{"analyses":[{"ciLowerLimit":"0.795","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.298","estimateComment":"Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.902","pValueComment":"P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.","paramType":"Hazard Ratio (HR)","paramValue":"1.015","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"Upper limit of 95% CI was not estimable due to low number of participants with events.","groupId":"OG000","lowerLimit":"68.7","upperLimit":"NA","value":"80.4"},{"comment":"Upper limit of 95% CI was not estimable due to low number of participants with events.","groupId":"OG001","lowerLimit":"67.22","upperLimit":"NA","value":"84.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"261"},{"groupId":"OG001","value":"395"}],"units":"Participants"}],"description":"PFS2 is defined as the time from the date of randomization to the date of objective disease progression on next line treatment or death from any cause (whichever occurs first). PD is defined as ≥25% increase from lowest value in: serum/urine M-component; participants without measurable serum and urine M-protein levels, the difference between involved and uninvolved FLC levels must be \\>10 mg/dL; participants without measurable serum, urine M-protein levels and FLC levels, bone marrow plasma cell percent must be ≥10%; new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size rise; hypercalcaemia development.","dispersionType":"95% Confidence Interval","groups":[{"description":"Ixazomib citrate placebo-matching capsules, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 26 until progressive disease (PD), unacceptable toxicity, or discontinuation for alternate reasons.","id":"OG000","title":"Placebo"},{"description":"Ixazomib citrate 3 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib citrate 4 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 until PD, unacceptable toxicity, or discontinuation for alternate reasons. Participants who had any dose reductions due to AEs were not dose escalated.","id":"OG001","title":"Ixazomib Citrate"}],"paramType":"MEDIAN","populationDescription":"ITT population was defined as all participants who were randomized and had post randomization data.","reportingStatus":"POSTED","timeFrame":"Randomization up to EOT (24 months); thereafter followed up every 4 weeks until initiation of next-line therapy and then every 12 weeks until second progressive disease (PD2) or death (up to 107 months)","title":"Second Progression Free Survival (PFS2)","type":"SECONDARY","unitOfMeasure":"months"}