{"analyses":[{"ciLowerLimit":"0.9","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.8","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":"0.147","paramType":"Cox Proportional Hazard","paramValue":"1.3","statisticalComment":"The log-rank test assesses the difference between the two treatment arms in the pattern of achieving complete remission","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"173","upperLimit":"177","value":"176"},{"groupId":"OG001","lowerLimit":"175","upperLimit":"178","value":"177"}]}],"title":"25% Quartile (95%CI)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"178","upperLimit":"182","value":"180"},{"groupId":"OG001","lowerLimit":"180","upperLimit":"187","value":"183"}]}],"title":"50% Quartile (95%CI)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"183","upperLimit":"253","value":"189"},{"groupId":"OG001","lowerLimit":"190","upperLimit":"287","value":"266"}]}],"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 and completing taper of glucocorticoid by 6 months post-randomization.\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 Complete Remission (BVAS=0, Off Glucocorticoids) From the Visit 1 Baseline Visit in the Two Treatment Groups","type":"SECONDARY","unitOfMeasure":"Days"}