Safety Analysis of Pembrolizumab in the General Population and Elderly Based on the FAERS Database
10.3870/j.issn.1004-0781.2025.09.012
- VernacularTitle:基于FAERS数据库的帕博丽珠单抗在全人群与老年人群中的安全性分析
- Author:
Yuxi ZHANG
1
;
Ao XU
;
Yan WANG
;
Haitao CHEN
;
Xiaoting XU
;
Li CHEN
Author Information
1. 四川省第三人民医院药剂科,成都 610100
- Publication Type:Journal Article
- Keywords:
Pembrolizumab;
Adverse drug events;
Food and Drug Administration Adverse Event Reporting System;
Elderly population
- From:
Herald of Medicine
2025;44(9):1448-1455
- CountryChina
- Language:Chinese
-
Abstract:
Objective To explore and analyze the adverse drug event(ADE)signals associated with pembrolizumab and to provide a reference for the real-world safety of drug use on elderly patients.Methods ADE reports of pembrolizumab in the general population and elderly population were collected from the FDA Adverse Event Reporting System(FAERS)for the period between January 1st,2019,and June 30th,2024.Multiple signal detection methods(ROR,PRR,MHRA)were employed for data mining.Classification and statistical analysis were performed using the System Organ Class(SOC)and Preferred Term(PT)from the MedDRA(Version 27.1)dictionary.Results A total of 966 signals were identified in the general population,spanning 24 SOCs,while 593 signals were detected in the elderly population,spanning 23 SOCs.Comparative visualization analysis of critical PTs under four major SOCs revealed no significant abnormal signals in elderly patients.Conclusion A comprehensive and multidimensional analysis of the ADE data from the FAERS database indicates that pembrolizumab appears to be relatively safe for use in elderly patients.
