Regulatory Post Marketing Surveillance Study on Nexavar®
Completed
- Conditions
- Carcinoma, Renal CellCarcinoma, 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.
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 Sorafenib (Nexavar, BAY43-9006) -
- Primary Outcome Measures
Name Time Method Adverse events collection From start of treatment to 4 weeks after discontinuation of treatment
- Secondary Outcome Measures
Name Time Method Duration of treatment, dosage and indication Whole treatment period Tumor status Whole treatment period Performance status Whole treatment period