Comprehensive safety assessment of ribociclib: A real-world analysis using the FDA Adverse Event Reporting System (FAERS) database

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成果类型：

期刊论文

作者：

Luo, Lan;Wang, Yue;Fu, Yumei;Chen, Xiangning;Liu, Shu;...

通讯作者：

Liu, S;Zhao, B

作者机构：

[Wang, Yue; Luo, Lan; Fu, Yumei; Liu, Shu] Guizhou Med Univ, Affiliated Hosp, Dept Breast Surg, Guiyang 550004, Peoples R China.

[Chen, Xiangning] Sun Yat Sen Univ, Canc Ctr, Dept Med Qual Control, Guangzhou, Peoples R China.

[Zhao, Bin] Xiamen Med Res Inst, Xiamen Hlth & Med Big Data Ctr, Xiamen 361000, Peoples R China.

[Zhao, Bin] Xiamen Key Lab Nat Med Res & Dev, Xiamen, Peoples R China.

[Zhao, Bin] Wuhan Polytech Univ, Hubei Grain Econ Res Ctr, Sch Econ, Wuhan, Peoples R China.

通讯机构：

[Liu, S ] G

[Zhao, B ] X

Guizhou Med Univ, Affiliated Hosp, Dept Breast Surg, Guiyang 550004, Peoples R China.

Xiamen Med Res Inst, Xiamen Hlth & Med Big Data Ctr, Xiamen 361000, Peoples R China.

语种：

英文

关键词：

adverse event;data mining;FAERS;pharmacovigilance;ribociclib

期刊：

British Journal of Clinical Pharmacology

ISSN：

0306-5251

年：

2025

DOI：

10.1002/bcp.70265

基金类别：

The authors declare that no financial support was received for the research, authorship and publication of this article.

机构署名：

本校为其他机构

院系归属：

经济学院

摘要：

AIMS: Ribociclib is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor that was approved by the US Food and Drug Administration (FDA) in 2017 for the treatment of advanced hormone receptor-positive (HR+) breast cancer. The presented study aimed to evaluate the ribociclib-associated adverse events (AEs) through data mining of the US Food and Drug Administration Adverse Event Reporting System (FAERS). METHODS: Data were collected from the FAERS database covering the period from the first quarter of 2017 to the first quarter of 2023. Disproportionality analyses were employed to quantify the associa...

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Comprehensive safety assessment of ribociclib: A real-world analysis using the FDA Adverse Event Reporting System (FAERS) database

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