| アブストラクト | BACKGROUND: Panitumumab has been extensively applied in antitumor therapy, and the regulation of its adverse drug reactions (ADRs) has become extremely important. This study utilized the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database to extract real-world panitumumab ADR signals and provide relevant information for drug safety. RESEARCH DESIGN AND METHODS: ROR, PRR, BCPNN, and MGPS were used to identify real-world ADR signals associated with panitumumab. RESULTS: Analysis of 9,033 patients identified 263 ADR signals across 20 MedDRA System Organ Classifications. New signals including peripheral sensory neuropathy, gene mutation, decreased neutrophil count, polyneuropathy, ileus, neutropenia, and febrile neutropenia. Age and sex subgroup analyses revealed specific risks, such as polyneuropathy and gene mutation in those under 65 years of age, decreased neutrophil count and peripheral sensory neuropathy in those over 65 years of age, and febrile neutropenia in men. Ileus was highlighted as a novel ADR in gastrointestinal disorders, with no significant age or sex differences. CONCLUSION: This study identified new signals of ADR associated with panitumumab, providing valuable information for the clinical use of panitumumab. |
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| ジャーナル名 | Expert opinion on drug safety |
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| Pubmed追加日 | 2024/12/9 |
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| 投稿者 | Wen, Heli; Lei, Yuqing; Mao, Lingjie |
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| 組織名 | Department of Gastroenterology, The First Affiliated Hospital of Wenzhou Medical;University, Wenzhou, Zhejiang, China.;The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang,;China.;Xiaocun town Health Service Center, Wenzhou, China.;Department of Intensive Care Unit, The First Affiliated Hospital of Wenzhou;Medical University, Wenzhou, China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/39651795/ |
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