Adverse event: Difference between revisions
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Any noxious, pathological or unintended change in a physical or metabolic function, revealed by signs or symptoms or a change in the results of laboratory tests, in any phase of a clinical study, whether or not the change is considered treatment-related. | '''Version 1:''' Any noxious, pathological or unintended change in a physical or metabolic function, revealed by signs or symptoms or a change in the results of laboratory tests, in any phase of a clinical study, whether or not the change is considered treatment-related. | ||
'''Note:''' It may involve the exacerbation of a pre-existing condition, intercurrent diseases, an accident, a drug interaction or a significant worsening of the disease. | '''Note:''' It may involve the exacerbation of a pre-existing condition, intercurrent diseases, an accident, a drug interaction or a significant worsening of the disease. | ||
'''Version 2:''' Any untoward medical occurrence in a subject, whether device related or not. | |||
== Reference == | == Reference == | ||
http://htaglossary.net/adverse-event | Version 1: http://htaglossary.net/adverse-event | ||
Version 2: https://medevis.who-healthtechnologies.org/glossary 2024 | |||
Latest revision as of 19:59, 20 June 2024
Version 1: Any noxious, pathological or unintended change in a physical or metabolic function, revealed by signs or symptoms or a change in the results of laboratory tests, in any phase of a clinical study, whether or not the change is considered treatment-related.
Note: It may involve the exacerbation of a pre-existing condition, intercurrent diseases, an accident, a drug interaction or a significant worsening of the disease.
Version 2: Any untoward medical occurrence in a subject, whether device related or not.
Reference
Version 1: http://htaglossary.net/adverse-event
Version 2: https://medevis.who-healthtechnologies.org/glossary 2024