A Post Marketing Surveillance As Required By Philippine Food And Drug Administration
This is a post marketing surveillance which determines the safety profile of the product to Filipinos. This is a FDA requirement for registration.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||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|
- Number of participants with Adverse Events [AEs] and Serious Adverse Events [SAEs] [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
|Patient Arm- temsirolimus||
The recommended dose of Torisel is 25 mg infused over a 30-60 minute period once a week.
Treatment will continue until disease progression or unacceptable toxicity.
The use and dosage recommendations for Torisel will take place on the basis of the approved local product document and will be adjusted solely according to medical and therapeutic necessity.
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.