{"analyses":[{"ciLowerLimit":"0.579","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.886","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":"0.002","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":"0.716","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"18.10","upperLimit":"24.67","value":"21.4"},{"groupId":"OG001","lowerLimit":"23.69","upperLimit":"33.81","value":"26.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"261"},{"groupId":"OG001","value":"395"}],"units":"Participants"}],"description":"TTP is defined as the time from the date of randomization to the date of first documentation of PD, using IMWG criteria. 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. Participants without documentation of PD at the time of analysis were censored at the date of last response assessment that is stable disease or better.","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 PD (up to 107 months)","title":"Time to Progression (TTP)","type":"SECONDARY","unitOfMeasure":"months"}