A Drug Use Investigation of LENVIMA 4 mg Capsules - A Post-marketing Observational Study on Risk Factors for Hepatic Encephalopathy in Patients With Unresectable Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 713
- 试验地点
- 2
- 主要终点
- Number of Participants With Hepatic Encephalopathy Risk Factors
研究概览
简要总结
This study is a post-marketing observational study of lenvatinib in participants with unresectable hepatocellular carcinoma. The primary objective of this study is assessment of risk factors for hepatic encephalopathy.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with unresectable hepatocellular carcinoma who were administered the lenvatinib mesilate for the first time within the registration period.
- •Have provided informed consent.
- •Underwent case registration by 14 days after the start of administration of drug.
排除标准
- 未提供
研究组 & 干预措施
Lenvatinib
Participants receiving lenvatinib capsules 12 milligrams (mg) based on participant's body weight greater than or equal to (>=) 60 kilograms (kg) or 8 mg based on participant's body weight less than (<) 60 kg, orally, once daily dose will be centrally registered and observed prospectively for up to 1 year after the administration of dose.
干预措施: Lenvatinib (Drug)
结局指标
主要结局
Number of Participants With Hepatic Encephalopathy Risk Factors
时间窗: Baseline up to 1 year
Hepatic encephalopathy risk factors such as constipation, dehydration, infection, gastrointestinal hemorrhage will be assessed.
次要结局
- Number of Participants with Hepatic Encephalopathy(Baseline up to 1 year)