Serious adverse event

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Serious Adverse Event

A Serious Adverse Event (SAE) (pronunciation: /ˈsɪər.i.əs ædˈvɜːs iːˈvent/) is a term used in clinical trials to refer to an untoward occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.

Etymology

The term "Serious Adverse Event" is derived from the combination of the words "serious", "adverse", and "event". "Serious" comes from the Latin word "serius" meaning "weighty, important, grave". "Adverse" is derived from the Latin word "adversus" meaning "opposite, hostile". "Event" comes from the Latin word "eventus" meaning "outcome, result, occurrence".

Related Terms

  • Adverse Event: Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
  • Unexpected Adverse Event: An adverse event, the nature or severity of which is not consistent with the applicable product information.
  • Suspected Unexpected Serious Adverse Reaction (SUSAR): A serious adverse reaction, the nature or severity of which is not consistent with the applicable product information.

See Also

External links

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