| アブストラクト | BACKGROUND: Exportin 1 (XPO1) inhibitors are being developed as a new agent for anti-cancer therapies. This study aimed to broadly portray the adverse event (AE) profile of selinexor, an XPO1 inhibitor, in actual clinical practice. RESEARCH DESIGN AND METHODS: Disproportionality analyses were conducted by calculating the information component and reporting odds ratio in VigiBase over different reporting periods. All selinexor-related AEs were classified by system organ class (SOC) and preferred term (PT) according to the Medical Dictionary for Regulatory Activities. RESULTS: A total of 116,443 AEs were identified in 2,608 patients that received selinexor. Patients with cardiac disorders had a higher propensity for death. Thirteen SOCs and 125 PTs were identified as having a potential connection with selinexor. Notably, 29 suspected signals detected in our study were defined as significant AEs by the European Medicines Agency, including febrile neutropenia, pancytopenia, and acute kidney injury. Attention should be paid to these AEs, despite most toxicities being manageable and reversible. CONCLUSIONS: This study highlights a number of AEs associated with selinexor. Most toxicities are reversible but require careful management. The benefit of selinexor still outweighs the potential risks, indicating XPO1 inhibitors as promising agents. |
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| ジャーナル名 | Expert opinion on drug safety |
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| 投稿日 | 2023/8/23 |
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| 投稿者 | Chen, Chenxin; Miao, Xiaoyong; Guo, Xiaojing; Xu, Jinfang; Liang, Jizhou; Zheng, Yi; Chi, Lijie; Chen, Xiao; Wei, Lianhui; Zhang, Hewei; Ye, Xiaofei; He, Jia |
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| 組織名 | Department of Health Statistics, Faculty of Health Service, Naval Medical;University, Shanghai, China.;Department of Anesthesiology, Naval Medical Center, Naval Medical University,;Shanghai, China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/37608630/ |
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