| アブストラクト | INTRODUCTION: Asciminib is primarily utilized for treating Philadelphia chromosome-positive chronic myeloid leukemia in its chronic phase among patients harboring the T315I mutation or those who have been previously treated with at least two tyrosine kinase inhibitors. The safety profile of asciminib across a broad patient population over an extended timeframe remains unverified. This study uses a real-world pharmacovigilance database to evaluate the adverse events (AEs) linked with asciminib, providing valuable insights for clinical drug safety. METHODS: Data from the FDA Adverse Event Reporting System (FAERS) database, spanning from October 2021 to December 2023, served as the basis for this analysis. The extent of disproportional events was assessed using sophisticated metrics such as the reporting odds ratio, proportional reporting ratio, information component, and empirical Bayesian geometric mean. RESULTS: Within the specified period, the FAERS database documented 3,913,574 AE reports, with asciminib being associated with 966 incidents. Reactions to asciminib spanned 27 system organ categories. Utilizing four distinct analytical algorithms, 663 significant preferred terms exhibiting disproportional frequencies were identified. Notably, this investigation uncovered 26 significant AEs linked to off-label asciminib use, encompassing conditions such as gynecomastia, nephrotic syndrome, orchitis, pyelonephritis, hepatotoxicity, and pancreatitis. The median onset time for asciminib-related AEs was 52.5 days, ranging from 17 to 122.75 days. CONCLUSION: The study sheds light on additional potential AEs associated with asciminib use, warranting further research to confirm these findings. |
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| ジャーナル名 | Oncology |
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| 投稿日 | 2024/8/6 |
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| 投稿者 | Liu, Zhijing; Wu, Dongzhi; Ke, Chengjie; Nian, Qichun; Chen, Yan; Huang, Yaping; Chen, Maohua |
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| 組織名 | Department of Pharmacy, Affiliated Hospital of Putian University, Pu Tian, China.;Department of Orthopedics Institute, Fuzhou Second General Hospital, Fuzhou,;China.;Department of Pharmacy, The First Affiliated Hospital of Fujian Medical;University, Fuzhou, China.;Department of Pharmacy, National Regional Medical Center, Binhai Campus of the;First Affiliated Hospital, Fujian Medical University, Fuzhou, China.;Department of Pharmacy, Pingtan Comprehensive Experimental Area Hospital, Pingtan;Comprehensive Experimental Area, Fuzhou, China.;Department of Pharmacy, Shengli Clinical Medical College of Fujian Medical;University, Fujian Provincial Hospital, Fuzhou University Affiliated Provincial;Hospital, Fuzhou, China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/39102794/ |
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