A Non-Interventional Study With SUTENT® In The First Line Treatment Of Renal Cell Cancer
The Statistical Analysis Plan provides detailed specification of the analysis
Observational
Observational Model: Cohort, Time Perspective: Prospective
Number of Participants With Categorical Best Overall Response
Best overall reponse based on investigator's disease status assessment. Complete response(CR)=disappearance of all target lesions.Partial Response(PR)=≥30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions.Progressive disease(PD)=≥20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of longest dimensions since treatment start or appearance of ≥1 new lesions. Stable disease(SD)=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.
Start of Treatment up through 12 Months or Early Discontinuation
No
Pfizer CT.gov Call Center
Study Director
Pfizer
Germany: Federal Institute for Drugs and Medical Devices
A6181115
NCT00460798
February 2007
September 2009
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