{"analyses":[{"ciLowerLimit":"0.594","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.975","groupDescription":"Superiority analysis","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.030","paramType":"Cox Proportional Hazard","paramValue":"0.761","statisticalComment":"Based on the Cox Proportional hazards model stratified by UISS High-Risk Group.","statisticalMethod":"Cox Proportional hazards model"}],"classes":[{"categories":[{"measurements":[{"comment":"The upper limit of the 95% confidence interval of the median DFS on Sunitinib was not reached","groupId":"OG000","lowerLimit":"5.8","upperLimit":"NA","value":"6.8"},{"groupId":"OG001","lowerLimit":"3.8","upperLimit":"6.6","value":"5.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"309"},{"groupId":"OG001","value":"306"}],"units":"Participants"}],"description":"DFS was defined as the time interval (in years) from the date of randomization to the first date of recurrence or occurrence of a secondary malignancy or death. Recurrence refers to relapse of the primary tumor in-situ or at metastatic sites. Date of recurrence or occurrence: The date of the recurrence or occurrence of a secondary malignancy for the first time, either by blinded independent central review (BICR) or investigator assessment for respective analyses. Participants were followed with tumor imaging for recurrence or occurrence of a secondary malignancy for remainder of follow-up period unless the participant had withdrawn consent. According to the statistical analysis plan there are two cohorts: 1.Global Cohort: primary analysis of DFS was performed approximately 5 years after last participant in the Global Cohort is randomized; 2. China Cohort: primary analysis of DFS was performed approximately 3 years after the last participant in China Cohort was randomized.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received Sunitinib on 9 6-week cycles on 4/2 dosing schedule: 4 weeks on, 2 weeks off.","id":"OG000","title":"Sunitinib"},{"description":"Participants received Placebo on 9 6-week cycles with 4/2 dosing schedule: 4 weeks on, 2 weeks off.","id":"OG001","title":"Placebo"}],"paramType":"MEDIAN","populationDescription":"ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.","reportingStatus":"POSTED","timeFrame":"Every 12 weeks during the first 3 years and every 6 months after that unless the participant had withdrawn consent. Performed 5 years after LSLV or when approximately 258 events survival status, whichever was later.","title":"Disease-free Survival (DFS)- Assessed by Blinded Independent Central Review","type":"PRIMARY","unitOfMeasure":"Number of years"}