{"analyses":[{"ciLowerLimit":"0.661","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.120","estimateComment":"Hazard ratio is based on an unadjusted Cox's proportional hazard regression model 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.","groupDescription":"Time to Pain Progression","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.260","paramType":"Hazard Ratio (HR)","paramValue":"0.860","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":[{"comment":"Upper limit of CI was not estimable due to insufficient number of participants with events.","groupId":"OG000","lowerLimit":"30.88","upperLimit":"NA","value":"47.1"},{"comment":"Median and upper limit of CI was not estimable due to insufficient number of participants with events.","groupId":"OG001","lowerLimit":"57.59","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"354"},{"groupId":"OG001","value":"351"}],"units":"Participants"}],"description":"Time to pain progression was assessed as the time from randomization to the date of initial progression classification. Pain progression was defined as the occurrence of 1 of the following and confirmed by 2 consecutive evaluations (To qualify as progression, the participant must have a BPI-SF worst pain score \\> 4 during pain progression): 1) a ≥ 2 point and 30% increase from Baseline in BPI-SF worst pain score without an increase in analgesic use, or 2) a 25% or more increase in analgesic use from Baseline without a decrease in BPI-SF worst pain score from Baseline. Brief Pain Inventory - Short Form (m-BPI-SF) is a participant rated 11-point Likert rating scale ranged from 0 (no pain) to 10 (worst pain imaginable).","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 9 years","title":"Time to Pain Progression","type":"SECONDARY","unitOfMeasure":"months"}