NCT01012011

Regulatory Post Marketing Surveillance Study on Nexavar®

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,845 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 20 Years – 91 Years
• Healthy volunteers: Not accepted

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

Conditions

• Carcinoma, Hepatocellular
• Carcinoma, Renal Cell

Interventions

Type	Name	Description
DRUG	Sorafenib (Nexavar, BAY43-9006)	Daily dose, dosage frequency and duration will be decided by physicians.

Timeline

• Start date: 2009-09-01
• Primary completion: 2015-01-01
• Completion: 2015-08-01
• First posted: 2009-11-11
• Last updated: 2015-09-21

Locations

1 site across 1 country: South Korea