Signal Mining and Analysis for Adverse Events of Entrectinib Based on FAERS
CHAO Yanhui
QIAO Lijuan
ZHANG Rui
LIU Kefeng
DU Shuzhang
Abstract：Objective To mine and analysis the adverse drug event(ADE)signals of entrectinib and provide reference for clinical drug use.Methods ADE related to entrectinib were collected based on the US FDA adverse event reporting system(FAERS)database from September 2019 to September 2023.Data mining and analysis was conducted using the report odds ratio(ROR)method.Results A total of 761 ADE reports of entrectinib were obtained,of which 522 were ADE reports of entrectinib as the primary suspect drug.ROR was used to screen and exclude irrelevant ADE signals,and 68 ADE signals with entrectinib as the primary suspect drug were mined,involving 15 systematic organ classification(SOC).The SOC of entritinib ADE signal was mainly concentrated in various nervous system diseases,heart organ diseases,various examinations,systemic diseases and various reactions at the administration site,kidney and urinary system diseases.ADE signals not mentioned in the entritinib instructions include disease progression,thrombosis,electrolyte imbalance,central nervous system metastasis,liver metastasis,and metastasis.Conclusion In addition to the ADE mentioned in the drug instructions,we should also pay close attention to the disease progression,thrombosis,electrolyte imbalance,central nervous system metastasis,liver metastasis,and potential adverse reactions of metastasis to avoid drug withdrawal or organ damage caused by ADE during the clinical use of entrectinib.
Keywords：entrectinibFDA adverse event reporting systemreport odds ratiosignal mining
Publication Date：2026-06-28
Online Publishing Date：2026-09-12(First online date of this platform, not the publication date of the document)
Pages：5( 2113-2117 )