Table of AEs of Special Interest adapted from https://insightsengineering.github.io/tlg-catalog/stable/tables/adverse-events/aet01_aesi.html
Source:R/t_aesi_slide.R
t_aesi_slide.RdTable of AEs of Special Interest adapted from https://insightsengineering.github.io/tlg-catalog/stable/tables/adverse-events/aet01_aesi.html
Arguments
- adsl
ADSL data set, dataframe
- adae
ADAE data set, dataframe.
- aesi
AESI variable which will act as a filter to select the rows required to create the table. An example of AESI variable is CQ01NAM.
- arm
Arm variable, character, `"ACTARM"` by default.
- grad_var
Grading variable, character, `"AETOXGR"` by default.
Examples
library(dplyr)
adsl <- eg_adsl
adae <- eg_adae
adae_atoxgr <- adae %>% dplyr::mutate(ATOXGR = AETOXGR)
t_aesi_slide(adsl, adae, aesi = "CQ01NAM")
#> 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 Total number of patients with study drug withdrawn due to AESI 21 (15.7%) 15 (11.2%) 26 (19.7%)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%)
t_aesi_slide(adsl, adae, aesi = "CQ01NAM", arm = "ARM", grad_var = "AESEV")
#> 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 4 (3.0%) 3 (2.2%) 0
#> Moderate 24 (17.9%) 24 (17.9%) 23 (17.4%)
#> 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%)
t_aesi_slide(adsl, adae_atoxgr, aesi = "CQ01NAM", grad_var = "ATOXGR")
#> 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%)