A Post-marketing Observational Study on Risk Factors for Hepatic Encephalopathy in Participants With Unresectable Hepatocellular Carcinoma

Eisai Inc.713 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

713

Conditions

Carcinoma, Hepatocellular

Interventions

LenvatinibDRUG

Lenvatinib capsule

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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.

Locations (2)

Eisai trial site 1

Osaka, Japan

Eisai trial site 2

Tokyo, Japan

Outcomes

Primary Outcomes

Number of Participants With Hepatic Encephalopathy Risk Factors

Hepatic encephalopathy risk factors such as constipation, dehydration, infection, gastrointestinal hemorrhage will be assessed.

Time frame: Baseline up to 1 year

Secondary Outcomes

Number of Participants with Hepatic Encephalopathy

Time frame: Baseline up to 1 year

Data from ClinicalTrials.gov

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