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@Melkiades
Melkiades committed Apr 3, 2024
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52 changes: 26 additions & 26 deletions tests/testthat/_snaps/table_aet01.md
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Original file line number Diff line number Diff line change
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Placebo Xanomeline High Dose Xanomeline Low Dose
(N=86) (N=72) (N=96)
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
Total number of patients with at least one AE 34 (39.5%) 61 (84.7%) 63 (65.6%)
Total number of AEs 71 189 177
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Total number of patients withdrawn from study due to an AE 9 (10.5%) 5 (6.9%) 10 (10.4%)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 1 (1.2%) 2 (2.8%) 3 (3.1%)
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 0
Related Serious AE 0 0 0
AE leading to withdrawal from treatment 3 (3.5%) 12 (16.7%) 11 (11.5%)
AE leading to dose modification/interruption 15 (17.4%) 37 (51.4%) 34 (35.4%)
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) 0 2 (2.8%) 8 (8.3%)
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

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Placebo Xanomeline High Dose Xanomeline Low Dose
(N=86) (N=72) (N=96)
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
Total number of patients with at least one AE 34 (39.5%) 61 (84.7%) 63 (65.6%)
Total number of AEs 71 189 177
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Total number of patients withdrawn from study due to an AE 9 (10.5%) 5 (6.9%) 10 (10.4%)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 1 (1.2%) 2 (2.8%) 3 (3.1%)
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 0
Related Serious AE 0 0 0
AE leading to withdrawal from treatment 3 (3.5%) 12 (16.7%) 11 (11.5%)
AE leading to dose modification/interruption 15 (17.4%) 37 (51.4%) 34 (35.4%)
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 8 (9.3%) 13 (18.1%) 16 (16.7%)
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%)
Expand All @@ -60,17 +60,17 @@
Placebo Xanomeline High Dose Xanomeline Low Dose
(N=86) (N=72) (N=96)
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
Total number of patients with at least one AE 34 (39.5%) 61 (84.7%) 63 (65.6%)
Total number of AEs 71 189 177
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 1 (1.2%) 2 (2.8%) 3 (3.1%)
AE with fatal outcome 2 (2.3%) 2 (2.8%) 2 (2.1%)
Serious AE 0 0 0
AE leading to withdrawal from treatment 3 (3.5%) 12 (16.7%) 11 (11.5%)
AE leading to withdrawal from treatment 6 (7.0%) 10 (13.9%) 10 (10.4%)
Related AE 0 0 0
Grade 3-5 AE 8 (9.3%) 13 (18.1%) 16 (16.7%)
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
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Placebo Xanomeline High Dose Xanomeline Low Dose
(N=86) (N=72) (N=96)
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
Total number of patients with at least one AE 34 (39.5%) 61 (84.7%) 63 (65.6%)
Total number of AEs 71 189 177
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 1 (1.2%) 2 (2.8%) 3 (3.1%)
AE with fatal outcome 2 (2.3%) 2 (2.8%) 2 (2.1%)
Serious AE 0 0 0
AE leading to withdrawal from treatment 3 (3.5%) 12 (16.7%) 11 (11.5%)
AE leading to dose modification/interruption 15 (17.4%) 37 (51.4%) 34 (35.4%)
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 8 (9.3%) 13 (18.1%) 16 (16.7%)
Grade 3-5 AE 8 (9.3%) 14 (19.4%) 16 (16.7%)
Total number of unique preferred terms which are
Serious AE 0 0 0
AE leading to dose modification/interruption 9 10 10
Related AE 0 0 0
Grade 3-5 AE 6 6 8
Grade 3-5 AE 7 7 8
Grade 4/5 AE 4 4 8
Total number of adverse events which are
Serious AE 0 0 0
AE leading to dose modification/interruption 20 49 46
AE leading to dose modification/interruption 21 52 48
Related AE 0 0 0
Grade 3-5 AE 10 15 19
Grade 3-5 AE 11 16 19
Grade 4/5 AE 7 7 11

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