Nothing
Code
t_aesi_slide(testdata$adsl, testdata$adae, aesi = "CQ01NAM", arm = "ACTARM")
Output
A: Drug X B: Placebo C: Combination
(N=134) (N=134) (N=132)
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
Total number of patients with at least one AESI 97 (72.4%) 93 (69.4%) 99 (75.0%)
Total number of AESIs 396 380 465
Total number of patients with at least one AESI by worst grade
Grade 1 4 (3.0%) 3 (2.2%) 0
Grade 2 6 (4.5%) 10 (7.5%) 7 (5.3%)
Grade 3 18 (13.4%) 14 (10.4%) 16 (12.1%)
Grade 4 15 (11.2%) 20 (14.9%) 18 (13.6%)
Grade 5 (fatal outcome) 76 (56.7%) 70 (52.2%) 75 (56.8%)
Total number of patients with study drug withdrawn due to AESI 21 (15.7%) 15 (11.2%) 26 (19.7%)
Total number of patients with dose modified/interrupted due to AESI 56 (41.8%) 63 (47.0%) 64 (48.5%)
Total number of patients with treatment received for AESI 91 (67.9%) 93 (69.4%) 95 (72.0%)
Total number of patients with all non-fatal AESIs resolved 23 (17.2%) 17 (12.7%) 19 (14.4%)
Total number of patients with at least one unresolved or ongoing non-fatal AESI 96 (71.6%) 100 (74.6%) 97 (73.5%)
Total number of patients with at least one serious AESI 104 (77.6%) 101 (75.4%) 99 (75.0%)
Total number of patients with at least one related AESI 99 (73.9%) 98 (73.1%) 102 (77.3%)
Code
t_aesi_slide(testdata$adsl, testdata$adae_aesev, aesi = "CQ01NAM", arm = "ACTARM",
grad_var = "AESEV")
Output
A: Drug X B: Placebo C: Combination
(N=134) (N=134) (N=132)
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
Total number of patients with at least one AESI 97 (72.4%) 93 (69.4%) 99 (75.0%)
Total number of AESIs 396 380 465
Total number of patients with at least one AESI by worst grade
Mild 10 (7.5%) 13 (9.7%) 7 (5.3%)
Moderate 18 (13.4%) 14 (10.4%) 16 (12.1%)
Severe 91 (67.9%) 90 (67.2%) 93 (70.5%)
Total number of patients with study drug withdrawn due to AESI 21 (15.7%) 15 (11.2%) 26 (19.7%)
Total number of patients with dose modified/interrupted due to AESI 56 (41.8%) 63 (47.0%) 64 (48.5%)
Total number of patients with treatment received for AESI 91 (67.9%) 93 (69.4%) 95 (72.0%)
Total number of patients with all non-fatal AESIs resolved 23 (17.2%) 17 (12.7%) 19 (14.4%)
Total number of patients with at least one unresolved or ongoing non-fatal AESI 96 (71.6%) 100 (74.6%) 97 (73.5%)
Total number of patients with at least one serious AESI 104 (77.6%) 101 (75.4%) 99 (75.0%)
Total number of patients with at least one related AESI 99 (73.9%) 98 (73.1%) 102 (77.3%)
Code
t_aesi_slide(testdata$adsl, testdata$adae_custom, aesi = "CQ01NAM", arm = "ARM",
grad_var = "AEGRP")
Output
A: Drug X B: Placebo C: Combination
(N=134) (N=134) (N=132)
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
Total number of patients with at least one AESI 97 (72.4%) 93 (69.4%) 99 (75.0%)
Total number of AESIs 396 380 465
Total number of patients with at least one AESI by worst grade
Grade 1-2 10 (7.5%) 13 (9.7%) 7 (5.3%)
Grade 3-5 109 (81.3%) 104 (77.6%) 109 (82.6%)
Total number of patients with study drug withdrawn due to AESI 21 (15.7%) 15 (11.2%) 26 (19.7%)
Total number of patients with dose modified/interrupted due to AESI 56 (41.8%) 63 (47.0%) 64 (48.5%)
Total number of patients with treatment received for AESI 91 (67.9%) 93 (69.4%) 95 (72.0%)
Total number of patients with all non-fatal AESIs resolved 23 (17.2%) 17 (12.7%) 19 (14.4%)
Total number of patients with at least one unresolved or ongoing non-fatal AESI 96 (71.6%) 100 (74.6%) 97 (73.5%)
Total number of patients with at least one serious AESI 104 (77.6%) 101 (75.4%) 99 (75.0%)
Total number of patients with at least one related AESI 99 (73.9%) 98 (73.1%) 102 (77.3%)
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