Subjects With Common Adverse Events Occurring at ≥X% Frequency by Preferred Term, Safety Population, Pooled Analysis (or Trial X)
FDA Table 15
table
FDA
safety
adverse events
FDA IG Shell
Programming Notes
Background and Instructions
For Table 15: Subjects With Common Adverse Events, 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. After analyzing this table, clinical reviewer should refer to Table 14: Subjects With Adverse Events by System Organ Class and Preferred Term, Safety Population, Pooled Analysis (or Trial X) to view the entire table of AEs and to support product labeling section 6.1 “Adverse Reactions - Clinical Studies Experience.”
Customization
Discuss the percent frequency cutoff with the CDS.
If the review team wishes to summarize the within-arm summary of incidence using an incidence rate rather than cumulative incidence, then an example table such as Table 16: Incidence Rate Analysis would be created that depicts that incidence rate for each treatment arm, as well as the rate difference.
Output
Code
# FDA TABLE 15 ---------------------------------------------------------------
# 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
data <- adae |>
filter(
# safety population
SAFFL == "Y"
)
tbl <-
tbl_hierarchical(
data,
variables = c(AEDECOD),
by = TRT01A,
id = USUBJID,
denominator = adsl,
label = AEDECOD ~ "**Preferred Term**"
) |>
# filter for >=5% frequency
filter_hierarchical(sum(n) / sum(N) >= 0.05)
ard <- gtsummary::gather_ard(tbl)| ****Preferred Term**** |
Placebo N = 861 |
Xanomeline High Dose N = 721 |
Xanomeline Low Dose N = 961 |
|---|---|---|---|
| APPLICATION SITE DERMATITIS | 5 (5.8%) | 7 (9.7%) | 9 (9.4%) |
| APPLICATION SITE ERYTHEMA | 3 (3.5%) | 14 (19%) | 13 (14%) |
| APPLICATION SITE IRRITATION | 3 (3.5%) | 9 (13%) | 9 (9.4%) |
| APPLICATION SITE PRURITUS | 6 (7.0%) | 21 (29%) | 23 (24%) |
| COUGH | 3 (3.5%) | 5 (6.9%) | 6 (6.3%) |
| DIARRHOEA | 9 (10%) | 3 (4.2%) | 6 (6.3%) |
| DIZZINESS | 2 (2.3%) | 11 (15%) | 9 (9.4%) |
| ERYTHEMA | 9 (10%) | 14 (19%) | 15 (16%) |
| HEADACHE | 7 (8.1%) | 6 (8.3%) | 3 (3.1%) |
| HYPERHIDROSIS | 2 (2.3%) | 8 (11%) | 4 (4.2%) |
| PRURITUS | 8 (9.3%) | 26 (36%) | 23 (24%) |
| RASH | 5 (5.8%) | 11 (15%) | 13 (14%) |
| SINUS BRADYCARDIA | 2 (2.3%) | 8 (11%) | 7 (7.3%) |
| SKIN IRRITATION | 3 (3.5%) | 5 (6.9%) | 6 (6.3%) |
| VOMITING | 3 (3.5%) | 6 (8.3%) | 4 (4.2%) |
| 1 n (%) | |||
$tbl_hierarchical
# An ARD data frame: 144 × 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 AEDECOD APPLICATION SITE DERMATITIS hierarchical n n 5 5 <fn> <NULL> <NULL> stat_1
11 TRT01A Placebo AEDECOD APPLICATION SITE DERMATITIS hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
12 TRT01A Placebo AEDECOD APPLICATION SITE DERMATITIS hierarchical p % 0.0581 5.8 <fn> <NULL> <NULL> stat_1
13 TRT01A Xanomeline High Dose AEDECOD APPLICATION SITE DERMATITIS hierarchical n n 7 7 <fn> <NULL> <NULL> stat_2
14 TRT01A Xanomeline High Dose AEDECOD APPLICATION SITE DERMATITIS hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
15 TRT01A Xanomeline High Dose AEDECOD APPLICATION SITE DERMATITIS hierarchical p % 0.0972 9.7 <fn> <NULL> <NULL> stat_2
16 TRT01A Xanomeline Low Dose AEDECOD APPLICATION SITE DERMATITIS hierarchical n n 9 9 <fn> <NULL> <NULL> stat_3
17 TRT01A Xanomeline Low Dose AEDECOD APPLICATION SITE DERMATITIS hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
18 TRT01A Xanomeline Low Dose AEDECOD APPLICATION SITE DERMATITIS hierarchical p % 0.0938 9.4 <fn> <NULL> <NULL> stat_3
19 TRT01A Placebo AEDECOD APPLICATION SITE ERYTHEMA hierarchical n n 3 3 <fn> <NULL> <NULL> stat_1
20 TRT01A Placebo AEDECOD APPLICATION SITE ERYTHEMA hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
21 TRT01A Placebo AEDECOD APPLICATION SITE ERYTHEMA hierarchical p % 0.0349 3.5 <fn> <NULL> <NULL> stat_1
22 TRT01A Xanomeline High Dose AEDECOD APPLICATION SITE ERYTHEMA hierarchical n n 14 14 <fn> <NULL> <NULL> stat_2
23 TRT01A Xanomeline High Dose AEDECOD APPLICATION SITE ERYTHEMA hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
24 TRT01A Xanomeline High Dose AEDECOD APPLICATION SITE ERYTHEMA hierarchical p % 0.194 19 <fn> <NULL> <NULL> stat_2
25 TRT01A Xanomeline Low Dose AEDECOD APPLICATION SITE ERYTHEMA hierarchical n n 13 13 <fn> <NULL> <NULL> stat_3
26 TRT01A Xanomeline Low Dose AEDECOD APPLICATION SITE ERYTHEMA hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
27 TRT01A Xanomeline Low Dose AEDECOD APPLICATION SITE ERYTHEMA hierarchical p % 0.135 14 <fn> <NULL> <NULL> stat_3
28 TRT01A Placebo AEDECOD APPLICATION SITE IRRITATION hierarchical n n 3 3 <fn> <NULL> <NULL> stat_1
29 TRT01A Placebo AEDECOD APPLICATION SITE IRRITATION hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
30 TRT01A Placebo AEDECOD APPLICATION SITE IRRITATION hierarchical p % 0.0349 3.5 <fn> <NULL> <NULL> stat_1
31 TRT01A Xanomeline High Dose AEDECOD APPLICATION SITE IRRITATION hierarchical n n 9 9 <fn> <NULL> <NULL> stat_2
32 TRT01A Xanomeline High Dose AEDECOD APPLICATION SITE IRRITATION hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
33 TRT01A Xanomeline High Dose AEDECOD APPLICATION SITE IRRITATION hierarchical p % 0.125 13 <fn> <NULL> <NULL> stat_2
34 TRT01A Xanomeline Low Dose AEDECOD APPLICATION SITE IRRITATION hierarchical n n 9 9 <fn> <NULL> <NULL> stat_3
35 TRT01A Xanomeline Low Dose AEDECOD APPLICATION SITE IRRITATION hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
36 TRT01A Xanomeline Low Dose AEDECOD APPLICATION SITE IRRITATION hierarchical p % 0.0938 9.4 <fn> <NULL> <NULL> stat_3
37 TRT01A Placebo AEDECOD APPLICATION SITE PRURITUS hierarchical n n 6 6 <fn> <NULL> <NULL> stat_1
38 TRT01A Placebo AEDECOD APPLICATION SITE PRURITUS hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
39 TRT01A Placebo AEDECOD APPLICATION SITE PRURITUS hierarchical p % 0.0698 7.0 <fn> <NULL> <NULL> stat_1
40 TRT01A Xanomeline High Dose AEDECOD APPLICATION SITE PRURITUS hierarchical n n 21 21 <fn> <NULL> <NULL> stat_2
41 TRT01A Xanomeline High Dose AEDECOD APPLICATION SITE PRURITUS hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
42 TRT01A Xanomeline High Dose AEDECOD APPLICATION SITE PRURITUS hierarchical p % 0.292 29 <fn> <NULL> <NULL> stat_2
43 TRT01A Xanomeline Low Dose AEDECOD APPLICATION SITE PRURITUS hierarchical n n 23 23 <fn> <NULL> <NULL> stat_3
44 TRT01A Xanomeline Low Dose AEDECOD APPLICATION SITE PRURITUS hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
45 TRT01A Xanomeline Low Dose AEDECOD APPLICATION SITE PRURITUS hierarchical p % 0.240 24 <fn> <NULL> <NULL> stat_3
46 TRT01A Placebo AEDECOD COUGH hierarchical n n 3 3 <fn> <NULL> <NULL> stat_1
47 TRT01A Placebo AEDECOD COUGH hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
48 TRT01A Placebo AEDECOD COUGH hierarchical p % 0.0349 3.5 <fn> <NULL> <NULL> stat_1
49 TRT01A Xanomeline High Dose AEDECOD COUGH hierarchical n n 5 5 <fn> <NULL> <NULL> stat_2
50 TRT01A Xanomeline High Dose AEDECOD COUGH hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
51 TRT01A Xanomeline High Dose AEDECOD COUGH hierarchical p % 0.0694 6.9 <fn> <NULL> <NULL> stat_2
52 TRT01A Xanomeline Low Dose AEDECOD COUGH hierarchical n n 6 6 <fn> <NULL> <NULL> stat_3
53 TRT01A Xanomeline Low Dose AEDECOD COUGH hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
54 TRT01A Xanomeline Low Dose AEDECOD COUGH hierarchical p % 0.0625 6.3 <fn> <NULL> <NULL> stat_3
55 TRT01A Placebo AEDECOD DIARRHOEA hierarchical n n 9 9 <fn> <NULL> <NULL> stat_1
56 TRT01A Placebo AEDECOD DIARRHOEA hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
57 TRT01A Placebo AEDECOD DIARRHOEA hierarchical p % 0.105 10 <fn> <NULL> <NULL> stat_1
58 TRT01A Xanomeline High Dose AEDECOD DIARRHOEA hierarchical n n 3 3 <fn> <NULL> <NULL> stat_2
59 TRT01A Xanomeline High Dose AEDECOD DIARRHOEA hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
60 TRT01A Xanomeline High Dose AEDECOD DIARRHOEA hierarchical p % 0.0417 4.2 <fn> <NULL> <NULL> stat_2
61 TRT01A Xanomeline Low Dose AEDECOD DIARRHOEA hierarchical n n 6 6 <fn> <NULL> <NULL> stat_3
62 TRT01A Xanomeline Low Dose AEDECOD DIARRHOEA hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
63 TRT01A Xanomeline Low Dose AEDECOD DIARRHOEA hierarchical p % 0.0625 6.3 <fn> <NULL> <NULL> stat_3
64 TRT01A Placebo AEDECOD DIZZINESS hierarchical n n 2 2 <fn> <NULL> <NULL> stat_1
65 TRT01A Placebo AEDECOD DIZZINESS hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
66 TRT01A Placebo AEDECOD DIZZINESS hierarchical p % 0.0233 2.3 <fn> <NULL> <NULL> stat_1
67 TRT01A Xanomeline High Dose AEDECOD DIZZINESS hierarchical n n 11 11 <fn> <NULL> <NULL> stat_2
68 TRT01A Xanomeline High Dose AEDECOD DIZZINESS hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
69 TRT01A Xanomeline High Dose AEDECOD DIZZINESS hierarchical p % 0.153 15 <fn> <NULL> <NULL> stat_2
70 TRT01A Xanomeline Low Dose AEDECOD DIZZINESS hierarchical n n 9 9 <fn> <NULL> <NULL> stat_3
71 TRT01A Xanomeline Low Dose AEDECOD DIZZINESS hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
72 TRT01A Xanomeline Low Dose AEDECOD DIZZINESS hierarchical p % 0.0938 9.4 <fn> <NULL> <NULL> stat_3
73 TRT01A Placebo AEDECOD ERYTHEMA hierarchical n n 9 9 <fn> <NULL> <NULL> stat_1
74 TRT01A Placebo AEDECOD ERYTHEMA hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
75 TRT01A Placebo AEDECOD ERYTHEMA hierarchical p % 0.105 10 <fn> <NULL> <NULL> stat_1
76 TRT01A Xanomeline High Dose AEDECOD ERYTHEMA hierarchical n n 14 14 <fn> <NULL> <NULL> stat_2
77 TRT01A Xanomeline High Dose AEDECOD ERYTHEMA hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
78 TRT01A Xanomeline High Dose AEDECOD ERYTHEMA hierarchical p % 0.194 19 <fn> <NULL> <NULL> stat_2
79 TRT01A Xanomeline Low Dose AEDECOD ERYTHEMA hierarchical n n 15 15 <fn> <NULL> <NULL> stat_3
80 TRT01A Xanomeline Low Dose AEDECOD ERYTHEMA hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
81 TRT01A Xanomeline Low Dose AEDECOD ERYTHEMA hierarchical p % 0.156 16 <fn> <NULL> <NULL> stat_3
82 TRT01A Placebo AEDECOD HEADACHE hierarchical n n 7 7 <fn> <NULL> <NULL> stat_1
83 TRT01A Placebo AEDECOD HEADACHE hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
84 TRT01A Placebo AEDECOD HEADACHE hierarchical p % 0.0814 8.1 <fn> <NULL> <NULL> stat_1
85 TRT01A Xanomeline High Dose AEDECOD HEADACHE hierarchical n n 6 6 <fn> <NULL> <NULL> stat_2
86 TRT01A Xanomeline High Dose AEDECOD HEADACHE hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
87 TRT01A Xanomeline High Dose AEDECOD HEADACHE hierarchical p % 0.0833 8.3 <fn> <NULL> <NULL> stat_2
88 TRT01A Xanomeline Low Dose AEDECOD HEADACHE hierarchical n n 3 3 <fn> <NULL> <NULL> stat_3
89 TRT01A Xanomeline Low Dose AEDECOD HEADACHE hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
90 TRT01A Xanomeline Low Dose AEDECOD HEADACHE hierarchical p % 0.0312 3.1 <fn> <NULL> <NULL> stat_3
91 TRT01A Placebo AEDECOD HYPERHIDROSIS hierarchical n n 2 2 <fn> <NULL> <NULL> stat_1
92 TRT01A Placebo AEDECOD HYPERHIDROSIS hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
93 TRT01A Placebo AEDECOD HYPERHIDROSIS hierarchical p % 0.0233 2.3 <fn> <NULL> <NULL> stat_1
94 TRT01A Xanomeline High Dose AEDECOD HYPERHIDROSIS hierarchical n n 8 8 <fn> <NULL> <NULL> stat_2
95 TRT01A Xanomeline High Dose AEDECOD HYPERHIDROSIS hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
96 TRT01A Xanomeline High Dose AEDECOD HYPERHIDROSIS hierarchical p % 0.111 11 <fn> <NULL> <NULL> stat_2
97 TRT01A Xanomeline Low Dose AEDECOD HYPERHIDROSIS hierarchical n n 4 4 <fn> <NULL> <NULL> stat_3
98 TRT01A Xanomeline Low Dose AEDECOD HYPERHIDROSIS hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
99 TRT01A Xanomeline Low Dose AEDECOD HYPERHIDROSIS hierarchical p % 0.0417 4.2 <fn> <NULL> <NULL> stat_3
100 TRT01A Placebo AEDECOD PRURITUS hierarchical n n 8 8 <fn> <NULL> <NULL> stat_1
101 TRT01A Placebo AEDECOD PRURITUS hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
102 TRT01A Placebo AEDECOD PRURITUS hierarchical p % 0.0930 9.3 <fn> <NULL> <NULL> stat_1
103 TRT01A Xanomeline High Dose AEDECOD PRURITUS hierarchical n n 26 26 <fn> <NULL> <NULL> stat_2
104 TRT01A Xanomeline High Dose AEDECOD PRURITUS hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
105 TRT01A Xanomeline High Dose AEDECOD PRURITUS hierarchical p % 0.361 36 <fn> <NULL> <NULL> stat_2
106 TRT01A Xanomeline Low Dose AEDECOD PRURITUS hierarchical n n 23 23 <fn> <NULL> <NULL> stat_3
107 TRT01A Xanomeline Low Dose AEDECOD PRURITUS hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
108 TRT01A Xanomeline Low Dose AEDECOD PRURITUS hierarchical p % 0.240 24 <fn> <NULL> <NULL> stat_3
109 TRT01A Placebo AEDECOD RASH hierarchical n n 5 5 <fn> <NULL> <NULL> stat_1
110 TRT01A Placebo AEDECOD RASH hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
111 TRT01A Placebo AEDECOD RASH hierarchical p % 0.0581 5.8 <fn> <NULL> <NULL> stat_1
112 TRT01A Xanomeline High Dose AEDECOD RASH hierarchical n n 11 11 <fn> <NULL> <NULL> stat_2
113 TRT01A Xanomeline High Dose AEDECOD RASH hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
114 TRT01A Xanomeline High Dose AEDECOD RASH hierarchical p % 0.153 15 <fn> <NULL> <NULL> stat_2
115 TRT01A Xanomeline Low Dose AEDECOD RASH hierarchical n n 13 13 <fn> <NULL> <NULL> stat_3
116 TRT01A Xanomeline Low Dose AEDECOD RASH hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
117 TRT01A Xanomeline Low Dose AEDECOD RASH hierarchical p % 0.135 14 <fn> <NULL> <NULL> stat_3
118 TRT01A Placebo AEDECOD SINUS BRADYCARDIA hierarchical n n 2 2 <fn> <NULL> <NULL> stat_1
119 TRT01A Placebo AEDECOD SINUS BRADYCARDIA hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
120 TRT01A Placebo AEDECOD SINUS BRADYCARDIA hierarchical p % 0.0233 2.3 <fn> <NULL> <NULL> stat_1
121 TRT01A Xanomeline High Dose AEDECOD SINUS BRADYCARDIA hierarchical n n 8 8 <fn> <NULL> <NULL> stat_2
122 TRT01A Xanomeline High Dose AEDECOD SINUS BRADYCARDIA hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
123 TRT01A Xanomeline High Dose AEDECOD SINUS BRADYCARDIA hierarchical p % 0.111 11 <fn> <NULL> <NULL> stat_2
124 TRT01A Xanomeline Low Dose AEDECOD SINUS BRADYCARDIA hierarchical n n 7 7 <fn> <NULL> <NULL> stat_3
125 TRT01A Xanomeline Low Dose AEDECOD SINUS BRADYCARDIA hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
126 TRT01A Xanomeline Low Dose AEDECOD SINUS BRADYCARDIA hierarchical p % 0.0729 7.3 <fn> <NULL> <NULL> stat_3
127 TRT01A Placebo AEDECOD SKIN IRRITATION hierarchical n n 3 3 <fn> <NULL> <NULL> stat_1
128 TRT01A Placebo AEDECOD SKIN IRRITATION hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
129 TRT01A Placebo AEDECOD SKIN IRRITATION hierarchical p % 0.0349 3.5 <fn> <NULL> <NULL> stat_1
130 TRT01A Xanomeline High Dose AEDECOD SKIN IRRITATION hierarchical n n 5 5 <fn> <NULL> <NULL> stat_2
131 TRT01A Xanomeline High Dose AEDECOD SKIN IRRITATION hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
132 TRT01A Xanomeline High Dose AEDECOD SKIN IRRITATION hierarchical p % 0.0694 6.9 <fn> <NULL> <NULL> stat_2
133 TRT01A Xanomeline Low Dose AEDECOD SKIN IRRITATION hierarchical n n 6 6 <fn> <NULL> <NULL> stat_3
134 TRT01A Xanomeline Low Dose AEDECOD SKIN IRRITATION hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
135 TRT01A Xanomeline Low Dose AEDECOD SKIN IRRITATION hierarchical p % 0.0625 6.3 <fn> <NULL> <NULL> stat_3
136 TRT01A Placebo AEDECOD VOMITING hierarchical n n 3 3 <fn> <NULL> <NULL> stat_1
137 TRT01A Placebo AEDECOD VOMITING hierarchical N N 86 86 <fn> <NULL> <NULL> stat_1
138 TRT01A Placebo AEDECOD VOMITING hierarchical p % 0.0349 3.5 <fn> <NULL> <NULL> stat_1
139 TRT01A Xanomeline High Dose AEDECOD VOMITING hierarchical n n 6 6 <fn> <NULL> <NULL> stat_2
140 TRT01A Xanomeline High Dose AEDECOD VOMITING hierarchical N N 72 72 <fn> <NULL> <NULL> stat_2
141 TRT01A Xanomeline High Dose AEDECOD VOMITING hierarchical p % 0.0833 8.3 <fn> <NULL> <NULL> stat_2
142 TRT01A Xanomeline Low Dose AEDECOD VOMITING hierarchical n n 4 4 <fn> <NULL> <NULL> stat_3
143 TRT01A Xanomeline Low Dose AEDECOD VOMITING hierarchical N N 96 96 <fn> <NULL> <NULL> stat_3
144 TRT01A Xanomeline Low Dose AEDECOD VOMITING hierarchical p % 0.0417 4.2 <fn> <NULL> <NULL> stat_3