{"analyses":[{"ciLowerLimit":"0.676","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.018","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.073","paramType":"Hazard Ratio (HR)","paramValue":"0.830","statisticalComment":"Log-rank 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":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"19.65","upperLimit":"30.78","value":"21.8"},{"groupId":"OG001","lowerLimit":"26.45","upperLimit":"43.70","value":"35.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"354"},{"groupId":"OG001","value":"351"}],"units":"Participants"}],"description":"PFS was defined as the time from the date of randomization to the date of first documentation of progressive disease (PD) or death due to any cause according to International Myeloma Working Group (IMWG) criteria whichever occurs first. PD required one of the following: Increase of \\>=25% from nadir in: Serum M-component and/or (the absolute increase must be \\>=0.5 g/dL); Urine M-component and/or (the absolute increase must be \\>=200 mg/24 hours); in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain (FLC) levels (absolute increase must be \\> 10 mg/dL); Bone marrow plasma cell percentage: the absolute % must be \\>10%; development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; hypercalcemia (corrected serum calcium \\> 11.5 mg/dL or 2.85 mmol/L).","dispersionType":"95% Confidence Interval","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":"MEDIAN","populationDescription":"ITT population included all participants who were randomized.","reportingStatus":"POSTED","timeFrame":"Up to approximately 79 months","title":"Progression Free Survival (PFS)","type":"PRIMARY","unitOfMeasure":"months"}