{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityComment":"Based on the published data on the effect of a standard of dosing schedule of \\> zoledronic acid compared to placebo, we choose ∆= 7%, πT= 42%, and πS= 35%. With a total of 1230 eligible patients (615 per arm), the probability of rejecting the null hypothesis using a one-sided test is at most 0.05 (Type I error α) when θ≥ 7% and the probability of rejecting the null hypothesis (the power) is at least 82% when θ≤0","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","pValue":"<=.05","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"67.6"},{"groupId":"OG001","value":"67.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"911"},{"groupId":"OG001","value":"911"}],"units":"Participants"}],"description":"To determine whether every-12-week therapy with zoledronic acid is not inferior to every-4-week therapy for patients with metastatic breast cancer, metastatic prostate cancer, or multiple myeloma involving bone, as measured by the proportion of patients who would have experienced at least one skeletal related event within 24 months after randomization.","groups":[{"description":"Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.","id":"OG000","title":"Arm I (Zoledronic Acid Every 4 Weeks)"},{"description":"Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.","id":"OG001","title":"Arm II (Zoledronic Acid Every 12 Weeks)"}],"paramType":"NUMBER","populationDescription":"All patients that were eligible and completed treatment were analyzed.","reportingStatus":"POSTED","timeFrame":"2 years","title":"Percentage of Participants With at Least One Skeletal-related Event (SRE) Within 2 Years After Randomization","type":"PRIMARY","unitOfMeasure":"percentage of participants"}