| アブストラクト | In this study, we delved into the safety profile of alpelisib, an FDA-approved treatment for hormone receptor-positive, HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer, and PIK3CA-Related Overgrowth Spectrum (PROS). Despite its approval, real-world, long-term safety data is lacking. Our research scrutinizes the FDA database to assess alpelisib 's safety. We retrospectively analyzed data from April 2019 to June 2023 using four algorithms. Among 7,609,450 reports, 6692 implicated alpelisib as the primary suspected drug, uncovering adverse events (AEs) across 26 organ systems. Notably, we identified 21 previously unlisted AEs. Furthermore, differences in AEs emerged between patients with PIK3CA-mutated breast cancer and those with PROS. This study provides vital insights for healthcare professionals to navigate AEs in clinical practice and informs future research for enhancing alpelisib 's safety profile. |
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| ジャーナル名 | Heliyon |
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| 投稿日 | 2024/3/18 |
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| 投稿者 | Lin, Yu; Zheng, Xinlei; Chen, Yan; Nian, Qichun; Lin, Li; Chen, Maohua |
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| 組織名 | Department of Orthopedics, Pingtan Comprehensive Experimental Area Hospital,;Pingtan Comprehensive Experimental Area, 350400, PR China.;Department of Orthopedics, Fujian Medical University Union Hospital, NO.29;Xinquan road, Fuzhou, 350001, PR China.;Department of Pharmacy, Pingtan Comprehensive Experimental Area Hospital, Pingtan;Comprehensive Experimental Area, 350400, PR China.;Department of Medical Oncology, Shengli Clinical Medical College of Fujian;Medical University, Fujian Provincial Hospital, NO.134 Dongjie Street, Fuzhou,;350001, Fujian, PR China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/38496864/ |
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