Hematologic and lymphatic disorders associated with chimeric antigen receptor T-cell therapy: a pharmacovigilance analysis of the FDA adverse event reporting system (FAERS) database.

Background: As the application of Chimeric Antigen Receptor T-cell (CAR-T) therapy in cancer treatment becomes increasingly widespread, associated hematologic and lymphatic system adverse events pose significant challenges to its clinical use. Therefore, we aim to comprehensively investigate and summarize the hematologic and lymphatic system AEs associated with CAR-T therapy.

Methods: We extracted CAR-T-related adverse event reports from the FDA Adverse Event Reporting System (FAERS) database for the period from August 2017 to December 2023.

Gastrointestinal adverse events associated with Lenvatinib versus Lenvatinib plus Pembrolizumab: A pharmacovigilance study in FDA adverse event reporting system.

This study aimed to empirically analyze gastrointestinal adverse events associated with Lenvatinib monotherapy and its combination with Pembrolizumab using FDA FAERS data (January 2015-December 2023), focusing on risk profiles, temporal patterns, and influencing factors. Proportional disproportionality analysis (ROR, PRR, BCPNN, EBGM) evaluated drug-AE associations. Kaplan-Meier curves characterized temporal distributions, while Wilcoxon rank-sum test compared median time-to-onset between regimens.