A Study of Lenvatinib in Korean Unresectable Hepatocellular Carcinoma (uHCC) Patients as a Post-marketing Surveillance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 658
- 试验地点
- 42
- 主要终点
- Number of Participants With Serious Adverse Events (SAEs)
研究概览
简要总结
The purpose of this study is to describe the following safety and the efficacy of Lenvima for the first-line treatment indication of participants with uHHC in the post marketing setting: (1) Serious adverse events and serious adverse drug reactions (2) Unexpected adverse events and adverse drug reactions not reflected in the precautions for use (3) Known adverse drug reactions (4) Non-serious adverse drug reactions (5) Other safety and efficacy related information.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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 over 18 years
- •Participants who are treated with lenvatinib according to the approved indication of uHCC as first-line therapy in Korea
- •Participants who have given their consent to study participation about the use of the personal data and medical data
排除标准
- •Participants who have hypersensitivity to active pharmaceutical ingredients or excipient of the study drug (lenvatinib)
- •Participants who are pregnant or breastfeeding.
结局指标
主要结局
Number of Participants With Serious Adverse Events (SAEs)
时间窗: From first dose of study drug up to 12 months
A SAE is defined as any untoward medical occurrence: resulting in death; life threatening requiring hospitalization or prolongation of hospitalization; resulting in persistent or significant disability or incapacity; resulting in birth defect or congenital anomaly or medically important due to other reasons than above mentioned criteria.
Number of Participants With Serious Adverse Drug Reactions (ADRs)
时间窗: From first dose of study drug up to 12 months
Serious ADR is defined as any untoward medical occurrence or effect that at any dose resulted in death or life-threatening conditions or required hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect or medically important condition.
Number of Participants With Unexpected AEs
时间窗: From first dose of study drug up to 12 months
AE is defined as any untoward and unintended signs (example, anomalies in laboratory test results) or symptoms/diseases occurring during administration/use of drugs, etc., which do not necessarily have a causal relationship with the drug in question.
Number of Participants With Unexpected ADRs
时间窗: From first dose of study drug up to 12 months
An ADR is defined as harmful and unintended responses to the normal administration/use of drugs, in which a causal relationship with the drug in question cannot be ruled out. AEs with unknown causality to the drug among those voluntarily reported will be also considered ADRs.
Number of Participants With Known ADRs
时间窗: From first dose of study drug up to 12 months
An ADR is defined as harmful and unintended responses to the normal administration/use of drugs, in which a causal relationship with the drug in question cannot be ruled out. AEs with unknown causality to the drug among those voluntarily reported will be also considered ADRs.
Number of Participants With Non-serious ADRs
时间窗: From first dose of study drug up to 12 months
An ADR is defined as harmful and unintended responses to the normal administration/use of drugs, in which a causal relationship with the drug in question cannot be ruled out. AEs with unknown causality to the drug among those voluntarily reported will be also considered ADRs.
次要结局
- Percentage of Participants With Overall Response(From first dose of study drug up to 12 months)