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Serious Adverse Event

Meaning

A Serious Adverse Event (SAE) is a clinical term, strictly defined by regulatory bodies like the FDA, referring to any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. In the context of hormonal health and clinical trials, the prompt and accurate identification of an SAE is a mandatory ethical and legal requirement. It serves as a critical safety signal for all therapeutic interventions, including hormone replacement and novel biotherapeutics.