Signal Mining and Analysis of Adverse Events Associated with Pemetrexed Based on the FAERS Database
Objective:To obtain and analyze adverse drug events (ADE) data of pemetrexed by mining the FDA Adverse Event Reporting System (FAERS) database,so as to provide reference information for clinical safe drug use.Methods:ADE reports associated with pemetrexed from FAERS database were collected until September 2023.The system organ class (SOC) and preferred term (PT) in Medical Dictionary for Regulatory Activities (MedDRA) (version 26.1) were used to analyze the mined ADE reports.The reporting odds ratio (ROR) and proportional reporting ratio (PRR) methods were used to screen valid signals.Results:A total of 6368 ADE reports associated with pemetrexed as the primary suspect drug were selected.The number of male ADE reports (3476 cases,54.59％) was higher than that of female ADE reports (2281 cases,35.82％).The reporting rate in the population aged 18～65 years was similar to that in the population aged ≥ 65 years.A total of 372 PT signals were retrieved,involving 23 SOCs,with higher number of reported SOCs including blood and lymphatic system disorders,respiratory,thoracic and mediastinal disorders,various examinations and renal and urinary disorders.The PTs with higher frequency included anaemia,pancytopenia,neutropenia and thrombocytopenia,which are listed ADE in the pemetrexed package insert.In addition,some ADEs not listed in the package insert were also mined.Conclusion:Hematological toxicity is still the most common adverse reaction with pemetrexed,while non-hematological adverse events most frequently reported include kidney and urinary system diseases,metabolism and nutrition disorders,infections and infestations diseases,gastrointestinal system diseases,skin and subcutaneous tissue diseases.etc.These adverse events may lead to treatment delay or discontinuation,which should be paid more attention in clinical practice.
pemetrexeddata miningadverse drug eventsdisproportionality methodFDA Adverse Event Reporting System
万方数据
维普
