ADAE

[MK_96]

Does ADAE dataset have screen failure subjects ..??

[Ksharp · Accepted solution]

I think it is not .
AE means adverse event which is from the subject who have already taken drugs.
If subject was screen failure,He can't take drugs.

[Ksharp]

And Better post it at CDISC forum:
https://communities.sas.com/t5/SAS-Health-and-Life-Sciences/bd-p/sas_health_pharma
https://communities.sas.com/t5/SAS-Life-Science-Analytics/cmp-p/grouphub%3Alife_sciences

[Noudjoum]

It depends on the definition of your protocol. I have seen studies where the AEs were collected two months before inclusion, in that case , yes it includes the screen failures. The AE that happen during the treatment period are called : treatment emergent AEs ( TEAEs).
Check your protocol, and if nothing is there, ask the clinician and the stat of your study.