Overview of Adverse Events, Safety Population, Pooled Analysis (or Trial X)
FDA Table 07
table
FDA
safety
adverse events
FDA IG Shell
Programming Notes
Background and Instructions
Table 7: Overview of Adverse Events summarizes AEs and includes incidence of SAEs based on individual components of the SAE criteria. The event values listed in this example table are placeholders that reflect CDISC controlled terminology. The values will be replaced by those found in the clinical trial data. When CDISC controlled terminology is used in the clinical trial data, the events shown in this table will reflect the controlled terminology.
Customization
Clinical reviewers may discuss with CDS if they would like to designate additional AEs as “Serious” and include them in the “Other” category in the table. These additional AEs may include important medical events that do not result in death, are not life-threatening, and do not require hospitalization but that jeopardize the subject and require medical or surgical intervention to prevent one of these outcomes.
Output
Code
# FDA TABLE 07 ---------------------------------------------------------------
# Self-contained template. Run top-to-bottom to build the objects below.
# Used by tests via run_template() and published in the catalog.
library(gtsummary)
library(dplyr)
adsl <- pharmaverseadam::adsl |>
filter(TRT01A != "Screen Failure")
adae <- pharmaverseadam::adae
# Use safety population only
adsl <- adsl |>
filter(SAFFL == "Y")
data <- adae |>
filter(SAFFL == "Y")
set.seed(1)
# this data set doesn't have treatment action recorded. We can generate a variable for demonstration.
aeacn_levels <- c("DRUG INTERRUPTED", "DOSE REDUCED", "DOSE RATE REDUCED", "DOSE INCREASED")
data <- data |>
mutate(AEACN = factor(sample(aeacn_levels, size = nrow(data), replace = TRUE),
levels = aeacn_levels
))
# --- PART 1: Overview of serious AEs
# Assign a label to each SAE category
sae_vars <- list(
"SAE" = "AESER",
"Death" = "AESDTH",
"Life-threatening" = "AESLIFE",
"Initial or prolonged hospitalization" = "AESHOSP",
"Disability or permanent damage" = "AESDISAB"
)
# Summarize SAEs per category
tbl_sae <-
lapply(
seq_along(sae_vars),
function(i) { # apply per category
data <- data |>
filter(.data[[sae_vars[[i]]]] == "Y") |>
mutate(!!sae_vars[[i]] := names(sae_vars)[i]) # convert flag to a meaningful value
tbl_hierarchical( # calculate rates
data = data,
variables = all_of(sae_vars[[i]]),
by = TRT01A,
id = USUBJID,
denominator = adsl,
label = sae_vars[[i]] ~ "Event"
)
}
) |>
tbl_stack() |>
modify_indent("label", rows = tbl_id1 != 1, indent = 4L)
# --- PART 2: Permanent discontinuation
disc_ae <- adae |>
# filtering for adverse events with a "discontinued" End of Study Status
filter(AESER == "Y" & EOSSTT == "DISCONTINUED") |>
mutate(
# convert label to a more meaningful value
AEDISC = "AE leading to permanent discontinuation of treatment"
)
tbl_disc_ae <- tbl_hierarchical( # calculate rates
data = disc_ae,
variables = AEDISC,
by = TRT01A,
id = USUBJID,
denominator = adsl,
label = AEDISC ~ "Event"
)
# -- PART 3: Dose modification
dose_mod_ae <- data |>
mutate(
AEACN = case_when( # convert to meaningful labels
AEACN == "DRUG INTERRUPTED" ~ "AE leading to interruption of study drug",
AEACN == "DOSE REDUCED" ~ "AE leading to reduction of study drug",
AEACN == "DOSE RATE REDUCED" ~ "AE leading to dose delay of study drug",
AEACN == "DOSE INCREASED" ~ "Other",
.default = "Other"
)
)
tbl_dose_mod_ae <- tbl_hierarchical( # calculate rates
data = dose_mod_ae,
denominator = adsl,
id = "USUBJID",
by = "TRT01A",
variables = "AEACN",
label = list(AEACN ~ "Event", ..ard_hierarchical_overall.. = "AE leading to action taken of treatment"),
overall_row = TRUE
) |>
modify_indent(columns = label, rows = variable == "AEACN", indent = 4L)
# -- PART 4: Any AE
tbl_any_ae <- tbl_hierarchical(
data = adae |> mutate(AESEV = factor(.data$AESEV, ordered = TRUE)),
variables = AESEV,
by = TRT01A,
id = USUBJID,
denominator = adsl,
label = list(AESEV ~ "Event", ..ard_hierarchical_overall.. = "Any AE"),
overall_row = TRUE
) |>
modify_indent(columns = label, rows = variable == "AESEV", indent = 4L)
# Put it all together
tbl <- list(tbl_sae, tbl_disc_ae, tbl_dose_mod_ae, tbl_any_ae) |>
tbl_stack() |>
modify_header(label = "**Adverse Event Category**")
ard <- gtsummary::gather_ard(tbl)| Adverse Event Category |
Xanomeline High Dose N = 721 |
Xanomeline Low Dose N = 961 |
Xanomeline Low Dose N = 961 |
|---|---|---|---|
| SAE | 1 (1.4%) | 2 (2.1%) | |
| Death | 2 (2.3%) | 1 (1.0%) | |
| Life-threatening | 2 (2.3%) | 2 (2.1%) | |
| Initial or prolonged hospitalization | 5 (5.8%) | 7 (9.7%) | 7 (7.3%) |
| Disability or permanent damage | 1 (1.0%) | ||
| AE leading to permanent discontinuation of treatment | 1 (1.4%) | 2 (2.1%) | |
| AE leading to action taken of treatment | 69 (80%) | 70 (97%) | 86 (90%) |
| AE leading to dose delay of study drug | 42 (49%) | 51 (71%) | 53 (55%) |
| AE leading to interruption of study drug | 44 (51%) | 55 (76%) | 65 (68%) |
| AE leading to reduction of study drug | 50 (58%) | 54 (75%) | 56 (58%) |
| Other | 35 (41%) | 50 (69%) | 61 (64%) |
| Any AE | 69 (80%) | 70 (97%) | 86 (90%) |
| MILD | 60 (70%) | 66 (92%) | 65 (68%) |
| MODERATE | 28 (33%) | 48 (67%) | 60 (63%) |
| SEVERE | 7 (8.1%) | 8 (11%) | 16 (17%) |
| 1 n (%) | |||
[[1]]
[[1]][[1]]
[[1]][[1]]$tbl_hierarchical
# An ARD data frame: 15 × 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 Xanomeline High Dose AESER SAE hierarchical n n 1 1 <fn> <NULL> <NULL> stat_1
11 TRT01A Xanomeline High Dose AESER SAE hierarchical N N 72 72 <fn> <NULL> <NULL> stat_1
12 TRT01A Xanomeline High Dose AESER SAE hierarchical p % 0.0139 1.4 <fn> <NULL> <NULL> stat_1
13 TRT01A Xanomeline Low Dose AESER SAE hierarchical n n 2 2 <fn> <NULL> <NULL> stat_2
14 TRT01A Xanomeline Low Dose AESER SAE hierarchical N N 96 96 <fn> <NULL> <NULL> stat_2
15 TRT01A Xanomeline Low Dose AESER SAE hierarchical p % 0.0208 2.1 <fn> <NULL> <NULL> stat_2
[[1]][[2]]
[[1]][[2]]$tbl_hierarchical
# An ARD data frame: 15 × 13
group1 group1_level variable variable_level context stat_name stat_label stat stat_fmt fmt_fun warning error gts_column
<chr> <list> <chr> <list> <chr> <chr> <chr> <list> <list> <list> <list> <list> <chr>
1 <NA> <NULL> TRT01A Placebo tabulate n n 86 86 0 <NULL> <NULL> stat_1
2 <NA> <NULL> TRT01A Placebo tabulate N N 254 254 0 <NULL> <NULL> stat_1
3 <NA> <NULL> TRT01A Placebo tabulate p % 0.339 33.9 <fn> <NULL> <NULL> stat_1
4 <NA> <NULL> TRT01A Xanomeline High Dose tabulate n n 72 72 0 <NULL> <NULL> stat_2
5 <NA> <NULL> TRT01A Xanomeline High Dose tabulate N N 254 254 0 <NULL> <NULL> stat_2
6 <NA> <NULL> TRT01A Xanomeline High Dose tabulate p % 0.283 28.3 <fn> <NULL> <NULL> stat_2
7 <NA> <NULL> TRT01A Xanomeline Low Dose tabulate n n 96 96 0 <NULL> <NULL> stat_3
8 <NA> <NULL> TRT01A Xanomeline Low Dose tabulate N N 254 254 0 <NULL> <NULL> stat_3
9 <NA> <NULL> TRT01A Xanomeline Low Dose tabulate p % 0.378 37.8 <fn> <NULL> <NULL> stat_3
10 TRT01A Placebo AESDTH Death hierarchical n n 2 2 <fn> <NULL> <NULL> stat_1
11 TRT01A Placebo AESDTH Death hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
12 TRT01A Placebo AESDTH Death hierarchical p % 0.0233 2.3 <fn> <NULL> <NULL> stat_1
13 TRT01A Xanomeline Low Dose AESDTH Death hierarchical n n 1 1 <fn> <NULL> <NULL> stat_2
14 TRT01A Xanomeline Low Dose AESDTH Death hierarchical N N 96 96 <fn> <NULL> <NULL> stat_2
15 TRT01A Xanomeline Low Dose AESDTH Death hierarchical p % 0.0104 1.0 <fn> <NULL> <NULL> stat_2
[[1]][[3]]
[[1]][[3]]$tbl_hierarchical
# An ARD data frame: 15 × 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 AESLIFE Life-threatening hierarchical n n 2 2 <fn> <NULL> <NULL> stat_1
11 TRT01A Placebo AESLIFE Life-threatening hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
12 TRT01A Placebo AESLIFE Life-threatening hierarchical p % 0.0233 2.3 <fn> <NULL> <NULL> stat_1
13 TRT01A Xanomeline Low Dose AESLIFE Life-threatening hierarchical n n 2 2 <fn> <NULL> <NULL> stat_2
14 TRT01A Xanomeline Low Dose AESLIFE Life-threatening hierarchical N N 96 96 <fn> <NULL> <NULL> stat_2
15 TRT01A Xanomeline Low Dose AESLIFE Life-threatening hierarchical p % 0.0208 2.1 <fn> <NULL> <NULL> stat_2
[[1]][[4]]
[[1]][[4]]$tbl_hierarchical
# An ARD data frame: 18 × 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 AESHOSP Initial or prolonged hospitalization hierarchical n n 5 5 <fn> <NULL> <NULL> stat_1
11 TRT01A Placebo AESHOSP Initial or prolonged hospitalization hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
12 TRT01A Placebo AESHOSP Initial or prolonged hospitalization hierarchical p % 0.0581 5.8 <fn> <NULL> <NULL> stat_1
13 TRT01A Xanomeline High Dose AESHOSP Initial or prolonged hospitalization hierarchical n n 7 7 <fn> <NULL> <NULL> stat_2
14 TRT01A Xanomeline High Dose AESHOSP Initial or prolonged hospitalization hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
15 TRT01A Xanomeline High Dose AESHOSP Initial or prolonged hospitalization hierarchical p % 0.0972 9.7 <fn> <NULL> <NULL> stat_2
16 TRT01A Xanomeline Low Dose AESHOSP Initial or prolonged hospitalization hierarchical n n 7 7 <fn> <NULL> <NULL> stat_3
17 TRT01A Xanomeline Low Dose AESHOSP Initial or prolonged hospitalization hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
18 TRT01A Xanomeline Low Dose AESHOSP Initial or prolonged hospitalization hierarchical p % 0.0729 7.3 <fn> <NULL> <NULL> stat_3
[[1]][[5]]
[[1]][[5]]$tbl_hierarchical
# An ARD data frame: 12 × 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 Xanomeline Low Dose AESDISAB Disability or permanent damage hierarchical n n 1 1 <fn> <NULL> <NULL> stat_1
11 TRT01A Xanomeline Low Dose AESDISAB Disability or permanent damage hierarchical N N 96 96 <fn> <NULL> <NULL> stat_1
12 TRT01A Xanomeline Low Dose AESDISAB Disability or permanent damage hierarchical p % 0.0104 1.0 <fn> <NULL> <NULL> stat_1
[[2]]
[[2]]$tbl_hierarchical
# An ARD data frame: 15 × 13
group1 group1_level variable variable_level context stat_name stat_label stat stat_fmt fmt_fun warning error gts_column
<chr> <list> <chr> <list> <chr> <chr> <chr> <list> <list> <list> <list> <list> <chr>
1 <NA> <NULL> TRT01A Placebo tabulate n n 86 86 0 <NULL> <NULL> stat_1
2 <NA> <NULL> TRT01A Placebo tabulate N N 254 254 0 <NULL> <NULL> stat_1
3 <NA> <NULL> TRT01A Placebo tabulate p % 0.339 33.9 <fn> <NULL> <NULL> stat_1
4 <NA> <NULL> TRT01A Xanomeline High Dose tabulate n n 72 72 0 <NULL> <NULL> stat_2
5 <NA> <NULL> TRT01A Xanomeline High Dose tabulate N N 254 254 0 <NULL> <NULL> stat_2
6 <NA> <NULL> TRT01A Xanomeline High Dose tabulate p % 0.283 28.3 <fn> <NULL> <NULL> stat_2
7 <NA> <NULL> TRT01A Xanomeline Low Dose tabulate n n 96 96 0 <NULL> <NULL> stat_3
8 <NA> <NULL> TRT01A Xanomeline Low Dose tabulate N N 254 254 0 <NULL> <NULL> stat_3
9 <NA> <NULL> TRT01A Xanomeline Low Dose tabulate p % 0.378 37.8 <fn> <NULL> <NULL> stat_3
10 TRT01A Xanomeline High Dose AEDISC AE leading to permanent discontinuation of treatment hierarchical n n 1 1 <fn> <NULL> <NULL> stat_1
11 TRT01A Xanomeline High Dose AEDISC AE leading to permanent discontinuation of treatment hierarchical N N 72 72 <fn> <NULL> <NULL> stat_1
12 TRT01A Xanomeline High Dose AEDISC AE leading to permanent discontinuation of treatment hierarchical p % 0.0139 1.4 <fn> <NULL> <NULL> stat_1
13 TRT01A Xanomeline Low Dose AEDISC AE leading to permanent discontinuation of treatment hierarchical n n 2 2 <fn> <NULL> <NULL> stat_2
14 TRT01A Xanomeline Low Dose AEDISC AE leading to permanent discontinuation of treatment hierarchical N N 96 96 <fn> <NULL> <NULL> stat_2
15 TRT01A Xanomeline Low Dose AEDISC AE leading to permanent discontinuation of treatment hierarchical p % 0.0208 2.1 <fn> <NULL> <NULL> stat_2
[[3]]
[[3]]$tbl_hierarchical
# An ARD data frame: 54 × 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 69 69 <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 % 0.802 80 <fn> <NULL> <NULL> stat_1
13 TRT01A Xanomeline High Dose ..ard_hierarchical_overall.. TRUE hierarchical n n 70 70 <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 % 0.972 97 <fn> <NULL> <NULL> stat_2
16 TRT01A Xanomeline Low Dose ..ard_hierarchical_overall.. TRUE hierarchical n n 86 86 <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 % 0.896 90 <fn> <NULL> <NULL> stat_3
19 TRT01A Placebo AEACN AE leading to dose delay of study drug hierarchical n n 42 42 <fn> <NULL> <NULL> stat_1
20 TRT01A Placebo AEACN AE leading to dose delay of study drug hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
21 TRT01A Placebo AEACN AE leading to dose delay of study drug hierarchical p % 0.488 49 <fn> <NULL> <NULL> stat_1
22 TRT01A Xanomeline High Dose AEACN AE leading to dose delay of study drug hierarchical n n 51 51 <fn> <NULL> <NULL> stat_2
23 TRT01A Xanomeline High Dose AEACN AE leading to dose delay of study drug hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
24 TRT01A Xanomeline High Dose AEACN AE leading to dose delay of study drug hierarchical p % 0.708 71 <fn> <NULL> <NULL> stat_2
25 TRT01A Xanomeline Low Dose AEACN AE leading to dose delay of study drug hierarchical n n 53 53 <fn> <NULL> <NULL> stat_3
26 TRT01A Xanomeline Low Dose AEACN AE leading to dose delay of study drug hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
27 TRT01A Xanomeline Low Dose AEACN AE leading to dose delay of study drug hierarchical p % 0.552 55 <fn> <NULL> <NULL> stat_3
28 TRT01A Placebo AEACN AE leading to interruption of study drug hierarchical n n 44 44 <fn> <NULL> <NULL> stat_1
29 TRT01A Placebo AEACN AE leading to interruption of study drug hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
30 TRT01A Placebo AEACN AE leading to interruption of study drug hierarchical p % 0.512 51 <fn> <NULL> <NULL> stat_1
31 TRT01A Xanomeline High Dose AEACN AE leading to interruption of study drug hierarchical n n 55 55 <fn> <NULL> <NULL> stat_2
32 TRT01A Xanomeline High Dose AEACN AE leading to interruption of study drug hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
33 TRT01A Xanomeline High Dose AEACN AE leading to interruption of study drug hierarchical p % 0.764 76 <fn> <NULL> <NULL> stat_2
34 TRT01A Xanomeline Low Dose AEACN AE leading to interruption of study drug hierarchical n n 65 65 <fn> <NULL> <NULL> stat_3
35 TRT01A Xanomeline Low Dose AEACN AE leading to interruption of study drug hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
36 TRT01A Xanomeline Low Dose AEACN AE leading to interruption of study drug hierarchical p % 0.677 68 <fn> <NULL> <NULL> stat_3
37 TRT01A Placebo AEACN AE leading to reduction of study drug hierarchical n n 50 50 <fn> <NULL> <NULL> stat_1
38 TRT01A Placebo AEACN AE leading to reduction of study drug hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
39 TRT01A Placebo AEACN AE leading to reduction of study drug hierarchical p % 0.581 58 <fn> <NULL> <NULL> stat_1
40 TRT01A Xanomeline High Dose AEACN AE leading to reduction of study drug hierarchical n n 54 54 <fn> <NULL> <NULL> stat_2
41 TRT01A Xanomeline High Dose AEACN AE leading to reduction of study drug hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
42 TRT01A Xanomeline High Dose AEACN AE leading to reduction of study drug hierarchical p % 0.75 75 <fn> <NULL> <NULL> stat_2
43 TRT01A Xanomeline Low Dose AEACN AE leading to reduction of study drug hierarchical n n 56 56 <fn> <NULL> <NULL> stat_3
44 TRT01A Xanomeline Low Dose AEACN AE leading to reduction of study drug hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
45 TRT01A Xanomeline Low Dose AEACN AE leading to reduction of study drug hierarchical p % 0.583 58 <fn> <NULL> <NULL> stat_3
46 TRT01A Placebo AEACN Other hierarchical n n 35 35 <fn> <NULL> <NULL> stat_1
47 TRT01A Placebo AEACN Other hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
48 TRT01A Placebo AEACN Other hierarchical p % 0.407 41 <fn> <NULL> <NULL> stat_1
49 TRT01A Xanomeline High Dose AEACN Other hierarchical n n 50 50 <fn> <NULL> <NULL> stat_2
50 TRT01A Xanomeline High Dose AEACN Other hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
51 TRT01A Xanomeline High Dose AEACN Other hierarchical p % 0.694 69 <fn> <NULL> <NULL> stat_2
52 TRT01A Xanomeline Low Dose AEACN Other hierarchical n n 61 61 <fn> <NULL> <NULL> stat_3
53 TRT01A Xanomeline Low Dose AEACN Other hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
54 TRT01A Xanomeline Low Dose AEACN Other hierarchical p % 0.635 64 <fn> <NULL> <NULL> stat_3
[[4]]
[[4]]$tbl_hierarchical
# An ARD data frame: 45 × 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 69 69 <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 % 0.802 80 <fn> <NULL> <NULL> stat_1
13 TRT01A Xanomeline High Dose ..ard_hierarchical_overall.. TRUE hierarchical n n 70 70 <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 % 0.972 97 <fn> <NULL> <NULL> stat_2
16 TRT01A Xanomeline Low Dose ..ard_hierarchical_overall.. TRUE hierarchical n n 86 86 <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 % 0.896 90 <fn> <NULL> <NULL> stat_3
19 TRT01A Placebo AESEV MILD hierarchical n n 60 60 <fn> <NULL> <NULL> stat_1
20 TRT01A Placebo AESEV MILD hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
21 TRT01A Placebo AESEV MILD hierarchical p % 0.698 70 <fn> <NULL> <NULL> stat_1
22 TRT01A Xanomeline High Dose AESEV MILD hierarchical n n 66 66 <fn> <NULL> <NULL> stat_2
23 TRT01A Xanomeline High Dose AESEV MILD hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
24 TRT01A Xanomeline High Dose AESEV MILD hierarchical p % 0.917 92 <fn> <NULL> <NULL> stat_2
25 TRT01A Xanomeline Low Dose AESEV MILD hierarchical n n 65 65 <fn> <NULL> <NULL> stat_3
26 TRT01A Xanomeline Low Dose AESEV MILD hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
27 TRT01A Xanomeline Low Dose AESEV MILD hierarchical p % 0.677 68 <fn> <NULL> <NULL> stat_3
28 TRT01A Placebo AESEV MODERATE hierarchical n n 28 28 <fn> <NULL> <NULL> stat_1
29 TRT01A Placebo AESEV MODERATE hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
30 TRT01A Placebo AESEV MODERATE hierarchical p % 0.326 33 <fn> <NULL> <NULL> stat_1
31 TRT01A Xanomeline High Dose AESEV MODERATE hierarchical n n 48 48 <fn> <NULL> <NULL> stat_2
32 TRT01A Xanomeline High Dose AESEV MODERATE hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
33 TRT01A Xanomeline High Dose AESEV MODERATE hierarchical p % 0.667 67 <fn> <NULL> <NULL> stat_2
34 TRT01A Xanomeline Low Dose AESEV MODERATE hierarchical n n 60 60 <fn> <NULL> <NULL> stat_3
35 TRT01A Xanomeline Low Dose AESEV MODERATE hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
36 TRT01A Xanomeline Low Dose AESEV MODERATE hierarchical p % 0.625 63 <fn> <NULL> <NULL> stat_3
37 TRT01A Placebo AESEV SEVERE hierarchical n n 7 7 <fn> <NULL> <NULL> stat_1
38 TRT01A Placebo AESEV SEVERE hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
39 TRT01A Placebo AESEV SEVERE hierarchical p % 0.0814 8.1 <fn> <NULL> <NULL> stat_1
40 TRT01A Xanomeline High Dose AESEV SEVERE hierarchical n n 8 8 <fn> <NULL> <NULL> stat_2
41 TRT01A Xanomeline High Dose AESEV SEVERE hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
42 TRT01A Xanomeline High Dose AESEV SEVERE hierarchical p % 0.111 11 <fn> <NULL> <NULL> stat_2
43 TRT01A Xanomeline Low Dose AESEV SEVERE hierarchical n n 16 16 <fn> <NULL> <NULL> stat_3
44 TRT01A Xanomeline Low Dose AESEV SEVERE hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
45 TRT01A Xanomeline Low Dose AESEV SEVERE hierarchical p % 0.167 17 <fn> <NULL> <NULL> stat_3