Product-emergent flag as defined for analysis Example derivation:
If ADSL.TRTSDT<=ASTDT<=ADSL.TRTEDT + x days then TRTEMFL="Y"
The numberxin 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.