基于 FAERS 数据库的甲磺酸达拉非尼联合曲美替尼 致药品不良事件信号挖掘.

OBJECTIVES: To probe into the signal of adverse events of dabrafenib mesylate combined with trametinib after marketing, so as to provide reference for clinical safe drug use. METHODS: OpenVigil 2. 1-MedDRA platform was used to collect adverse event data of dabrafenib mesylate combined with trametinib which reported in FDA adverse event reporting system (FAERS), as of the second quarter of 2022. Disproportionality analysis methods were used to mine the adverse events risk signals. Characteristics of the population reporting adverse events and information on frequent and new adverse events were analyzed. RESULTS: A total of 9 712 adverse event reports related to dabrafenib combined with trametinib were screened, in which 4 555 cases ( 46. 90%) were males, 3 921 cases (40. 37%) were females. Cases were major in age from 18 to <65 years (2 503 cases, 25. 77%). Most of the cases were reported from America (4 287 cases, 44. 14%). Severe adverse event reports were mainly in death (2 100 cases, 21. 62%) and hospitalization-initial or prolonged (1 889 cases, 19. 45%). Adverse events with high frequency mainly included malignant tumor metastasis, pyrexia, and skin toxicity. New adverse events mainly included dysphagia, convulsions and panniculitis. CONCLUSIONS: In clinical medication, attention should be paid to the high frequency and new signal of adverse events for dabrafenib mesylate combined with trametinib. Relevant monitoring should be done before, during and after drug treatment to effectively ensure the safety of patients’ medication. [ABSTRACT FROM AUTHOR]