Nexavar Post-marketing Surveillance for Renal Cell Carcinoma in Japan

Bayer

Status: Completed

Conditions: Carcinoma, Renal Cell

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

Study type: Observational

Funder types: Industry

Identifiers

NCT01411423

NEXAVAR-RCC-02 (Other Identifier)

15038

Details and patient eligibility

About

This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have been administered with Nexavar for unresectable or advanced renal cell carcinoma (RCC). The objective of this study is to assess safety and effectiveness of Nexavar under real-life practice conditions. This study is an all case investigation of which the enrollment period is 15 months, and all patients who received Nexavar will be recruited and followed one year since starting Nexavar administration.

Enrollment: 3,305 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who received Nexavar for unresectable or advanced renal cell carcinoma

Exclusion criteria

• Patients who are contraindicated based on the product label

Trial design

3,305 participants in 1 patient group

Group 1

Treatment:

Drug: Sorafenib (Nexavar, BAY43-9006)