Subjects With Adverse Events by Organ System and OCMQ, Safety Population, Pooled Analysis (or Trial X)
FDA Table 17
table
FDA
safety
adverse events
FDA IG Shell
Programming Notes
Background and Instructions
For Table 17: Subjects With Adverse Events by Organ System, it is important to review the entire table (or spreadsheet) produced by the CDS before deciding on the appropriate cutoff to be presented in the review. Depending on the data presented, a >5%, >2%, or >1% frequency or none may be an appropriate cutoff. Refer to Table 31 Subjects With Adverse Events by Organ System, OCMQ (Narrow) and Preferred Term, Safety Population, Pooled Analysis (or Trial X) to view specific preferred terms under each narrow OCMQ by organ system.
Customization
After analyzing, clinical reviewers may request to view specific preferred terms under each broad OCMQ by organ system. Based on the assessment of the OCMQ results, clinical reviewers may request Table 41: Subjects With Select Narrow FDA Medical Queries and Table 42: Subjects With Select Broad FDA Medical Queries found in Section 4.1 Optional Adverse Event Analyses to explore the data on specific subjects.
Output
Code
# FDA TABLE 17 ---------------------------------------------------------------
# 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 |>
rename(OCMQ01SC = AEHLTCD, OCMQ01NAM = AEHLT)
adsl <- pharmaverseadam::adsl
set.seed(23)
adae$OCMQ01SC <- sample(c("BROAD", "NARROW"), size = nrow(adae), replace = TRUE)
# Pre-processing --------------------------------------------
adae <- adae |>
# safety population
filter(SAFFL == "Y") |>
# filter 0CMQ to truncate table
filter(
OCMQ01NAM %in%
c("HLT_0649", "HLT_0644", " HLT_0570", " HLT_0256", "HLT_0742", "HLT_0244", "HLT_0097", "HLT_0738")
)
adsl <- adsl |>
# safety population
filter(SAFFL == "Y")
tbl <- adae |>
select(OCMQ01SC, TRT01A, OCMQ01NAM, AEBODSYS, USUBJID) |>
# setting an explicit level for NA values so empty strata combinations are shown.
mutate(across(everything(), ~ {
if (anyNA(.)) {
forcats::fct_na_value_to_level(as.factor(.), level = "<Missing>")
} else {
.
}
})) |>
tbl_strata(
strata = OCMQ01SC,
~ tbl_hierarchical(
.x,
by = TRT01A,
variables = c(AEBODSYS, OCMQ01NAM),
id = USUBJID,
denominator = adsl,
# variables to calculate rates for
include = c(OCMQ01NAM),
label = list(OCMQ01NAM ~ "OCMQ", AEBODSYS ~ "System Organ Class")
)
) |>
modify_missing_symbol("NA", columns = everything(), rows = row_type == "level")
ard <- gtsummary::gather_ard(tbl)|
System Organ Class OCMQ |
BROAD
|
NARROW
|
||||
|---|---|---|---|---|---|---|
|
Placebo N = 861 |
Xanomeline High Dose N = 721 |
Xanomeline Low Dose N = 961 |
Placebo N = 861 |
Xanomeline High Dose N = 721 |
Xanomeline Low Dose N = 961 |
|
| CARDIAC DISORDERS | ||||||
| HLT_0644 | 0 (0%) | 7 (9.7%) | 6 (6.3%) | 2 (2.3%) | 4 (5.6%) | 3 (3.1%) |
| HLT_0649 | 2 (2.3%) | 1 (1.4%) | 2 (2.1%) | 2 (2.3%) | 3 (4.2%) | 1 (1.0%) |
| GASTROINTESTINAL DISORDERS | ||||||
| HLT_0244 | 1 (1.2%) | 0 (0%) | 1 (1.0%) | 1 (1.2%) | 1 (1.4%) | 1 (1.0%) |
| HLT_0742 | 2 (2.3%) | 3 (4.2%) | 2 (2.1%) | 1 (1.2%) | 5 (6.9%) | 3 (3.1%) |
| INJURY, POISONING AND PROCEDURAL COMPLICATIONS | ||||||
| HLT_0097 | 1 (1.2%) | 1 (1.4%) | 0 (0%) | 1 (1.2%) | 1 (1.4%) | 0 (0%) |
| HLT_0738 | 2 (2.3%) | 0 (0%) | 1 (1.0%) | 1 (1.2%) | 1 (1.4%) | 1 (1.0%) |
| 1 n (%) | ||||||
$`OCMQ01SC="BROAD"`
$`OCMQ01SC="BROAD"`$tbl_hierarchical
# An ARD data frame: 63 × 15
group1 group1_level group2 group2_level variable variable_level context stat_name stat_label stat stat_fmt fmt_fun warning error gts_column
<chr> <list> <chr> <list> <chr> <list> <chr> <chr> <chr> <list> <list> <list> <list> <list> <chr>
1 <NA> <NULL> <NA> <NULL> TRT01A Placebo tabulate n n 86 86 0 <NULL> <NULL> stat_1
2 <NA> <NULL> <NA> <NULL> TRT01A Placebo tabulate N N 254 254 0 <NULL> <NULL> stat_1
3 <NA> <NULL> <NA> <NULL> TRT01A Placebo tabulate p % 0.339 33.9 <fn> <NULL> <NULL> stat_1
4 <NA> <NULL> <NA> <NULL> TRT01A Xanomeline High Dose tabulate n n 72 72 0 <NULL> <NULL> stat_2
5 <NA> <NULL> <NA> <NULL> TRT01A Xanomeline High Dose tabulate N N 254 254 0 <NULL> <NULL> stat_2
6 <NA> <NULL> <NA> <NULL> TRT01A Xanomeline High Dose tabulate p % 0.283 28.3 <fn> <NULL> <NULL> stat_2
7 <NA> <NULL> <NA> <NULL> TRT01A Xanomeline Low Dose tabulate n n 96 96 0 <NULL> <NULL> stat_3
8 <NA> <NULL> <NA> <NULL> TRT01A Xanomeline Low Dose tabulate N N 254 254 0 <NULL> <NULL> stat_3
9 <NA> <NULL> <NA> <NULL> TRT01A Xanomeline Low Dose tabulate p % 0.378 37.8 <fn> <NULL> <NULL> stat_3
10 TRT01A Placebo AEBODSYS CARDIAC DISORDERS OCMQ01NAM HLT_0644 hierarchical n n 0 0 <fn> <NULL> <NULL> stat_1
11 TRT01A Placebo AEBODSYS CARDIAC DISORDERS OCMQ01NAM HLT_0644 hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
12 TRT01A Placebo AEBODSYS CARDIAC DISORDERS OCMQ01NAM HLT_0644 hierarchical p % 0 0 <fn> <NULL> <NULL> stat_1
13 TRT01A Xanomeline High Dose AEBODSYS CARDIAC DISORDERS OCMQ01NAM HLT_0644 hierarchical n n 7 7 <fn> <NULL> <NULL> stat_2
14 TRT01A Xanomeline High Dose AEBODSYS CARDIAC DISORDERS OCMQ01NAM HLT_0644 hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
15 TRT01A Xanomeline High Dose AEBODSYS CARDIAC DISORDERS OCMQ01NAM HLT_0644 hierarchical p % 0.0972 9.7 <fn> <NULL> <NULL> stat_2
16 TRT01A Xanomeline Low Dose AEBODSYS CARDIAC DISORDERS OCMQ01NAM HLT_0644 hierarchical n n 6 6 <fn> <NULL> <NULL> stat_3
17 TRT01A Xanomeline Low Dose AEBODSYS CARDIAC DISORDERS OCMQ01NAM HLT_0644 hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
18 TRT01A Xanomeline Low Dose AEBODSYS CARDIAC DISORDERS OCMQ01NAM HLT_0644 hierarchical p % 0.0625 6.3 <fn> <NULL> <NULL> stat_3
19 TRT01A Placebo AEBODSYS CARDIAC DISORDERS OCMQ01NAM HLT_0649 hierarchical n n 2 2 <fn> <NULL> <NULL> stat_1
20 TRT01A Placebo AEBODSYS CARDIAC DISORDERS OCMQ01NAM HLT_0649 hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
21 TRT01A Placebo AEBODSYS CARDIAC DISORDERS OCMQ01NAM HLT_0649 hierarchical p % 0.0233 2.3 <fn> <NULL> <NULL> stat_1
22 TRT01A Xanomeline High Dose AEBODSYS CARDIAC DISORDERS OCMQ01NAM HLT_0649 hierarchical n n 1 1 <fn> <NULL> <NULL> stat_2
23 TRT01A Xanomeline High Dose AEBODSYS CARDIAC DISORDERS OCMQ01NAM HLT_0649 hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
24 TRT01A Xanomeline High Dose AEBODSYS CARDIAC DISORDERS OCMQ01NAM HLT_0649 hierarchical p % 0.0139 1.4 <fn> <NULL> <NULL> stat_2
25 TRT01A Xanomeline Low Dose AEBODSYS CARDIAC DISORDERS OCMQ01NAM HLT_0649 hierarchical n n 2 2 <fn> <NULL> <NULL> stat_3
26 TRT01A Xanomeline Low Dose AEBODSYS CARDIAC DISORDERS OCMQ01NAM HLT_0649 hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
27 TRT01A Xanomeline Low Dose AEBODSYS CARDIAC DISORDERS OCMQ01NAM HLT_0649 hierarchical p % 0.0208 2.1 <fn> <NULL> <NULL> stat_3
28 TRT01A Placebo AEBODSYS GASTROINTESTINAL DISORDERS OCMQ01NAM HLT_0244 hierarchical n n 1 1 <fn> <NULL> <NULL> stat_1
29 TRT01A Placebo AEBODSYS GASTROINTESTINAL DISORDERS OCMQ01NAM HLT_0244 hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
30 TRT01A Placebo AEBODSYS GASTROINTESTINAL DISORDERS OCMQ01NAM HLT_0244 hierarchical p % 0.0116 1.2 <fn> <NULL> <NULL> stat_1
31 TRT01A Xanomeline High Dose AEBODSYS GASTROINTESTINAL DISORDERS OCMQ01NAM HLT_0244 hierarchical n n 0 0 <fn> <NULL> <NULL> stat_2
32 TRT01A Xanomeline High Dose AEBODSYS GASTROINTESTINAL DISORDERS OCMQ01NAM HLT_0244 hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
33 TRT01A Xanomeline High Dose AEBODSYS GASTROINTESTINAL DISORDERS OCMQ01NAM HLT_0244 hierarchical p % 0 0 <fn> <NULL> <NULL> stat_2
34 TRT01A Xanomeline Low Dose AEBODSYS GASTROINTESTINAL DISORDERS OCMQ01NAM HLT_0244 hierarchical n n 1 1 <fn> <NULL> <NULL> stat_3
35 TRT01A Xanomeline Low Dose AEBODSYS GASTROINTESTINAL DISORDERS OCMQ01NAM HLT_0244 hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
36 TRT01A Xanomeline Low Dose AEBODSYS GASTROINTESTINAL DISORDERS OCMQ01NAM HLT_0244 hierarchical p % 0.0104 1.0 <fn> <NULL> <NULL> stat_3
37 TRT01A Placebo AEBODSYS GASTROINTESTINAL DISORDERS OCMQ01NAM HLT_0742 hierarchical n n 2 2 <fn> <NULL> <NULL> stat_1
38 TRT01A Placebo AEBODSYS GASTROINTESTINAL DISORDERS OCMQ01NAM HLT_0742 hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
39 TRT01A Placebo AEBODSYS GASTROINTESTINAL DISORDERS OCMQ01NAM HLT_0742 hierarchical p % 0.0233 2.3 <fn> <NULL> <NULL> stat_1
40 TRT01A Xanomeline High Dose AEBODSYS GASTROINTESTINAL DISORDERS OCMQ01NAM HLT_0742 hierarchical n n 3 3 <fn> <NULL> <NULL> stat_2
41 TRT01A Xanomeline High Dose AEBODSYS GASTROINTESTINAL DISORDERS OCMQ01NAM HLT_0742 hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
42 TRT01A Xanomeline High Dose AEBODSYS GASTROINTESTINAL DISORDERS OCMQ01NAM HLT_0742 hierarchical p % 0.0417 4.2 <fn> <NULL> <NULL> stat_2
43 TRT01A Xanomeline Low Dose AEBODSYS GASTROINTESTINAL DISORDERS OCMQ01NAM HLT_0742 hierarchical n n 2 2 <fn> <NULL> <NULL> stat_3
44 TRT01A Xanomeline Low Dose AEBODSYS GASTROINTESTINAL DISORDERS OCMQ01NAM HLT_0742 hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
45 TRT01A Xanomeline Low Dose AEBODSYS GASTROINTESTINAL DISORDERS OCMQ01NAM HLT_0742 hierarchical p % 0.0208 2.1 <fn> <NULL> <NULL> stat_3
46 TRT01A Placebo AEBODSYS INJURY, POISONING AND PROCEDURAL COMPLICATIONS OCMQ01NAM HLT_0097 hierarchical n n 1 1 <fn> <NULL> <NULL> stat_1
47 TRT01A Placebo AEBODSYS INJURY, POISONING AND PROCEDURAL COMPLICATIONS OCMQ01NAM HLT_0097 hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
48 TRT01A Placebo AEBODSYS INJURY, POISONING AND PROCEDURAL COMPLICATIONS OCMQ01NAM HLT_0097 hierarchical p % 0.0116 1.2 <fn> <NULL> <NULL> stat_1
49 TRT01A Xanomeline High Dose AEBODSYS INJURY, POISONING AND PROCEDURAL COMPLICATIONS OCMQ01NAM HLT_0097 hierarchical n n 1 1 <fn> <NULL> <NULL> stat_2
50 TRT01A Xanomeline High Dose AEBODSYS INJURY, POISONING AND PROCEDURAL COMPLICATIONS OCMQ01NAM HLT_0097 hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
51 TRT01A Xanomeline High Dose AEBODSYS INJURY, POISONING AND PROCEDURAL COMPLICATIONS OCMQ01NAM HLT_0097 hierarchical p % 0.0139 1.4 <fn> <NULL> <NULL> stat_2
52 TRT01A Xanomeline Low Dose AEBODSYS INJURY, POISONING AND PROCEDURAL COMPLICATIONS OCMQ01NAM HLT_0097 hierarchical n n 0 0 <fn> <NULL> <NULL> stat_3
53 TRT01A Xanomeline Low Dose AEBODSYS INJURY, POISONING AND PROCEDURAL COMPLICATIONS OCMQ01NAM HLT_0097 hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
54 TRT01A Xanomeline Low Dose AEBODSYS INJURY, POISONING AND PROCEDURAL COMPLICATIONS OCMQ01NAM HLT_0097 hierarchical p % 0 0 <fn> <NULL> <NULL> stat_3
55 TRT01A Placebo AEBODSYS INJURY, POISONING AND PROCEDURAL COMPLICATIONS OCMQ01NAM HLT_0738 hierarchical n n 2 2 <fn> <NULL> <NULL> stat_1
56 TRT01A Placebo AEBODSYS INJURY, POISONING AND PROCEDURAL COMPLICATIONS OCMQ01NAM HLT_0738 hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
57 TRT01A Placebo AEBODSYS INJURY, POISONING AND PROCEDURAL COMPLICATIONS OCMQ01NAM HLT_0738 hierarchical p % 0.0233 2.3 <fn> <NULL> <NULL> stat_1
58 TRT01A Xanomeline High Dose AEBODSYS INJURY, POISONING AND PROCEDURAL COMPLICATIONS OCMQ01NAM HLT_0738 hierarchical n n 0 0 <fn> <NULL> <NULL> stat_2
59 TRT01A Xanomeline High Dose AEBODSYS INJURY, POISONING AND PROCEDURAL COMPLICATIONS OCMQ01NAM HLT_0738 hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
60 TRT01A Xanomeline High Dose AEBODSYS INJURY, POISONING AND PROCEDURAL COMPLICATIONS OCMQ01NAM HLT_0738 hierarchical p % 0 0 <fn> <NULL> <NULL> stat_2
61 TRT01A Xanomeline Low Dose AEBODSYS INJURY, POISONING AND PROCEDURAL COMPLICATIONS OCMQ01NAM HLT_0738 hierarchical n n 1 1 <fn> <NULL> <NULL> stat_3
62 TRT01A Xanomeline Low Dose AEBODSYS INJURY, POISONING AND PROCEDURAL COMPLICATIONS OCMQ01NAM HLT_0738 hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
63 TRT01A Xanomeline Low Dose AEBODSYS INJURY, POISONING AND PROCEDURAL COMPLICATIONS OCMQ01NAM HLT_0738 hierarchical p % 0.0104 1.0 <fn> <NULL> <NULL> stat_3
$`OCMQ01SC="NARROW"`
$`OCMQ01SC="NARROW"`$tbl_hierarchical
# An ARD data frame: 63 × 15
group1 group1_level group2 group2_level variable variable_level context stat_name stat_label stat stat_fmt fmt_fun warning error gts_column
<chr> <list> <chr> <list> <chr> <list> <chr> <chr> <chr> <list> <list> <list> <list> <list> <chr>
1 <NA> <NULL> <NA> <NULL> TRT01A Placebo tabulate n n 86 86 0 <NULL> <NULL> stat_1
2 <NA> <NULL> <NA> <NULL> TRT01A Placebo tabulate N N 254 254 0 <NULL> <NULL> stat_1
3 <NA> <NULL> <NA> <NULL> TRT01A Placebo tabulate p % 0.339 33.9 <fn> <NULL> <NULL> stat_1
4 <NA> <NULL> <NA> <NULL> TRT01A Xanomeline High Dose tabulate n n 72 72 0 <NULL> <NULL> stat_2
5 <NA> <NULL> <NA> <NULL> TRT01A Xanomeline High Dose tabulate N N 254 254 0 <NULL> <NULL> stat_2
6 <NA> <NULL> <NA> <NULL> TRT01A Xanomeline High Dose tabulate p % 0.283 28.3 <fn> <NULL> <NULL> stat_2
7 <NA> <NULL> <NA> <NULL> TRT01A Xanomeline Low Dose tabulate n n 96 96 0 <NULL> <NULL> stat_3
8 <NA> <NULL> <NA> <NULL> TRT01A Xanomeline Low Dose tabulate N N 254 254 0 <NULL> <NULL> stat_3
9 <NA> <NULL> <NA> <NULL> TRT01A Xanomeline Low Dose tabulate p % 0.378 37.8 <fn> <NULL> <NULL> stat_3
10 TRT01A Placebo AEBODSYS CARDIAC DISORDERS OCMQ01NAM HLT_0644 hierarchical n n 2 2 <fn> <NULL> <NULL> stat_1
11 TRT01A Placebo AEBODSYS CARDIAC DISORDERS OCMQ01NAM HLT_0644 hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
12 TRT01A Placebo AEBODSYS CARDIAC DISORDERS OCMQ01NAM HLT_0644 hierarchical p % 0.0233 2.3 <fn> <NULL> <NULL> stat_1
13 TRT01A Xanomeline High Dose AEBODSYS CARDIAC DISORDERS OCMQ01NAM HLT_0644 hierarchical n n 4 4 <fn> <NULL> <NULL> stat_2
14 TRT01A Xanomeline High Dose AEBODSYS CARDIAC DISORDERS OCMQ01NAM HLT_0644 hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
15 TRT01A Xanomeline High Dose AEBODSYS CARDIAC DISORDERS OCMQ01NAM HLT_0644 hierarchical p % 0.0556 5.6 <fn> <NULL> <NULL> stat_2
16 TRT01A Xanomeline Low Dose AEBODSYS CARDIAC DISORDERS OCMQ01NAM HLT_0644 hierarchical n n 3 3 <fn> <NULL> <NULL> stat_3
17 TRT01A Xanomeline Low Dose AEBODSYS CARDIAC DISORDERS OCMQ01NAM HLT_0644 hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
18 TRT01A Xanomeline Low Dose AEBODSYS CARDIAC DISORDERS OCMQ01NAM HLT_0644 hierarchical p % 0.0312 3.1 <fn> <NULL> <NULL> stat_3
19 TRT01A Placebo AEBODSYS CARDIAC DISORDERS OCMQ01NAM HLT_0649 hierarchical n n 2 2 <fn> <NULL> <NULL> stat_1
20 TRT01A Placebo AEBODSYS CARDIAC DISORDERS OCMQ01NAM HLT_0649 hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
21 TRT01A Placebo AEBODSYS CARDIAC DISORDERS OCMQ01NAM HLT_0649 hierarchical p % 0.0233 2.3 <fn> <NULL> <NULL> stat_1
22 TRT01A Xanomeline High Dose AEBODSYS CARDIAC DISORDERS OCMQ01NAM HLT_0649 hierarchical n n 3 3 <fn> <NULL> <NULL> stat_2
23 TRT01A Xanomeline High Dose AEBODSYS CARDIAC DISORDERS OCMQ01NAM HLT_0649 hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
24 TRT01A Xanomeline High Dose AEBODSYS CARDIAC DISORDERS OCMQ01NAM HLT_0649 hierarchical p % 0.0417 4.2 <fn> <NULL> <NULL> stat_2
25 TRT01A Xanomeline Low Dose AEBODSYS CARDIAC DISORDERS OCMQ01NAM HLT_0649 hierarchical n n 1 1 <fn> <NULL> <NULL> stat_3
26 TRT01A Xanomeline Low Dose AEBODSYS CARDIAC DISORDERS OCMQ01NAM HLT_0649 hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
27 TRT01A Xanomeline Low Dose AEBODSYS CARDIAC DISORDERS OCMQ01NAM HLT_0649 hierarchical p % 0.0104 1.0 <fn> <NULL> <NULL> stat_3
28 TRT01A Placebo AEBODSYS GASTROINTESTINAL DISORDERS OCMQ01NAM HLT_0244 hierarchical n n 1 1 <fn> <NULL> <NULL> stat_1
29 TRT01A Placebo AEBODSYS GASTROINTESTINAL DISORDERS OCMQ01NAM HLT_0244 hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
30 TRT01A Placebo AEBODSYS GASTROINTESTINAL DISORDERS OCMQ01NAM HLT_0244 hierarchical p % 0.0116 1.2 <fn> <NULL> <NULL> stat_1
31 TRT01A Xanomeline High Dose AEBODSYS GASTROINTESTINAL DISORDERS OCMQ01NAM HLT_0244 hierarchical n n 1 1 <fn> <NULL> <NULL> stat_2
32 TRT01A Xanomeline High Dose AEBODSYS GASTROINTESTINAL DISORDERS OCMQ01NAM HLT_0244 hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
33 TRT01A Xanomeline High Dose AEBODSYS GASTROINTESTINAL DISORDERS OCMQ01NAM HLT_0244 hierarchical p % 0.0139 1.4 <fn> <NULL> <NULL> stat_2
34 TRT01A Xanomeline Low Dose AEBODSYS GASTROINTESTINAL DISORDERS OCMQ01NAM HLT_0244 hierarchical n n 1 1 <fn> <NULL> <NULL> stat_3
35 TRT01A Xanomeline Low Dose AEBODSYS GASTROINTESTINAL DISORDERS OCMQ01NAM HLT_0244 hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
36 TRT01A Xanomeline Low Dose AEBODSYS GASTROINTESTINAL DISORDERS OCMQ01NAM HLT_0244 hierarchical p % 0.0104 1.0 <fn> <NULL> <NULL> stat_3
37 TRT01A Placebo AEBODSYS GASTROINTESTINAL DISORDERS OCMQ01NAM HLT_0742 hierarchical n n 1 1 <fn> <NULL> <NULL> stat_1
38 TRT01A Placebo AEBODSYS GASTROINTESTINAL DISORDERS OCMQ01NAM HLT_0742 hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
39 TRT01A Placebo AEBODSYS GASTROINTESTINAL DISORDERS OCMQ01NAM HLT_0742 hierarchical p % 0.0116 1.2 <fn> <NULL> <NULL> stat_1
40 TRT01A Xanomeline High Dose AEBODSYS GASTROINTESTINAL DISORDERS OCMQ01NAM HLT_0742 hierarchical n n 5 5 <fn> <NULL> <NULL> stat_2
41 TRT01A Xanomeline High Dose AEBODSYS GASTROINTESTINAL DISORDERS OCMQ01NAM HLT_0742 hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
42 TRT01A Xanomeline High Dose AEBODSYS GASTROINTESTINAL DISORDERS OCMQ01NAM HLT_0742 hierarchical p % 0.0694 6.9 <fn> <NULL> <NULL> stat_2
43 TRT01A Xanomeline Low Dose AEBODSYS GASTROINTESTINAL DISORDERS OCMQ01NAM HLT_0742 hierarchical n n 3 3 <fn> <NULL> <NULL> stat_3
44 TRT01A Xanomeline Low Dose AEBODSYS GASTROINTESTINAL DISORDERS OCMQ01NAM HLT_0742 hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
45 TRT01A Xanomeline Low Dose AEBODSYS GASTROINTESTINAL DISORDERS OCMQ01NAM HLT_0742 hierarchical p % 0.0312 3.1 <fn> <NULL> <NULL> stat_3
46 TRT01A Placebo AEBODSYS INJURY, POISONING AND PROCEDURAL COMPLICATIONS OCMQ01NAM HLT_0097 hierarchical n n 1 1 <fn> <NULL> <NULL> stat_1
47 TRT01A Placebo AEBODSYS INJURY, POISONING AND PROCEDURAL COMPLICATIONS OCMQ01NAM HLT_0097 hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
48 TRT01A Placebo AEBODSYS INJURY, POISONING AND PROCEDURAL COMPLICATIONS OCMQ01NAM HLT_0097 hierarchical p % 0.0116 1.2 <fn> <NULL> <NULL> stat_1
49 TRT01A Xanomeline High Dose AEBODSYS INJURY, POISONING AND PROCEDURAL COMPLICATIONS OCMQ01NAM HLT_0097 hierarchical n n 1 1 <fn> <NULL> <NULL> stat_2
50 TRT01A Xanomeline High Dose AEBODSYS INJURY, POISONING AND PROCEDURAL COMPLICATIONS OCMQ01NAM HLT_0097 hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
51 TRT01A Xanomeline High Dose AEBODSYS INJURY, POISONING AND PROCEDURAL COMPLICATIONS OCMQ01NAM HLT_0097 hierarchical p % 0.0139 1.4 <fn> <NULL> <NULL> stat_2
52 TRT01A Xanomeline Low Dose AEBODSYS INJURY, POISONING AND PROCEDURAL COMPLICATIONS OCMQ01NAM HLT_0097 hierarchical n n 0 0 <fn> <NULL> <NULL> stat_3
53 TRT01A Xanomeline Low Dose AEBODSYS INJURY, POISONING AND PROCEDURAL COMPLICATIONS OCMQ01NAM HLT_0097 hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
54 TRT01A Xanomeline Low Dose AEBODSYS INJURY, POISONING AND PROCEDURAL COMPLICATIONS OCMQ01NAM HLT_0097 hierarchical p % 0 0 <fn> <NULL> <NULL> stat_3
55 TRT01A Placebo AEBODSYS INJURY, POISONING AND PROCEDURAL COMPLICATIONS OCMQ01NAM HLT_0738 hierarchical n n 1 1 <fn> <NULL> <NULL> stat_1
56 TRT01A Placebo AEBODSYS INJURY, POISONING AND PROCEDURAL COMPLICATIONS OCMQ01NAM HLT_0738 hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
57 TRT01A Placebo AEBODSYS INJURY, POISONING AND PROCEDURAL COMPLICATIONS OCMQ01NAM HLT_0738 hierarchical p % 0.0116 1.2 <fn> <NULL> <NULL> stat_1
58 TRT01A Xanomeline High Dose AEBODSYS INJURY, POISONING AND PROCEDURAL COMPLICATIONS OCMQ01NAM HLT_0738 hierarchical n n 1 1 <fn> <NULL> <NULL> stat_2
59 TRT01A Xanomeline High Dose AEBODSYS INJURY, POISONING AND PROCEDURAL COMPLICATIONS OCMQ01NAM HLT_0738 hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
60 TRT01A Xanomeline High Dose AEBODSYS INJURY, POISONING AND PROCEDURAL COMPLICATIONS OCMQ01NAM HLT_0738 hierarchical p % 0.0139 1.4 <fn> <NULL> <NULL> stat_2
61 TRT01A Xanomeline Low Dose AEBODSYS INJURY, POISONING AND PROCEDURAL COMPLICATIONS OCMQ01NAM HLT_0738 hierarchical n n 1 1 <fn> <NULL> <NULL> stat_3
62 TRT01A Xanomeline Low Dose AEBODSYS INJURY, POISONING AND PROCEDURAL COMPLICATIONS OCMQ01NAM HLT_0738 hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
63 TRT01A Xanomeline Low Dose AEBODSYS INJURY, POISONING AND PROCEDURAL COMPLICATIONS OCMQ01NAM HLT_0738 hierarchical p % 0.0104 1.0 <fn> <NULL> <NULL> stat_3