{"analyses":[{"ciLowerLimit":"0.7","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.3","estimateComment":"The hazard ratio and confidence interval are based on a Cox proportional hazard model comparing rituximab to the control group, adjusting for clinical study site, ANCA type, and glucocorticoid use prior to baseline.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.497","paramType":"Cox Proportional Hazard","paramValue":"1.0","statisticalComment":"The log-rank test assesses the difference between the two treatment arms in the pattern of achieving remission","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"29","upperLimit":"34","value":"30"},{"comment":"Confidence limits not estimable due to no variability around quartile","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"29"}]}],"title":"25% Quartile (95%CI)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"41","upperLimit":"63","value":"57"},{"groupId":"OG001","lowerLimit":"30","upperLimit":"58","value":"43"}]}],"title":"50% Quartile (95%CI)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"69","upperLimit":"123","value":"119"},{"groupId":"OG001","lowerLimit":"61","upperLimit":"120","value":"112"}]}],"title":"75% Quartile (95%CI)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"99"},{"groupId":"OG001","value":"98"}],"units":"Participants"}],"description":"Time to complete remission is defined as the number of days from baseline visit (Visit 1) to a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)\\[1\\] of 0.\n\n\\[1\\] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease","dispersionType":"95% Confidence Interval","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","reportingStatus":"POSTED","timeFrame":"18 months post-randomization","title":"Time to Remission (BVAS=0) From the Visit 1 Baseline Visit in the Two Treatment Groups","type":"SECONDARY","unitOfMeasure":"Days"}