clinical trial · NCT01210482
Temsirolimus (Torisel) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
Pfizer·—·completed·n = 1,050
Renal Cell CarcinomaTemsirolimus
brief summary
The objective of this investigation is to determine the following items in all patients receiving Torisel for a certain period after marketing: 1. Confirmation of efficacy and safety for medical practice use. 2. Investigation of factors that may influence the incidence of adverse events (Particularly priority investigation items). 3. Investigation of the incidence status and the risk factors for interstitial lung diseases.
started
Aug 24, 2010
primary completion
Mar 30, 2018
completion
May 31, 2018
last updated
Sep 25, 2024
detailed description
Implemented as a Drug Use Investigation by Central Registration System
official title
SAFETY AND EFFECTIVENESS OF TEMSIROLIMUS IN JAPANESE PATIENTS WITH UNRESECTABLE OR METASTATIC RENAL CELL CARCINOMA: A POST-MARKETING, ALL-CASE SURVEILLANCE STUDY INCLUDING B1771016 STUDY - SURVEY ON LONG-TERM USE -
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol