Variable Name,Variable Label,Type,Code List / Controlled Terms,Core,CDISC Notes
TRTEMFL,Treatment Emergent Analysis Flag,Char,Y,Cond,"Treatment emergent flag as defined for analysis. Variable TRTEMFL is to be used for any analysis of treatment-emergent AEs. This variable is conditional on whether the concept of treatment emergent is a key feature of the AE analyses.
Example derivation:
If ADSL.TRTSDT?ASTDT?ADSL.TRTEDT + x days then TRTEMFL=’Y’
The number x is defined by the producer and often incorporates the known half-life of the drug. It should be consistent with variable APHASE (described above) if APHASE is also used."
AETRTEM,Treatment Emergent Flag,Char,(NY),Perm,"Treatment emergent flag from SDTM, if available. See the SDTMIG version 3.2 [3] 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."
