Regulatory Post Marketing Surveillance Study on Nexavar®

N/ACompletedNCT01012011

Bayer2,845 enrolled

Overview

This surveillance are to identify problems/questions regarding adverse events, factors that are considered to affect on safety and efficacy in the clinical practice of using Nexavar

The objectives of this surveillance are to identify problems/questions regarding the followings in the clinical practice of using Nexavar®. 1. Unknown adverse events (in particular, serious adverse events) 2. Identification of adverse events occurred in the real practice. 3. Factors that are considered to affect on safety. 4. Factors that are considered to affect on effectiveness

Study Type

OBSERVATIONAL

Enrollment

2,845

Conditions

Carcinoma, Hepatocellular Carcinoma, Renal Cell

Interventions

Sorafenib (Nexavar, BAY43-9006)DRUG

Daily dose, dosage frequency and duration will be decided by physicians.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 91 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with diagnosis of advanced RCC or HCC and decision taken by the physician to prescribe Nexavar. Exclusion Criteria: * Exclusion criteria must be read in conjunction with the local product information but patients who are participating in other interventional studies currently will be excluded.

Locations (1)

Unnamed facility

Many Locations, South Korea

Outcomes

Primary Outcomes

Adverse events collection

Time frame: From start of treatment to 4 weeks after discontinuation of treatment

Secondary Outcomes

Duration of treatment, dosage and indication

Time frame: Whole treatment period

Tumor status

Time frame: Whole treatment period

Performance status

Time frame: Whole treatment period

Data from ClinicalTrials.gov

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