Demographics and Baseline Clinical Characteristics, Safety Population, Pooled Analysis (or Trial X)
FDA Table 02
table
FDA
safety
demographics
FDA IG Shell
Programming Notes
Background and Instructions
For Table 2: Demographics and Baseline Clinical Characteristics, consider the key baseline characteristics and subpopulations with different disease characteristics that could influence the effectiveness or safety of the drug. The latter may include baseline entry criteria and other specific characteristics that were recorded but not considered as entry criteria, such as duration, stage, or severity of disease; a history of failure on particular treatments; comorbid conditions; use of relevant concomitant medications; risk factors; or baseline laboratory measurements not part of the entry criteria (e.g., LDL cholesterol, C-reactive protein levels, kidney function, or hepatic function) that could affect safety. Depending on the geographic makeup of the trial, the region of participation rather than country may be included.
Table 2 is typically generated for each trial listed in Table 1: Clinical Trials Submitted in Support of Efficacy and Safety. When there is missing data in one of the demographic categories, a row labeled as “Missing” will be included in this table and explanatory footnotes added. The table currently displays placeholder values for the characteristics. These placeholder values will change to reflect the data from the respective clinical trial. Demographic characteristics in this table will reflect the Clinical Data Interchange Standards Consortium (CDISC) controlled terminology when submitted data conforms to CDISC data standards.
Customization
In addition to the standard groupings, the clinical reviewer may request custom age groups (e.g., <45, 45 to <65 years, etc.), additional baseline characteristics (e.g., anthropometric measurements such as body mass index [BMI], disease characteristics such as medical history of diabetes) to be displayed as needed. For trials that include older subjects (e.g., Alzheimer’s disease trials), additional geriatric age subgroups may be included (e.g., 65 to 74 years of age, 75 to 84 years of age, and 85 years of age and older). Refer to the guidance for industry E7 Studies in Support of Special Populations: Geriatrics, Questions and Answers (March 2012).
Output
Code
# FDA TABLE 02 ---------------------------------------------------------------
# Self-contained template. Run top-to-bottom to build the objects below.
# Used by tests via run_template() and published in the catalog.
library(cardinalfda)
library(dplyr)
adsl <- pharmaverseadam::adsl |>
# removing screen failure observations
filter(TRT01A != "Screen Failure")
tbl <- adsl |>
dplyr::filter(SAFFL == "Y") |>
gtsummary::tbl_summary(
by = dplyr::all_of("TRT01A"),
include = dplyr::all_of(c("SEX", "AGE", "AGEGR1", "ETHNIC", "RACE")),
type = gtsummary::all_continuous() ~ "continuous2",
statistic = list(
gtsummary::all_continuous() ~ c(
"{mean} ({sd})",
"{median} ({min}, {max})"
),
gtsummary::all_categorical() ~ "{n} ({p}%)"
),
label = list(AGEGR1 = "Age Group, Years")
) |>
gtsummary::add_overall(last = TRUE, col_label = "**Total Population** \nN = {N}") |>
gtsummary::remove_footnote_header(columns = dplyr::everything())
ard <- gtsummary::gather_ard(tbl)| Characteristic |
Placebo N = 86 |
Xanomeline High Dose N = 72 |
Xanomeline Low Dose N = 96 |
Total Population N = 254 |
|---|---|---|---|---|
| Sex | ||||
| F | 53 (62%) | 35 (49%) | 55 (57%) | 143 (56%) |
| M | 33 (38%) | 37 (51%) | 41 (43%) | 111 (44%) |
| Age | ||||
| Mean (SD) | 75 (9) | 74 (8) | 76 (8) | 75 (8) |
| Median (Min, Max) | 76 (52, 89) | 76 (56, 88) | 78 (51, 88) | 77 (51, 89) |
| Age Group, Years | ||||
| 18-64 | 14 (16%) | 11 (15%) | 8 (8.3%) | 33 (13%) |
| >64 | 72 (84%) | 61 (85%) | 88 (92%) | 221 (87%) |
| Ethnicity | ||||
| HISPANIC OR LATINO | 3 (3.5%) | 3 (4.2%) | 6 (6.3%) | 12 (4.7%) |
| NOT HISPANIC OR LATINO | 83 (97%) | 69 (96%) | 90 (94%) | 242 (95%) |
| Race | ||||
| AMERICAN INDIAN OR ALASKA NATIVE | 0 (0%) | 1 (1.4%) | 0 (0%) | 1 (0.4%) |
| BLACK OR AFRICAN AMERICAN | 8 (9.3%) | 9 (13%) | 6 (6.3%) | 23 (9.1%) |
| WHITE | 78 (91%) | 62 (86%) | 90 (94%) | 230 (91%) |
$tbl_summary
# An ARD data frame: 193 × 12
group1 group1_level variable variable_level context stat_name stat_label stat fmt_fun warning error gts_column
<chr> <list> <chr> <list> <chr> <chr> <chr> <list> <list> <list> <list> <chr>
1 TRT01A Placebo AGEGR1 18-64 tabulate n n 14 <fn> <NULL> <NULL> stat_1
2 TRT01A Placebo AGEGR1 18-64 tabulate N N 86 <fn> <NULL> <NULL> stat_1
3 TRT01A Placebo AGEGR1 18-64 tabulate p % 0.1627907 <fn> <NULL> <NULL> stat_1
4 TRT01A Placebo AGEGR1 >64 tabulate n n 72 <fn> <NULL> <NULL> stat_1
5 TRT01A Placebo AGEGR1 >64 tabulate N N 86 <fn> <NULL> <NULL> stat_1
6 TRT01A Placebo AGEGR1 >64 tabulate p % 0.8372093 <fn> <NULL> <NULL> stat_1
7 TRT01A Placebo SEX F tabulate n n 53 <fn> <NULL> <NULL> stat_1
8 TRT01A Placebo SEX F tabulate N N 86 <fn> <NULL> <NULL> stat_1
9 TRT01A Placebo SEX F tabulate p % 0.6162791 <fn> <NULL> <NULL> stat_1
10 TRT01A Placebo SEX M tabulate n n 33 <fn> <NULL> <NULL> stat_1
11 TRT01A Placebo SEX M tabulate N N 86 <fn> <NULL> <NULL> stat_1
12 TRT01A Placebo SEX M tabulate p % 0.3837209 <fn> <NULL> <NULL> stat_1
13 TRT01A Placebo RACE AMERICAN INDIAN OR ALASKA NATIVE tabulate n n 0 <fn> <NULL> <NULL> stat_1
14 TRT01A Placebo RACE AMERICAN INDIAN OR ALASKA NATIVE tabulate N N 86 <fn> <NULL> <NULL> stat_1
15 TRT01A Placebo RACE AMERICAN INDIAN OR ALASKA NATIVE tabulate p % 0 <fn> <NULL> <NULL> stat_1
16 TRT01A Placebo RACE BLACK OR AFRICAN AMERICAN tabulate n n 8 <fn> <NULL> <NULL> stat_1
17 TRT01A Placebo RACE BLACK OR AFRICAN AMERICAN tabulate N N 86 <fn> <NULL> <NULL> stat_1
18 TRT01A Placebo RACE BLACK OR AFRICAN AMERICAN tabulate p % 0.09302326 <fn> <NULL> <NULL> stat_1
19 TRT01A Placebo RACE WHITE tabulate n n 78 <fn> <NULL> <NULL> stat_1
20 TRT01A Placebo RACE WHITE tabulate N N 86 <fn> <NULL> <NULL> stat_1
21 TRT01A Placebo RACE WHITE tabulate p % 0.9069767 <fn> <NULL> <NULL> stat_1
22 TRT01A Placebo ETHNIC HISPANIC OR LATINO tabulate n n 3 <fn> <NULL> <NULL> stat_1
23 TRT01A Placebo ETHNIC HISPANIC OR LATINO tabulate N N 86 <fn> <NULL> <NULL> stat_1
24 TRT01A Placebo ETHNIC HISPANIC OR LATINO tabulate p % 0.03488372 <fn> <NULL> <NULL> stat_1
25 TRT01A Placebo ETHNIC NOT HISPANIC OR LATINO tabulate n n 83 <fn> <NULL> <NULL> stat_1
26 TRT01A Placebo ETHNIC NOT HISPANIC OR LATINO tabulate N N 86 <fn> <NULL> <NULL> stat_1
27 TRT01A Placebo ETHNIC NOT HISPANIC OR LATINO tabulate p % 0.9651163 <fn> <NULL> <NULL> stat_1
28 TRT01A Xanomeline High Dose AGEGR1 18-64 tabulate n n 11 <fn> <NULL> <NULL> stat_2
29 TRT01A Xanomeline High Dose AGEGR1 18-64 tabulate N N 72 <fn> <NULL> <NULL> stat_2
30 TRT01A Xanomeline High Dose AGEGR1 18-64 tabulate p % 0.1527778 <fn> <NULL> <NULL> stat_2
31 TRT01A Xanomeline High Dose AGEGR1 >64 tabulate n n 61 <fn> <NULL> <NULL> stat_2
32 TRT01A Xanomeline High Dose AGEGR1 >64 tabulate N N 72 <fn> <NULL> <NULL> stat_2
33 TRT01A Xanomeline High Dose AGEGR1 >64 tabulate p % 0.8472222 <fn> <NULL> <NULL> stat_2
34 TRT01A Xanomeline High Dose SEX F tabulate n n 35 <fn> <NULL> <NULL> stat_2
35 TRT01A Xanomeline High Dose SEX F tabulate N N 72 <fn> <NULL> <NULL> stat_2
36 TRT01A Xanomeline High Dose SEX F tabulate p % 0.4861111 <fn> <NULL> <NULL> stat_2
37 TRT01A Xanomeline High Dose SEX M tabulate n n 37 <fn> <NULL> <NULL> stat_2
38 TRT01A Xanomeline High Dose SEX M tabulate N N 72 <fn> <NULL> <NULL> stat_2
39 TRT01A Xanomeline High Dose SEX M tabulate p % 0.5138889 <fn> <NULL> <NULL> stat_2
40 TRT01A Xanomeline High Dose RACE AMERICAN INDIAN OR ALASKA NATIVE tabulate n n 1 <fn> <NULL> <NULL> stat_2
41 TRT01A Xanomeline High Dose RACE AMERICAN INDIAN OR ALASKA NATIVE tabulate N N 72 <fn> <NULL> <NULL> stat_2
42 TRT01A Xanomeline High Dose RACE AMERICAN INDIAN OR ALASKA NATIVE tabulate p % 0.01388889 <fn> <NULL> <NULL> stat_2
43 TRT01A Xanomeline High Dose RACE BLACK OR AFRICAN AMERICAN tabulate n n 9 <fn> <NULL> <NULL> stat_2
44 TRT01A Xanomeline High Dose RACE BLACK OR AFRICAN AMERICAN tabulate N N 72 <fn> <NULL> <NULL> stat_2
45 TRT01A Xanomeline High Dose RACE BLACK OR AFRICAN AMERICAN tabulate p % 0.125 <fn> <NULL> <NULL> stat_2
46 TRT01A Xanomeline High Dose RACE WHITE tabulate n n 62 <fn> <NULL> <NULL> stat_2
47 TRT01A Xanomeline High Dose RACE WHITE tabulate N N 72 <fn> <NULL> <NULL> stat_2
48 TRT01A Xanomeline High Dose RACE WHITE tabulate p % 0.8611111 <fn> <NULL> <NULL> stat_2
49 TRT01A Xanomeline High Dose ETHNIC HISPANIC OR LATINO tabulate n n 3 <fn> <NULL> <NULL> stat_2
50 TRT01A Xanomeline High Dose ETHNIC HISPANIC OR LATINO tabulate N N 72 <fn> <NULL> <NULL> stat_2
51 TRT01A Xanomeline High Dose ETHNIC HISPANIC OR LATINO tabulate p % 0.04166667 <fn> <NULL> <NULL> stat_2
52 TRT01A Xanomeline High Dose ETHNIC NOT HISPANIC OR LATINO tabulate n n 69 <fn> <NULL> <NULL> stat_2
53 TRT01A Xanomeline High Dose ETHNIC NOT HISPANIC OR LATINO tabulate N N 72 <fn> <NULL> <NULL> stat_2
54 TRT01A Xanomeline High Dose ETHNIC NOT HISPANIC OR LATINO tabulate p % 0.9583333 <fn> <NULL> <NULL> stat_2
55 TRT01A Xanomeline Low Dose AGEGR1 18-64 tabulate n n 8 <fn> <NULL> <NULL> stat_3
56 TRT01A Xanomeline Low Dose AGEGR1 18-64 tabulate N N 96 <fn> <NULL> <NULL> stat_3
57 TRT01A Xanomeline Low Dose AGEGR1 18-64 tabulate p % 0.08333333 <fn> <NULL> <NULL> stat_3
58 TRT01A Xanomeline Low Dose AGEGR1 >64 tabulate n n 88 <fn> <NULL> <NULL> stat_3
59 TRT01A Xanomeline Low Dose AGEGR1 >64 tabulate N N 96 <fn> <NULL> <NULL> stat_3
60 TRT01A Xanomeline Low Dose AGEGR1 >64 tabulate p % 0.9166667 <fn> <NULL> <NULL> stat_3
61 TRT01A Xanomeline Low Dose SEX F tabulate n n 55 <fn> <NULL> <NULL> stat_3
62 TRT01A Xanomeline Low Dose SEX F tabulate N N 96 <fn> <NULL> <NULL> stat_3
63 TRT01A Xanomeline Low Dose SEX F tabulate p % 0.5729167 <fn> <NULL> <NULL> stat_3
64 TRT01A Xanomeline Low Dose SEX M tabulate n n 41 <fn> <NULL> <NULL> stat_3
65 TRT01A Xanomeline Low Dose SEX M tabulate N N 96 <fn> <NULL> <NULL> stat_3
66 TRT01A Xanomeline Low Dose SEX M tabulate p % 0.4270833 <fn> <NULL> <NULL> stat_3
67 TRT01A Xanomeline Low Dose RACE AMERICAN INDIAN OR ALASKA NATIVE tabulate n n 0 <fn> <NULL> <NULL> stat_3
68 TRT01A Xanomeline Low Dose RACE AMERICAN INDIAN OR ALASKA NATIVE tabulate N N 96 <fn> <NULL> <NULL> stat_3
69 TRT01A Xanomeline Low Dose RACE AMERICAN INDIAN OR ALASKA NATIVE tabulate p % 0 <fn> <NULL> <NULL> stat_3
70 TRT01A Xanomeline Low Dose RACE BLACK OR AFRICAN AMERICAN tabulate n n 6 <fn> <NULL> <NULL> stat_3
71 TRT01A Xanomeline Low Dose RACE BLACK OR AFRICAN AMERICAN tabulate N N 96 <fn> <NULL> <NULL> stat_3
72 TRT01A Xanomeline Low Dose RACE BLACK OR AFRICAN AMERICAN tabulate p % 0.0625 <fn> <NULL> <NULL> stat_3
73 TRT01A Xanomeline Low Dose RACE WHITE tabulate n n 90 <fn> <NULL> <NULL> stat_3
74 TRT01A Xanomeline Low Dose RACE WHITE tabulate N N 96 <fn> <NULL> <NULL> stat_3
75 TRT01A Xanomeline Low Dose RACE WHITE tabulate p % 0.9375 <fn> <NULL> <NULL> stat_3
76 TRT01A Xanomeline Low Dose ETHNIC HISPANIC OR LATINO tabulate n n 6 <fn> <NULL> <NULL> stat_3
77 TRT01A Xanomeline Low Dose ETHNIC HISPANIC OR LATINO tabulate N N 96 <fn> <NULL> <NULL> stat_3
78 TRT01A Xanomeline Low Dose ETHNIC HISPANIC OR LATINO tabulate p % 0.0625 <fn> <NULL> <NULL> stat_3
79 TRT01A Xanomeline Low Dose ETHNIC NOT HISPANIC OR LATINO tabulate n n 90 <fn> <NULL> <NULL> stat_3
80 TRT01A Xanomeline Low Dose ETHNIC NOT HISPANIC OR LATINO tabulate N N 96 <fn> <NULL> <NULL> stat_3
81 TRT01A Xanomeline Low Dose ETHNIC NOT HISPANIC OR LATINO tabulate p % 0.9375 <fn> <NULL> <NULL> stat_3
82 TRT01A Placebo AGE <NULL> summary mean Mean 75.2093 <fn> <NULL> <NULL> stat_1
83 TRT01A Placebo AGE <NULL> summary sd SD 8.590167 <fn> <NULL> <NULL> stat_1
84 TRT01A Placebo AGE <NULL> summary median Median 76 <fn> <NULL> <NULL> stat_1
85 TRT01A Placebo AGE <NULL> summary min Min 52 <fn> <NULL> <NULL> stat_1
86 TRT01A Placebo AGE <NULL> summary max Max 89 <fn> <NULL> <NULL> stat_1
87 TRT01A Xanomeline High Dose AGE <NULL> summary mean Mean 73.77778 <fn> <NULL> <NULL> stat_2
88 TRT01A Xanomeline High Dose AGE <NULL> summary sd SD 7.943856 <fn> <NULL> <NULL> stat_2
89 TRT01A Xanomeline High Dose AGE <NULL> summary median Median 75.5 <fn> <NULL> <NULL> stat_2
90 TRT01A Xanomeline High Dose AGE <NULL> summary min Min 56 <fn> <NULL> <NULL> stat_2
91 TRT01A Xanomeline High Dose AGE <NULL> summary max Max 88 <fn> <NULL> <NULL> stat_2
92 TRT01A Xanomeline Low Dose AGE <NULL> summary mean Mean 75.95833 <fn> <NULL> <NULL> stat_3
93 TRT01A Xanomeline Low Dose AGE <NULL> summary sd SD 8.113558 <fn> <NULL> <NULL> stat_3
94 TRT01A Xanomeline Low Dose AGE <NULL> summary median Median 78 <fn> <NULL> <NULL> stat_3
95 TRT01A Xanomeline Low Dose AGE <NULL> summary min Min 51 <fn> <NULL> <NULL> stat_3
96 TRT01A Xanomeline Low Dose AGE <NULL> summary max Max 88 <fn> <NULL> <NULL> stat_3
97 <NA> <NULL> SEX <NULL> attributes label Variable Label Sex <fn> <NULL> <NULL> <NA>
98 <NA> <NULL> SEX <NULL> attributes class Variable Class character <NULL> <NULL> <NULL> <NA>
99 <NA> <NULL> AGE <NULL> attributes label Variable Label Age <fn> <NULL> <NULL> <NA>
100 <NA> <NULL> AGE <NULL> attributes class Variable Class numeric <NULL> <NULL> <NULL> <NA>
101 <NA> <NULL> AGEGR1 <NULL> attributes label Variable Label Age Group, Years <fn> <NULL> <NULL> <NA>
102 <NA> <NULL> AGEGR1 <NULL> attributes class Variable Class character <NULL> <NULL> <NULL> <NA>
103 <NA> <NULL> ETHNIC <NULL> attributes label Variable Label Ethnicity <fn> <NULL> <NULL> <NA>
104 <NA> <NULL> ETHNIC <NULL> attributes class Variable Class character <NULL> <NULL> <NULL> <NA>
105 <NA> <NULL> RACE <NULL> attributes label Variable Label Race <fn> <NULL> <NULL> <NA>
106 <NA> <NULL> RACE <NULL> attributes class Variable Class character <NULL> <NULL> <NULL> <NA>
107 <NA> <NULL> TRT01A <NULL> attributes label Variable Label Actual Treatment for Period 01 <fn> <NULL> <NULL> <NA>
108 <NA> <NULL> TRT01A <NULL> attributes class Variable Class character <NULL> <NULL> <NULL> <NA>
109 TRT01A Placebo SEX <NULL> missing N_obs No. obs. 86 <fn> <NULL> <NULL> stat_1
110 TRT01A Placebo SEX <NULL> missing N_miss N Missing 0 <fn> <NULL> <NULL> stat_1
111 TRT01A Placebo SEX <NULL> missing N_nonmiss N Non-missing 86 <fn> <NULL> <NULL> stat_1
112 TRT01A Placebo SEX <NULL> missing p_miss % Missing 0 <fn> <NULL> <NULL> stat_1
113 TRT01A Placebo SEX <NULL> missing p_nonmiss % Non-missing 1 <fn> <NULL> <NULL> stat_1
114 TRT01A Placebo AGE <NULL> missing N_obs No. obs. 86 <fn> <NULL> <NULL> stat_1
115 TRT01A Placebo AGE <NULL> missing N_miss N Missing 0 <fn> <NULL> <NULL> stat_1
116 TRT01A Placebo AGE <NULL> missing N_nonmiss N Non-missing 86 <fn> <NULL> <NULL> stat_1
117 TRT01A Placebo AGE <NULL> missing p_miss % Missing 0 <fn> <NULL> <NULL> stat_1
118 TRT01A Placebo AGE <NULL> missing p_nonmiss % Non-missing 1 <fn> <NULL> <NULL> stat_1
119 TRT01A Placebo AGEGR1 <NULL> missing N_obs No. obs. 86 <fn> <NULL> <NULL> stat_1
120 TRT01A Placebo AGEGR1 <NULL> missing N_miss N Missing 0 <fn> <NULL> <NULL> stat_1
121 TRT01A Placebo AGEGR1 <NULL> missing N_nonmiss N Non-missing 86 <fn> <NULL> <NULL> stat_1
122 TRT01A Placebo AGEGR1 <NULL> missing p_miss % Missing 0 <fn> <NULL> <NULL> stat_1
123 TRT01A Placebo AGEGR1 <NULL> missing p_nonmiss % Non-missing 1 <fn> <NULL> <NULL> stat_1
124 TRT01A Placebo ETHNIC <NULL> missing N_obs No. obs. 86 <fn> <NULL> <NULL> stat_1
125 TRT01A Placebo ETHNIC <NULL> missing N_miss N Missing 0 <fn> <NULL> <NULL> stat_1
126 TRT01A Placebo ETHNIC <NULL> missing N_nonmiss N Non-missing 86 <fn> <NULL> <NULL> stat_1
127 TRT01A Placebo ETHNIC <NULL> missing p_miss % Missing 0 <fn> <NULL> <NULL> stat_1
128 TRT01A Placebo ETHNIC <NULL> missing p_nonmiss % Non-missing 1 <fn> <NULL> <NULL> stat_1
129 TRT01A Placebo RACE <NULL> missing N_obs No. obs. 86 <fn> <NULL> <NULL> stat_1
130 TRT01A Placebo RACE <NULL> missing N_miss N Missing 0 <fn> <NULL> <NULL> stat_1
131 TRT01A Placebo RACE <NULL> missing N_nonmiss N Non-missing 86 <fn> <NULL> <NULL> stat_1
132 TRT01A Placebo RACE <NULL> missing p_miss % Missing 0 <fn> <NULL> <NULL> stat_1
133 TRT01A Placebo RACE <NULL> missing p_nonmiss % Non-missing 1 <fn> <NULL> <NULL> stat_1
134 TRT01A Xanomeline High Dose SEX <NULL> missing N_obs No. obs. 72 <fn> <NULL> <NULL> stat_2
135 TRT01A Xanomeline High Dose SEX <NULL> missing N_miss N Missing 0 <fn> <NULL> <NULL> stat_2
136 TRT01A Xanomeline High Dose SEX <NULL> missing N_nonmiss N Non-missing 72 <fn> <NULL> <NULL> stat_2
137 TRT01A Xanomeline High Dose SEX <NULL> missing p_miss % Missing 0 <fn> <NULL> <NULL> stat_2
138 TRT01A Xanomeline High Dose SEX <NULL> missing p_nonmiss % Non-missing 1 <fn> <NULL> <NULL> stat_2
139 TRT01A Xanomeline High Dose AGE <NULL> missing N_obs No. obs. 72 <fn> <NULL> <NULL> stat_2
140 TRT01A Xanomeline High Dose AGE <NULL> missing N_miss N Missing 0 <fn> <NULL> <NULL> stat_2
141 TRT01A Xanomeline High Dose AGE <NULL> missing N_nonmiss N Non-missing 72 <fn> <NULL> <NULL> stat_2
142 TRT01A Xanomeline High Dose AGE <NULL> missing p_miss % Missing 0 <fn> <NULL> <NULL> stat_2
143 TRT01A Xanomeline High Dose AGE <NULL> missing p_nonmiss % Non-missing 1 <fn> <NULL> <NULL> stat_2
144 TRT01A Xanomeline High Dose AGEGR1 <NULL> missing N_obs No. obs. 72 <fn> <NULL> <NULL> stat_2
145 TRT01A Xanomeline High Dose AGEGR1 <NULL> missing N_miss N Missing 0 <fn> <NULL> <NULL> stat_2
146 TRT01A Xanomeline High Dose AGEGR1 <NULL> missing N_nonmiss N Non-missing 72 <fn> <NULL> <NULL> stat_2
147 TRT01A Xanomeline High Dose AGEGR1 <NULL> missing p_miss % Missing 0 <fn> <NULL> <NULL> stat_2
148 TRT01A Xanomeline High Dose AGEGR1 <NULL> missing p_nonmiss % Non-missing 1 <fn> <NULL> <NULL> stat_2
149 TRT01A Xanomeline High Dose ETHNIC <NULL> missing N_obs No. obs. 72 <fn> <NULL> <NULL> stat_2
150 TRT01A Xanomeline High Dose ETHNIC <NULL> missing N_miss N Missing 0 <fn> <NULL> <NULL> stat_2
151 TRT01A Xanomeline High Dose ETHNIC <NULL> missing N_nonmiss N Non-missing 72 <fn> <NULL> <NULL> stat_2
152 TRT01A Xanomeline High Dose ETHNIC <NULL> missing p_miss % Missing 0 <fn> <NULL> <NULL> stat_2
153 TRT01A Xanomeline High Dose ETHNIC <NULL> missing p_nonmiss % Non-missing 1 <fn> <NULL> <NULL> stat_2
154 TRT01A Xanomeline High Dose RACE <NULL> missing N_obs No. obs. 72 <fn> <NULL> <NULL> stat_2
155 TRT01A Xanomeline High Dose RACE <NULL> missing N_miss N Missing 0 <fn> <NULL> <NULL> stat_2
156 TRT01A Xanomeline High Dose RACE <NULL> missing N_nonmiss N Non-missing 72 <fn> <NULL> <NULL> stat_2
157 TRT01A Xanomeline High Dose RACE <NULL> missing p_miss % Missing 0 <fn> <NULL> <NULL> stat_2
158 TRT01A Xanomeline High Dose RACE <NULL> missing p_nonmiss % Non-missing 1 <fn> <NULL> <NULL> stat_2
159 TRT01A Xanomeline Low Dose SEX <NULL> missing N_obs No. obs. 96 <fn> <NULL> <NULL> stat_3
160 TRT01A Xanomeline Low Dose SEX <NULL> missing N_miss N Missing 0 <fn> <NULL> <NULL> stat_3
161 TRT01A Xanomeline Low Dose SEX <NULL> missing N_nonmiss N Non-missing 96 <fn> <NULL> <NULL> stat_3
162 TRT01A Xanomeline Low Dose SEX <NULL> missing p_miss % Missing 0 <fn> <NULL> <NULL> stat_3
163 TRT01A Xanomeline Low Dose SEX <NULL> missing p_nonmiss % Non-missing 1 <fn> <NULL> <NULL> stat_3
164 TRT01A Xanomeline Low Dose AGE <NULL> missing N_obs No. obs. 96 <fn> <NULL> <NULL> stat_3
165 TRT01A Xanomeline Low Dose AGE <NULL> missing N_miss N Missing 0 <fn> <NULL> <NULL> stat_3
166 TRT01A Xanomeline Low Dose AGE <NULL> missing N_nonmiss N Non-missing 96 <fn> <NULL> <NULL> stat_3
167 TRT01A Xanomeline Low Dose AGE <NULL> missing p_miss % Missing 0 <fn> <NULL> <NULL> stat_3
168 TRT01A Xanomeline Low Dose AGE <NULL> missing p_nonmiss % Non-missing 1 <fn> <NULL> <NULL> stat_3
169 TRT01A Xanomeline Low Dose AGEGR1 <NULL> missing N_obs No. obs. 96 <fn> <NULL> <NULL> stat_3
170 TRT01A Xanomeline Low Dose AGEGR1 <NULL> missing N_miss N Missing 0 <fn> <NULL> <NULL> stat_3
171 TRT01A Xanomeline Low Dose AGEGR1 <NULL> missing N_nonmiss N Non-missing 96 <fn> <NULL> <NULL> stat_3
172 TRT01A Xanomeline Low Dose AGEGR1 <NULL> missing p_miss % Missing 0 <fn> <NULL> <NULL> stat_3
173 TRT01A Xanomeline Low Dose AGEGR1 <NULL> missing p_nonmiss % Non-missing 1 <fn> <NULL> <NULL> stat_3
174 TRT01A Xanomeline Low Dose ETHNIC <NULL> missing N_obs No. obs. 96 <fn> <NULL> <NULL> stat_3
175 TRT01A Xanomeline Low Dose ETHNIC <NULL> missing N_miss N Missing 0 <fn> <NULL> <NULL> stat_3
176 TRT01A Xanomeline Low Dose ETHNIC <NULL> missing N_nonmiss N Non-missing 96 <fn> <NULL> <NULL> stat_3
177 TRT01A Xanomeline Low Dose ETHNIC <NULL> missing p_miss % Missing 0 <fn> <NULL> <NULL> stat_3
178 TRT01A Xanomeline Low Dose ETHNIC <NULL> missing p_nonmiss % Non-missing 1 <fn> <NULL> <NULL> stat_3
179 TRT01A Xanomeline Low Dose RACE <NULL> missing N_obs No. obs. 96 <fn> <NULL> <NULL> stat_3
180 TRT01A Xanomeline Low Dose RACE <NULL> missing N_miss N Missing 0 <fn> <NULL> <NULL> stat_3
181 TRT01A Xanomeline Low Dose RACE <NULL> missing N_nonmiss N Non-missing 96 <fn> <NULL> <NULL> stat_3
182 TRT01A Xanomeline Low Dose RACE <NULL> missing p_miss % Missing 0 <fn> <NULL> <NULL> stat_3
183 TRT01A Xanomeline Low Dose RACE <NULL> missing p_nonmiss % Non-missing 1 <fn> <NULL> <NULL> stat_3
184 <NA> <NULL> ..ard_total_n.. <NULL> total_n N N 254 0 <NULL> <NULL> <NA>
185 <NA> <NULL> TRT01A Placebo tabulate n n 86 0 <NULL> <NULL> <NA>
186 <NA> <NULL> TRT01A Placebo tabulate N N 254 0 <NULL> <NULL> <NA>
187 <NA> <NULL> TRT01A Placebo tabulate p % 0.3385827 <fn> <NULL> <NULL> <NA>
188 <NA> <NULL> TRT01A Xanomeline High Dose tabulate n n 72 0 <NULL> <NULL> <NA>
189 <NA> <NULL> TRT01A Xanomeline High Dose tabulate N N 254 0 <NULL> <NULL> <NA>
190 <NA> <NULL> TRT01A Xanomeline High Dose tabulate p % 0.2834646 <fn> <NULL> <NULL> <NA>
191 <NA> <NULL> TRT01A Xanomeline Low Dose tabulate n n 96 0 <NULL> <NULL> <NA>
192 <NA> <NULL> TRT01A Xanomeline Low Dose tabulate N N 254 0 <NULL> <NULL> <NA>
193 <NA> <NULL> TRT01A Xanomeline Low Dose tabulate p % 0.3779528 <fn> <NULL> <NULL> <NA>
$add_overall
# An ARD data frame: 68 × 10
variable variable_level context stat_name stat_label stat fmt_fun warning error gts_column
<chr> <list> <chr> <chr> <chr> <list> <list> <list> <list> <chr>
1 AGEGR1 18-64 tabulate n n 33 <fn> <NULL> <NULL> stat_0
2 AGEGR1 18-64 tabulate N N 254 <fn> <NULL> <NULL> stat_0
3 AGEGR1 18-64 tabulate p % 0.1299213 <fn> <NULL> <NULL> stat_0
4 AGEGR1 >64 tabulate n n 221 <fn> <NULL> <NULL> stat_0
5 AGEGR1 >64 tabulate N N 254 <fn> <NULL> <NULL> stat_0
6 AGEGR1 >64 tabulate p % 0.8700787 <fn> <NULL> <NULL> stat_0
7 SEX F tabulate n n 143 <fn> <NULL> <NULL> stat_0
8 SEX F tabulate N N 254 <fn> <NULL> <NULL> stat_0
9 SEX F tabulate p % 0.5629921 <fn> <NULL> <NULL> stat_0
10 SEX M tabulate n n 111 <fn> <NULL> <NULL> stat_0
11 SEX M tabulate N N 254 <fn> <NULL> <NULL> stat_0
12 SEX M tabulate p % 0.4370079 <fn> <NULL> <NULL> stat_0
13 RACE AMERICAN INDIAN OR ALASKA NATIVE tabulate n n 1 <fn> <NULL> <NULL> stat_0
14 RACE AMERICAN INDIAN OR ALASKA NATIVE tabulate N N 254 <fn> <NULL> <NULL> stat_0
15 RACE AMERICAN INDIAN OR ALASKA NATIVE tabulate p % 0.003937008 <fn> <NULL> <NULL> stat_0
16 RACE BLACK OR AFRICAN AMERICAN tabulate n n 23 <fn> <NULL> <NULL> stat_0
17 RACE BLACK OR AFRICAN AMERICAN tabulate N N 254 <fn> <NULL> <NULL> stat_0
18 RACE BLACK OR AFRICAN AMERICAN tabulate p % 0.09055118 <fn> <NULL> <NULL> stat_0
19 RACE WHITE tabulate n n 230 <fn> <NULL> <NULL> stat_0
20 RACE WHITE tabulate N N 254 <fn> <NULL> <NULL> stat_0
21 RACE WHITE tabulate p % 0.9055118 <fn> <NULL> <NULL> stat_0
22 ETHNIC HISPANIC OR LATINO tabulate n n 12 <fn> <NULL> <NULL> stat_0
23 ETHNIC HISPANIC OR LATINO tabulate N N 254 <fn> <NULL> <NULL> stat_0
24 ETHNIC HISPANIC OR LATINO tabulate p % 0.04724409 <fn> <NULL> <NULL> stat_0
25 ETHNIC NOT HISPANIC OR LATINO tabulate n n 242 <fn> <NULL> <NULL> stat_0
26 ETHNIC NOT HISPANIC OR LATINO tabulate N N 254 <fn> <NULL> <NULL> stat_0
27 ETHNIC NOT HISPANIC OR LATINO tabulate p % 0.9527559 <fn> <NULL> <NULL> stat_0
28 AGE <NULL> summary mean Mean 75.08661 <fn> <NULL> <NULL> stat_0
29 AGE <NULL> summary sd SD 8.246234 <fn> <NULL> <NULL> stat_0
30 AGE <NULL> summary median Median 77 <fn> <NULL> <NULL> stat_0
31 AGE <NULL> summary min Min 51 <fn> <NULL> <NULL> stat_0
32 AGE <NULL> summary max Max 89 <fn> <NULL> <NULL> stat_0
33 SEX <NULL> attributes label Variable Label Sex <fn> <NULL> <NULL> <NA>
34 SEX <NULL> attributes class Variable Class character <NULL> <NULL> <NULL> <NA>
35 AGE <NULL> attributes label Variable Label Age <fn> <NULL> <NULL> <NA>
36 AGE <NULL> attributes class Variable Class numeric <NULL> <NULL> <NULL> <NA>
37 AGEGR1 <NULL> attributes label Variable Label Age Group, Years <fn> <NULL> <NULL> <NA>
38 AGEGR1 <NULL> attributes class Variable Class character <NULL> <NULL> <NULL> <NA>
39 ETHNIC <NULL> attributes label Variable Label Ethnicity <fn> <NULL> <NULL> <NA>
40 ETHNIC <NULL> attributes class Variable Class character <NULL> <NULL> <NULL> <NA>
41 RACE <NULL> attributes label Variable Label Race <fn> <NULL> <NULL> <NA>
42 RACE <NULL> attributes class Variable Class character <NULL> <NULL> <NULL> <NA>
43 SEX <NULL> missing N_obs No. obs. 254 <fn> <NULL> <NULL> stat_0
44 SEX <NULL> missing N_miss N Missing 0 <fn> <NULL> <NULL> stat_0
45 SEX <NULL> missing N_nonmiss N Non-missing 254 <fn> <NULL> <NULL> stat_0
46 SEX <NULL> missing p_miss % Missing 0 <fn> <NULL> <NULL> stat_0
47 SEX <NULL> missing p_nonmiss % Non-missing 1 <fn> <NULL> <NULL> stat_0
48 AGE <NULL> missing N_obs No. obs. 254 <fn> <NULL> <NULL> stat_0
49 AGE <NULL> missing N_miss N Missing 0 <fn> <NULL> <NULL> stat_0
50 AGE <NULL> missing N_nonmiss N Non-missing 254 <fn> <NULL> <NULL> stat_0
51 AGE <NULL> missing p_miss % Missing 0 <fn> <NULL> <NULL> stat_0
52 AGE <NULL> missing p_nonmiss % Non-missing 1 <fn> <NULL> <NULL> stat_0
53 AGEGR1 <NULL> missing N_obs No. obs. 254 <fn> <NULL> <NULL> stat_0
54 AGEGR1 <NULL> missing N_miss N Missing 0 <fn> <NULL> <NULL> stat_0
55 AGEGR1 <NULL> missing N_nonmiss N Non-missing 254 <fn> <NULL> <NULL> stat_0
56 AGEGR1 <NULL> missing p_miss % Missing 0 <fn> <NULL> <NULL> stat_0
57 AGEGR1 <NULL> missing p_nonmiss % Non-missing 1 <fn> <NULL> <NULL> stat_0
58 ETHNIC <NULL> missing N_obs No. obs. 254 <fn> <NULL> <NULL> stat_0
59 ETHNIC <NULL> missing N_miss N Missing 0 <fn> <NULL> <NULL> stat_0
60 ETHNIC <NULL> missing N_nonmiss N Non-missing 254 <fn> <NULL> <NULL> stat_0
61 ETHNIC <NULL> missing p_miss % Missing 0 <fn> <NULL> <NULL> stat_0
62 ETHNIC <NULL> missing p_nonmiss % Non-missing 1 <fn> <NULL> <NULL> stat_0
63 RACE <NULL> missing N_obs No. obs. 254 <fn> <NULL> <NULL> stat_0
64 RACE <NULL> missing N_miss N Missing 0 <fn> <NULL> <NULL> stat_0
65 RACE <NULL> missing N_nonmiss N Non-missing 254 <fn> <NULL> <NULL> stat_0
66 RACE <NULL> missing p_miss % Missing 0 <fn> <NULL> <NULL> stat_0
67 RACE <NULL> missing p_nonmiss % Non-missing 1 <fn> <NULL> <NULL> stat_0
68 ..ard_total_n.. <NULL> total_n N N 254 0 <NULL> <NULL> <NA>