All-cause Death

Illustrates Domains

AE
DS
DD

Illustrates Variables

AETERM
AEDECOD
AEBODSYS
AESER
AEOUT
DSTERM
DSDECOD
DSCAT
EPOCH
DDTESTCD
DDTEST
DDORRES
DDSTRESC

Content

When a subject dies on study, information about the death appears in several SDTM domains. The death is represented as a disposition event in the Disposition (DS) domain and additional details are recorded in the Death Details (DD) domain. In this example, the adverse events that lead to the deaths of 3 subjects were recorded in the Adverse Events (AE) domain (AEOUT = "FATAL"). The DTHFL and DTHDTC variables would also be populated in the Demographics (DM) domain; a DM record is not included in this example.

ae.xpt

ae.xpt

Row	STUDYID	DOMAIN	USUBJID	AESEQ	AELNKID	AETERM	AEDECOD	AEBODSYS	AESER	AEOUT	AESDTH	AESTDTC	AEENDTC
1	XYZ-001	AE	XYZ-001-001	1	DTH	BLOOD STREAM INFECTION	Sepsis	Infections and infestations	Y	FATAL	Y	2013-10-25	2013-11-02
2	XYZ-001	AE	XYZ-001-002	1	DTH	HEART ATTACK	Sudden cardiac death	Cardiac disorders	Y	FATAL	Y	2015-03-20	2015-03-20
3	XYZ-001	AE	XYZ-001-004	1	DTH	RENAL FAILURE	Renal failure	Renal and urinary system disorders	Y	FATAL	Y	2015-03-27	2015-04-03

The disposition events of death for each subject related to the adverse events described in AE were represented in the DS domain. In this example, 3 subjects completed the study and 3 died before day 90.

ds.xpt

ds.xpt

Row	STUDYID	DOMAIN	USUBJID	DSSEQ	DSLNKID	DSTERM	DSDECOD	DSCAT	EPOCH	DSSTDTC	DSSTDY
1	XYZ-001	DS	XYZ-001-001	1	DTH	BLOOD STREAM INFECTION	DEATH	DISPOSITION EVENT	TREATMENT	2013-11-02	85
2	XYZ-001	DS	XYZ-001-002	1	DTH	HEART ATTACK	DEATH	DISPOSITION EVENT	TREATMENT	2015-03-20	82
3	XYZ-001	DS	XYZ-001-003	1		COMPLETED	COMPLETED	DISPOSITION EVENT	TREATMENT	2010-10-12	94
4	XYZ-001	DS	XYZ-001-004	1	DTH	RENAL FAILURE	DEATH	DISPOSITION EVENT	TREATMENT	2015-04-03	63
5	XYZ-001	DS	XYZ-001-005	1		COMPLETED	COMPLETED	DISPOSITION EVENT	TREATMENT	2015-01-23	90
6	XYZ-001	DS	XYZ-001-006	1		COMPLETED	COMPLETED	DISPOSITION EVENT	TREATMENT	2015-01-25	90

The death details were represented in DD domain.

The locations were populated from the environmental settings codelist (C127262).

dd.xpt

Rows 1-2:	Show that the subject died of sepsis in the hospital.
Rows 3-5:	Show that the subject died at home. The primary cause of death was sudden cardiac death; the secondary cause was renal failure.
Rows 6-7:	Show that the subject died of renal complications in the hospital.

dd.xpt

Row	STUDYID	DOMAIN	USUBJID	DDSEQ	DDLNKID	DDTESTCD	DDTEST	DDORRES	DDSTRESC	DDDTC	DDDY
1	XYZ-001	DD	XYZ-001-001	1	DTH	PRCDTH	Primary Cause of Death	SEPSIS	SEPSIS	2013-11-02	85
2	XYZ-001	DD	XYZ-001-001	2	DTH	LOCDTH	Location of Death	VETERAN'S HOSPITAL	HOSPITAL	2013-11-02	85
3	XYZ-001	DD	XYZ-001-002	1	DTH	PRCDTH	Primary Cause of Death	SUDDEN CARDIAC DEATH	SUDDEN CARDIAC DEATH	2015-03-20	82
4	XYZ-001	DD	XYZ-001-002	2	DTH	SECDTH	Secondary Cause of Death	RENAL FAILURE	RENAL FAILURE	2015-03-20	82
5	XYZ-001	DD	XYZ-001-002	3	DTH	LOCDTH	Location of Death	HOME	HOME	2015-03-20	82
6	XYZ-001	DD	XYZ-001-004	1	DTH	PRCDTH	Primary Cause of Death	RENAL FAILURE	RENAL FAILURE	2015-04-03	63
7	XYZ-001	DD	XYZ-001-004	2	DTH	LOCDTH	Location of Death	MEMORIAL HOSPITAL	HOSPITAL	2015-04-03	63

RELREC represents the relationship between the AE, DS, and DD domains via the --LNKID variable.

relrec.xpt

relrec.xpt

Row	STUDYID	RDOMAIN	IDVAR	RELTYPE	RELID
1	XYZ-001	AE	AELNKID	ONE	1
2	XYZ-001	DS	DSLNKID	ONE	1
3	XYZ-001	DD	DDLNKID	MANY	1