Mining and analysis of adverse events for trastuzumab deruxtecan based on the FAERS database

Objective: This study aims to mine and analyze adverse event (AE) signals for trastuzumab deruxtecan (T-DXd) using the FAERS database, particularly focusing on AEs that are not fully described in clinical trials and early market surveillance. Methods: The study selected data from the first quarter of 2020 to the third quarter of 2023, searching with T-DXd as the primary suspected drug. Four advanced signal mining and analysis methods were employed: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayesian Geometric Mean (EBGM), to comprehensively assess the AE signals in the FAERS database. Results: The study collected 6,703,410 AE reports, of which 4,055 reports involved T-DXd. Through comprehensive analysis, 118 PT signals involving 26 SOCs were identified. The study revealed various newly discovered AEs associated with T-DXd treatment, including immune dysregulation events like Gastroenteritis listeria and Coronavirus pneumonia, hepatobiliary disorders like Pseudocirrhosis and Hepatic failure, and hematological issues like Neutropenia and Thrombocytopenia. Additionally, new safety signals for cardiovascular and ocular problems were found. Conclusion: This study confirmed known AEs and identified a range of new AEs, aiding clinicians in making more informed decisions when using T-DXd.