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Regulatory Post Marketing Surveillance Study on Nexavar®

Completed
Conditions
Carcinoma, Renal Cell
Carcinoma, Hepatocellular
Interventions
Registration Number
NCT01012011
Lead Sponsor
Bayer
Brief Summary

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

Detailed Description

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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
2845
Inclusion Criteria
  • Patients with diagnosis of advanced RCC or HCC and decision taken by the physician to prescribe Nexavar.
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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.
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Group 1Sorafenib (Nexavar, BAY43-9006)-
Primary Outcome Measures
NameTimeMethod
Adverse events collectionFrom start of treatment to 4 weeks after discontinuation of treatment
Secondary Outcome Measures
NameTimeMethod
Duration of treatment, dosage and indicationWhole treatment period
Tumor statusWhole treatment period
Performance statusWhole treatment period
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