Definitions for "Adverse event"
An injury that was caused by medical management and that results in measurable disability. (definition courtesy the Quality Interagency Coordination Task Force)
an undesirable and unintended, although not necessarily unexpected, result of therapy or other intervention (e.g., headache following spinal tap or intestinal bleeding associated with aspirin therapy).
Occurrence which causes an adverse effect.
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a physical, psychological, or social injury to a participant in a research study.
Any negative experience that a participant has during the course of a research project, including new or worsening symptoms or laboratory abnormalities
A general term for harm or death, whether by nature or by acts or omissions.
something that happens to the subject which violates the stated level of expected risk