{"analyses":[{"ciLowerLimit":"0.43","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.90","estimateComment":"OR was based on logistic regression model with treatment group as categorical predictor variable and age, ISS and prior lines of therapy. OR \\>1 was deemed to indicate better response in Ixazomib+Dexamethasone arm over Pomalidomide+Dexamethasone arm.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.634","paramType":"Odds Ratio (OR)","paramValue":"0.90","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"27","upperLimit":"56","value":"41"},{"groupId":"OG001","lowerLimit":"27","upperLimit":"50","value":"38"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"49"},{"groupId":"OG001","value":"73"}],"units":"Participants"}],"description":"Overall Response Rate (ORR) was defined as the percentage of participants who achieved partial response (PR), very good partial response (VGPR), or complete response (CR) based on laboratory results and IRC assessment using modified IMWG criteria. PR: \\>=50% reduction of serum M protein + reduction in 24-hour urinary M protein by \\>=90% or to \\<200 mg/24-hour; if M protein is not measurable, \\>=50% decrease in difference between involved and uninvolved FLC levels is required; if not measurable by FLC, \\>=50% reduction in bone marrow plasma cells, when baseline value \\>=30% and; if present at baseline, \\>=50% reduction in size of soft tissue plasmacytomas is required. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or \\>=90% reduction in serum M-protein + urine M-protein level \\<100 mg/24-hour. CR: negative immunofixation on serum + urine; disappearance of soft tissue plasmacytomas; \\<5 % plasma cells in bone marrow.","dispersionType":"95% Confidence Interval","groups":[{"description":"Pomalidomide 4 mg, capsules, orally, once daily on Days 1 to 21 of each 28-day cycle, plus dexamethasone 40 mg, (or 20 mg if participant is aged \\>=75 years), tablets, orally, once daily on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.","id":"OG000","title":"Pomalidomide 4 mg + Dexamethasone 40 mg"},{"description":"Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged \\>=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.","id":"OG001","title":"Ixazomib 4 mg + Dexamethasone 20 mg"}],"paramType":"NUMBER","populationDescription":"ITT Population included all participants who were randomized.","reportingStatus":"POSTED","timeFrame":"From date of randomization until first documentation of CR, VGPR or PR (Up to approximately 3 years)","title":"Percentage of Participants With Overall Response","type":"SECONDARY","unitOfMeasure":"percentage of participants"}