lsting <-as_listing( out,key_cols =c("TRT01A", "CPID", "ASR"),disp_cols =names(out),main_title ="Listing of Serious 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taken with study drug: 1 = dose increased; 2 = dose not changed; 3 = dose reduced; 4 = drug interrupted; 5 = drug withdrawn; 6 = not applicable; 7 = unknown.(3) Reason classified as serious: 1 = resulted in death; 2 = life threatening; 3 = required prolonged in patient hospitalization; 4 = disabling; 5 = a congenital anomaly/birth defect in offspring of study subject; 6 = does not meet any of the above serious criteria, but may jeopardize the subject, and may require medical or surgical intervention to prevent one of the outcomes listed above.* Study day derived from imputed onset date.** Duration derived from imputed onset date and/or end date.")head(lsting, 20)
Listing of Serious Adverse Events
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Date of Reason
Adverse First Study Study AE Most Caused by Action Classified
Event MedDRA Drug Day of Duration Extreme Study Outcome Treatment Taken as Serious
Treatment Center/Patient ID Age/Sex/Race Preferred Term Administration Onset in Days Intensity Drug (1) for AE (2) (3)
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A: Drug X BRA-1/id-134 47/M/WHITE dcd A.1.1.1.2 04NOV2020 321 149 MODERATE No 5 Yes 2 4
dcd A.1.1.1.2 04NOV2020 393 43 MODERATE No 5 No 5 5
BRA-1/id-42 36/M/BLACK OR AFRICAN AMERICAN dcd D.1.1.1.1 01JAN2020 64 630 SEVERE Yes 1 No 6 1
dcd A.1.1.1.2 01JAN2020 160 259 MODERATE No 2 Yes 2 4
dcd B.2.2.3.1 01JAN2020 292 50 MILD No 3 No 2 4
dcd A.1.1.1.2 01JAN2020 459 195 MODERATE No 5 Yes 2 5
dcd B.1.1.1.1 01JAN2020 470 131 SEVERE Yes 1 No 6 1
dcd A.1.1.1.2 01JAN2020 475 113 MODERATE No 4 Yes 2 4
dcd B.1.1.1.1 01JAN2020 641 15 SEVERE Yes 1 Yes 6 1
BRA-1/id-93 34/F/ASIAN dcd D.1.1.1.1 20JUN2020 316 250 SEVERE Yes 1 No 6 1
dcd B.1.1.1.1 20JUN2020 523 24 SEVERE Yes 1 No 6 1
dcd B.2.2.3.1 20JUN2020 596 10 MILD No 3 Yes 2 4
BRA-11/id-345 37/F/WHITE dcd B.1.1.1.1 18AUG2020 1009 35 SEVERE Yes 1 No 6 1
BRA-11/id-397 38/M/ASIAN dcd D.1.1.1.1 27JUN2020 516 441 SEVERE Yes 1 No 6 1
dcd B.1.1.1.1 27JUN2020 1011 30 SEVERE Yes 1 Yes 6 1
BRA-11/id-50 26/M/BLACK OR AFRICAN AMERICAN dcd A.1.1.1.2 28APR2019 1007 68 MODERATE No 3 Yes 2 5
BRA-13/id-177 24/M/WHITE dcd B.1.1.1.1 30AUG2020 249 470 SEVERE Yes 1 No 6 1
dcd B.1.1.1.1 30AUG2020 1012 33 SEVERE Yes 1 No 6 1
BRA-15/id-36 38/F/ASIAN dcd B.1.1.1.1 08JAN2020 372 154 SEVERE Yes 1 Yes 6 1
dcd A.1.1.1.2 08JAN2020 573 134 MODERATE No 3 Yes 2 3
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(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.
(3) Reason classified as serious: 1 = resulted in death; 2 = life threatening;
3 = required prolonged in patient hospitalization; 4 = disabling;
5 = a congenital anomaly/birth defect in offspring of study subject;
6 = does not meet any of the above serious criteria, but may jeopardize the subject,
and may require medical or surgical intervention to prevent one of the outcomes listed above.
* Study day derived from imputed onset date.
** Duration derived from imputed onset date and/or end date.
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