What are the six seriousness criteria for a Serious Adverse Reaction?

  • Death
  • Life-threatening
  • requires inpatient hospitalization or prolongation of existing hospitalization
  • Disability or Permanent Damage
  • Congenital Anomaly/Birth Defect
  • Important Medical Event (IME):¬†when the event does not fit the other outcomes, but the event may jeopardize the patient and may require medical or surgical intervention (treatment) to prevent one of the other outcomes

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