{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.1","upperLimit":"8.5","value":"8.0"},{"groupId":"OG001","lowerLimit":"6.3","upperLimit":"7.4","value":"6.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"252"},{"groupId":"OG001","value":"254"}],"units":"Participants"}],"description":"The primary analysis of PFS will be a two-sided stratified log-rank test comparing arm A and arm B. The stratification factors will consist of the two stratification factors used for patient randomization: prior nephrectomy (yes vs. no) and Motzer score (0 vs. 1-2 vs. 3+). Results from unstratified log-rank tests will also be provided. Kaplan-Meier methodology will be used to estimate median PFS for each treatment arm.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients receive gemcitabine hydrochloride and cisplatin as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.","id":"OG000","title":"Arm II (GCB)"},{"description":"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV and placebo IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive placebo IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.","id":"OG001","title":"Arm I (GCP)"}],"paramType":"MEDIAN","reportingStatus":"POSTED","timeFrame":"From the date of randomization to date of progression or death due to any cause, whichever occurs first, assessed up to 7 years","title":"Progression-free Survival (PFS)","type":"SECONDARY","unitOfMeasure":"months"}