Real-world FAERS safety analysis of Pralsetinib.

ABSTRACT: The FDA has approved pralsetinib as a chemotherapeutic drug for the treatment of individuals with cancers such as medullary thyroid cancer (MTC), papillary thyroid cancer (PTC), and non-small cell lung cancer (NSCLC). However, there is a lack of information on drug safety in large cohorts. Using data from the FDA Adverse Event Reporting System (FAERS) database, the aim of this study was to investigate the adverse events (AEs) linked to pralsetinib. All pralsetinib data reported from Q3 2020 to Q1 2023 were obtained from FAERS. The data was filtered and the AEs signals were found using Reporting Ratio Ratio (ROR), Proportionate Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-Item Gamma-Poisson Shrinker (MGPS). SAS 9.4 software was used for statistica

SUBMITTER: Zhang D 

PROVIDER: S-EPMC12559386 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature