Glossary

Serious Adverse Event (SAE) or Serious Adverse Reaction (SAR)

  • 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

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