Torisel Special Investigation (Regulatory Post Marketing Commitment Plan)
Implemented as a Drug Use Investigation by Central Registration System
- Patients treated with Torisel (patients with metastatic and/or radically unresectable
or advanced renal cell carcinoma).
- Among patients registered and treated in the Special Investigation, All-case Survey
of Torisel, those continuously treated with Torisel for more than 24 weeks will be
- Patients not administered Torisel.
- Patients with a history of severe hypersensitivity to temsirolimus, sirolimus
derivative, or any of their components and/or derivatives.
Type of Study:
Observational Model: Case-Only, Time Perspective: Prospective
Response rate (Responsive cases: CR, PR, PD, SD)
Outcome Time Frame:
Pfizer CT.gov Call Center
JAPAN:Pharmaceuticals and Medical Devices Agency (PMDA)
- Renal Cell Carcinoma
- Long-term use
- Regulatory Post Marketing Commitment Plan
- Carcinoma, Renal Cell