A Non-interventional, Observational Post-marketing Registry of Patients Treated With Revlimid (Lenalidomide) in Taiwan
The REVLIMID Registry will provide safety data from a large cohort of Taiwanese patients treated with REVLIMID. In addition, the registry will provide efficacy data and outcomes in a real-world setting (versus a clinical trial).
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Target Follow-Up Duration:||2 Years|
|Official Title:||A Non-interventional, Observational Post-marketing Registry of Patients Treated With Revlimid (Lenalidomide) in Taiwan|
- Adverse Events [ Time Frame: Up to two years ] [ Designated as safety issue: Yes ]Number of participants with adverse events
- Efficacy [ Time Frame: Up to two years ] [ Designated as safety issue: Yes ]Revlimid dosage, reason for Revlimid discontinuation
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
The REVLIMID Registry is a prospective, multi-center, observational study. The registry will register 100 patients being prescribed REVLIMID in Taiwan during and patients will be followed for two years after the enrollment of the last patient.
Safety and efficacy data will be recorded in the registry monthly or bi-monthly. In accordance with the Risk Minimization Program for REVLIMID (RevAssure) a patient categorized as a woman of childbearing potential will be prescribed REVLIMID on a monthly basis, whereas women of non-childbearing potential and men will be allowed up to two months supply per prescription.
After entry of baseline data, the prescribing physician should prescribe and monitor REVLIMID therapy according to the guidance and recommended schedules given in the approved Taiwan package insert (PI)