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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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