Variable Name

Variable Label

Type

Codelist/ Controlled Terms

Core

CDISC Notes

ONTRTFL

On Product Record Flag

Char

Y

Cond

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

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

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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