■需要确定lenvatinib相关的真实世界不良事件(AE),因为其不良反应可能导致其停药。
■对与Lenvatinib相关的AE进行了分析和量化,并通过数据挖掘检测了2015年第一季度至2023年第四季度的风险信号。lenvatinib相关胆囊炎的潜在目标,胆管炎,通过数据挖掘识别肝性脑病。
■保留具有重要不平衡的68个优选术语(PT)。意外AE,如免疫介导的肝炎,门静脉血栓形成和肾上腺功能不全与乐伐替尼的使用有关.与lenvatinib和pembrolizumab联合用药相比,单独使用lenvatinib与肾上腺功能不全的相关性更强.当Lenvatinib用于男性肝细胞癌患者时,肝性脑病与药物使用密切相关。大多数不良事件发生在治疗后的第一个月。中位发病时间为41天。FGFR4,PDGFRA,和KIT(Lenvatinib靶标)可能与胆囊炎有关,胆管炎,和肝性脑病.
■我们确定了与Lenvatinib相关的不良事件,并发现了新的不良事件,可用于临床监测和风险评估。
UNASSIGNED: There is a need to determine lenvatinib-associated real-world adverse events (AEs) as its adverse effects may result in its discontinuation.
UNASSIGNED: Lenvatinib-associated AEs were analyzed and quantified and risk signals from the first quarter of 2015 to the fourth quarter of 2023 were detected through data mining. Potential targets for lenvatinib-associated cholecystitis, cholangitis, and hepatic encephalopathy were identified by data mining.
UNASSIGNED: 68 Preferred Terms (PTs) with an important imbalance were kept. Unexpected AEs, such as immune-mediated hepatitis, portal vein thrombosis and adrenal insufficiency were associated with the use of lenvatinib use. lenvatinib alone was more strongly associated with adrenal insufficiency than lenvatinib and pembrolizumab combination. Hepatic encephalopathy was more strongly correlated with drug use when Lenvatinib was administered to male patients with hepatocellular carcinoma. Most AEs occurred during the first month after treatment, with a median onset time of 41 days. FGFR4, PDGFRA, and KIT (Lenvatinib targets) are potentially linked to cholecystitis, cholangitis, and hepatic encephalopathy.
UNASSIGNED: We identified Lenvatinib-associated AEs and discovered new AEs that will be useful for clinical monitoring and risk assessment.