Code
lsting <- as_listing(
out,
key_cols = c("TRT01A", "CPID", "ASR"),
disp_cols = names(out),
main_title = "Listing of Adverse Events",
main_footer = "
(1) Outcome: 1 = fatal; 2 = not recovered/not resolved; 3 = recovered/resolved;
4 = recovered/resolved with sequelae; 5 = recovering/resolving; 6 = unknown.
(2) Action taken with study drug: 1 = dose increased; 2 = dose not changed;
3 = dose reduced; 4 = drug interrupted; 5 = drug withdrawn; 6 = not applicable;
7 = unknown.
* Study day derived from imputed onset date.
** Duration derived from imputed onset date and/or end date."
)
head(lsting, 20)Listing of Adverse Events
—————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
Date of
Adverse First Study Study AE Most Caused by Action
Event MedDRA Drug Day of Duration Extreme Study Outcome Treatment Taken
Treatment Center/Patient ID Age/Sex/Race Preferred Term Administration Onset in Days Serious Intensity Drug (1) for AE (2)
—————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
A: Drug X BRA-1/id-134 47/M/WHITE dcd B.2.1.2.1 04NOV2020 162 173 No MODERATE No 5 Yes 2
dcd D.1.1.4.2 04NOV2020 196 166 No MODERATE No 5 No 2
dcd A.1.1.1.2 04NOV2020 321 149 Yes MODERATE No 5 Yes 2
dcd A.1.1.1.2 04NOV2020 393 43 Yes MODERATE No 5 No 5
BRA-1/id-42 36/M/BLACK OR AFRICAN AMERICAN dcd C.2.1.2.1 01JAN2020 39 506 No MODERATE Yes 2 No 6
dcd D.1.1.1.1 01JAN2020 64 630 Yes SEVERE Yes 1 No 6
dcd C.2.1.2.1 01JAN2020 95 306 No MODERATE Yes 5 No 2
dcd A.1.1.1.2 01JAN2020 160 259 Yes MODERATE No 2 Yes 2
dcd B.2.2.3.1 01JAN2020 292 50 Yes MILD No 3 No 2
dcd A.1.1.1.2 01JAN2020 459 195 Yes MODERATE No 5 Yes 2
dcd B.1.1.1.1 01JAN2020 470 131 Yes SEVERE Yes 1 No 6
dcd A.1.1.1.2 01JAN2020 475 113 Yes MODERATE No 4 Yes 2
dcd C.1.1.1.3 01JAN2020 496 162 No SEVERE Yes 5 Yes 2
dcd B.1.1.1.1 01JAN2020 641 15 Yes SEVERE Yes 1 Yes 6
BRA-1/id-93 34/F/ASIAN dcd D.1.1.4.2 20JUN2020 44 47 No MODERATE No 5 Yes 2
dcd D.2.1.5.3 20JUN2020 79 300 No MILD Yes 5 No 3
dcd A.1.1.1.1 20JUN2020 136 78 No MILD No 3 Yes 2
dcd D.2.1.5.3 20JUN2020 260 305 No MILD Yes 5 No 2
dcd C.1.1.1.3 20JUN2020 281 106 No SEVERE Yes 5 Yes 2
dcd D.1.1.1.1 20JUN2020 316 250 Yes SEVERE Yes 1 No 6
—————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
(1) Outcome: 1 = fatal; 2 = not recovered/not resolved; 3 = recovered/resolved;
4 = recovered/resolved with sequelae; 5 = recovering/resolving; 6 = unknown.
(2) Action taken with study drug: 1 = dose increased; 2 = dose not changed;
3 = dose reduced; 4 = drug interrupted; 5 = drug withdrawn; 6 = not applicable;
7 = unknown.
* Study day derived from imputed onset date.
** Duration derived from imputed onset date and/or end date.