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A subject in a clinical trial for a new hypertension drug experiences a severe headache, is hospitalized overnight for observation, and is discharged the next day with a diagnosis of a migraine. The event resolves. How should the site staff classify this event?

A non-serious Adverse Event because it resolved completely. A Serious Adverse Event (SAE) because it resulted in inpatient hospitalization. Not an Adverse Event because it was diagnosed as a common migraine. An unexpected adverse event that does not require expedited reporting.

Correct Answer:

A Serious Adverse Event (SAE) because it resulted in inpatient hospitalization.

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