Code
lsting <- as_listing(
out,
key_cols = c("TRT01A", "cent_subj", "ASR"),
disp_cols = names(out),
main_title = "Listing of Adverse Events (for early development studies)",
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3 = dose reduced; 4 = drug interrupted; 5 = drug withdrawn; 6 = not applicable;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 (for early development studies)
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
Time from Time from Time from
Adverse Study Last Dose Last Dose Last Dose AE Most Caused by Action
Event MedDRA Day of to Onset to Onset to Onset Duration Extreme Study Outcome Treatment Taken
Treatment Center/Patient ID Age/Sex/Race Preferred Term Onset days hrs mins in Days Serious Intensity Drug (1) for AE (2)
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
A: Drug X BRA-1/id-134 47/M/WHITE dcd B.2.1.2.1 162 7 19 4 173 No MODERATE No 5 Yes 2
dcd D.1.1.4.2 196 1 20 48 166 No MODERATE No 5 No 2
dcd A.1.1.1.2 321 28 12 54 149 Yes MODERATE No 5 Yes 2
dcd A.1.1.1.2 393 12 19 17 43 Yes MODERATE No 5 No 5
BRA-1/id-42 36/M/BLACK OR AFRICAN AMERICAN dcd C.2.1.2.1 39 30 9 4 506 No MODERATE Yes 2 No 6
dcd D.1.1.1.1 64 26 17 10 630 Yes SEVERE Yes 1 No 6
dcd C.2.1.2.1 95 4 12 58 306 No MODERATE Yes 5 No 2
dcd A.1.1.1.2 160 24 5 57 259 Yes MODERATE No 2 Yes 2
dcd B.2.2.3.1 292 9 23 4 50 Yes MILD No 3 No 2
dcd A.1.1.1.2 459 9 5 4 195 Yes MODERATE No 5 Yes 2
dcd B.1.1.1.1 470 6 5 0 131 Yes SEVERE Yes 1 No 6
dcd A.1.1.1.2 475 20 16 16 113 Yes MODERATE No 4 Yes 2
dcd C.1.1.1.3 496 5 5 28 162 No SEVERE Yes 5 Yes 2
dcd B.1.1.1.1 641 8 17 4 15 Yes SEVERE Yes 1 Yes 6
BRA-1/id-93 34/F/ASIAN dcd D.1.1.4.2 44 18 15 39 47 No MODERATE No 5 Yes 2
dcd D.2.1.5.3 79 2 3 58 300 No MILD Yes 5 No 3
dcd A.1.1.1.1 136 22 1 19 78 No MILD No 3 Yes 2
dcd D.2.1.5.3 260 12 12 26 305 No MILD Yes 5 No 2
dcd C.1.1.1.3 281 4 14 52 106 No SEVERE Yes 5 Yes 2
dcd D.1.1.1.1 316 6 12 43 250 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.