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Compound Evidence InstituteEvidence synthesis · established 2023Graded assessments of compounds, trials, methods and supply
Document set current to 30 July 2026
Defined term · Outcomes and endpoints

Serious adverse event

An adverse event that results in death, is life-threatening, requires hospitalisation, produces persistent disability or is a congenital anomaly. A regulatory classification and not a judgement of…

Document identifier
CEI-GT-099
Series
Defined term
Version
1.0
Published
30 Jul 2026
Last reviewed
30 Jul 2026
Certainty
Not rated

§1Serious adverse event

§1.1Also known as

SAE

§1.2Category

Outcomes and endpoints — Terms describing what a study measures and what the measurement supports.

§1.3Related terms

  • Adverse event — Any untoward occurrence in a participant, whether or not attributed to treatment. Ascertained by spontaneous report in most trials, which underestimates incidence…
Compound Evidence Institute · CEI-GT-099 · https://compoundevidence.com/glossary/serious-adverse-event/ · retrieved 30 July 2026
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