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Document set current to 30 July 2026
Defined term · Outcomes and endpoints

Adverse event

Any untoward occurrence in a participant, whether or not attributed to treatment. Ascertained by spontaneous report in most trials, which underestimates incidence relative to systematic questioning.

Document identifier
CEI-GT-098
Series
Defined term
Version
1.0
Published
30 Jul 2026
Last reviewed
30 Jul 2026
Certainty
Not rated

§1Adverse event

§1.1Also known as

AE

§1.2Category

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

§1.3Related terms

  • 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…
  • Discontinuation for adverse events — Cessation of randomised treatment because of an adverse event. Reported by the Institute in the summary-of-findings table alongside efficacy outcomes rather than in a…
Compound Evidence Institute · CEI-GT-098 · https://compoundevidence.com/glossary/adverse-event/ · retrieved 30 July 2026
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