Serious Adverse Event (SAE)

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A Serious Adverse Event (SAE) is an untoward medical occurrence that results in a significant reduction in quality of life.



References

2021

  • (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Serious_adverse_event Retrieved:2021-12-24.
    • A serious adverse event (SAE) in human drug trials is defined as any untoward medical occurrence 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 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. Adverse events are further defined 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.”