Table 3.2.5.4 Concomitant Medications Indicator Variables (Copy)

ONTRTFL

On Treatment Record Flag

Char

Y

Cond

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.

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.

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.