OCCDS Adverse Events and Concomitant Medications Indicator Variables

PREFL

Pre-product Flag

Char

Y

Cond

Character indicator of whether the observation occurred before the subject started product

Example derivation:

If ASTDT < ADSL.TRTSDT then PREFL="Y"

This variable is conditional on whether the concept of pre-product is a feature of the study and used in analysis.

FUPFL

Follow-up Flag

Char

Y

Cond

Character indicator of whether the observation occurred while the subject was on follow-up

Example derivation:

If ASTDT > ADSL.TRTEDT then FUPFL="Y"

This variable is conditional on whether the concept of follow-up is a feature of the study and used in analysis.