FDA Table 10

Subjects With Serious Adverse Events by System Organ Class and Preferred Term, Safety Population, Pooled Analysis (or Trial X)

table

FDA

safety

adverse events

Code

# Load libraries & data -------------------------------------
library(dplyr)
library(gtsummary)

adsl <- random.cdisc.data::cadsl
adae <- random.cdisc.data::cadae

# Pre-processing --------------------------------------------
adae <- adae |>
  filter(
    # safety population
    SAFFL == "Y",
    # serious adverse events
    AESER == "Y"
  )

Code

tbl <- adae |>
  tbl_hierarchical(
    variables = c(AESOC, AEDECOD),
    by = TRT01A,
    id = USUBJID,
    denominator = adsl,
    overall_row = TRUE,
    label = "..ard_hierarchical_overall.." ~ "Any SAE"
  )

tbl

Code

ard <- gather_ard(tbl)
ard

$tbl_hierarchical

{cards} data frame: 81 x 15

   group1 group1_level group2 group2_level                     variable variable_level   context stat_name stat_label  stat stat_fmt fmt_fun warning error gts_column
1    <NA>                <NA>                                    TRT01A      A: Drug X  tabulate         n          n   134      134       0                   stat_1
2    <NA>                <NA>                                    TRT01A      A: Drug X  tabulate         N          N   400      400       0                   stat_1
3    <NA>                <NA>                                    TRT01A      A: Drug X  tabulate         p          % 0.335     33.5    <fn>                   stat_1
4    <NA>                <NA>                                    TRT01A      B: Place…  tabulate         n          n   134      134       0                   stat_2
5    <NA>                <NA>                                    TRT01A      B: Place…  tabulate         N          N   400      400       0                   stat_2
6    <NA>                <NA>                                    TRT01A      B: Place…  tabulate         p          % 0.335     33.5    <fn>                   stat_2
7    <NA>                <NA>                                    TRT01A      C: Combi…  tabulate         n          n   132      132       0                   stat_3
8    <NA>                <NA>                                    TRT01A      C: Combi…  tabulate         N          N   400      400       0                   stat_3
9    <NA>                <NA>                                    TRT01A      C: Combi…  tabulate         p          %  0.33     33.0    <fn>                   stat_3
10 TRT01A    A: Drug X   <NA>              ..ard_hierarchical_overall..           TRUE hierarch…         n          n   104      104    <fn>                   stat_1

ℹ 71 more rows

ℹ Use `print(n = ...)` to see more rows