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.
Study Type
OBSERVATIONAL
Enrollment
3,305
Patients who have received Nexavar for unresectable or advanced RCC.
Unnamed facility
Multiple Locations, Japan
Incidence of adverse drug reactions and serious adverse events in subjects who received Nexavar
Time frame: After Nexavar administration, up to 1 year
Incidence of adverse drug reactions in subpopulation in a variety of baseline data [such as demographic data, concomitant disease, medical history data, clinical staging, etiology of HCC, Eastern Cooperative Oncology Group-Performance Status (ECOG-PS)]
Time frame: After Nexavar administration, up to 1 year
Effectiveness evaluation assessment [overall survival, response rate, stable disease rate, progression disease rate] by investigator-determined overall best response [according to the General rule for clinical and pathological studies on RCC]
Time frame: After Nexavar administration, up to 1 year
The status of therapy with Nexavar [duration of treatment, daily dose]
Time frame: After Nexavar administration, up to 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.