Page History

Variable Name

Variable Label

Type

Codelist^a

Controlled Terms

Core

SubClass ADVERSE EVENT Core

CDISC Notes

TRTEMFL

Treatment Product Emergent Analysis Flag

Char

Y

Cond

Req

TreatmentProduct-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 product emergent is a key feature of the analysis.

TREMxxFL

Treatment Product Emergent Period xx Flag

Char

Y

Cond

Cond

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

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

TRTEMwFL

Treatment Product Emergent Analysis w Flag

Char

Y

Perm

Perm

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

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

AETRTEM

Treatment Product Emergent Flag

Char

(NY)

Perm

Cond

TreatmentProduct-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

Variable Name

Variable Label

Type

Codelist

Controlled Terms

Core

SubClass ADVERSE EVENT Core

CDISC Notes

ONTRTFL

On Treatment Product Record Flag

Char

Y

Cond

Perm

Character indicator of whether the observation occurred while the subject was on treatmentproduct. A codelist of Y, N, null may be used as described in ADaMIG Section 3.3.8, Indicator Variables for BDS Datasets.

Example derivation:

If ADSL.TRTSDT <= ASTDT <= ADSL.TRTEDT then ONTRTFL = "Y"

This variable is conditional on whether the concept of on treatment product is a feature of the study and used in analysis.

ONTRxxFL

On Treatment Product Period xx Flag

Char

Y

Perm

Perm

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

If ONTRxxFL is included, ONTRTFL is defined as the overall on-treatment product flag.

ONTRTwFL

On Treatment Product Record w Flag

Char

Y

Perm

Perm

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

If ONTRTwFL is included, ONTRTFL is defined as the overall on-treatment product flag.