Real-world adverse event profile of trabectedin: A signal mining and spatiotemporal analysis based on FAERS database

Abstract Objective To analyze the characteristics of real-world adverse drug events (ADEs) of trabectedin based on the FDA Adverse Event Reporting System (FAERS) database in order to provide references for clinical drug safety management. Methods A total of 1 349 trabectedin-related reports were extracted from the FAERS database from Q1 2007 to Q4 2024. Using the MedDRA coding classification system for system organ class (SOC) and preferred term (PT), signal detection was performed through 4 proportional imbalance methods, including reporting odds ratio (ROR) and proportional reporting ratio (PRR). Subgroup analyses by gender, age, and temporal trends were also conducted. Results Hematological and lymphatic system disorders and hepatobiliary system disorders were the primary SOCs involved. High-frequency PTs included neutropenia (123 cases) and anemia (117 cases). Eight potential ADEs that have not been listed in the drug product instruction were identified. The median onset time of ADEs was 21 d, showing an early failure pattern, with differences observed by gender (females more prone to hematological toxicity) and age (elderly more susceptible to febrile neutropenia). Conclusion Trabectedin requires close attention to hematological toxicity, hepatotoxicity, and newly identified multi-system potential risks. Clinically, monitoring should be strengthened based on time windows and population characteristics to optimize drug regimens. Countermeasure It is recommended to strengthen the full cycle monitoring of anti-tumor drugs, standardize the reporting of adverse reactions, and establish a multi-departmental collaborative research platform.