OCCDS Adverse Events and Concomitant Medications Indicator Variables

Variable Name

Variable Label

Type

Codelist

Controlled Terms

Core

SubClass ADVERSE EVENT Core

CDISC Notes

PREFL

Pre-treatment Flag

Char

Y

Cond

Cond

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

Example derivation:

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

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

FUPFL

Follow-up Flag

Char

Y

Cond

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.