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Post-marketing safety concerns of sotorasib: A disproportionality analysis based on FDA adverse event reporting system

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资源类型：
Pubmed体系：
作者：
Ding Yiling[1] * ; Su Hongyan[2] * ; Shu Yamin[1] ; Chen Jing[1,*1] ;
单位： [1]Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China. [2]Department of Pharmacy, The People's Hospital of Lincang, Lincang, 677099, China.
出处：
DOI： 10.1016/j.heliyon.2024.e30437
ISSN：

关键词： Sotorasib FAERS AEs Disproportionality analyses WSP

摘要：
Sotorasib has been approved for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). Due to the limitations of clinical trials, potential adverse events (AEs) and long-term safety issues cannot be detected. The presented study aimed to evaluate sotorasib-associated AEs using the FDA Adverse Event Reporting System (FAERS) database.Post-marketing AE reports of sotorasib in the database were collected for analysis. Disproportionality analyses, including the reporting odds ratio (ROR), proportional reporting ratio (PRR), information component (IC) and empirical bayes geometric mean (EBGM) algorithms, were performed to mine the signals of sotorasib-associated AEs. The median duration, quartiles and the Weibull shape parameter (WSP) test were used to assess the onset time data.The database contained 1538 cases of sotorasib as primary suspect (PS), with 27 signals detected, scattering in 5 SOCs. The SOC of hepatobiliary disorders (182, ROR 4.48, PRR 4.07, IC 2.02, EBGM 4.07) met the four methodological thresholds. The median onset time of sotorasib-associated AEs was 42 days (interquartile range [IQR] 14-86.75 days). Different SOCs had different types of risk over time.After obtaining marketing authorization, the study identified all potentially relevant adverse event (AE) signals expected to have a reporting frequency higher than anticipated and characterized them during sotorasib treatment.© 2024 The Authors. Published by Elsevier Ltd.

基金：
This study was supported by grants from Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology (No. 2022B26).
语种：
外文
PubmedID：
中科院(CAS)分区：
出版当年[2023]版：
大类 | 3 区 综合性期刊
小类 | 3 区 综合性期刊
最新[2025]版：
大类 | 4 区 综合性期刊
小类 | 4 区 综合性期刊
第一作者：
第一作者单位： [1]Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.
共同第一作者：
通讯作者：
通讯机构： [1]Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China. [*1]Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, No.1095 Jiefang Avenue, Qiaokou District, Wuhan 430030, China
推荐引用方式(GB/T 7714)：
Ding Yiling,Su Hongyan,Shu Yamin,et al.Post-marketing safety concerns of sotorasib: A disproportionality analysis based on FDA adverse event reporting system[J].Heliyon.2024,10(9):e30437.doi:10.1016/j.heliyon.2024.e30437.
APA：
Ding Yiling,Su Hongyan,Shu Yamin&Chen Jing.(2024).Post-marketing safety concerns of sotorasib: A disproportionality analysis based on FDA adverse event reporting system.Heliyon,10,(9)
MLA：
Ding Yiling,et al."Post-marketing safety concerns of sotorasib: A disproportionality analysis based on FDA adverse event reporting system".Heliyon 10..9(2024):e30437

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