{"analyses":[{"ciLowerLimit":"0.06","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.39","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"P-value is from a stratified log-rank test used to test the time to first disease flare between the RTX and MMF treatment arms over the 52-week treatment period, adjusting for the stratification factors applied at randomization","paramType":"Hazard Ratio (HR)","paramValue":"0.15","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"The median is not estimable due to limited number of events","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"The median is not estimable due to limited number of events","groupId":"OG001","lowerLimit":"36.9","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"63"}],"units":"Participants"}],"description":"Disease flare is defined as the appearance of three or more new lesions a month that do not heal spontaneously within 1 week or by the extension of established lesions in a participant who has achieved disease control.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received rituximab by IV infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants also received MMF matching placebo orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52.","id":"OG000","title":"Rituximab (RTX)"},{"description":"Participants received Mycophenolate Mofetil (MMF) orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants also received rituximab matching placebo by intravenous (IV) infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met.","id":"OG001","title":"Mycophenolate Mofetil (MMF)"}],"paramType":"MEDIAN","populationDescription":"The mITT population included participants in the ITT population (all randomized participants who received any part of an infusion of study drug or oral administration of study drug), excluding the 10 TM participants. This population was used in the analyses of efficacy outcomes.","reportingStatus":"POSTED","timeFrame":"From Baseline up to 52 Weeks (up to CCOD of 28 November 2018)","title":"Time to Protocol Defined Disease Flare","type":"SECONDARY","unitOfMeasure":"Weeks"}