| アブストラクト | This study aims to monitor and identify adverse events (AEs) associated with cetuximab, a drug used to treat various late-stage (metastatic) tumors, to improve patient safety and guide drug use. This study retrospectively analyzed the cases reported in the FDA adverse event reporting system (FAERS) related to the application of cetuximab from 2013 Q1 to 2022 Q4. Disproportionality analyses, including the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN), and the empirical Bayesian geometric mean (EBGM) algorithms, were employed to quantify the signals of cetuximab-associated AEs. A total of 8364225 reports were contained in the FAERS database, of which 5186 reports of cetuximab were identified as 'primary suspected (PS)' AEs. The application of cetuximab resulted in AEs in 22 system organ classes (SOCs), which preserved 176 significant disproportionality preferred terms (PTs) through the computation of four algorithms. The main SOCs (Skin and subcutaneous tissue disorders, investigations, metabolism and nutrition disorders, and blood and lymphatic system disorders) accounted for 58.63%. Some AEs were not on the drug label: speech disorder, intervertebral discitis, glomerulonephritis rapidly progressive and disseminated intravascular coagulation. This study identified new signals of adverse drug reactions (ADRs) other than those mentioned in the specification associated with cetuximab, providing valuable insights into the relationship between ADRs and cetuximab use. The findings highlight the importance of continuous surveillance to detect and manage AEs effectively, ultimately improving patient safety during treatment with cetuximab. |
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| ジャーナル名 | Scientific reports |
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| Pubmed追加日 | 2025/2/4 |
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| 投稿者 | Zhao, Shuai; Wang, Yan; Deng, Xiaoli; Chen, Xi; Lu, Zhaoyi |
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| 組織名 | Department of Galactophore, Fujian Maternity and Child Health Hospital,;Affiliated Hospital of Fujian Medical University, Fuzhou, 350005, China.;Medical Reproductive Center, Jiuquan Hospital, Shanghai General Hospital,;Jiuquan, 735000, Gansu, China.;Changzhou Vocational Institute of Textile and Garment, Textile College,;Changzhou, 213164, Jiangsu, China.;Department of Otorhinolaryngology, The First Affiliated Hospital, Nanjing Medical;University, Nanjing, 210029, China. chenxi2882@jsph.org.cn.;University, Nanjing, 210029, China. luzhaoyi@jsph.org.cn. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/39901061/ |
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