Subjects With Maximum Postbaseline Systolic Blood Pressure by Category of Blood Pressure, Safety Population, Pooled Analysis (or Trial X)
FDA Table 36
table
FDA
safety
vital signs
FDA IG Shell
Programming Notes
Background and Instructions
Subject counts are cumulative for each abnormality threshold.
Customization
Clinical review team may customize the cutoff criteria they wish to use.
Output
Code
# FDA TABLE 36 ---------------------------------------------------------------
# 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",
# systolic blood pressure
PARAMCD == "SYSBP",
# post-baseline visits
AVISITN >= 2
) |>
# analyze maximum values of each subject
slice_max(AVAL, n = 1L, by = USUBJID) |>
# define analysis value cutoffs
mutate(
L90 = AVAL < 90,
GE90 = AVAL >= 90,
GE120 = AVAL >= 120,
GE140 = AVAL >= 140,
GE160 = AVAL >= 160,
GE180 = AVAL >= 180
)
ard <- bind_ard(
ard_tabulate_value(
data,
variables = c(L90, GE90, GE120, GE140, GE160, GE180),
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(
L90 = "<90",
GE90 = ">=90",
GE120 = ">=120",
GE140 = ">=140",
GE160 = ">=160",
GE180 = ">=180"
)
) |>
modify_header(
# Update label, add analysis value units
label ~ paste0("**Systolic Blood Pressure (", data$VSORRESU[1], ")**"),
# Add N values to `by` variable labels
all_stat_cols() ~ "**{level}** \nN = {n}"
)
ard <- gtsummary::gather_ard(tbl)| Systolic Blood Pressure (mmHg) |
Placebo N = 861 |
Xanomeline High Dose N = 721 |
Xanomeline Low Dose N = 961 |
|---|---|---|---|
| <90 | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| >=90 | 135 (160.7%) | 109 (151.4%) | 134 (142.6%) |
| >=120 | 131 (156.0%) | 108 (150.0%) | 132 (140.4%) |
| >=140 | 101 (120.2%) | 69 (95.8%) | 105 (111.7%) |
| >=160 | 49 (58.3%) | 24 (33.3%) | 50 (53.2%) |
| >=180 | 6 (7.1%) | 4 (5.6%) | 9 (9.6%) |
| 1 n (%) | |||
$tbl_ard_summary
# An ARD data frame: 57 × 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 L90 TRUE tabulate_value n n 0 0 <NULL> <NULL> stat_1
2 TRT01A Placebo L90 TRUE tabulate_value p % 0 <fn> <NULL> <NULL> stat_1
3 TRT01A Placebo GE90 TRUE tabulate_value n n 135 0 <NULL> <NULL> stat_1
4 TRT01A Placebo GE90 TRUE tabulate_value p % 1.607143 <fn> <NULL> <NULL> stat_1
5 TRT01A Placebo GE120 TRUE tabulate_value n n 131 0 <NULL> <NULL> stat_1
6 TRT01A Placebo GE120 TRUE tabulate_value p % 1.559524 <fn> <NULL> <NULL> stat_1
7 TRT01A Placebo GE140 TRUE tabulate_value n n 101 0 <NULL> <NULL> stat_1
8 TRT01A Placebo GE140 TRUE tabulate_value p % 1.202381 <fn> <NULL> <NULL> stat_1
9 TRT01A Placebo GE160 TRUE tabulate_value n n 49 0 <NULL> <NULL> stat_1
10 TRT01A Placebo GE160 TRUE tabulate_value p % 0.5833333 <fn> <NULL> <NULL> stat_1
11 TRT01A Placebo GE180 TRUE tabulate_value n n 6 0 <NULL> <NULL> stat_1
12 TRT01A Placebo GE180 TRUE tabulate_value p % 0.07142857 <fn> <NULL> <NULL> stat_1
13 TRT01A Xanomeline High Dose L90 TRUE tabulate_value n n 0 0 <NULL> <NULL> stat_2
14 TRT01A Xanomeline High Dose L90 TRUE tabulate_value p % 0 <fn> <NULL> <NULL> stat_2
15 TRT01A Xanomeline High Dose GE90 TRUE tabulate_value n n 109 0 <NULL> <NULL> stat_2
16 TRT01A Xanomeline High Dose GE90 TRUE tabulate_value p % 1.513889 <fn> <NULL> <NULL> stat_2
17 TRT01A Xanomeline High Dose GE120 TRUE tabulate_value n n 108 0 <NULL> <NULL> stat_2
18 TRT01A Xanomeline High Dose GE120 TRUE tabulate_value p % 1.5 <fn> <NULL> <NULL> stat_2
19 TRT01A Xanomeline High Dose GE140 TRUE tabulate_value n n 69 0 <NULL> <NULL> stat_2
20 TRT01A Xanomeline High Dose GE140 TRUE tabulate_value p % 0.9583333 <fn> <NULL> <NULL> stat_2
21 TRT01A Xanomeline High Dose GE160 TRUE tabulate_value n n 24 0 <NULL> <NULL> stat_2
22 TRT01A Xanomeline High Dose GE160 TRUE tabulate_value p % 0.3333333 <fn> <NULL> <NULL> stat_2
23 TRT01A Xanomeline High Dose GE180 TRUE tabulate_value n n 4 0 <NULL> <NULL> stat_2
24 TRT01A Xanomeline High Dose GE180 TRUE tabulate_value p % 0.05555556 <fn> <NULL> <NULL> stat_2
25 TRT01A Xanomeline Low Dose L90 TRUE tabulate_value n n 0 0 <NULL> <NULL> stat_3
26 TRT01A Xanomeline Low Dose L90 TRUE tabulate_value p % 0 <fn> <NULL> <NULL> stat_3
27 TRT01A Xanomeline Low Dose GE90 TRUE tabulate_value n n 134 0 <NULL> <NULL> stat_3
28 TRT01A Xanomeline Low Dose GE90 TRUE tabulate_value p % 1.425532 <fn> <NULL> <NULL> stat_3
29 TRT01A Xanomeline Low Dose GE120 TRUE tabulate_value n n 132 0 <NULL> <NULL> stat_3
30 TRT01A Xanomeline Low Dose GE120 TRUE tabulate_value p % 1.404255 <fn> <NULL> <NULL> stat_3
31 TRT01A Xanomeline Low Dose GE140 TRUE tabulate_value n n 105 0 <NULL> <NULL> stat_3
32 TRT01A Xanomeline Low Dose GE140 TRUE tabulate_value p % 1.117021 <fn> <NULL> <NULL> stat_3
33 TRT01A Xanomeline Low Dose GE160 TRUE tabulate_value n n 50 0 <NULL> <NULL> stat_3
34 TRT01A Xanomeline Low Dose GE160 TRUE tabulate_value p % 0.5319149 <fn> <NULL> <NULL> stat_3
35 TRT01A Xanomeline Low Dose GE180 TRUE tabulate_value n n 9 0 <NULL> <NULL> stat_3
36 TRT01A Xanomeline Low Dose GE180 TRUE tabulate_value p % 0.09574468 <fn> <NULL> <NULL> stat_3
37 <NA> <NULL> TRT01A Placebo tabulate n n 86 0 <NULL> <NULL> <NA>
38 <NA> <NULL> TRT01A Placebo tabulate N N 254 0 <NULL> <NULL> <NA>
39 <NA> <NULL> TRT01A Placebo tabulate p % 0.3385827 <fn> <NULL> <NULL> <NA>
40 <NA> <NULL> TRT01A Xanomeline High Dose tabulate n n 72 0 <NULL> <NULL> <NA>
41 <NA> <NULL> TRT01A Xanomeline High Dose tabulate N N 254 0 <NULL> <NULL> <NA>
42 <NA> <NULL> TRT01A Xanomeline High Dose tabulate p % 0.2834646 <fn> <NULL> <NULL> <NA>
43 <NA> <NULL> TRT01A Xanomeline Low Dose tabulate n n 96 0 <NULL> <NULL> <NA>
44 <NA> <NULL> TRT01A Xanomeline Low Dose tabulate N N 254 0 <NULL> <NULL> <NA>
45 <NA> <NULL> TRT01A Xanomeline Low Dose tabulate p % 0.3779528 <fn> <NULL> <NULL> <NA>
46 <NA> <NULL> L90 <NULL> attributes label Variable Label <90 <fn> <NULL> <NULL> <NA>
47 <NA> <NULL> L90 <NULL> attributes class Variable Class logical <NULL> <NULL> <NULL> <NA>
48 <NA> <NULL> GE90 <NULL> attributes label Variable Label >=90 <fn> <NULL> <NULL> <NA>
49 <NA> <NULL> GE90 <NULL> attributes class Variable Class logical <NULL> <NULL> <NULL> <NA>
50 <NA> <NULL> GE120 <NULL> attributes label Variable Label >=120 <fn> <NULL> <NULL> <NA>
51 <NA> <NULL> GE120 <NULL> attributes class Variable Class logical <NULL> <NULL> <NULL> <NA>
52 <NA> <NULL> GE140 <NULL> attributes label Variable Label >=140 <fn> <NULL> <NULL> <NA>
53 <NA> <NULL> GE140 <NULL> attributes class Variable Class logical <NULL> <NULL> <NULL> <NA>
54 <NA> <NULL> GE160 <NULL> attributes label Variable Label >=160 <fn> <NULL> <NULL> <NA>
55 <NA> <NULL> GE160 <NULL> attributes class Variable Class logical <NULL> <NULL> <NULL> <NA>
56 <NA> <NULL> GE180 <NULL> attributes label Variable Label >=180 <fn> <NULL> <NULL> <NA>
57 <NA> <NULL> GE180 <NULL> attributes class Variable Class logical <NULL> <NULL> <NULL> <NA>