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Borel Fields

07/21/20 5:47 PM

#96842 RE: misiu143 #96818

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.