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