6 Domain Models Based on the General Observation Classes

6.3 Events

Adverse Events (AE) AE - Description/Overview for Adverse Events Domain Model Adverse events may be captured either as free text or a pre-specified list of terms. AE - Specification for Adverse Events Domain Model

VariableName	VariableLabel	Type	CT, CodeList or Format	Role	CDISC Notes	Core	xml
STUDYID	Study Identifier	Char		Identifier	Unique identifier for a study.	Req	xml
DOMAIN	Domain Abbreviation	Char	AE	Identifier	Two-character abbreviation for the domain.	Req	xml
USUBJID	Unique Subject Identifier	Char		Identifier	Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.	Req	xml
AESEQ	Sequence Number	Num		Identifier	Sequence Number given to ensure uniqueness of subject records within a domain. May be any valid number.	Req	xml
...
AELOC	Location of Event	Char	(LOC)	Record Qualifier	Describes anatomical location relevant for the event (e.g., ARM for skin rash).	Perm	xml