Bioequivalence and Bioavailability Forum

Dear Soma,
In my experience, (6 years at a Phase I CRO), Adverse Events were coded; (before unblinding), by the clinician for not only Severity but also "Likelihood of relation to Study drug" with a scale similar to that below.

Very Likely, Probable, Possible, Unlikely, Unrelated

Most likely such a review would then class an event like this as Unrelated, and report it only in listings. However I am not a Clinician and would advise that you follow your own Clinician's assessment of the circumstances.

Simon.