diff --git a/tests/testthat/_snaps/table_aet01.md b/tests/testthat/_snaps/table_aet01.md index 8c83d8a..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 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(84.7%) 64 (66.7%) + Total number of AEs 75 197 181 Total number of deaths 2 (2.3%) 0 1 (1.0%) Total number of patients withdrawn from study due to an AE 9 (10.5%) 5 (6.9%) 10 (10.4%) Total number of patients with at least one - AE with fatal outcome 1 (1.2%) 2 (2.8%) 3 (3.1%) + AE with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 @@ -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 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(84.7%) 64 (66.7%) + Total number of AEs 75 197 181 Total number of deaths 2 (2.3%) 0 1 (1.0%) Total number of patients withdrawn from study due to an AE 9 (10.5%) 5 (6.9%) 10 (10.4%) Total number of patients with at least one - AE with fatal outcome 1 (1.2%) 2 (2.8%) 3 (3.1%) + AE with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%) @@ -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 @@ -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 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 diff --git a/tests/testthat/_snaps/table_aet01_aesi.md b/tests/testthat/_snaps/table_aet01_aesi.md index 32d3aca..b987c4c 100644 --- a/tests/testthat/_snaps/table_aet01_aesi.md +++ b/tests/testthat/_snaps/table_aet01_aesi.md @@ -6,19 +6,19 @@ 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 patients with at least one AE by worst grade - Grade 1 15 (17.4%) 29 (40.3%) 29 (30.2%) - Grade 2 11 (12.8%) 19 (26.4%) 18 (18.8%) - Grade 3 2 (2.3%) 6 (8.3%) 5 (5.2%) + 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 34 (39.5%) 61 (84.7%) 63 (65.6%) - Total number of patients with all non-fatal AEs resolved 5 (5.8%) 2 (2.8%) 4 (4.2%) - Total number of patients with at least one unresolved or ongoing non-fatal AE 29 (33.7%) 59 (81.9%) 59 (61.5%) + 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 @@ -30,25 +30,25 @@ 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 patients with at least one AE by worst grade - Grade 1 15 (17.4%) 29 (40.3%) 29 (30.2%) - Grade 2 11 (12.8%) 19 (26.4%) 18 (18.8%) - Grade 3 2 (2.3%) 6 (8.3%) 5 (5.2%) + 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 34 (39.5%) 61 (84.7%) 63 (65.6%) - Total number of patients with all non-fatal AEs resolved 5 (5.8%) 2 (2.8%) 4 (4.2%) + 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 5 (5.8%) 2 (2.8%) 4 (4.2%) - Total number of patients with at least one unresolved or ongoing non-fatal AE 29 (33.7%) 59 (81.9%) 59 (61.5%) + 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 29 (33.7%) 59 (81.9%) 59 (61.5%) + 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 @@ -67,31 +67,31 @@ 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 patients with at least one AE by worst grade - Grade 1 15 (17.4%) 29 (40.3%) 29 (30.2%) - Grade 2 11 (12.8%) 19 (26.4%) 18 (18.8%) - Grade 3 2 (2.3%) 6 (8.3%) 5 (5.2%) + 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 34 (39.5%) 61 (84.7%) 63 (65.6%) - Total number of patients with all non-fatal AEs resolved 5 (5.8%) 2 (2.8%) 4 (4.2%) + 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 5 (5.8%) 2 (2.8%) 4 (4.2%) - Total number of patients with at least one non-fatal unresolved or ongoing AE 29 (33.7%) 59 (81.9%) 59 (61.5%) + 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 29 (33.7%) 59 (81.9%) 59 (61.5%) + 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 diff --git a/tests/testthat/_snaps/table_aet02.md b/tests/testthat/_snaps/table_aet02.md index 832aa92..32aaa27 100644 --- a/tests/testthat/_snaps/table_aet02.md +++ b/tests/testthat/_snaps/table_aet02.md @@ -6,8 +6,8 @@ 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 34 (39.5%) 61 (84.7%) 63 (65.6%) 158 (62.2%) - Overall total number of events 71 189 177 437 + 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 @@ -30,6 +30,10 @@ 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 @@ -43,8 +47,8 @@ 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 34 (39.5%) 61 (84.7%) 63 (65.6%) 158 (62.2%) - Overall total number of events 71 189 177 437 + 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%) @@ -67,6 +71,10 @@ 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%) @@ -81,8 +89,8 @@ 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 34 (39.5%) 61 (84.7%) 63 (65.6%) - Overall total number of events 71 189 177 + 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 @@ -135,6 +143,13 @@ 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 @@ -151,8 +166,8 @@ 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 34 (39.5%) 61 (84.7%) 63 (65.6%) - Total number of events 71 189 177 + 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%) @@ -163,6 +178,7 @@ SKIN IRRITATION 3 (3.5%) 5 (6.9%) 6 (6.2%) VOMITING 3 (3.5%) 6 (8.3%) 4 (4.2%) NAUSEA 3 (3.5%) 6 (8.3%) 3 (3.1%) + MYOCARDIAL INFARCTION 4 (4.7%) 4 (5.6%) 2 (2.1%) WOUND HAEMORRHAGE 0 1 (1.4%) 0 # AET02 variant 5 is produced correctly @@ -173,8 +189,8 @@ 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 34 (39.5%) 61 (84.7%) 0 - Overall total number of events 71 189 0 + 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 @@ -197,6 +213,10 @@ 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 @@ -224,6 +244,8 @@ NAUSEA 3 (3.5%) 6 (8.3%) 3 (3.1%) NERVOUS SYSTEM DISORDERS HEADACHE 7 (8.1%) 6 (8.3%) 3 (3.1%) + CARDIAC DISORDERS + MYOCARDIAL INFARCTION 4 (4.7%) 4 (5.6%) 2 (2.1%) # AET02 variant 7 is produced correctly @@ -258,6 +280,9 @@ NERVOUS SYSTEM DISORDERS HLT_0064 HEADACHE 7 (8.1%) 6 (8.3%) 3 (3.1%) + CARDIAC DISORDERS + HLT_0649 + MYOCARDIAL INFARCTION 4 (4.7%) 4 (5.6%) 2 (2.1%) # AET02 variant 8 is produced correctly @@ -298,6 +323,8 @@ NAUSEA 3 (3.5%) 6 (8.3%) 3 (3.1%) NERVOUS SYSTEM DISORDERS HEADACHE 7 (8.1%) 6 (8.3%) 3 (3.1%) + CARDIAC DISORDERS + MYOCARDIAL INFARCTION 4 (4.7%) 4 (5.6%) 2 (2.1%) # AET02 variant 10 is produced correctly diff --git a/tests/testthat/_snaps/table_aet03.md b/tests/testthat/_snaps/table_aet03.md index beee32b..3cf0309 100644 --- a/tests/testthat/_snaps/table_aet03.md +++ b/tests/testthat/_snaps/table_aet03.md @@ -7,10 +7,10 @@ MedDRA Preferred Term Placebo Xanomeline High Dose Xanomeline Low Dose Severity/Intensity (N=86) (N=72) (N=96) —————————————————————————————————————————————————————————————————————————————————————————————————————————————— - - Any Intensity - 34 (39.5%) 61 (84.7%) 63 (65.6%) - MILD 22 (25.6%) 27 (37.5%) 27 (28.1%) - MODERATE 10 (11.6%) 30 (41.7%) 26 (27.1%) - SEVERE 0 2 (2.8%) 8 (8.3%) + - 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%) @@ -86,6 +86,16 @@ 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 diff --git a/tests/testthat/_snaps/table_aet04.md b/tests/testthat/_snaps/table_aet04.md index 44f3838..5659328 100644 --- a/tests/testthat/_snaps/table_aet04.md +++ b/tests/testthat/_snaps/table_aet04.md @@ -8,23 +8,23 @@ Grade (N=86) (N=72) (N=96) —————————————————————————————————————————————————————————————————————————————————————————————————————————————— - Any adverse events - - - Any Grade - 22 (25.6%) 50 (69.4%) 49 (51.0%) - Grade 1-2 17 (19.8%) 41 (56.9%) 40 (41.7%) - 1 12 (14.0%) 27 (37.5%) 25 (26.0%) - 2 5 (5.8%) 14 (19.4%) 15 (15.6%) - Grade 3-4 5 (5.8%) 9 (12.5%) 8 (8.3%) - 3 1 (1.2%) 4 (5.6%) 4 (4.2%) - 4 4 (4.7%) 5 (6.9%) 4 (4.2%) + - 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 - 14 (16.3%) 28 (38.9%) 26 (27.1%) - Grade 1-2 11 (12.8%) 22 (30.6%) 22 (22.9%) - 1 9 (10.5%) 17 (23.6%) 12 (12.5%) - 2 2 (2.3%) 5 (6.9%) 10 (10.4%) - Grade 3-4 3 (3.5%) 6 (8.3%) 3 (3.1%) - 3 1 (1.2%) 3 (4.2%) 2 (2.1%) - 4 2 (2.3%) 3 (4.2%) 1 (1.0%) + - 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%) @@ -43,6 +43,14 @@ 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%) @@ -79,19 +87,19 @@ Grade (N=86) (N=72) (N=96) ——————————————————————————————————————————————————————————————————————————————————————————————————————————— - Any adverse events - - - Any Grade - 0 50 (69.4%) 0 - Grade 1-2 0 41 (56.9%) 0 - 1 0 27 (37.5%) 0 - 2 0 14 (19.4%) 0 + - 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 28 (38.9%) 0 - Grade 1-2 0 22 (30.6%) 0 - 1 0 17 (23.6%) 0 - 2 0 5 (6.9%) 0 + - 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 @@ -108,6 +116,13 @@ 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 @@ -142,23 +157,23 @@ Grade (N=86) (N=72) (N=96) —————————————————————————————————————————————————————————————————————————————————————————————————————————————— - Any adverse events - - - Any Grade - 22 (25.6%) 50 (69.4%) 49 (51.0%) - Grade 1-2 17 (19.8%) 41 (56.9%) 40 (41.7%) - 1 12 (14.0%) 27 (37.5%) 25 (26.0%) - 2 5 (5.8%) 14 (19.4%) 15 (15.6%) - Grade 3-4 5 (5.8%) 9 (12.5%) 8 (8.3%) - 3 1 (1.2%) 4 (5.6%) 4 (4.2%) - 4 4 (4.7%) 5 (6.9%) 4 (4.2%) + - 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 - 14 (16.3%) 28 (38.9%) 26 (27.1%) - Grade 1-2 11 (12.8%) 22 (30.6%) 22 (22.9%) - 1 9 (10.5%) 17 (23.6%) 12 (12.5%) - 2 2 (2.3%) 5 (6.9%) 10 (10.4%) - Grade 3-4 3 (3.5%) 6 (8.3%) 3 (3.1%) - 3 1 (1.2%) 3 (4.2%) 2 (2.1%) - 4 2 (2.3%) 3 (4.2%) 1 (1.0%) + - 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%) @@ -178,6 +193,15 @@ 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%) @@ -217,23 +241,23 @@ Grade (N=86) (N=72) (N=96) —————————————————————————————————————————————————————————————————————————————————————————————————————————————— - Any adverse events - - - Any Grade - 22 (25.6%) 50 (69.4%) 49 (51.0%) - Grade 1-2 17 (19.8%) 41 (56.9%) 40 (41.7%) - 1 12 (14.0%) 27 (37.5%) 25 (26.0%) - 2 5 (5.8%) 14 (19.4%) 15 (15.6%) - Grade 3-5 5 (5.8%) 9 (12.5%) 9 (9.4%) - 3 1 (1.2%) 4 (5.6%) 4 (4.2%) - 4 4 (4.7%) 5 (6.9%) 4 (4.2%) + - 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 - 14 (16.3%) 28 (38.9%) 26 (27.1%) - Grade 1-2 11 (12.8%) 22 (30.6%) 22 (22.9%) - 1 9 (10.5%) 17 (23.6%) 12 (12.5%) - 2 2 (2.3%) 5 (6.9%) 10 (10.4%) - Grade 3-5 3 (3.5%) 6 (8.3%) 4 (4.2%) - 3 1 (1.2%) 3 (4.2%) 2 (2.1%) - 4 2 (2.3%) 3 (4.2%) 1 (1.0%) + - 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%) @@ -252,6 +276,14 @@ 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%) @@ -288,23 +320,23 @@ Grade (N=86) (N=72) (N=96) —————————————————————————————————————————————————————————————————————————————————————————————————————————————— - Any adverse events - - - Any Grade - 22 (25.6%) 50 (69.4%) 49 (51.0%) - Grade 1-2 17 (19.8%) 41 (56.9%) 40 (41.7%) - 1 12 (14.0%) 27 (37.5%) 25 (26.0%) - 2 5 (5.8%) 14 (19.4%) 15 (15.6%) - Grade 3-4 5 (5.8%) 9 (12.5%) 8 (8.3%) - 3 1 (1.2%) 4 (5.6%) 4 (4.2%) - 4 4 (4.7%) 5 (6.9%) 4 (4.2%) + - 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 - 14 (16.3%) 28 (38.9%) 26 (27.1%) - Grade 1-2 11 (12.8%) 22 (30.6%) 22 (22.9%) - 1 9 (10.5%) 17 (23.6%) 12 (12.5%) - 2 2 (2.3%) 5 (6.9%) 10 (10.4%) - Grade 3-4 3 (3.5%) 6 (8.3%) 3 (3.1%) - 3 1 (1.2%) 3 (4.2%) 2 (2.1%) - 4 2 (2.3%) 3 (4.2%) 1 (1.0%) + - 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%) @@ -323,6 +355,14 @@ 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%) @@ -359,23 +399,23 @@ Grade (N=86) (N=72) (N=96) —————————————————————————————————————————————————————————————————————————————————————————————————————————————— - Any adverse events - - - Any Grade - 22 (25.6%) 50 (69.4%) 49 (51.0%) - Grade 1-2 17 (19.8%) 41 (56.9%) 40 (41.7%) - 1 12 (14.0%) 27 (37.5%) 25 (26.0%) - 2 5 (5.8%) 14 (19.4%) 15 (15.6%) - Grade 3-4 5 (5.8%) 9 (12.5%) 8 (8.3%) - 3 1 (1.2%) 4 (5.6%) 4 (4.2%) - 4 4 (4.7%) 5 (6.9%) 4 (4.2%) + - 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 - 14 (16.3%) 28 (38.9%) 26 (27.1%) - Grade 1-2 11 (12.8%) 22 (30.6%) 22 (22.9%) - 1 9 (10.5%) 17 (23.6%) 12 (12.5%) - 2 2 (2.3%) 5 (6.9%) 10 (10.4%) - Grade 3-4 3 (3.5%) 6 (8.3%) 3 (3.1%) - 3 1 (1.2%) 3 (4.2%) 2 (2.1%) - 4 2 (2.3%) 3 (4.2%) 1 (1.0%) + - 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%) @@ -394,6 +434,14 @@ 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%) @@ -430,23 +478,23 @@ Grade (N=86) (N=72) (N=96) —————————————————————————————————————————————————————————————————————————————————————————————————————————————— - Any adverse events - - - Any Grade - 22 (25.6%) 50 (69.4%) 49 (51.0%) - Grade 1-2 17 (19.8%) 41 (56.9%) 40 (41.7%) - 1 12 (14.0%) 27 (37.5%) 25 (26.0%) - 2 5 (5.8%) 14 (19.4%) 15 (15.6%) - Grade 3-4 5 (5.8%) 9 (12.5%) 8 (8.3%) - 3 1 (1.2%) 4 (5.6%) 4 (4.2%) - 4 4 (4.7%) 5 (6.9%) 4 (4.2%) + - 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 - 14 (16.3%) 28 (38.9%) 26 (27.1%) - Grade 1-2 11 (12.8%) 22 (30.6%) 22 (22.9%) - 1 9 (10.5%) 17 (23.6%) 12 (12.5%) - 2 2 (2.3%) 5 (6.9%) 10 (10.4%) - Grade 3-4 3 (3.5%) 6 (8.3%) 3 (3.1%) - 3 1 (1.2%) 3 (4.2%) 2 (2.1%) - 4 2 (2.3%) 3 (4.2%) 1 (1.0%) + - 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%) @@ -465,6 +513,14 @@ 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%) @@ -501,23 +557,23 @@ Grade (N=86) (N=72) (N=96) —————————————————————————————————————————————————————————————————————————————————————————————————————————————— - Any adverse events - - - Any Grade - 22 (25.6%) 50 (69.4%) 49 (51.0%) - Grade 1-2 17 (19.8%) 41 (56.9%) 40 (41.7%) - 1 12 (14.0%) 27 (37.5%) 25 (26.0%) - 2 5 (5.8%) 14 (19.4%) 15 (15.6%) - Grade 3-4 5 (5.8%) 9 (12.5%) 8 (8.3%) - 3 1 (1.2%) 4 (5.6%) 4 (4.2%) - 4 4 (4.7%) 5 (6.9%) 4 (4.2%) + - 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 - 14 (16.3%) 28 (38.9%) 26 (27.1%) - Grade 1-2 11 (12.8%) 22 (30.6%) 22 (22.9%) - 1 9 (10.5%) 17 (23.6%) 12 (12.5%) - 2 2 (2.3%) 5 (6.9%) 10 (10.4%) - Grade 3-4 3 (3.5%) 6 (8.3%) 3 (3.1%) - 3 1 (1.2%) 3 (4.2%) 2 (2.1%) - 4 2 (2.3%) 3 (4.2%) 1 (1.0%) + - 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%) @@ -536,6 +592,14 @@ 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%) diff --git a/tests/testthat/_snaps/table_aet04_pi.md b/tests/testthat/_snaps/table_aet04_pi.md index 5e0149a..9e890dc 100644 --- a/tests/testthat/_snaps/table_aet04_pi.md +++ b/tests/testthat/_snaps/table_aet04_pi.md @@ -25,6 +25,9 @@ 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 @@ -52,6 +55,8 @@ NAUSEA 3 0 0 8 3 1 3 1 0 NERVOUS SYSTEM DISORDERS HEADACHE 8 1 0 8 0 0 3 0 0 + CARDIAC DISORDERS + MYOCARDIAL INFARCTION 5 1 0 6 1 0 2 0 0 # AET04_PI variant 2 is produced correctly diff --git a/tests/testthat/_snaps/table_aet05.md b/tests/testthat/_snaps/table_aet05.md index 1093428..b717c04 100644 --- a/tests/testthat/_snaps/table_aet05.md +++ b/tests/testthat/_snaps/table_aet05.md @@ -6,10 +6,10 @@ Placebo Xanomeline High Dose Xanomeline Low Dose (N=86) (N=84) (N=84) —————————————————————————————————————————————————————————————————————————————————————————————————————— - Total patient-years at risk -0.2 -1.9 -2.9 - Number of adverse events observed 20 30 36 - AE rate per 100 patient-years -11068.18 -1563.12 -1240.47 - 95% CI (-15918.94, -6217.43) (-2122.47, -1003.78) (-1645.69, -835.26) + 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 @@ -19,8 +19,8 @@ Placebo Xanomeline High Dose Xanomeline Low Dose (N=86) (N=84) (N=84) —————————————————————————————————————————————————————————————————————————————————————————————————————— - Total patient-years at risk -0.2 -1.9 -2.9 - Number of adverse events observed 20 30 36 - AE rate per 100 patient-years -11068.18 -1563.12 -1240.47 - 95% CI (-6760.73, -17093.91) (-1054.63, -2231.46) (-868.81, -1717.34) + 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 1dcad4e..480ba8f 100644 --- a/tests/testthat/_snaps/table_aet06.md +++ b/tests/testthat/_snaps/table_aet06.md @@ -7,8 +7,8 @@ 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 21 (39.6%) 13 (39.4%) 27 (67.5%) 36 (81.8%) 34 (68.0%) 27 (79.4%) - Overall total number of events 51 20 84 108 106 68 + 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 @@ -31,6 +31,10 @@ 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 @@ -45,8 +49,8 @@ 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 18 (31.6%) 13 (65.0%) 3 (50.0%) 1 (50.0%) 30 (71.4%) 24 (85.7%) 8 (66.7%) 2 (66.7%) 29 (67.4%) 21 (77.8%) 8 (80.0%) - Overall total number of events 0 45 21 5 1 89 75 27 6 83 58 25 + 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 @@ -69,6 +73,10 @@ 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 @@ -83,8 +91,8 @@ 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 21 (39.6%) 13 (39.4%) 27 (67.5%) 36 (81.8%) 34 (68.0%) 27 (79.4%) - Overall total number of events 51 20 84 108 106 68 + 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 @@ -137,6 +145,13 @@ 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 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 b04ca1b..ce7bce8 100644 --- a/tests/testthat/_snaps/table_aet09.md +++ b/tests/testthat/_snaps/table_aet09.md @@ -6,8 +6,8 @@ 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 28 (32.6%) 61 (72.6%) 57 (67.9%) 146 (57.5%) - Overall total number of events related to study drug 63 179 158 400 + 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 18 (20.9%) 32 (38.1%) 31 (36.9%) 81 (31.9%) Total number of events related to study drug 34 80 77 191 @@ -26,6 +26,10 @@ 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%) + CARDIAC DISORDERS + 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%) 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 @@ -43,8 +47,8 @@ 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 28 (32.6%) 61 (72.6%) 57 (67.9%) - Overall total number of events related to study drug 63 179 158 + 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 18 (20.9%) 32 (38.1%) 31 (36.9%) Total number of events related to study drug 34 80 77 @@ -90,6 +94,13 @@ 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%) + CARDIAC DISORDERS + 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%) 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 diff --git a/tests/testthat/setup.R b/tests/testthat/setup.R index 981118c..9a0cf37 100644 --- a/tests/testthat/setup.R +++ b/tests/testthat/setup.R @@ -210,7 +210,10 @@ adae_pharmaverse <- pharmaverseadam::adae %>% # 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") + add_specific_value = c( + "VOMITING", "NAUSEA", "SKIN IRRITATION", "HEADACHE", # For SMQ01NAM, SMQ02NAM, CQ01NAM + "MYOCARDIAL INFARCTION" # for aet07 AESDTH == "Y" + ) ) set.seed(NULL) diff --git a/tests/testthat/test-table_aet04.R b/tests/testthat/test-table_aet04.R index d035c9d..ffee904 100644 --- a/tests/testthat/test-table_aet04.R +++ b/tests/testthat/test-table_aet04.R @@ -279,7 +279,7 @@ testthat::test_that("AET04 variant 3 is produced correctly (Fill in of Grades)", ) testthat::expect_identical( to_string_matrix(pag_result[[1]], with_spaces = FALSE)[5:6, 2], - c("22 (25.6%)", "17 (19.8%)") + c("23 (26.7%)", "17 (19.8%)") ) }) diff --git a/tests/testthat/test-table_aet07.R b/tests/testthat/test-table_aet07.R index 4362bcd..230ca2e 100644 --- a/tests/testthat/test-table_aet07.R +++ b/tests/testthat/test-table_aet07.R @@ -19,7 +19,7 @@ preprocess_adae <- function(adae) { } adsl <- adsl_pharmaverse -adae <- pharmaverseadam::adae +adae <- adae_pharmaverse testthat::test_that("AET07 variant 1 is produced correctly", { adae <- adae %>% diff --git a/tests/testthat/test-table_lbt13.R b/tests/testthat/test-table_lbt13.R index e0970c8..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 <- adlb_f %>% # does nothing here ? - 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 %>%