Analysis of adverse drug events signals for neratinib based on FAERS database
Objective To excavate and analyze the adverse drug events(ADE)signals of neratinib,investigate its potential adverse reactions,and to provide reference for clinical safe medication.Methods Data of ADE reports to neratinib in the third quarter of 2017 to third quarter of 2022 included 21 quarterlies were collected from FDA adverse event reporting system(FAERS).The reporting odd ratio(ROR)method and the proportional reporting ratio(PRR)method were used for ADE signal screening and analysis.Results A total of 21 quarterly ADE reports from the third quarter of 2017 to the third quarter of 2022 were extracted from the FAERS database.After data deduplication and exclusion of undeterminable ADEs,a total of 5,098 adverse event reports were extracted with neratinib as the first suspected drug,including 627 ADEs of 1611 patients.From the known data there were more females(3.66%)than males(0.25%);the age distribution was mostly 40-65 years(2.11%),but further studies were still needed to validate this due to the high number of reports(>90%)with missing gender and age information in the database.The reporting country had the highest number of reported cases in the United States,with a total of 1,443 cases(89.57%);the reporters were predominantly pharmacists,with a total of 554 cases(34.39%);and the outcomes were predominantly hospitalization or prolongation of hospitalization as reported in severe ADEs,with a total of 319 cases(19.80%).ROR method and PRR method were used for screening,ADE signals were detected one by one,and 83 effective signals were finally excavated.In the signal PT,the first 30 ADEs were sorted by occurrence frequency(a value)and ADE signal strength[95%confidence interval(CI)lower limit of ROR value].Among the positive signals,the ADE reported more frequently were diarrhea,nausea,fatigue,constipation,vomiting,etc.,while the ADE with higher correlation was cellulitis,diarrhea,anorexia,bloating,constipation,nail fracture,folate deficiency,etc.Referring to the total number of ADE cases under each system-organ classification(SOC),the top 3 were gastrointestinal system diseases(1989 cases,58.44%),systemic diseases and administration site reactions(530 cases,15.57%),and metabolism and nutrition disorders(291 cases,8.55%).The signal detection results showed that gastrointestinal system diseases(23 signals)had the largest number of signals,followed by skin and subcutaneous tissue diseases(10 signals)and benign,malignant and unknown tumors(including cystic and polyp)(8 signals).56 kinds of ADE signals which were not recorded in the instrutions of neratinib were found.Conclusion Clinical application of neratinib should be pay attention to the adverse drug events signals of gastrointestinal,systemic diseases and metabolism and nutrition disorders,and the patient's blood indicators and renal function should be evaluated during medication,thus ensuring the safety and effectiveness of clinical medication.
NeratinibAdverse drug eventsMeasures of disproportionalityData mining
NETL
NSTL
万方数据
维普
