{"analyses":[{"ciLowerLimit":"0.74","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.07","estimateComment":"Zoledronic acid versus placebo group","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.22","paramType":"Hazard Ratio (HR)","paramValue":"0.89","statisticalComment":"Adjusted for stratification factors: performance status, prior SRE, and serum alkaline phosphatase.","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.5","upperLimit":"15.4","value":"10.6"},{"groupId":"OG001","lowerLimit":"8.0","upperLimit":"11.9","value":"9.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"323"},{"groupId":"OG001","value":"322"}],"units":"Participants"}],"description":"Progression Free Survival (PFS) was defined as the time from registration until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method.\n\nProgression is defined as one or more of the following: new bone metastases, biochemical progression of PSA, treatment with radiation therapy while on treatment.","dispersionType":"95% Confidence Interval","groups":[{"description":"4mg by IV over 15 minutes every 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progression on blinded treatment before having a skeletal event may continue on open label Zoledronic acid (4 mg by IV over 15 minutes every 3 weeks).","id":"OG000","title":"Zoledronic Acid + Androgen Deprivation Therapy"},{"description":"Placebo bu IV over 15 minutes for 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progress on blinded treatment before having a skeletal event may continue on open label Zoledronic acid.","id":"OG001","title":"Placebo + Androgen Deprivation Therapy"}],"paramType":"MEDIAN","reportingStatus":"POSTED","timeFrame":"Up to 10 years","title":"Progression-free Survival","type":"SECONDARY","unitOfMeasure":"months"}