Serious Adverse Event (SAE)

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

• Example(s):
  • Death.
  • a Life-Threatening Event.
  • a Congenital Anomaly.
• See: Adverse Event, Drug Trials, Death, Inpatient Care.

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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.”

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