Descriptive Variables

Variables that describe the record are often used in analysis. Include these and any other SDTM variables if used in analysis. If the analysis version of the variable differs from the version in the SDTM, additional variables must be added using the conventions below and described in How to Create Analysis Variables.

The table below lists some common descriptive variables that are often included in ADAE. Any other SDTM variables should be included as appropriate (e.g. AEOUT, AESDTH).

Adverse Event Descriptive Variables

Variable Name	Variable Label	Type	Codelist/ Controlled Terms	Core	CDISC Notes
--SER	Serious Event	Char	(NY)	Perm	XX.–SER AESER is equired for adverse event data.
--SEV	Severity/Intensity	Char	(AESEV) or (SEVRS)	Perm	XX.--SEV For SubClass ADVERSE EVENT, conditional on whether the --SEV variable is in the SDTM AE dataset. Note that either --SEV or --TOXGR should be included in SDTM.
--SEVN	Severity/Intensity (N)	Num	1, 2, 3	Perm	Code XX.--SEV to numeric Low intensity should correspond to low value
ASEV	Analysis Severity/Intensity	Char		Perm	Apply imputation rules for missing severity of adverse events as specified in the SAP or metadata. May change case of text, such as from all uppercase in --SEV to mixed case in ASEV.
ASEVN	Analysis Severity/Intensity (N)	Num	1, 2, 3	Perm	Code ASEV to numeric Low intensity should correspond to low value
SEVGRy	Pooled Severity Group y	Char		Perm	Pooled grouping of AE severity for analysis (e.g., mild/moderate, severe)
SEVGRyN	Pooled Severity Group y (N)	Num		Perm	Code SEVGRy to numeric Low intensity should correspond to low value
--REL	Causality	Char		Perm	XX.--REL
--RELN	Causality (N)	Num		Perm	Code XX.--REL to numeric Low relation should correspond to low value
AREL	Analysis Causality	Char		Perm	Apply imputation rules for missing causality of study drug as specified in the SAP or metadata. May change case of text, such as from all uppercase in --REL to mixed case in AREL.
ARELN	Analysis Causality (N)	Num		Perm	Code AREL to numeric
RELGRy	Pooled Causality Group y	Char		Perm	Pooled grouping of causality of study drug for analysis (e.g. related, not related)
RELGRyN	Pooled Causality Group y (N)	Num		Perm	Code of RELGRy to numeric Low relation should correspond to low value
--TOXGR	Standard Toxicity Grade	Char		Perm	XX.--TOXGR For SubClass ADVERSE EVENT, conditional on whether the --TOXGR variable is in the SDTM AE dataset. Note that either --SEV or --TOXGR should be included in SDTM.
--TOXGRN	Standard Toxicity Grade (N)	Num		Perm	Code --TOXGR to numeric Low toxicity should correspond to low value
ATOXGR	Analysis Toxicity Grade	Char		Perm	Toxicity grade for analysis. May be based on --TOXGR or an imputed or assigned value. May change case of text, such as from all uppercase in --TOXGR to mixed case in ATOXGR.
ATOXGRN	Analysis Toxicity Grade (N)	Num		Perm	Code ATOXGR to numeric Low toxicity should correspond to low value
TOXGGRy	Pooled Toxicity Grade Group y	Char		Perm	Pooled grouping of toxicity grade for analysis
TOXGGRyN	Pooled Toxicity Grade Group y (N)	Num		Perm	Code of TOXGGRy to numeric Low toxicity should correspond to low value
--ACN	Action Taken with Study Product	Char	(TPACN)	Perm	XX.--ACN Required if XX.--ACN is present and populated

Medical history data typically does not contain descriptive variables. If needed for analysis, use variables as shown above for adverse events, replacing the prefix “AE” with “MH”.

Concomitant Medications Descriptive Variables

Variable Name	Variable Label	Type	Core	CDISC Notes
--STAT	Completion Status	Char	Perm	XX.--STAT
--INDC	Indication	Char	Perm	XX.--INDC
--DOSE	Dose per Administration	Num	Perm	XX.--DOSE
--DOSFRM	Dose Form	Char	Perm	XX.--DOSFRM
--DOSRGM	Intended Dose Regimen	Char	Perm	XX.--DOSRGM
--ROUTE	Route of Administration	Char	Perm	XX.--ROUTE

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Descriptive Variables