Variable Name | Variable Label | Type | Codelist |
|---|
aCoreSubClass ADVERSE EVENT Treatment TreatmentProduct 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 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 |
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 |
|