 - 2 0 NA 1 (1.4%) 0 - 2 1 0 0 0 - 2 1 (1.2%) NA 0 0 - Sodium (mmol/L) - Not High 80 0 68 75 - Not High 70 (81.4%) NA 59 (81.9%) 69 (71.9%) - 1 10 (11.6%) NA 7 (9.7%) 6 (6.2%) - 2 0 NA 2 (2.8%) 0 - 1 3 0 4 0 - Not High 3 (3.5%) NA 2 (2.8%) 0 - 1 0 NA 2 (2.8%) 0 + Parameter + Baseline NCI-CTCAE Grade Placebo Xanomeline High Dose Xanomeline Low Dose + Post-baseline NCI-CTCAE Grade (N=86) (N=72) (N=96) + ————————————————————————————————————————————————————————————————————————————————————————————————————— + Alanine Aminotransferase (U/L) + Not High 79 68 73 + Not High 73 (84.9%) 61 (84.7%) 65 (67.7%) + 1 5 (5.8%) 6 (8.3%) 8 (8.3%) + 2 1 (1.2%) 1 (1.4%) 0 + 1 4 4 2 + Not High 1 (1.2%) 0 0 + 1 2 (2.3%) 4 (5.6%) 2 (2.1%) + 2 1 (1.2%) 0 0 + Albumin (g/L) + Not High 83 72 75 + Not High 83 (96.5%) 72 (100%) 75 (78.1%) + Alkaline Phosphatase (U/L) + Not High 78 71 71 + Not High 74 (86.0%) 67 (93.1%) 67 (69.8%) + 1 3 (3.5%) 4 (5.6%) 4 (4.2%) + 3 1 (1.2%) 0 0 + 1 4 0 3 + Not High 1 (1.2%) 0 0 + 1 3 (3.5%) 0 3 (3.1%) + 2 1 1 0 + 2 0 1 (1.4%) 0 + 3 1 (1.2%) 0 0 + Aspartate Aminotransferase (U/L) + Not High 77 69 67 + Not High 69 (80.2%) 64 (88.9%) 61 (63.5%) + 1 7 (8.1%) 4 (5.6%) 6 (6.2%) + 2 1 (1.2%) 1 (1.4%) 0 + 1 6 3 8 + Not High 2 (2.3%) 1 (1.4%) 4 (4.2%) + 1 3 (3.5%) 2 (2.8%) 3 (3.1%) + 2 1 (1.2%) 0 1 (1.0%) + Bilirubin (umol/L) + Not High 81 69 71 + Not High 77 (89.5%) 67 (93.1%) 70 (72.9%) + 1 4 (4.7%) 2 (2.8%) 1 (1.0%) + 1 2 2 3 + Not High 0 0 2 (2.1%) + 1 1 (1.2%) 0 0 + 2 0 2 (2.8%) 1 (1.0%) + 3 1 (1.2%) 0 0 + 2 0 1 0 + 2 0 1 (1.4%) 0 + Calcium (mmol/L) + Not High 83 72 73 + Not High 82 (95.3%) 70 (97.2%) 71 (74.0%) + 1 1 (1.2%) 2 (2.8%) 2 (2.1%) + 1 0 0 2 + Not High 0 0 1 (1.0%) + 1 0 0 1 (1.0%) + Cholesterol (mmol/L) + Not High 79 70 74 + Not High 76 (88.4%) 67 (93.1%) 71 (74.0%) + 1 1 (1.2%) 3 (4.2%) 1 (1.0%) + 2 2 (2.3%) 0 2 (2.1%) + 2 4 2 1 + Not High 2 (2.3%) 1 (1.4%) 0 + 2 2 (2.3%) 1 (1.4%) 1 (1.0%) + Creatinine (umol/L) + Not High 82 67 70 + Not High 25 (29.1%) 16 (22.2%) 20 (20.8%) + 1 57 (66.3%) 51 (70.8%) 50 (52.1%) + 1 1 5 5 + 1 1 (1.2%) 5 (6.9%) 5 (5.2%) + Gamma Glutamyl Transferase (U/L) + Not High 79 69 70 + Not High 76 (88.4%) 64 (88.9%) 65 (67.7%) + 1 3 (3.5%) 4 (5.6%) 5 (5.2%) + 2 0 1 (1.4%) 0 + 1 3 3 5 + Not High 0 0 1 (1.0%) + 1 3 (3.5%) 2 (2.8%) 4 (4.2%) + 2 0 1 (1.4%) 0 + 3 1 0 0 + 3 1 (1.2%) 0 0 + Phosphate (mmol/L) + Not High 83 72 74 + Not High 83 (96.5%) 72 (100%) 74 (77.1%) + Sodium (mmol/L) + Not High 80 68 75 + Not High 70 (81.4%) 59 (81.9%) 69 (71.9%) + 1 10 (11.6%) 7 (9.7%) 6 (6.2%) + 2 0 2 (2.8%) 0 + 1 3 4 0 + Not High 3 (3.5%) 2 (2.8%) 0 + 1 0 2 (2.8%) 0 # LBT14 variant 4: LOW and force 1 missing both baseline and post-baseline, then force the missing baseline as 0 as expected Code res Output - Parameter - Baseline NCI-CTCAE Grade Placebo Screen Failure Xanomeline High Dose Xanomeline Low Dose - Post-baseline NCI-CTCAE Grade (N=86) (N=0) (N=72) (N=96) - —————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— - Alanine Aminotransferase (U/L) - Not Low 83 0 72 75 - Not Low 83 (96.5%) NA 72 (100%) 75 (78.1%) - Albumin (g/L) - Not Low 81 0 72 74 - Not Low 66 (76.7%) NA 67 (93.1%) 62 (64.6%) - 1 14 (16.3%) NA 5 (6.9%) 12 (12.5%) - 2 1 (1.2%) NA 0 0 - 1 2 0 0 1 - 1 1 (1.2%) NA 0 1 (1.0%) - 2 1 (1.2%) NA 0 0 - Alkaline Phosphatase (U/L) - Not Low 83 0 72 75 - Not Low 83 (96.5%) NA 72 (100%) 75 (78.1%) - Aspartate Aminotransferase (U/L) - Not Low 83 0 72 75 - Not Low 83 (96.5%) NA 72 (100%) 75 (78.1%) - Bilirubin (umol/L) - Not Low 83 0 72 74 - Not Low 83 (96.5%) NA 72 (100%) 74 (77.1%) - Calcium (mmol/L) - Not Low 82 0 71 73 - Not Low 72 (83.7%) NA 62 (86.1%) 65 (67.7%) - 1 10 (11.6%) NA 7 (9.7%) 7 (7.3%) - 2 0 NA 2 (2.8%) 1 (1.0%) - 1 1 0 1 2 - Not Low 1 (1.2%) NA 0 2 (2.1%) - 1 0 NA 1 (1.4%) 0 - Cholesterol (mmol/L) - Not Low 83 0 72 75 - Not Low 83 (96.5%) NA 72 (100%) 75 (78.1%) - Creatinine (umol/L) - Not Low 83 0 72 75 - Not Low 83 (96.5%) NA 72 (100%) 75 (78.1%) - Creatinine Kinase (U/L) - Not Low 83 0 72 75 - Not Low 83 (96.5%) NA 72 (100%) 75 (78.1%) - Gamma Glutamyl Transferase (U/L) - Not Low 83 0 72 75 - Not Low 83 (96.5%) NA 72 (100%) 75 (78.1%) - Glucose (mmol/L) - Not Low 83 0 72 75 - Not Low 82 (95.3%) NA 72 (100%) 73 (76.0%) - 2 1 (1.2%) NA 0 2 (2.1%) - Leukocytes (10^9/L) - Not Low 83 0 70 73 - Not Low 77 (89.5%) NA 70 (97.2%) 69 (71.9%) - 1 6 (7.0%) NA 0 4 (4.2%) - 1 0 0 2 2 - Not Low 0 NA 0 1 (1.0%) - 1 0 NA 1 (1.4%) 0 - 2 0 NA 1 (1.4%) 1 (1.0%) - Lymphocytes (10^9/L) - Not Low 78 0 72 74 - Not Low 74 (86.0%) NA 69 (95.8%) 70 (72.9%) - 1 4 (4.7%) NA 3 (4.2%) 3 (3.1%) - 2 0 NA 0 1 (1.0%) - 1 2 0 0 1 - Not Low 1 (1.2%) NA 0 1 (1.0%) - 2 1 (1.2%) NA 0 0 - 2 1 0 0 0 - Not Low 1 (1.2%) NA 0 0 - Phosphate (mmol/L) - Not Low 83 0 72 75 - Not Low 78 (90.7%) NA 68 (94.4%) 73 (76.0%) - 2 4 (4.7%) NA 4 (5.6%) 2 (2.1%) - 3 1 (1.2%) NA 0 0 - Platelet (10^9/L) - Not Low 83 0 71 73 - Not Low 83 (96.5%) NA 70 (97.2%) 73 (76.0%) - 1 0 NA 1 (1.4%) 0 - 1 0 0 1 1 - 1 0 NA 1 (1.4%) 1 (1.0%) - Potassium (mmol/L) - Not Low 83 0 72 75 - Not Low 80 (93.0%) NA 70 (97.2%) 73 (76.0%) - 2 3 (3.5%) NA 2 (2.8%) 2 (2.1%) - Sodium (mmol/L) - Not Low 81 0 70 73 - Not Low 78 (90.7%) NA 66 (91.7%) 71 (74.0%) - 1 3 (3.5%) NA 4 (5.6%) 2 (2.1%) - 1 2 0 2 2 - Not Low 1 (1.2%) NA 1 (1.4%) 1 (1.0%) - 1 0 NA 1 (1.4%) 1 (1.0%) - 3 1 (1.2%) NA 0 0 + Parameter + Baseline NCI-CTCAE Grade Placebo Xanomeline High Dose Xanomeline Low Dose + Post-baseline NCI-CTCAE Grade (N=86) (N=72) (N=96) + ————————————————————————————————————————————————————————————————————————————————————————————————————— + Alanine Aminotransferase (U/L) + Not Low 83 72 75 + Not Low 83 (96.5%) 72 (100%) 75 (78.1%) + Albumin (g/L) + Not Low 81 72 74 + Not Low 66 (76.7%) 67 (93.1%) 62 (64.6%) + 1 14 (16.3%) 5 (6.9%) 12 (12.5%) + 2 1 (1.2%) 0 0 + 1 2 0 1 + 1 1 (1.2%) 0 1 (1.0%) + 2 1 (1.2%) 0 0 + Alkaline Phosphatase (U/L) + Not Low 83 72 75 + Not Low 83 (96.5%) 72 (100%) 75 (78.1%) + Aspartate Aminotransferase (U/L) + Not Low 83 72 75 + Not Low 83 (96.5%) 72 (100%) 75 (78.1%) + Bilirubin (umol/L) + Not Low 83 72 74 + Not Low 83 (96.5%) 72 (100%) 74 (77.1%) + Calcium (mmol/L) + Not Low 82 71 73 + Not Low 72 (83.7%) 62 (86.1%) 65 (67.7%) + 1 10 (11.6%) 7 (9.7%) 7 (7.3%) + 2 0 2 (2.8%) 1 (1.0%) + 1 1 1 2 + Not Low 1 (1.2%) 0 2 (2.1%) + 1 0 1 (1.4%) 0 + Cholesterol (mmol/L) + Not Low 83 72 75 + Not Low 83 (96.5%) 72 (100%) 75 (78.1%) + Creatinine (umol/L) + Not Low 83 72 75 + Not Low 83 (96.5%) 72 (100%) 75 (78.1%) + Gamma Glutamyl Transferase (U/L) + Not Low 83 72 75 + Not Low 83 (96.5%) 72 (100%) 75 (78.1%) + Phosphate (mmol/L) + Not Low 83 72 75 + Not Low 78 (90.7%) 68 (94.4%) 73 (76.0%) + 2 4 (4.7%) 4 (5.6%) 2 (2.1%) + 3 1 (1.2%) 0 0 + Sodium (mmol/L) + Not Low 81 70 73 + Not Low 78 (90.7%) 66 (91.7%) 71 (74.0%) + 1 3 (3.5%) 4 (5.6%) 2 (2.1%) + 1 2 2 2 + Not Low 1 (1.2%) 1 (1.4%) 1 (1.0%) + 1 0 1 (1.4%) 1 (1.0%) + 3 1 (1.2%) 0 0 # LBT14 variant 5: HIGH with fillings works as expected Code res Output - Parameter - Baseline NCI-CTCAE Grade Placebo Screen Failure Xanomeline High Dose Xanomeline Low Dose - Post-baseline NCI-CTCAE Grade (N=86) (N=0) (N=72) (N=96) - ——————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— - Alanine Aminotransferase (U/L) - Not High 79 0 68 73 - Not High 73 (84.9%) NA 61 (84.7%) 65 (67.7%) - 1 5 (5.8%) NA 6 (8.3%) 8 (8.3%) - 2 1 (1.2%) NA 1 (1.4%) 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 4 0 4 2 - Not High 1 (1.2%) NA 0 0 - 1 2 (2.3%) NA 4 (5.6%) 2 (2.1%) - 2 1 (1.2%) NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Albumin (g/L) - Not High 83 0 72 75 - Not High 83 (96.5%) NA 72 (100%) 75 (78.1%) - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Alkaline Phosphatase (U/L) - Not High 78 0 71 71 - Not High 74 (86.0%) NA 67 (93.1%) 67 (69.8%) - 1 3 (3.5%) NA 4 (5.6%) 4 (4.2%) - 2 0 NA 0 0 - 3 1 (1.2%) NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 4 0 0 3 - Not High 1 (1.2%) NA 0 0 - 1 3 (3.5%) NA 0 3 (3.1%) - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 1 0 1 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 1 (1.4%) 0 - 3 1 (1.2%) NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 0 0 0 1 - Not High 0 NA 0 1 (1.0%) - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Anisocytes - Not High 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 26 0 15 21 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 26 (30.2%) NA 15 (20.8%) 21 (21.9%) - Aspartate Aminotransferase (U/L) - Not High 77 0 69 67 - Not High 69 (80.2%) NA 64 (88.9%) 61 (63.5%) - 1 7 (8.1%) NA 4 (5.6%) 6 (6.2%) - 2 1 (1.2%) NA 1 (1.4%) 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 6 0 3 8 - Not High 2 (2.3%) NA 1 (1.4%) 4 (4.2%) - 1 3 (3.5%) NA 2 (2.8%) 3 (3.1%) - 2 1 (1.2%) NA 0 1 (1.0%) - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Basophils (10^9/L) - Not High 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 80 0 70 75 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 80 (93.0%) NA 70 (97.2%) 75 (78.1%) - Basophils Abs (10^9/L) - Not High 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 3 0 2 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 3 (3.5%) NA 2 (2.8%) 0 - Basophils/Leukocytes (FRACTION) - Not High 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 3 0 2 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 3 (3.5%) NA 2 (2.8%) 0 - Bilirubin (umol/L) - Not High 81 0 69 71 - Not High 77 (89.5%) NA 67 (93.1%) 70 (72.9%) - 1 4 (4.7%) NA 2 (2.8%) 1 (1.0%) - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 2 0 2 3 - Not High 0 NA 0 2 (2.1%) - 1 1 (1.2%) NA 0 0 - 2 0 NA 2 (2.8%) 1 (1.0%) - 3 1 (1.2%) NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 0 0 1 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 1 (1.4%) 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Blood Urea Nitrogen (mmol/L) - Not High 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 83 0 72 75 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 83 (96.5%) NA 72 (100%) 75 (78.1%) - Calcium (mmol/L) - Not High 83 0 72 73 - Not High 82 (95.3%) NA 70 (97.2%) 71 (74.0%) - 1 1 (1.2%) NA 2 (2.8%) 2 (2.1%) - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 0 0 0 2 - Not High 0 NA 0 1 (1.0%) - 1 0 NA 0 1 (1.0%) - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Chloride (mmol/L) - Not High 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 83 0 72 75 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 83 (96.5%) NA 72 (100%) 75 (78.1%) - Cholesterol (mmol/L) - Not High 79 0 70 74 - Not High 76 (88.4%) NA 67 (93.1%) 71 (74.0%) - 1 1 (1.2%) NA 3 (4.2%) 1 (1.0%) - 2 2 (2.3%) NA 0 2 (2.1%) - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 4 0 2 1 - Not High 2 (2.3%) NA 1 (1.4%) 0 - 1 0 NA 0 0 - 2 2 (2.3%) NA 1 (1.4%) 1 (1.0%) - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Creatinine (umol/L) - Not High 82 0 67 70 - Not High 25 (29.1%) NA 16 (22.2%) 20 (20.8%) - 1 57 (66.3%) NA 51 (70.8%) 50 (52.1%) - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 1 0 5 5 - Not High 0 NA 0 0 - 1 1 (1.2%) NA 5 (6.9%) 5 (5.2%) - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Creatinine Kinase (U/L) - Not High 79 0 65 68 - Not High 63 (73.3%) NA 57 (79.2%) 61 (63.5%) - 1 11 (12.8%) NA 8 (11.1%) 6 (6.2%) - 2 3 (3.5%) NA 0 1 (1.0%) - 3 2 (2.3%) NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 4 0 7 6 - Not High 2 (2.3%) NA 2 (2.8%) 2 (2.1%) - 1 2 (2.3%) NA 4 (5.6%) 4 (4.2%) - 2 0 NA 0 0 - 3 0 NA 1 (1.4%) 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 0 0 0 1 - Not High 0 NA 0 1 (1.0%) - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Eosinophils (10^9/L) - Not High 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 81 0 72 75 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 81 (94.2%) NA 72 (100%) 75 (78.1%) - Eosinophils/Leukocytes (FRACTION) - Not High 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 3 0 2 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 3 (3.5%) NA 2 (2.8%) 0 - Ery. Mean Corpuscular Hemoglobin (fmol(Fe)) - Not High 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 83 0 72 75 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 83 (96.5%) NA 72 (100%) 75 (78.1%) - Ery. Mean Corpuscular HGB Concentration (mmol/L) - Not High 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 82 0 72 75 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 82 (95.3%) NA 72 (100%) 75 (78.1%) - Ery. Mean Corpuscular Volume (f/L) - Not High 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 82 0 72 75 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 82 (95.3%) NA 72 (100%) 75 (78.1%) - Erythrocytes (TI/L) - Not High 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 83 0 72 75 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 83 (96.5%) NA 72 (100%) 75 (78.1%) - Gamma Glutamyl Transferase (U/L) - Not High 79 0 69 70 - Not High 76 (88.4%) NA 64 (88.9%) 65 (67.7%) - 1 3 (3.5%) NA 4 (5.6%) 5 (5.2%) - 2 0 NA 1 (1.4%) 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 3 0 3 5 - Not High 0 NA 0 1 (1.0%) - 1 3 (3.5%) NA 2 (2.8%) 4 (4.2%) - 2 0 NA 1 (1.4%) 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 1 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 1 (1.2%) NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Glucose (mmol/L) - Not High 82 0 72 75 - Not High 81 (94.2%) NA 66 (91.7%) 74 (77.1%) - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 1 (1.2%) NA 6 (8.3%) 1 (1.0%) - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 1 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 1 (1.2%) NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Hematocrit (1) - Not High 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 82 0 72 75 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 82 (95.3%) NA 72 (100%) 75 (78.1%) - Hemoglobin (mmol/L) - Not High 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 83 0 72 75 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 83 (96.5%) NA 72 (100%) 75 (78.1%) - Hemoglobin A1C (1) - Not High 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 1 0 0 1 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 1 (1.2%) NA 0 1 (1.0%) - Ketones - Not High 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 82 0 71 71 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 82 (95.3%) NA 71 (98.6%) 71 (74.0%) - Leukocytes (10^9/L) - Not High 83 0 72 75 - Not High 83 (96.5%) NA 72 (100%) 75 (78.1%) - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Lymphocytes (10^9/L) - Not High 81 0 70 75 - Not High 81 (94.2%) NA 70 (97.2%) 75 (78.1%) - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 0 0 1 0 - Not High 0 NA 1 (1.4%) 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Lymphocytes Abs (10^9/L) - Not High 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 2 0 1 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 2 (2.3%) NA 1 (1.4%) 0 - Lymphocytes/Leukocytes (FRACTION) - Not High 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 3 0 2 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 3 (3.5%) NA 2 (2.8%) 0 - Macrocytes - Not High 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 21 0 13 12 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 21 (24.4%) NA 13 (18.1%) 12 (12.5%) - Microcytes - Not High 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 0 0 1 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 1 (1.4%) 0 - Monocytes (10^9/L) - Not High 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 81 0 72 75 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 81 (94.2%) NA 72 (100%) 75 (78.1%) - Monocytes/Leukocytes (FRACTION) - Not High 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 3 0 2 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 3 (3.5%) NA 2 (2.8%) 0 - pH - Not High 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 82 0 71 71 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 82 (95.3%) NA 71 (98.6%) 71 (74.0%) - Phosphate (mmol/L) - Not High 83 0 72 74 - Not High 83 (96.5%) NA 72 (100%) 74 (77.1%) - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 0 0 0 1 - Not High 0 NA 0 1 (1.0%) - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Platelet (10^9/L) - Not High 83 0 72 73 - Not High 83 (96.5%) NA 72 (100%) 73 (76.0%) - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 0 0 0 1 - Not High 0 NA 0 1 (1.0%) - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Poikilocytes - Not High 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 1 0 1 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 1 (1.2%) NA 1 (1.4%) 0 - Polychromasia - Not High 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 8 0 4 7 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 8 (9.3%) NA 4 (5.6%) 7 (7.3%) - Potassium (mmol/L) - Not High 82 0 72 74 - Not High 82 (95.3%) NA 70 (97.2%) 74 (77.1%) - 1 0 NA 1 (1.4%) 0 - 2 0 NA 1 (1.4%) 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 1 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 1 (1.2%) NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 0 0 0 1 - Not High 0 NA 0 1 (1.0%) - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Protein (g/L) - Not High 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 83 0 72 75 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 83 (96.5%) NA 72 (100%) 75 (78.1%) - Sodium (mmol/L) - Not High 80 0 68 75 - Not High 70 (81.4%) NA 59 (81.9%) 69 (71.9%) - 1 10 (11.6%) NA 7 (9.7%) 6 (6.2%) - 2 0 NA 2 (2.8%) 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 3 0 4 0 - Not High 3 (3.5%) NA 2 (2.8%) 0 - 1 0 NA 2 (2.8%) 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Specific Gravity - Not High 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 82 0 71 71 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 82 (95.3%) NA 71 (98.6%) 71 (74.0%) - Urate (umol/L) - Not High 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 83 0 72 75 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 83 (96.5%) NA 72 (100%) 75 (78.1%) - Urobilinogen - Not High 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 82 0 71 71 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 82 (95.3%) NA 71 (98.6%) 71 (74.0%) - Vitamin B12 (pmol/L) - Not High 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 1 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 2 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 3 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - 4 0 0 0 0 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 0 NA 0 0 - Missing 1 0 0 1 - Not High 0 NA 0 0 - 1 0 NA 0 0 - 2 0 NA 0 0 - 3 0 NA 0 0 - 4 0 NA 0 0 - Missing 1 (1.2%) NA 0 1 (1.0%) + Parameter + Baseline NCI-CTCAE Grade Placebo Xanomeline High Dose Xanomeline Low Dose + Post-baseline NCI-CTCAE Grade (N=86) (N=72) (N=96) + ————————————————————————————————————————————————————————————————————————————————————————————————————— + Alanine Aminotransferase (U/L) + Not High 79 68 73 + Not High 73 (84.9%) 61 (84.7%) 65 (67.7%) + 1 5 (5.8%) 6 (8.3%) 8 (8.3%) + 2 1 (1.2%) 1 (1.4%) 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 1 4 4 2 + Not High 1 (1.2%) 0 0 + 1 2 (2.3%) 4 (5.6%) 2 (2.1%) + 2 1 (1.2%) 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 2 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 3 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 4 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + Missing 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + Albumin (g/L) + Not High 83 72 75 + Not High 83 (96.5%) 72 (100%) 75 (78.1%) + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 1 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 2 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 3 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 4 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + Missing 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + Alkaline Phosphatase (U/L) + Not High 78 71 71 + Not High 74 (86.0%) 67 (93.1%) 67 (69.8%) + 1 3 (3.5%) 4 (5.6%) 4 (4.2%) + 2 0 0 0 + 3 1 (1.2%) 0 0 + 4 0 0 0 + Missing 0 0 0 + 1 4 0 3 + Not High 1 (1.2%) 0 0 + 1 3 (3.5%) 0 3 (3.1%) + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 2 1 1 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 1 (1.4%) 0 + 3 1 (1.2%) 0 0 + 4 0 0 0 + Missing 0 0 0 + 3 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 4 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + Missing 0 0 1 + Not High 0 0 1 (1.0%) + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + Aspartate Aminotransferase (U/L) + Not High 77 69 67 + Not High 69 (80.2%) 64 (88.9%) 61 (63.5%) + 1 7 (8.1%) 4 (5.6%) 6 (6.2%) + 2 1 (1.2%) 1 (1.4%) 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 1 6 3 8 + Not High 2 (2.3%) 1 (1.4%) 4 (4.2%) + 1 3 (3.5%) 2 (2.8%) 3 (3.1%) + 2 1 (1.2%) 0 1 (1.0%) + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 2 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 3 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 4 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + Missing 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + Bilirubin (umol/L) + Not High 81 69 71 + Not High 77 (89.5%) 67 (93.1%) 70 (72.9%) + 1 4 (4.7%) 2 (2.8%) 1 (1.0%) + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 1 2 2 3 + Not High 0 0 2 (2.1%) + 1 1 (1.2%) 0 0 + 2 0 2 (2.8%) 1 (1.0%) + 3 1 (1.2%) 0 0 + 4 0 0 0 + Missing 0 0 0 + 2 0 1 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 1 (1.4%) 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 3 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 4 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + Missing 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + Blood Urea Nitrogen (mmol/L) + Not High 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 1 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 2 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 3 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 4 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + Missing 83 72 75 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 83 (96.5%) 72 (100%) 75 (78.1%) + Calcium (mmol/L) + Not High 83 72 73 + Not High 82 (95.3%) 70 (97.2%) 71 (74.0%) + 1 1 (1.2%) 2 (2.8%) 2 (2.1%) + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 1 0 0 2 + Not High 0 0 1 (1.0%) + 1 0 0 1 (1.0%) + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 2 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 3 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 4 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + Missing 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + Cholesterol (mmol/L) + Not High 79 70 74 + Not High 76 (88.4%) 67 (93.1%) 71 (74.0%) + 1 1 (1.2%) 3 (4.2%) 1 (1.0%) + 2 2 (2.3%) 0 2 (2.1%) + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 1 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 2 4 2 1 + Not High 2 (2.3%) 1 (1.4%) 0 + 1 0 0 0 + 2 2 (2.3%) 1 (1.4%) 1 (1.0%) + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 3 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 4 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + Missing 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + Creatinine (umol/L) + Not High 82 67 70 + Not High 25 (29.1%) 16 (22.2%) 20 (20.8%) + 1 57 (66.3%) 51 (70.8%) 50 (52.1%) + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 1 1 5 5 + Not High 0 0 0 + 1 1 (1.2%) 5 (6.9%) 5 (5.2%) + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 2 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 3 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 4 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + Missing 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + Gamma Glutamyl Transferase (U/L) + Not High 79 69 70 + Not High 76 (88.4%) 64 (88.9%) 65 (67.7%) + 1 3 (3.5%) 4 (5.6%) 5 (5.2%) + 2 0 1 (1.4%) 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 1 3 3 5 + Not High 0 0 1 (1.0%) + 1 3 (3.5%) 2 (2.8%) 4 (4.2%) + 2 0 1 (1.4%) 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 2 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 3 1 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 1 (1.2%) 0 0 + 4 0 0 0 + Missing 0 0 0 + 4 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + Missing 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + Microcytes + Not High 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 1 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 2 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 3 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 4 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + Missing 0 1 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 1 (1.4%) 0 + Phosphate (mmol/L) + Not High 83 72 74 + Not High 83 (96.5%) 72 (100%) 74 (77.1%) + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 1 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 2 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 3 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 4 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + Missing 0 0 1 + Not High 0 0 1 (1.0%) + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + Protein (g/L) + Not High 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 1 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 2 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 3 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 4 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + Missing 83 72 75 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 83 (96.5%) 72 (100%) 75 (78.1%) + Sodium (mmol/L) + Not High 80 68 75 + Not High 70 (81.4%) 59 (81.9%) 69 (71.9%) + 1 10 (11.6%) 7 (9.7%) 6 (6.2%) + 2 0 2 (2.8%) 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 1 3 4 0 + Not High 3 (3.5%) 2 (2.8%) 0 + 1 0 2 (2.8%) 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 2 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 3 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 4 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + Missing 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + Urate (umol/L) + Not High 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 1 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 2 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 3 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + 4 0 0 0 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 0 0 0 + Missing 83 72 75 + Not High 0 0 0 + 1 0 0 0 + 2 0 0 0 + 3 0 0 0 + 4 0 0 0 + Missing 83 (96.5%) 72 (100%) 75 (78.1%) diff --git a/tests/testthat/_snaps/table_lbt15.md b/tests/testthat/_snaps/table_lbt15.md index 3aca36f..354e8f8 100644 --- a/tests/testthat/_snaps/table_lbt15.md +++ b/tests/testthat/_snaps/table_lbt15.md @@ -5,7 +5,7 @@ Output Category for Lab Test Parameter Placebo Xanomeline High Dose Xanomeline Low Dose All Patients - Direction of Abnormality (N=86) (N=84) (N=84) (N=306) + Direction of Abnormality (N=86) (N=84) (N=84) (N=254) —————————————————————————————————————————————————————————————————————————————————————————————————————————————— CHEMISTRY Albumin (g/L) @@ -29,37 +29,18 @@ Cholesterol (mmol/L) low 0/83 0/73 0/74 0/230 high 0/83 0/73 0/74 0/230 - Creatinine Kinase (U/L) - low 0/83 0/73 0/74 0/230 - high 2/83 (2.4%) 1/73 (1.4%) 0/74 3/230 (1.3%) Creatinine (umol/L) low 0/83 0/73 0/74 0/230 high 0/83 0/73 0/74 0/230 Gamma Glutamyl Transferase (U/L) low 0/83 0/73 0/74 0/230 high 0/82 0/73 0/74 0/229 - Glucose (mmol/L) - low 0/83 0/73 0/74 0/230 - high 1/82 (1.2%) 6/73 (8.2%) 1/74 (1.4%) 8/229 (3.5%) Phosphate (mmol/L) low 1/83 (1.2%) 0/73 0/73 1/229 (0.4%) high 0/83 0/73 0/73 0/229 - Potassium (mmol/L) - low 0/83 0/73 0/73 0/229 - high 0/83 0/73 0/73 0/229 Sodium (mmol/L) low 1/83 (1.2%) 0/73 0/74 1/230 (0.4%) high 0/83 0/73 0/74 0/230 - HEMATOLOGY - Lymphocytes (10^9/L) - low 0/81 0/71 0/74 0/226 - high 0/81 0/71 0/74 0/226 - Platelet (10^9/L) - low 0/83 0/73 0/72 0/228 - high 0/83 0/73 0/72 0/228 - Leukocytes (10^9/L) - low 0/83 0/73 0/74 0/230 - high 0/83 0/73 0/74 0/230 # LBT15 variant 2 works as expected @@ -68,7 +49,7 @@ Output Category for Lab Test Parameter Placebo Xanomeline High Dose Xanomeline Low Dose All Patients - Direction of Abnormality (N=86) (N=84) (N=84) (N=306) + Direction of Abnormality (N=86) (N=84) (N=84) (N=254) ——————————————————————————————————————————————————————————————————————————————————————————————————————————————— CHEMISTRY Albumin (g/L) @@ -92,35 +73,16 @@ Cholesterol (mmol/L) low 0/83 0/73 0/74 0/230 high 2/79 (2.5%) 0/71 2/73 (2.7%) 4/223 (1.8%) - Creatinine Kinase (U/L) - low 0/83 0/73 0/74 0/230 - high 5/83 (6%) 1/73 (1.4%) 1/73 (1.4%) 7/229 (3.1%) Creatinine (umol/L) low 0/83 0/73 0/74 0/230 high 0/83 0/73 0/74 0/230 Gamma Glutamyl Transferase (U/L) low 0/83 0/73 0/74 0/230 high 0/82 2/73 (2.7%) 0/74 2/229 (0.9%) - Glucose (mmol/L) - low 1/83 (1.2%) 0/73 2/74 (2.7%) 3/230 (1.3%) - high 1/82 (1.2%) 6/73 (8.2%) 1/74 (1.4%) 8/229 (3.5%) Phosphate (mmol/L) low 5/83 (6%) 4/73 (5.5%) 2/73 (2.7%) 11/229 (4.8%) high 0/83 0/73 0/73 0/229 - Potassium (mmol/L) - low 3/83 (3.6%) 2/73 (2.7%) 2/73 (2.7%) 7/229 (3.1%) - high 0/82 1/73 (1.4%) 0/73 1/228 (0.4%) Sodium (mmol/L) low 1/83 (1.2%) 0/73 0/74 1/230 (0.4%) high 0/83 2/73 (2.7%) 0/74 2/230 (0.9%) - HEMATOLOGY - Lymphocytes (10^9/L) - low 1/80 (1.2%) 0/71 1/74 (1.4%) 2/225 (0.9%) - high 0/81 0/71 0/74 0/226 - Platelet (10^9/L) - low 0/83 0/73 0/72 0/228 - high 0/83 0/73 0/72 0/228 - Leukocytes (10^9/L) - low 0/83 1/73 (1.4%) 1/74 (1.4%) 2/230 (0.9%) - high 0/83 0/73 0/74 0/230 diff --git a/tests/testthat/_snaps/table_ratet01.md b/tests/testthat/_snaps/table_ratet01.md index 5b82c88..9b3ec52 100644 --- a/tests/testthat/_snaps/table_ratet01.md +++ b/tests/testthat/_snaps/table_ratet01.md @@ -3,32 +3,32 @@ Code res Output - B: Placebo A: Drug X C: Combination - (N=134) (N=134) (N=132) - —————————————————————————————————————————————————————————————————————————————————————————————————————— - Number of exacerbations per patient - 0 10 (7.46%) 6 (4.48%) 11 (8.33%) - 1 25 (18.66%) 21 (15.67%) 14 (10.61%) - 2 38 (28.36%) 41 (30.60%) 33 (25.00%) - 3 22 (16.42%) 26 (19.40%) 21 (15.91%) - 4 13 (9.70%) 18 (13.43%) 30 (22.73%) - 5 11 (8.21%) 10 (7.46%) 12 (9.09%) - 6 10 (7.46%) 7 (5.22%) 7 (5.30%) - 7 3 (2.24%) 4 (2.99%) 3 (2.27%) - 8 1 (0.75%) 1 (0.75%) 1 (0.76%) - 9 1 (0.75%) 0 (0.00%) 0 (0.00%) - Unadjusted exacerbation rate (per year) - Rate 7.2364 8.2148 9.8131 - Adjusted (QP) exacerbation rate (per year) - Rate 7.1215 8.2714 9.9508 - Rate CI (4.6899, 10.8140) (5.5080, 12.4212) (6.6579, 14.8723) - Rate Ratio 1.1615 1.3973 - Rate Ratio CI (0.6462, 2.0877) (0.7789, 2.5067) - p value 0.6169 0.2619 - Adjusted (NB) exacerbation rate (per year) - Rate 2.7374 2.8150 2.9789 - Rate CI (2.3932, 3.1311) (2.4681, 3.2106) (2.6152, 3.3932) - Rate Ratio 1.0283 1.0882 - Rate Ratio CI (0.8856, 1.1941) (0.9381, 1.2624) - p value 0.7140 0.2643 + B: Placebo A: Drug X C: Combination + (N=134) (N=134) (N=132) + ——————————————————————————————————————————————————————————————————————————————————————————————————— + Number of exacerbations per patient + 0 10 (7.46%) 6 (4.48%) 11 (8.33%) + 1 25 (18.66%) 21 (15.67%) 14 (10.61%) + 2 38 (28.36%) 41 (30.60%) 33 (25.00%) + 3 22 (16.42%) 26 (19.40%) 21 (15.91%) + 4 13 (9.70%) 18 (13.43%) 30 (22.73%) + 5 11 (8.21%) 10 (7.46%) 12 (9.09%) + 6 10 (7.46%) 7 (5.22%) 7 (5.30%) + 7 3 (2.24%) 4 (2.99%) 3 (2.27%) + 8 1 (0.75%) 1 (0.75%) 1 (0.76%) + 9 1 (0.75%) 0 (0.00%) 0 (0.00%) + Unadjusted exacerbation rate (per year) + Rate 7.2364 8.2148 9.8131 + Adjusted (QP) exacerbation rate (per year) + Rate 2.4550 2.8514 3.4304 + Rate CI (1.6194, 3.7219) (1.8974, 4.2850) (2.2946, 5.1284) + Rate Ratio 1.1615 1.3973 + Rate Ratio CI (0.6462, 2.0877) (0.7789, 2.5067) + p value 0.6169 0.2619 + Adjusted (NB) exacerbation rate (per year) + Rate 2.7374 2.8150 2.9789 + Rate CI (2.3932, 3.1311) (2.4681, 3.2106) (2.6152, 3.3932) + Rate Ratio 1.0283 1.0882 + Rate Ratio CI (0.8856, 1.1941) (0.9381, 1.2624) + p value 0.7140 0.2643 diff --git a/tests/testthat/setup.R b/tests/testthat/setup.R index 8111e49..9a0cf37 100644 --- a/tests/testthat/setup.R +++ b/tests/testthat/setup.R @@ -1,9 +1,165 @@ # Extra libraries (suggested) for tests library(dplyr) library(tidyr) -library(tern) library(lubridate) +# Helper function to reduce the number of levels in a column of a data frame +level_reducer <- function(dt, variable, p_to_keep = 0.7, + num_max_values = NULL, num_of_rare_values = 0, explorative = FALSE, + add_specific_value = NULL, keep_spec_rows = NULL) { # Latter no exploration + checkmate::assert_number(p_to_keep, lower = 0, upper = 1) + checkmate::assert_data_frame(dt) + checkmate::assert_string(variable) + checkmate::assert_character(add_specific_value, null.ok = TRUE) + checkmate::assert_choice(variable, names(dt)) + checkmate::assert_integer(keep_spec_rows, + null.ok = TRUE, + lower = 1, upper = nrow(dt), unique = TRUE + ) + checkmate::assert_flag(explorative) + cur_vec <- dt[[variable]] + + if (is.factor(cur_vec)) { + cur_vec <- as.character(cur_vec) + } + + lev_freq <- sort(table(cur_vec), decreasing = TRUE) + + # Explorative plot + if (explorative && interactive()) { + require(ggplot2) + plot_tbl <- tibble( + level = names(lev_freq), + freq = lev_freq + ) %>% + arrange(desc(freq)) %>% + mutate(level = factor(level, levels = level)) + + how_many_to_plot <- min(10, nrow(plot_tbl)) + spacing <- round(nrow(plot_tbl) / how_many_to_plot) + gg <- ggplot(plot_tbl) + + geom_col(aes(x = level, y = freq), width = 1) + + theme_classic() + + labs(title = paste0("Frequency of levels in ", variable), x = "Level", y = "Frequency") + + scale_x_discrete( + breaks = plot_tbl$level[seq(1, nrow(plot_tbl), by = spacing)], + labels = seq(1, nrow(plot_tbl))[seq(1, nrow(plot_tbl), by = spacing)] + ) + + # Adding % annotation + annot_x <- tail(plot_tbl$level[cumsum(plot_tbl$freq) <= sum(plot_tbl$freq) * p_to_keep], 1) + annot_y <- 0.9 * max(plot_tbl$freq) + annot_label <- paste0( + "Desired: ", round(p_to_keep * 100, 1), "%", + "\n", "Levels to keep: ", sum(cumsum(plot_tbl$freq) <= sum(plot_tbl$freq) * p_to_keep) + ) + gg <- gg + geom_vline(aes(xintercept = tail(level[cumsum(freq) <= sum(freq) * p_to_keep], 1)), color = "red") + + annotate("text", x = annot_x, y = annot_y, label = annot_label, vjust = 0, hjust = 0) + + if (!is.null(num_max_values)) { + annot_x <- num_max_values - num_of_rare_values + annot_y <- 0.5 * max(plot_tbl$freq) + annot_label <- paste0( + "Desired: ", num_max_values - num_of_rare_values, + "\n Kept: ", + round(sum(plot_tbl$freq[seq(1, num_max_values - num_of_rare_values)]) * 100 / sum(plot_tbl$freq), 1), + "%" + ) + gg <- gg + geom_vline(aes(xintercept = num_max_values - num_of_rare_values), color = "blue") + + annotate("text", x = annot_x, y = annot_y, label = annot_label, vjust = 0, hjust = 0) + } + + if (!is.null(add_specific_value)) { + xint <- which(plot_tbl$level %in% add_specific_value) + annot_x <- tail(which(plot_tbl$level %in% add_specific_value), 1) + annot_y <- 0.1 * max(plot_tbl$freq) + if (length(add_specific_value) == 1L) { + annot_label <- paste0( + "Specific value: ", add_specific_value, + "\nAdded freq: ", + round(plot_tbl$freq[which(plot_tbl$level == add_specific_value)] * 100 / sum(plot_tbl$freq), 1), + "%\n", + "Rank: ", which(plot_tbl$level == add_specific_value) + ) + } else { + xint <- max(xint) + annot_label <- paste0( + "Num spec values: ", length(add_specific_value), + "\nAdded freq: ", + round(sum(plot_tbl$freq[which(plot_tbl$level %in% add_specific_value)]) * 100 / sum(plot_tbl$freq), 1), + "%\n", + "Max rank: ", max(which(plot_tbl$level %in% add_specific_value)) + ) + } + gg <- gg + + geom_vline(aes(xintercept = xint), color = "black") + + annotate("text", x = annot_x, y = annot_y, label = annot_label, vjust = 0, hjust = 0) + } + + print(gg) + + # Effective calculations + } else { + checkmate::assert_int(num_of_rare_values, lower = 0, upper = length(lev_freq)) + checkmate::assert_int(num_max_values, lower = num_of_rare_values, upper = length(lev_freq), null.ok = TRUE) + + if (!is.null(num_max_values)) { + lev_to_keep <- names(lev_freq)[seq(1, num_max_values - num_of_rare_values)] + + if (num_of_rare_values > 0) { + lev_to_keep <- c( + lev_to_keep, + names(lev_freq)[seq(length(lev_freq) - num_of_rare_values + 1, length(lev_freq))] + ) + } + } else { + cum_freq <- cumsum(lev_freq) / sum(lev_freq) + if (p_to_keep < min(cum_freq)) { + stop(paste0("p_to_keep is too low. The minimum value of p_to_keep is ", round(min(cum_freq), 3))) + } + lev_to_keep <- names(lev_freq)[cum_freq <= p_to_keep] + } + + if (!is.null(add_specific_value)) { + checkmate::assert_subset(add_specific_value, names(lev_freq)) + lev_to_keep <- unique(c(lev_to_keep, add_specific_value)) + } + + if (!is.null(keep_spec_rows)) { + lev_to_keep <- c(lev_to_keep, keep_spec_rows) + filter1 <- which(cur_vec %in% lev_to_keep) + keep_spec_rows <- keep_spec_rows[!keep_spec_rows %in% filter1] + } + + if (interactive()) { + msg <- paste0( + "Reducing levels of ", deparse(substitute(dt)), " for variable ", + variable, ": keeping ", length(lev_to_keep), + " levels out of ", length(lev_freq), " levels. Total kept (%): ", + round(sum(lev_freq[lev_to_keep]) * 100 / sum(lev_freq), 1) + ) + if (length(keep_spec_rows) > 0) { + msg <- paste0( + msg, "\n", "Keeping other rows for a total: ", + round((sum(lev_freq[lev_to_keep]) + length(keep_spec_rows)) * 100 / sum(lev_freq), 1) + ) + } + message(msg) + } + + out <- dt %>% filter(!!sym(variable) %in% lev_to_keep) + + if (length(keep_spec_rows) > 0) { + out <- rbind(out, dt %>% slice(keep_spec_rows)) + } + + # Simple check of filtering + stopifnot(nrow(out) == sum(cur_vec %in% lev_to_keep)) + + out + } +} + # Data loading for tests adsl_raw <- random.cdisc.data::cadsl adab_raw <- random.cdisc.data::cadab @@ -35,7 +191,6 @@ adsl_pharmaverse <- pharmaverseadam::adsl %>% DCSREAS = with_label(DCSREAS, "Discontinuation Reason") ) %>% filter(ACTARM != "Screen Failure") - adae_pharmaverse <- pharmaverseadam::adae %>% mutate( AETOXGR = sample( @@ -52,10 +207,31 @@ adae_pharmaverse <- pharmaverseadam::adae %>% SMQ02SC = ifelse(SMQ02NAM == "SMQ02", "NARROW", NA_character_), CQ01NAM = ifelse(AEDECOD == "HEADACHE", "CQ01", NA_character_) ) +# adae_pharmaverse trimming of variables with too many levels +adae_pharmaverse <- level_reducer(adae_pharmaverse, "AEDECOD", + num_max_values = 7, num_of_rare_values = 1, + add_specific_value = c( + "VOMITING", "NAUSEA", "SKIN IRRITATION", "HEADACHE", # For SMQ01NAM, SMQ02NAM, CQ01NAM + "MYOCARDIAL INFARCTION" # for aet07 AESDTH == "Y" + ) +) + set.seed(NULL) adlb_pharmaverse <- pharmaverseadam::adlb %>% mutate(AVALU = LBORRESU) +needed_paramcd <- adlb_pharmaverse %>% + filter(PARAMCD %in% c("AST", "ALT", "BILI", "ALB")) %>% # needed for lbt11 and lbt13 + pull(PARAM) %>% + unique() + +adlb_pharmaverse <- level_reducer( + adlb_pharmaverse, "PARAM", + num_max_values = 10, num_of_rare_values = 1, + add_specific_value = c(needed_paramcd, "Sodium (mmol/L)") # for ATOXGR == "-3" in lbt07 +) advs_pharmaverse <- pharmaverseadam::advs + + # skip_if_too_deep skip_if_too_deep <- function(depth) { # nolint checkmate::assert_number(depth, lower = 0, upper = 5) diff --git a/tests/testthat/test-listing_adal02.R b/tests/testthat/test-listing_adal02.R index 58fe355..8ec2fa0 100644 --- a/tests/testthat/test-listing_adal02.R +++ b/tests/testthat/test-listing_adal02.R @@ -72,15 +72,15 @@ testthat::test_that("ADAL02 listing is produced correctly", { ) %>% select(USUBJID, unique(adab_x$VISN[order(adab_x$NFRLT)]), PTES) - formatters::var_labels(out) <- names(out) + var_labels(out) <- names(out) out <- out %>% - formatters::var_relabel( + var_relabel( USUBJID = "Subject ID", PTES = "Patient Treatment\nEmergent ADA Status" ) - testthat::expect_message(result <- as_listing( + result <- as_listing( out, key_cols = "USUBJID", disp_cols = names(out), @@ -104,7 +104,7 @@ Persistent ADA = ADA positive result detected (a) at the last post-baseline sam time points during treatment where the first and last ADA positive samples are separated by a period ≥ 16 weeks, irrespective of any negative samples in between. Asterisk denotes sample that tested positive for Neutralizing Antibodies." - ) %>% head(50), "sorting incoming data by key columns") + ) %>% head(50) testthat::expect_snapshot(result) }) diff --git a/tests/testthat/test-listing_ael01.R b/tests/testthat/test-listing_ael01.R index 39187a6..4eb2ea8 100644 --- a/tests/testthat/test-listing_ael01.R +++ b/tests/testthat/test-listing_ael01.R @@ -3,19 +3,19 @@ testthat::test_that("AEL01 listing is produced correctly", { select(AESOC, AEDECOD, AELLT, AETERM) %>% unique() - formatters::var_labels(out) <- c( + var_labels(out) <- c( AESOC = "MedDRA System Organ Class", AEDECOD = "MedDRA Preferred Term", AELLT = "MedDRA Lowest Level Term", AETERM = "Investigator-Specified\nAdverse Event Term" ) - testthat::expect_message(result <- as_listing( + result <- as_listing( out, key_cols = c("AESOC", "AEDECOD", "AELLT"), disp_cols = names(out), main_title = "Listing of Preferred Terms, Lowest Level Terms, and Investigator-Specified Adverse Event Terms" - ) %>% head(50), "sorting incoming data by key columns") + ) %>% head(50) testthat::expect_snapshot(result) }) diff --git a/tests/testthat/test-listing_ael01_nollt.R b/tests/testthat/test-listing_ael01_nollt.R index 2e17faf..414106c 100644 --- a/tests/testthat/test-listing_ael01_nollt.R +++ b/tests/testthat/test-listing_ael01_nollt.R @@ -3,22 +3,22 @@ testthat::test_that("AEL01_NOLLT listing is produced correctly", { select(AESOC, AEDECOD, AETERM) %>% unique() - formatters::var_labels(out) <- c( + var_labels(out) <- c( AESOC = "MedDRA System Organ Class", AEDECOD = "MedDRA Preferred Term", AETERM = "Investigator-Specified\nAdverse Event Term" ) - testthat::expect_message(result <- as_listing( + result <- as_listing( out, key_cols = c("AESOC", "AEDECOD"), disp_cols = names(out), default_formatting = list( - all = formatters::fmt_config(align = "left"), - numeric = formatters::fmt_config(align = "center") + all = fmt_config(align = "left"), + numeric = fmt_config(align = "center") ), main_title = "Listing of Preferred Terms and Investigator-Specified Adverse Event Terms" - ) %>% head(50), "sorting incoming data by key columns") + ) %>% head(50) testthat::expect_snapshot(result) }) diff --git a/tests/testthat/test-listing_ael02.R b/tests/testthat/test-listing_ael02.R index 7d7c549..e601134 100644 --- a/tests/testthat/test-listing_ael02.R +++ b/tests/testthat/test-listing_ael02.R @@ -28,7 +28,7 @@ testthat::test_that("AEL02 listing is produced correctly", { ) %>% select(CPID, ASR, TRT01A, AEDECOD, Date_First, ASTDY, Duration, Serious, AESEV, Related, Outcome, Treated, Action) - formatters::var_labels(out) <- c( + var_labels(out) <- c( CPID = "Center/Patient ID", ASR = "Age/Sex/Race", TRT01A = "Treatment", diff --git a/tests/testthat/test-listing_ael02_ed.R b/tests/testthat/test-listing_ael02_ed.R index 595bd4d..51ce3d1 100644 --- a/tests/testthat/test-listing_ael02_ed.R +++ b/tests/testthat/test-listing_ael02_ed.R @@ -43,7 +43,7 @@ testthat::test_that("AEL02_ED listing is produced correctly", { ADURN, AESER_F, AESEV, AEREL_F, AEOUT_F, AECONTRT_F, AEACN_F ) - formatters::var_labels(out) <- c( + var_labels(out) <- c( cent_subj = "Center/Patient ID", ASR = "Age/Sex/Race", TRT01A = "Treatment", diff --git a/tests/testthat/test-listing_ael03.R b/tests/testthat/test-listing_ael03.R index 49603e7..c920d70 100644 --- a/tests/testthat/test-listing_ael03.R +++ b/tests/testthat/test-listing_ael03.R @@ -37,7 +37,7 @@ testthat::test_that("AEL03 listing is produced correctly", { ) %>% select(CPID, ASR, TRT01A, AEDECOD, Date_First, ASTDY, Duration, AESEV, Related, Outcome, Treated, Action, SERREAS) - formatters::var_labels(out) <- c( + var_labels(out) <- c( CPID = "Center/Patient ID", ASR = "Age/Sex/Race", TRT01A = "Treatment", diff --git a/tests/testthat/test-listing_ael04.R b/tests/testthat/test-listing_ael04.R index 3ed8cbb..f610223 100644 --- a/tests/testthat/test-listing_ael04.R +++ b/tests/testthat/test-listing_ael04.R @@ -9,7 +9,7 @@ testthat::test_that("AEL04 listing is produced correctly", { arrange(SUBJID) %>% select(ID, AGSXRC, TRT01A, TRTSD, EOSDY, DTHADY, DTHCAUS, ADTHAUT) - formatters::var_labels(out) <- c( + var_labels(out) <- c( ID = "Center/Patient ID", AGSXRC = "Age/Sex/Race", TRT01A = "Treatment", @@ -20,12 +20,12 @@ testthat::test_that("AEL04 listing is produced correctly", { ADTHAUT = "Autopsy\nPerformed?" ) - testthat::expect_message(result <- as_listing( + result <- as_listing( out, key_cols = c("TRT01A", "ID"), disp_cols = names(out), main_title = "Listing of Patient Deaths" - ) %>% head(50), "sorting incoming data by key columns") + ) %>% head(50) testthat::expect_snapshot(result) }) diff --git a/tests/testthat/test-listing_cml01.R b/tests/testthat/test-listing_cml01.R index 12ef593..b77e213 100644 --- a/tests/testthat/test-listing_cml01.R +++ b/tests/testthat/test-listing_cml01.R @@ -14,7 +14,7 @@ testthat::test_that("CML01 listing is produced correctly", { CMSTRFL, CMENRFL, CMDOSE, CMDOSU, CMDOSFRQ, CMROUTE ) - formatters::var_labels(out) <- c( + var_labels(out) <- c( ID = "Center/Patient ID", AGSXRC = "Age/Sex/Race", TRT01A = "Treatment", @@ -31,12 +31,12 @@ testthat::test_that("CML01 listing is produced correctly", { CMROUTE = "Route" ) - testthat::expect_message(result <- as_listing( + result <- as_listing( out, key_cols = c("TRT01A", "ID", "AGSXRC", "CMDECOD"), disp_cols = names(out), main_title = "Listing of Previous and Concomitant Medications" - ) %>% head(50), "sorting incoming data by key columns") + ) %>% head(50) testthat::expect_snapshot(result) }) diff --git a/tests/testthat/test-listing_cml02a_gl.R b/tests/testthat/test-listing_cml02a_gl.R index 4126868..64b771a 100644 --- a/tests/testthat/test-listing_cml02a_gl.R +++ b/tests/testthat/test-listing_cml02a_gl.R @@ -3,18 +3,18 @@ testthat::test_that("CML02A_GL listing is produced correctly", { select(ATC2, CMDECOD, CMTRT) %>% unique() - formatters::var_labels(out) <- c( + var_labels(out) <- c( ATC2 = "ATC Class Level 2", CMDECOD = "WHODrug Preferred Name", CMTRT = "Investigator-Specified\nTreatment Term" ) - testthat::expect_message(result <- as_listing( + result <- as_listing( out, key_cols = c("ATC2", "CMDECOD", "CMTRT"), disp_cols = names(out), main_title = "Listing of Concomitant Medication Class Level 2, Preferred Name, and Investigator-Specified Terms" - ) %>% head(50), "sorting incoming data by key columns") + ) %>% head(50) testthat::expect_snapshot(result) }) diff --git a/tests/testthat/test-listing_cml02b_gl.R b/tests/testthat/test-listing_cml02b_gl.R index e9e2821..793f1da 100644 --- a/tests/testthat/test-listing_cml02b_gl.R +++ b/tests/testthat/test-listing_cml02b_gl.R @@ -3,7 +3,7 @@ testthat::test_that("CML02B_GL listing is produced correctly", { select(ATC1, ATC2, ATC3, ATC4, CMDECOD, CMTRT) %>% unique() - formatters::var_labels(out) <- c( + var_labels(out) <- c( ATC1 = "ATC Class Level 1", ATC2 = "ATC Class Level 2", ATC3 = "ATC Class Level 3", @@ -12,12 +12,12 @@ testthat::test_that("CML02B_GL listing is produced correctly", { CMTRT = "Investigator-Specified\nTreatment Term" ) - testthat::expect_message(result <- as_listing( + result <- as_listing( out, key_cols = c("ATC1", "ATC2", "ATC3", "ATC4", "CMDECOD", "CMTRT"), disp_cols = names(out), main_title = "Listing of Concomitant Medication Class, Preferred Name, and Investigator-Specified Terms" - ) %>% head(50), "sorting incoming data by key columns") + ) %>% head(50) testthat::expect_snapshot(result) }) diff --git a/tests/testthat/test-listing_dsl01.R b/tests/testthat/test-listing_dsl01.R index 2844f97..750195a 100644 --- a/tests/testthat/test-listing_dsl01.R +++ b/tests/testthat/test-listing_dsl01.R @@ -9,7 +9,7 @@ testthat::test_that("DSL01 listing is produced correctly", { ) %>% select(ID, ASR, ARMCD, SSADM, STDWD, DISCONT) - formatters::var_labels(out) <- c( + var_labels(out) <- c( ID = "Center/Patient ID", ASR = "Age/Sex/Race", ARMCD = "Treatment", @@ -18,7 +18,7 @@ testthat::test_that("DSL01 listing is produced correctly", { DISCONT = "Discontinued\nEarly from Study?" ) - testthat::expect_message(result <- as_listing( + result <- as_listing( out, key_cols = "ARMCD", disp_cols = names(out), @@ -26,7 +26,7 @@ testthat::test_that("DSL01 listing is produced correctly", { subtitles = "Population: All Patients", main_footer = c("Program: xxxx", "Output: xxxx"), prov_footer = "Page 1 of 1" - ) %>% head(50), "sorting incoming data by key columns") + ) %>% head(50) testthat::expect_snapshot(result) }) diff --git a/tests/testthat/test-listing_dsl02.R b/tests/testthat/test-listing_dsl02.R index ed3daf1..4c3625c 100644 --- a/tests/testthat/test-listing_dsl02.R +++ b/tests/testthat/test-listing_dsl02.R @@ -16,7 +16,7 @@ testthat::test_that("DSL02 listing is produced correctly", { filter(DISCONT == "Yes") %>% select(ID, ASR, TRT01A, SSADTM, EOSDY, SSAEDY, RANDEDY, DCSREAS) - formatters::var_labels(out) <- c( + var_labels(out) <- c( ID = "Center/Patient ID", ASR = "Age/Sex/Race", TRT01A = "Treatment", @@ -27,12 +27,12 @@ testthat::test_that("DSL02 listing is produced correctly", { DCSREAS = "Reason for\nDiscontinuation" ) - testthat::expect_message(result <- as_listing( + result <- as_listing( out, key_cols = "TRT01A", disp_cols = names(out), main_title = "Listing of Patients Who Discontinued Early from Study" - ) %>% head(50), "sorting incoming data by key columns") + ) %>% head(50) testthat::expect_snapshot(result) }) diff --git a/tests/testthat/test-listing_dsur4.R b/tests/testthat/test-listing_dsur4.R index b682405..eee0813 100644 --- a/tests/testthat/test-listing_dsur4.R +++ b/tests/testthat/test-listing_dsur4.R @@ -5,19 +5,19 @@ testthat::test_that("DSUR4 listing is produced correctly", { select(ARM, ID, DTHCAUS) death_num <- length(unique(out$ID)) - formatters::var_labels(out) <- c( + var_labels(out) <- c( ARM = "Treatment Group", ID = "Center/Patient ID", DTHCAUS = "Cause of Death" ) - testthat::expect_message(result <- as_listing( + result <- as_listing( out, key_cols = c("ARM"), disp_cols = names(out), main_title = "Listing of Patients Who Died During Reporting Period", subtitles = paste("Number of patient deaths during reporting period =", death_num) - ) %>% head(50), "sorting incoming data by key columns") + ) %>% head(50) testthat::expect_snapshot(result) }) diff --git a/tests/testthat/test-listing_egl01.R b/tests/testthat/test-listing_egl01.R index 2d10904..248e4c3 100644 --- a/tests/testthat/test-listing_egl01.R +++ b/tests/testthat/test-listing_egl01.R @@ -35,7 +35,7 @@ testthat::test_that("EGL01 listing is produced correctly", { select( CRTNPT, AGSXRC, TRT01A, AVISIT, ADY, AVAL_ANRIND_HR, CHG_HR, AVAL_ANRIND_QT, CHG_QT, AVAL_ANRIND_RR, CHG_RR ) %>% - formatters::var_relabel( + var_relabel( CRTNPT = "Center/Subject ID", AGSXRC = "Age/Sex/Race", TRT01A = "Treatment", diff --git a/tests/testthat/test-listing_exl01.R b/tests/testthat/test-listing_exl01.R index fc60f1f..e267b5b 100644 --- a/tests/testthat/test-listing_exl01.R +++ b/tests/testthat/test-listing_exl01.R @@ -7,7 +7,7 @@ testthat::test_that("EXL01 listing is produced correctly", { arrange(CRTNPT, AVISIT) %>% select(CRTNPT, AVISIT, EXSTDY, EXENDY, TRT01A, AVAL, AVALU, EXDOSFRQ, EXROUTE) - formatters::var_labels(out) <- c( + var_labels(out) <- c( CRTNPT = "Center/Subject ID", AVISIT = "Visit", EXSTDY = "Study Day\nFrom", diff --git a/tests/testthat/test-listing_lbl01.R b/tests/testthat/test-listing_lbl01.R index fab0eba..61c4a96 100644 --- a/tests/testthat/test-listing_lbl01.R +++ b/tests/testthat/test-listing_lbl01.R @@ -33,8 +33,8 @@ testthat::test_that("LBL01 listing is produced correctly", { ungroup() %>% select(CPID, TRT01A, ADY, DLD, unique(adlb_x$PARAM_U)) - formatters::var_labels(out) <- names(out) - out <- out %>% formatters::var_relabel( + var_labels(out) <- names(out) + out <- out %>% var_relabel( TRT01A = "Treatment", CPID = "Center/Patient ID", ADY = "Study\nDay", diff --git a/tests/testthat/test-listing_lbl01_rls.R b/tests/testthat/test-listing_lbl01_rls.R index ed42883..9e6d753 100644 --- a/tests/testthat/test-listing_lbl01_rls.R +++ b/tests/testthat/test-listing_lbl01_rls.R @@ -37,8 +37,8 @@ testthat::test_that("LBL01_RLS listing is produced correctly", { ungroup() %>% select(CPID, TRT01A, ADY, DLD, unique(adlb_x$PARAM_U)) - formatters::var_labels(out) <- names(out) - out <- out %>% formatters::var_relabel( + var_labels(out) <- names(out) + out <- out %>% var_relabel( TRT01A = "Treatment", CPID = "Center/Patient ID", ADY = "Study\nDay", diff --git a/tests/testthat/test-listing_lbl02a.R b/tests/testthat/test-listing_lbl02a.R index 4cdbcb1..c193589 100644 --- a/tests/testthat/test-listing_lbl02a.R +++ b/tests/testthat/test-listing_lbl02a.R @@ -26,8 +26,8 @@ testthat::test_that("LBL02A listing is produced correctly", { out <- adlb_x %>% select(LBTEST_U, TRT01A, CPID, ADY, ADTM, DLD, AVAL, LBNRNG, ANRIND_GR) - formatters::var_labels(out) <- names(out) - out <- out %>% formatters::var_relabel( + var_labels(out) <- names(out) + out <- out %>% var_relabel( LBTEST_U = "Lab Test (Unit)", TRT01A = "Treatment", CPID = "Center/Patient ID", @@ -39,13 +39,13 @@ testthat::test_that("LBL02A listing is produced correctly", { ANRIND_GR = "NCI\nCTCAE\nGrade" ) - testthat::expect_message(result <- as_listing( + result <- as_listing( out, key_cols = c("TRT01A", "LBTEST_U", "CPID"), disp_cols = names(out), main_title = "Listing of Laboratory Abnormalities Defined by NCI CTCAE Grade >= 1", main_footer = "NCI CTCAE grade is displayed as abnormal high (H) or low (L) followed by the grade." - ) %>% head(50), "sorting incoming data by key columns") + ) %>% head(50) testthat::expect_snapshot(result) }) diff --git a/tests/testthat/test-listing_lbl02a_rls.R b/tests/testthat/test-listing_lbl02a_rls.R index 9608d10..d7df62e 100644 --- a/tests/testthat/test-listing_lbl02a_rls.R +++ b/tests/testthat/test-listing_lbl02a_rls.R @@ -47,9 +47,9 @@ testthat::test_that("LBL02A_RLS listing is produced correctly", { out <- adlb_x %>% select(LBTEST_U, TRT01A, CPID, ADY, DLD, AVAL, PCHG, STD_RNG, LBNRNG, CRC, ANRIND) - formatters::var_labels(out) <- names(out) + var_labels(out) <- names(out) out <- out %>% - formatters::var_relabel( + var_relabel( LBTEST_U = "Lab Test (Unit)", TRT01A = "Treatment", CPID = "Center/Patient ID", @@ -63,7 +63,7 @@ testthat::test_that("LBL02A_RLS listing is produced correctly", { ANRIND = "Abnormality\nFlag" ) - testthat::expect_message(result <- as_listing( + result <- as_listing( out, key_cols = c("TRT01A", "LBTEST_U", "CPID"), disp_cols = names(out), @@ -74,7 +74,7 @@ testthat::test_that("LBL02A_RLS listing is produced correctly", { "the standard reference range; high high (HH) or low low (LL) if outside the marked reference range with a", "clinically relevant change from baseline." ) - ) %>% head(50), "sorting incoming data by key columns") + ) %>% head(50) testthat::expect_snapshot(result) }) diff --git a/tests/testthat/test-listing_lbl02b.R b/tests/testthat/test-listing_lbl02b.R index e72a9b0..202efdd 100644 --- a/tests/testthat/test-listing_lbl02b.R +++ b/tests/testthat/test-listing_lbl02b.R @@ -30,9 +30,9 @@ testthat::test_that("LBL02B listing is produced correctly", { out <- adlb_x %>% select(LBTEST, TRT01A, CPID, ADY, ADTM, DLD, AVAL, AVALU, LBNRNG, ANRIND_GR) - formatters::var_labels(out) <- names(out) + var_labels(out) <- names(out) out <- out %>% - formatters::var_relabel( + var_relabel( LBTEST = "Lab Test", TRT01A = "Treatment", CPID = "Center/Patient ID", @@ -45,13 +45,13 @@ testthat::test_that("LBL02B listing is produced correctly", { ANRIND_GR = "NCI\nCTCAE\nGrade" ) - testthat::expect_message(result <- as_listing( + result <- as_listing( out, key_cols = c("TRT01A", "LBTEST", "CPID"), disp_cols = names(out), main_title = "Listing of Laboratory Abnormalities Defined by NCI CTCAE Grade >= 2", main_footer = "NCI CTCAE grade is displayed as abnormal high (H) or low (L) followed by the grade." - ) %>% head(50), "sorting incoming data by key columns") + ) %>% head(50) testthat::expect_snapshot(result) }) diff --git a/tests/testthat/test-listing_mhl01.R b/tests/testthat/test-listing_mhl01.R index b97fdc4..b0c52bd 100644 --- a/tests/testthat/test-listing_mhl01.R +++ b/tests/testthat/test-listing_mhl01.R @@ -9,7 +9,7 @@ testthat::test_that("MHL01 listing is produced correctly", { ) %>% select(ID, ASR, TRT01A, MHBODSYS, MHDECOD, TRTSDTM, ASTDTM, ASTDY, AENDTM, AENDY, ATIREL) - formatters::var_labels(out) <- c( + var_labels(out) <- c( ID = "Center/Patient ID", ASR = "Age/Sex/Race", TRT01A = "Treatment", @@ -23,12 +23,12 @@ testthat::test_that("MHL01 listing is produced correctly", { ATIREL = "Time Relation\nof Disease" ) - testthat::expect_message(result <- as_listing( + result <- as_listing( out, key_cols = c("TRT01A", "ID", "ASR", "MHBODSYS", "MHDECOD"), disp_cols = names(out), main_title = "Listing of Medical History and Concurrent Diseases" - ) %>% head(50), "sorting incoming data by key columns") + ) %>% head(50) testthat::expect_snapshot(result) }) diff --git a/tests/testthat/test-listing_pkcl01.R b/tests/testthat/test-listing_pkcl01.R index e306964..a171f5a 100644 --- a/tests/testthat/test-listing_pkcl01.R +++ b/tests/testthat/test-listing_pkcl01.R @@ -5,7 +5,7 @@ testthat::test_that("PKCL01 listing is produced correctly", { filter(PARAM == analyte) %>% select(ARM, USUBJID, VISIT, NFRLT, AFRLT, AVAL) - formatters::var_labels(out) <- c( + var_labels(out) <- c( ARM = "Treatment Group", USUBJID = "Subject ID", VISIT = "Visit", @@ -14,7 +14,7 @@ testthat::test_that("PKCL01 listing is produced correctly", { AVAL = paste0("Concentration\n(", adpc$AVALU[1], ")") ) - testthat::expect_message(result <- as_listing( + result <- as_listing( out, key_cols = c("ARM", "USUBJID", "VISIT"), disp_cols = names(out), @@ -23,7 +23,7 @@ testthat::test_that("PKCL01 listing is produced correctly", { "PK Population\nProtocol: xxnnnnn" ), subtitles = paste("Analyte:", analyte) - ) %>% head(50), "sorting incoming data by key columns") + ) %>% head(50) testthat::expect_snapshot(result) }) diff --git a/tests/testthat/test-listing_pkcl02.R b/tests/testthat/test-listing_pkcl02.R index af8e0e8..b38ba6b 100644 --- a/tests/testthat/test-listing_pkcl02.R +++ b/tests/testthat/test-listing_pkcl02.R @@ -42,14 +42,14 @@ testthat::test_that("PKCL02 listing is produced correctly", { values_from = VALUE ) - formatters::var_labels(out) <- names(out) - out <- out %>% formatters::var_relabel( + var_labels(out) <- names(out) + out <- out %>% var_relabel( TRT01A = "Treatment Group", USUBJID = "Subject ID", VISIT = "Visit" ) - testthat::expect_message(result <- as_listing( + result <- as_listing( out, key_cols = c("TRT01A", "USUBJID", "VISIT"), disp_cols = names(out), @@ -58,7 +58,7 @@ testthat::test_that("PKCL02 listing is produced correctly", { unique(adpc_x$REGIMEN)[1], " of ", drug_a, ", PK Population\nProtocol: xxnnnnn" ), subtitles = paste("Analyte:", drug_a) - ) %>% head(50), "sorting incoming data by key columns") + ) %>% head(50) testthat::expect_snapshot(result) }) diff --git a/tests/testthat/test-listing_pkpl01.R b/tests/testthat/test-listing_pkpl01.R index 214f1df..9892012 100644 --- a/tests/testthat/test-listing_pkpl01.R +++ b/tests/testthat/test-listing_pkpl01.R @@ -20,20 +20,20 @@ testthat::test_that("PKPL01 listing is produced correctly", { values_from = AVAL ) - formatters::var_labels(out) <- names(out) - out <- out %>% formatters::var_relabel( + var_labels(out) <- names(out) + out <- out %>% var_relabel( TRT01A = "Treatment Group", USUBJID = "Subject ID", AVISIT = "Visit" ) - testthat::expect_message(result <- as_listing( + result <- as_listing( out, key_cols = c("TRT01A", "USUBJID", "AVISIT"), disp_cols = names(out), main_title = paste("Listing of", drug_a, spec, "PK Parameters, PK Population\nProtocol: xxnnnnn"), subtitles = paste("Analyte:", drug_a) - ) %>% head(50), "sorting incoming data by key columns") + ) %>% head(50) testthat::expect_snapshot(result) }) diff --git a/tests/testthat/test-listing_pkpl02.R b/tests/testthat/test-listing_pkpl02.R index 797c482..25c31d5 100644 --- a/tests/testthat/test-listing_pkpl02.R +++ b/tests/testthat/test-listing_pkpl02.R @@ -17,20 +17,20 @@ testthat::test_that("PKPL02 listing is produced correctly", { values_from = AVAL ) - formatters::var_labels(out) <- names(out) - out <- out %>% formatters::var_relabel( + var_labels(out) <- names(out) + out <- out %>% var_relabel( TRT01A = "Treatment Group", USUBJID = "Subject ID", AVISIT = "Visit" ) - testthat::expect_message(result <- as_listing( + result <- as_listing( out, key_cols = c("TRT01A", "USUBJID", "AVISIT"), disp_cols = names(out), main_title = paste("Listing of", drug_a, spec, "PK Parameters, PK Population\nProtocol: xxnnnnn"), subtitles = paste("Analyte:", drug_a) - ) %>% head(50), "sorting incoming data by key columns") + ) %>% head(50) testthat::expect_snapshot(result) }) diff --git a/tests/testthat/test-listing_pkpl04.R b/tests/testthat/test-listing_pkpl04.R index 0bd96ac..6ef87e1 100644 --- a/tests/testthat/test-listing_pkpl04.R +++ b/tests/testthat/test-listing_pkpl04.R @@ -32,10 +32,10 @@ testthat::test_that("PKPL04 listing is produced correctly", { ) %>% select(names(.)[c(1:2, 4, 6, 3, 5, 7)]) - formatters::var_labels(out) <- names(out) - out <- out %>% formatters::var_relabel(USUBJID = "Subject ID") + var_labels(out) <- names(out) + out <- out %>% var_relabel(USUBJID = "Subject ID") - testthat::expect_message(result <- as_listing( + result <- as_listing( out, key_cols = "USUBJID", disp_cols = names(out), @@ -45,7 +45,7 @@ testthat::test_that("PKPL04 listing is produced correctly", { "\nVisit: ", unique(adpp_x$AVISIT) ), subtitles = paste0("\nAnalytes: ", paste(drug_a, drug_b, sep = " and ")) - ) %>% head(50), "sorting incoming data by key columns") + ) %>% head(50) testthat::expect_snapshot(result) }) diff --git a/tests/testthat/test-listing_vsl01.R b/tests/testthat/test-listing_vsl01.R index 3af3a23..a54259d 100644 --- a/tests/testthat/test-listing_vsl01.R +++ b/tests/testthat/test-listing_vsl01.R @@ -36,7 +36,7 @@ testthat::test_that("VSL01 listing is produced correctly", { AVAL_ANRIND_DIABP, CHG_DIABP, AVAL_ANRIND_SYSBP, CHG_SYSBP, AVAL_ANRIND_PULSE, CHG_PULSE, AVAL_ANRIND_RESP, CHG_RESP ) %>% - formatters::var_relabel( + var_relabel( CRTNPT = "Center/Subject ID", AGSXRC = "Age/Sex/Race", TRT01A = "Treatment", diff --git a/tests/testthat/test-pagination_listing.R b/tests/testthat/test-pagination_listing.R index d5a4d6e..a542089 100644 --- a/tests/testthat/test-pagination_listing.R +++ b/tests/testthat/test-pagination_listing.R @@ -40,7 +40,7 @@ result <- adae_raw %>% select(CPID, ASR, TRT01A, AEDECOD, Date_First, ASTDY, Duration, AESEV, Related, Outcome, Treated, Action, SERREAS) # Adding labels -formatters::var_labels(result) <- c( +var_labels(result) <- c( CPID = "Center/Patient ID", ASR = "Age/Sex/Race", TRT01A = "Treatment", @@ -79,12 +79,14 @@ lst_res <- as_listing( testthat::test_that("Direct pagination works fine", { testthat::expect_equal(nrow(lst_res), 50) # head() worked - clw <- formatters::propose_column_widths(lst_res) / 2 + 1 + clw <- propose_column_widths(lst_res) / 2 + 1 - pg_lst <- testthat::expect_silent(paginate_listing(lst_res, lpp = 50, colwidths = floor(clw))) + pg_lst <- testthat::expect_silent( + paginate_listing(lst_res, lpp = 50, colwidths = floor(clw), print_pages = FALSE) + ) testthat::expect_equal(length(pg_lst), 10L) - pg_lst <- paginate_listing(lst_res, page_type = "a4", font_size = 9) + pg_lst <- paginate_listing(lst_res, page_type = "a4", font_size = 9, print_pages = FALSE) testthat::expect_equal(length(pg_lst), 9L) testthat::expect_silent( # for footers \n diff --git a/tests/testthat/test-pagination_table.R b/tests/testthat/test-pagination_table.R index 2dcec3c..14ff69b 100644 --- a/tests/testthat/test-pagination_table.R +++ b/tests/testthat/test-pagination_table.R @@ -66,7 +66,7 @@ testthat::test_that("Direct pagination with standard values", { testthat::test_that("Pagination with specific column widths and minimum lines per page", { # With combo of rows and cols per page - std_col_widths <- formatters::propose_column_widths(raw_result) + std_col_widths <- propose_column_widths(raw_result) # Min h-width: first value is the row label, second is the largest content, 3 is the inter-space cpp_width <- std_col_widths[1] + max(std_col_widths[-1]) + 3 pag_res <- testthat::expect_silent( @@ -84,7 +84,7 @@ main_footer(res) <- "main footer" prov_footer(res) <- "prov \nfooter that has a lot of \nnew \nlines" top_left(res) <- "SOME TOPLEFT" table_inset(res) <- 5 -rtables::fnotes_at_path( +fnotes_at_path( res, c(make_row_df(res)$path[[7]]), c("B: Placebo") # nolint @@ -211,7 +211,7 @@ testthat::test_that("AET04 variant 2 page_by pagination tests", { res <- testthat::expect_silent(result) pag_res <- testthat::expect_silent(paginate_table(res)) testthat::expect_setequal( - sapply(pag_res, formatters::page_titles), + sapply(pag_res, page_titles), paste0("AEBODSYS: ", levels(adae$AEBODSYS)) ) testthat::expect_snapshot(pag_res[c(2, 5)]) # randomly picked to have a comparison diff --git a/tests/testthat/test-table_aet02.R b/tests/testthat/test-table_aet02.R index 3e5dac3..568b884 100644 --- a/tests/testthat/test-table_aet02.R +++ b/tests/testthat/test-table_aet02.R @@ -73,7 +73,7 @@ testthat::test_that("AET02 variant 1 is produced correctly", { ) testthat::expect_identical( to_string_matrix(pag_result[[2]], with_spaces = FALSE)[5, 1], - "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS" + "SKIN AND SUBCUTANEOUS TISSUE DISORDERS" ) }) diff --git a/tests/testthat/test-table_aet03.R b/tests/testthat/test-table_aet03.R index 4ffd2ea..03f48bf 100644 --- a/tests/testthat/test-table_aet03.R +++ b/tests/testthat/test-table_aet03.R @@ -79,7 +79,7 @@ testthat::test_that("AET03 variant 1 is produced correctly", { result_matrix <- to_string_matrix(result, with_spaces = FALSE) # Pagination also works (and sorting) - lpp_test <- 16 + lpp_test <- 20 testthat::expect_equal( nrow(paginate_table(result, lpp = lpp_test)[[3]]) + 4, # 4 is the header lpp_test @@ -94,7 +94,7 @@ testthat::test_that("AET03 variant 1 is produced correctly", { pag_result <- paginate_table(result) testthat::expect_identical( - to_string_matrix(pag_result[[3]], with_spaces = FALSE)[3, 1], + to_string_matrix(pag_result[[2]], with_spaces = FALSE)[3, 1], " Severity/Intensity" ) testthat::expect_identical( diff --git a/tests/testthat/test-table_aet04.R b/tests/testthat/test-table_aet04.R index f255bab..ffee904 100644 --- a/tests/testthat/test-table_aet04.R +++ b/tests/testthat/test-table_aet04.R @@ -19,6 +19,9 @@ grade_groups <- list( ) adae$TOTAL_VAR <- "- Any adverse events - " +# Further reducing burden of the table size +adae <- level_reducer(adae, "AEDECOD", p_to_keep = 0.7) + # Helper function to avoid filtering also the first part of the table, where general information is given. my_row_condition <- function(row_fnc_condition) { function(table_row) { @@ -110,8 +113,8 @@ testthat::test_that("AET04 variant 1 is produced correctly", { ) testthat::expect_identical( - to_string_matrix(pag_result[[3]])[4, 1], - "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS" + "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", + to_string_matrix(pag_result[[3]], with_spaces = FALSE)[4, 1] ) testthat::expect_identical( trimws(to_string_matrix(pag_result[[1]], with_spaces = FALSE)[5:6, 1]), @@ -192,11 +195,11 @@ testthat::test_that("AET04 variant 2 is produced correctly (Fill in of Treatment ) testthat::expect_identical( - to_string_matrix(pag_result[[3]])[4, 1], + to_string_matrix(pag_result[[3]], with_spaces = FALSE)[4, 1], "SKIN AND SUBCUTANEOUS TISSUE DISORDERS" ) testthat::expect_identical( - to_string_matrix(pag_result[[1]])[5:6, 2], + to_string_matrix(pag_result[[1]], with_spaces = FALSE)[5:6, 2], c("0", "0") ) }) @@ -271,12 +274,12 @@ testthat::test_that("AET04 variant 3 is produced correctly (Fill in of Grades)", ) testthat::expect_identical( - to_string_matrix(pag_result[[3]])[4, 1], - "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS" + to_string_matrix(pag_result[[3]], with_spaces = FALSE)[4, 1], + "SKIN AND SUBCUTANEOUS TISSUE DISORDERS" ) testthat::expect_identical( - to_string_matrix(pag_result[[1]])[5:6, 2], - c("69 (80.2%)", "46 (53.5%)") + to_string_matrix(pag_result[[1]], with_spaces = FALSE)[5:6, 2], + c("23 (26.7%)", "17 (19.8%)") ) }) diff --git a/tests/testthat/test-table_aet05.R b/tests/testthat/test-table_aet05.R index 600e661..919d323 100644 --- a/tests/testthat/test-table_aet05.R +++ b/tests/testthat/test-table_aet05.R @@ -10,7 +10,7 @@ adaette <- left_join( ) %>% mutate( PARAM = "Time to first occurrence of any adverse event", - AVAL = as.numeric(difftime(TRTSDT, ASTDTM, unit = "days")) / 365.25, + AVAL = as.numeric(difftime(TRTSDT, ASTDTM, units = "days")) / 365.25, AVALU = "YEARS", CNSR = ifelse(is.na(AVAL), 1, 0) ) diff --git a/tests/testthat/test-table_aet06_smq.R b/tests/testthat/test-table_aet06_smq.R index 9e25939..9545268 100644 --- a/tests/testthat/test-table_aet06_smq.R +++ b/tests/testthat/test-table_aet06_smq.R @@ -3,8 +3,8 @@ adsl <- adsl_pharmaverse adae <- adae_pharmaverse testthat::test_that("AET06_SMQ variant 1 is produced correctly", { - adsl_labels <- formatters::var_labels(adsl) - adae_labels <- formatters::var_labels(adae) + adsl_labels <- var_labels(adsl) + adae_labels <- var_labels(adae) adae <- adae %>% dplyr::mutate( @@ -39,7 +39,7 @@ testthat::test_that("AET06_SMQ variant 1 is produced correctly", { adae_f <- rbind(adae_smq1, adae_smq2, adae_smq3) - formatters::var_labels(adae_f) <- c(adae_labels, "SMQ" = "Standardised MedDRA Queries") + var_labels(adae_f) <- c(adae_labels, "SMQ" = "Standardised MedDRA Queries") lyt <- basic_table() %>% split_cols_by("ARM") %>% @@ -74,8 +74,8 @@ testthat::test_that("AET06_SMQ variant 1 is produced correctly", { }) testthat::test_that("AET06_SMQ variant 2 is produced correctly", { - adsl_labels <- formatters::var_labels(adsl) - adae_labels <- formatters::var_labels(adae) + adsl_labels <- var_labels(adsl) + adae_labels <- var_labels(adae) adsl <- adsl %>% dplyr::mutate( @@ -86,7 +86,7 @@ testthat::test_that("AET06_SMQ variant 2 is produced correctly", { AGE65 = factor(AGE65, levels = c(">= 65", "< 65")) ) - formatters::var_labels(adsl) <- c(adsl_labels, "AGE65" = "AGE65 GROUP") + var_labels(adsl) <- c(adsl_labels, "AGE65" = "AGE65 GROUP") adae <- adae %>% dplyr::mutate( @@ -126,7 +126,7 @@ testthat::test_that("AET06_SMQ variant 2 is produced correctly", { adae_f <- rbind(adae_smq1, adae_smq2, adae_smq3) - formatters::var_labels(adae_f) <- c(adae_labels, "SMQ" = "Standardised MedDRA Queries", "AGE65" = "AGE65 GROUP") + var_labels(adae_f) <- c(adae_labels, "SMQ" = "Standardised MedDRA Queries", "AGE65" = "AGE65 GROUP") lyt <- basic_table() %>% split_cols_by("ARM") %>% diff --git a/tests/testthat/test-table_aet09_smq.R b/tests/testthat/test-table_aet09_smq.R index 006c51a..e3c5bab 100644 --- a/tests/testthat/test-table_aet09_smq.R +++ b/tests/testthat/test-table_aet09_smq.R @@ -13,8 +13,8 @@ adsl <- adsl_pharmaverse adae <- adae_pharmaverse testthat::test_that("AET09 variant 1 (AEs related to study drug by SMQ) is produced correctly", { - adsl_labels <- formatters::var_labels(adsl) - adae_labels <- formatters::var_labels(adae) + adsl_labels <- var_labels(adsl) + adae_labels <- var_labels(adae) adae <- adae %>% dplyr::mutate( @@ -72,8 +72,8 @@ testthat::test_that("AET09 variant 1 (AEs related to study drug by SMQ) is produ testthat::test_that( "AET09 variant 2 (AEs related to study drug by SMQ with customized queries) is produced correctly", { - adsl_labels <- formatters::var_labels(adsl) - adae_labels <- formatters::var_labels(adae) + adsl_labels <- var_labels(adsl) + adae_labels <- var_labels(adae) adae <- adae %>% dplyr::mutate( diff --git a/tests/testthat/test-table_coxt01.R b/tests/testthat/test-table_coxt01.R index b405349..9f919a5 100644 --- a/tests/testthat/test-table_coxt01.R +++ b/tests/testthat/test-table_coxt01.R @@ -1,5 +1,5 @@ adtte <- adtte_raw -saved_labels <- formatters::var_labels(adtte) +saved_labels <- var_labels(adtte) adtte_f <- adtte %>% dplyr::filter( PARAMCD == "OS", @@ -13,7 +13,7 @@ adtte_f <- adtte %>% RACE = droplevels(RACE), EVENT = 1 - CNSR ) -formatters::var_labels(adtte_f) <- c(saved_labels, "Event") +var_labels(adtte_f) <- c(saved_labels, "Event") testthat::test_that("1. Cox Regression", { variables <- list( diff --git a/tests/testthat/test-table_coxt02.R b/tests/testthat/test-table_coxt02.R index 237036a..f0b5e67 100644 --- a/tests/testthat/test-table_coxt02.R +++ b/tests/testthat/test-table_coxt02.R @@ -11,7 +11,7 @@ adtte_f <- adtte %>% RACE = droplevels(RACE), EVENT = 1 - CNSR ) %>% - formatters::var_relabel( + var_relabel( SEX = "Sex", AGE = "Age" ) diff --git a/tests/testthat/test-table_disclosures.R b/tests/testthat/test-table_disclosures.R index 92bba49..b6ade15 100644 --- a/tests/testthat/test-table_disclosures.R +++ b/tests/testthat/test-table_disclosures.R @@ -30,7 +30,7 @@ adsl_local <- local({ ) columns <- c("STSTFL", "COMPSTUD", "DISCSTUD", "AGEGRP", "ETHNIC") labels <- c("Start Study", "Study Completion Flag", "Study Discontinuation Flag", "Age Group", "Ethnicity") - formatters::var_labels(adsl_f)[columns] <- labels + var_labels(adsl_f)[columns] <- labels adsl_f$AGEGRP <- factor(adsl_f$AGEGRP, levels = c("< 65 yrs", ">= 65 yrs")) adsl_f$ETHNIC <- factor(adsl_f$ETHNIC, levels = c("Ethnicity 1", "Ethnicity 2", "Unknown")) @@ -166,9 +166,9 @@ testthat::test_that("Table of Serious Adverse Events is produced correctly (for adae_serious_arm <- adae_serious %>% dplyr::filter(ARM == "A: Drug X") filters_list <- list( - related = formatters::with_label(c(AEREL = "Y"), "Events (Related)"), - fatal = formatters::with_label(c(AESDTH = "Y"), "Events (Fatal)"), - fatal_related = formatters::with_label(c(AEREL = "Y", AESDTH = "Y"), "Events (Fatal & Related)") + related = with_label(c(AEREL = "Y"), "Events (Related)"), + fatal = with_label(c(AESDTH = "Y"), "Events (Fatal)"), + fatal_related = with_label(c(AEREL = "Y", AESDTH = "Y"), "Events (Fatal & Related)") ) result <- basic_table() %>% diff --git a/tests/testthat/test-table_egt03.R b/tests/testthat/test-table_egt03.R index 914caf0..1c99bf2 100644 --- a/tests/testthat/test-table_egt03.R +++ b/tests/testthat/test-table_egt03.R @@ -5,7 +5,7 @@ adeg <- adeg_raw testthat::test_that("EGT03 variant 1 is produced correctly", { set.seed(123, kind = "Mersenne-Twister") - adeg_labels <- formatters::var_labels(adeg) + adeg_labels <- var_labels(adeg) # Filtering # --------- @@ -36,7 +36,7 @@ testthat::test_that("EGT03 variant 1 is produced correctly", { adeg_f$BNRIND[sample(seq_len(nrow(adeg_f)), size = 5)] <- "Missing" adeg_f$ANRIND[sample(seq_len(nrow(adeg_f)), size = 5)] <- "Missing" - formatters::var_labels(adeg_f) <- adeg_labels + var_labels(adeg_f) <- adeg_labels lyt <- basic_table() %>% split_cols_by("ANRIND") %>% @@ -52,7 +52,7 @@ testthat::test_that("EGT03 variant 1 is produced correctly", { testthat::test_that("EGT03 variant 2 is produced correctly", { set.seed(123, kind = "Mersenne-Twister") - adeg_labels <- formatters::var_labels(adeg) + adeg_labels <- var_labels(adeg) # Filtering # --------- @@ -77,7 +77,7 @@ testthat::test_that("EGT03 variant 2 is produced correctly", { adeg_f$BNRIND[sample(seq_len(nrow(adeg_f)), size = 5)] <- "Missing" - formatters::var_labels(adeg_f) <- adeg_labels + var_labels(adeg_f) <- adeg_labels lyt <- basic_table() %>% split_cols_by("ANRIND") %>% @@ -93,7 +93,7 @@ testthat::test_that("EGT03 variant 2 is produced correctly", { testthat::test_that("EGT03 variant 3 is produced correctly", { set.seed(123, kind = "Mersenne-Twister") - adeg_labels <- formatters::var_labels(adeg) + adeg_labels <- var_labels(adeg) # Filtering # --------- @@ -118,7 +118,7 @@ testthat::test_that("EGT03 variant 3 is produced correctly", { adeg_f$ANRIND[sample(seq_len(nrow(adeg_f)), size = 5)] <- "Missing" - formatters::var_labels(adeg_f) <- adeg_labels + var_labels(adeg_f) <- adeg_labels lyt <- basic_table() %>% split_cols_by("ANRIND") %>% @@ -134,7 +134,7 @@ testthat::test_that("EGT03 variant 3 is produced correctly", { testthat::test_that("EGT03 variant 4 is produced correctly", { set.seed(123, kind = "Mersenne-Twister") - adeg_labels <- formatters::var_labels(adeg) + adeg_labels <- var_labels(adeg) # Filtering # --------- @@ -165,7 +165,7 @@ testthat::test_that("EGT03 variant 4 is produced correctly", { adeg_f$BNRIND[sample(seq_len(nrow(adeg_f)), size = 5)] <- "Missing" adeg_f$ANRIND[sample(seq_len(nrow(adeg_f)), size = 5)] <- "Missing" - formatters::var_labels(adeg_f) <- adeg_labels + var_labels(adeg_f) <- adeg_labels lyt <- basic_table() %>% split_cols_by("ANRIND") %>% diff --git a/tests/testthat/test-table_egt04.R b/tests/testthat/test-table_egt04.R index d685346..f2895bc 100644 --- a/tests/testthat/test-table_egt04.R +++ b/tests/testthat/test-table_egt04.R @@ -4,7 +4,7 @@ adsl <- adsl_raw adeg <- adeg_raw testthat::test_that("EGT04 default variant is produced correctly", { - adeg_labels <- formatters::var_labels(adeg) + adeg_labels <- var_labels(adeg) adeg_f <- subset( adeg, PARAMCD == "ECGINTP" & # Analysis in terms of "NORMAL"/"ABNORMAL" (AVALC) @@ -32,7 +32,7 @@ testthat::test_that("EGT04 default variant is produced correctly", { levels = c("NORMAL", "ABNORMAL", "Missing"), labels = c("Normal", "Abnormal", "Missing") ) - formatters::var_labels(adeg_f) <- adeg_labels + var_labels(adeg_f) <- adeg_labels l <- basic_table() %>% split_cols_by("AVALC") %>% diff --git a/tests/testthat/test-table_lbt11.R b/tests/testthat/test-table_lbt11.R index 18151a2..e1dd202 100644 --- a/tests/testthat/test-table_lbt11.R +++ b/tests/testthat/test-table_lbt11.R @@ -36,7 +36,7 @@ anl <- adlb_pharmaverse %>% ) %>% mutate( PARAM = "Time to Hy's Law Elevation in relation to ULN", - AVAL = as.numeric(difftime(ADT2, TRTSDT, unit = "days")), + AVAL = as.numeric(difftime(ADT2, TRTSDT, units = "days")), AVAL = ifelse(is.na(AVAL) & !is.na(ARMCD), 1, AVAL), AVALU = ifelse(!is.na(AVAL), "DAYS", NA_character_), AVALU = as.factor(AVALU), diff --git a/tests/testthat/test-table_lbt13.R b/tests/testthat/test-table_lbt13.R index 706567b..accb436 100644 --- a/tests/testthat/test-table_lbt13.R +++ b/tests/testthat/test-table_lbt13.R @@ -17,13 +17,7 @@ testthat::test_that("LBT13 variant 1: LOW works as expected", { adlb_f <- adlb %>% filter(WGRLOVFL == "Y") # Please note the step below can be skipped if you are using DTYPE PHANTOM - adlb_out <- adsl_f %>% - h_adsl_adlb_merge_using_worst_flag( - adlb_f, - worst_flag = c("WGRLOVFL" = "Y"), - by_visit = TRUE, - no_fillin_visits = c("SCREENING", "BASELINE", "UNSCHEDULED") - ) + # you would use this adsl_adlb_merge_using_worst_flag # Create new grouping variables ATOXGR_GP, BTOXGR_GP adlb_out <- adlb_f %>% diff --git a/tests/testthat/test-table_lgrt02.R b/tests/testthat/test-table_lgrt02.R index 749d4ad..9dd2633 100644 --- a/tests/testthat/test-table_lgrt02.R +++ b/tests/testthat/test-table_lgrt02.R @@ -5,10 +5,10 @@ adrs <- adrs_raw adsl_cached <- adsl %>% dplyr::filter(SEX %in% c("F", "M")) %>% - reapply_varlabels(formatters::var_labels(adsl)) + reapply_varlabels(var_labels(adsl)) adrs_cached <- adrs %>% dplyr::filter(SEX %in% c("F", "M")) %>% - reapply_varlabels(formatters::var_labels(adrs)) + reapply_varlabels(var_labels(adrs)) get_adrs <- function() { adrs_f <- adrs_cached %>% @@ -27,7 +27,7 @@ get_adrs <- function() { ) ) ) - formatters::var_labels(adrs_f) <- c(formatters::var_labels(adrs_cached), Response = "Response") # nolint + var_labels(adrs_f) <- c(var_labels(adrs_cached), Response = "Response") # nolint adrs_f } diff --git a/tests/testthat/test-table_onct05.R b/tests/testthat/test-table_onct05.R index a45b6f5..d10d4f9 100644 --- a/tests/testthat/test-table_onct05.R +++ b/tests/testthat/test-table_onct05.R @@ -1,5 +1,5 @@ preprocess_adrs <- function(adrs, n_records = 20) { - adrs_labels <- formatters::var_labels(adrs) + adrs_labels <- var_labels(adrs) adrs <- adrs %>% dplyr::filter(PARAMCD == "BESRSPI") %>% dplyr::filter(ARM %in% c("A: Drug X", "B: Placebo")) %>% @@ -10,7 +10,7 @@ preprocess_adrs <- function(adrs, n_records = 20) { ARM = forcats::fct_relevel(ARM, "B: Placebo"), rsp = AVALC == "CR" ) - formatters::var_labels(adrs) <- c(adrs_labels, "Response") + var_labels(adrs) <- c(adrs_labels, "Response") adrs } diff --git a/tests/testthat/test-table_pkct01.R b/tests/testthat/test-table_pkct01.R index ab158b9..071bb08 100644 --- a/tests/testthat/test-table_pkct01.R +++ b/tests/testthat/test-table_pkct01.R @@ -127,7 +127,7 @@ testthat::test_that("Specific PKCT01 features are present", { testthat::expect_equal(sum(sapply(string_res, grepl, pattern = "NE")), 3L) # Checking significative digits (DISCLAIMER: this is an hack and is NOT well supported) - mean_vals <- rtables::cell_values(result, + mean_vals <- cell_values(result, rowpath = NULL, colpath = c("multivars", "AVAL._[[2]]_.") ) %>% diff --git a/tests/testthat/test-table_ratet01.R b/tests/testthat/test-table_ratet01.R index cd9f554..4ed359c 100644 --- a/tests/testthat/test-table_ratet01.R +++ b/tests/testthat/test-table_ratet01.R @@ -15,7 +15,7 @@ testthat::test_that("RATET01 is produced correctly", { var_labels = "Number of exacerbations per patient", .stats = c("count_fraction"), .formats = c("count_fraction" = "xx (xx.xx%)"), - .label = c("Number of exacerbations per patient") + .labels = c("Number of exacerbations per patient") ) %>% summarize_glm_count( vars = "AVAL",