Sample Subject Level Adverse Events Dataset
USUBJID	AEDECOD	AEBODSYS	TRTAN	TRTA	TRT_DESC	VERSION	AESER	TRTEMFL	SAFFL
XYZ-001-001	Headache	Nervous system disorders	1	Drug A	Study Drug	MedDRA 17.1	N	Y	Y
XYZ-001-001	Back pain	Musculoskeletal and connective tissue disorders	1	Drug A	Study Drug	MedDRA 17.1	N	Y	Y
XYZ-001-002	Hypotension	Vascular disorders	2	Drug B	Comparator Drug	MedDRA 17.1	Y		Y
XYZ-001-003	Abdominal discomfort	Gastrointestinal disorders	3	Drug C	Comparator Drug	MedDRA 17.1	N	Y	N
Sample Corresponding Data Entry for Subject Level Adverse Data
Subject Identification	USUBJID
Preferred Term	AEDECOD
System Organ Class	AEBODSYS
Treatment Group / Arm ID (Optional)	TRTAN
Treatment Group /Arm	TRTA
Treatment Description / Arm (Optional)	TRT_DESC
MedDRA version (optional if specified in the adverse Events section)	VERSION
Serious Adverse Events	AESER
Serious flag value (ex:"Serious" , "Yes" , 1, etc..)	Y
Non-Serious flag value (ex:"Non-Serious", "No" , 2, etc..)	N
Treatment Emergent	TRTEMFL
Treatment Emergent Value	Y
Population Flag (Optional)	SAFFL
Sample Subject Level Dataset
AGE	AGEU	RACE	ARM	ARMCD	ENRFL	TRTSDT	EOSDREAS	EOSREASP	ACTARM	ACTARMCD	EVAFL
40	Years	White	Drug A	1	Y	14-Mar-2013	Completed		Drug B	2	Y
35	Years	Black	Drug B	2	Y	17-May-2014	Adverse Events		Drug A	1	Y
56	Years	Asian	Drug B	2	Y	16-Mar-2015	Other	Subject Refused further treatment	Drug B	2	Y
21	Years	White	Drug C	3	N	17-Jun-2015	Adverse Events		Drug C	3
Sample Corresponding Data Entry for Subject Level Data
Age	AGE
Age Unit	AGEU
RACE	RACE
Planned Treatment Arm	ARM
Planned Treatment Arm code	ARMCD
Baseline Population Flag (optional)	ENRFL
Treatment Start Date	TRTSDT
Discontinuation Variables (Separated by Space if more than one)	EOSDREAS
Discontinuation Variables Specify (optional) (Sparated by Space if more than one)	EOSREASP
Name of Corresponding Periods (separated by space — leave blank if Overall Study Period)
Actual Treatment Arm	ACTARM
Actual Treatment Arm Code	ACTARMCD
Participant Flow Population flag (optional)	EVAFL