Death

Illustrates Domains

DS
DD
RELREC

Illustrates Variables

DSLNKID
DSDECOD
DSCAT
DDLNKID
DDTEST
DDORRES
DDSTRESC
RELID


Content

Subjects in this example were followed until death or the end of the study, whether or not they were still on the study treatment. The sponsor included only an end-of-study disposition CRF; no end-of-treatment form was used. Information on treatment exposure was reported only in the EX domain (not shown). A typical study disposition form was used to collect the data (per CDASH; https://www.cdisc.org/standards/foundational/cdash). This study disposition data was represented as a disposition event in the DS domain, as referenced in the SDTMIG (https://www.cdisc.org/standards/foundational/sdtmig). The sponsor created DSLNKID in the data management system.

ds.xpt

ds.xpt

RowSTUDYIDDOMAINUSUBJIDDSSEQDSLNKIDDSTERMDSDECODDSCATDSSTDTC
1HF3DSHF3-0011

Informed Consent

INFORMED CONSENTPROTOCOL MILESTONE2019-04-04
2HF3DSHF3-0012DTH-1DeathDEATHDISPOSITION EVENT2019-08-01
3HF3DSHF3-0021
Informed ConsentINFORMED CONSENTPROTOCOL MILESTONE2019-04-03
4HF3DSHF3-0022
CompletedCOMPLETEDDISPOSITION EVENT2019-10-02

The sponsor used a Death Detail CRF to collect additional information on the deaths. This data was represented in the Death Details (DD) domain. For any subject death, the DTHFL and DTHDTC variables in the DM domain are also populated. 

dd.xpt

dd.xpt

RowSTUDYIDDOMAINUSUBJIDDDSEQDDLNKIDDDTESTCDDDTESTDDORRESDDSTRESCDDDTC
1HF3DDHF3-0011DTH-1PRCDTHPrimary Cause of DeathSUDDEN CARDIAC DEATHSUDDEN CARDIAC DEATH2019-08-01
2HF3DDHF3-0012DTH-1SECDTHSecondary Cause of DeathHEART FAILUREHEART FAILURE2019-08-01
3HF3DDHF3-0013DTH-1LOCDTHLocation of DeathHOMEHOME2019-08-01
4HF3DDHF3-0014DTH-1DTHWIND

Death Witnessed Indicator

YY2019-08-01
RELREC

shows the relationship between the DS and DD domains. In this example, because death data were collected on a single CRF, the sponsor created a RELREC. A RELREC dataset is not necessary in all cases.

relrec.xpt

relrec.xpt

RowSTUDYIDRDOMAINUSUBJIDIDVARIDVARVALRELTYPERELID
1HF3DS
DSLNKID
ONEA
2HF3DD
DDLNKID
MANYA