{"analyses":[{"ciLowerLimit":"0.79","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.70","estimateComment":"Odds ratio and confidence interval are based on logistic regression model with treatment group as categorical predictor variable,age(\\<75 years vs \\>=75), ISS(stage I or II vs stage III),and BPI-SF worst pain score(\\<4 vs \\>=4)at screening as covariates.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.436","paramType":"Odds Ratio (OR)","paramValue":"1.16","statisticalComment":"CMH test is stratified by age (\\<75 years vs \\>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\\<4 vs \\>=4) at screening.","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"82"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"354"},{"groupId":"OG001","value":"351"}],"units":"Participants"}],"description":"ORR was defined as the percentage of participants who achieved CR + partial response (PR) + very good partial response (VGPR) (including sCR) or better relative to the ITT population during treatment period. CR was defined as negative immunofixation of serum and urine along with the disappearance of any soft tissue plasmacytomas and \\<5 % PC's in bone marrow. PR was defined as ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% along with ≥50% reduction in the size of soft tissue plasmacytomas. VGPR was defined as ≥90% in serum M-component plus urine M-component \\<100 mg/24. sCR is defined as stringent complete response. Percentages are rounded off to nearest whole numbers.","groups":[{"description":"Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib matching placebo capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).","id":"OG000","title":"Placebo + LenDex"},{"description":"Participants who were randomly assigned to receive Ixazomib 4.0 mg capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).","id":"OG001","title":"Ixazomib + LenDex"}],"paramType":"NUMBER","populationDescription":"ITT population included all participants who were randomized.","reportingStatus":"POSTED","timeFrame":"Up to approximately 9 years","title":"Overall Response Rate (ORR)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}