OCCDS Adverse Events Indicator Variables

Variable Name

Variable Label

Type

Codelist

Controlled Terms

Core

SubClass ADVERSE EVENT Core

CDISC Notes

TRTEMFL

Product Emergent Analysis Flag

Char

Y

Cond

Req

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

TREMxxFL

Product Emergent Period xx Flag

Char

Y

Cond

Cond

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

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

TRTEMwFL

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 product emergence is a key feature of the analysis.

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

AETRTEM

Product Emergent Flag

Char

(NY)

Perm

Cond

Product-emergent flag from SDTM, if available.

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.