ArticleThrombosis journal2026
Thromboembolic events associated with antiangiogenic monoclonal antibodies: a disproportionality analysis from FDA adverse event reporting system (FAERS) database.
Article in Thrombosis journal, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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Who cites it
1 citing paper in PubMed.
- Adverse Event Profiles of Monoclonal Antibodies: A Descriptive Analysis of FAERS Data.Health services insights · 2026Article
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4 authors.
Funding
Abstract
backgroundAntiangiogenic monoclonal antibodies are increasingly used for various cancers. Although studies have reported thromboembolic events (TEEs) in patients receiving antiangiogenic monoclonal antibodies (mAbs), a comprehensive analysis of various thromboembolic events and their correlation with clinical outcomes is lacking.
objectivesTo evaluate potential signals and clinical outcomes of thromboembolic events associated with antiangiogenic monoclonal antibodies.
designAn observational, retrospective, and pharmacovigilance study based on the FAERS database collected from the first quarter of 2004 to the third quarter of 2024 was conducted.
methodsThe reporting odds ratio (ROR) and the Bayesian Information Criterion (IC) with 95% confidence intervals (CIs) were employed to assess the disproportionate reporting of TEEs linked with antiangiogenic mAbs. A multivariable logistic regression model was implemented to evaluate the association between TEEs and mortality outcomes.
resultsA total of 3319 TEEs with antiangiogenic mAbs were identified including bevacizumab intravenously (3117 reports), ramucirumab (95 reports), and aflibercept intravenously (107 reports) from health professionals. All three antiangiogenic mAbs detected positive signals, including VTE, PE, ATE, and overall TEEs. Interestingly, no positive signals for myocardial Infarction were detected for all the three antiangiogenic mAbs, and no cerebral ATE was detected for aflibercept. Additionally, no signal was detected when comparing the antiangiogenic mAbs directly with one another. Multivariable logistic regression analysis revealed that fatal TEEs occurred more frequently compared to non-TEE outcomes. This association reached statistical significance in the subgroup of reports for bevacizumab in colorectal cancer.
conclusionThis post-marketing data revealed that antiangiogenic mAbs had similar risks of TEEs. However, the occurrence of TEEs was associated with a higher risk of mortality. Due to the inherent limitations of pharmacovigilance data, these findings represent signals that require validation in prospective studies to establish causality.
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