Mengqiu Yan

and 3 more

Background and objective: Eribulin, a halichondrin, inhibits microtubule dynamics non-taxanely, which showed neuropathy and maintained effectiveness that had developed resistance to paclitaxel. This study evaluates Eribulin-related adverse events (AEs) in real-world settings using the Food and Drug Administration Adverse Event Reporting System (FAERS) data mining. Methods: Retrospectively query FAERS for Eribulin reports from 2010 Q4 to 2024 Q3. Use odds ratio, Bayesian neural networks, and multi-item γ Poisson IC to quantify adverse event signals. To identify and evaluate potential AEs in patients undergoing Eribulin, we used reported odds ratio (ROR) and proportional reported ratio (PRR). Univariable and multivariable logistic regression analyses were applied to investigate the effects of age, weight, and medication time on the occurrence of Eribulin-related AEs. Result: 3,684 Eribulin reports identified. AEs affected 26 organ systems and 100 significantly PTs identified by all four disproportionality methods. New AEs were Myelosuppression, Neutrophil Count Decreased, Interstitial Lung Disease, and Pulmonary Embolism. In females, we identified 37 drug related AEs and in males were total 128. We found there were 203 drug related AEs in the ≥ 65years old. The median time-to-onset was 13 days, and the Weibull distribution test revealed curve types were early failure. Univariate and multivariable logistic regression analysis showed medication time has significant impact on the risk of Blood and Lymphatic System Disorders. Conclusion: Our study validates common AEs and potential safety concerns with Eribulin, enhancing awareness of its toxicities, onset times, outcomes, and clinical priority. Supporting evidence aids clinicians in managing Eribulin safety issues.

mengqiu yan

and 3 more

Abemaciclib, a novel cyclin-dependent kinase 4 and 6 inhibitor, shows promising outcomes and far-reaching influence in the therapeutic scenario of women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer. Query the FAERS database retrospectively to extract reports related to Abemaciclib from the first quarter of 2004 to the first quarter of 2024. Reporting the odds ratio and Bayesian confidence propagation neural networks as well as the information component of the multi-item γ Poisson contractile apparatus was used to quantify the adverse event signal of the Abemaciclib.10,070 reports of Abemaciclib were identified and significantly associated with an increased risk of blood lymphatic system disorder and hepatobiliary disorders at the SOC level. New and Unexpected AEs include Embolism venous, Lymphangiosis carcinomatosa, Malignant neoplasm progression, Blood creatinine increased and Thrombosis were also be detected. The median time to onset of Abemaciclib-related AEs was 33 days, with the majority occurring within the initial month of Abemaciclib treatment. Gender and age differences existed in in the top 30 signal strength of PTs related to Abemaciclib. Our study found significant new AEs signals of Abemaciclib and reveal that different patient characteristics (such as age, gender, severity) affect treatment outcomes, which might provide support for clinical monitoring and risk identification of Abemaciclib.Our study validates the common AEs and some potential emerging safety concerns related to Abemaciclib in real clinical practice, which could potentially prompt increase the awareness of toxicities for Abemaciclib.