INSIGHT - Post Marketing Surveillance

Bayer791 enrolled

Overview

In this international non-interventional post-marketing surveillance study we want to evaluate patient characteristics in HCC patients as well as efficacy and safety of Sorafenib (Nexavar®) treatment under daily-life treatment conditions. Specifically investigated are the tumor status, prior and/ or concomitant surgical, radiological and drug treatment and the duration of Sorafenib treatment.

Study Type

OBSERVATIONAL

Enrollment

791

Conditions

Carcinoma, Hepatocellular

Interventions

Sorafenib (Nexavar, BAY43-9006)DRUG

Treatment of Hepatocellular Carcinoma with Nexavar (HCC)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * In- and outpatients with diagnosis of hepatocellular carcinoma (HCC) and decision taken by the investigator to prescribe Nexavar Exclusion Criteria: * Exclusion criteria must be read in conjunction with the local product information

Locations (2)

Unnamed facility

Many Locations, Austria

Unnamed facility

Many Locations, Germany

Outcomes

Primary Outcomes

Efficacy: status of tumor, patients performance status

Time frame: At each follow-up visit, every 2-4 months

Secondary Outcomes

Duration of treatment

Time frame: At each follow-up visit, every 2-4 months

Time of survival

Time frame: At each follow-up visit, every 2-4 months

Reports of adverse events

Time frame: At each follow-up visit, every 2-4 months

Data from ClinicalTrials.gov

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