Page History

Variable Name

Variable Label

Type

Codelist

Controlled Terms

Core

SubClass ADVERSE EVENT Core

CDISC Notes

--SER

Serious Event

Char

(NY)

Perm

Req

XX.--SER

--SEV

Severity/Intensity

Char

(AESEV) or (SEVRS)

Perm

Cond

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

Perm

Code XX.--SEV to numeric

Low intensity should correspond to low value

ASEV

Analysis Severity/Intensity

Char

*

Perm

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

Perm

Code ASEV to numeric

Low intensity should correspond to low value

SEVGRy

Pooled Severity Group y

Char

*

Perm

Perm

Pooled grouping of AE severity for analysis (e.g., mild/moderate, severe)

SEVGRyN

Pooled Severity Group y (N)

Num

*

Perm

Perm

Code SEVGRy to numeric

Low intensity should correspond to low value

--REL

Causality

Char

*

Perm

Req

XX.--REL

--RELN

Causality (N)

Num

*

Perm

Perm

Code XX.--REL to numeric

Low relation should correspond to low value

AREL

Analysis Causality

Char

*

Perm

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

Perm

Code AREL to numeric

RELGRy

Pooled Causality Group y

Char

*

Perm

Perm

Pooled grouping of causality of study drug for analysis (e.g. related, not related)

RELGRyN

Pooled Causality Group y (N)

Num

*

Perm

Perm

Code of RELGRy to numeric

Low relation should correspond to low value

--TOXGR

Standard Toxicity Grade

Char

*

Perm

Cond

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

Perm

Code --TOXGR to numeric

Low toxicity should correspond to low value

ATOXGR

Analysis Toxicity Grade

Char

*

Perm

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

Perm

Code ATOXGR to numeric

Low toxicity should correspond to low value

TOXGGRy

Pooled Toxicity Grade Group y

Char

*

Perm

Perm

Pooled grouping of toxicity grade for analysis

TOXGGRyN

Pooled Toxicity Grade Group y (N)

Num

*

Perm

Perm

Code of TOXGGRy to numeric

Low toxicity should correspond to low value

--ACN

Action Taken with Study Product

Char

(ACN)

Perm

Cond

XX.--ACN

Required if XX.--ACN is present and populated