Subjects Meeting Specific Postbaseline Hypotension Levels, Safety Population, Pooled Analysis (or Trial X)

FDA Table 38

FDA IG Shell

Programming Notes

Background and Instructions

N/A (per FDA IG)

Customization

Clinical review team may customize the cutoff criteria they wish to use.

Output

Full Code

# FDA TABLE 38 ---------------------------------------------------------------
# Self-contained template. Run top-to-bottom to build the objects below.
# Used by tests via run_template() and published in the catalog.

library(dplyr)
library(cards)
library(gtsummary)

adsl <- pharmaverseadam::adsl
advs <- pharmaverseadam::advs

# Pre-processing --------------------------------------------
adsl <- adsl |>
  filter(SAFFL == "Y") # safety population

data <- advs |>
  filter(
    # safety population
    SAFFL == "Y",
    # diastolic & systolic blood pressure
    PARAMCD %in% c("DIABP", "SYSBP"),
    # post-baseline visits
    AVISITN >= 2
  ) |>
  # analyze minimum values per parameter of each subject
  slice_min(AVAL, n = 1L, by = c(USUBJID, PARAMCD)) |>
  # define analysis value cutoffs per parameter
  mutate(
    SBP90 = PARAMCD == "SYSBP" & AVAL < 90,
    DBP60 = PARAMCD == "DIABP" & AVAL < 60
  )

ard <- bind_ard(
  ard_tabulate_value(
    data,
    variables = c(SBP90, DBP60),
    by = TRT01A,
    statistic = ~ c("n", "p"),
    # denominator values are number of subjects in arm with BP data
    denominator = data |> distinct(USUBJID, TRT01A)
  ),
  # ARD for header N values
  ard_tabulate(adsl, variables = TRT01A)
)

tbl <- tbl_ard_summary(
  ard,
  by = TRT01A,
  # Add labels for each range
  label = list(
    SBP90 = "SBP<90",
    DBP60 = "DBP<60"
  )
) |>
  modify_header(
    # Update label, add analysis value units
    label ~ paste0("**Blood Pressure (", data$VSORRESU[1], ")**"),
    # Add N values to `by` variable labels
    all_stat_cols() ~ "**{level}**  \nN = {n}"
  )


ard <- gtsummary::gather_ard(tbl)

Table

tbl

Blood Pressure (mmHg)	Placebo N = 861	Xanomeline High Dose N = 721	Xanomeline Low Dose N = 961
SBP<90	8 (9.5%)	0 (0.0%)	1 (1.1%)
DBP<60	32 (38.1%)	27 (37.5%)	29 (30.9%)
1 n (%)

ARD

withr::local_options(width = 9999, tibble.print_max = Inf)
print(ard, columns = "all")

$tbl_ard_summary
# An ARD data frame: 25 × 12
   group1 group1_level         variable variable_level       context        stat_name stat_label     stat      fmt_fun warning error  gts_column
   <chr>  <list>               <chr>    <list>               <chr>          <chr>     <chr>          <list>    <list>  <list>  <list> <chr>     
 1 TRT01A Placebo              SBP90    TRUE                 tabulate_value n         n              8         0       <NULL>  <NULL> stat_1    
 2 TRT01A Placebo              SBP90    TRUE                 tabulate_value p         %              0.0952381 <fn>    <NULL>  <NULL> stat_1    
 3 TRT01A Placebo              DBP60    TRUE                 tabulate_value n         n              32        0       <NULL>  <NULL> stat_1    
 4 TRT01A Placebo              DBP60    TRUE                 tabulate_value p         %              0.3809524 <fn>    <NULL>  <NULL> stat_1    
 5 TRT01A Xanomeline High Dose SBP90    TRUE                 tabulate_value n         n              0         0       <NULL>  <NULL> stat_2    
 6 TRT01A Xanomeline High Dose SBP90    TRUE                 tabulate_value p         %              0         <fn>    <NULL>  <NULL> stat_2    
 7 TRT01A Xanomeline High Dose DBP60    TRUE                 tabulate_value n         n              27        0       <NULL>  <NULL> stat_2    
 8 TRT01A Xanomeline High Dose DBP60    TRUE                 tabulate_value p         %              0.375     <fn>    <NULL>  <NULL> stat_2    
 9 TRT01A Xanomeline Low Dose  SBP90    TRUE                 tabulate_value n         n              1         0       <NULL>  <NULL> stat_3    
10 TRT01A Xanomeline Low Dose  SBP90    TRUE                 tabulate_value p         %              0.0106383 <fn>    <NULL>  <NULL> stat_3    
11 TRT01A Xanomeline Low Dose  DBP60    TRUE                 tabulate_value n         n              29        0       <NULL>  <NULL> stat_3    
12 TRT01A Xanomeline Low Dose  DBP60    TRUE                 tabulate_value p         %              0.3085106 <fn>    <NULL>  <NULL> stat_3    
13 <NA>   <NULL>               TRT01A   Placebo              tabulate       n         n              86        0       <NULL>  <NULL> <NA>      
14 <NA>   <NULL>               TRT01A   Placebo              tabulate       N         N              254       0       <NULL>  <NULL> <NA>      
15 <NA>   <NULL>               TRT01A   Placebo              tabulate       p         %              0.3385827 <fn>    <NULL>  <NULL> <NA>      
16 <NA>   <NULL>               TRT01A   Xanomeline High Dose tabulate       n         n              72        0       <NULL>  <NULL> <NA>      
17 <NA>   <NULL>               TRT01A   Xanomeline High Dose tabulate       N         N              254       0       <NULL>  <NULL> <NA>      
18 <NA>   <NULL>               TRT01A   Xanomeline High Dose tabulate       p         %              0.2834646 <fn>    <NULL>  <NULL> <NA>      
19 <NA>   <NULL>               TRT01A   Xanomeline Low Dose  tabulate       n         n              96        0       <NULL>  <NULL> <NA>      
20 <NA>   <NULL>               TRT01A   Xanomeline Low Dose  tabulate       N         N              254       0       <NULL>  <NULL> <NA>      
21 <NA>   <NULL>               TRT01A   Xanomeline Low Dose  tabulate       p         %              0.3779528 <fn>    <NULL>  <NULL> <NA>      
22 <NA>   <NULL>               SBP90    <NULL>               attributes     label     Variable Label SBP<90    <fn>    <NULL>  <NULL> <NA>      
23 <NA>   <NULL>               SBP90    <NULL>               attributes     class     Variable Class logical   <NULL>  <NULL>  <NULL> <NA>      
24 <NA>   <NULL>               DBP60    <NULL>               attributes     label     Variable Label DBP<60    <fn>    <NULL>  <NULL> <NA>      
25 <NA>   <NULL>               DBP60    <NULL>               attributes     class     Variable Class logical   <NULL>  <NULL>  <NULL> <NA>