Signal Mining of Entrectinib-Related Adverse Drug Events Based on FAERS Database
Objective To provide a reference for the safe clinical use of entrectinib.Methods The entrectinib-related adverse drug event(ADE)reports in the Food and Drug Administration Adverse Event Reporting System(FAERS)system were searched,and the ADE signals were mined by the reporting odds ratio(ROR)method and proportional reporting ratio(PRR)method.The preferred term(PT)and system organ classifications(SOC)in MedDRA 25.0 were used to standrdize the expression of aduerse drug reactions(ADRs).Results A total of 600 entrectinib-related ADE reports were searched,involving 600 patients with a male-to-female ratio of 1∶1.27,with the highest number reported in the United States(49.17％).Eighty ADE signals were excavated,involving fifteen SOC,mainly including various nervous system diseases(thirteen signals),various examinations(eleven signals),heart organ diseases(eight signals),etc.The top three PT in terms of the number of ADE reports were death(61 cases),dizziness(60 cases),and renal dysfunction(38 cases).The top three PT in terms of the intensity of ADE signals were dyspnea(PRR=254.501),lymphangioma(PRR=125.753),and elevated troponin I(PRR=90.203).A total of 27 ADRs were found that were not listed in the package insert,mainly including deaths(61 cases),renal dysfunction(38 cases),and heart failure(26 cases).Conclusion The entrectinib-related ADRs excavated are basically consistent with those listed in the package insert.In addition to the ADRs listed in the package insert,it is also necessary to pay close attention to the cardiac function and kidney function of patients during the clinical use of drugs,in order to timely detect and deal with new ADRs and ensure the medication safety of patients.
entrectinibFAERSadverse drug eventssignal miningreporting odds ratio methodproportional reporting ratio method
万方数据
维普
