Special Investigation For Renal Cell Carcinoma (RCC) Of Sunitinib Malate (Regulatory Post Marketing Commitment Plan)
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Special Investigation For Rcc Of Sutent (Regulatory Post Marketing Commitment Plan).|
- Adverse drug reaction not expected from the LPD (unknown adverse drug reaction). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Factors considered to affect the safety and/or efficacy of this drug. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- The incidence of adverse drug reactions in this surveillance. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Follow up for safety information. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
|Estimated Study Completion Date:||July 2016|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Patients taking sunitinib malate
Drug: sunitinib malate
SUTENT® Capsule 12.5 mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. "The usual adult dosage for oral sunitinib is 50 mg once daily, 4 weeks on followed by 2 weeks off (Schedule 4/2). This comprises 1 treatment cycle, which may be repeated.
The dosage may be decreased according to the patient's clinical condition."
Other Name: Sutent
All the patients whom an investigator prescribes the first sunitinib malate(Sutent) should be registered.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00716625
|Study Director:||Pfizer CT.gov Call Center||Pfizer|