diff --git a/tests/testthat/_snaps/table_egt01.md b/tests/testthat/_snaps/table_egt01.md index 47dda15..2d9c0a9 100644 --- a/tests/testthat/_snaps/table_egt01.md +++ b/tests/testthat/_snaps/table_egt01.md @@ -3,102 +3,147 @@ Code res Output - A: Drug X B: Placebo C: Combination - Change from Change from Change from - Parameter Value at Visit Baseline Value at Visit Baseline Value at Visit Baseline - Analysis Visit (N=134) (N=134) (N=134) (N=134) (N=132) (N=132) - ———————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— - Heart Rate - BASELINE - n 134 134 132 - Mean (SD) 71.45 (17.93) 69.83 (20.72) 69.34 (20.95) - Median 72.70 73.35 71.96 - Min - Max 9.09 - 106.91 13.49 - 115.52 11.63 - 115.49 - WEEK 1 DAY 8 - n 134 134 134 134 132 132 - Mean (SD) 70.19 (20.27) -1.26 (25.97) 69.43 (20.80) -0.40 (29.73) 68.65 (18.06) -0.69 (27.81) - Median 70.70 -2.20 70.46 -0.52 68.57 -0.76 - Min - Max 8.53 - 127.50 -50.97 - 89.16 16.85 - 129.14 -68.18 - 88.38 16.87 - 115.60 -68.25 - 67.20 - WEEK 2 DAY 15 - n 134 134 134 134 132 132 - Mean (SD) 70.32 (19.56) -1.13 (26.26) 71.11 (20.56) 1.28 (31.35) 69.19 (18.06) -0.15 (28.61) - Median 70.88 -1.10 72.52 -0.31 69.30 -1.55 - Min - Max 17.14 - 116.32 -85.03 - 67.52 9.22 - 120.54 -73.07 - 81.44 29.62 - 120.50 -67.75 - 66.29 - WEEK 3 DAY 22 - n 134 134 134 134 132 132 - Mean (SD) 68.25 (20.17) -3.20 (28.66) 68.95 (20.56) -0.88 (30.14) 70.88 (20.28) 1.54 (27.28) - Median 68.79 -2.17 67.80 1.19 70.12 0.14 - Min - Max 13.33 - 131.73 -81.20 - 72.57 23.98 - 130.41 -73.03 - 103.31 20.91 - 116.79 -64.51 - 72.52 - WEEK 4 DAY 29 - n 134 134 134 134 132 132 - Mean (SD) 70.06 (18.41) -1.38 (26.59) 71.60 (20.34) 1.77 (30.26) 71.02 (20.59) 1.68 (29.60) - Median 69.33 -4.54 72.21 -0.88 70.52 3.81 - Min - Max 22.30 - 116.51 -58.07 - 77.32 17.53 - 129.06 -64.32 - 85.34 10.35 - 117.30 -65.91 - 105.67 - WEEK 5 DAY 36 - n 134 134 134 134 132 132 - Mean (SD) 66.41 (19.74) -5.04 (27.11) 71.25 (18.92) 1.42 (27.08) 71.26 (18.56) 1.92 (29.59) - Median 65.40 -6.83 70.86 0.64 73.29 1.74 - Min - Max 23.89 - 110.38 -73.26 - 57.24 25.86 - 125.73 -71.15 - 67.37 23.89 - 117.19 -58.23 - 68.86 - QT Duration - BASELINE - n 134 134 132 - Mean (SD) 336.83 (117.96) 351.00 (98.44) 352.60 (105.11) - Median 344.41 351.48 347.96 - Min - Max 86.98 - 665.40 98.90 - 641.92 105.68 - 628.14 - WEEK 1 DAY 8 - n 134 134 134 134 132 132 - Mean (SD) 342.57 (101.09) 5.74 (159.94) 363.95 (102.34) 12.94 (140.73) 359.42 (105.16) 6.83 (147.13) - Median 347.26 -1.78 356.54 13.73 363.84 8.69 - Min - Max 91.63 - 591.42 -346.44 - 452.75 114.92 - 656.45 -317.53 - 416.35 51.91 - 611.88 -473.19 - 358.00 - WEEK 2 DAY 15 - n 134 134 134 134 132 132 - Mean (SD) 353.24 (93.93) 16.41 (162.10) 345.93 (96.78) -5.08 (152.51) 335.69 (98.61) -16.91 (138.45) - Median 351.10 16.72 346.83 -9.68 320.96 -22.27 - Min - Max 138.01 - 587.30 -414.07 - 389.16 146.42 - 556.07 -440.28 - 364.76 104.91 - 562.34 -326.55 - 325.27 - WEEK 3 DAY 22 - n 134 134 134 134 132 132 - Mean (SD) 370.12 (101.57) 33.28 (152.78) 343.41 (102.58) -7.59 (138.80) 346.95 (94.96) -5.65 (144.65) - Median 378.21 39.59 335.12 -15.89 352.15 9.11 - Min - Max 118.14 - 615.18 -391.72 - 520.09 63.37 - 566.51 -311.28 - 293.76 126.09 - 580.81 -412.11 - 410.01 - WEEK 4 DAY 29 - n 134 134 134 134 132 132 - Mean (SD) 345.77 (95.97) 8.94 (145.65) 354.38 (108.29) 3.37 (142.39) 341.36 (106.75) -11.24 (145.65) - Median 340.13 5.58 346.70 -17.13 352.30 -11.87 - Min - Max 110.12 - 616.58 -393.34 - 456.04 80.82 - 687.69 -439.90 - 364.80 4.95 - 570.61 -480.94 - 330.67 - WEEK 5 DAY 36 - n 134 134 134 134 132 132 - Mean (SD) 358.90 (97.69) 22.07 (155.68) 338.65 (99.26) -12.36 (130.46) 349.30 (95.77) -3.30 (136.00) - Median 351.96 5.89 344.17 0.40 350.32 12.68 - Min - Max 88.38 - 661.12 -353.30 - 539.84 31.25 - 563.90 -338.85 - 352.75 119.02 - 581.83 -311.45 - 295.53 - RR Duration - BASELINE - n 134 134 132 - Mean (SD) 1028.42 (286.38) 1027.48 (324.00) 1074.62 (277.33) - Median 1041.86 1047.27 1080.87 - Min - Max 34.33 - 1783.71 5.29 - 1877.19 289.60 - 1617.06 - WEEK 1 DAY 8 - n 134 134 134 134 132 132 - Mean (SD) 990.15 (318.74) -38.26 (446.40) 1061.59 (269.14) 34.10 (401.76) 1039.64 (284.39) -34.98 (406.04) - Median 963.88 -86.50 1061.50 66.91 1014.78 -97.83 - Min - Max 110.82 - 2014.56 -1014.82 - 1389.40 276.83 - 1711.99 -942.16 - 993.82 498.21 - 1937.47 -958.61 - 908.90 - WEEK 2 DAY 15 - n 134 134 134 134 132 132 - Mean (SD) 1013.37 (304.13) -15.05 (425.81) 1109.40 (318.23) 81.92 (453.11) 1045.21 (277.51) -29.41 (380.84) - Median 1040.69 40.49 1117.76 69.27 1034.64 -15.33 - Min - Max 164.19 - 1677.10 -1216.10 - 1053.15 160.73 - 2048.73 -1127.10 - 1148.61 252.84 - 1722.33 -859.27 - 871.54 - WEEK 3 DAY 22 - n 134 134 134 134 132 132 - Mean (SD) 1013.99 (304.99) -14.43 (406.53) 1118.35 (296.53) 90.86 (409.57) 1036.59 (268.52) -38.03 (421.48) - Median 1027.23 -50.54 1134.60 52.03 1030.72 -60.72 - Min - Max 357.04 - 1798.65 -882.94 - 1080.26 97.14 - 1825.43 -887.06 - 1166.15 446.02 - 1713.38 -984.79 - 902.37 - WEEK 4 DAY 29 - n 134 134 134 134 132 132 - Mean (SD) 1033.31 (313.92) 4.89 (483.15) 1079.76 (298.94) 52.28 (429.25) 1027.55 (295.86) -47.07 (378.23) - Median 1050.40 5.60 1051.61 69.55 1023.36 -49.52 - Min - Max 54.33 - 1979.43 -1345.93 - 1195.41 347.94 - 1762.04 -826.43 - 1191.83 341.62 - 2144.86 -1002.03 - 1048.66 - WEEK 5 DAY 36 - n 134 134 134 134 132 132 - Mean (SD) 1072.33 (282.90) 43.92 (379.05) 1058.45 (271.01) 30.97 (436.03) 1029.04 (271.21) -45.58 (405.53) - Median 1067.33 55.87 1068.95 33.61 1065.26 -34.40 - Min - Max 352.97 - 2000.56 -1028.79 - 1418.57 208.83 - 1794.73 -978.97 - 1365.13 436.28 - 1794.07 -962.18 - 1329.88 + Placebo Xanomeline High Dose Xanomeline Low Dose + Change from Change from Change from + Parameter Value at Visit Baseline Value at Visit Baseline Value at Visit Baseline + Analysis Visit (N=86) (N=86) (N=72) (N=72) (N=96) (N=96) + ————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— + Heart Rate (beats/min) + Week 12 + n 272 204 196 147 200 150 + Mean (SD) 75.12 (11.41) 1.74 (10.95) 72.97 (10.25) 0.38 (9.61) 73.19 (9.63) 3.15 (11.47) + Median 74.83 0.00 74.00 0.00 74.00 2.00 + Min - Max 51.00 - 106.00 -28.00 - 36.00 50.00 - 98.00 -20.00 - 28.00 48.00 - 94.00 -28.00 - 28.00 + Week 16 + n 268 201 144 108 160 120 + Mean (SD) 70.58 (8.82) -2.89 (10.04) 72.86 (9.45) 0.08 (11.79) 68.78 (9.58) -1.74 (10.08) + Median 70.17 -2.00 72.00 0.00 68.00 -2.00 + Min - Max 50.00 - 90.00 -50.00 - 28.00 51.00 - 96.00 -28.00 - 32.00 48.00 - 104.00 -28.00 - 34.00 + Week 2 + n 336 252 285 214 374 280 + Mean (SD) 73.25 (10.05) -0.02 (11.32) 76.32 (9.13) 3.83 (9.09) 74.62 (11.03) 2.71 (10.46) + Median 72.00 0.00 76.00 4.00 74.00 2.00 + Min - Max 50.00 - 106.00 -53.00 - 42.00 56.00 - 102.00 -18.00 - 32.00 52.00 - 116.00 -28.00 - 40.00 + Week 20 + n 264 198 128 96 116 87 + Mean (SD) 72.00 (8.70) -1.29 (11.88) 76.74 (10.92) 3.39 (10.52) 70.34 (11.39) -0.95 (12.24) + Median 72.00 -2.00 78.83 4.00 70.00 0.00 + Min - Max 53.00 - 96.00 -67.00 - 26.00 52.00 - 100.00 -28.00 - 30.00 40.00 - 100.00 -40.00 - 32.00 + Week 24 + n 236 177 120 90 104 78 + Mean (SD) 71.57 (8.97) -1.09 (10.28) 71.69 (11.68) -2.16 (11.82) 70.24 (9.82) -1.81 (9.51) + Median 72.00 0.00 70.00 -2.00 70.67 0.00 + Min - Max 50.00 - 92.00 -53.00 - 24.00 47.00 - 98.00 -40.00 - 20.00 52.00 - 96.00 -24.00 - 25.00 + Week 26 + n 232 174 112 84 100 75 + Mean (SD) 73.07 (10.70) 0.28 (11.71) 73.44 (11.01) -1.30 (10.78) 70.45 (8.66) -2.19 (11.28) + Median 74.00 0.00 72.00 -2.00 70.00 -2.00 + Min - Max 50.00 - 108.00 -46.00 - 44.00 53.00 - 100.00 -32.00 - 24.00 53.00 - 92.00 -26.00 - 24.00 + Week 4 + n 328 246 288 216 292 219 + Mean (SD) 73.81 (10.50) 0.48 (8.74) 75.94 (10.91) 3.55 (10.26) 73.13 (10.26) 1.79 (10.71) + Median 74.00 0.00 74.33 4.00 74.00 1.00 + Min - Max 50.00 - 120.00 -22.00 - 30.00 48.00 - 114.00 -24.00 - 36.00 48.00 - 100.00 -28.00 - 32.00 + Week 6 + n 304 228 268 201 260 195 + Mean (SD) 72.93 (10.25) -0.86 (12.05) 74.27 (9.90) 1.97 (10.49) 72.01 (9.01) 1.33 (8.72) + Median 72.00 0.00 74.00 2.00 72.00 2.00 + Min - Max 53.00 - 108.00 -65.00 - 40.00 52.00 - 100.00 -32.00 - 29.00 52.00 - 96.00 -28.00 - 24.00 + Week 8 + n 288 216 220 165 232 174 + Mean (SD) 71.85 (9.03) -1.57 (10.86) 74.02 (8.95) 1.42 (8.81) 72.62 (11.16) 2.86 (10.29) + Median 72.00 -2.00 72.00 2.00 72.00 4.00 + Min - Max 52.00 - 102.00 -74.00 - 30.00 50.00 - 104.00 -20.00 - 26.00 49.00 - 104.00 -26.00 - 30.00 + QT Duration (msec) + Week 12 + n 272 204 196 147 200 150 + Mean (SD) 444.88 (64.60) -17.88 (54.96) 446.98 (54.84) -23.71 (65.92) 455.08 (65.10) -5.76 (61.09) + Median 437.00 -15.00 456.00 -18.00 456.00 -12.00 + Min - Max 294.00 - 624.00 -156.00 - 120.00 324.00 - 552.00 -276.00 - 120.00 300.00 - 600.00 -150.00 - 204.00 + Week 16 + n 268 201 144 108 160 120 + Mean (SD) 450.03 (65.76) -11.13 (58.00) 455.50 (54.40) -10.72 (65.65) 449.55 (58.67) -10.65 (61.78) + Median 456.00 0.00 460.00 0.00 454.00 -12.00 + Min - Max 294.00 - 588.00 -180.00 - 144.00 300.00 - 552.00 -228.00 - 162.00 330.00 - 588.00 -180.00 - 228.00 + Week 2 + n 336 252 285 214 374 280 + Mean (SD) 446.74 (61.40) -16.31 (58.56) 457.63 (58.50) -11.66 (64.47) 458.25 (62.36) -0.99 (54.55) + Median 444.00 -12.00 456.00 0.00 458.00 0.00 + Min - Max 270.00 - 600.00 -204.00 - 180.00 258.00 - 606.00 -228.00 - 156.00 270.00 - 708.00 -168.00 - 192.00 + Week 20 + n 264 198 128 96 116 87 + Mean (SD) 440.39 (62.63) -19.18 (56.76) 444.44 (60.83) -17.69 (66.22) 443.45 (57.31) -15.17 (61.06) + Median 432.00 -24.00 432.00 -12.00 446.00 -6.00 + Min - Max 288.00 - 600.00 -162.00 - 108.00 324.00 - 588.00 -216.00 - 168.00 306.00 - 588.00 -180.00 - 120.00 + Week 24 + n 236 177 120 90 104 78 + Mean (SD) 442.78 (70.02) -12.41 (61.86) 449.60 (60.27) -13.20 (59.11) 455.46 (58.05) -3.00 (47.44) + Median 444.00 -18.00 453.00 -24.00 456.00 0.00 + Min - Max 264.00 - 702.00 -168.00 - 246.00 300.00 - 588.00 -120.00 - 132.00 342.00 - 588.00 -120.00 - 108.00 + Week 26 + n 232 174 112 84 100 75 + Mean (SD) 435.79 (64.69) -21.59 (59.05) 447.29 (61.84) -18.21 (58.96) 437.68 (58.18) -21.68 (48.39) + Median 432.00 -24.00 446.00 -24.00 432.00 -12.00 + Min - Max 234.00 - 588.00 -162.00 - 144.00 300.00 - 558.00 -120.00 - 120.00 336.00 - 552.00 -120.00 - 132.00 + Week 4 + n 328 246 288 216 292 219 + Mean (SD) 452.59 (68.09) -9.76 (58.63) 459.97 (56.04) -9.44 (66.51) 456.90 (55.38) -3.84 (55.71) + Median 456.00 -12.00 468.00 -6.00 456.00 0.00 + Min - Max 234.00 - 600.00 -168.00 - 180.00 324.00 - 600.00 -192.00 - 156.00 300.00 - 612.00 -180.00 - 168.00 + Week 6 + n 304 228 268 201 260 195 + Mean (SD) 446.89 (59.86) -18.00 (57.79) 450.96 (58.42) -20.93 (59.69) 449.42 (54.02) -6.74 (51.66) + Median 444.00 -12.00 456.00 -12.00 456.00 0.00 + Min - Max 288.00 - 660.00 -168.00 - 156.00 312.00 - 588.00 -300.00 - 108.00 300.00 - 600.00 -174.00 - 204.00 + Week 8 + n 288 216 220 165 232 174 + Mean (SD) 450.75 (54.72) -12.64 (54.18) 463.64 (54.71) -6.91 (58.28) 450.66 (63.79) -4.41 (64.71) + Median 454.00 -12.00 468.00 0.00 444.00 0.00 + Min - Max 294.00 - 606.00 -180.00 - 144.00 324.00 - 588.00 -270.00 - 132.00 312.00 - 600.00 -180.00 - 204.00 + RR Duration (msec) + Week 12 + n 272 204 196 147 200 150 + Mean (SD) 529.88 (59.83) -15.98 (68.32) 520.46 (61.77) -32.73 (61.63) 536.21 (66.14) -8.77 (56.40) + Median 528.00 -14.00 520.00 -32.00 533.33 -10.00 + Min - Max 312.00 - 672.00 -240.00 - 136.00 400.00 - 708.00 -208.00 - 140.00 368.00 - 680.00 -172.00 - 128.00 + Week 16 + n 268 201 144 108 160 120 + Mean (SD) 537.65 (73.43) -7.46 (77.25) 532.96 (63.92) -19.07 (68.88) 528.03 (56.81) -9.43 (60.42) + Median 534.67 -24.00 524.00 -16.00 520.00 0.00 + Min - Max 304.00 - 760.00 -176.00 - 200.00 396.00 - 744.00 -208.00 - 180.00 400.00 - 672.00 -184.00 - 120.00 + Week 2 + n 336 252 285 214 374 280 + Mean (SD) 535.25 (70.15) -13.48 (58.36) 527.12 (59.41) -23.61 (63.22) 541.15 (73.20) -9.67 (61.01) + Median 520.00 -10.00 524.00 -24.00 536.00 -8.00 + Min - Max 360.00 - 692.00 -152.00 - 160.00 384.00 - 764.00 -208.00 - 160.00 352.00 - 760.00 -192.00 - 160.00 + Week 20 + n 264 198 128 96 116 87 + Mean (SD) 533.31 (78.83) -11.88 (68.45) 508.29 (61.34) -40.83 (73.31) 519.26 (62.16) -13.70 (56.14) + Median 520.00 -8.00 496.00 -40.00 518.67 -24.00 + Min - Max 320.00 - 800.00 -184.00 - 232.00 392.00 - 740.00 -328.00 - 180.00 400.00 - 648.00 -156.00 - 120.00 + Week 24 + n 236 177 120 90 104 78 + Mean (SD) 538.71 (70.69) -7.66 (63.32) 522.49 (72.89) -27.87 (70.99) 528.72 (69.21) 0.36 (68.31) + Median 524.00 -8.00 512.00 -32.00 528.00 0.00 + Min - Max 360.00 - 796.00 -144.00 - 200.00 360.00 - 792.00 -160.00 - 168.00 368.00 - 692.00 -192.00 - 192.00 + Week 26 + n 232 174 112 84 100 75 + Mean (SD) 523.54 (72.48) -24.21 (70.65) 496.52 (56.87) -57.76 (80.23) 517.55 (71.56) -10.29 (61.63) + Median 520.00 -24.00 489.33 -72.00 519.33 0.00 + Min - Max 320.00 - 704.00 -200.00 - 168.00 380.00 - 716.00 -248.00 - 136.00 396.00 - 692.00 -156.00 - 128.00 + Week 4 + n 328 246 288 216 292 219 + Mean (SD) 535.77 (69.49) -12.50 (62.54) 527.04 (63.28) -24.00 (63.69) 543.07 (71.89) -6.94 (67.17) + Median 536.00 -8.00 520.00 -24.00 536.00 -8.00 + Min - Max 336.00 - 808.00 -192.00 - 200.00 380.00 - 724.00 -208.00 - 160.00 380.00 - 720.00 -172.00 - 320.00 + Week 6 + n 304 228 268 201 260 195 + Mean (SD) 535.33 (72.10) -10.19 (62.45) 519.52 (62.28) -36.14 (66.65) 539.63 (77.07) -7.32 (59.81) + Median 522.67 -8.00 517.33 -32.00 526.00 -8.00 + Min - Max 320.00 - 840.00 -184.00 - 192.00 360.00 - 696.00 -288.00 - 176.00 392.00 - 800.00 -220.00 - 240.00 + Week 8 + n 288 216 220 165 232 174 + Mean (SD) 544.07 (67.98) -0.35 (60.57) 539.30 (62.33) -14.08 (64.16) 535.43 (66.19) -8.37 (65.41) + Median 544.67 0.00 536.00 -16.00 528.00 -4.00 + Min - Max 360.00 - 756.00 -160.00 - 200.00 364.00 - 792.00 -172.00 - 200.00 368.00 - 720.00 -208.00 - 184.00 diff --git a/tests/testthat/_snaps/table_egt02.md b/tests/testthat/_snaps/table_egt02.md index a3550b6..2fcded9 100644 --- a/tests/testthat/_snaps/table_egt02.md +++ b/tests/testthat/_snaps/table_egt02.md @@ -3,34 +3,34 @@ Code res Output - Assessment A: Drug X B: Placebo C: Combination - Abnormality (N=134) (N=134) (N=132) - ———————————————————————————————————————————————————————————————— - Heart Rate - Low 40/134 (29.9%) 43/134 (32.1%) 37/132 (28%) - High 39/134 (29.1%) 45/134 (33.6%) 36/132 (27.3%) - QT Duration - Low 33/134 (24.6%) 44/134 (32.8%) 47/132 (35.6%) - High 30/134 (22.4%) 42/134 (31.3%) 34/132 (25.8%) - RR Duration - Low 45/134 (33.6%) 26/134 (19.4%) 38/132 (28.8%) - High 29/134 (21.6%) 49/134 (36.6%) 27/132 (20.5%) + Assessment Placebo Xanomeline High Dose Xanomeline Low Dose + Abnormality (N=86) (N=72) (N=96) + ——————————————————————————————————————————————————————————————————————————————————— + Heart Rate (beats/min) + Low 0/84 0/72 0/94 + High 6/84 (7.1%) 4/72 (5.6%) 6/94 (6.4%) + QT Duration (msec) + Low 23/84 (27.4%) 15/72 (20.8%) 21/94 (22.3%) + High 70/84 (83.3%) 66/72 (91.7%) 85/94 (90.4%) + RR Duration (msec) + Low 84/84 (100%) 71/72 (98.6%) 90/94 (95.7%) + High 0/84 0/72 0/94 # (EGT02) 2. Among Subjects Without Abnormality at Baseline Code res Output - Assessment A: Drug X B: Placebo C: Combination - Abnormality (N=134) (N=134) (N=132) - ———————————————————————————————————————————————————————————————— - Heart Rate - Low 39/128 (30.5%) 42/124 (33.9%) 33/117 (28.2%) - High 37/127 (29.1%) 43/129 (33.3%) 31/122 (25.4%) - QT Duration - Low 29/113 (25.7%) 42/126 (33.3%) 43/124 (34.7%) - High 30/125 (24%) 40/130 (30.8%) 30/119 (25.2%) - RR Duration - Low 45/129 (34.9%) 26/123 (21.1%) 37/126 (29.4%) - High 27/127 (21.3%) 43/122 (35.2%) 25/125 (20%) + Assessment Placebo Xanomeline High Dose Xanomeline Low Dose + Abnormality (N=86) (N=72) (N=96) + ——————————————————————————————————————————————————————————————————————————————————— + Heart Rate (beats/min) + Low 0/84 0/72 0/94 + High 5/84 (6%) 4/72 (5.6%) 6/94 (6.4%) + QT Duration (msec) + Low 23/84 (27.4%) 15/72 (20.8%) 20/94 (21.3%) + High 69/84 (82.1%) 65/72 (90.3%) 81/94 (86.2%) + RR Duration (msec) + Low 83/84 (98.8%) 71/72 (98.6%) 90/94 (95.7%) + High 0/84 0/72 0/94 diff --git a/tests/testthat/_snaps/table_egt03.md b/tests/testthat/_snaps/table_egt03.md index 9ed871e..8793a82 100644 --- a/tests/testthat/_snaps/table_egt03.md +++ b/tests/testthat/_snaps/table_egt03.md @@ -3,99 +3,102 @@ Code res Output - LOW NORMAL HIGH Missing - —————————————————————————————————————————————————————————————————— - A: Drug X (N=134) - n 40 92 0 2 - LOW 1 (0.7%) 5 (3.7%) 0 0 - NORMAL 36 (26.9%) 83 (61.9%) 0 1 (0.7%) - HIGH 2 (1.5%) 4 (3%) 0 0 - Missing 1 (0.7%) 0 0 1 (0.7%) - B: Placebo (N=134) - n 43 89 0 2 - LOW 1 (0.7%) 9 (6.7%) 0 0 - NORMAL 40 (29.9%) 75 (56%) 0 2 (1.5%) - HIGH 1 (0.7%) 4 (3%) 0 0 - Missing 1 (0.7%) 1 (0.7%) 0 0 - C: Combination (N=132) - n 37 94 0 1 - LOW 4 (3%) 11 (8.3%) 0 0 - NORMAL 31 (23.5%) 75 (56.8%) 0 0 - HIGH 1 (0.8%) 8 (6.1%) 0 1 (0.8%) - Missing 1 (0.8%) 0 0 0 + LOW NORMAL HIGH Missing + ——————————————————————————————————————————————————————————————————————————— + Placebo (N=336) + n 0 331 3 2 + LOW 0 83 (24.7%) 1 (0.3%) 0 + NORMAL 0 243 (72.3%) 2 (0.6%) 0 + HIGH 0 5 (1.5%) 0 0 + Missing 0 0 0 2 (0.6%) + Xanomeline High Dose (N=324) + n 0 321 3 0 + LOW 0 80 (24.7%) 1 (0.3%) 0 + NORMAL 0 241 (74.4%) 2 (0.6%) 0 + HIGH 0 0 0 0 + Missing 0 0 0 0 + Xanomeline Low Dose (N=336) + n 1 326 6 3 + LOW 0 83 (24.7%) 1 (0.3%) 0 + NORMAL 1 (0.3%) 242 (72%) 5 (1.5%) 0 + HIGH 0 1 (0.3%) 0 0 + Missing 0 0 0 3 (0.9%) # EGT03 variant 2 is produced correctly Code res Output - LOW NORMAL HIGH - ——————————————————————————————————————————————————————— - A: Drug X (N=134) - n 40 94 0 - LOW 1 (0.7%) 5 (3.7%) 0 - NORMAL 36 (26.9%) 84 (62.7%) 0 - HIGH 2 (1.5%) 4 (3%) 0 - Missing 1 (0.7%) 1 (0.7%) 0 - B: Placebo (N=134) - n 43 91 0 - LOW 1 (0.7%) 9 (6.7%) 0 - NORMAL 40 (29.9%) 77 (57.5%) 0 - HIGH 1 (0.7%) 4 (3%) 0 - Missing 1 (0.7%) 1 (0.7%) 0 - C: Combination (N=132) - n 37 95 0 - LOW 4 (3%) 11 (8.3%) 0 - NORMAL 31 (23.5%) 75 (56.8%) 0 - HIGH 1 (0.8%) 9 (6.8%) 0 - Missing 1 (0.8%) 0 0 + NORMAL LOW HIGH + ———————————————————————————————————————————————————————————————— + Placebo (N=336) + n 333 0 3 + LOW 83 (24.7%) 0 1 (0.3%) + NORMAL 243 (72.3%) 0 2 (0.6%) + HIGH 5 (1.5%) 0 0 + Missing 2 (0.6%) 0 0 + Xanomeline High Dose (N=324) + n 321 0 3 + LOW 80 (24.7%) 0 1 (0.3%) + NORMAL 241 (74.4%) 0 2 (0.6%) + HIGH 0 0 0 + Missing 0 0 0 + Xanomeline Low Dose (N=336) + n 329 1 6 + LOW 83 (24.7%) 0 1 (0.3%) + NORMAL 242 (72%) 1 (0.3%) 5 (1.5%) + HIGH 1 (0.3%) 0 0 + Missing 3 (0.9%) 0 0 # EGT03 variant 3 is produced correctly Code res Output - LOW NORMAL HIGH Missing - —————————————————————————————————————————————————————————————————— - A: Drug X (N=134) - n 39 93 0 2 - LOW 1 (0.7%) 5 (3.7%) 0 0 - NORMAL 36 (26.9%) 84 (62.7%) 0 1 (0.7%) - HIGH 2 (1.5%) 4 (3%) 0 1 (0.7%) - B: Placebo (N=134) - n 42 90 0 2 - LOW 1 (0.7%) 9 (6.7%) 0 0 - NORMAL 40 (29.9%) 77 (57.5%) 0 2 (1.5%) - HIGH 1 (0.7%) 4 (3%) 0 0 - C: Combination (N=132) - n 36 95 0 1 - LOW 4 (3%) 11 (8.3%) 0 0 - NORMAL 31 (23.5%) 75 (56.8%) 0 1 (0.8%) - HIGH 1 (0.8%) 9 (6.8%) 0 0 + LOW NORMAL HIGH Missing + ——————————————————————————————————————————————————————————————————————————— + Placebo (N=336) + n 0 331 3 2 + LOW 0 83 (24.7%) 1 (0.3%) 0 + NORMAL 0 243 (72.3%) 2 (0.6%) 0 + HIGH 0 5 (1.5%) 0 0 + Missing 0 0 0 2 (0.6%) + Xanomeline High Dose (N=324) + n 0 321 3 0 + LOW 0 80 (24.7%) 1 (0.3%) 0 + NORMAL 0 241 (74.4%) 2 (0.6%) 0 + HIGH 0 0 0 0 + Missing 0 0 0 0 + Xanomeline Low Dose (N=336) + n 1 326 6 3 + LOW 0 83 (24.7%) 1 (0.3%) 0 + NORMAL 1 (0.3%) 242 (72%) 5 (1.5%) 0 + HIGH 0 1 (0.3%) 0 0 + Missing 0 0 0 3 (0.9%) # EGT03 variant 4 is produced correctly Code res Output - LOW NORMAL HIGH Missing - ————————————————————————————————————————————————————————————————— - A: Drug X (N=134) - n 0 95 37 2 - LOW 0 2 (1.5%) 4 (3%) 0 - NORMAL 0 88 (65.7%) 31 (23.1%) 1 (0.7%) - HIGH 0 5 (3.7%) 1 (0.7%) 0 - Missing 0 0 1 (0.7%) 1 (0.7%) - B: Placebo (N=134) - n 0 88 44 2 - LOW 0 8 (6%) 2 (1.5%) 0 - NORMAL 0 76 (56.7%) 39 (29.1%) 2 (1.5%) - HIGH 0 3 (2.2%) 2 (1.5%) 0 - Missing 0 1 (0.7%) 1 (0.7%) 0 - C: Combination (N=132) - n 0 96 35 1 - LOW 0 12 (9.1%) 3 (2.3%) 0 - NORMAL 0 79 (59.8%) 27 (20.5%) 0 - HIGH 0 5 (3.8%) 4 (3%) 1 (0.8%) - Missing 0 0 1 (0.8%) 0 + LOW NORMAL HIGH Missing + ——————————————————————————————————————————————————————————————————————————— + Placebo (N=336) + n 0 331 3 2 + LOW 0 83 (24.7%) 1 (0.3%) 0 + NORMAL 0 243 (72.3%) 2 (0.6%) 0 + HIGH 0 5 (1.5%) 0 0 + Missing 0 0 0 2 (0.6%) + Xanomeline High Dose (N=324) + n 0 321 3 0 + LOW 0 80 (24.7%) 1 (0.3%) 0 + NORMAL 0 241 (74.4%) 2 (0.6%) 0 + HIGH 0 0 0 0 + Missing 0 0 0 0 + Xanomeline Low Dose (N=336) + n 1 326 6 3 + LOW 0 83 (24.7%) 1 (0.3%) 0 + NORMAL 1 (0.3%) 242 (72%) 5 (1.5%) 0 + HIGH 0 1 (0.3%) 0 0 + Missing 0 0 0 3 (0.9%) diff --git a/tests/testthat/_snaps/table_egt04.md b/tests/testthat/_snaps/table_egt04.md index 142ab71..23fa58d 100644 --- a/tests/testthat/_snaps/table_egt04.md +++ b/tests/testthat/_snaps/table_egt04.md @@ -3,18 +3,18 @@ Code res Output - Normal Abnormal Missing - ——————————————————————————————————————————————————————————— - A: Drug X (N=134) - Normal 20 (14.9%) 81 (60.4%) 1 (0.7%) - Abnormal 11 (8.2%) 19 (14.2%) 0 - Missing 0 1 (0.7%) 1 (0.7%) - B: Placebo (N=134) - Normal 18 (13.4%) 81 (60.4%) 2 (1.5%) - Abnormal 3 (2.2%) 28 (20.9%) 0 - Missing 0 2 (1.5%) 0 - C: Combination (N=132) - Normal 26 (19.7%) 69 (52.3%) 1 (0.8%) - Abnormal 6 (4.5%) 29 (22%) 0 - Missing 1 (0.8%) 0 0 + Normal Abnormal Missing + ——————————————————————————————————————————————————————————————— + Placebo (N=145) + Normal 73 (50.3%) 0 1 (0.7%) + Abnormal 38 (26.2%) 1 (0.7%) 2 (1.4%) + Missing 30 (20.7%) 0 0 + Xanomeline High Dose (N=113) + Normal 45 (39.8%) 9 (8%) 1 (0.9%) + Abnormal 27 (23.9%) 7 (6.2%) 0 + Missing 23 (20.4%) 1 (0.9%) 0 + Xanomeline Low Dose (N=119) + Normal 52 (43.7%) 8 (6.7%) 0 + Abnormal 30 (25.2%) 3 (2.5%) 0 + Missing 25 (21%) 0 1 (0.8%) diff --git a/tests/testthat/_snaps/table_egt05_qtcat.md b/tests/testthat/_snaps/table_egt05_qtcat.md index 9c0886f..1531a57 100644 --- a/tests/testthat/_snaps/table_egt05_qtcat.md +++ b/tests/testthat/_snaps/table_egt05_qtcat.md @@ -3,76 +3,117 @@ Code res Output - Parameter - Analysis Visit A: Drug X B: Placebo C: Combination - Category (N=134) (N=134) (N=132) - —————————————————————————————————————————————————————————————————————— - QT Duration - BASELINE - Value at Visit - n 134 134 132 - <=450 msec 115 (85.8%) 117 (87.3%) 104 (78.8%) - >450 to <=480 msec 6 (4.5%) 10 (7.5%) 9 (6.8%) - >480 to <= 500 msec 4 (3%) 3 (2.2%) 6 (4.5%) - >500 msec 9 (6.7%) 4 (3%) 13 (9.8%) - WEEK 1 DAY 8 - Value at Visit - n 134 134 132 - <=450 msec 113 (84.3%) 106 (79.1%) 106 (80.3%) - >450 to <=480 msec 10 (7.5%) 10 (7.5%) 11 (8.3%) - >480 to <= 500 msec 4 (3%) 4 (3%) 3 (2.3%) - >500 msec 7 (5.2%) 14 (10.4%) 12 (9.1%) - Change from Baseline - n 134 134 132 - <=30 msec 76 (56.7%) 75 (56%) 75 (56.8%) - >30 to <=60 msec 7 (5.2%) 13 (9.7%) 11 (8.3%) - >60 msec 51 (38.1%) 46 (34.3%) 46 (34.8%) - WEEK 2 DAY 15 - Value at Visit - n 134 134 132 - <=450 msec 111 (82.8%) 114 (85.1%) 112 (84.8%) - >450 to <=480 msec 10 (7.5%) 9 (6.7%) 9 (6.8%) - >480 to <= 500 msec 7 (5.2%) 2 (1.5%) 5 (3.8%) - >500 msec 6 (4.5%) 9 (6.7%) 6 (4.5%) - Change from Baseline - n 134 134 132 - <=30 msec 71 (53%) 87 (64.9%) 89 (67.4%) - >30 to <=60 msec 11 (8.2%) 9 (6.7%) 9 (6.8%) - >60 msec 52 (38.8%) 38 (28.4%) 34 (25.8%) - WEEK 3 DAY 22 - Value at Visit - n 134 134 132 - <=450 msec 106 (79.1%) 112 (83.6%) 118 (89.4%) - >450 to <=480 msec 13 (9.7%) 7 (5.2%) 3 (2.3%) - >480 to <= 500 msec 4 (3%) 5 (3.7%) 2 (1.5%) - >500 msec 11 (8.2%) 10 (7.5%) 9 (6.8%) - Change from Baseline - n 134 134 132 - <=30 msec 63 (47%) 80 (59.7%) 81 (61.4%) - >30 to <=60 msec 14 (10.4%) 8 (6%) 11 (8.3%) - >60 msec 57 (42.5%) 46 (34.3%) 40 (30.3%) - WEEK 4 DAY 29 - Value at Visit - n 134 134 132 - <=450 msec 117 (87.3%) 103 (76.9%) 114 (86.4%) - >450 to <=480 msec 7 (5.2%) 14 (10.4%) 6 (4.5%) - >480 to <= 500 msec 4 (3%) 7 (5.2%) 3 (2.3%) - >500 msec 6 (4.5%) 10 (7.5%) 9 (6.8%) - Change from Baseline - n 134 134 132 - <=30 msec 79 (59%) 80 (59.7%) 79 (59.8%) - >30 to <=60 msec 11 (8.2%) 7 (5.2%) 10 (7.6%) - >60 msec 44 (32.8%) 47 (35.1%) 43 (32.6%) - WEEK 5 DAY 36 - Value at Visit - n 134 134 132 - <=450 msec 107 (79.9%) 117 (87.3%) 112 (84.8%) - >450 to <=480 msec 16 (11.9%) 5 (3.7%) 13 (9.8%) - >480 to <= 500 msec 5 (3.7%) 9 (6.7%) 3 (2.3%) - >500 msec 6 (4.5%) 3 (2.2%) 4 (3%) - Change from Baseline - n 134 134 132 - <=30 msec 72 (53.7%) 82 (61.2%) 73 (55.3%) - >30 to <=60 msec 10 (7.5%) 11 (8.2%) 11 (8.3%) - >60 msec 52 (38.8%) 41 (30.6%) 48 (36.4%) + Parameter + Analysis Visit Placebo Xanomeline High Dose Xanomeline Low Dose + Category (N=86) (N=84) (N=84) + ———————————————————————————————————————————————————————————————————————————————————— + QT Duration (msec) + Week 2 + Value at Visit + n 272 196 200 + <=450 msec 154 (56.6%) 94 (48%) 97 (48.5%) + >450 to <=480 msec 48 (17.6%) 48 (24.5%) 31 (15.5%) + >480 to <= 500 msec 15 (5.5%) 21 (10.7%) 21 (10.5%) + >500 msec 55 (20.2%) 33 (16.8%) 51 (25.5%) + Change from Baseline + n 204 147 150 + <=30 msec 162 (79.4%) 120 (81.6%) 112 (74.7%) + >30 to <=60 msec 32 (15.7%) 16 (10.9%) 23 (15.3%) + >60 msec 10 (4.9%) 11 (7.5%) 15 (10%) + Week 4 + Value at Visit + n 268 144 160 + <=450 msec 128 (47.8%) 63 (43.8%) 77 (48.1%) + >450 to <=480 msec 54 (20.1%) 44 (30.6%) 36 (22.5%) + >480 to <= 500 msec 24 (9%) 9 (6.2%) 11 (6.9%) + >500 msec 62 (23.1%) 28 (19.4%) 36 (22.5%) + Change from Baseline + n 201 108 120 + <=30 msec 157 (78.1%) 86 (79.6%) 92 (76.7%) + >30 to <=60 msec 29 (14.4%) 16 (14.8%) 15 (12.5%) + >60 msec 15 (7.5%) 6 (5.6%) 13 (10.8%) + Week 6 + Value at Visit + n 336 324 335 + <=450 msec 189 (56.2%) 151 (46.6%) 158 (47.2%) + >450 to <=480 msec 65 (19.3%) 62 (19.1%) 83 (24.8%) + >480 to <= 500 msec 11 (3.3%) 22 (6.8%) 18 (5.4%) + >500 msec 71 (21.1%) 89 (27.5%) 76 (22.7%) + Change from Baseline + n 252 243 251 + <=30 msec 204 (81%) 180 (74.1%) 186 (74.1%) + >30 to <=60 msec 31 (12.3%) 41 (16.9%) 43 (17.1%) + >60 msec 17 (6.7%) 22 (9.1%) 22 (8.8%) + Week 8 + Value at Visit + n 264 128 116 + <=450 msec 153 (58%) 73 (57%) 60 (51.7%) + >450 to <=480 msec 49 (18.6%) 26 (20.3%) 32 (27.6%) + >480 to <= 500 msec 14 (5.3%) 3 (2.3%) 6 (5.2%) + >500 msec 48 (18.2%) 26 (20.3%) 18 (15.5%) + Change from Baseline + n 198 96 87 + <=30 msec 157 (79.3%) 81 (84.4%) 68 (78.2%) + >30 to <=60 msec 30 (15.2%) 7 (7.3%) 13 (14.9%) + >60 msec 11 (5.6%) 8 (8.3%) 6 (6.9%) + Week 12 + Value at Visit + n 236 120 104 + <=450 msec 125 (53%) 60 (50%) 45 (43.3%) + >450 to <=480 msec 64 (27.1%) 28 (23.3%) 31 (29.8%) + >480 to <= 500 msec 13 (5.5%) 12 (10%) 5 (4.8%) + >500 msec 34 (14.4%) 20 (16.7%) 23 (22.1%) + Change from Baseline + n 177 90 78 + <=30 msec 137 (77.4%) 70 (77.8%) 58 (74.4%) + >30 to <=60 msec 25 (14.1%) 6 (6.7%) 17 (21.8%) + >60 msec 15 (8.5%) 14 (15.6%) 3 (3.8%) + Week 16 + Value at Visit + n 232 112 100 + <=450 msec 138 (59.5%) 57 (50.9%) 57 (57%) + >450 to <=480 msec 51 (22%) 25 (22.3%) 23 (23%) + >480 to <= 500 msec 13 (5.6%) 6 (5.4%) 3 (3%) + >500 msec 30 (12.9%) 24 (21.4%) 17 (17%) + Change from Baseline + n 174 84 75 + <=30 msec 143 (82.2%) 68 (81%) 69 (92%) + >30 to <=60 msec 18 (10.3%) 10 (11.9%) 2 (2.7%) + >60 msec 13 (7.5%) 6 (7.1%) 4 (5.3%) + Week 20 + Value at Visit + n 328 292 288 + <=450 msec 158 (48.2%) 128 (43.8%) 132 (45.8%) + >450 to <=480 msec 81 (24.7%) 58 (19.9%) 78 (27.1%) + >480 to <= 500 msec 12 (3.7%) 31 (10.6%) 27 (9.4%) + >500 msec 77 (23.5%) 75 (25.7%) 51 (17.7%) + Change from Baseline + n 246 219 216 + <=30 msec 190 (77.2%) 167 (76.3%) 163 (75.5%) + >30 to <=60 msec 37 (15%) 24 (11%) 30 (13.9%) + >60 msec 19 (7.7%) 28 (12.8%) 23 (10.6%) + Week 24 + Value at Visit + n 304 268 260 + <=450 msec 159 (52.3%) 122 (45.5%) 125 (48.1%) + >450 to <=480 msec 84 (27.6%) 66 (24.6%) 83 (31.9%) + >480 to <= 500 msec 20 (6.6%) 19 (7.1%) 20 (7.7%) + >500 msec 41 (13.5%) 61 (22.8%) 32 (12.3%) + Change from Baseline + n 228 201 195 + <=30 msec 188 (82.5%) 168 (83.6%) 158 (81%) + >30 to <=60 msec 21 (9.2%) 24 (11.9%) 30 (15.4%) + >60 msec 19 (8.3%) 9 (4.5%) 7 (3.6%) + Week 26 + Value at Visit + n 288 220 232 + <=450 msec 143 (49.7%) 84 (38.2%) 123 (53%) + >450 to <=480 msec 75 (26%) 58 (26.4%) 38 (16.4%) + >480 to <= 500 msec 23 (8%) 21 (9.5%) 15 (6.5%) + >500 msec 47 (16.3%) 57 (25.9%) 56 (24.1%) + Change from Baseline + n 216 165 174 + <=30 msec 181 (83.8%) 125 (75.8%) 128 (73.6%) + >30 to <=60 msec 18 (8.3%) 29 (17.6%) 26 (14.9%) + >60 msec 17 (7.9%) 11 (6.7%) 20 (11.5%) diff --git a/tests/testthat/_snaps/table_ext01.md b/tests/testthat/_snaps/table_ext01.md index 31b47e2..a75905f 100644 --- a/tests/testthat/_snaps/table_ext01.md +++ b/tests/testthat/_snaps/table_ext01.md @@ -3,167 +3,157 @@ Code res Output - A: Drug X B: Placebo C: Combination - Parameter Category (Drug A/Drug B) (N=134) (N=134) (N=132) - ————————————————————————————————————————————————————————————————————————————————————————————————— - Drug A - Overall duration (days) - n 75 67 75 - Mean (SD) 74.3 (41.6) 79.0 (43.1) 74.2 (39.5) - Median 77.0 80.0 78.0 - Min - Max 5.0 - 149.0 2.0 - 150.0 1.0 - 147.0 - Total dose administered - n 75 67 75 - Mean (SD) 6675.2 (1110.9) 6505.1 (1249.3) 6982.4 (1272.5) - Median 6720.0 6480.0 7200.0 - Min - Max 4800.0 - 9360.0 4080.0 - 9360.0 4320.0 - 9360.0 - Total number of doses administered - n 75 67 75 - Mean (SD) 7.0 (0.0) 7.0 (0.0) 7.0 (0.0) - Median 7.0 7.0 7.0 - Min - Max 7.0 - 7.0 7.0 - 7.0 7.0 - 7.0 - Total number of missed doses during study - n 75 67 75 - Mean (SD) 10.5 (5.9) 10.0 (6.1) 9.5 (5.5) - Median 10.0 11.0 9.0 - Min - Max 0.0 - 20.0 0.0 - 19.0 0.0 - 20.0 - Drug B - Overall duration (days) - n 59 67 57 - Mean (SD) 77.5 (40.5) 76.3 (41.0) 69.5 (46.2) - Median 79.0 76.0 65.0 - Min - Max 2.0 - 149.0 5.0 - 148.0 1.0 - 149.0 - Total dose administered - n 59 67 57 - Mean (SD) 6630.5 (1334.0) 6297.3 (1291.1) 6505.3 (1080.7) - Median 6720.0 6240.0 6480.0 - Min - Max 4320.0 - 8880.0 4080.0 - 9120.0 4320.0 - 8640.0 - Total number of doses administered - n 59 67 57 - Mean (SD) 7.0 (0.0) 7.0 (0.0) 7.0 (0.0) - Median 7.0 7.0 7.0 - Min - Max 7.0 - 7.0 7.0 - 7.0 7.0 - 7.0 - Total number of missed doses during study - n 59 67 57 - Mean (SD) 9.1 (6.5) 10.0 (6.3) 10.7 (5.8) - Median 9.0 10.0 11.0 - Min - Max 0.0 - 20.0 0.0 - 20.0 1.0 - 20.0 + Placebo Xanomeline High Dose Xanomeline Low Dose + Parameter Category (Drug A/Drug B) (N=86) (N=72) (N=96) + ——————————————————————————————————————————————————————————————————————————————————————————————————————— + Drug A + Overall duration (days) + n 39 43 50 + Mean (SD) 84.1 (40.5) 80.3 (43.5) 78.8 (41.4) + Median 81.0 81.0 85.5 + Min - Max 9.0 - 142.0 9.0 - 148.0 7.0 - 145.0 + Total number of doses administered + n 39 43 50 + Mean (SD) 141.6 (65.9) 109.3 (66.6) 90.3 (70.3) + Median 182.0 95.0 71.5 + Min - Max 0.0 - 210.0 15.0 - 190.0 0.0 - 193.0 + Total number of missed doses during study + n 39 43 50 + Mean (SD) 10.2 (5.9) 9.8 (5.9) 9.4 (6.2) + Median 11.0 9.0 10.0 + Min - Max 0.0 - 20.0 0.0 - 20.0 0.0 - 20.0 + Drug B + Overall duration (days) + n 47 29 46 + Mean (SD) 68.6 (33.8) 78.4 (42.1) 79.8 (44.9) + Median 65.0 69.0 82.5 + Min - Max 7.0 - 134.0 11.0 - 148.0 1.0 - 149.0 + Total number of doses administered + n 47 29 46 + Mean (SD) 153.0 (59.1) 116.5 (64.8) 81.1 (71.5) + Median 182.0 114.0 60.5 + Min - Max 7.0 - 198.0 22.0 - 200.0 1.0 - 212.0 + Total number of missed doses during study + n 47 29 46 + Mean (SD) 9.1 (6.5) 10.7 (6.1) 10.2 (6.5) + Median 9.0 12.0 10.0 + Min - Max 0.0 - 20.0 1.0 - 20.0 0.0 - 20.0 # EXT01 variant: with both numeric and categorical parameters Code res Output - A: Drug X B: Placebo C: Combination - Parameter Category (Drug A/Drug B) (N=134) (N=134) (N=132) - —————————————————————————————————————————————————————————————————————————————————————————— - Drug A - Overall duration (days) - n 75 67 75 - Mean (SD) 74.3 (41.6) 79.0 (43.1) 74.2 (39.5) - Median 77.0 80.0 78.0 - Min - Max 5.0 - 149.0 2.0 - 150.0 1.0 - 147.0 - Overall duration (days) - n 75 67 75 - 0 - 30 12 (16%) 12 (17.9%) 15 (20%) - 31 - 60 18 (24%) 12 (17.9%) 14 (18.7%) - 61 - 90 19 (25.3%) 15 (22.4%) 18 (24%) - >= 91 26 (34.7%) 28 (41.8%) 28 (37.3%) - Total dose administered - n 75 67 75 - Mean (SD) 6675.2 (1110.9) 6505.1 (1249.3) 6982.4 (1272.5) - Median 6720.0 6480.0 7200.0 - Min - Max 4800.0 - 9360.0 4080.0 - 9360.0 4320.0 - 9360.0 - Total number of doses administered - n 75 67 75 - Mean (SD) 7.0 (0.0) 7.0 (0.0) 7.0 (0.0) - Median 7.0 7.0 7.0 - Min - Max 7.0 - 7.0 7.0 - 7.0 7.0 - 7.0 - Drug B - Overall duration (days) - n 59 67 57 - Mean (SD) 77.5 (40.5) 76.3 (41.0) 69.5 (46.2) - Median 79.0 76.0 65.0 - Min - Max 2.0 - 149.0 5.0 - 148.0 1.0 - 149.0 - Overall duration (days) - n 59 67 57 - 0 - 30 8 (13.6%) 10 (14.9%) 16 (28.1%) - 31 - 60 14 (23.7%) 16 (23.9%) 12 (21.1%) - 61 - 90 15 (25.4%) 17 (25.4%) 11 (19.3%) - >= 91 22 (37.3%) 24 (35.8%) 18 (31.6%) - Total dose administered - n 59 67 57 - Mean (SD) 6630.5 (1334.0) 6297.3 (1291.1) 6505.3 (1080.7) - Median 6720.0 6240.0 6480.0 - Min - Max 4320.0 - 8880.0 4080.0 - 9120.0 4320.0 - 8640.0 - Total number of doses administered - n 59 67 57 - Mean (SD) 7.0 (0.0) 7.0 (0.0) 7.0 (0.0) - Median 7.0 7.0 7.0 - Min - Max 7.0 - 7.0 7.0 - 7.0 7.0 - 7.0 + Placebo Xanomeline High Dose Xanomeline Low Dose + Parameter Category (Drug A/Drug B) (N=86) (N=72) (N=96) + ———————————————————————————————————————————————————————————————————————————————————————————————— + Drug A + Overall duration (days) + n 39 43 50 + Mean (SD) 84.1 (40.5) 80.3 (43.5) 78.8 (41.4) + Median 81.0 81.0 85.5 + Min - Max 9.0 - 142.0 9.0 - 148.0 7.0 - 145.0 + Overall duration (days) + n 39 43 50 + 0 - 30 4 (10.3%) 6 (14%) 10 (20%) + 31 - 60 6 (15.4%) 10 (23.3%) 8 (16%) + 61 - 90 13 (33.3%) 9 (20.9%) 12 (24%) + >= 91 16 (41%) 18 (41.9%) 20 (40%) + Total dose administered + n 39 43 50 + Mean (SD) 0.0 (0.0) 8305.3 (5230.6) 4877.3 (3798.0) + Median 0.0 7263.0 3861.0 + Min - Max 0.0 - 0.0 810.0 - 14607.0 0.0 - 10422.0 + Total number of doses administered + n 39 43 50 + Mean (SD) 141.6 (65.9) 109.3 (66.6) 90.3 (70.3) + Median 182.0 95.0 71.5 + Min - Max 0.0 - 210.0 15.0 - 190.0 0.0 - 193.0 + Drug B + Overall duration (days) + n 47 29 46 + Mean (SD) 68.6 (33.8) 78.4 (42.1) 79.8 (44.9) + Median 65.0 69.0 82.5 + Min - Max 7.0 - 134.0 11.0 - 148.0 1.0 - 149.0 + Overall duration (days) + n 47 29 46 + 0 - 30 8 (17%) 5 (17.2%) 7 (15.2%) + 31 - 60 13 (27.7%) 7 (24.1%) 10 (21.7%) + 61 - 90 11 (23.4%) 6 (20.7%) 9 (19.6%) + >= 91 15 (31.9%) 11 (37.9%) 20 (43.5%) + Total dose administered + n 47 29 46 + Mean (SD) 0.0 (0.0) 8395.1 (5203.2) 4379.9 (3859.6) + Median 0.0 6966.0 3267.0 + Min - Max 0.0 - 0.0 810.0 - 15417.0 54.0 - 11448.0 + Total number of doses administered + n 47 29 46 + Mean (SD) 153.0 (59.1) 116.5 (64.8) 81.1 (71.5) + Median 182.0 114.0 60.5 + Min - Max 7.0 - 198.0 22.0 - 200.0 1.0 - 212.0 # EXT01 variant: with user specified categories for missed doses Code res Output - A: Drug X B: Placebo C: Combination - Parameter Category (Drug A/Drug B) (N=134) (N=134) (N=132) - —————————————————————————————————————————————————————————————————————————————————————————— - Drug A - Overall duration (days) - n 75 67 75 - Mean (SD) 74.3 (41.6) 79.0 (43.1) 74.2 (39.5) - Median 77.0 80.0 78.0 - Min - Max 5.0 - 149.0 2.0 - 150.0 1.0 - 147.0 - Overall duration (days) - n 75 67 75 - 0 - 30 12 (16%) 12 (17.9%) 15 (20%) - 31 - 60 18 (24%) 12 (17.9%) 14 (18.7%) - 61 - 90 19 (25.3%) 15 (22.4%) 18 (24%) - >= 91 26 (34.7%) 28 (41.8%) 28 (37.3%) - Total dose administered - n 75 67 75 - Mean (SD) 6675.2 (1110.9) 6505.1 (1249.3) 6982.4 (1272.5) - Median 6720.0 6480.0 7200.0 - Min - Max 4800.0 - 9360.0 4080.0 - 9360.0 4320.0 - 9360.0 - Total number of doses administered - n 75 67 75 - Mean (SD) 7.0 (0.0) 7.0 (0.0) 7.0 (0.0) - Median 7.0 7.0 7.0 - Min - Max 7.0 - 7.0 7.0 - 7.0 7.0 - 7.0 - Missed Doses - n 75 67 75 - At least 1 missed dose 74 (55.2%) 63 (47%) 73 (55.3%) - At least 5 missed doses 59 (44%) 49 (36.6%) 59 (44.7%) - At least 10 missed doses 41 (30.6%) 38 (28.4%) 37 (28%) - At least 15 missed doses 26 (19.4%) 21 (15.7%) 16 (12.1%) - Drug B - Overall duration (days) - n 59 67 57 - Mean (SD) 77.5 (40.5) 76.3 (41.0) 69.5 (46.2) - Median 79.0 76.0 65.0 - Min - Max 2.0 - 149.0 5.0 - 148.0 1.0 - 149.0 - Overall duration (days) - n 59 67 57 - 0 - 30 8 (13.6%) 10 (14.9%) 16 (28.1%) - 31 - 60 14 (23.7%) 16 (23.9%) 12 (21.1%) - 61 - 90 15 (25.4%) 17 (25.4%) 11 (19.3%) - >= 91 22 (37.3%) 24 (35.8%) 18 (31.6%) - Total dose administered - n 59 67 57 - Mean (SD) 6630.5 (1334.0) 6297.3 (1291.1) 6505.3 (1080.7) - Median 6720.0 6240.0 6480.0 - Min - Max 4320.0 - 8880.0 4080.0 - 9120.0 4320.0 - 8640.0 - Total number of doses administered - n 59 67 57 - Mean (SD) 7.0 (0.0) 7.0 (0.0) 7.0 (0.0) - Median 7.0 7.0 7.0 - Min - Max 7.0 - 7.0 7.0 - 7.0 7.0 - 7.0 - Missed Doses - n 59 67 57 - At least 1 missed dose 56 (41.8%) 63 (47%) 57 (43.2%) - At least 5 missed doses 41 (30.6%) 50 (37.3%) 47 (35.6%) - At least 10 missed doses 27 (20.1%) 36 (26.9%) 31 (23.5%) - At least 15 missed doses 17 (12.7%) 18 (13.4%) 20 (15.2%) + Placebo Xanomeline High Dose Xanomeline Low Dose + Parameter Category (Drug A/Drug B) (N=86) (N=72) (N=96) + ———————————————————————————————————————————————————————————————————————————————————————————————— + Drug A + Overall duration (days) + n 39 43 50 + Mean (SD) 84.1 (40.5) 80.3 (43.5) 78.8 (41.4) + Median 81.0 81.0 85.5 + Min - Max 9.0 - 142.0 9.0 - 148.0 7.0 - 145.0 + Overall duration (days) + n 39 43 50 + 0 - 30 4 (10.3%) 6 (14%) 10 (20%) + 31 - 60 6 (15.4%) 10 (23.3%) 8 (16%) + 61 - 90 13 (33.3%) 9 (20.9%) 12 (24%) + >= 91 16 (41%) 18 (41.9%) 20 (40%) + Total dose administered + n 39 43 50 + Mean (SD) 0.0 (0.0) 8305.3 (5230.6) 4877.3 (3798.0) + Median 0.0 7263.0 3861.0 + Min - Max 0.0 - 0.0 810.0 - 14607.0 0.0 - 10422.0 + Total number of doses administered + n 39 43 50 + Mean (SD) 141.6 (65.9) 109.3 (66.6) 90.3 (70.3) + Median 182.0 95.0 71.5 + Min - Max 0.0 - 210.0 15.0 - 190.0 0.0 - 193.0 + Missed Doses + n 39 43 50 + At least 1 missed dose 37 (43%) 42 (58.3%) 48 (50%) + At least 5 missed doses 32 (37.2%) 34 (47.2%) 36 (37.5%) + At least 10 missed doses 21 (24.4%) 20 (27.8%) 26 (27.1%) + At least 15 missed doses 10 (11.6%) 13 (18.1%) 12 (12.5%) + Drug B + Overall duration (days) + n 47 29 46 + Mean (SD) 68.6 (33.8) 78.4 (42.1) 79.8 (44.9) + Median 65.0 69.0 82.5 + Min - Max 7.0 - 134.0 11.0 - 148.0 1.0 - 149.0 + Overall duration (days) + n 47 29 46 + 0 - 30 8 (17%) 5 (17.2%) 7 (15.2%) + 31 - 60 13 (27.7%) 7 (24.1%) 10 (21.7%) + 61 - 90 11 (23.4%) 6 (20.7%) 9 (19.6%) + >= 91 15 (31.9%) 11 (37.9%) 20 (43.5%) + Total dose administered + n 47 29 46 + Mean (SD) 0.0 (0.0) 8395.1 (5203.2) 4379.9 (3859.6) + Median 0.0 6966.0 3267.0 + Min - Max 0.0 - 0.0 810.0 - 15417.0 54.0 - 11448.0 + Total number of doses administered + n 47 29 46 + Mean (SD) 153.0 (59.1) 116.5 (64.8) 81.1 (71.5) + Median 182.0 114.0 60.5 + Min - Max 7.0 - 198.0 22.0 - 200.0 1.0 - 212.0 + Missed Doses + n 47 29 46 + At least 1 missed dose 42 (48.8%) 29 (40.3%) 42 (43.8%) + At least 5 missed doses 31 (36%) 22 (30.6%) 33 (34.4%) + At least 10 missed doses 22 (25.6%) 18 (25%) 24 (25%) + At least 15 missed doses 12 (14%) 11 (15.3%) 16 (16.7%) diff --git a/tests/testthat/_snaps/table_vst01.md b/tests/testthat/_snaps/table_vst01.md index 0d0cbf8..9c5edad 100644 --- a/tests/testthat/_snaps/table_vst01.md +++ b/tests/testthat/_snaps/table_vst01.md @@ -3,59 +3,84 @@ Code res Output - A: Drug X B: Placebo C: Combination + Placebo Xanomeline High Dose Xanomeline Low Dose Change from Change from Change from Value at Visit Baseline Value at Visit Baseline Value at Visit Baseline - Analysis Visit (N=134) (N=134) (N=134) (N=134) (N=132) (N=132) + Analysis Visit (N=86) (N=86) (N=72) (N=72) (N=96) (N=96) ——————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— - SCREENING - n 134 0 134 0 132 0 - Mean (SD) 99.92 (17.99) NE (NE) 101.88 (21.07) NE (NE) 100.48 (19.07) NE (NE) - Median 99.26 NE 100.22 NE 99.10 NE - Min - Max 54.22 - 152.98 NE - NE 48.15 - 148.03 NE - NE 42.22 - 149.95 NE - NE - BASELINE - n 134 134 132 - Mean (SD) 96.50 (19.90) 101.10 (19.87) 102.77 (19.48) - Median 96.05 100.45 102.01 - Min - Max 44.28 - 136.59 29.21 - 143.77 49.37 - 153.50 - WEEK 1 DAY 8 - n 134 134 134 134 132 132 - Mean (SD) 100.65 (18.79) 4.14 (26.93) 99.19 (19.36) -1.92 (27.37) 97.14 (19.72) -5.63 (25.95) - Median 100.22 1.52 99.37 -2.79 94.19 -5.57 - Min - Max 57.60 - 147.46 -50.92 - 74.84 59.28 - 141.21 -64.50 - 70.93 50.98 - 142.47 -55.15 - 56.11 - WEEK 2 DAY 15 - n 134 134 134 134 132 132 - Mean (SD) 102.09 (19.62) 5.58 (29.38) 99.29 (21.11) -1.81 (31.11) 99.95 (20.85) -2.81 (29.10) - Median 103.59 7.82 100.57 -1.77 102.52 -5.68 - Min - Max 54.73 - 150.85 -59.71 - 98.08 51.60 - 145.28 -71.00 - 92.43 37.06 - 138.92 -73.10 - 76.80 - WEEK 3 DAY 22 - n 134 134 134 134 132 132 - Mean (SD) 101.78 (19.54) 5.28 (27.16) 97.73 (19.85) -3.37 (27.76) 99.86 (19.15) -2.91 (27.25) - Median 100.39 6.53 98.83 -5.79 100.06 -1.54 - Min - Max 47.68 - 162.22 -64.46 - 76.64 36.25 - 142.78 -70.23 - 84.74 53.80 - 146.37 -74.30 - 67.46 - WEEK 4 DAY 29 - n 134 134 134 134 132 132 - Mean (SD) 100.18 (20.18) 3.68 (27.21) 99.06 (17.75) -2.04 (26.59) 99.27 (20.12) -3.50 (27.62) - Median 98.17 3.00 97.98 -1.89 99.61 -0.46 - Min - Max 48.52 - 153.41 -77.30 - 61.90 56.78 - 142.45 -82.96 - 89.87 46.87 - 146.12 -88.68 - 70.90 - WEEK 5 DAY 36 - n 134 134 134 134 132 132 - Mean (SD) 101.42 (18.83) 4.92 (28.02) 95.92 (19.90) -5.19 (29.34) 97.73 (18.92) -5.04 (26.64) - Median 98.56 3.93 94.30 -7.18 98.09 -5.62 - Min - Max 62.66 - 155.52 -63.05 - 78.66 51.06 - 151.52 -78.07 - 72.91 51.48 - 157.27 -76.13 - 86.42 - Post-Baseline Last - n 134 134 134 134 132 132 - Mean (SD) 101.42 (18.83) 4.92 (28.02) 95.92 (19.90) -5.19 (29.34) 97.73 (18.92) -5.04 (26.64) - Median 98.56 3.93 94.30 -7.18 98.09 -5.62 - Min - Max 62.66 - 155.52 -63.05 - 78.66 51.06 - 151.52 -78.07 - 72.91 51.48 - 157.27 -76.13 - 86.42 + Baseline + n 340 255 288 216 384 288 + Mean (SD) 77.09 (10.74) 0.00 (0.00) 78.24 (10.29) 0.00 (0.00) 76.62 (9.82) 0.00 (0.00) + Median 77.67 0.00 78.83 0.00 76.67 0.00 + Min - Max 40.00 - 110.00 0.00 - 0.00 51.00 - 108.00 0.00 - 0.00 48.00 - 108.00 0.00 - 0.00 + Week 2 + n 222 222 168 168 177 177 + Mean (SD) 74.44 (10.68) -3.00 (9.00) 76.03 (9.86) -2.74 (11.34) 75.95 (11.17) 0.11 (10.12) + Median 73.50 -2.00 78.00 -2.00 76.00 0.00 + Min - Max 49.00 - 104.00 -26.00 - 20.00 56.00 - 98.00 -46.00 - 20.00 50.00 - 100.00 -25.00 - 34.00 + Week 4 + n 276 207 200 150 208 156 + Mean (SD) 74.29 (10.75) -2.92 (9.11) 74.61 (9.08) -4.07 (10.91) 75.67 (10.68) -0.96 (10.29) + Median 73.17 -2.00 76.00 -3.50 75.00 -2.00 + Min - Max 49.00 - 104.00 -26.00 - 20.00 54.00 - 92.00 -46.00 - 20.00 50.00 - 100.00 -25.00 - 34.00 + Week 6 + n 272 204 148 111 168 126 + Mean (SD) 75.12 (10.92) -1.83 (9.60) 76.03 (8.97) -2.01 (10.87) 75.23 (9.96) -1.56 (10.24) + Median 76.00 0.00 77.33 0.00 75.67 -2.00 + Min - Max 49.00 - 98.00 -30.00 - 24.00 50.00 - 92.00 -38.00 - 27.00 55.00 - 98.00 -30.00 - 38.00 + Week 8 + n 336 252 286 214 374 280 + Mean (SD) 74.46 (10.23) -2.72 (9.76) 76.28 (9.74) -1.94 (10.75) 76.38 (10.39) -0.16 (9.09) + Median 74.00 -2.00 76.00 0.00 76.33 0.00 + Min - Max 45.00 - 100.00 -34.00 - 30.00 43.00 - 101.00 -38.00 - 26.00 45.00 - 118.00 -28.00 - 32.00 + Week 12 + n 264 198 128 96 120 90 + Mean (SD) 73.40 (10.44) -3.20 (9.46) 74.07 (10.14) -2.95 (11.04) 73.67 (9.51) -3.04 (10.44) + Median 72.00 -4.00 72.00 -2.00 73.17 -2.00 + Min - Max 48.00 - 100.00 -27.00 - 18.00 54.00 - 98.00 -36.00 - 28.00 51.00 - 98.00 -30.00 - 20.00 + Week 16 + n 236 177 120 90 108 81 + Mean (SD) 73.80 (11.67) -2.07 (10.31) 74.93 (10.04) -2.20 (9.85) 76.21 (9.62) -0.51 (7.76) + Median 74.00 -3.00 75.50 -4.00 76.00 0.00 + Min - Max 44.00 - 117.00 -28.00 - 41.00 50.00 - 98.00 -20.00 - 22.00 57.00 - 98.00 -20.00 - 18.00 + Week 20 + n 232 174 112 84 100 75 + Mean (SD) 72.63 (10.78) -3.60 (9.84) 74.55 (10.31) -3.04 (9.83) 72.95 (9.70) -3.61 (8.07) + Median 72.00 -4.00 74.33 -4.00 72.00 -2.00 + Min - Max 39.00 - 98.00 -27.00 - 24.00 50.00 - 93.00 -20.00 - 20.00 56.00 - 92.00 -20.00 - 22.00 + Week 24 + n 328 246 288 216 292 219 + Mean (SD) 75.43 (11.35) -1.63 (9.77) 76.66 (9.34) -1.57 (11.09) 76.15 (9.23) -0.64 (9.28) + Median 76.00 -2.00 78.00 -1.00 76.00 0.00 + Min - Max 39.00 - 100.00 -28.00 - 30.00 54.00 - 100.00 -32.00 - 26.00 50.00 - 102.00 -30.00 - 28.00 + Week 26 + n 304 228 271 203 260 195 + Mean (SD) 74.48 (9.98) -3.00 (9.63) 75.27 (9.75) -3.31 (10.08) 74.90 (9.00) -1.12 (8.61) + Median 74.00 -2.00 76.00 -2.00 76.00 0.00 + Min - Max 48.00 - 110.00 -28.00 - 26.00 52.00 - 98.00 -50.00 - 20.00 50.00 - 100.00 -29.00 - 34.00 + End of Treatment + n 292 219 224 168 240 180 + Mean (SD) 75.25 (9.12) -2.06 (8.98) 77.37 (9.07) -1.26 (9.67) 75.40 (10.59) -0.68 (10.70) + Median 76.00 -2.00 78.33 0.00 74.00 0.00 + Min - Max 49.00 - 101.00 -30.00 - 24.00 54.00 - 98.00 -45.00 - 22.00 52.00 - 100.00 -30.00 - 34.00 Post-Baseline Minimum - n 134 134 134 134 132 132 - Mean (SD) 78.98 (11.94) -17.52 (23.92) 75.77 (13.25) -25.33 (25.39) 76.35 (13.13) -26.41 (22.78) - Median 80.14 -13.96 75.71 -26.70 76.26 -27.17 - Min - Max 47.68 - 110.54 -77.30 - 33.00 36.25 - 113.53 -82.96 - 69.23 37.06 - 112.35 -88.68 - 34.24 + n 1284 963 1111 834 1346 1010 + Mean (SD) 76.29 (10.41) -0.97 (9.19) 77.33 (9.83) -1.01 (9.23) 76.02 (9.77) -0.26 (9.30) + Median 78.00 0.00 78.00 0.00 76.00 0.00 + Min - Max 39.00 - 108.00 -28.00 - 49.00 40.00 - 100.00 -43.00 - 32.00 40.00 - 110.00 -34.00 - 46.00 Post-Baseline Maximum - n 134 134 134 134 132 132 - Mean (SD) 125.08 (12.28) 28.57 (23.20) 121.33 (12.01) 20.23 (23.64) 121.42 (12.09) 18.65 (22.74) - Median 124.20 29.14 120.80 18.74 122.55 16.93 - Min - Max 94.06 - 162.22 -21.49 - 98.08 94.43 - 151.52 -34.95 - 92.43 79.39 - 157.27 -43.32 - 86.42 + n 86 84 72 72 96 94 + Mean (SD) 73.29 (9.96) -2.42 (9.74) 74.65 (9.36) -2.26 (9.66) 75.61 (10.28) -0.97 (9.37) + Median 72.50 -2.00 76.00 -2.00 76.00 0.00 + Min - Max 50.00 - 99.00 -34.00 - 20.00 56.00 - 94.00 -36.00 - 20.00 45.00 - 100.00 -21.00 - 26.00 + Post-Baseline Last + n 86 85 72 70 96 92 + Mean (SD) 62.58 (8.60) -13.35 (7.62) 63.62 (8.31) -14.23 (9.76) 63.68 (9.52) -11.82 (8.66) + Median 62.00 -13.00 63.00 -13.00 64.00 -10.00 + Min - Max 39.00 - 90.00 -34.00 - 6.00 40.00 - 82.00 -38.00 - 3.00 40.00 - 85.00 -34.00 - 7.00 + + n 86 84 72 69 96 94 + Mean (SD) 88.32 (9.17) 10.44 (8.74) 88.87 (7.68) 10.06 (8.11) 88.32 (8.21) 11.24 (8.44) + Median 88.50 8.00 90.00 10.00 88.00 10.00 + Min - Max 58.00 - 117.00 -2.00 - 49.00 62.00 - 102.00 -11.00 - 28.00 70.00 - 118.00 -6.00 - 46.00 diff --git a/tests/testthat/_snaps/table_vst02.md b/tests/testthat/_snaps/table_vst02.md index 8f51969..0b9b021 100644 --- a/tests/testthat/_snaps/table_vst02.md +++ b/tests/testthat/_snaps/table_vst02.md @@ -3,52 +3,40 @@ Code res Output - Assessment A: Drug X B: Placebo C: Combination All Patients - Abnormality (N=134) (N=134) (N=132) (N=400) - ———————————————————————————————————————————————————————————————————————————————————————————————— - Diastolic Blood Pressure - Low 66/134 (49.3%) 86/134 (64.2%) 78/132 (59.1%) 230/400 (57.5%) - High 88/134 (65.7%) 70/134 (52.2%) 76/132 (57.6%) 234/400 (58.5%) - Pulse Rate - Low 58/134 (43.3%) 32/134 (23.9%) 48/132 (36.4%) 138/400 (34.5%) - High 53/134 (39.6%) 49/134 (36.6%) 44/132 (33.3%) 146/400 (36.5%) - Respiratory Rate - Low 97/134 (72.4%) 84/134 (62.7%) 98/132 (74.2%) 279/400 (69.8%) - High 96/134 (71.6%) 98/134 (73.1%) 98/132 (74.2%) 292/400 (73%) - Systolic Blood Pressure - Low 71/134 (53%) 77/134 (57.5%) 73/132 (55.3%) 221/400 (55.2%) - High 78/134 (58.2%) 74/134 (55.2%) 73/132 (55.3%) 225/400 (56.2%) - Temperature - Low 108/134 (80.6%) 110/134 (82.1%) 108/132 (81.8%) 326/400 (81.5%) - High 112/134 (83.6%) 106/134 (79.1%) 107/132 (81.1%) 325/400 (81.2%) - Weight - Low 43/134 (32.1%) 39/134 (29.1%) 39/132 (29.5%) 121/400 (30.2%) - High 46/134 (34.3%) 43/134 (32.1%) 44/132 (33.3%) 133/400 (33.2%) + Assessment Placebo Xanomeline High Dose Xanomeline Low Dose All Patients + Abnormality (N=86) (N=72) (N=96) (N=254) + —————————————————————————————————————————————————————————————————————————————————————————————————————————————— + Diastolic Blood Pressure (mmHg) + Low 22/83 (26.5%) 14/72 (19.4%) 18/76 (23.7%) 54/231 (23.4%) + High 63/83 (75.9%) 53/72 (73.6%) 62/76 (81.6%) 178/231 (77.1%) + Pulse Rate (beats/min) + Low 25/83 (30.1%) 17/72 (23.6%) 24/76 (31.6%) 66/231 (28.6%) + High 6/83 (7.2%) 4/72 (5.6%) 5/76 (6.6%) 15/231 (6.5%) + Systolic Blood Pressure (mmHg) + Low 4/83 (4.8%) 0/72 1/76 (1.3%) 5/231 (2.2%) + High 76/83 (91.6%) 64/72 (88.9%) 69/76 (90.8%) 209/231 (90.5%) + Temperature (C) + Low 63/83 (75.9%) 48/72 (66.7%) 55/76 (72.4%) 166/231 (71.9%) + High 6/83 (7.2%) 1/72 (1.4%) 4/76 (5.3%) 11/231 (4.8%) # 2. Vital Sign Abnormalities (Among Subject Without Abnormality at Baseline, VST02_2) Code res Output - Assessment A: Drug X B: Placebo C: Combination All Patients - Abnormality (N=134) (N=134) (N=132) (N=400) - ————————————————————————————————————————————————————————————————————————————————————————————— - Diastolic Blood Pressure - Low 54/108 (50%) 76/116 (65.5%) 68/114 (59.6%) 198/338 (58.6%) - High 74/114 (64.9%) 56/109 (51.4%) 62/106 (58.5%) 192/329 (58.4%) - Pulse Rate - Low 53/121 (43.8%) 30/125 (24%) 42/119 (35.3%) 125/365 (34.2%) - High 48/123 (39%) 45/116 (38.8%) 39/120 (32.5%) 132/359 (36.8%) - Respiratory Rate - Low 72/100 (72%) 72/110 (65.5%) 79/102 (77.5%) 223/312 (71.5%) - High 77/107 (72%) 78/108 (72.2%) 79/109 (72.5%) 234/324 (72.2%) - Systolic Blood Pressure - Low 62/117 (53%) 63/114 (55.3%) 57/103 (55.3%) 182/334 (54.5%) - High 64/110 (58.2%) 67/120 (55.8%) 68/115 (59.1%) 199/345 (57.7%) - Temperature - Low 77/96 (80.2%) 78/94 (83%) 74/90 (82.2%) 229/280 (81.8%) - High 78/93 (83.9%) 73/92 (79.3%) 81/100 (81%) 232/285 (81.4%) - Weight - Low 42/129 (32.6%) 37/125 (29.6%) 37/123 (30.1%) 116/377 (30.8%) - High 41/126 (32.5%) 41/124 (33.1%) 42/121 (34.7%) 124/371 (33.4%) + Assessment Placebo Xanomeline High Dose Xanomeline Low Dose All Patients + Abnormality (N=86) (N=72) (N=96) (N=254) + —————————————————————————————————————————————————————————————————————————————————————————————————————————————— + Diastolic Blood Pressure (mmHg) + Low 22/83 (26.5%) 14/72 (19.4%) 18/76 (23.7%) 54/231 (23.4%) + High 61/83 (73.5%) 52/72 (72.2%) 62/76 (81.6%) 175/231 (75.8%) + Pulse Rate (beats/min) + Low 25/83 (30.1%) 17/72 (23.6%) 23/76 (30.3%) 65/231 (28.1%) + High 5/83 (6%) 4/72 (5.6%) 5/76 (6.6%) 14/231 (6.1%) + Systolic Blood Pressure (mmHg) + Low 4/83 (4.8%) 0/72 1/76 (1.3%) 5/231 (2.2%) + High 75/83 (90.4%) 63/72 (87.5%) 66/76 (86.8%) 204/231 (88.3%) + Temperature (C) + Low 34/54 (63%) 23/47 (48.9%) 28/45 (62.2%) 85/146 (58.2%) + High 6/83 (7.2%) 1/72 (1.4%) 4/76 (5.3%) 11/231 (4.8%) diff --git a/tests/testthat/setup.R b/tests/testthat/setup.R index 9a0cf37..d6fa788 100644 --- a/tests/testthat/setup.R +++ b/tests/testthat/setup.R @@ -1,8 +1,11 @@ -# Extra libraries (suggested) for tests +## Extra libraries (suggested) for tests ----------- + library(dplyr) library(tidyr) library(lubridate) +## level_reducer ----------------------------------- + # 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, @@ -160,6 +163,8 @@ level_reducer <- function(dt, variable, p_to_keep = 0.7, } } +## random.cdisc.data ------------------------------- + # Data loading for tests adsl_raw <- random.cdisc.data::cadsl adab_raw <- random.cdisc.data::cadab @@ -181,10 +186,15 @@ adsub_raw <- random.cdisc.data::cadsub adtte_raw <- random.cdisc.data::cadtte advs_raw <- random.cdisc.data::cadvs +## pharmaverseadam --------------------------------- + # Data loading for pharmaverse + adpp_pharmaverse <- pharmaverseadam::adpp adpc_pharmaverse <- pharmaverseadam::adpc + set.seed(99) + adsl_pharmaverse <- pharmaverseadam::adsl %>% mutate( DCSREAS = sample(c("ADVERSE EVENT", ""), nrow(.), replace = TRUE, prob = c(0.08, 0.92)), @@ -216,6 +226,19 @@ adae_pharmaverse <- level_reducer(adae_pharmaverse, "AEDECOD", ) ) +adeg_pharmaverse <- pharmaverseadam::adeg + +adex_pharmaverse <- pharmaverseadam::adex %>% + mutate( + AVALU = EXDOSU + ) %>% + group_by(USUBJID) %>% + mutate( + PARCAT1 = ifelse(PARAMCD %in% c("TDOSE", "TNDOSE"), "OVERALL", "INDIVIDUAL"), + PARCAT2 = sample(c("Drug A", "Drug B"), 1, replace = TRUE) + ) %>% + ungroup() + set.seed(NULL) adlb_pharmaverse <- pharmaverseadam::adlb %>% mutate(AVALU = LBORRESU) @@ -231,8 +254,8 @@ adlb_pharmaverse <- level_reducer( ) advs_pharmaverse <- pharmaverseadam::advs +# skip_if_too_deep --------------------------------- -# 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-table_egt01.R b/tests/testthat/test-table_egt01.R index 93e70a6..af1e272 100644 --- a/tests/testthat/test-table_egt01.R +++ b/tests/testthat/test-table_egt01.R @@ -1,14 +1,14 @@ # Test the single variant for EGT01 -adsl <- adsl_raw -adeg <- adeg_raw +adsl <- adsl_pharmaverse +adeg <- adeg_pharmaverse adsl <- df_explicit_na(adsl) adeg <- df_explicit_na(adeg) adeg_f <- adeg %>% filter(ANL01FL == "Y") %>% - filter(PARAM %in% c("Heart Rate", "QT Duration", "RR Duration")) + filter(PARAMCD %in% c("HR", "QT", "RR")) testthat::test_that("EGT01 default variant is produced correctly", { split_fun <- drop_split_levels diff --git a/tests/testthat/test-table_egt02.R b/tests/testthat/test-table_egt02.R index b70cf9d..487385b 100644 --- a/tests/testthat/test-table_egt02.R +++ b/tests/testthat/test-table_egt02.R @@ -1,14 +1,14 @@ # Tests the variants for EGT02 -adsl <- adsl_raw -adeg <- adeg_raw +adsl <- adsl_pharmaverse +adeg <- adeg_pharmaverse adsl <- df_explicit_na(adsl) adeg <- df_explicit_na(adeg) adeg_f <- adeg %>% filter(ONTRTFL == "Y") %>% - filter(PARAM %in% c("Heart Rate", "QT Duration", "RR Duration")) %>% + filter(PARAMCD %in% c("HR", "QT", "RR")) %>% filter(ANRIND != "") %>% var_relabel( PARAM = "Assessment", diff --git a/tests/testthat/test-table_egt03.R b/tests/testthat/test-table_egt03.R index 1c99bf2..a0da10d 100644 --- a/tests/testthat/test-table_egt03.R +++ b/tests/testthat/test-table_egt03.R @@ -1,41 +1,48 @@ # Tests variant 1 for EGT03 -adsl <- adsl_raw -adeg <- adeg_raw +adsl <- adsl_pharmaverse +adeg <- adeg_pharmaverse + +set.seed(123, kind = "Mersenne-Twister") +adeg_labels <- var_labels(adeg) + +# Filtering +# --------- +adeg_f <- subset( + adeg, + PARAMCD == "HR" & # Heart Rate + SAFFL == "Y" & # "Safety Population Flag" + ONTRTFL == "Y" & # "On Treatment Record Flag" + AVISIT == "Week 2" # "Analysis Visit" +) + +# Preprocessing + +# For the EGT03 template, data imputation should be avoided, and missing data +# explicit and accounted for, so the contingency table sum adds up to the group N. +# For illustration purpose, missing data are added to the example. +adeg_f$BNRIND[is.na(adeg_f$BNRIND)] <- "LOW" +adeg_f$ANRIND[is.na(adeg_f$ANRIND)] <- "LOW" + +adeg_f$BNRIND <- factor( # nolint + adeg_f$BNRIND, + levels = c("LOW", "NORMAL", "HIGH", "Missing"), + labels = c("LOW", "NORMAL", "HIGH", "Missing") +) + +adeg_f$BNRIND[sample(seq_len(nrow(adeg_f)), size = 5)] <- "Missing" testthat::test_that("EGT03 variant 1 is produced correctly", { set.seed(123, kind = "Mersenne-Twister") - adeg_labels <- var_labels(adeg) - - # Filtering - # --------- - adeg_f <- subset( - adeg, - PARAMCD == "HR" & # Heart Rate - SAFFL == "Y" & # "Safety Population Flag" - ONTRTFL == "Y" & # "On Treatment Record Flag" - AVISIT == "POST-BASELINE MINIMUM" # "Analysis Visit" - ) # Preprocessing - - # For the EGT03 template, data imputation shoud be avoided, and missing data - # explicit and accounted for, so the contingency table sum adds up to the group N. - # For illustration purpose, missing data are added to the example. - adeg_f$BNRIND <- factor( # nolint - adeg_f$BNRIND, - levels = c("LOW", "NORMAL", "HIGH", "Missing"), - labels = c("LOW", "NORMAL", "HIGH", "Missing") - ) adeg_f$ANRIND <- factor( # nolint adeg_f$ANRIND, levels = c("LOW", "NORMAL", "HIGH", "Missing"), labels = c("LOW", "NORMAL", "HIGH", "Missing") ) - adeg_f$BNRIND[sample(seq_len(nrow(adeg_f)), size = 5)] <- "Missing" adeg_f$ANRIND[sample(seq_len(nrow(adeg_f)), size = 5)] <- "Missing" - var_labels(adeg_f) <- adeg_labels lyt <- basic_table() %>% @@ -51,32 +58,6 @@ testthat::test_that("EGT03 variant 1 is produced correctly", { }) testthat::test_that("EGT03 variant 2 is produced correctly", { - set.seed(123, kind = "Mersenne-Twister") - adeg_labels <- var_labels(adeg) - - # Filtering - # --------- - adeg_f <- subset( - adeg, - PARAMCD == "HR" & # Heart Rate - SAFFL == "Y" & # "Safety Population Flag" - ONTRTFL == "Y" & # "On Treatment Record Flag" - AVISIT == "POST-BASELINE MINIMUM" # "Analysis Visit" - ) - - # Preprocessing - - # For the EGT03 template, data imputation shoud be avoided, and missing data - # explicit and accounted for, so the contingency table sum adds up to the group N. - # For illustration purpose, missing data are added to the example. - adeg_f$BNRIND <- factor( # nolint - adeg_f$BNRIND, - levels = c("LOW", "NORMAL", "HIGH", "Missing"), - labels = c("LOW", "NORMAL", "HIGH", "Missing") - ) - - adeg_f$BNRIND[sample(seq_len(nrow(adeg_f)), size = 5)] <- "Missing" - var_labels(adeg_f) <- adeg_labels lyt <- basic_table() %>% @@ -93,23 +74,8 @@ 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 <- var_labels(adeg) - - # Filtering - # --------- - adeg_f <- subset( - adeg, - PARAMCD == "HR" & # Heart Rate - SAFFL == "Y" & # "Safety Population Flag" - ONTRTFL == "Y" & # "On Treatment Record Flag" - AVISIT == "POST-BASELINE MINIMUM" # "Analysis Visit" - ) # Preprocessing - - # For the EGT03 template, data imputation shoud be avoided, and missing data - # explicit and accounted for, so the contingency table sum adds up to the group N. - # For illustration purpose, missing data are added to the example. adeg_f$ANRIND <- factor( # nolint adeg_f$ANRIND, levels = c("LOW", "NORMAL", "HIGH", "Missing"), @@ -134,37 +100,15 @@ 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 <- var_labels(adeg) - - # Filtering - # --------- - adeg_f <- subset( - adeg, - PARAMCD == "HR" & # Heart Rate - SAFFL == "Y" & # "Safety Population Flag" - ONTRTFL == "Y" & # "On Treatment Record Flag" - AVISIT == "POST-BASELINE MAXIMUM" # "Analysis Visit" - ) # Preprocessing - - # For the EGT03 template, data imputation shoud be avoided, and missing data - # explicit and accounted for, so the contingency table sum adds up to the group N. - # For illustration purpose, missing data are added to the example. - adeg_f$BNRIND <- factor( # nolint - adeg_f$BNRIND, - levels = c("LOW", "NORMAL", "HIGH", "Missing"), - labels = c("LOW", "NORMAL", "HIGH", "Missing") - ) adeg_f$ANRIND <- factor( # nolint adeg_f$ANRIND, levels = c("LOW", "NORMAL", "HIGH", "Missing"), labels = c("LOW", "NORMAL", "HIGH", "Missing") ) - adeg_f$BNRIND[sample(seq_len(nrow(adeg_f)), size = 5)] <- "Missing" adeg_f$ANRIND[sample(seq_len(nrow(adeg_f)), size = 5)] <- "Missing" - var_labels(adeg_f) <- adeg_labels lyt <- basic_table() %>% diff --git a/tests/testthat/test-table_egt04.R b/tests/testthat/test-table_egt04.R index f2895bc..936a389 100644 --- a/tests/testthat/test-table_egt04.R +++ b/tests/testthat/test-table_egt04.R @@ -1,13 +1,22 @@ # Tests the single variant for EGT04 - -adsl <- adsl_raw -adeg <- adeg_raw +set.seed(99) + +adsl <- adsl_pharmaverse +adeg <- adeg_pharmaverse %>% + group_by(USUBJID, AVISIT, PARAMCD) %>% + slice_head(n = 1) %>% + ungroup() %>% + mutate( + AVALU = EGSTRESU, + WORS02FL = sample(c("Y", ""), nrow(.), replace = TRUE, prob = c(0.25, 0.75)), + BASEC = sample(c("NORMAL", "ABNORMAL", "Missing"), nrow(.), replace = TRUE, prob = c(0.5, 0.3, 0.2)) + ) testthat::test_that("EGT04 default variant is produced correctly", { adeg_labels <- var_labels(adeg) adeg_f <- subset( adeg, - PARAMCD == "ECGINTP" & # Analysis in terms of "NORMAL"/"ABNORMAL" (AVALC) + PARAMCD == "EGINTP" & # Analysis in terms of "NORMAL"/"ABNORMAL" (AVALC) SAFFL == "Y" & # "Safety Population Flag" ONTRTFL == "Y" & # "On Treatment Record Flag" WORS02FL == "Y" # "Worst Post-Baseline Observation" diff --git a/tests/testthat/test-table_egt05_qtcat.R b/tests/testthat/test-table_egt05_qtcat.R index acaa2c2..fdab2e4 100644 --- a/tests/testthat/test-table_egt05_qtcat.R +++ b/tests/testthat/test-table_egt05_qtcat.R @@ -1,7 +1,7 @@ # Test the single variant for EGT05_QTCAT -adsl <- adsl_raw -adeg <- adeg_raw +adsl <- adsl_pharmaverse +adeg <- adeg_pharmaverse adsl <- df_explicit_na(adsl) adeg <- df_explicit_na(adeg) @@ -53,6 +53,10 @@ adeg_f <- adeg %>% CHGCAT1 = "Change from Baseline" ) +levels(adeg_f$AVISIT) <- c( + "Baseline", "Week 2", "Week 4", "Week 6", "Week 8", "Week 12", "Week 16", "Week 20", "Week 24", "Week 26", "" +) + testthat::test_that("EGT05_QTCAT default variant is produced correctly", { split_fun <- drop_split_levels diff --git a/tests/testthat/test-table_ext01.R b/tests/testthat/test-table_ext01.R index c86e1cc..eec503f 100644 --- a/tests/testthat/test-table_ext01.R +++ b/tests/testthat/test-table_ext01.R @@ -1,21 +1,35 @@ # Tests all variants of EXT01 +set.seed(99) -adsl <- adsl_raw -adex <- adex_raw +adsl <- adsl_pharmaverse +adex <- adex_pharmaverse adsl <- df_explicit_na(adsl) adex <- df_explicit_na(adex) +adex_tndose <- adex %>% + filter(PARAMCD == "TDURD") %>% + mutate( + PARAMCD = "TNDOSE", + PARAM = "Total number of doses administered", + PARCAT1 = "OVERALL" + ) + adex <- adex %>% + rbind(adex_tndose) %>% filter(PARCAT1 == "OVERALL") %>% select(STUDYID, USUBJID, ACTARM, PARAMCD, PARAM, AVAL, PARCAT2) %>% mutate( PARAMCD = as.character(PARAMCD), - AVALC = "" + AVALC = case_when( + 0 <= AVAL & AVAL <= 30 ~ "0 - 30", + 31 <= AVAL & AVAL <= 60 ~ "31 - 60", + 61 <= AVAL & AVAL <= 90 ~ "61 - 90", + TRUE ~ ">= 91" + ) ) %>% droplevels() -set.seed(99) tdurd_adsl <- adsl %>% select(STUDYID, USUBJID, ACTARM) %>% mutate( diff --git a/tests/testthat/test-table_vst01.R b/tests/testthat/test-table_vst01.R index b0d3b70..0281ea8 100644 --- a/tests/testthat/test-table_vst01.R +++ b/tests/testthat/test-table_vst01.R @@ -1,7 +1,7 @@ # Test the single variant for VST01 -adsl <- adsl_raw -advs <- advs_raw +adsl <- adsl_pharmaverse +advs <- advs_pharmaverse adsl <- df_explicit_na(adsl) advs <- df_explicit_na(advs) @@ -9,17 +9,14 @@ advs <- df_explicit_na(advs) advs_label <- var_labels(advs) advs <- advs %>% - filter( - PARAMCD == "DIABP", - PARAM == "Diastolic Blood Pressure" - ) %>% + filter(PARAMCD == "DIABP") %>% mutate( PARAMCD = droplevels(PARAMCD), PARAM = droplevels(PARAM) ) advs_pb <- advs %>% - filter(ABLFL != "Y", ABLFL2 != "Y") + filter(ABLFL != "Y") advs_pb_max <- advs_pb %>% group_by(PARAM, USUBJID) %>% @@ -51,6 +48,10 @@ advs_f <- rbind( advs_f <- advs_f %>% mutate(AVISIT = droplevels(AVISIT)) +levels(advs_f$AVISIT) <- c( + "Baseline", "Week 2", "Week 4", "Week 6", "Week 8", "Week 12", "Week 16", "Week 20", "Week 24", "Week 26", + "End of Treatment", "Post-Baseline Minimum", "Post-Baseline Maximum", "Post-Baseline Last", "" +) var_labels(advs_f) <- advs_label diff --git a/tests/testthat/test-table_vst02.R b/tests/testthat/test-table_vst02.R index 8f2f96f..30de36d 100644 --- a/tests/testthat/test-table_vst02.R +++ b/tests/testthat/test-table_vst02.R @@ -1,7 +1,7 @@ # Test the single variant for VST02 -adsl <- adsl_raw -advs <- advs_raw +adsl <- adsl_pharmaverse +advs <- advs_pharmaverse adsl <- df_explicit_na(adsl) advs <- df_explicit_na(advs)