Overview of Adverse Events by Demographic Subgroup, Safety Population, Pooled Analysis (or Trial X)
FDA Table 51
table
FDA
safety
adverse events
FDA IG Shell
Programming Notes
Background and Instructions
Table 50: Overview of Serious Adverse Events by Demographic Subgroup and Table 51: Overview of Adverse Events by Demographic Subgroup in this section display placeholder values for the demographic characteristics for subgroup analysis of SAEs and AEs. These placeholder values will change to reflect the values found in the clinical trial data. When CDISC-controlled terminology is used in the clinical trial data, the demographic characteristics in this table will reflect the controlled terminology.
Customization
Provide any additional potentially relevant subgroups beyond the standard demographic ones that may shed light on which subjects are most susceptible to the safety event (e.g., baseline diseases [e.g., cardiovascular disease or diabetes, or by CKD stage], concomitant medication, anthropometric characteristics [e.g., BMI]). The clinical reviewer should discuss appropriate age groups for the subgroup analysis with the CDS.
Output
Code
# FDA TABLE 51 ---------------------------------------------------------------
# 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)
adae <- pharmaverseadam::adae
adsl <- pharmaverseadam::adsl
adsl <- adsl |>
filter(SAFFL == "Y") |>
mutate(any_ae = "Any AE")
data <- adae |>
filter(
SAFFL == "Y",
TRTEMFL == "Y"
) |>
mutate(any_ae = "Any AE") |>
# subset to one AE per subject
dplyr::slice_tail(n = 1L, by = all_of(c("USUBJID", "ARM")))
# generate ARD for `n` statistic
ard_summary <- data |>
ard_categorical(
variables = c(any_ae, SEX, AGEGR1, RACE, ETHNIC),
by = ARM,
statistic = ~"n"
)
# generate ARD for `N_s` statistic
ard_ns <- adsl |>
ard_categorical(
variables = c(any_ae, SEX, AGEGR1, RACE, ETHNIC),
by = ARM,
statistic = ~"n",
stat_label = ~ list(n = "N_s")
) |>
mutate(stat_name = "N_s")
# generate ARD for `p` statistic
ard_p <-
cards::bind_ard(
ard_summary,
ard_ns
) |>
select(-stat_label) |>
tidyr::pivot_wider(names_from = stat_name, values_from = stat, values_fn = unlist) |>
rowwise() |>
mutate(
stat_name = "p",
stat_label = "%",
stat = if_else(n > 0, list(n / N_s), list(0)),
fmt_fun = list(label_round(digits = 1, scale = 100))
) |>
select(-n, -N_s)
# combine all ARDs
ard <- cards::bind_ard(ard_summary, ard_ns, ard_p, ard_categorical(adsl, variables = ARM, statistic = ~"n")) |>
cards::tidy_ard_row_order()
# generate table from ARDs
tbl <-
tbl_ard_summary(
ard,
by = ARM,
# set variable labels
label = list(
SEX = "Sex",
AGEGR1 = "Age Group, years",
RACE = "Race",
ETHNIC = "Ethnicity"
)
) |>
gtsummary::modify_table_body(
\(x) x |> filter(!label %in% "any_ae")
) |>
gtsummary::modify_indent(columns = label, rows = variable == "any_ae", indent = 0L) |>
# update statistic footnote
gtsummary::modify_footnote_header(
footnote = "n/N_s (%)",
columns = all_stat_cols()
) |>
gtsummary::modify_header(all_stat_cols() ~ "**{level}** \n N = {n}")
ard <- gtsummary::gather_ard(tbl)| Characteristic |
Placebo N = 861 |
Xanomeline High Dose N = 841 |
Xanomeline Low Dose N = 841 |
|---|---|---|---|
| Any AE | 65 (75.6%) | 75 (89.3%) | 77 (91.7%) |
| Sex | |||
| F | 40 (75.5%) | 36 (90.0%) | 44 (88.0%) |
| M | 25 (75.8%) | 39 (88.6%) | 33 (97.1%) |
| Age Group, years | |||
| 18-64 | 10 (71.4%) | 10 (90.9%) | 8 (100.0%) |
| >64 | 55 (76.4%) | 65 (89.0%) | 69 (90.8%) |
| Race | |||
| AMERICAN INDIAN OR ALASKA NATIVE | 0 (0.0%) | 1 (100.0%) | 0 (0.0%) |
| BLACK OR AFRICAN AMERICAN | 6 (75.0%) | 7 (77.8%) | 4 (66.7%) |
| WHITE | 59 (75.6%) | 67 (90.5%) | 73 (93.6%) |
| Ethnicity | |||
| HISPANIC OR LATINO | 3 (100.0%) | 3 (100.0%) | 6 (100.0%) |
| NOT HISPANIC OR LATINO | 62 (74.7%) | 72 (88.9%) | 71 (91.0%) |
| 1 n/N_s (%) | |||
$tbl_ard_summary
# An ARD data frame: 103 × 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 <NA> <NULL> any_ae <NULL> attributes label Variable Label any_ae <fn> <NULL> <NULL> <NA>
2 <NA> <NULL> any_ae <NULL> attributes class Variable Class logical <NULL> <NULL> <NULL> <NA>
3 ARM Placebo any_ae Any AE categorical n n 65 0 <NULL> <NULL> stat_1
4 ARM Placebo SEX F categorical n n 40 0 <NULL> <NULL> stat_1
5 ARM Placebo SEX M categorical n n 25 0 <NULL> <NULL> stat_1
6 ARM Placebo AGEGR1 18-64 categorical n n 10 0 <NULL> <NULL> stat_1
7 ARM Placebo AGEGR1 >64 categorical n n 55 0 <NULL> <NULL> stat_1
8 ARM Placebo RACE AMERICAN INDIAN OR ALASKA NATIVE categorical n n 0 0 <NULL> <NULL> stat_1
9 ARM Placebo RACE BLACK OR AFRICAN AMERICAN categorical n n 6 0 <NULL> <NULL> stat_1
10 ARM Placebo RACE WHITE categorical n n 59 0 <NULL> <NULL> stat_1
11 ARM Placebo ETHNIC HISPANIC OR LATINO categorical n n 3 0 <NULL> <NULL> stat_1
12 ARM Placebo ETHNIC NOT HISPANIC OR LATINO categorical n n 62 0 <NULL> <NULL> stat_1
13 ARM Placebo any_ae Any AE categorical N_s N_s 86 0 <NULL> <NULL> stat_1
14 ARM Placebo SEX F categorical N_s N_s 53 0 <NULL> <NULL> stat_1
15 ARM Placebo SEX M categorical N_s N_s 33 0 <NULL> <NULL> stat_1
16 ARM Placebo AGEGR1 18-64 categorical N_s N_s 14 0 <NULL> <NULL> stat_1
17 ARM Placebo AGEGR1 >64 categorical N_s N_s 72 0 <NULL> <NULL> stat_1
18 ARM Placebo RACE AMERICAN INDIAN OR ALASKA NATIVE categorical N_s N_s 0 0 <NULL> <NULL> stat_1
19 ARM Placebo RACE BLACK OR AFRICAN AMERICAN categorical N_s N_s 8 0 <NULL> <NULL> stat_1
20 ARM Placebo RACE WHITE categorical N_s N_s 78 0 <NULL> <NULL> stat_1
21 ARM Placebo ETHNIC HISPANIC OR LATINO categorical N_s N_s 3 0 <NULL> <NULL> stat_1
22 ARM Placebo ETHNIC NOT HISPANIC OR LATINO categorical N_s N_s 83 0 <NULL> <NULL> stat_1
23 ARM Placebo any_ae Any AE categorical p % 0.755814 <fn> <NULL> <NULL> stat_1
24 ARM Placebo SEX F categorical p % 0.754717 <fn> <NULL> <NULL> stat_1
25 ARM Placebo SEX M categorical p % 0.7575758 <fn> <NULL> <NULL> stat_1
26 ARM Placebo AGEGR1 18-64 categorical p % 0.7142857 <fn> <NULL> <NULL> stat_1
27 ARM Placebo AGEGR1 >64 categorical p % 0.7638889 <fn> <NULL> <NULL> stat_1
28 ARM Placebo RACE AMERICAN INDIAN OR ALASKA NATIVE categorical p % 0 <fn> <NULL> <NULL> stat_1
29 ARM Placebo RACE BLACK OR AFRICAN AMERICAN categorical p % 0.75 <fn> <NULL> <NULL> stat_1
30 ARM Placebo RACE WHITE categorical p % 0.7564103 <fn> <NULL> <NULL> stat_1
31 ARM Placebo ETHNIC HISPANIC OR LATINO categorical p % 1 <fn> <NULL> <NULL> stat_1
32 ARM Placebo ETHNIC NOT HISPANIC OR LATINO categorical p % 0.746988 <fn> <NULL> <NULL> stat_1
33 ARM Xanomeline High Dose any_ae Any AE categorical n n 75 0 <NULL> <NULL> stat_2
34 ARM Xanomeline High Dose SEX F categorical n n 36 0 <NULL> <NULL> stat_2
35 ARM Xanomeline High Dose SEX M categorical n n 39 0 <NULL> <NULL> stat_2
36 ARM Xanomeline High Dose AGEGR1 18-64 categorical n n 10 0 <NULL> <NULL> stat_2
37 ARM Xanomeline High Dose AGEGR1 >64 categorical n n 65 0 <NULL> <NULL> stat_2
38 ARM Xanomeline High Dose RACE AMERICAN INDIAN OR ALASKA NATIVE categorical n n 1 0 <NULL> <NULL> stat_2
39 ARM Xanomeline High Dose RACE BLACK OR AFRICAN AMERICAN categorical n n 7 0 <NULL> <NULL> stat_2
40 ARM Xanomeline High Dose RACE WHITE categorical n n 67 0 <NULL> <NULL> stat_2
41 ARM Xanomeline High Dose ETHNIC HISPANIC OR LATINO categorical n n 3 0 <NULL> <NULL> stat_2
42 ARM Xanomeline High Dose ETHNIC NOT HISPANIC OR LATINO categorical n n 72 0 <NULL> <NULL> stat_2
43 ARM Xanomeline High Dose any_ae Any AE categorical N_s N_s 84 0 <NULL> <NULL> stat_2
44 ARM Xanomeline High Dose SEX F categorical N_s N_s 40 0 <NULL> <NULL> stat_2
45 ARM Xanomeline High Dose SEX M categorical N_s N_s 44 0 <NULL> <NULL> stat_2
46 ARM Xanomeline High Dose AGEGR1 18-64 categorical N_s N_s 11 0 <NULL> <NULL> stat_2
47 ARM Xanomeline High Dose AGEGR1 >64 categorical N_s N_s 73 0 <NULL> <NULL> stat_2
48 ARM Xanomeline High Dose RACE AMERICAN INDIAN OR ALASKA NATIVE categorical N_s N_s 1 0 <NULL> <NULL> stat_2
49 ARM Xanomeline High Dose RACE BLACK OR AFRICAN AMERICAN categorical N_s N_s 9 0 <NULL> <NULL> stat_2
50 ARM Xanomeline High Dose RACE WHITE categorical N_s N_s 74 0 <NULL> <NULL> stat_2
51 ARM Xanomeline High Dose ETHNIC HISPANIC OR LATINO categorical N_s N_s 3 0 <NULL> <NULL> stat_2
52 ARM Xanomeline High Dose ETHNIC NOT HISPANIC OR LATINO categorical N_s N_s 81 0 <NULL> <NULL> stat_2
53 ARM Xanomeline High Dose any_ae Any AE categorical p % 0.8928571 <fn> <NULL> <NULL> stat_2
54 ARM Xanomeline High Dose SEX F categorical p % 0.9 <fn> <NULL> <NULL> stat_2
55 ARM Xanomeline High Dose SEX M categorical p % 0.8863636 <fn> <NULL> <NULL> stat_2
56 ARM Xanomeline High Dose AGEGR1 18-64 categorical p % 0.9090909 <fn> <NULL> <NULL> stat_2
57 ARM Xanomeline High Dose AGEGR1 >64 categorical p % 0.890411 <fn> <NULL> <NULL> stat_2
58 ARM Xanomeline High Dose RACE AMERICAN INDIAN OR ALASKA NATIVE categorical p % 1 <fn> <NULL> <NULL> stat_2
59 ARM Xanomeline High Dose RACE BLACK OR AFRICAN AMERICAN categorical p % 0.7777778 <fn> <NULL> <NULL> stat_2
60 ARM Xanomeline High Dose RACE WHITE categorical p % 0.9054054 <fn> <NULL> <NULL> stat_2
61 ARM Xanomeline High Dose ETHNIC HISPANIC OR LATINO categorical p % 1 <fn> <NULL> <NULL> stat_2
62 ARM Xanomeline High Dose ETHNIC NOT HISPANIC OR LATINO categorical p % 0.8888889 <fn> <NULL> <NULL> stat_2
63 ARM Xanomeline Low Dose any_ae Any AE categorical n n 77 0 <NULL> <NULL> stat_3
64 ARM Xanomeline Low Dose SEX F categorical n n 44 0 <NULL> <NULL> stat_3
65 ARM Xanomeline Low Dose SEX M categorical n n 33 0 <NULL> <NULL> stat_3
66 ARM Xanomeline Low Dose AGEGR1 18-64 categorical n n 8 0 <NULL> <NULL> stat_3
67 ARM Xanomeline Low Dose AGEGR1 >64 categorical n n 69 0 <NULL> <NULL> stat_3
68 ARM Xanomeline Low Dose RACE AMERICAN INDIAN OR ALASKA NATIVE categorical n n 0 0 <NULL> <NULL> stat_3
69 ARM Xanomeline Low Dose RACE BLACK OR AFRICAN AMERICAN categorical n n 4 0 <NULL> <NULL> stat_3
70 ARM Xanomeline Low Dose RACE WHITE categorical n n 73 0 <NULL> <NULL> stat_3
71 ARM Xanomeline Low Dose ETHNIC HISPANIC OR LATINO categorical n n 6 0 <NULL> <NULL> stat_3
72 ARM Xanomeline Low Dose ETHNIC NOT HISPANIC OR LATINO categorical n n 71 0 <NULL> <NULL> stat_3
73 ARM Xanomeline Low Dose any_ae Any AE categorical N_s N_s 84 0 <NULL> <NULL> stat_3
74 ARM Xanomeline Low Dose SEX F categorical N_s N_s 50 0 <NULL> <NULL> stat_3
75 ARM Xanomeline Low Dose SEX M categorical N_s N_s 34 0 <NULL> <NULL> stat_3
76 ARM Xanomeline Low Dose AGEGR1 18-64 categorical N_s N_s 8 0 <NULL> <NULL> stat_3
77 ARM Xanomeline Low Dose AGEGR1 >64 categorical N_s N_s 76 0 <NULL> <NULL> stat_3
78 ARM Xanomeline Low Dose RACE AMERICAN INDIAN OR ALASKA NATIVE categorical N_s N_s 0 0 <NULL> <NULL> stat_3
79 ARM Xanomeline Low Dose RACE BLACK OR AFRICAN AMERICAN categorical N_s N_s 6 0 <NULL> <NULL> stat_3
80 ARM Xanomeline Low Dose RACE WHITE categorical N_s N_s 78 0 <NULL> <NULL> stat_3
81 ARM Xanomeline Low Dose ETHNIC HISPANIC OR LATINO categorical N_s N_s 6 0 <NULL> <NULL> stat_3
82 ARM Xanomeline Low Dose ETHNIC NOT HISPANIC OR LATINO categorical N_s N_s 78 0 <NULL> <NULL> stat_3
83 ARM Xanomeline Low Dose any_ae Any AE categorical p % 0.9166667 <fn> <NULL> <NULL> stat_3
84 ARM Xanomeline Low Dose SEX F categorical p % 0.88 <fn> <NULL> <NULL> stat_3
85 ARM Xanomeline Low Dose SEX M categorical p % 0.9705882 <fn> <NULL> <NULL> stat_3
86 ARM Xanomeline Low Dose AGEGR1 18-64 categorical p % 1 <fn> <NULL> <NULL> stat_3
87 ARM Xanomeline Low Dose AGEGR1 >64 categorical p % 0.9078947 <fn> <NULL> <NULL> stat_3
88 ARM Xanomeline Low Dose RACE AMERICAN INDIAN OR ALASKA NATIVE categorical p % 0 <fn> <NULL> <NULL> stat_3
89 ARM Xanomeline Low Dose RACE BLACK OR AFRICAN AMERICAN categorical p % 0.6666667 <fn> <NULL> <NULL> stat_3
90 ARM Xanomeline Low Dose RACE WHITE categorical p % 0.9358974 <fn> <NULL> <NULL> stat_3
91 ARM Xanomeline Low Dose ETHNIC HISPANIC OR LATINO categorical p % 1 <fn> <NULL> <NULL> stat_3
92 ARM Xanomeline Low Dose ETHNIC NOT HISPANIC OR LATINO categorical p % 0.9102564 <fn> <NULL> <NULL> stat_3
93 <NA> <NULL> ARM Placebo categorical n n 86 0 <NULL> <NULL> <NA>
94 <NA> <NULL> ARM Xanomeline High Dose categorical n n 84 0 <NULL> <NULL> <NA>
95 <NA> <NULL> ARM Xanomeline Low Dose categorical n n 84 0 <NULL> <NULL> <NA>
96 <NA> <NULL> SEX <NULL> attributes label Variable Label Sex <fn> <NULL> <NULL> <NA>
97 <NA> <NULL> SEX <NULL> attributes class Variable Class logical <NULL> <NULL> <NULL> <NA>
98 <NA> <NULL> AGEGR1 <NULL> attributes label Variable Label Age Group, years <fn> <NULL> <NULL> <NA>
99 <NA> <NULL> AGEGR1 <NULL> attributes class Variable Class logical <NULL> <NULL> <NULL> <NA>
100 <NA> <NULL> RACE <NULL> attributes label Variable Label Race <fn> <NULL> <NULL> <NA>
101 <NA> <NULL> RACE <NULL> attributes class Variable Class logical <NULL> <NULL> <NULL> <NA>
102 <NA> <NULL> ETHNIC <NULL> attributes label Variable Label Ethnicity <fn> <NULL> <NULL> <NA>
103 <NA> <NULL> ETHNIC <NULL> attributes class Variable Class logical <NULL> <NULL> <NULL> <NA>