Mining and analysis of capasetinib adverse events signals based on FAERS database
10.3969/j.issn.1671-8348.2025.09.024
- VernacularTitle:基于FAERS的卡帕塞替尼不良事件信号挖掘与分析
- Author:
Wenjing HU
1
;
Liang SUN
Author Information
1. 温州医科大学附属第一医院麻醉科,浙江温州 325000
- Keywords:
capasetinib;
adverse event reporting system of FDA;
pharmacovigilance;
adverse events;
signal digging
- From:
Chongqing Medicine
2025;54(9):2132-2137
- CountryChina
- Language:Chinese
-
Abstract:
Objective To mine the risk signals of capasetinib related adverse events(ADE)by the Ad-verse Event Reporting System of the U.S.Food and Drug Administration(FAERS)to provide reference for the safe use of this drug in clinic.Methods The ADE reports of capasetinib were retrieved in FAERS from the fourth quarter of 2023 to the fourth quarter of 2024.After deleting the duplicate data and standardization with MedDRA v26.1,the signals were mined by using disproportionation analysis(ROR,PRR,EBGM,BCPNN).Results A total of 731 ADE reports of capasetinib were collected.There were 1 794 case times of ADE.A total of 12 categories of system organs were involved.A total of 492 preferred terms were involved,a-mong which 49 were positive signals.Among the top 30 signals reported by frequency,21 were positive sig-nals,including rashes,diarrhea,hyperglycemia,etc.The potential ADE not listed in the instruction manual in-cluded diabetic ketoacidosis,urinary tract infection,pleural effusion and atrial fibrillation.Potential ADE in fe-male patients meeting the positive signal criteria also included hyperkalemia and elevated blood bilirubin.82.35％(42/51)of capasetinib ADE cases occurred within the first month after the initiation of medication.Conclusion Capasetinib has the new ADE signals.The risk evaluation should be done well before clinical use.
