Regulatory Post Marketing Surveillance Study on Nexavar®

Bayer

Status: Completed

Conditions: Carcinoma, Renal Cell; Carcinoma, Hepatocellular

Treatments: Drug: Sorafenib (Nexavar, BAY43-9006)

Study type: Observational

Funder types: Industry

Identifiers

NCT01012011

NX0910KR (Other Identifier)

14792

Details and patient eligibility

About

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

Full 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

Enrollment: 2,845 patients

Sex: All

Ages: 20 to 91 years old

Volunteers: No Healthy Volunteers

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.

Trial design

2,845 participants in 1 patient group

Group 1

Treatment:

Drug: Sorafenib (Nexavar, BAY43-9006)