Adverse event
Definition: 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. An adverse event (AE) can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. NOTE: For further information, see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting. "[Modified from ICH E2A]" Synonyms: side effect, adverse experience. See also serious adverse event, serious adverse experience. (CDISC glossary)
Synonyms (terms occurring on more labels are shown first): adverse events, adverse event, adverse experience
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