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

Author

Listed:
  • Roman Lyakhovetsky
  • Maria Skryma
  • Silvie Slepickova

    (Pharmacovigilance Unit, Medical Affairs Department)

  • Lisa Carlson
  • Robin Richardson
  • Derek Tom

    (Medical Writing Unit, Medical Affairs Department)

  • Maxim Belotserkovskiy

    (Medical Affairs Department)

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.

Suggested Citation

  • Roman Lyakhovetsky & Maria Skryma & Silvie Slepickova & Lisa Carlson & Robin Richardson & Derek Tom & Maxim Belotserkovskiy, 2024. "AoSEberg Journey- Analysis of Similar Events as an Important Tool of Signal Detection and Safety Surveillance of Investigational Medicinal Products," Biomedical Journal of Scientific & Technical Research, Biomedical Research Network+, LLC, vol. 55(5), pages 47503-47511, April.
    • Handle: RePEc:abf:journl:v:55:y:2024:i:5:p:47503-47511
    DOI: 10.26717/BJSTR.2024.55.008773
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