AoSEberg Journey- Analysis of Similar Events as an Important Tool of Signal Detection and Safety Surveillance of Investigational Medicinal Products

Roman Lyakhovetsky, Maria Skryma, Silvie Slepickova, Lisa Carlson, Robin Richardson, Derek Tom and Maxim Belotserkovskiy
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Silvie Slepickova: Pharmacovigilance Unit, Medical Affairs Department
Derek Tom: Medical Writing Unit, Medical Affairs Department
Maxim Belotserkovskiy: Medical Affairs Department

Biomedical Journal of Scientific & Technical Research, 2024, vol. 55, issue 5, 47503-47511

Abstract: Reporting of adverse events is mandatory in the clinical development of investigational medicinal products (IMPs). While most reporting requirements have been globally harmonized, some local ones are vaguely formulated. Analysis of Similar Events (AoSE) may serve as an example of such vague requirement. Here, we advocate the AoSE as a useful tool for signal detection and strongly recommend including both non-serious and serious treatment-emergent adverse events (TEAEs) in the analysis. We studied datasets of two separate and distinct clinical studies (designated Study 1 and 2). Non-serious TEAEs exceed the serious TEAEs by ~30-fold. Interestingly.

Keywords: Journals on Medical Drug and Therapeutics; Journals on Emergency Medicine; Physical Medicine and Rehabilitation; Journals on Infectious Diseases Addiction Science and Clinical Pathology; Open Access Clinical and Medical Journal; Journals on Biomedical Science; List of Open Access Medical Journal; Journals on Biomedical Engineering; Open Access Medical Journal; Biomedical Science Articles; Journal of Scientific and Technical Research (search for similar items in EconPapers)
Date: 2024
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Persistent link: https://EconPapers.repec.org/RePEc:abf:journl:v:55:y:2024:i:5:p:47503-47511

DOI: 10.26717/BJSTR.2024.55.008773

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