Signal Mining of Adverse Drug Events of Sorafenib Based on FAERS Database
Objective To mine the adverse drug event(ADE)signals of sorafenib,and to promote the safe clinical application of sorafenib.Methods The ADE reports of sorafenib from the first quarter of 2006 to the fourth quarter of 2022 were extracted from the US Food and Drug Administration Adverse Event Reporting System(FAERS)database.The reporting odds ratio(ROR)method and the Medicines and Healthcare Products Regulatory Agency(MHRA)comprehensive method were used to mine the signals.The preferred terms(PT)and system organ classification(SOC)in the MedDRA were used for encoding and classification.Results A total of 17 838 reports(involving 17 838 patients)were retrieved with sorafenib as the primary suspected drug,and 77 033 ADEs were reported.Through ROR and MHRA comprehensive methods,29 880 ADE signals were screened,with a cumulative total of 375 PTs and 21 SOCs involved.The SOC with the highest number of reported ADE signals was skin and subcutaneous tissue diseases(7 557 items),and the ADE with the strongest signal was the protein elevation induced by vitamin K absence or antagonist Ⅱ(ROR 95％CI lower limit=181.29).Conclusion The description of adverse reactions in the drug instructions of sorafenib is not comprehensive,and the clinical application of this drug is relatively extensive,while the new clinical studies are few.This study supplements ADEs that are not included in the drug instructions but have strong signals in the real world,which provids a reference for the pharmacovigilance work and clinical use of sorafenib.
万方数据
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