Subject Populations, Randomized Population, Pooled Analysis (or Trial X)

FDA Table 04

table

FDA

safety

disposition

Code

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

adsl <- pharmaverseadam::adsl |>
  filter(TRT01A != "Screen Failure") # Remove screen failure observations

# Pre-processing --------------------------------------------
pop_vars <- c("rand_fl", "ITTFL", "SAFFL", "prot_fl")
lbl_pop_vars <- c("Subjects randomized", "ITT population", "Safety population", "Per-protocol population")

data <- adsl |>
  mutate(
    across(all_of("SAFFL"), ~ . == "Y"),
    ITTFL = !is.na(RANDDT),
    rand_fl = !is.na(RANDDT),
    prot_fl = EOSSTT == "COMPLETED"
  )

Code

tbl <- data |>
  tbl_summary(
    by = "TRT01A",
    statistic = list(all_dichotomous() ~ "{n} ({p}%)"),
    include = all_of(pop_vars),
    digits = list(all_categorical() ~ c(0, 1)),
    label = as.list(lbl_pop_vars) |> setNames(pop_vars)
  ) |>
  # Define which variables are children of parent variables
  modify_indent(
    columns = "label",
    rows = variable != "rand_fl",
    indent = 4L
  ) |>
  modify_header(label = "**Population**")

tbl

Code

ard <- gather_ard(tbl)
ard

$tbl_summary

{cards} data frame: 116 x 12

   group1 group1_level variable variable_level   context stat_name stat_label stat fmt_fun warning error gts_column
1  TRT01A      Placebo    SAFFL           TRUE tabulate…         n          n   86    <fn>                   stat_1
2  TRT01A      Placebo    SAFFL           TRUE tabulate…         N          N   86       0                   stat_1
3  TRT01A      Placebo    SAFFL           TRUE tabulate…         p          %    1    <fn>                   stat_1
4  TRT01A      Placebo    ITTFL           TRUE tabulate…         n          n   86    <fn>                   stat_1
5  TRT01A      Placebo    ITTFL           TRUE tabulate…         N          N   86       0                   stat_1
6  TRT01A      Placebo    ITTFL           TRUE tabulate…         p          %    1    <fn>                   stat_1
7  TRT01A      Placebo  rand_fl           TRUE tabulate…         n          n   86    <fn>                   stat_1
8  TRT01A      Placebo  rand_fl           TRUE tabulate…         N          N   86       0                   stat_1
9  TRT01A      Placebo  rand_fl           TRUE tabulate…         p          %    1    <fn>                   stat_1
10 TRT01A      Placebo  prot_fl           TRUE tabulate…         n          n   58    <fn>                   stat_1

ℹ 106 more rows

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