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 theanalysis.
TREMxxFL
Treatment Emergent Period xx Flag
Char
Y
Cond
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.
TRTEMwFL
Treatment Emergent Analysis w Flag
Char
Y
Perm
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
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.
1Codelists in parenthesis are the names of CDISC Controlled Terminology.