Variable Name | Variable Label | Type | Codelist/ Controlled Terms |
|---|
1Treatment Product Emergent Analysis Flag | Char | Y | Cond |
TreatmentProduct-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 | 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 | 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 |
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. |
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