{"analyses":[{"ciLowerLimit":"-4.577","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-1.167","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0012","pValueComment":"P-value is from Mixed Model Repeated Measures (MMRM) with unstructured covariance matrix, adjusting for treatment, region, duration of illness, baseline DLQI score, visit, and an interaction terms for visit × baseline DLQI score and visit × treatment","paramType":"Difference in Estimated Means","paramValue":"-2.872","statisticalMethod":"Mixed Model Repeated Measures"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"7.89","value":"10.14"},{"groupId":"OG001","spread":"8.52","value":"11.09"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"57"},{"groupId":"OG001","value":"58"}],"units":"Participants"}],"title":"Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.532","value":"-8.874"},{"groupId":"OG001","spread":"0.662","value":"-6.002"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"45"},{"groupId":"OG001","value":"27"}],"units":"Participants"}],"title":"Week 52"}],"denoms":[{"counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"63"}],"units":"Participants"}],"description":"Total DLQI scores range from 0 to 30 with higher DLQI scores reflecting greater impairment in a participant's health-related quality of life. The DLQI score is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The measure type mean is the estimated mean from adjusted MMRM.","dispersionType":"Standard Error","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":"MEAN","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. Only participants for whom data were collected are included in the analysis.","reportingStatus":"POSTED","timeFrame":"From Baseline up to 52 Weeks (up to CCOD of 28 November 2018)","title":"Change in Health-Related Quality of Life (HRQoL), as Measured by the Dermatology Life Quality Index (DLQI) Score","type":"SECONDARY","unitOfMeasure":"Scores on a Scale"}