Adverse event signal mining of ramucirumab based on FAERS database
AIM To mine the adverse drug event(ADE)signals of ramucirumab based on the database of FDA Adverse Event Reporting System(FAERS),so as to provide evidence for safe clinical medication.METHODS The ADE reports related to ramucirumab from the second quarter of 2014 to the fourth quarter of 2023 in the FAERS database were extracted,and the reporting odds ratio method of disproportional method and comprehensive standard method of British Medicines and Healthcare Products Regulatory Agency were used for data mining and analysis.RESULTS A total of 4 704 ADE reports of ramucirumab were collected.Most reporting objects were male(58.38％),with the age of 65-85(40.45％).The main sources of reported events was Japan(46.64％).A total of 140 ADE signals were detected,involving 18 system organ class(SOC).Among them,a large number of reports were general disorders and administration site conditions(18.04％),neoplasms benign,malignant and unspecified(15.82％),respiratory,thoracic and mediastinal disorders(13.32％)and gastrointestinal disorders(12.83％).ADE signals with high frequency were basically consistent with the drug instructions.The ADE signals that need to be focused on clinically were mainly hemorrhagic ADE such as gastrointestinal bleeding,tumor bleeding,colorectal bleeding,and brainstem bleeding,as well as ADE of organ perforation.CONCLUSION The medication evaluation of patients should be done before using ramucirumab.During treatment,close attention should be paid to the occurrence of ADE such as bleeding and perforation,and timely intervention should be taken in case of abnormality.
ramucirumabadverse drug reactionsdata miningvascular endothelial growth factor receptor-2safety
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NSTL
万方数据
