HCLSIG/Drug Safety and Efficacy/SDTM Codes

SDTM Reserved Domain Codes

Dataset	Description	Location	Structure	Purpose
DM	Demographics	DM.XPT	One record per subject	Tabulation
CO	Comments	CO.XPT	One record per comment per subject	Tabulation
CM	Concomitant	CM.XPT	One record per medication intervention episode per subject	Tabulation
EX	Exposure	EX.XPT	One record per constant dosing interval per subject	Tabulation
SU	Substance Use	SU.XPT	One record per substance use type per subject	Tabulation
AE	Adverse Events	SAEXPT	One record per event per subject	Tabulation
DS	Disposition	DS.XPT	One record per disposition status or protocol milestone per subject	Tabulation
MH	Medical History	MH.XPT	One record per medical history event per subject	Tabulation
EG	ECG	EG.XPT	One record per ECG measurement per subject	Tabulation
IE	Inclusion/Exclusion Exceptions	IE.XPT	One record per I/E criteria not met per subject	Tabulation
LB	Laboratory Tests	LB.XPT	One record per lab test per subject	Tabulation
PE	Physical Exam	PE.XPT	One record per subject or body system or body system finding	Tabulation
QS	Questionnaires	QS.XP	one record per question per subject	Tabulation
SC	Subject Characteristics	SC.XPT	One record per subject characteristic	Tabulation
VS	Vital Signs	VS.XPT	One record per vital sign measurement per subject	Tabulation
TE	Trial Elements	TE.XPT	One record per element	Tabulation
TA	Trial Arms	TA.XPT	One record per element per arm	Tabulation
TV	Trial Visits	TV.XPT	One record per visit per arm	Tabulation
SE	Subject Elements	SE.XPT	One record per actual element per subject	Tabulation
SV	Subject Visits	SV.XPT	One record per subject per actual visit	Tabulation
TI	Trial Inclusion/ Exclusion Criteria	TI.XPT	One record per I/E criterion	Tabulation
RELREC	Related Records	RELREC .XPT	One record per relationship	Tabulation
SUPPQAL	Supplemental Qualifiers	SUPPQUAL.XPT	One record per qualifier value.	Tabulation