Mining and analysis of adverse drug reaction signals of trastuzumab deruxtecan based on the FDA Adverse Event Reporting System
10.3969/j.issn.1673-9701.2025.25.017
- VernacularTitle:基于FDA不良事件报告系统对德曲妥珠单抗不良事件信号的挖掘与分析
- Author:
Zhuo ZHANG
1
;
Datian FU
;
Min YANG
;
Yizheng CAI
;
Anqi GU
;
Weifeng WANG
Author Information
1. 海南省肿瘤医院放疗科,海南海口 570100
- Publication Type:Journal Article
- Keywords:
Trastuzumab deruxtecan;
Food and Drug Administration Adverse Event Reporting System;
Nausea;
Interstitial lung disease
- From:
China Modern Doctor
2025;63(25):79-83,102
- CountryChina
- Language:Chinese
-
Abstract:
Objective The data related to adverse drug reaction of trastuzumab deruxtecan(T-DXd)were mined to provide references for its clinical management and adverse event handling.Methods Based on the Food and Drug Administration Adverse Event Reporting System(FAERS)database,the data reported from the post-marketing period of T-DXd until the fourth quarter of 2024 were extracted.The proportion imbalance method,specifically the reporting odds ratio(ROR)method,was used to mine and analyze the data related to adverse events of T-DXd.Results A total of 13 134 cases of adverse events related to T-DXd were obtained from the FAERS database.Gastrointestinal disorders were the most common,with 2348 adverse reaction signals,accounting for 17.88％.The most frequent adverse reactions were nausea(n=809),interstitial lung disease(n=732),and fatigue(n=579).The one with the highest ROR value was Listeriosis gastroenteritis(ROR=1228.74).The highest number of deaths were from interstitial lung disease(226),pneumonitis(90),and nausea(67).Conclusion By mining data on real-world adverse drug reaction related to T-DXd,suggests that pulmonary function,cardiac function,complete blood count and other parameters should be closely monitored during treatment for early diagnosis and treatment of corresponding complications.
