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MK_96
Fluorite | Level 6
Does ADAE dataset have screen failure subjects ..??
1 ACCEPTED SOLUTION

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Ksharp
Super User
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.

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3 REPLIES 3
Ksharp
Super User
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.
Noudjoum
Fluorite | Level 6
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.

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