Data mining and analysis of adverse event signals of entrectinib based on US FDA adverse event reporting system
Objective:To mine adverse event(ADE)signals associated with entrectinib from the FAERS database,providing a reference for safe clinical use.Methods:Utilizing the OpenVigil 2.1 platform,we collected entrectinib-related adverse event reports from the U.S.FDA Adverse Event Reporting System(FAERS)database,spanning from the first quarter of 2004 to the first quarter of 2023.Data mining was performed using the Reporting Odds Ratio(ROR)and Proportional Reporting Ratio(PRR)methods.Results:A total of 600 adverse event reports related to entrectinib were retrieved,showing a fluctuating upward trend.Eighty-two adverse event signals were identified,involving 16 SOC systems,primarily including various nervous system disorders and general disorders and administration site reactions,followed by renal and urinary disorders,and cardiac disorders.The top-ranked ADE signals by report count involved PTs such as death,dizziness,and renal impairment,with PTs like renal impairment,increased blood creatinine,acute kidney injury,and myocarditis not included in the drug's labeling.The top-ranked ADE signals by signal strength involved PTs such as dysarthria,taste disorder,and ataxia,with most of these PTs already included in the drug's labeling,while PTs like elevated troponin I were not included.Conclusion:Entrectinib-related ADEs include various nervous system disorders,cardiac disorders,and renal and urinary disorders.During clinical use of entrectinib,particular attention should be paid to the neurotoxicity,nephrotoxicity,and cardiotoxicity in patients.
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