{"analyses":[{"ciLowerLimit":"0.05","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.29","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"The model was adjusted for the following covariates in addition to log (each participant's duration in study) as an offset: treatment, region, duration of illness, baseline PDAI activity score, and baseline prednisone dose.","paramType":"Adjusted Rate Ratio","paramValue":"0.12","statisticalMethod":"Negative Binominal Regression"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"44"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"63"}],"units":"Participants"}],"description":"Disease flare is defined as 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.","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":"NUMBER","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":"Total Number of Protocol Defined Disease Flares","type":"SECONDARY","unitOfMeasure":"Number of Flares"}