An Open Label, Non-interventional Study Of The Safety Of Temsirolimus Injection (Torisel) In The Treatment Of Advanced Renal Cell Carcinoma In Filipino Adult Patients: A Post Marketing Surveillance Study
The Philippine Food and Drug Administration requires that a post marketing surveillance
study be conducted nationwide and enroll approximately 3,000 study patients. In cases where
the 3,000 patients will not be met, the total sample size can be reduced to 10% of the
volume of drug use during the first year of it being marketed. Final sample size will be
determined after one year of marketing authorization. The decision to use Torisel must be a
joint decision made by the subject and the investigator.
The investigator must discuss product information with the subject as per usual practice.
Observational Model: Cohort, Time Perspective: Prospective
Number of participants with Adverse Events [AEs] and Serious Adverse Events [SAEs]
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Philippines : Food and Drug Administration