{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"12.81","upperLimit":"18.50","value":"16.8"},{"groupId":"OG001","lowerLimit":"12.06","upperLimit":"31.15","value":"18.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"61"}],"units":"Participants"}],"description":"High-risk population included but not be limited to participants carrying deletion (del)17, t(4:14), t(14:16), amplification (ampl) 1q, del13, or del1p. PFS was defined as the time from the date of randomization to the date of first documentation of PD, as evaluated by an independent review committee according to IMWG criteria, or death due to 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 \\>10mg/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. Overall number of participants analyzed is the number of participants present in the high-risk group.","reportingStatus":"POSTED","timeFrame":"Randomization up to 107 months","title":"PFS Benefits in a High-Risk Population","type":"SECONDARY","unitOfMeasure":"months"}