ONTRTFL | On Treatment Product Record Flag | Char | Y | Cond | Character indicator of whether the observation occurred while the subject was on treatmentproduct. A codelist of Y, N, null may be used as described in ADaMIG Section 3.3.8, Indicator Variables for BDS Datasets. Example derivation: If ADSL.TRTSDT <= ASTDT <= ADSL.TRTEDT then ONTRTFL = "Y" This variable is conditional on whether the concept of on treatment product is a feature of the study and used in analysis. |
ONTRxxFL | On Treatment Product Period xx Flag | Char | Y | Perm | This variable is used if there are multiple periods where on treatment product is a key feature of the analysis for each period. If ONTRxxFL is included, ONTRTFL is defined as the overall on-treatment product flag. |
ONTRTwFL | On Treatment Product Record w Flag | Char | Y | Perm | This variable is used if there are other analysis needs (e.g., different cut-offs) where on treatment product is a key feature of the analysis. If ONTRTwFL is included, ONTRTFL is defined as the overall on-treatment product flag. |