A real-world disproportionality analysis of apalutamide: data mining of the FDA adverse event reporting system.

ABSTRACT: Background: Apalutamide is a new drug class, which is approved to treat prostate cancer (PCa). The aim of our study was to assess the safety profiles of apalutamide in real-world through data mining of the United States Food and Drug Administration Adverse Event Reporting System (FAERS). Method: We included adverse event (AE) reports regarding apalutamide submitted to the FAERS from 2018 quarter 1 (2018Q1) to 2022 quarter 1 (2022Q1). Disproportionality analyses, including reporting odds ratio (ROR), were performed to identify the signals of AEs in patients receiving apalutamide. A signal was detected if the lower limit of the 95% confidence interval (CI) of ROR >1 and at least 3 AEs were reported. Results: The FAERS database documented 4,156 reports regarding apalutami

SUBMITTER: Fang Z 

PROVIDER: S-EPMC10277739 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature