{"analyses":[{"ciLowerLimit":"0","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.174","estimateComment":"Patients randomly assigned to zoledronic acid were compared with patients assigned to placebo","groupDescription":"The null hypothesis was that the hazard ratio is greater than or equal to 1.0 versus the alternative hypothesis that the hazard ratio is less than 0.77. With a target of 470 SREs, log-rank statistic had 88% power to detect a 23% decrease in hazard of SRE (equivalent to an increase in median time to SRE from 30 months to 39 months), assuming a one-sided type I error rate of .05.","groupIds":["OG000","OG001"],"nonInferiorityComment":"Superiority and futility analysis were conducted for time to first SRE. Lan-Demets analog of the Emerson-Fleming sequential boundary was used to maintain overall significance level of α = .05 while conducting interim analyses on time to first SRE.","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE_LEGACY","pValue":"0.385","pValueComment":"Because of early termination, conditional power was performed under the alternative hypothesis. This is the probability that zoledronic acid is superior to placebo, given time to first SRE data at interim analysis under alternative hypothesis.","paramType":"Hazard Ratio (HR)","paramValue":"0.97","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"24.2","upperLimit":"40.3","value":"31.9"},{"groupId":"OG001","lowerLimit":"25.3","upperLimit":"37.2","value":"28.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"323"},{"groupId":"OG001","value":"322"}],"units":"Participants"}],"description":"Time to first skeletal related event (SRE) was defined as the time from randomization to first skeletal event. Skeletal events are defined as radiation to bone, clinical fracture, surgery to bone and spinal cord compression and death due to prostate cancer. The median with 95% CI was estimated using the Kaplan Meier method.","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":"Time to First Skeletal Related Event","type":"PRIMARY","unitOfMeasure":"months"}