Subjects With Adverse Events Leading to Treatment Discontinuation by System Organ Class and Preferred Term, Safety Population, Pooled Analysis (or Trial X)
FDA Table 12
table
FDA
safety
adverse events
FDA IG Shell
Programming Notes
Background and Instructions
Customization
Output
Code
# FDA TABLE 12 ---------------------------------------------------------------
# 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 <- random.cdisc.data::cadsl
adae <- random.cdisc.data::cadae
adae$DCSREAS[is.na(adae$DCSREAS)] <- "ADVERSE EVENT"
# Pre-processing --------------------------------------------
adsl <- adsl |>
filter(SAFFL == "Y") # safety population
data <- adae |>
filter(
# safety population
SAFFL == "Y",
# discontinuation due to AE
DCSREAS == "ADVERSE EVENT"
)
ard <- ard_stack_hierarchical(
data,
variables = c(AEBODSYS, AEDECOD),
by = TRT01A,
denominator = adsl,
id = USUBJID
)
tbl <- tbl_hierarchical(
data,
variables = c(AEBODSYS, AEDECOD),
by = TRT01A,
id = USUBJID,
denominator = adsl,
overall_row = TRUE,
label = list(..ard_hierarchical_overall.. = "Subjects with at least one AE leading to treatment discontinuation")
)
ard <- gtsummary::gather_ard(tbl)|
Body System or Organ Class Dictionary-Derived Term |
A: Drug X N = 1341 |
B: Placebo N = 1341 |
C: Combination N = 1321 |
|---|---|---|---|
| Subjects with at least one AE leading to treatment discontinuation | 86 (64%) | 93 (69%) | 90 (68%) |
| cl A.1 | 53 (40%) | 55 (41%) | 69 (52%) |
| dcd A.1.1.1.1 | 37 (28%) | 37 (28%) | 50 (38%) |
| dcd A.1.1.1.2 | 33 (25%) | 31 (23%) | 40 (30%) |
| cl B.1 | 35 (26%) | 41 (31%) | 36 (27%) |
| dcd B.1.1.1.1 | 35 (26%) | 41 (31%) | 36 (27%) |
| cl B.2 | 55 (41%) | 56 (42%) | 65 (49%) |
| dcd B.2.1.2.1 | 36 (27%) | 33 (25%) | 35 (27%) |
| dcd B.2.2.3.1 | 34 (25%) | 41 (31%) | 41 (31%) |
| cl C.1 | 28 (21%) | 36 (27%) | 32 (24%) |
| dcd C.1.1.1.3 | 28 (21%) | 36 (27%) | 32 (24%) |
| cl C.2 | 26 (19%) | 39 (29%) | 43 (33%) |
| dcd C.2.1.2.1 | 26 (19%) | 39 (29%) | 43 (33%) |
| cl D.1 | 51 (38%) | 51 (38%) | 60 (45%) |
| dcd D.1.1.1.1 | 29 (22%) | 31 (23%) | 37 (28%) |
| dcd D.1.1.4.2 | 33 (25%) | 34 (25%) | 39 (30%) |
| cl D.2 | 35 (26%) | 46 (34%) | 44 (33%) |
| dcd D.2.1.5.3 | 35 (26%) | 46 (34%) | 44 (33%) |
| 1 n (%) | |||
$tbl_hierarchical
# An ARD data frame: 171 × 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 A: Drug X tabulate n n 134 134 0 <NULL> <NULL> stat_1
2 <NA> <NULL> <NA> <NULL> TRT01A A: Drug X tabulate N N 400 400 0 <NULL> <NULL> stat_1
3 <NA> <NULL> <NA> <NULL> TRT01A A: Drug X tabulate p % 0.335 33.5 <fn> <NULL> <NULL> stat_1
4 <NA> <NULL> <NA> <NULL> TRT01A B: Placebo tabulate n n 134 134 0 <NULL> <NULL> stat_2
5 <NA> <NULL> <NA> <NULL> TRT01A B: Placebo tabulate N N 400 400 0 <NULL> <NULL> stat_2
6 <NA> <NULL> <NA> <NULL> TRT01A B: Placebo tabulate p % 0.335 33.5 <fn> <NULL> <NULL> stat_2
7 <NA> <NULL> <NA> <NULL> TRT01A C: Combination tabulate n n 132 132 0 <NULL> <NULL> stat_3
8 <NA> <NULL> <NA> <NULL> TRT01A C: Combination tabulate N N 400 400 0 <NULL> <NULL> stat_3
9 <NA> <NULL> <NA> <NULL> TRT01A C: Combination tabulate p % 0.33 33.0 <fn> <NULL> <NULL> stat_3
10 TRT01A A: Drug X <NA> <NULL> ..ard_hierarchical_overall.. TRUE hierarchical n n 86 86 <fn> <NULL> <NULL> stat_1
11 TRT01A A: Drug X <NA> <NULL> ..ard_hierarchical_overall.. TRUE hierarchical N N 134 134 <fn> <NULL> <NULL> stat_1
12 TRT01A A: Drug X <NA> <NULL> ..ard_hierarchical_overall.. TRUE hierarchical p % 0.642 64 <fn> <NULL> <NULL> stat_1
13 TRT01A B: Placebo <NA> <NULL> ..ard_hierarchical_overall.. TRUE hierarchical n n 93 93 <fn> <NULL> <NULL> stat_2
14 TRT01A B: Placebo <NA> <NULL> ..ard_hierarchical_overall.. TRUE hierarchical N N 134 134 <fn> <NULL> <NULL> stat_2
15 TRT01A B: Placebo <NA> <NULL> ..ard_hierarchical_overall.. TRUE hierarchical p % 0.694 69 <fn> <NULL> <NULL> stat_2
16 TRT01A C: Combination <NA> <NULL> ..ard_hierarchical_overall.. TRUE hierarchical n n 90 90 <fn> <NULL> <NULL> stat_3
17 TRT01A C: Combination <NA> <NULL> ..ard_hierarchical_overall.. TRUE hierarchical N N 132 132 <fn> <NULL> <NULL> stat_3
18 TRT01A C: Combination <NA> <NULL> ..ard_hierarchical_overall.. TRUE hierarchical p % 0.682 68 <fn> <NULL> <NULL> stat_3
19 TRT01A A: Drug X <NA> <NULL> AEBODSYS cl A.1 hierarchical n n 53 53 <fn> <NULL> <NULL> stat_1
20 TRT01A A: Drug X <NA> <NULL> AEBODSYS cl A.1 hierarchical N N 134 134 <fn> <NULL> <NULL> stat_1
21 TRT01A A: Drug X <NA> <NULL> AEBODSYS cl A.1 hierarchical p % 0.396 40 <fn> <NULL> <NULL> stat_1
22 TRT01A B: Placebo <NA> <NULL> AEBODSYS cl A.1 hierarchical n n 55 55 <fn> <NULL> <NULL> stat_2
23 TRT01A B: Placebo <NA> <NULL> AEBODSYS cl A.1 hierarchical N N 134 134 <fn> <NULL> <NULL> stat_2
24 TRT01A B: Placebo <NA> <NULL> AEBODSYS cl A.1 hierarchical p % 0.410 41 <fn> <NULL> <NULL> stat_2
25 TRT01A C: Combination <NA> <NULL> AEBODSYS cl A.1 hierarchical n n 69 69 <fn> <NULL> <NULL> stat_3
26 TRT01A C: Combination <NA> <NULL> AEBODSYS cl A.1 hierarchical N N 132 132 <fn> <NULL> <NULL> stat_3
27 TRT01A C: Combination <NA> <NULL> AEBODSYS cl A.1 hierarchical p % 0.523 52 <fn> <NULL> <NULL> stat_3
28 TRT01A A: Drug X AEBODSYS cl A.1 AEDECOD dcd A.1.1.1.1 hierarchical n n 37 37 <fn> <NULL> <NULL> stat_1
29 TRT01A A: Drug X AEBODSYS cl A.1 AEDECOD dcd A.1.1.1.1 hierarchical N N 134 134 <fn> <NULL> <NULL> stat_1
30 TRT01A A: Drug X AEBODSYS cl A.1 AEDECOD dcd A.1.1.1.1 hierarchical p % 0.276 28 <fn> <NULL> <NULL> stat_1
31 TRT01A B: Placebo AEBODSYS cl A.1 AEDECOD dcd A.1.1.1.1 hierarchical n n 37 37 <fn> <NULL> <NULL> stat_2
32 TRT01A B: Placebo AEBODSYS cl A.1 AEDECOD dcd A.1.1.1.1 hierarchical N N 134 134 <fn> <NULL> <NULL> stat_2
33 TRT01A B: Placebo AEBODSYS cl A.1 AEDECOD dcd A.1.1.1.1 hierarchical p % 0.276 28 <fn> <NULL> <NULL> stat_2
34 TRT01A C: Combination AEBODSYS cl A.1 AEDECOD dcd A.1.1.1.1 hierarchical n n 50 50 <fn> <NULL> <NULL> stat_3
35 TRT01A C: Combination AEBODSYS cl A.1 AEDECOD dcd A.1.1.1.1 hierarchical N N 132 132 <fn> <NULL> <NULL> stat_3
36 TRT01A C: Combination AEBODSYS cl A.1 AEDECOD dcd A.1.1.1.1 hierarchical p % 0.379 38 <fn> <NULL> <NULL> stat_3
37 TRT01A A: Drug X AEBODSYS cl A.1 AEDECOD dcd A.1.1.1.2 hierarchical n n 33 33 <fn> <NULL> <NULL> stat_1
38 TRT01A A: Drug X AEBODSYS cl A.1 AEDECOD dcd A.1.1.1.2 hierarchical N N 134 134 <fn> <NULL> <NULL> stat_1
39 TRT01A A: Drug X AEBODSYS cl A.1 AEDECOD dcd A.1.1.1.2 hierarchical p % 0.246 25 <fn> <NULL> <NULL> stat_1
40 TRT01A B: Placebo AEBODSYS cl A.1 AEDECOD dcd A.1.1.1.2 hierarchical n n 31 31 <fn> <NULL> <NULL> stat_2
41 TRT01A B: Placebo AEBODSYS cl A.1 AEDECOD dcd A.1.1.1.2 hierarchical N N 134 134 <fn> <NULL> <NULL> stat_2
42 TRT01A B: Placebo AEBODSYS cl A.1 AEDECOD dcd A.1.1.1.2 hierarchical p % 0.231 23 <fn> <NULL> <NULL> stat_2
43 TRT01A C: Combination AEBODSYS cl A.1 AEDECOD dcd A.1.1.1.2 hierarchical n n 40 40 <fn> <NULL> <NULL> stat_3
44 TRT01A C: Combination AEBODSYS cl A.1 AEDECOD dcd A.1.1.1.2 hierarchical N N 132 132 <fn> <NULL> <NULL> stat_3
45 TRT01A C: Combination AEBODSYS cl A.1 AEDECOD dcd A.1.1.1.2 hierarchical p % 0.303 30 <fn> <NULL> <NULL> stat_3
46 TRT01A A: Drug X <NA> <NULL> AEBODSYS cl B.1 hierarchical n n 35 35 <fn> <NULL> <NULL> stat_1
47 TRT01A A: Drug X <NA> <NULL> AEBODSYS cl B.1 hierarchical N N 134 134 <fn> <NULL> <NULL> stat_1
48 TRT01A A: Drug X <NA> <NULL> AEBODSYS cl B.1 hierarchical p % 0.261 26 <fn> <NULL> <NULL> stat_1
49 TRT01A B: Placebo <NA> <NULL> AEBODSYS cl B.1 hierarchical n n 41 41 <fn> <NULL> <NULL> stat_2
50 TRT01A B: Placebo <NA> <NULL> AEBODSYS cl B.1 hierarchical N N 134 134 <fn> <NULL> <NULL> stat_2
51 TRT01A B: Placebo <NA> <NULL> AEBODSYS cl B.1 hierarchical p % 0.306 31 <fn> <NULL> <NULL> stat_2
52 TRT01A C: Combination <NA> <NULL> AEBODSYS cl B.1 hierarchical n n 36 36 <fn> <NULL> <NULL> stat_3
53 TRT01A C: Combination <NA> <NULL> AEBODSYS cl B.1 hierarchical N N 132 132 <fn> <NULL> <NULL> stat_3
54 TRT01A C: Combination <NA> <NULL> AEBODSYS cl B.1 hierarchical p % 0.273 27 <fn> <NULL> <NULL> stat_3
55 TRT01A A: Drug X AEBODSYS cl B.1 AEDECOD dcd B.1.1.1.1 hierarchical n n 35 35 <fn> <NULL> <NULL> stat_1
56 TRT01A A: Drug X AEBODSYS cl B.1 AEDECOD dcd B.1.1.1.1 hierarchical N N 134 134 <fn> <NULL> <NULL> stat_1
57 TRT01A A: Drug X AEBODSYS cl B.1 AEDECOD dcd B.1.1.1.1 hierarchical p % 0.261 26 <fn> <NULL> <NULL> stat_1
58 TRT01A B: Placebo AEBODSYS cl B.1 AEDECOD dcd B.1.1.1.1 hierarchical n n 41 41 <fn> <NULL> <NULL> stat_2
59 TRT01A B: Placebo AEBODSYS cl B.1 AEDECOD dcd B.1.1.1.1 hierarchical N N 134 134 <fn> <NULL> <NULL> stat_2
60 TRT01A B: Placebo AEBODSYS cl B.1 AEDECOD dcd B.1.1.1.1 hierarchical p % 0.306 31 <fn> <NULL> <NULL> stat_2
61 TRT01A C: Combination AEBODSYS cl B.1 AEDECOD dcd B.1.1.1.1 hierarchical n n 36 36 <fn> <NULL> <NULL> stat_3
62 TRT01A C: Combination AEBODSYS cl B.1 AEDECOD dcd B.1.1.1.1 hierarchical N N 132 132 <fn> <NULL> <NULL> stat_3
63 TRT01A C: Combination AEBODSYS cl B.1 AEDECOD dcd B.1.1.1.1 hierarchical p % 0.273 27 <fn> <NULL> <NULL> stat_3
64 TRT01A A: Drug X <NA> <NULL> AEBODSYS cl B.2 hierarchical n n 55 55 <fn> <NULL> <NULL> stat_1
65 TRT01A A: Drug X <NA> <NULL> AEBODSYS cl B.2 hierarchical N N 134 134 <fn> <NULL> <NULL> stat_1
66 TRT01A A: Drug X <NA> <NULL> AEBODSYS cl B.2 hierarchical p % 0.410 41 <fn> <NULL> <NULL> stat_1
67 TRT01A B: Placebo <NA> <NULL> AEBODSYS cl B.2 hierarchical n n 56 56 <fn> <NULL> <NULL> stat_2
68 TRT01A B: Placebo <NA> <NULL> AEBODSYS cl B.2 hierarchical N N 134 134 <fn> <NULL> <NULL> stat_2
69 TRT01A B: Placebo <NA> <NULL> AEBODSYS cl B.2 hierarchical p % 0.418 42 <fn> <NULL> <NULL> stat_2
70 TRT01A C: Combination <NA> <NULL> AEBODSYS cl B.2 hierarchical n n 65 65 <fn> <NULL> <NULL> stat_3
71 TRT01A C: Combination <NA> <NULL> AEBODSYS cl B.2 hierarchical N N 132 132 <fn> <NULL> <NULL> stat_3
72 TRT01A C: Combination <NA> <NULL> AEBODSYS cl B.2 hierarchical p % 0.492 49 <fn> <NULL> <NULL> stat_3
73 TRT01A A: Drug X AEBODSYS cl B.2 AEDECOD dcd B.2.1.2.1 hierarchical n n 36 36 <fn> <NULL> <NULL> stat_1
74 TRT01A A: Drug X AEBODSYS cl B.2 AEDECOD dcd B.2.1.2.1 hierarchical N N 134 134 <fn> <NULL> <NULL> stat_1
75 TRT01A A: Drug X AEBODSYS cl B.2 AEDECOD dcd B.2.1.2.1 hierarchical p % 0.269 27 <fn> <NULL> <NULL> stat_1
76 TRT01A B: Placebo AEBODSYS cl B.2 AEDECOD dcd B.2.1.2.1 hierarchical n n 33 33 <fn> <NULL> <NULL> stat_2
77 TRT01A B: Placebo AEBODSYS cl B.2 AEDECOD dcd B.2.1.2.1 hierarchical N N 134 134 <fn> <NULL> <NULL> stat_2
78 TRT01A B: Placebo AEBODSYS cl B.2 AEDECOD dcd B.2.1.2.1 hierarchical p % 0.246 25 <fn> <NULL> <NULL> stat_2
79 TRT01A C: Combination AEBODSYS cl B.2 AEDECOD dcd B.2.1.2.1 hierarchical n n 35 35 <fn> <NULL> <NULL> stat_3
80 TRT01A C: Combination AEBODSYS cl B.2 AEDECOD dcd B.2.1.2.1 hierarchical N N 132 132 <fn> <NULL> <NULL> stat_3
81 TRT01A C: Combination AEBODSYS cl B.2 AEDECOD dcd B.2.1.2.1 hierarchical p % 0.265 27 <fn> <NULL> <NULL> stat_3
82 TRT01A A: Drug X AEBODSYS cl B.2 AEDECOD dcd B.2.2.3.1 hierarchical n n 34 34 <fn> <NULL> <NULL> stat_1
83 TRT01A A: Drug X AEBODSYS cl B.2 AEDECOD dcd B.2.2.3.1 hierarchical N N 134 134 <fn> <NULL> <NULL> stat_1
84 TRT01A A: Drug X AEBODSYS cl B.2 AEDECOD dcd B.2.2.3.1 hierarchical p % 0.254 25 <fn> <NULL> <NULL> stat_1
85 TRT01A B: Placebo AEBODSYS cl B.2 AEDECOD dcd B.2.2.3.1 hierarchical n n 41 41 <fn> <NULL> <NULL> stat_2
86 TRT01A B: Placebo AEBODSYS cl B.2 AEDECOD dcd B.2.2.3.1 hierarchical N N 134 134 <fn> <NULL> <NULL> stat_2
87 TRT01A B: Placebo AEBODSYS cl B.2 AEDECOD dcd B.2.2.3.1 hierarchical p % 0.306 31 <fn> <NULL> <NULL> stat_2
88 TRT01A C: Combination AEBODSYS cl B.2 AEDECOD dcd B.2.2.3.1 hierarchical n n 41 41 <fn> <NULL> <NULL> stat_3
89 TRT01A C: Combination AEBODSYS cl B.2 AEDECOD dcd B.2.2.3.1 hierarchical N N 132 132 <fn> <NULL> <NULL> stat_3
90 TRT01A C: Combination AEBODSYS cl B.2 AEDECOD dcd B.2.2.3.1 hierarchical p % 0.311 31 <fn> <NULL> <NULL> stat_3
91 TRT01A A: Drug X <NA> <NULL> AEBODSYS cl C.1 hierarchical n n 28 28 <fn> <NULL> <NULL> stat_1
92 TRT01A A: Drug X <NA> <NULL> AEBODSYS cl C.1 hierarchical N N 134 134 <fn> <NULL> <NULL> stat_1
93 TRT01A A: Drug X <NA> <NULL> AEBODSYS cl C.1 hierarchical p % 0.209 21 <fn> <NULL> <NULL> stat_1
94 TRT01A B: Placebo <NA> <NULL> AEBODSYS cl C.1 hierarchical n n 36 36 <fn> <NULL> <NULL> stat_2
95 TRT01A B: Placebo <NA> <NULL> AEBODSYS cl C.1 hierarchical N N 134 134 <fn> <NULL> <NULL> stat_2
96 TRT01A B: Placebo <NA> <NULL> AEBODSYS cl C.1 hierarchical p % 0.269 27 <fn> <NULL> <NULL> stat_2
97 TRT01A C: Combination <NA> <NULL> AEBODSYS cl C.1 hierarchical n n 32 32 <fn> <NULL> <NULL> stat_3
98 TRT01A C: Combination <NA> <NULL> AEBODSYS cl C.1 hierarchical N N 132 132 <fn> <NULL> <NULL> stat_3
99 TRT01A C: Combination <NA> <NULL> AEBODSYS cl C.1 hierarchical p % 0.242 24 <fn> <NULL> <NULL> stat_3
100 TRT01A A: Drug X AEBODSYS cl C.1 AEDECOD dcd C.1.1.1.3 hierarchical n n 28 28 <fn> <NULL> <NULL> stat_1
101 TRT01A A: Drug X AEBODSYS cl C.1 AEDECOD dcd C.1.1.1.3 hierarchical N N 134 134 <fn> <NULL> <NULL> stat_1
102 TRT01A A: Drug X AEBODSYS cl C.1 AEDECOD dcd C.1.1.1.3 hierarchical p % 0.209 21 <fn> <NULL> <NULL> stat_1
103 TRT01A B: Placebo AEBODSYS cl C.1 AEDECOD dcd C.1.1.1.3 hierarchical n n 36 36 <fn> <NULL> <NULL> stat_2
104 TRT01A B: Placebo AEBODSYS cl C.1 AEDECOD dcd C.1.1.1.3 hierarchical N N 134 134 <fn> <NULL> <NULL> stat_2
105 TRT01A B: Placebo AEBODSYS cl C.1 AEDECOD dcd C.1.1.1.3 hierarchical p % 0.269 27 <fn> <NULL> <NULL> stat_2
106 TRT01A C: Combination AEBODSYS cl C.1 AEDECOD dcd C.1.1.1.3 hierarchical n n 32 32 <fn> <NULL> <NULL> stat_3
107 TRT01A C: Combination AEBODSYS cl C.1 AEDECOD dcd C.1.1.1.3 hierarchical N N 132 132 <fn> <NULL> <NULL> stat_3
108 TRT01A C: Combination AEBODSYS cl C.1 AEDECOD dcd C.1.1.1.3 hierarchical p % 0.242 24 <fn> <NULL> <NULL> stat_3
109 TRT01A A: Drug X <NA> <NULL> AEBODSYS cl C.2 hierarchical n n 26 26 <fn> <NULL> <NULL> stat_1
110 TRT01A A: Drug X <NA> <NULL> AEBODSYS cl C.2 hierarchical N N 134 134 <fn> <NULL> <NULL> stat_1
111 TRT01A A: Drug X <NA> <NULL> AEBODSYS cl C.2 hierarchical p % 0.194 19 <fn> <NULL> <NULL> stat_1
112 TRT01A B: Placebo <NA> <NULL> AEBODSYS cl C.2 hierarchical n n 39 39 <fn> <NULL> <NULL> stat_2
113 TRT01A B: Placebo <NA> <NULL> AEBODSYS cl C.2 hierarchical N N 134 134 <fn> <NULL> <NULL> stat_2
114 TRT01A B: Placebo <NA> <NULL> AEBODSYS cl C.2 hierarchical p % 0.291 29 <fn> <NULL> <NULL> stat_2
115 TRT01A C: Combination <NA> <NULL> AEBODSYS cl C.2 hierarchical n n 43 43 <fn> <NULL> <NULL> stat_3
116 TRT01A C: Combination <NA> <NULL> AEBODSYS cl C.2 hierarchical N N 132 132 <fn> <NULL> <NULL> stat_3
117 TRT01A C: Combination <NA> <NULL> AEBODSYS cl C.2 hierarchical p % 0.326 33 <fn> <NULL> <NULL> stat_3
118 TRT01A A: Drug X AEBODSYS cl C.2 AEDECOD dcd C.2.1.2.1 hierarchical n n 26 26 <fn> <NULL> <NULL> stat_1
119 TRT01A A: Drug X AEBODSYS cl C.2 AEDECOD dcd C.2.1.2.1 hierarchical N N 134 134 <fn> <NULL> <NULL> stat_1
120 TRT01A A: Drug X AEBODSYS cl C.2 AEDECOD dcd C.2.1.2.1 hierarchical p % 0.194 19 <fn> <NULL> <NULL> stat_1
121 TRT01A B: Placebo AEBODSYS cl C.2 AEDECOD dcd C.2.1.2.1 hierarchical n n 39 39 <fn> <NULL> <NULL> stat_2
122 TRT01A B: Placebo AEBODSYS cl C.2 AEDECOD dcd C.2.1.2.1 hierarchical N N 134 134 <fn> <NULL> <NULL> stat_2
123 TRT01A B: Placebo AEBODSYS cl C.2 AEDECOD dcd C.2.1.2.1 hierarchical p % 0.291 29 <fn> <NULL> <NULL> stat_2
124 TRT01A C: Combination AEBODSYS cl C.2 AEDECOD dcd C.2.1.2.1 hierarchical n n 43 43 <fn> <NULL> <NULL> stat_3
125 TRT01A C: Combination AEBODSYS cl C.2 AEDECOD dcd C.2.1.2.1 hierarchical N N 132 132 <fn> <NULL> <NULL> stat_3
126 TRT01A C: Combination AEBODSYS cl C.2 AEDECOD dcd C.2.1.2.1 hierarchical p % 0.326 33 <fn> <NULL> <NULL> stat_3
127 TRT01A A: Drug X <NA> <NULL> AEBODSYS cl D.1 hierarchical n n 51 51 <fn> <NULL> <NULL> stat_1
128 TRT01A A: Drug X <NA> <NULL> AEBODSYS cl D.1 hierarchical N N 134 134 <fn> <NULL> <NULL> stat_1
129 TRT01A A: Drug X <NA> <NULL> AEBODSYS cl D.1 hierarchical p % 0.381 38 <fn> <NULL> <NULL> stat_1
130 TRT01A B: Placebo <NA> <NULL> AEBODSYS cl D.1 hierarchical n n 51 51 <fn> <NULL> <NULL> stat_2
131 TRT01A B: Placebo <NA> <NULL> AEBODSYS cl D.1 hierarchical N N 134 134 <fn> <NULL> <NULL> stat_2
132 TRT01A B: Placebo <NA> <NULL> AEBODSYS cl D.1 hierarchical p % 0.381 38 <fn> <NULL> <NULL> stat_2
133 TRT01A C: Combination <NA> <NULL> AEBODSYS cl D.1 hierarchical n n 60 60 <fn> <NULL> <NULL> stat_3
134 TRT01A C: Combination <NA> <NULL> AEBODSYS cl D.1 hierarchical N N 132 132 <fn> <NULL> <NULL> stat_3
135 TRT01A C: Combination <NA> <NULL> AEBODSYS cl D.1 hierarchical p % 0.455 45 <fn> <NULL> <NULL> stat_3
136 TRT01A A: Drug X AEBODSYS cl D.1 AEDECOD dcd D.1.1.1.1 hierarchical n n 29 29 <fn> <NULL> <NULL> stat_1
137 TRT01A A: Drug X AEBODSYS cl D.1 AEDECOD dcd D.1.1.1.1 hierarchical N N 134 134 <fn> <NULL> <NULL> stat_1
138 TRT01A A: Drug X AEBODSYS cl D.1 AEDECOD dcd D.1.1.1.1 hierarchical p % 0.216 22 <fn> <NULL> <NULL> stat_1
139 TRT01A B: Placebo AEBODSYS cl D.1 AEDECOD dcd D.1.1.1.1 hierarchical n n 31 31 <fn> <NULL> <NULL> stat_2
140 TRT01A B: Placebo AEBODSYS cl D.1 AEDECOD dcd D.1.1.1.1 hierarchical N N 134 134 <fn> <NULL> <NULL> stat_2
141 TRT01A B: Placebo AEBODSYS cl D.1 AEDECOD dcd D.1.1.1.1 hierarchical p % 0.231 23 <fn> <NULL> <NULL> stat_2
142 TRT01A C: Combination AEBODSYS cl D.1 AEDECOD dcd D.1.1.1.1 hierarchical n n 37 37 <fn> <NULL> <NULL> stat_3
143 TRT01A C: Combination AEBODSYS cl D.1 AEDECOD dcd D.1.1.1.1 hierarchical N N 132 132 <fn> <NULL> <NULL> stat_3
144 TRT01A C: Combination AEBODSYS cl D.1 AEDECOD dcd D.1.1.1.1 hierarchical p % 0.280 28 <fn> <NULL> <NULL> stat_3
145 TRT01A A: Drug X AEBODSYS cl D.1 AEDECOD dcd D.1.1.4.2 hierarchical n n 33 33 <fn> <NULL> <NULL> stat_1
146 TRT01A A: Drug X AEBODSYS cl D.1 AEDECOD dcd D.1.1.4.2 hierarchical N N 134 134 <fn> <NULL> <NULL> stat_1
147 TRT01A A: Drug X AEBODSYS cl D.1 AEDECOD dcd D.1.1.4.2 hierarchical p % 0.246 25 <fn> <NULL> <NULL> stat_1
148 TRT01A B: Placebo AEBODSYS cl D.1 AEDECOD dcd D.1.1.4.2 hierarchical n n 34 34 <fn> <NULL> <NULL> stat_2
149 TRT01A B: Placebo AEBODSYS cl D.1 AEDECOD dcd D.1.1.4.2 hierarchical N N 134 134 <fn> <NULL> <NULL> stat_2
150 TRT01A B: Placebo AEBODSYS cl D.1 AEDECOD dcd D.1.1.4.2 hierarchical p % 0.254 25 <fn> <NULL> <NULL> stat_2
151 TRT01A C: Combination AEBODSYS cl D.1 AEDECOD dcd D.1.1.4.2 hierarchical n n 39 39 <fn> <NULL> <NULL> stat_3
152 TRT01A C: Combination AEBODSYS cl D.1 AEDECOD dcd D.1.1.4.2 hierarchical N N 132 132 <fn> <NULL> <NULL> stat_3
153 TRT01A C: Combination AEBODSYS cl D.1 AEDECOD dcd D.1.1.4.2 hierarchical p % 0.295 30 <fn> <NULL> <NULL> stat_3
154 TRT01A A: Drug X <NA> <NULL> AEBODSYS cl D.2 hierarchical n n 35 35 <fn> <NULL> <NULL> stat_1
155 TRT01A A: Drug X <NA> <NULL> AEBODSYS cl D.2 hierarchical N N 134 134 <fn> <NULL> <NULL> stat_1
156 TRT01A A: Drug X <NA> <NULL> AEBODSYS cl D.2 hierarchical p % 0.261 26 <fn> <NULL> <NULL> stat_1
157 TRT01A B: Placebo <NA> <NULL> AEBODSYS cl D.2 hierarchical n n 46 46 <fn> <NULL> <NULL> stat_2
158 TRT01A B: Placebo <NA> <NULL> AEBODSYS cl D.2 hierarchical N N 134 134 <fn> <NULL> <NULL> stat_2
159 TRT01A B: Placebo <NA> <NULL> AEBODSYS cl D.2 hierarchical p % 0.343 34 <fn> <NULL> <NULL> stat_2
160 TRT01A C: Combination <NA> <NULL> AEBODSYS cl D.2 hierarchical n n 44 44 <fn> <NULL> <NULL> stat_3
161 TRT01A C: Combination <NA> <NULL> AEBODSYS cl D.2 hierarchical N N 132 132 <fn> <NULL> <NULL> stat_3
162 TRT01A C: Combination <NA> <NULL> AEBODSYS cl D.2 hierarchical p % 0.333 33 <fn> <NULL> <NULL> stat_3
163 TRT01A A: Drug X AEBODSYS cl D.2 AEDECOD dcd D.2.1.5.3 hierarchical n n 35 35 <fn> <NULL> <NULL> stat_1
164 TRT01A A: Drug X AEBODSYS cl D.2 AEDECOD dcd D.2.1.5.3 hierarchical N N 134 134 <fn> <NULL> <NULL> stat_1
165 TRT01A A: Drug X AEBODSYS cl D.2 AEDECOD dcd D.2.1.5.3 hierarchical p % 0.261 26 <fn> <NULL> <NULL> stat_1
166 TRT01A B: Placebo AEBODSYS cl D.2 AEDECOD dcd D.2.1.5.3 hierarchical n n 46 46 <fn> <NULL> <NULL> stat_2
167 TRT01A B: Placebo AEBODSYS cl D.2 AEDECOD dcd D.2.1.5.3 hierarchical N N 134 134 <fn> <NULL> <NULL> stat_2
168 TRT01A B: Placebo AEBODSYS cl D.2 AEDECOD dcd D.2.1.5.3 hierarchical p % 0.343 34 <fn> <NULL> <NULL> stat_2
169 TRT01A C: Combination AEBODSYS cl D.2 AEDECOD dcd D.2.1.5.3 hierarchical n n 44 44 <fn> <NULL> <NULL> stat_3
170 TRT01A C: Combination AEBODSYS cl D.2 AEDECOD dcd D.2.1.5.3 hierarchical N N 132 132 <fn> <NULL> <NULL> stat_3
171 TRT01A C: Combination AEBODSYS cl D.2 AEDECOD dcd D.2.1.5.3 hierarchical p % 0.333 33 <fn> <NULL> <NULL> stat_3