| アブストラクト | Immune checkpoint inhibitors (ICIs) have significantly improved the outcome of cancer treatment, but they also expose most patients to a variety of treatment-related adverse events (AEs). This study introduces a modified pharmacovigilance approach to identify "ICI-related high-mortality AEs", a subset of treatment-related complications that are disproportionately reported with elevated fatality during ICI therapy. Utilizing large-scale pharmacovigilance data from 148,972 ICI-treated cases in the FDA AEs Reporting System and 142,645 ICI-treated cases in the WHO global VigiBase, we found 63 types of ICI-related high-mortality AE, such as interstitial lung disease, myositis, and hepatic failure, which necessitate heightened clinical vigilance. Patients who experienced these events had significantly higher fatality reporting rates compared to other cases (36.25% vs. 10.66%). These findings were corroborated in the additional clinical datasets to ensure their generalizability. In summary, identifying these ICI-related high-mortality AEs provides crucial insights for developing proactive monitoring strategies and prioritizes specific events for prevention and intervention to mitigate fatality risk. |
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| ジャーナル名 | Proceedings of the National Academy of Sciences of the United States of America |
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| Pubmed追加日 | 2026/3/2 |
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| 投稿者 | Sun, Zhen; Deng, Xuan; Guo, Jianglong; Liu, Mengsi; Wang, Siying; Wang, Jian; Zheng, Jiaojiao; Niu, Kongyan; Shen, Weiming; Ye, Zhen; Zheng, Chongming; Wang, Hongye; Yang, Fan; Bao, Zhouzhou; Chan, Kui Ming; Chen, Gang; Guan, Ming; Jin, Haojie |
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| 組織名 | State Key Laboratory of Systems Medicine for Cancer, Shanghai Cancer Institute,;Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai;200032, China.;Department of Laboratory Medicine, Huashan Hospital, Fudan University, Shanghai;200040, China.;Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital,;Guangdong Academy of Medical Sciences, Guangzhou 510080, China.;Department of Ophthalmology, The First Affiliated Hospital of University of South;China, Hengyang 421001, China.;Zhejiang Key Laboratory of intelligent Cancer Biomarker Discovery & Translation,;Department of Hepatopancreatobiliary Surgery, The First Affiliated Hospital of;Wenzhou Medical University, Wenzhou 325035, China.;Department of interventional oncology, Renji Hospital, Shanghai Jiao Tong;University School of Medicine, Shanghai 200127, China.;Department of Pharmacy, Renji Hospital, Shanghai Jiao Tong University School of;Medicine, Shanghai 200127, China.;Shanghai Key Laboratory of Gynecologic Oncology, Ren Ji Hospital, Shanghai Jiao;Tong University School of Medicine, Shanghai 200127, China.;Department of Biomedical Sciences, City University of Hong Kong, Hong Kong,;China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/41770934/ |
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