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Serious Adverse Event (SAE) or Serious Adverse Reaction (SAR)
- Any untoward medical occurrence that at any dose:
• results in death
• requires patient hospitalization
• results in persistent or significant disability or incapacity
• is life-threatening
• or is a congenital anomaly/birth defect.
In addition, medical judgment should be used to assess an AE as serious due to its medical importance: refer to MedDRA IME (important medical event) terms list. Remark: “severe” is not synonymous with “serious”:
• “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
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