{"analyses":[{"ciLowerLimit":"0.5","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.7","groupDescription":"Participants are censored at the time of crossover, open label rituximab, or best medical judgement, if applicable. If a participant has no flare after complete remission prior to their Month 18 visit, the duration is censored at the date of the Month 18 Visit","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.761","pValueComment":"The log-rank test assesses the difference between the two treatment arms in the flaring pattern after complete remission","paramType":"Cox Proportional Hazard","paramValue":"0.9","statisticalComment":"The log-rank test assesses the difference between the two treatment arms in the flaring pattern after complete remission","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"Some survival parameters are not estimable when there are small numbers of events","groupId":"OG000","lowerLimit":"172","upperLimit":"NA","value":"243"},{"comment":"Some survival parameters are not estimable when there are small numbers of events","groupId":"OG001","lowerLimit":"145","upperLimit":"NA","value":"230"}]}],"title":"25% Quartile (95%CI)"},{"categories":[{"measurements":[{"comment":"Some survival parameters are not estimable when there are small numbers of events","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Some survival parameters are not estimable when there are small numbers of events","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}],"title":"50% Quartile (95%CI)"},{"categories":[{"measurements":[{"comment":"Some survival parameters are not estimable when there are small numbers of events","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Some survival parameters are not estimable when there are small numbers of events","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}],"title":"75% Quartile (95%CI)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"99"},{"groupId":"OG001","value":"98"}],"units":"Participants"}],"description":"Duration of complete remission is defined as a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)\\[1\\] of 0 and a completing taper of Prednisone to the first flare, BVAS/WG score of greater than 0, or an increase in Prednisone dosing.\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":"The Duration of Complete Remission (BVAS=0, Off Glucocorticoids), the Time to Limited and/or Severe Flare After Remission in the Two Treatment Groups","type":"SECONDARY","unitOfMeasure":"Days"}