Trial Information
Torisel Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
Implemented as a Drug Use Investigation by Central Registration System
Inclusion Criteria:
- Patients treated with Torisel (patients with metastatic and/or radically unresectable
or advanced renal cell carcinoma).
Exclusion Criteria:
- 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
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
The incidence of adverse events
Outcome Time Frame:
24 weeks
Safety Issue:
Yes
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
Japan: Pharmaceuticals and Medical Devices Agency
Study ID:
3066K5-4406
NCT ID:
NCT01210482
Start Date:
October 2010
Completion Date:
August 2015
Related Keywords:
- Renal Cell Carcinoma
- Torisel
- Regulatory Post Marketing Commitment Plan
- Carcinoma
- Carcinoma, Renal Cell