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Variable Name

Variable Label

Type

Codelista

Controlled Terms

Core

SubClass ADVERSE EVENT Core

CDISC Notes

TRTEMFL

Treatment Emergent Analysis Flag

Char

Y


Cond

Req

Treatment-emergent flag as defined for analysis

Example derivation:

If ADSL.TRTSDT<=ASTDT<=ADSL.TRTEDT + x days then TRTEMFL="Y"

The number x in this derivation is defined by the producer and often incorporates the known half-life of the drug.

For datasets other than SubClass ADVERSE EVENT, this variable is conditional on whether the concept of treatment emergent is a key feature of the analysis.

TREMxxFL

Treatment Emergent Period xx FlagCharY
CondCond

This variable is required if there are multiple periods where treatment emergence is a key feature of the analysis for each period.

If TREMxxFL is included, TRTEMFL is defined as the overall treatment-emergent flag.

TRTEMwFLTreatment Emergent Analysis w FlagCharY
PermPerm

This variable is used if there are other analysis needs (e.g., different cut-offs) where treatment emergence is a key feature of the analysis.

If TREMwFL is included, TRTEMFL is defined as the overall treatment-emergent flag.

AETRTEM

Treatment Emergent Flag

Char

(NY)


Perm

Cond

Treatment-emergent flag from SDTM, if available. See SDTMIG v3.3, Appendix C2, Supplemental Qualifiers Name Codes, for more information.

Derivation:

SUPPAE.QVAL where QNAM="AETRTEM"

TRTEMFL may differ from AETRTEM due to different definitions, date imputation, and other analysis rules. Including AETRTEM in addition to TRTEMFL will add traceability.

For SubClass ADVERSE EVENT, conditional on whether the AETRTEM variable is in the SDTM AE dataset and populated

 aCodelists in parenthesis are the names of CDISC Controlled Terminology.

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