Variables that describe the record are often used in analysis. Include these and any other SDTM variables if used in analysis. If the analysis version of the variable differs from the version in the SDTM, additional variables must be added using the conventions below and described in Section 2.9.3, How to Create Analysis Variables.

The following table lists some common descriptive variables that are often included in ADAE. Any other SDTM variables should be included as appropriate (e.g. AEOUT, AESDTH).

Adverse Event Descriptive Variables

Variable Name

Variable Label

Type

Codelist/ Controlled Terms

Core

CDISC Notes

--SER

Serious Event

Char

(NY)

Perm

XX.–SER AESER is equired for adverse event data.

--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

(TPACN)

Perm

XX.--ACN

Required if XX.--ACN is present and populated

Medical history data typically does not contain descriptive variables. If needed for analysis, use variables as shown above for adverse events, replacing the prefix “AE” with “MH”.

Concomitant Medications Descriptive Variables

Variable Name

Variable Label

Type

Codelist/ Controlled Terms

Core

CDISC Notes

--STAT

Completion Status

Char


Perm

XX.--STAT

--INDC

Indication

Char


Perm

XX.--INDC

--DOSE

Dose per Administration

Num


Perm

XX.--DOSE

--DOSFRM

Dose Form

Char


Perm

XX.--DOSFRM

--DOSRGM

Intended Dose Regimen

Char


Perm

XX.--DOSRGM

--ROUTE

Route of Administration

Char


Perm

XX.--ROUTE

« Product/Dose Variables

Standardized MedDRA Query Variables »

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