Character indicator of whether the observation occurred while the subject was on treatment. 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 is a feature of the study and used in analysis.
ONTRxxFL
On Treatment Period xx Flag
Char
Y
Perm
This variable is used if there are multiple periods where on treatment is a key feature of the analysis for each period.
If ONTRxxFL is included, ONTRTFL is defined as the overall on-treatment flag.
ONTRTwFL
On Treatment Record w Flag
Char
Y
Perm
This variable is used if there are other analysis needs (e.g., different cut-offs) where on treatment is a key feature of the analysis.
If ONTRTwFL is included, ONTRTFL is defined as the overall on-treatment flag.