Subjects With Adverse Events Leading to Treatment Discontinuation by Organ System and OCMQ (Narrow), Safety Population, Pooled Analysis (or Trial X)
FDA Table 13
table
FDA
safety
adverse events
FDA IG Shell
Programming Notes
Background and Instructions
Refer to Table 30: Subjects With Adverse Events Leading to Discontinuation for AEs leading to treatment discontinuation by organ system, OCMQs (narrow), and the specific preferred terms for these OCMQs.
Customization
Clinical reviewers may request a similar table of OCMQs (broad) leading to treatment discontinuation. Clinical reviewers may also request tables from Section 4.1 Optional Adverse Event Analyses to explore the data on specific subjects.
Output
Code
# FDA TABLE 13 ---------------------------------------------------------------
# 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)
set.seed(1)
adsl <- pharmaverseadam::adsl
adae <- pharmaverseadam::adae
adae <- adae |>
rename(OCMQ01SC = AEHLTCD) |>
mutate(
AESER = sample(c("Y", "N"), size = nrow(adae), replace = TRUE),
OCMQ01NAM = sample(c("OCMQ1", "OCMQ2", "OCMQ3"), size = nrow(adae), replace = TRUE)
)
adae$OCMQ01SC[is.na(adae$OCMQ01SC)] <- "NARROW"
# Pre-processing --------------------------------------------
adsl <- adsl |>
filter(SAFFL == "Y") # safety population
data <- adae |>
filter(
# safety population
SAFFL == "Y",
# narrow OCMQ
OCMQ01SC == "NARROW"
)
sliced_data <- data |>
count(AEBODSYS, sort = TRUE) |>
slice_head(n = 3) |> # keep top 3
pull(AEBODSYS)
data <- data |>
filter(AEBODSYS %in% sliced_data)
tbl <-
tbl_hierarchical(
data,
variables = c(AEBODSYS, OCMQ01NAM),
by = TRT01A,
id = USUBJID,
denominator = adsl,
label = list(AEBODSYS = "Organ System", OCMQ01NAM = "OCMQ (Narrow)")
)
ard <- gtsummary::gather_ard(tbl)|
Organ System OCMQ (Narrow) |
Placebo N = 861 |
Xanomeline High Dose N = 721 |
Xanomeline Low Dose N = 961 |
|---|---|---|---|
| GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | 21 (24%) | 36 (50%) | 51 (53%) |
| OCMQ1 | 8 (9.3%) | 23 (32%) | 25 (26%) |
| OCMQ2 | 11 (13%) | 22 (31%) | 26 (27%) |
| OCMQ3 | 14 (16%) | 26 (36%) | 32 (33%) |
| NERVOUS SYSTEM DISORDERS | 12 (14%) | 25 (35%) | 22 (23%) |
| OCMQ1 | 3 (3.5%) | 10 (14%) | 11 (11%) |
| OCMQ2 | 5 (5.8%) | 12 (17%) | 13 (14%) |
| OCMQ3 | 7 (8.1%) | 15 (21%) | 8 (8.3%) |
| SKIN AND SUBCUTANEOUS TISSUE DISORDERS | 21 (24%) | 42 (58%) | 42 (44%) |
| OCMQ1 | 11 (13%) | 18 (25%) | 28 (29%) |
| OCMQ2 | 14 (16%) | 27 (38%) | 25 (26%) |
| OCMQ3 | 11 (13%) | 25 (35%) | 23 (24%) |
| 1 n (%) | |||
$tbl_hierarchical
# An ARD data frame: 117 × 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 <NA> <NULL> AEBODSYS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS hierarchical n n 21 21 <fn> <NULL> <NULL> stat_1
11 TRT01A Placebo <NA> <NULL> AEBODSYS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
12 TRT01A Placebo <NA> <NULL> AEBODSYS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS hierarchical p % 0.244 24 <fn> <NULL> <NULL> stat_1
13 TRT01A Xanomeline High Dose <NA> <NULL> AEBODSYS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS hierarchical n n 36 36 <fn> <NULL> <NULL> stat_2
14 TRT01A Xanomeline High Dose <NA> <NULL> AEBODSYS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
15 TRT01A Xanomeline High Dose <NA> <NULL> AEBODSYS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS hierarchical p % 0.5 50 <fn> <NULL> <NULL> stat_2
16 TRT01A Xanomeline Low Dose <NA> <NULL> AEBODSYS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS hierarchical n n 51 51 <fn> <NULL> <NULL> stat_3
17 TRT01A Xanomeline Low Dose <NA> <NULL> AEBODSYS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
18 TRT01A Xanomeline Low Dose <NA> <NULL> AEBODSYS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS hierarchical p % 0.531 53 <fn> <NULL> <NULL> stat_3
19 TRT01A Placebo AEBODSYS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS OCMQ01NAM OCMQ1 hierarchical n n 8 8 <fn> <NULL> <NULL> stat_1
20 TRT01A Placebo AEBODSYS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS OCMQ01NAM OCMQ1 hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
21 TRT01A Placebo AEBODSYS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS OCMQ01NAM OCMQ1 hierarchical p % 0.0930 9.3 <fn> <NULL> <NULL> stat_1
22 TRT01A Xanomeline High Dose AEBODSYS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS OCMQ01NAM OCMQ1 hierarchical n n 23 23 <fn> <NULL> <NULL> stat_2
23 TRT01A Xanomeline High Dose AEBODSYS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS OCMQ01NAM OCMQ1 hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
24 TRT01A Xanomeline High Dose AEBODSYS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS OCMQ01NAM OCMQ1 hierarchical p % 0.319 32 <fn> <NULL> <NULL> stat_2
25 TRT01A Xanomeline Low Dose AEBODSYS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS OCMQ01NAM OCMQ1 hierarchical n n 25 25 <fn> <NULL> <NULL> stat_3
26 TRT01A Xanomeline Low Dose AEBODSYS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS OCMQ01NAM OCMQ1 hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
27 TRT01A Xanomeline Low Dose AEBODSYS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS OCMQ01NAM OCMQ1 hierarchical p % 0.260 26 <fn> <NULL> <NULL> stat_3
28 TRT01A Placebo AEBODSYS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS OCMQ01NAM OCMQ2 hierarchical n n 11 11 <fn> <NULL> <NULL> stat_1
29 TRT01A Placebo AEBODSYS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS OCMQ01NAM OCMQ2 hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
30 TRT01A Placebo AEBODSYS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS OCMQ01NAM OCMQ2 hierarchical p % 0.128 13 <fn> <NULL> <NULL> stat_1
31 TRT01A Xanomeline High Dose AEBODSYS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS OCMQ01NAM OCMQ2 hierarchical n n 22 22 <fn> <NULL> <NULL> stat_2
32 TRT01A Xanomeline High Dose AEBODSYS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS OCMQ01NAM OCMQ2 hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
33 TRT01A Xanomeline High Dose AEBODSYS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS OCMQ01NAM OCMQ2 hierarchical p % 0.306 31 <fn> <NULL> <NULL> stat_2
34 TRT01A Xanomeline Low Dose AEBODSYS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS OCMQ01NAM OCMQ2 hierarchical n n 26 26 <fn> <NULL> <NULL> stat_3
35 TRT01A Xanomeline Low Dose AEBODSYS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS OCMQ01NAM OCMQ2 hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
36 TRT01A Xanomeline Low Dose AEBODSYS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS OCMQ01NAM OCMQ2 hierarchical p % 0.271 27 <fn> <NULL> <NULL> stat_3
37 TRT01A Placebo AEBODSYS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS OCMQ01NAM OCMQ3 hierarchical n n 14 14 <fn> <NULL> <NULL> stat_1
38 TRT01A Placebo AEBODSYS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS OCMQ01NAM OCMQ3 hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
39 TRT01A Placebo AEBODSYS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS OCMQ01NAM OCMQ3 hierarchical p % 0.163 16 <fn> <NULL> <NULL> stat_1
40 TRT01A Xanomeline High Dose AEBODSYS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS OCMQ01NAM OCMQ3 hierarchical n n 26 26 <fn> <NULL> <NULL> stat_2
41 TRT01A Xanomeline High Dose AEBODSYS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS OCMQ01NAM OCMQ3 hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
42 TRT01A Xanomeline High Dose AEBODSYS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS OCMQ01NAM OCMQ3 hierarchical p % 0.361 36 <fn> <NULL> <NULL> stat_2
43 TRT01A Xanomeline Low Dose AEBODSYS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS OCMQ01NAM OCMQ3 hierarchical n n 32 32 <fn> <NULL> <NULL> stat_3
44 TRT01A Xanomeline Low Dose AEBODSYS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS OCMQ01NAM OCMQ3 hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
45 TRT01A Xanomeline Low Dose AEBODSYS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS OCMQ01NAM OCMQ3 hierarchical p % 0.333 33 <fn> <NULL> <NULL> stat_3
46 TRT01A Placebo <NA> <NULL> AEBODSYS NERVOUS SYSTEM DISORDERS hierarchical n n 12 12 <fn> <NULL> <NULL> stat_1
47 TRT01A Placebo <NA> <NULL> AEBODSYS NERVOUS SYSTEM DISORDERS hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
48 TRT01A Placebo <NA> <NULL> AEBODSYS NERVOUS SYSTEM DISORDERS hierarchical p % 0.140 14 <fn> <NULL> <NULL> stat_1
49 TRT01A Xanomeline High Dose <NA> <NULL> AEBODSYS NERVOUS SYSTEM DISORDERS hierarchical n n 25 25 <fn> <NULL> <NULL> stat_2
50 TRT01A Xanomeline High Dose <NA> <NULL> AEBODSYS NERVOUS SYSTEM DISORDERS hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
51 TRT01A Xanomeline High Dose <NA> <NULL> AEBODSYS NERVOUS SYSTEM DISORDERS hierarchical p % 0.347 35 <fn> <NULL> <NULL> stat_2
52 TRT01A Xanomeline Low Dose <NA> <NULL> AEBODSYS NERVOUS SYSTEM DISORDERS hierarchical n n 22 22 <fn> <NULL> <NULL> stat_3
53 TRT01A Xanomeline Low Dose <NA> <NULL> AEBODSYS NERVOUS SYSTEM DISORDERS hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
54 TRT01A Xanomeline Low Dose <NA> <NULL> AEBODSYS NERVOUS SYSTEM DISORDERS hierarchical p % 0.229 23 <fn> <NULL> <NULL> stat_3
55 TRT01A Placebo AEBODSYS NERVOUS SYSTEM DISORDERS OCMQ01NAM OCMQ1 hierarchical n n 3 3 <fn> <NULL> <NULL> stat_1
56 TRT01A Placebo AEBODSYS NERVOUS SYSTEM DISORDERS OCMQ01NAM OCMQ1 hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
57 TRT01A Placebo AEBODSYS NERVOUS SYSTEM DISORDERS OCMQ01NAM OCMQ1 hierarchical p % 0.0349 3.5 <fn> <NULL> <NULL> stat_1
58 TRT01A Xanomeline High Dose AEBODSYS NERVOUS SYSTEM DISORDERS OCMQ01NAM OCMQ1 hierarchical n n 10 10 <fn> <NULL> <NULL> stat_2
59 TRT01A Xanomeline High Dose AEBODSYS NERVOUS SYSTEM DISORDERS OCMQ01NAM OCMQ1 hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
60 TRT01A Xanomeline High Dose AEBODSYS NERVOUS SYSTEM DISORDERS OCMQ01NAM OCMQ1 hierarchical p % 0.139 14 <fn> <NULL> <NULL> stat_2
61 TRT01A Xanomeline Low Dose AEBODSYS NERVOUS SYSTEM DISORDERS OCMQ01NAM OCMQ1 hierarchical n n 11 11 <fn> <NULL> <NULL> stat_3
62 TRT01A Xanomeline Low Dose AEBODSYS NERVOUS SYSTEM DISORDERS OCMQ01NAM OCMQ1 hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
63 TRT01A Xanomeline Low Dose AEBODSYS NERVOUS SYSTEM DISORDERS OCMQ01NAM OCMQ1 hierarchical p % 0.115 11 <fn> <NULL> <NULL> stat_3
64 TRT01A Placebo AEBODSYS NERVOUS SYSTEM DISORDERS OCMQ01NAM OCMQ2 hierarchical n n 5 5 <fn> <NULL> <NULL> stat_1
65 TRT01A Placebo AEBODSYS NERVOUS SYSTEM DISORDERS OCMQ01NAM OCMQ2 hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
66 TRT01A Placebo AEBODSYS NERVOUS SYSTEM DISORDERS OCMQ01NAM OCMQ2 hierarchical p % 0.0581 5.8 <fn> <NULL> <NULL> stat_1
67 TRT01A Xanomeline High Dose AEBODSYS NERVOUS SYSTEM DISORDERS OCMQ01NAM OCMQ2 hierarchical n n 12 12 <fn> <NULL> <NULL> stat_2
68 TRT01A Xanomeline High Dose AEBODSYS NERVOUS SYSTEM DISORDERS OCMQ01NAM OCMQ2 hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
69 TRT01A Xanomeline High Dose AEBODSYS NERVOUS SYSTEM DISORDERS OCMQ01NAM OCMQ2 hierarchical p % 0.167 17 <fn> <NULL> <NULL> stat_2
70 TRT01A Xanomeline Low Dose AEBODSYS NERVOUS SYSTEM DISORDERS OCMQ01NAM OCMQ2 hierarchical n n 13 13 <fn> <NULL> <NULL> stat_3
71 TRT01A Xanomeline Low Dose AEBODSYS NERVOUS SYSTEM DISORDERS OCMQ01NAM OCMQ2 hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
72 TRT01A Xanomeline Low Dose AEBODSYS NERVOUS SYSTEM DISORDERS OCMQ01NAM OCMQ2 hierarchical p % 0.135 14 <fn> <NULL> <NULL> stat_3
73 TRT01A Placebo AEBODSYS NERVOUS SYSTEM DISORDERS OCMQ01NAM OCMQ3 hierarchical n n 7 7 <fn> <NULL> <NULL> stat_1
74 TRT01A Placebo AEBODSYS NERVOUS SYSTEM DISORDERS OCMQ01NAM OCMQ3 hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
75 TRT01A Placebo AEBODSYS NERVOUS SYSTEM DISORDERS OCMQ01NAM OCMQ3 hierarchical p % 0.0814 8.1 <fn> <NULL> <NULL> stat_1
76 TRT01A Xanomeline High Dose AEBODSYS NERVOUS SYSTEM DISORDERS OCMQ01NAM OCMQ3 hierarchical n n 15 15 <fn> <NULL> <NULL> stat_2
77 TRT01A Xanomeline High Dose AEBODSYS NERVOUS SYSTEM DISORDERS OCMQ01NAM OCMQ3 hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
78 TRT01A Xanomeline High Dose AEBODSYS NERVOUS SYSTEM DISORDERS OCMQ01NAM OCMQ3 hierarchical p % 0.208 21 <fn> <NULL> <NULL> stat_2
79 TRT01A Xanomeline Low Dose AEBODSYS NERVOUS SYSTEM DISORDERS OCMQ01NAM OCMQ3 hierarchical n n 8 8 <fn> <NULL> <NULL> stat_3
80 TRT01A Xanomeline Low Dose AEBODSYS NERVOUS SYSTEM DISORDERS OCMQ01NAM OCMQ3 hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
81 TRT01A Xanomeline Low Dose AEBODSYS NERVOUS SYSTEM DISORDERS OCMQ01NAM OCMQ3 hierarchical p % 0.0833 8.3 <fn> <NULL> <NULL> stat_3
82 TRT01A Placebo <NA> <NULL> AEBODSYS SKIN AND SUBCUTANEOUS TISSUE DISORDERS hierarchical n n 21 21 <fn> <NULL> <NULL> stat_1
83 TRT01A Placebo <NA> <NULL> AEBODSYS SKIN AND SUBCUTANEOUS TISSUE DISORDERS hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
84 TRT01A Placebo <NA> <NULL> AEBODSYS SKIN AND SUBCUTANEOUS TISSUE DISORDERS hierarchical p % 0.244 24 <fn> <NULL> <NULL> stat_1
85 TRT01A Xanomeline High Dose <NA> <NULL> AEBODSYS SKIN AND SUBCUTANEOUS TISSUE DISORDERS hierarchical n n 42 42 <fn> <NULL> <NULL> stat_2
86 TRT01A Xanomeline High Dose <NA> <NULL> AEBODSYS SKIN AND SUBCUTANEOUS TISSUE DISORDERS hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
87 TRT01A Xanomeline High Dose <NA> <NULL> AEBODSYS SKIN AND SUBCUTANEOUS TISSUE DISORDERS hierarchical p % 0.583 58 <fn> <NULL> <NULL> stat_2
88 TRT01A Xanomeline Low Dose <NA> <NULL> AEBODSYS SKIN AND SUBCUTANEOUS TISSUE DISORDERS hierarchical n n 42 42 <fn> <NULL> <NULL> stat_3
89 TRT01A Xanomeline Low Dose <NA> <NULL> AEBODSYS SKIN AND SUBCUTANEOUS TISSUE DISORDERS hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
90 TRT01A Xanomeline Low Dose <NA> <NULL> AEBODSYS SKIN AND SUBCUTANEOUS TISSUE DISORDERS hierarchical p % 0.438 44 <fn> <NULL> <NULL> stat_3
91 TRT01A Placebo AEBODSYS SKIN AND SUBCUTANEOUS TISSUE DISORDERS OCMQ01NAM OCMQ1 hierarchical n n 11 11 <fn> <NULL> <NULL> stat_1
92 TRT01A Placebo AEBODSYS SKIN AND SUBCUTANEOUS TISSUE DISORDERS OCMQ01NAM OCMQ1 hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
93 TRT01A Placebo AEBODSYS SKIN AND SUBCUTANEOUS TISSUE DISORDERS OCMQ01NAM OCMQ1 hierarchical p % 0.128 13 <fn> <NULL> <NULL> stat_1
94 TRT01A Xanomeline High Dose AEBODSYS SKIN AND SUBCUTANEOUS TISSUE DISORDERS OCMQ01NAM OCMQ1 hierarchical n n 18 18 <fn> <NULL> <NULL> stat_2
95 TRT01A Xanomeline High Dose AEBODSYS SKIN AND SUBCUTANEOUS TISSUE DISORDERS OCMQ01NAM OCMQ1 hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
96 TRT01A Xanomeline High Dose AEBODSYS SKIN AND SUBCUTANEOUS TISSUE DISORDERS OCMQ01NAM OCMQ1 hierarchical p % 0.25 25 <fn> <NULL> <NULL> stat_2
97 TRT01A Xanomeline Low Dose AEBODSYS SKIN AND SUBCUTANEOUS TISSUE DISORDERS OCMQ01NAM OCMQ1 hierarchical n n 28 28 <fn> <NULL> <NULL> stat_3
98 TRT01A Xanomeline Low Dose AEBODSYS SKIN AND SUBCUTANEOUS TISSUE DISORDERS OCMQ01NAM OCMQ1 hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
99 TRT01A Xanomeline Low Dose AEBODSYS SKIN AND SUBCUTANEOUS TISSUE DISORDERS OCMQ01NAM OCMQ1 hierarchical p % 0.292 29 <fn> <NULL> <NULL> stat_3
100 TRT01A Placebo AEBODSYS SKIN AND SUBCUTANEOUS TISSUE DISORDERS OCMQ01NAM OCMQ2 hierarchical n n 14 14 <fn> <NULL> <NULL> stat_1
101 TRT01A Placebo AEBODSYS SKIN AND SUBCUTANEOUS TISSUE DISORDERS OCMQ01NAM OCMQ2 hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
102 TRT01A Placebo AEBODSYS SKIN AND SUBCUTANEOUS TISSUE DISORDERS OCMQ01NAM OCMQ2 hierarchical p % 0.163 16 <fn> <NULL> <NULL> stat_1
103 TRT01A Xanomeline High Dose AEBODSYS SKIN AND SUBCUTANEOUS TISSUE DISORDERS OCMQ01NAM OCMQ2 hierarchical n n 27 27 <fn> <NULL> <NULL> stat_2
104 TRT01A Xanomeline High Dose AEBODSYS SKIN AND SUBCUTANEOUS TISSUE DISORDERS OCMQ01NAM OCMQ2 hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
105 TRT01A Xanomeline High Dose AEBODSYS SKIN AND SUBCUTANEOUS TISSUE DISORDERS OCMQ01NAM OCMQ2 hierarchical p % 0.375 38 <fn> <NULL> <NULL> stat_2
106 TRT01A Xanomeline Low Dose AEBODSYS SKIN AND SUBCUTANEOUS TISSUE DISORDERS OCMQ01NAM OCMQ2 hierarchical n n 25 25 <fn> <NULL> <NULL> stat_3
107 TRT01A Xanomeline Low Dose AEBODSYS SKIN AND SUBCUTANEOUS TISSUE DISORDERS OCMQ01NAM OCMQ2 hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
108 TRT01A Xanomeline Low Dose AEBODSYS SKIN AND SUBCUTANEOUS TISSUE DISORDERS OCMQ01NAM OCMQ2 hierarchical p % 0.260 26 <fn> <NULL> <NULL> stat_3
109 TRT01A Placebo AEBODSYS SKIN AND SUBCUTANEOUS TISSUE DISORDERS OCMQ01NAM OCMQ3 hierarchical n n 11 11 <fn> <NULL> <NULL> stat_1
110 TRT01A Placebo AEBODSYS SKIN AND SUBCUTANEOUS TISSUE DISORDERS OCMQ01NAM OCMQ3 hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
111 TRT01A Placebo AEBODSYS SKIN AND SUBCUTANEOUS TISSUE DISORDERS OCMQ01NAM OCMQ3 hierarchical p % 0.128 13 <fn> <NULL> <NULL> stat_1
112 TRT01A Xanomeline High Dose AEBODSYS SKIN AND SUBCUTANEOUS TISSUE DISORDERS OCMQ01NAM OCMQ3 hierarchical n n 25 25 <fn> <NULL> <NULL> stat_2
113 TRT01A Xanomeline High Dose AEBODSYS SKIN AND SUBCUTANEOUS TISSUE DISORDERS OCMQ01NAM OCMQ3 hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
114 TRT01A Xanomeline High Dose AEBODSYS SKIN AND SUBCUTANEOUS TISSUE DISORDERS OCMQ01NAM OCMQ3 hierarchical p % 0.347 35 <fn> <NULL> <NULL> stat_2
115 TRT01A Xanomeline Low Dose AEBODSYS SKIN AND SUBCUTANEOUS TISSUE DISORDERS OCMQ01NAM OCMQ3 hierarchical n n 23 23 <fn> <NULL> <NULL> stat_3
116 TRT01A Xanomeline Low Dose AEBODSYS SKIN AND SUBCUTANEOUS TISSUE DISORDERS OCMQ01NAM OCMQ3 hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
117 TRT01A Xanomeline Low Dose AEBODSYS SKIN AND SUBCUTANEOUS TISSUE DISORDERS OCMQ01NAM OCMQ3 hierarchical p % 0.240 24 <fn> <NULL> <NULL> stat_3