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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 -
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.
Implemented as a Drug Use Investigation by Central Registration System
Age
15 - 99 years
Sex
ALL
Healthy Volunteers
No
Kyusyu University Hospital
Fukuoka, Fukuoka PREF, Japan
Start Date
August 24, 2010
Primary Completion Date
March 30, 2018
Completion Date
May 31, 2018
Last Updated
September 25, 2024
1,050
ACTUAL participants
Temsirolimus
DRUG
Lead Sponsor
Pfizer
NCT07485114
NCT06391099
Data Source & Attribution
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