{"analyses":[{"ciLowerLimit":"-3.2","ciPctValue":"95.1","ciUpperLimit":"24.3","groupDescription":"In calculating the sample size, we assumed that the percentage of patients in both treatment groups would achieve disease remission off prednisone by 6 months was 70%. We specified a non-inferiority margin of -20% on the difference in remission rates (rituximab rate minus cyclophosphamide rate) and a one-sided 0.025 level test. Assuming a 10% dropout rate, RAVE required 100 patients in each arm to have 83% power to conclude non-inferiority.","groupIds":["OG000","OG001"],"nonInferiorityComment":"non-inferiority margin of -20%","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","pValue":"<0.001","pValueComment":"P-value is adjusted for interim analysis using a Lan-DeMets alpha spending function with an O'Brien-Fleming boundary, allocating 0.003 alpha to the interim analysis and 0.049 alpha to the final analysis.","paramType":"Difference between group success rates","paramValue":"10.6","statisticalComment":"Calculate 95.1% CI around the difference in success rates between arms. Lower bound above non-inferiority margin of -20% indicates non-inferiority.","statisticalMethod":"95.1% CI of difference"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"63"},{"groupId":"OG001","value":"52"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"99"},{"groupId":"OG001","value":"98"}],"units":"Participants"}],"description":"A Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) score of 0 with prednisone taper successfully completed at six months. The BVAS/WG is a validated disease activity index. The BVAS/WG is designed to document new or worsening clinically active vasculitis and consists of a set of items divided into nine organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease.","groups":[{"description":"Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo-cyclophosphamide. Refer to section titled \"Detailed Description\" for additional treatment information.","id":"OG000","title":"Rituximab"},{"description":"Participants received placebo-rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled \"Detailed Description\" for additional treatment information.","id":"OG001","title":"Control Group"}],"paramType":"NUMBER","populationDescription":"Intent-to-treat (ITT) sample with worst case imputation","reportingStatus":"POSTED","timeFrame":"6 months post-randomization","title":"Disease Remission","type":"PRIMARY","unitOfMeasure":"Participants"}