Pathologic Function
adverse event
[ ad-vurs, ad-vurs ih-vent ]
Definitions related to adverse event:
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An unexpected medical problem that happens during treatment with a drug or other therapy. Adverse effects do not have to be caused by the drug or therapy, and they may be mild, moderate, or severe.NCI Dictionary of Cancer TermsU.S. National Cancer Institute, 2021
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Any unfavorable and unintended sign, symptom, disease, or other medical occurrence with a temporal association with the use of a medical product, procedure or other therapy, or in conjunction with a research study, regardless of causal relationship. Example(s): death, back pain, headache, pulmonary embolism, heart attack.BRIDG Model DictionaryBiomedical Research Integrated Domain Group, 2019
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Any unfavorable or unintended disease, sign, or symptom (including an abnormal laboratory finding) that is temporally associated with the use of a medical treatment or procedure, and that may or may not be considered related to the medical treatment or procedure. Such events can be related to the intervention, dose, route of administration, patient, or caused by an interaction with another drug(s) or procedure(s).NCI ThesaurusU.S. National Cancer Institute, 2021
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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.CDISC TerminologyClinical Data Interchange Standards Consortium (CDISC), 2021
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