Carcinoma, Hepatocellular, Liver Neoplasms
Conditions
Keywords
Lenvatinib, Lenvima
Brief summary
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.
Interventions
OTHERNon-interventional
No intervention will be administered.
Sponsors
Eisai Korea Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participants over 18 years 2. Participants who are treated with lenvatinib according to the approved indication of uHCC as first-line therapy in Korea 3. Participants who have given their consent to study participation about the use of the personal data and medical data
Exclusion criteria
1. Participants who have hypersensitivity to active pharmaceutical ingredients or excipient of the study drug (lenvatinib) 2. Participants who are pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious Adverse Drug Reactions (ADRs) | 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 | 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 Serious Adverse Events (SAEs) | 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 Non-serious ADRs | 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 Unexpected ADRs | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Overall Response | From first dose of study drug up to 12 months | Overall response will include complete response (CR), and partial response (PR). The confirmation of overall response will be based on investigator's judgement. |
Countries
South Korea
Outcome results
None listed