- results in death
- requires patient hospitalization
- results in persistent or significant disability or incapacity
- is life-threatening
- or is a congenital anomaly/birth defect.
- “Severe” describes the intensity of an event (mild, moderate or severe), the event itself may be of minor medical significance (severe headache) and therefore not “serious”
- “Serious” describes the potential outcome for the patient and is used to define regulatory reporting obligations
Glossary
Serious Adverse Event (SAE) or Serious Adverse Reaction (SAR)
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Glossary
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