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 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
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Germany: Federal Institute for Drugs and Medical Devices