Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.
Metadataspec

Variable Name

Variable Label

Type

Codelist/ Controlled Terms

Core

CDISC Notes

PREFL

Pre-treatment product Flag

Char

Y

Cond

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

Example derivation:

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

This variable is conditional on whether the concept of pre-treatment 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.