Abnormal lab parameters [Study Per­for­mance]

posted by ElMaestro  – Denmark, 2011-03-04 18:10 (5588 d 02:32 ago) – Posting: # 6705
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Hi HS,

❝ Any cross-over study should be designed in such a way that no residual effects of period 1 are substantial in period 2 (= no carry-over). Following this rationale you should code the AE to the treatment of period 2, IMHO.


Wow, I never gave that a thought.
If an AE occurs after period 1 at any time during the washout period, then the AE is a period 1 AE. My intuition (we both know it's frequently malfunctioning as my cerebral capacity is dictated by a spongy structure approximately the size of a walnut) suggests me that one can assign the AE to period 2 if it occurs within the same washout time after dosing in that period. Or whut?

Pass or fail!
ElMaestro

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