Subjects With Adverse Events by System Organ Class and Preferred Term, Safety Population, Pooled Analysis (or Trial X)
FDA Table 14
table
FDA
safety
adverse events
FDA IG Shell
Programming Notes
Background and Instructions
Table 14: Subjects With Adverse Events by System Organ Class and Preferred Term, Safety Population, Pooled Analysis (or Trial X) presents the entire table of AEs by SOC, while Table 15: Subjects With Common Adverse Events shows common AEs by PT. Review of PTs by SOC can elucidate potential imbalances within the same body system that may not be as apparent when looking at individual AEs.
Customization
The full list of PTs to be included in this table may lead to a multi-page table and affect readability. In this case, the review team could consider displaying this table using a frequency cutoff for ease of review. The full table containing all data can be reviewed in the spreadsheet provided by CDS.
Output
Code
# FDA TABLE 14 ---------------------------------------------------------------
# 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)
adsl <- pharmaverseadam::adsl
adae <- pharmaverseadam::adae
# Pre-processing --------------------------------------------
adsl <- adsl |>
filter(SAFFL == "Y") # safety population
# for display purpose showing only bottom 5 SOCs
sliced_data <- adae |>
count(AESOC) |>
slice_min(order_by = n, n = 5) |>
pull(AESOC)
data <- adae |>
filter(AESOC %in% sliced_data)
ard <- ard_stack_hierarchical(
data,
variables = c(AESOC, AEDECOD),
by = TRT01A,
id = USUBJID,
denominator = adsl
)
# create table using ARD-first approach (ARD -> table)
tbl <-
tbl_ard_hierarchical(
ard,
variables = c(AESOC, AEDECOD),
by = TRT01A,
# add custom variable labels
label = list(
AESOC = "System Organ Class",
AEDECOD = "Preferred Term"
)
)
ard <- gtsummary::gather_ard(tbl)|
System Organ Class Preferred Term |
Placebo N = 861 |
Xanomeline High Dose N = 721 |
Xanomeline Low Dose N = 961 |
|---|---|---|---|
| CONGENITAL, FAMILIAL AND GENETIC DISORDERS | 0 (0.0%) | 2 (2.8%) | 1 (1.0%) |
| VENTRICULAR SEPTAL DEFECT | 0 (0.0%) | 2 (2.8%) | 1 (1.0%) |
| HEPATOBILIARY DISORDERS | 1 (1.2%) | 0 (0.0%) | 0 (0.0%) |
| HYPERBILIRUBINAEMIA | 1 (1.2%) | 0 (0.0%) | 0 (0.0%) |
| IMMUNE SYSTEM DISORDERS | 0 (0.0%) | 1 (1.4%) | 1 (1.0%) |
| HYPERSENSITIVITY | 0 (0.0%) | 0 (0.0%) | 1 (1.0%) |
| SEASONAL ALLERGY | 0 (0.0%) | 1 (1.4%) | 0 (0.0%) |
| NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) | 0 (0.0%) | 1 (1.4%) | 2 (2.1%) |
| COLON CANCER | 0 (0.0%) | 0 (0.0%) | 1 (1.0%) |
| MALIGNANT FIBROUS HISTIOCYTOMA | 0 (0.0%) | 0 (0.0%) | 1 (1.0%) |
| PROSTATE CANCER | 0 (0.0%) | 1 (1.4%) | 0 (0.0%) |
| SOCIAL CIRCUMSTANCES | 0 (0.0%) | 1 (1.4%) | 0 (0.0%) |
| ALCOHOL USE | 0 (0.0%) | 1 (1.4%) | 0 (0.0%) |
| 1 n (%) | |||
$tbl_ard_hierarchical
# An ARD data frame: 126 × 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> AESOC CONGENITAL, FAMILIAL AND GENETIC DISORDERS hierarchical n n 0 0 0 <NULL> <NULL> stat_1
11 TRT01A Placebo <NA> <NULL> AESOC CONGENITAL, FAMILIAL AND GENETIC DISORDERS hierarchical N N 86 86 0 <NULL> <NULL> stat_1
12 TRT01A Placebo <NA> <NULL> AESOC CONGENITAL, FAMILIAL AND GENETIC DISORDERS hierarchical p % 0 0.0 <fn> <NULL> <NULL> stat_1
13 TRT01A Xanomeline High Dose <NA> <NULL> AESOC CONGENITAL, FAMILIAL AND GENETIC DISORDERS hierarchical n n 2 2 0 <NULL> <NULL> stat_2
14 TRT01A Xanomeline High Dose <NA> <NULL> AESOC CONGENITAL, FAMILIAL AND GENETIC DISORDERS hierarchical N N 72 72 0 <NULL> <NULL> stat_2
15 TRT01A Xanomeline High Dose <NA> <NULL> AESOC CONGENITAL, FAMILIAL AND GENETIC DISORDERS hierarchical p % 0.0278 2.8 <fn> <NULL> <NULL> stat_2
16 TRT01A Xanomeline Low Dose <NA> <NULL> AESOC CONGENITAL, FAMILIAL AND GENETIC DISORDERS hierarchical n n 1 1 0 <NULL> <NULL> stat_3
17 TRT01A Xanomeline Low Dose <NA> <NULL> AESOC CONGENITAL, FAMILIAL AND GENETIC DISORDERS hierarchical N N 96 96 0 <NULL> <NULL> stat_3
18 TRT01A Xanomeline Low Dose <NA> <NULL> AESOC CONGENITAL, FAMILIAL AND GENETIC DISORDERS hierarchical p % 0.0104 1.0 <fn> <NULL> <NULL> stat_3
19 TRT01A Placebo AESOC CONGENITAL, FAMILIAL AND GENETIC DISORDERS AEDECOD VENTRICULAR SEPTAL DEFECT hierarchical n n 0 0 0 <NULL> <NULL> stat_1
20 TRT01A Placebo AESOC CONGENITAL, FAMILIAL AND GENETIC DISORDERS AEDECOD VENTRICULAR SEPTAL DEFECT hierarchical N N 86 86 0 <NULL> <NULL> stat_1
21 TRT01A Placebo AESOC CONGENITAL, FAMILIAL AND GENETIC DISORDERS AEDECOD VENTRICULAR SEPTAL DEFECT hierarchical p % 0 0.0 <fn> <NULL> <NULL> stat_1
22 TRT01A Xanomeline High Dose AESOC CONGENITAL, FAMILIAL AND GENETIC DISORDERS AEDECOD VENTRICULAR SEPTAL DEFECT hierarchical n n 2 2 0 <NULL> <NULL> stat_2
23 TRT01A Xanomeline High Dose AESOC CONGENITAL, FAMILIAL AND GENETIC DISORDERS AEDECOD VENTRICULAR SEPTAL DEFECT hierarchical N N 72 72 0 <NULL> <NULL> stat_2
24 TRT01A Xanomeline High Dose AESOC CONGENITAL, FAMILIAL AND GENETIC DISORDERS AEDECOD VENTRICULAR SEPTAL DEFECT hierarchical p % 0.0278 2.8 <fn> <NULL> <NULL> stat_2
25 TRT01A Xanomeline Low Dose AESOC CONGENITAL, FAMILIAL AND GENETIC DISORDERS AEDECOD VENTRICULAR SEPTAL DEFECT hierarchical n n 1 1 0 <NULL> <NULL> stat_3
26 TRT01A Xanomeline Low Dose AESOC CONGENITAL, FAMILIAL AND GENETIC DISORDERS AEDECOD VENTRICULAR SEPTAL DEFECT hierarchical N N 96 96 0 <NULL> <NULL> stat_3
27 TRT01A Xanomeline Low Dose AESOC CONGENITAL, FAMILIAL AND GENETIC DISORDERS AEDECOD VENTRICULAR SEPTAL DEFECT hierarchical p % 0.0104 1.0 <fn> <NULL> <NULL> stat_3
28 TRT01A Placebo <NA> <NULL> AESOC HEPATOBILIARY DISORDERS hierarchical n n 1 1 0 <NULL> <NULL> stat_1
29 TRT01A Placebo <NA> <NULL> AESOC HEPATOBILIARY DISORDERS hierarchical N N 86 86 0 <NULL> <NULL> stat_1
30 TRT01A Placebo <NA> <NULL> AESOC HEPATOBILIARY DISORDERS hierarchical p % 0.0116 1.2 <fn> <NULL> <NULL> stat_1
31 TRT01A Xanomeline High Dose <NA> <NULL> AESOC HEPATOBILIARY DISORDERS hierarchical n n 0 0 0 <NULL> <NULL> stat_2
32 TRT01A Xanomeline High Dose <NA> <NULL> AESOC HEPATOBILIARY DISORDERS hierarchical N N 72 72 0 <NULL> <NULL> stat_2
33 TRT01A Xanomeline High Dose <NA> <NULL> AESOC HEPATOBILIARY DISORDERS hierarchical p % 0 0.0 <fn> <NULL> <NULL> stat_2
34 TRT01A Xanomeline Low Dose <NA> <NULL> AESOC HEPATOBILIARY DISORDERS hierarchical n n 0 0 0 <NULL> <NULL> stat_3
35 TRT01A Xanomeline Low Dose <NA> <NULL> AESOC HEPATOBILIARY DISORDERS hierarchical N N 96 96 0 <NULL> <NULL> stat_3
36 TRT01A Xanomeline Low Dose <NA> <NULL> AESOC HEPATOBILIARY DISORDERS hierarchical p % 0 0.0 <fn> <NULL> <NULL> stat_3
37 TRT01A Placebo AESOC HEPATOBILIARY DISORDERS AEDECOD HYPERBILIRUBINAEMIA hierarchical n n 1 1 0 <NULL> <NULL> stat_1
38 TRT01A Placebo AESOC HEPATOBILIARY DISORDERS AEDECOD HYPERBILIRUBINAEMIA hierarchical N N 86 86 0 <NULL> <NULL> stat_1
39 TRT01A Placebo AESOC HEPATOBILIARY DISORDERS AEDECOD HYPERBILIRUBINAEMIA hierarchical p % 0.0116 1.2 <fn> <NULL> <NULL> stat_1
40 TRT01A Xanomeline High Dose AESOC HEPATOBILIARY DISORDERS AEDECOD HYPERBILIRUBINAEMIA hierarchical n n 0 0 0 <NULL> <NULL> stat_2
41 TRT01A Xanomeline High Dose AESOC HEPATOBILIARY DISORDERS AEDECOD HYPERBILIRUBINAEMIA hierarchical N N 72 72 0 <NULL> <NULL> stat_2
42 TRT01A Xanomeline High Dose AESOC HEPATOBILIARY DISORDERS AEDECOD HYPERBILIRUBINAEMIA hierarchical p % 0 0.0 <fn> <NULL> <NULL> stat_2
43 TRT01A Xanomeline Low Dose AESOC HEPATOBILIARY DISORDERS AEDECOD HYPERBILIRUBINAEMIA hierarchical n n 0 0 0 <NULL> <NULL> stat_3
44 TRT01A Xanomeline Low Dose AESOC HEPATOBILIARY DISORDERS AEDECOD HYPERBILIRUBINAEMIA hierarchical N N 96 96 0 <NULL> <NULL> stat_3
45 TRT01A Xanomeline Low Dose AESOC HEPATOBILIARY DISORDERS AEDECOD HYPERBILIRUBINAEMIA hierarchical p % 0 0.0 <fn> <NULL> <NULL> stat_3
46 TRT01A Placebo <NA> <NULL> AESOC IMMUNE SYSTEM DISORDERS hierarchical n n 0 0 0 <NULL> <NULL> stat_1
47 TRT01A Placebo <NA> <NULL> AESOC IMMUNE SYSTEM DISORDERS hierarchical N N 86 86 0 <NULL> <NULL> stat_1
48 TRT01A Placebo <NA> <NULL> AESOC IMMUNE SYSTEM DISORDERS hierarchical p % 0 0.0 <fn> <NULL> <NULL> stat_1
49 TRT01A Xanomeline High Dose <NA> <NULL> AESOC IMMUNE SYSTEM DISORDERS hierarchical n n 1 1 0 <NULL> <NULL> stat_2
50 TRT01A Xanomeline High Dose <NA> <NULL> AESOC IMMUNE SYSTEM DISORDERS hierarchical N N 72 72 0 <NULL> <NULL> stat_2
51 TRT01A Xanomeline High Dose <NA> <NULL> AESOC IMMUNE SYSTEM DISORDERS hierarchical p % 0.0139 1.4 <fn> <NULL> <NULL> stat_2
52 TRT01A Xanomeline Low Dose <NA> <NULL> AESOC IMMUNE SYSTEM DISORDERS hierarchical n n 1 1 0 <NULL> <NULL> stat_3
53 TRT01A Xanomeline Low Dose <NA> <NULL> AESOC IMMUNE SYSTEM DISORDERS hierarchical N N 96 96 0 <NULL> <NULL> stat_3
54 TRT01A Xanomeline Low Dose <NA> <NULL> AESOC IMMUNE SYSTEM DISORDERS hierarchical p % 0.0104 1.0 <fn> <NULL> <NULL> stat_3
55 TRT01A Placebo AESOC IMMUNE SYSTEM DISORDERS AEDECOD HYPERSENSITIVITY hierarchical n n 0 0 0 <NULL> <NULL> stat_1
56 TRT01A Placebo AESOC IMMUNE SYSTEM DISORDERS AEDECOD HYPERSENSITIVITY hierarchical N N 86 86 0 <NULL> <NULL> stat_1
57 TRT01A Placebo AESOC IMMUNE SYSTEM DISORDERS AEDECOD HYPERSENSITIVITY hierarchical p % 0 0.0 <fn> <NULL> <NULL> stat_1
58 TRT01A Xanomeline High Dose AESOC IMMUNE SYSTEM DISORDERS AEDECOD HYPERSENSITIVITY hierarchical n n 0 0 0 <NULL> <NULL> stat_2
59 TRT01A Xanomeline High Dose AESOC IMMUNE SYSTEM DISORDERS AEDECOD HYPERSENSITIVITY hierarchical N N 72 72 0 <NULL> <NULL> stat_2
60 TRT01A Xanomeline High Dose AESOC IMMUNE SYSTEM DISORDERS AEDECOD HYPERSENSITIVITY hierarchical p % 0 0.0 <fn> <NULL> <NULL> stat_2
61 TRT01A Xanomeline Low Dose AESOC IMMUNE SYSTEM DISORDERS AEDECOD HYPERSENSITIVITY hierarchical n n 1 1 0 <NULL> <NULL> stat_3
62 TRT01A Xanomeline Low Dose AESOC IMMUNE SYSTEM DISORDERS AEDECOD HYPERSENSITIVITY hierarchical N N 96 96 0 <NULL> <NULL> stat_3
63 TRT01A Xanomeline Low Dose AESOC IMMUNE SYSTEM DISORDERS AEDECOD HYPERSENSITIVITY hierarchical p % 0.0104 1.0 <fn> <NULL> <NULL> stat_3
64 TRT01A Placebo AESOC IMMUNE SYSTEM DISORDERS AEDECOD SEASONAL ALLERGY hierarchical n n 0 0 0 <NULL> <NULL> stat_1
65 TRT01A Placebo AESOC IMMUNE SYSTEM DISORDERS AEDECOD SEASONAL ALLERGY hierarchical N N 86 86 0 <NULL> <NULL> stat_1
66 TRT01A Placebo AESOC IMMUNE SYSTEM DISORDERS AEDECOD SEASONAL ALLERGY hierarchical p % 0 0.0 <fn> <NULL> <NULL> stat_1
67 TRT01A Xanomeline High Dose AESOC IMMUNE SYSTEM DISORDERS AEDECOD SEASONAL ALLERGY hierarchical n n 1 1 0 <NULL> <NULL> stat_2
68 TRT01A Xanomeline High Dose AESOC IMMUNE SYSTEM DISORDERS AEDECOD SEASONAL ALLERGY hierarchical N N 72 72 0 <NULL> <NULL> stat_2
69 TRT01A Xanomeline High Dose AESOC IMMUNE SYSTEM DISORDERS AEDECOD SEASONAL ALLERGY hierarchical p % 0.0139 1.4 <fn> <NULL> <NULL> stat_2
70 TRT01A Xanomeline Low Dose AESOC IMMUNE SYSTEM DISORDERS AEDECOD SEASONAL ALLERGY hierarchical n n 0 0 0 <NULL> <NULL> stat_3
71 TRT01A Xanomeline Low Dose AESOC IMMUNE SYSTEM DISORDERS AEDECOD SEASONAL ALLERGY hierarchical N N 96 96 0 <NULL> <NULL> stat_3
72 TRT01A Xanomeline Low Dose AESOC IMMUNE SYSTEM DISORDERS AEDECOD SEASONAL ALLERGY hierarchical p % 0 0.0 <fn> <NULL> <NULL> stat_3
73 TRT01A Placebo <NA> <NULL> AESOC NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) hierarchical n n 0 0 0 <NULL> <NULL> stat_1
74 TRT01A Placebo <NA> <NULL> AESOC NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) hierarchical N N 86 86 0 <NULL> <NULL> stat_1
75 TRT01A Placebo <NA> <NULL> AESOC NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) hierarchical p % 0 0.0 <fn> <NULL> <NULL> stat_1
76 TRT01A Xanomeline High Dose <NA> <NULL> AESOC NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) hierarchical n n 1 1 0 <NULL> <NULL> stat_2
77 TRT01A Xanomeline High Dose <NA> <NULL> AESOC NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) hierarchical N N 72 72 0 <NULL> <NULL> stat_2
78 TRT01A Xanomeline High Dose <NA> <NULL> AESOC NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) hierarchical p % 0.0139 1.4 <fn> <NULL> <NULL> stat_2
79 TRT01A Xanomeline Low Dose <NA> <NULL> AESOC NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) hierarchical n n 2 2 0 <NULL> <NULL> stat_3
80 TRT01A Xanomeline Low Dose <NA> <NULL> AESOC NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) hierarchical N N 96 96 0 <NULL> <NULL> stat_3
81 TRT01A Xanomeline Low Dose <NA> <NULL> AESOC NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) hierarchical p % 0.0208 2.1 <fn> <NULL> <NULL> stat_3
82 TRT01A Placebo AESOC NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) AEDECOD COLON CANCER hierarchical n n 0 0 0 <NULL> <NULL> stat_1
83 TRT01A Placebo AESOC NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) AEDECOD COLON CANCER hierarchical N N 86 86 0 <NULL> <NULL> stat_1
84 TRT01A Placebo AESOC NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) AEDECOD COLON CANCER hierarchical p % 0 0.0 <fn> <NULL> <NULL> stat_1
85 TRT01A Xanomeline High Dose AESOC NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) AEDECOD COLON CANCER hierarchical n n 0 0 0 <NULL> <NULL> stat_2
86 TRT01A Xanomeline High Dose AESOC NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) AEDECOD COLON CANCER hierarchical N N 72 72 0 <NULL> <NULL> stat_2
87 TRT01A Xanomeline High Dose AESOC NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) AEDECOD COLON CANCER hierarchical p % 0 0.0 <fn> <NULL> <NULL> stat_2
88 TRT01A Xanomeline Low Dose AESOC NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) AEDECOD COLON CANCER hierarchical n n 1 1 0 <NULL> <NULL> stat_3
89 TRT01A Xanomeline Low Dose AESOC NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) AEDECOD COLON CANCER hierarchical N N 96 96 0 <NULL> <NULL> stat_3
90 TRT01A Xanomeline Low Dose AESOC NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) AEDECOD COLON CANCER hierarchical p % 0.0104 1.0 <fn> <NULL> <NULL> stat_3
91 TRT01A Placebo AESOC NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) AEDECOD MALIGNANT FIBROUS HISTIOCYTOMA hierarchical n n 0 0 0 <NULL> <NULL> stat_1
92 TRT01A Placebo AESOC NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) AEDECOD MALIGNANT FIBROUS HISTIOCYTOMA hierarchical N N 86 86 0 <NULL> <NULL> stat_1
93 TRT01A Placebo AESOC NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) AEDECOD MALIGNANT FIBROUS HISTIOCYTOMA hierarchical p % 0 0.0 <fn> <NULL> <NULL> stat_1
94 TRT01A Xanomeline High Dose AESOC NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) AEDECOD MALIGNANT FIBROUS HISTIOCYTOMA hierarchical n n 0 0 0 <NULL> <NULL> stat_2
95 TRT01A Xanomeline High Dose AESOC NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) AEDECOD MALIGNANT FIBROUS HISTIOCYTOMA hierarchical N N 72 72 0 <NULL> <NULL> stat_2
96 TRT01A Xanomeline High Dose AESOC NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) AEDECOD MALIGNANT FIBROUS HISTIOCYTOMA hierarchical p % 0 0.0 <fn> <NULL> <NULL> stat_2
97 TRT01A Xanomeline Low Dose AESOC NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) AEDECOD MALIGNANT FIBROUS HISTIOCYTOMA hierarchical n n 1 1 0 <NULL> <NULL> stat_3
98 TRT01A Xanomeline Low Dose AESOC NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) AEDECOD MALIGNANT FIBROUS HISTIOCYTOMA hierarchical N N 96 96 0 <NULL> <NULL> stat_3
99 TRT01A Xanomeline Low Dose AESOC NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) AEDECOD MALIGNANT FIBROUS HISTIOCYTOMA hierarchical p % 0.0104 1.0 <fn> <NULL> <NULL> stat_3
100 TRT01A Placebo AESOC NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) AEDECOD PROSTATE CANCER hierarchical n n 0 0 0 <NULL> <NULL> stat_1
101 TRT01A Placebo AESOC NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) AEDECOD PROSTATE CANCER hierarchical N N 86 86 0 <NULL> <NULL> stat_1
102 TRT01A Placebo AESOC NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) AEDECOD PROSTATE CANCER hierarchical p % 0 0.0 <fn> <NULL> <NULL> stat_1
103 TRT01A Xanomeline High Dose AESOC NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) AEDECOD PROSTATE CANCER hierarchical n n 1 1 0 <NULL> <NULL> stat_2
104 TRT01A Xanomeline High Dose AESOC NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) AEDECOD PROSTATE CANCER hierarchical N N 72 72 0 <NULL> <NULL> stat_2
105 TRT01A Xanomeline High Dose AESOC NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) AEDECOD PROSTATE CANCER hierarchical p % 0.0139 1.4 <fn> <NULL> <NULL> stat_2
106 TRT01A Xanomeline Low Dose AESOC NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) AEDECOD PROSTATE CANCER hierarchical n n 0 0 0 <NULL> <NULL> stat_3
107 TRT01A Xanomeline Low Dose AESOC NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) AEDECOD PROSTATE CANCER hierarchical N N 96 96 0 <NULL> <NULL> stat_3
108 TRT01A Xanomeline Low Dose AESOC NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) AEDECOD PROSTATE CANCER hierarchical p % 0 0.0 <fn> <NULL> <NULL> stat_3
109 TRT01A Placebo <NA> <NULL> AESOC SOCIAL CIRCUMSTANCES hierarchical n n 0 0 0 <NULL> <NULL> stat_1
110 TRT01A Placebo <NA> <NULL> AESOC SOCIAL CIRCUMSTANCES hierarchical N N 86 86 0 <NULL> <NULL> stat_1
111 TRT01A Placebo <NA> <NULL> AESOC SOCIAL CIRCUMSTANCES hierarchical p % 0 0.0 <fn> <NULL> <NULL> stat_1
112 TRT01A Xanomeline High Dose <NA> <NULL> AESOC SOCIAL CIRCUMSTANCES hierarchical n n 1 1 0 <NULL> <NULL> stat_2
113 TRT01A Xanomeline High Dose <NA> <NULL> AESOC SOCIAL CIRCUMSTANCES hierarchical N N 72 72 0 <NULL> <NULL> stat_2
114 TRT01A Xanomeline High Dose <NA> <NULL> AESOC SOCIAL CIRCUMSTANCES hierarchical p % 0.0139 1.4 <fn> <NULL> <NULL> stat_2
115 TRT01A Xanomeline Low Dose <NA> <NULL> AESOC SOCIAL CIRCUMSTANCES hierarchical n n 0 0 0 <NULL> <NULL> stat_3
116 TRT01A Xanomeline Low Dose <NA> <NULL> AESOC SOCIAL CIRCUMSTANCES hierarchical N N 96 96 0 <NULL> <NULL> stat_3
117 TRT01A Xanomeline Low Dose <NA> <NULL> AESOC SOCIAL CIRCUMSTANCES hierarchical p % 0 0.0 <fn> <NULL> <NULL> stat_3
118 TRT01A Placebo AESOC SOCIAL CIRCUMSTANCES AEDECOD ALCOHOL USE hierarchical n n 0 0 0 <NULL> <NULL> stat_1
119 TRT01A Placebo AESOC SOCIAL CIRCUMSTANCES AEDECOD ALCOHOL USE hierarchical N N 86 86 0 <NULL> <NULL> stat_1
120 TRT01A Placebo AESOC SOCIAL CIRCUMSTANCES AEDECOD ALCOHOL USE hierarchical p % 0 0.0 <fn> <NULL> <NULL> stat_1
121 TRT01A Xanomeline High Dose AESOC SOCIAL CIRCUMSTANCES AEDECOD ALCOHOL USE hierarchical n n 1 1 0 <NULL> <NULL> stat_2
122 TRT01A Xanomeline High Dose AESOC SOCIAL CIRCUMSTANCES AEDECOD ALCOHOL USE hierarchical N N 72 72 0 <NULL> <NULL> stat_2
123 TRT01A Xanomeline High Dose AESOC SOCIAL CIRCUMSTANCES AEDECOD ALCOHOL USE hierarchical p % 0.0139 1.4 <fn> <NULL> <NULL> stat_2
124 TRT01A Xanomeline Low Dose AESOC SOCIAL CIRCUMSTANCES AEDECOD ALCOHOL USE hierarchical n n 0 0 0 <NULL> <NULL> stat_3
125 TRT01A Xanomeline Low Dose AESOC SOCIAL CIRCUMSTANCES AEDECOD ALCOHOL USE hierarchical N N 96 96 0 <NULL> <NULL> stat_3
126 TRT01A Xanomeline Low Dose AESOC SOCIAL CIRCUMSTANCES AEDECOD ALCOHOL USE hierarchical p % 0 0.0 <fn> <NULL> <NULL> stat_3