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Adverse events of Capmatinib: A real-world drug safety surveillance study based on the FDA adverse event reporting
Hao Zhang1, Panli Zhao, Hua Huang
1Department of Pharmacy, Chengdu Seventh People's Hospital (Affiliated Tumor Hospital of Chengdu Medical College), Chengdu, Sichuan, China.
Abstract:
The present study aims to evaluate the adverse events associated with Capmatinib using real-world data, providing a reference basis for its rational use in clinical practice. Relevant data from the Food and Drug Administration adverse event reporting system database was mined. Next, reporting odds ratio and Bayesian confidence propagation neural network method were used to analyze real-world adverse events associated with Capmatinib. The study revealed significant adverse event signals of Capmatinib, primarily involving general disorders and administration site conditions, cardiac disorders, gastrointestinal disorders, respiratory, thoracic and mediastinal disorders, neoplasms benign, malignant and unspecified (including cysts and polyps) and investigations, among others. A total of 79 signals were identified, with 13 of them not mentioned in the drug's specifications. Taken together, our comprehensive analysis of the Food and Drug Administration adverse event reporting system database enhances the understanding of Capmatinib's safety profile, thereby contributing to informed decision-making in its clinical application and facilitating the timely management of associated adverse reactions.
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