{"analyses":[{"ciLowerLimit":"0.587","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.939","estimateComment":"HR is estimated from Cox Regression.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.012","paramType":"Hazard Ratio (HR)","paramValue":"0.742","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"The upper limit of 95% confidence interval was not estimable due to low number of participants with events.","groupId":"OG000","lowerLimit":"17.02","upperLimit":"NA","value":"20.6"},{"groupId":"OG001","lowerLimit":"12.91","upperLimit":"17.58","value":"14.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"360"},{"groupId":"OG001","value":"362"}],"units":"Participants"}],"description":"Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of first documentation of disease progression (PD) or death due to any cause, whichever occurs first. Response including PD was assessed by independent review committee (IRC) using the International Myeloma Working Group (IMWG) response criteria. PD requires 1 of the following: Increase of ≥ 25% from nadir in: Serum M-component (absolute increase ≥ 0.5 g/dl); Urine M-component (absolute increase ≥ 200 mg/24 hours); In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase \\> 10 mg/dl); Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium \\> 11.5 mg/dl) attributed solely to plasma cell proliferative disease. Status evaluated every 4 weeks until disease progression (PD) was confirmed.","dispersionType":"95% Confidence Interval","groups":[{"description":"Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until PD or unacceptable toxicity, whichever occurred first up to EOT (up to approximately 42.9 months).","id":"OG000","title":"Ixazomib+ Lenalidomide + Dexamethasone"},{"description":"Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until PD or unacceptable toxicity, whichever occurred first (up to approximately 41 months).","id":"OG001","title":"Placebo + Lenalidomide + Dexamethasone"}],"paramType":"MEDIAN","populationDescription":"ITT population was defined as all randomized participants.","reportingStatus":"POSTED","timeFrame":"From date of randomization until disease progression or death up to approximately 27 months (approximate median follow-up 15 months)","title":"Progression Free Survival (PFS) as Assessed by the Independent Review Committee (IRC)","type":"PRIMARY","unitOfMeasure":"months"}