Bioequivalence and Bioavailability Forum

Neeraj ☆ 2009-02-06 12:07 (5939 d 23:02 ago) Posting: # 3188 Views: 5,227	Adverse Event [Study Performance] Post reply
	Dear all, In a two-way cross over study, during pre study dinner (after check-in) a subject got an adverse event in Period II. The subject was given Test drug in Period I and necessary wash out period was maintained. How to report the event in final study report? As a predose adverse event or due to test drug? Regards, Neeraj

Helmut
★★★

Vienna, Austria,
2009-02-06 13:35
(5939 d 21:34 ago)

@ Neeraj
Posting: # 3190
Views: 3,893

Adverse Event

Post reply

Dear Neeraj,

there's no category like 'predose adverse event'. It's an AE, full stop (in one of our studies a volunteer was bitten by a dog in the washout - still that's an AE). The investigator should rate the relationship of the AE to the study medication. The rating scale hopefully is given in both the protocol and the CRF. IMHO most investigators would rate such an AE as 'unlikely'.
For examples of rating scales see this post.

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