| アブストラクト | BACKGROUND: Antineoplastic drug-associated adverse cardiovascular events (ACEs) are a concern; however, information on new antineoplastic drugs is limited. In this situation, signal detection and hypothesis building by analyzing the pharmacovigilance database are useful. However, increased numbers of reports on COVID-19 vaccine-related ACEs in the pharmacovigilance database have affected the results of the disproportionality analysis. Therefore, examining the effect of increased reports on COVID-19 vaccine-related ACEs on detecting anticancer drug-related ACEs is critical. RESEARCH DESIGN AND METHODS: Disproportionality analysis was performed using the Japanese Adverse Drug Event Report (JADER) database. Reporting odds ratio and information components were used as indicators to detect potential associations between drugs and adverse events. The analysis was performed in two situations: using all data in the JADER database and excluding cases with the COVID-19 vaccine. RESULTS: Various antineoplastic drugs were associated with diverse ACEs. Additionally, safety signals for ACEs of some antineoplastic drugs were masked by reports on COVID-19 vaccine-related ACEs. CONCLUSIONS: The rapid increased reports on COVID-19 vaccine-related ACEs in the JADER database had an impact on signal detection activities for antineoplastic drug-associated ACEs. Therefore, the impact of reporting COVID-19 vaccine-related ACEs on current signal detection activities should be evaluated over time. |
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| ジャーナル名 | Expert opinion on drug safety |
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| Pubmed追加日 | 2025/3/4 |
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| 投稿者 | Matsuo, Hajime; Tanaka, Hiroyuki; Endo, Kiri; Ishii, Toshihiro |
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| 組織名 | Department of Practical Pharmacy, Faculty of Pharmaceutical Sciences, Toho;University, Chiba, Japan.;Clinical Operation Department, Daiichi Sankyo Co., Ltd, Tokyo, Japan. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/40035831/ |
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