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ORIGINAL RESEARCH article

Front. Pharmacol.
Sec. Drugs Outcomes Research and Policies
Volume 15 - 2024 | doi: 10.3389/fphar.2024.1417661

Mining and Evaluation of Adverse Event Signals for Capmatinib Based on the FAERS Database

Provisionally accepted
Xinnan Chen Xinnan Chen 1Ying Jiang Ying Jiang 2Haohao Zhu Haohao Zhu 2*Man Tian Man Tian 3
  • 1 School of Pediatrics, Nanjing Medical University, Nanjing, Jiangsu Province, China
  • 2 Mental Health Center of Jiangnan University, Wuxi Central Rehabilitation Hospital, Wuxi, China
  • 3 Department of Respiratory Medicine, Children’s Hospital of Nanjing Medical University, Nanjing, Jiangsu Province, China

The final, formatted version of the article will be published soon.

    Objective: To conduct a comprehensive data analysis based on the FDA's Adverse Event Reporting System (FAERS) to mine possible adverse event (AE) signals of Capmatinib, providing valuable references for its clinical application.Capmatinib was the primary suspected drug in the search of FAERS database from the second quarter of 2020 to the fourth quarter of 2023. Data processing, screening, and classification were performed using methods such as the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS).Results: A total of 1,991 AE reports directly related to Capmatinib were screened, identifying 269 Preferred Terms (PTs) involving 26 System Organ Classes (SOCs).Besides the AEs recorded in the drug label (such as edema, nausea, fatigue, and dyspnea), the study unearthed other high-risk AEs not listed in the label, including Renal and urinary disorders, Vocal cord paralysis, and Ear and labyrinth disorders. Among these, renal and urinary disorders, and ear and labyrinth disorders had a higher frequency and intensity of signals, suggesting that their mechanisms of occurrence could be a future research direction.This study uncovered new potential AEs of Capmatinib based on the FAERS database, providing reference for its safe clinical use. Special attention should be given to the occurrence of ear and labyrinth disorders and renal and urinary disorders, primarily presenting as pseudo-acute kidney injury, during treatment.

    Keywords: Capmatinib, adverse events, FAERS database, Ear and labyrinth disorders, Renal and urinary disorders

    Received: 15 Apr 2024; Accepted: 03 Sep 2024.

    Copyright: © 2024 Chen, Jiang, Zhu and Tian. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Haohao Zhu, Mental Health Center of Jiangnan University, Wuxi Central Rehabilitation Hospital, Wuxi, China

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.