Variable Name,Variable Label,Type,Codelist / Controlled Terms,Core,CDISC Notes
AESER,Serious Event,Char,(NY),Req,AE.AESER
AESEV,Severity/Intensity,Char,(AESEV),Perm,AE.AESEV
AESEVN,Severity/Intensity (N),Num,"1, 2, 3",Perm,"Code AE.AESEV 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 AESEV 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 or severe).
SEVGRyN,"Pooled Severity Group y
(N)",Num,*,Perm,"Code SEVGRy to numeric
Low intensity should correspond to low value"
AEREL,Causality,Char,*,Perm,AE.AEREL
AERELN,Causality (N),Num,*,Perm,"Code AE.AEREL 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 AEREL 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"
AETOXGR,Standard Toxicity Grade,Char,*,Perm,AE.AETOXGR
AETOXGRN,"Standard Toxicity Grade
(N)",Num,*,Perm,"Code AETOXGR to numeric
Low toxicity should correspond to low value"
ATOXGR,Analysis Toxicity Grade,Char,*,Perm,"Toxicity grade for analysis. May be based on AETOXGR or an imputed or assigned value. May
change case of text, such as from all uppercase in AETOXGR 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 y
(N)",Num,*,Perm,"Code of TOXGGRy to numeric
Low toxicity should correspond to low value"
AEACN,Action Taken with Study Treatment,Char,(ACN),Perm,AE.AEACN
