Serious adverse event

In drug development, serious adverse event (SAE) is defined as any untoward medical occurrence during a human drug trial that at any dose

  1. Results in death
  2. Is life-threatening
  3. Requires inpatient hospitalization or causes prolongation of existing hospitalization
  4. Results in persistent or significant disability/incapacity
  5. May have caused a congenital anomaly/birth defect
  6. Requires intervention to prevent permanent impairment or damage[1]

The term "life-threatening" in the definition of "serious" refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe.[2] Adverse events are more broadly defined by international regulation as “Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.”[2]

  1. ^ "What is a Serious Adverse Event?". FDA. 9 September 2020.
  2. ^ a b Expert Working Group (Efficacy) of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). (August 25, 2007). "Guideline for Industry - Clinical safety data management: definitions and standards for expedited reporting" (PDF). FDA Center for Drug Evaluation and Research. Archived from the original (PDF) on October 18, 1996.
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