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 Treatment
Char
(ACN)
Perm
XX.--ACN
Required if XX.--ACN is present and populated
1Codelists in parenthesis are the names of CDISC Controlled Terminology. Asterisk indicates variable may be subject to producer-defined controlled terminology.