Cytodyn Inc (CYDY): SAE definition: in a clinical trial cont...

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Re: misiu143 post# 96818

Tuesday, 07/21/2020 5:47:04 PM

Tuesday, July 21, 2020 5:47:04 PM

SAE definition: in a clinical trial context, the FDA defines an SAE as any "untoward medical occurrence," however caused, that (a) causes or prolongs a hospital stay, or (b) is life threatening or causes death.

Drug related SAEs are called SARs - serious adverse reactions. Not relevant to the calculation, but good not to have on your record.

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