Name | Variable Label | Type | Codelist |
|---|
SubClass ADVERSE EVENT Core | CDISC Notes |
|---|
ONTRTFL | On Product Record Flag | Char | Y | Cond |
Perm | Character indicator of whether the observation occurred while the subject was on product. 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 product is a feature of the study and used in analysis. | ONTRxxFL | On Product Period xx Flag | Char | Y | Perm |
Perm | This variable is used if there are multiple periods where on product is a key feature of the analysis for each period. If ONTRxxFL is included, ONTRTFL is defined as the overall on-product flag. | ONTRTwFL | On Product Record w Flag | Char | Y |
Perm | Perm | This variable is used if there are other analysis needs (e.g., different cut-offs) where on product is a key feature of the analysis. If ONTRTwFL is included, ONTRTFL is defined as the overall on-product flag. |
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