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Variable Name

Variable Label

Type

Codelist/ Controlled Terms

Core

CDISC Notes

--SER

Serious Event

Char

(NY)

Perm

XX.--SER

--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

(ACN)

Perm

XX.--ACN

Required if XX.--ACN is present and populated

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