Subjects With Adverse Events Leading to Treatment Discontinuation by System Organ Class and Preferred Term, Safety Population, Pooled Analysis (or Trial X)
FDA Table 12
table
FDA
safety
adverse events
Code
# Load libraries & data -------------------------------------
library(dplyr)
library(cards)
library(gtsummary)
adsl <- random.cdisc.data::cadsl
adae <- random.cdisc.data::cadae
adae$DCSREAS[is.na(adae$DCSREAS)] <- "ADVERSE EVENT"
# Pre-processing --------------------------------------------
adsl <- adsl |>
filter(SAFFL == "Y") # safety population
data <- adae |>
filter(
# safety population
SAFFL == "Y",
# discontinuation due to AE
DCSREAS == "ADVERSE EVENT"
){cards} data frame: 162 x 13 group1 group1_level group2 group2_level variable variable_level context stat_name stat_label stat fmt_fun warning error
1 <NA> <NA> TRT01A A: Drug X tabulate n n 134 0
2 <NA> <NA> TRT01A A: Drug X tabulate N N 400 0
3 <NA> <NA> TRT01A A: Drug X tabulate p % 0.335 <fn>
4 <NA> <NA> TRT01A B: Place… tabulate n n 134 0
5 <NA> <NA> TRT01A B: Place… tabulate N N 400 0
6 <NA> <NA> TRT01A B: Place… tabulate p % 0.335 <fn>
7 <NA> <NA> TRT01A C: Combi… tabulate n n 132 0
8 <NA> <NA> TRT01A C: Combi… tabulate N N 400 0
9 <NA> <NA> TRT01A C: Combi… tabulate p % 0.33 <fn>
10 TRT01A A: Drug X <NA> AEBODSYS cl A.1 hierarch… n n 53 0
11 TRT01A A: Drug X <NA> AEBODSYS cl A.1 hierarch… N N 134 0
12 TRT01A A: Drug X <NA> AEBODSYS cl A.1 hierarch… p % 0.396 <fn>
13 TRT01A B: Place… <NA> AEBODSYS cl A.1 hierarch… n n 55 0
14 TRT01A B: Place… <NA> AEBODSYS cl A.1 hierarch… N N 134 0
15 TRT01A B: Place… <NA> AEBODSYS cl A.1 hierarch… p % 0.41 <fn>
16 TRT01A C: Combi… <NA> AEBODSYS cl A.1 hierarch… n n 69 0
17 TRT01A C: Combi… <NA> AEBODSYS cl A.1 hierarch… N N 132 0
18 TRT01A C: Combi… <NA> AEBODSYS cl A.1 hierarch… p % 0.523 <fn>
19 TRT01A A: Drug X AEBODSYS cl A.1 AEDECOD dcd A.1.… hierarch… n n 37 0
20 TRT01A A: Drug X AEBODSYS cl A.1 AEDECOD dcd A.1.… hierarch… N N 134 0
21 TRT01A A: Drug X AEBODSYS cl A.1 AEDECOD dcd A.1.… hierarch… p % 0.276 <fn>
22 TRT01A B: Place… AEBODSYS cl A.1 AEDECOD dcd A.1.… hierarch… n n 37 0
23 TRT01A B: Place… AEBODSYS cl A.1 AEDECOD dcd A.1.… hierarch… N N 134 0
24 TRT01A B: Place… AEBODSYS cl A.1 AEDECOD dcd A.1.… hierarch… p % 0.276 <fn>
25 TRT01A C: Combi… AEBODSYS cl A.1 AEDECOD dcd A.1.… hierarch… n n 50 0
26 TRT01A C: Combi… AEBODSYS cl A.1 AEDECOD dcd A.1.… hierarch… N N 132 0
27 TRT01A C: Combi… AEBODSYS cl A.1 AEDECOD dcd A.1.… hierarch… p % 0.379 <fn>
28 TRT01A A: Drug X AEBODSYS cl A.1 AEDECOD dcd A.1.… hierarch… n n 33 0
29 TRT01A A: Drug X AEBODSYS cl A.1 AEDECOD dcd A.1.… hierarch… N N 134 0
30 TRT01A A: Drug X AEBODSYS cl A.1 AEDECOD dcd A.1.… hierarch… p % 0.246 <fn>
31 TRT01A B: Place… AEBODSYS cl A.1 AEDECOD dcd A.1.… hierarch… n n 31 0
32 TRT01A B: Place… AEBODSYS cl A.1 AEDECOD dcd A.1.… hierarch… N N 134 0
33 TRT01A B: Place… AEBODSYS cl A.1 AEDECOD dcd A.1.… hierarch… p % 0.231 <fn>
34 TRT01A C: Combi… AEBODSYS cl A.1 AEDECOD dcd A.1.… hierarch… n n 40 0
35 TRT01A C: Combi… AEBODSYS cl A.1 AEDECOD dcd A.1.… hierarch… N N 132 0
36 TRT01A C: Combi… AEBODSYS cl A.1 AEDECOD dcd A.1.… hierarch… p % 0.303 <fn>
37 TRT01A A: Drug X <NA> AEBODSYS cl B.1 hierarch… n n 35 0
38 TRT01A A: Drug X <NA> AEBODSYS cl B.1 hierarch… N N 134 0
39 TRT01A A: Drug X <NA> AEBODSYS cl B.1 hierarch… p % 0.261 <fn>
40 TRT01A B: Place… <NA> AEBODSYS cl B.1 hierarch… n n 41 0 ℹ 122 more rowsℹ Use `print(n = ...)` to see more rows