adverse event
- Guideline or reference source
- CDISC Glossary of terms
- ICHE6(r1) Guideline for good clinical practice
- 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 can therefore be any unfavourable and 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.
- Abbreviation for
- AE
- Used For
- adverse experience
- adverse incident
- side effect
- Narrower Term
- adverse event of special interest
- serious adverse event
- Related Term
- adverse drug reaction
- adverse effect
- fda adverse event reporting system
- near-missed event
- treatment emergent
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