Summary Assessment of [Insert AE of Interest], Safety Population, Pooled Analysis (or Trial X)
FDA Table 18
table
FDA
safety
adverse events
FDA IG Shell
Programming Notes
Background and Instructions
Table 18: Summary Assessment of [Insert AE of Interest] is created for each AE of interest and may be created for any AEs identified during application review that may warrant further analysis. The table name should be updated to reflect the event being displayed. The approach to analysis and summary of safety data should be tailored to each AE.
Customization
Discuss with CDS specific AEs and other information (e.g., laboratory information) to be included in Table 18 to provide a complete picture of the AE of Interest. When information across different datasets is combined, carefully consider the number of subjects used as the denominator in analyses, as they may differ across datasets.
Output
Code
# FDA TABLE 18 ---------------------------------------------------------------
# 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(cardx)
library(gtsummary)
adsl <- pharmaverseadam::adsl
adae <- pharmaverseadam::adae
set.seed(1)
adae$AESIFL <- ifelse(adae$AESOC %in% c("VASCULAR DISORDERS"), "Y", "N")
# Pre-processing --------------------------------------------
adsl <- adsl |>
# safety population
filter(SAFFL == "Y")
data <- adae |>
filter(
# safety population
SAFFL == "Y",
# AESI assessment
AESIFL == "Y"
)
# dataset of AE flag variable counts by subject
data_ae_fl <-
adsl |>
select(USUBJID, TRT01A) |>
# create subject-level flags from adae data
left_join(
data |>
select(USUBJID, AESER, AESDTH, AESLIFE, AESHOSP, AESDISAB, AESCONG, AEACN) |>
mutate(
# Serious AE
ae_ser = any(AESER == "Y"),
# Serious AE leading to death
ae_ser_death = any(AESER == "Y" & AESDTH == "Y"),
ae_ser_life = any(AESER == "Y" & AESLIFE == "Y"),
ae_ser_hosp = any(AESER == "Y" & AESHOSP == "Y"),
ae_ser_disab = any(AESER == "Y" & AESDISAB == "Y"),
ae_ser_cong = any(AESER == "Y" & AESCONG == "Y"),
# AE resulting in discontinuation
ae_withdraw = any(AEACN == "DRUG WITHDRAWN"),
.by = USUBJID
),
by = "USUBJID"
) |>
distinct(USUBJID, .keep_all = TRUE) |>
# add number of AEs
left_join(
data |> summarise(.by = USUBJID, ae_count = n()),
by = "USUBJID",
relationship = "one-to-one"
)
## AE grouping flags section --------
tbl_ae_gp <- data |>
tbl_hierarchical(
variables = AEDECOD,
id = USUBJID,
denominator = adsl,
by = TRT01A,
overall_row = TRUE,
label = list(
..ard_hierarchical_overall.. = "[Insert AE of Interest]",
AEDECOD = "AE of Interest Assessment"
)
) |>
modify_indent(columns = label, rows = variable != "..ard_hierarchical_overall..", indent = 4L)
## Maximum severity section ---------
tbl_ae_sev <- data |>
ard_tabulate_max(variables = AESEV, id = USUBJID, by = TRT01A, denominator = adsl, quiet = TRUE) |>
tbl_ard_summary(by = TRT01A, label = list(AESEV = "Maximum severity"))
## Events section -------------------
tbl_ae_fl <- data_ae_fl |>
tbl_summary(
by = "TRT01A",
include = c(ae_ser, ae_ser_death, ae_ser_life, ae_ser_hosp, ae_ser_disab, ae_ser_cong, ae_withdraw),
missing = "no",
percent = adsl,
label = list(
ae_ser = "SAE",
ae_ser_death = "Death",
ae_ser_life = "Life-threatening",
ae_ser_hosp = "Initial or prolonged hospitalization",
ae_ser_disab = "Disability or permanent damage",
ae_ser_cong = "Congenital anomaly or birth defect",
ae_withdraw = "Resulting in treatment discontinuation"
)
) |>
modify_indent(columns = label, rows = !variable %in% c("ae_ser", "ae_withdraw"), indent = 4L)
## Build table ----------------------
tbl <- tbl_stack(list(tbl_ae_gp, tbl_ae_sev, tbl_ae_fl), quiet = TRUE)
ard <- gtsummary::gather_ard(tbl)| AE of Interest Assessment |
Placebo N = 861 |
Xanomeline High Dose N = 721 |
Xanomeline Low Dose N = 961 |
|---|---|---|---|
| [Insert AE of Interest] | 3 (3.5%) | 1 (1.4%) | 4 (4.2%) |
| HOT FLUSH | 0 (0%) | 0 (0%) | 1 (1.0%) |
| HYPERTENSION | 1 (1.2%) | 0 (0%) | 2 (2.1%) |
| HYPOTENSION | 2 (2.3%) | 0 (0%) | 1 (1.0%) |
| ORTHOSTATIC HYPOTENSION | 1 (1.2%) | 0 (0%) | 0 (0%) |
| WOUND HAEMORRHAGE | 0 (0%) | 1 (1.4%) | 0 (0%) |
| Maximum severity | |||
| MILD | 1 (1.2%) | 0 (0.0%) | 3 (3.1%) |
| MODERATE | 2 (2.3%) | 1 (1.4%) | 1 (1.0%) |
| SAE | 0 (0%) | 0 (0%) | 0 (0%) |
| Death | 0 (0%) | 0 (0%) | 0 (0%) |
| Life-threatening | 0 (0%) | 0 (0%) | 0 (0%) |
| Initial or prolonged hospitalization | 0 (0%) | 0 (0%) | 0 (0%) |
| Disability or permanent damage | 0 (0%) | 0 (0%) | 0 (0%) |
| Congenital anomaly or birth defect | 0 (0%) | 0 (0%) | 0 (0%) |
| Resulting in treatment discontinuation | 0 (0%) | 0 (0%) | 0 (0%) |
| 1 n (%) | |||
[[1]]
[[1]]$tbl_hierarchical
# An ARD data frame: 63 × 13
group1 group1_level variable variable_level context stat_name stat_label stat stat_fmt fmt_fun warning error gts_column
<chr> <list> <chr> <list> <chr> <chr> <chr> <list> <list> <list> <list> <list> <chr>
1 <NA> <NULL> TRT01A Placebo tabulate n n 86 86 0 <NULL> <NULL> stat_1
2 <NA> <NULL> TRT01A Placebo tabulate N N 254 254 0 <NULL> <NULL> stat_1
3 <NA> <NULL> TRT01A Placebo tabulate p % 0.339 33.9 <fn> <NULL> <NULL> stat_1
4 <NA> <NULL> TRT01A Xanomeline High Dose tabulate n n 72 72 0 <NULL> <NULL> stat_2
5 <NA> <NULL> TRT01A Xanomeline High Dose tabulate N N 254 254 0 <NULL> <NULL> stat_2
6 <NA> <NULL> TRT01A Xanomeline High Dose tabulate p % 0.283 28.3 <fn> <NULL> <NULL> stat_2
7 <NA> <NULL> TRT01A Xanomeline Low Dose tabulate n n 96 96 0 <NULL> <NULL> stat_3
8 <NA> <NULL> TRT01A Xanomeline Low Dose tabulate N N 254 254 0 <NULL> <NULL> stat_3
9 <NA> <NULL> TRT01A Xanomeline Low Dose tabulate p % 0.378 37.8 <fn> <NULL> <NULL> stat_3
10 TRT01A Placebo ..ard_hierarchical_overall.. TRUE hierarchical n n 3 3 <fn> <NULL> <NULL> stat_1
11 TRT01A Placebo ..ard_hierarchical_overall.. TRUE hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
12 TRT01A Placebo ..ard_hierarchical_overall.. TRUE hierarchical p % 0.0349 3.5 <fn> <NULL> <NULL> stat_1
13 TRT01A Xanomeline High Dose ..ard_hierarchical_overall.. TRUE hierarchical n n 1 1 <fn> <NULL> <NULL> stat_2
14 TRT01A Xanomeline High Dose ..ard_hierarchical_overall.. TRUE hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
15 TRT01A Xanomeline High Dose ..ard_hierarchical_overall.. TRUE hierarchical p % 0.0139 1.4 <fn> <NULL> <NULL> stat_2
16 TRT01A Xanomeline Low Dose ..ard_hierarchical_overall.. TRUE hierarchical n n 4 4 <fn> <NULL> <NULL> stat_3
17 TRT01A Xanomeline Low Dose ..ard_hierarchical_overall.. TRUE hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
18 TRT01A Xanomeline Low Dose ..ard_hierarchical_overall.. TRUE hierarchical p % 0.0417 4.2 <fn> <NULL> <NULL> stat_3
19 TRT01A Placebo AEDECOD HOT FLUSH hierarchical n n 0 0 <fn> <NULL> <NULL> stat_1
20 TRT01A Placebo AEDECOD HOT FLUSH hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
21 TRT01A Placebo AEDECOD HOT FLUSH hierarchical p % 0 0 <fn> <NULL> <NULL> stat_1
22 TRT01A Xanomeline High Dose AEDECOD HOT FLUSH hierarchical n n 0 0 <fn> <NULL> <NULL> stat_2
23 TRT01A Xanomeline High Dose AEDECOD HOT FLUSH hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
24 TRT01A Xanomeline High Dose AEDECOD HOT FLUSH hierarchical p % 0 0 <fn> <NULL> <NULL> stat_2
25 TRT01A Xanomeline Low Dose AEDECOD HOT FLUSH hierarchical n n 1 1 <fn> <NULL> <NULL> stat_3
26 TRT01A Xanomeline Low Dose AEDECOD HOT FLUSH hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
27 TRT01A Xanomeline Low Dose AEDECOD HOT FLUSH hierarchical p % 0.0104 1.0 <fn> <NULL> <NULL> stat_3
28 TRT01A Placebo AEDECOD HYPERTENSION hierarchical n n 1 1 <fn> <NULL> <NULL> stat_1
29 TRT01A Placebo AEDECOD HYPERTENSION hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
30 TRT01A Placebo AEDECOD HYPERTENSION hierarchical p % 0.0116 1.2 <fn> <NULL> <NULL> stat_1
31 TRT01A Xanomeline High Dose AEDECOD HYPERTENSION hierarchical n n 0 0 <fn> <NULL> <NULL> stat_2
32 TRT01A Xanomeline High Dose AEDECOD HYPERTENSION hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
33 TRT01A Xanomeline High Dose AEDECOD HYPERTENSION hierarchical p % 0 0 <fn> <NULL> <NULL> stat_2
34 TRT01A Xanomeline Low Dose AEDECOD HYPERTENSION hierarchical n n 2 2 <fn> <NULL> <NULL> stat_3
35 TRT01A Xanomeline Low Dose AEDECOD HYPERTENSION hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
36 TRT01A Xanomeline Low Dose AEDECOD HYPERTENSION hierarchical p % 0.0208 2.1 <fn> <NULL> <NULL> stat_3
37 TRT01A Placebo AEDECOD HYPOTENSION hierarchical n n 2 2 <fn> <NULL> <NULL> stat_1
38 TRT01A Placebo AEDECOD HYPOTENSION hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
39 TRT01A Placebo AEDECOD HYPOTENSION hierarchical p % 0.0233 2.3 <fn> <NULL> <NULL> stat_1
40 TRT01A Xanomeline High Dose AEDECOD HYPOTENSION hierarchical n n 0 0 <fn> <NULL> <NULL> stat_2
41 TRT01A Xanomeline High Dose AEDECOD HYPOTENSION hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
42 TRT01A Xanomeline High Dose AEDECOD HYPOTENSION hierarchical p % 0 0 <fn> <NULL> <NULL> stat_2
43 TRT01A Xanomeline Low Dose AEDECOD HYPOTENSION hierarchical n n 1 1 <fn> <NULL> <NULL> stat_3
44 TRT01A Xanomeline Low Dose AEDECOD HYPOTENSION hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
45 TRT01A Xanomeline Low Dose AEDECOD HYPOTENSION hierarchical p % 0.0104 1.0 <fn> <NULL> <NULL> stat_3
46 TRT01A Placebo AEDECOD ORTHOSTATIC HYPOTENSION hierarchical n n 1 1 <fn> <NULL> <NULL> stat_1
47 TRT01A Placebo AEDECOD ORTHOSTATIC HYPOTENSION hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
48 TRT01A Placebo AEDECOD ORTHOSTATIC HYPOTENSION hierarchical p % 0.0116 1.2 <fn> <NULL> <NULL> stat_1
49 TRT01A Xanomeline High Dose AEDECOD ORTHOSTATIC HYPOTENSION hierarchical n n 0 0 <fn> <NULL> <NULL> stat_2
50 TRT01A Xanomeline High Dose AEDECOD ORTHOSTATIC HYPOTENSION hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
51 TRT01A Xanomeline High Dose AEDECOD ORTHOSTATIC HYPOTENSION hierarchical p % 0 0 <fn> <NULL> <NULL> stat_2
52 TRT01A Xanomeline Low Dose AEDECOD ORTHOSTATIC HYPOTENSION hierarchical n n 0 0 <fn> <NULL> <NULL> stat_3
53 TRT01A Xanomeline Low Dose AEDECOD ORTHOSTATIC HYPOTENSION hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
54 TRT01A Xanomeline Low Dose AEDECOD ORTHOSTATIC HYPOTENSION hierarchical p % 0 0 <fn> <NULL> <NULL> stat_3
55 TRT01A Placebo AEDECOD WOUND HAEMORRHAGE hierarchical n n 0 0 <fn> <NULL> <NULL> stat_1
56 TRT01A Placebo AEDECOD WOUND HAEMORRHAGE hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
57 TRT01A Placebo AEDECOD WOUND HAEMORRHAGE hierarchical p % 0 0 <fn> <NULL> <NULL> stat_1
58 TRT01A Xanomeline High Dose AEDECOD WOUND HAEMORRHAGE hierarchical n n 1 1 <fn> <NULL> <NULL> stat_2
59 TRT01A Xanomeline High Dose AEDECOD WOUND HAEMORRHAGE hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
60 TRT01A Xanomeline High Dose AEDECOD WOUND HAEMORRHAGE hierarchical p % 0.0139 1.4 <fn> <NULL> <NULL> stat_2
61 TRT01A Xanomeline Low Dose AEDECOD WOUND HAEMORRHAGE hierarchical n n 0 0 <fn> <NULL> <NULL> stat_3
62 TRT01A Xanomeline Low Dose AEDECOD WOUND HAEMORRHAGE hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
63 TRT01A Xanomeline Low Dose AEDECOD WOUND HAEMORRHAGE hierarchical p % 0 0 <fn> <NULL> <NULL> stat_3
[[2]]
[[2]]$tbl_ard_summary
# An ARD data frame: 20 × 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 AESEV MILD categorical_max n n 1 0 <NULL> <NULL> stat_1
2 TRT01A Placebo AESEV MILD categorical_max N N 86 0 <NULL> <NULL> stat_1
3 TRT01A Placebo AESEV MILD categorical_max p % 0.01162791 <fn> <NULL> <NULL> stat_1
4 TRT01A Placebo AESEV MODERATE categorical_max n n 2 0 <NULL> <NULL> stat_1
5 TRT01A Placebo AESEV MODERATE categorical_max N N 86 0 <NULL> <NULL> stat_1
6 TRT01A Placebo AESEV MODERATE categorical_max p % 0.02325581 <fn> <NULL> <NULL> stat_1
7 TRT01A Xanomeline High Dose AESEV MILD categorical_max n n 0 0 <NULL> <NULL> stat_2
8 TRT01A Xanomeline High Dose AESEV MILD categorical_max N N 72 0 <NULL> <NULL> stat_2
9 TRT01A Xanomeline High Dose AESEV MILD categorical_max p % 0 <fn> <NULL> <NULL> stat_2
10 TRT01A Xanomeline High Dose AESEV MODERATE categorical_max n n 1 0 <NULL> <NULL> stat_2
11 TRT01A Xanomeline High Dose AESEV MODERATE categorical_max N N 72 0 <NULL> <NULL> stat_2
12 TRT01A Xanomeline High Dose AESEV MODERATE categorical_max p % 0.01388889 <fn> <NULL> <NULL> stat_2
13 TRT01A Xanomeline Low Dose AESEV MILD categorical_max n n 3 0 <NULL> <NULL> stat_3
14 TRT01A Xanomeline Low Dose AESEV MILD categorical_max N N 96 0 <NULL> <NULL> stat_3
15 TRT01A Xanomeline Low Dose AESEV MILD categorical_max p % 0.03125 <fn> <NULL> <NULL> stat_3
16 TRT01A Xanomeline Low Dose AESEV MODERATE categorical_max n n 1 0 <NULL> <NULL> stat_3
17 TRT01A Xanomeline Low Dose AESEV MODERATE categorical_max N N 96 0 <NULL> <NULL> stat_3
18 TRT01A Xanomeline Low Dose AESEV MODERATE categorical_max p % 0.01041667 <fn> <NULL> <NULL> stat_3
19 <NA> <NULL> AESEV <NULL> attributes label Variable Label Maximum severity <fn> <NULL> <NULL> <NA>
20 <NA> <NULL> AESEV <NULL> attributes class Variable Class logical <NULL> <NULL> <NULL> <NA>
[[3]]
[[3]]$tbl_summary
# An ARD data frame: 194 × 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 ae_ser TRUE tabulate_value n n 0 <fn> <NULL> <NULL> stat_1
2 TRT01A Placebo ae_ser TRUE tabulate_value N N 86 <fn> <NULL> <NULL> stat_1
3 TRT01A Placebo ae_ser TRUE tabulate_value p % 0 <fn> <NULL> <NULL> stat_1
4 TRT01A Placebo ae_ser_death TRUE tabulate_value n n 0 <fn> <NULL> <NULL> stat_1
5 TRT01A Placebo ae_ser_death TRUE tabulate_value N N 86 <fn> <NULL> <NULL> stat_1
6 TRT01A Placebo ae_ser_death TRUE tabulate_value p % 0 <fn> <NULL> <NULL> stat_1
7 TRT01A Placebo ae_ser_life TRUE tabulate_value n n 0 <fn> <NULL> <NULL> stat_1
8 TRT01A Placebo ae_ser_life TRUE tabulate_value N N 86 <fn> <NULL> <NULL> stat_1
9 TRT01A Placebo ae_ser_life TRUE tabulate_value p % 0 <fn> <NULL> <NULL> stat_1
10 TRT01A Placebo ae_ser_hosp TRUE tabulate_value n n 0 <fn> <NULL> <NULL> stat_1
11 TRT01A Placebo ae_ser_hosp TRUE tabulate_value N N 86 <fn> <NULL> <NULL> stat_1
12 TRT01A Placebo ae_ser_hosp TRUE tabulate_value p % 0 <fn> <NULL> <NULL> stat_1
13 TRT01A Placebo ae_ser_disab TRUE tabulate_value n n 0 <fn> <NULL> <NULL> stat_1
14 TRT01A Placebo ae_ser_disab TRUE tabulate_value N N 86 <fn> <NULL> <NULL> stat_1
15 TRT01A Placebo ae_ser_disab TRUE tabulate_value p % 0 <fn> <NULL> <NULL> stat_1
16 TRT01A Placebo ae_ser_cong TRUE tabulate_value n n 0 <fn> <NULL> <NULL> stat_1
17 TRT01A Placebo ae_ser_cong TRUE tabulate_value N N 86 <fn> <NULL> <NULL> stat_1
18 TRT01A Placebo ae_ser_cong TRUE tabulate_value p % 0 <fn> <NULL> <NULL> stat_1
19 TRT01A Placebo ae_withdraw TRUE tabulate_value n n 0 <fn> <NULL> <NULL> stat_1
20 TRT01A Placebo ae_withdraw TRUE tabulate_value N N 86 <fn> <NULL> <NULL> stat_1
21 TRT01A Placebo ae_withdraw TRUE tabulate_value p % 0 <fn> <NULL> <NULL> stat_1
22 TRT01A Xanomeline High Dose ae_ser TRUE tabulate_value n n 0 <fn> <NULL> <NULL> stat_2
23 TRT01A Xanomeline High Dose ae_ser TRUE tabulate_value N N 72 <fn> <NULL> <NULL> stat_2
24 TRT01A Xanomeline High Dose ae_ser TRUE tabulate_value p % 0 <fn> <NULL> <NULL> stat_2
25 TRT01A Xanomeline High Dose ae_ser_death TRUE tabulate_value n n 0 <fn> <NULL> <NULL> stat_2
26 TRT01A Xanomeline High Dose ae_ser_death TRUE tabulate_value N N 72 <fn> <NULL> <NULL> stat_2
27 TRT01A Xanomeline High Dose ae_ser_death TRUE tabulate_value p % 0 <fn> <NULL> <NULL> stat_2
28 TRT01A Xanomeline High Dose ae_ser_life TRUE tabulate_value n n 0 <fn> <NULL> <NULL> stat_2
29 TRT01A Xanomeline High Dose ae_ser_life TRUE tabulate_value N N 72 <fn> <NULL> <NULL> stat_2
30 TRT01A Xanomeline High Dose ae_ser_life TRUE tabulate_value p % 0 <fn> <NULL> <NULL> stat_2
31 TRT01A Xanomeline High Dose ae_ser_hosp TRUE tabulate_value n n 0 <fn> <NULL> <NULL> stat_2
32 TRT01A Xanomeline High Dose ae_ser_hosp TRUE tabulate_value N N 72 <fn> <NULL> <NULL> stat_2
33 TRT01A Xanomeline High Dose ae_ser_hosp TRUE tabulate_value p % 0 <fn> <NULL> <NULL> stat_2
34 TRT01A Xanomeline High Dose ae_ser_disab TRUE tabulate_value n n 0 <fn> <NULL> <NULL> stat_2
35 TRT01A Xanomeline High Dose ae_ser_disab TRUE tabulate_value N N 72 <fn> <NULL> <NULL> stat_2
36 TRT01A Xanomeline High Dose ae_ser_disab TRUE tabulate_value p % 0 <fn> <NULL> <NULL> stat_2
37 TRT01A Xanomeline High Dose ae_ser_cong TRUE tabulate_value n n 0 <fn> <NULL> <NULL> stat_2
38 TRT01A Xanomeline High Dose ae_ser_cong TRUE tabulate_value N N 72 <fn> <NULL> <NULL> stat_2
39 TRT01A Xanomeline High Dose ae_ser_cong TRUE tabulate_value p % 0 <fn> <NULL> <NULL> stat_2
40 TRT01A Xanomeline High Dose ae_withdraw TRUE tabulate_value n n 0 <fn> <NULL> <NULL> stat_2
41 TRT01A Xanomeline High Dose ae_withdraw TRUE tabulate_value N N 72 <fn> <NULL> <NULL> stat_2
42 TRT01A Xanomeline High Dose ae_withdraw TRUE tabulate_value p % 0 <fn> <NULL> <NULL> stat_2
43 TRT01A Xanomeline Low Dose ae_ser TRUE tabulate_value n n 0 <fn> <NULL> <NULL> stat_3
44 TRT01A Xanomeline Low Dose ae_ser TRUE tabulate_value N N 96 <fn> <NULL> <NULL> stat_3
45 TRT01A Xanomeline Low Dose ae_ser TRUE tabulate_value p % 0 <fn> <NULL> <NULL> stat_3
46 TRT01A Xanomeline Low Dose ae_ser_death TRUE tabulate_value n n 0 <fn> <NULL> <NULL> stat_3
47 TRT01A Xanomeline Low Dose ae_ser_death TRUE tabulate_value N N 96 <fn> <NULL> <NULL> stat_3
48 TRT01A Xanomeline Low Dose ae_ser_death TRUE tabulate_value p % 0 <fn> <NULL> <NULL> stat_3
49 TRT01A Xanomeline Low Dose ae_ser_life TRUE tabulate_value n n 0 <fn> <NULL> <NULL> stat_3
50 TRT01A Xanomeline Low Dose ae_ser_life TRUE tabulate_value N N 96 <fn> <NULL> <NULL> stat_3
51 TRT01A Xanomeline Low Dose ae_ser_life TRUE tabulate_value p % 0 <fn> <NULL> <NULL> stat_3
52 TRT01A Xanomeline Low Dose ae_ser_hosp TRUE tabulate_value n n 0 <fn> <NULL> <NULL> stat_3
53 TRT01A Xanomeline Low Dose ae_ser_hosp TRUE tabulate_value N N 96 <fn> <NULL> <NULL> stat_3
54 TRT01A Xanomeline Low Dose ae_ser_hosp TRUE tabulate_value p % 0 <fn> <NULL> <NULL> stat_3
55 TRT01A Xanomeline Low Dose ae_ser_disab TRUE tabulate_value n n 0 <fn> <NULL> <NULL> stat_3
56 TRT01A Xanomeline Low Dose ae_ser_disab TRUE tabulate_value N N 96 <fn> <NULL> <NULL> stat_3
57 TRT01A Xanomeline Low Dose ae_ser_disab TRUE tabulate_value p % 0 <fn> <NULL> <NULL> stat_3
58 TRT01A Xanomeline Low Dose ae_ser_cong TRUE tabulate_value n n 0 <fn> <NULL> <NULL> stat_3
59 TRT01A Xanomeline Low Dose ae_ser_cong TRUE tabulate_value N N 96 <fn> <NULL> <NULL> stat_3
60 TRT01A Xanomeline Low Dose ae_ser_cong TRUE tabulate_value p % 0 <fn> <NULL> <NULL> stat_3
61 TRT01A Xanomeline Low Dose ae_withdraw TRUE tabulate_value n n 0 <fn> <NULL> <NULL> stat_3
62 TRT01A Xanomeline Low Dose ae_withdraw TRUE tabulate_value N N 96 <fn> <NULL> <NULL> stat_3
63 TRT01A Xanomeline Low Dose ae_withdraw TRUE tabulate_value p % 0 <fn> <NULL> <NULL> stat_3
64 <NA> <NULL> ae_ser <NULL> attributes label Variable Label SAE <fn> <NULL> <NULL> <NA>
65 <NA> <NULL> ae_ser <NULL> attributes class Variable Class logical <NULL> <NULL> <NULL> <NA>
66 <NA> <NULL> ae_ser_death <NULL> attributes label Variable Label Death <fn> <NULL> <NULL> <NA>
67 <NA> <NULL> ae_ser_death <NULL> attributes class Variable Class logical <NULL> <NULL> <NULL> <NA>
68 <NA> <NULL> ae_ser_life <NULL> attributes label Variable Label Life-threatening <fn> <NULL> <NULL> <NA>
69 <NA> <NULL> ae_ser_life <NULL> attributes class Variable Class logical <NULL> <NULL> <NULL> <NA>
70 <NA> <NULL> ae_ser_hosp <NULL> attributes label Variable Label Initial or prolonged hospitalization <fn> <NULL> <NULL> <NA>
71 <NA> <NULL> ae_ser_hosp <NULL> attributes class Variable Class logical <NULL> <NULL> <NULL> <NA>
72 <NA> <NULL> ae_ser_disab <NULL> attributes label Variable Label Disability or permanent damage <fn> <NULL> <NULL> <NA>
73 <NA> <NULL> ae_ser_disab <NULL> attributes class Variable Class logical <NULL> <NULL> <NULL> <NA>
74 <NA> <NULL> ae_ser_cong <NULL> attributes label Variable Label Congenital anomaly or birth defect <fn> <NULL> <NULL> <NA>
75 <NA> <NULL> ae_ser_cong <NULL> attributes class Variable Class logical <NULL> <NULL> <NULL> <NA>
76 <NA> <NULL> ae_withdraw <NULL> attributes label Variable Label Resulting in treatment discontinuation <fn> <NULL> <NULL> <NA>
77 <NA> <NULL> ae_withdraw <NULL> attributes class Variable Class logical <NULL> <NULL> <NULL> <NA>
78 <NA> <NULL> TRT01A <NULL> attributes label Variable Label Actual Treatment for Period 01 <fn> <NULL> <NULL> <NA>
79 <NA> <NULL> TRT01A <NULL> attributes class Variable Class character <NULL> <NULL> <NULL> <NA>
80 TRT01A Placebo ae_ser <NULL> missing N_obs No. obs. 86 <fn> <NULL> <NULL> stat_1
81 TRT01A Placebo ae_ser <NULL> missing N_miss N Missing 83 <fn> <NULL> <NULL> stat_1
82 TRT01A Placebo ae_ser <NULL> missing N_nonmiss N Non-missing 3 <fn> <NULL> <NULL> stat_1
83 TRT01A Placebo ae_ser <NULL> missing p_miss % Missing 0.9651163 <fn> <NULL> <NULL> stat_1
84 TRT01A Placebo ae_ser <NULL> missing p_nonmiss % Non-missing 0.03488372 <fn> <NULL> <NULL> stat_1
85 TRT01A Placebo ae_ser_death <NULL> missing N_obs No. obs. 86 <fn> <NULL> <NULL> stat_1
86 TRT01A Placebo ae_ser_death <NULL> missing N_miss N Missing 83 <fn> <NULL> <NULL> stat_1
87 TRT01A Placebo ae_ser_death <NULL> missing N_nonmiss N Non-missing 3 <fn> <NULL> <NULL> stat_1
88 TRT01A Placebo ae_ser_death <NULL> missing p_miss % Missing 0.9651163 <fn> <NULL> <NULL> stat_1
89 TRT01A Placebo ae_ser_death <NULL> missing p_nonmiss % Non-missing 0.03488372 <fn> <NULL> <NULL> stat_1
90 TRT01A Placebo ae_ser_life <NULL> missing N_obs No. obs. 86 <fn> <NULL> <NULL> stat_1
91 TRT01A Placebo ae_ser_life <NULL> missing N_miss N Missing 83 <fn> <NULL> <NULL> stat_1
92 TRT01A Placebo ae_ser_life <NULL> missing N_nonmiss N Non-missing 3 <fn> <NULL> <NULL> stat_1
93 TRT01A Placebo ae_ser_life <NULL> missing p_miss % Missing 0.9651163 <fn> <NULL> <NULL> stat_1
94 TRT01A Placebo ae_ser_life <NULL> missing p_nonmiss % Non-missing 0.03488372 <fn> <NULL> <NULL> stat_1
95 TRT01A Placebo ae_ser_hosp <NULL> missing N_obs No. obs. 86 <fn> <NULL> <NULL> stat_1
96 TRT01A Placebo ae_ser_hosp <NULL> missing N_miss N Missing 83 <fn> <NULL> <NULL> stat_1
97 TRT01A Placebo ae_ser_hosp <NULL> missing N_nonmiss N Non-missing 3 <fn> <NULL> <NULL> stat_1
98 TRT01A Placebo ae_ser_hosp <NULL> missing p_miss % Missing 0.9651163 <fn> <NULL> <NULL> stat_1
99 TRT01A Placebo ae_ser_hosp <NULL> missing p_nonmiss % Non-missing 0.03488372 <fn> <NULL> <NULL> stat_1
100 TRT01A Placebo ae_ser_disab <NULL> missing N_obs No. obs. 86 <fn> <NULL> <NULL> stat_1
101 TRT01A Placebo ae_ser_disab <NULL> missing N_miss N Missing 83 <fn> <NULL> <NULL> stat_1
102 TRT01A Placebo ae_ser_disab <NULL> missing N_nonmiss N Non-missing 3 <fn> <NULL> <NULL> stat_1
103 TRT01A Placebo ae_ser_disab <NULL> missing p_miss % Missing 0.9651163 <fn> <NULL> <NULL> stat_1
104 TRT01A Placebo ae_ser_disab <NULL> missing p_nonmiss % Non-missing 0.03488372 <fn> <NULL> <NULL> stat_1
105 TRT01A Placebo ae_ser_cong <NULL> missing N_obs No. obs. 86 <fn> <NULL> <NULL> stat_1
106 TRT01A Placebo ae_ser_cong <NULL> missing N_miss N Missing 83 <fn> <NULL> <NULL> stat_1
107 TRT01A Placebo ae_ser_cong <NULL> missing N_nonmiss N Non-missing 3 <fn> <NULL> <NULL> stat_1
108 TRT01A Placebo ae_ser_cong <NULL> missing p_miss % Missing 0.9651163 <fn> <NULL> <NULL> stat_1
109 TRT01A Placebo ae_ser_cong <NULL> missing p_nonmiss % Non-missing 0.03488372 <fn> <NULL> <NULL> stat_1
110 TRT01A Placebo ae_withdraw <NULL> missing N_obs No. obs. 86 <fn> <NULL> <NULL> stat_1
111 TRT01A Placebo ae_withdraw <NULL> missing N_miss N Missing 86 <fn> <NULL> <NULL> stat_1
112 TRT01A Placebo ae_withdraw <NULL> missing N_nonmiss N Non-missing 0 <fn> <NULL> <NULL> stat_1
113 TRT01A Placebo ae_withdraw <NULL> missing p_miss % Missing 1 <fn> <NULL> <NULL> stat_1
114 TRT01A Placebo ae_withdraw <NULL> missing p_nonmiss % Non-missing 0 <fn> <NULL> <NULL> stat_1
115 TRT01A Xanomeline High Dose ae_ser <NULL> missing N_obs No. obs. 72 <fn> <NULL> <NULL> stat_2
116 TRT01A Xanomeline High Dose ae_ser <NULL> missing N_miss N Missing 71 <fn> <NULL> <NULL> stat_2
117 TRT01A Xanomeline High Dose ae_ser <NULL> missing N_nonmiss N Non-missing 1 <fn> <NULL> <NULL> stat_2
118 TRT01A Xanomeline High Dose ae_ser <NULL> missing p_miss % Missing 0.9861111 <fn> <NULL> <NULL> stat_2
119 TRT01A Xanomeline High Dose ae_ser <NULL> missing p_nonmiss % Non-missing 0.01388889 <fn> <NULL> <NULL> stat_2
120 TRT01A Xanomeline High Dose ae_ser_death <NULL> missing N_obs No. obs. 72 <fn> <NULL> <NULL> stat_2
121 TRT01A Xanomeline High Dose ae_ser_death <NULL> missing N_miss N Missing 71 <fn> <NULL> <NULL> stat_2
122 TRT01A Xanomeline High Dose ae_ser_death <NULL> missing N_nonmiss N Non-missing 1 <fn> <NULL> <NULL> stat_2
123 TRT01A Xanomeline High Dose ae_ser_death <NULL> missing p_miss % Missing 0.9861111 <fn> <NULL> <NULL> stat_2
124 TRT01A Xanomeline High Dose ae_ser_death <NULL> missing p_nonmiss % Non-missing 0.01388889 <fn> <NULL> <NULL> stat_2
125 TRT01A Xanomeline High Dose ae_ser_life <NULL> missing N_obs No. obs. 72 <fn> <NULL> <NULL> stat_2
126 TRT01A Xanomeline High Dose ae_ser_life <NULL> missing N_miss N Missing 71 <fn> <NULL> <NULL> stat_2
127 TRT01A Xanomeline High Dose ae_ser_life <NULL> missing N_nonmiss N Non-missing 1 <fn> <NULL> <NULL> stat_2
128 TRT01A Xanomeline High Dose ae_ser_life <NULL> missing p_miss % Missing 0.9861111 <fn> <NULL> <NULL> stat_2
129 TRT01A Xanomeline High Dose ae_ser_life <NULL> missing p_nonmiss % Non-missing 0.01388889 <fn> <NULL> <NULL> stat_2
130 TRT01A Xanomeline High Dose ae_ser_hosp <NULL> missing N_obs No. obs. 72 <fn> <NULL> <NULL> stat_2
131 TRT01A Xanomeline High Dose ae_ser_hosp <NULL> missing N_miss N Missing 71 <fn> <NULL> <NULL> stat_2
132 TRT01A Xanomeline High Dose ae_ser_hosp <NULL> missing N_nonmiss N Non-missing 1 <fn> <NULL> <NULL> stat_2
133 TRT01A Xanomeline High Dose ae_ser_hosp <NULL> missing p_miss % Missing 0.9861111 <fn> <NULL> <NULL> stat_2
134 TRT01A Xanomeline High Dose ae_ser_hosp <NULL> missing p_nonmiss % Non-missing 0.01388889 <fn> <NULL> <NULL> stat_2
135 TRT01A Xanomeline High Dose ae_ser_disab <NULL> missing N_obs No. obs. 72 <fn> <NULL> <NULL> stat_2
136 TRT01A Xanomeline High Dose ae_ser_disab <NULL> missing N_miss N Missing 71 <fn> <NULL> <NULL> stat_2
137 TRT01A Xanomeline High Dose ae_ser_disab <NULL> missing N_nonmiss N Non-missing 1 <fn> <NULL> <NULL> stat_2
138 TRT01A Xanomeline High Dose ae_ser_disab <NULL> missing p_miss % Missing 0.9861111 <fn> <NULL> <NULL> stat_2
139 TRT01A Xanomeline High Dose ae_ser_disab <NULL> missing p_nonmiss % Non-missing 0.01388889 <fn> <NULL> <NULL> stat_2
140 TRT01A Xanomeline High Dose ae_ser_cong <NULL> missing N_obs No. obs. 72 <fn> <NULL> <NULL> stat_2
141 TRT01A Xanomeline High Dose ae_ser_cong <NULL> missing N_miss N Missing 71 <fn> <NULL> <NULL> stat_2
142 TRT01A Xanomeline High Dose ae_ser_cong <NULL> missing N_nonmiss N Non-missing 1 <fn> <NULL> <NULL> stat_2
143 TRT01A Xanomeline High Dose ae_ser_cong <NULL> missing p_miss % Missing 0.9861111 <fn> <NULL> <NULL> stat_2
144 TRT01A Xanomeline High Dose ae_ser_cong <NULL> missing p_nonmiss % Non-missing 0.01388889 <fn> <NULL> <NULL> stat_2
145 TRT01A Xanomeline High Dose ae_withdraw <NULL> missing N_obs No. obs. 72 <fn> <NULL> <NULL> stat_2
146 TRT01A Xanomeline High Dose ae_withdraw <NULL> missing N_miss N Missing 72 <fn> <NULL> <NULL> stat_2
147 TRT01A Xanomeline High Dose ae_withdraw <NULL> missing N_nonmiss N Non-missing 0 <fn> <NULL> <NULL> stat_2
148 TRT01A Xanomeline High Dose ae_withdraw <NULL> missing p_miss % Missing 1 <fn> <NULL> <NULL> stat_2
149 TRT01A Xanomeline High Dose ae_withdraw <NULL> missing p_nonmiss % Non-missing 0 <fn> <NULL> <NULL> stat_2
150 TRT01A Xanomeline Low Dose ae_ser <NULL> missing N_obs No. obs. 96 <fn> <NULL> <NULL> stat_3
151 TRT01A Xanomeline Low Dose ae_ser <NULL> missing N_miss N Missing 92 <fn> <NULL> <NULL> stat_3
152 TRT01A Xanomeline Low Dose ae_ser <NULL> missing N_nonmiss N Non-missing 4 <fn> <NULL> <NULL> stat_3
153 TRT01A Xanomeline Low Dose ae_ser <NULL> missing p_miss % Missing 0.9583333 <fn> <NULL> <NULL> stat_3
154 TRT01A Xanomeline Low Dose ae_ser <NULL> missing p_nonmiss % Non-missing 0.04166667 <fn> <NULL> <NULL> stat_3
155 TRT01A Xanomeline Low Dose ae_ser_death <NULL> missing N_obs No. obs. 96 <fn> <NULL> <NULL> stat_3
156 TRT01A Xanomeline Low Dose ae_ser_death <NULL> missing N_miss N Missing 92 <fn> <NULL> <NULL> stat_3
157 TRT01A Xanomeline Low Dose ae_ser_death <NULL> missing N_nonmiss N Non-missing 4 <fn> <NULL> <NULL> stat_3
158 TRT01A Xanomeline Low Dose ae_ser_death <NULL> missing p_miss % Missing 0.9583333 <fn> <NULL> <NULL> stat_3
159 TRT01A Xanomeline Low Dose ae_ser_death <NULL> missing p_nonmiss % Non-missing 0.04166667 <fn> <NULL> <NULL> stat_3
160 TRT01A Xanomeline Low Dose ae_ser_life <NULL> missing N_obs No. obs. 96 <fn> <NULL> <NULL> stat_3
161 TRT01A Xanomeline Low Dose ae_ser_life <NULL> missing N_miss N Missing 92 <fn> <NULL> <NULL> stat_3
162 TRT01A Xanomeline Low Dose ae_ser_life <NULL> missing N_nonmiss N Non-missing 4 <fn> <NULL> <NULL> stat_3
163 TRT01A Xanomeline Low Dose ae_ser_life <NULL> missing p_miss % Missing 0.9583333 <fn> <NULL> <NULL> stat_3
164 TRT01A Xanomeline Low Dose ae_ser_life <NULL> missing p_nonmiss % Non-missing 0.04166667 <fn> <NULL> <NULL> stat_3
165 TRT01A Xanomeline Low Dose ae_ser_hosp <NULL> missing N_obs No. obs. 96 <fn> <NULL> <NULL> stat_3
166 TRT01A Xanomeline Low Dose ae_ser_hosp <NULL> missing N_miss N Missing 92 <fn> <NULL> <NULL> stat_3
167 TRT01A Xanomeline Low Dose ae_ser_hosp <NULL> missing N_nonmiss N Non-missing 4 <fn> <NULL> <NULL> stat_3
168 TRT01A Xanomeline Low Dose ae_ser_hosp <NULL> missing p_miss % Missing 0.9583333 <fn> <NULL> <NULL> stat_3
169 TRT01A Xanomeline Low Dose ae_ser_hosp <NULL> missing p_nonmiss % Non-missing 0.04166667 <fn> <NULL> <NULL> stat_3
170 TRT01A Xanomeline Low Dose ae_ser_disab <NULL> missing N_obs No. obs. 96 <fn> <NULL> <NULL> stat_3
171 TRT01A Xanomeline Low Dose ae_ser_disab <NULL> missing N_miss N Missing 92 <fn> <NULL> <NULL> stat_3
172 TRT01A Xanomeline Low Dose ae_ser_disab <NULL> missing N_nonmiss N Non-missing 4 <fn> <NULL> <NULL> stat_3
173 TRT01A Xanomeline Low Dose ae_ser_disab <NULL> missing p_miss % Missing 0.9583333 <fn> <NULL> <NULL> stat_3
174 TRT01A Xanomeline Low Dose ae_ser_disab <NULL> missing p_nonmiss % Non-missing 0.04166667 <fn> <NULL> <NULL> stat_3
175 TRT01A Xanomeline Low Dose ae_ser_cong <NULL> missing N_obs No. obs. 96 <fn> <NULL> <NULL> stat_3
176 TRT01A Xanomeline Low Dose ae_ser_cong <NULL> missing N_miss N Missing 92 <fn> <NULL> <NULL> stat_3
177 TRT01A Xanomeline Low Dose ae_ser_cong <NULL> missing N_nonmiss N Non-missing 4 <fn> <NULL> <NULL> stat_3
178 TRT01A Xanomeline Low Dose ae_ser_cong <NULL> missing p_miss % Missing 0.9583333 <fn> <NULL> <NULL> stat_3
179 TRT01A Xanomeline Low Dose ae_ser_cong <NULL> missing p_nonmiss % Non-missing 0.04166667 <fn> <NULL> <NULL> stat_3
180 TRT01A Xanomeline Low Dose ae_withdraw <NULL> missing N_obs No. obs. 96 <fn> <NULL> <NULL> stat_3
181 TRT01A Xanomeline Low Dose ae_withdraw <NULL> missing N_miss N Missing 96 <fn> <NULL> <NULL> stat_3
182 TRT01A Xanomeline Low Dose ae_withdraw <NULL> missing N_nonmiss N Non-missing 0 <fn> <NULL> <NULL> stat_3
183 TRT01A Xanomeline Low Dose ae_withdraw <NULL> missing p_miss % Missing 1 <fn> <NULL> <NULL> stat_3
184 TRT01A Xanomeline Low Dose ae_withdraw <NULL> missing p_nonmiss % Non-missing 0 <fn> <NULL> <NULL> stat_3
185 <NA> <NULL> ..ard_total_n.. <NULL> total_n N N 254 0 <NULL> <NULL> <NA>
186 <NA> <NULL> TRT01A Placebo tabulate n n 86 0 <NULL> <NULL> <NA>
187 <NA> <NULL> TRT01A Placebo tabulate N N 254 0 <NULL> <NULL> <NA>
188 <NA> <NULL> TRT01A Placebo tabulate p % 0.3385827 <fn> <NULL> <NULL> <NA>
189 <NA> <NULL> TRT01A Xanomeline High Dose tabulate n n 72 0 <NULL> <NULL> <NA>
190 <NA> <NULL> TRT01A Xanomeline High Dose tabulate N N 254 0 <NULL> <NULL> <NA>
191 <NA> <NULL> TRT01A Xanomeline High Dose tabulate p % 0.2834646 <fn> <NULL> <NULL> <NA>
192 <NA> <NULL> TRT01A Xanomeline Low Dose tabulate n n 96 0 <NULL> <NULL> <NA>
193 <NA> <NULL> TRT01A Xanomeline Low Dose tabulate N N 254 0 <NULL> <NULL> <NA>
194 <NA> <NULL> TRT01A Xanomeline Low Dose tabulate p % 0.3779528 <fn> <NULL> <NULL> <NA>