Risk analysis of enfortumab vedotin: A real-world approach based on the FAERS database.

ABSTRACT:

Purpose

To analyze the risk of enfortumab vedotin (EV), a targeted therapy for advanced bladder cancer, using real-world data from the U.S. Food and Drug Administration's Federal Adverse Event Reporting System (FAERS).

Methods

A retrospective pharmacovigilance analysis was conducted using FAERS data from Q1 2020 to Q1 2024. Adverse drug events (ADEs) related to EV were identified and categorized according to the System Organ Classes (SOCs) and specific events. Statistical methods, such as the proportional reporting ratio, reporting odds ratio (ROR), Bayesian confidence propagation neural network, and empirical Bayesian geometric mean were used to detect safety signals.

Results

Of the 7,449,181 FAERS case reports, 1,617 EV-related ADEs were identified, including 101 pr

SUBMITTER: Zheng F 

PROVIDER: S-EPMC11415710 | biostudies-literature | 2024 Sep

REPOSITORIES: biostudies-literature