{"analyses":[{"ciLowerLimit":"0.516","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.626","estimateComment":"HR:estimated from Cox Regression with stratification factors: prior therapies, proteasome inhibitor, and ISS Stage at Screening with treatment as factor in model. \\<1 hazard ratio for treatment=better prevention of death in drug arm vs control.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.764","paramType":"Hazard Ratio (HR)","paramValue":"0.916","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"27.56","upperLimit":"56.74","value":"42.2"},{"groupId":"OG001","lowerLimit":"16.99","upperLimit":"44.22","value":"29.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"33"}],"units":"Participants"}],"description":"Overall survival is defined as the time from the date of randomization to the date of death. The high-risk participants whose myeloma carried del(17) subgroup was defined as the cases reported as positive for del(17) by the central laboratory combined with those cases that lacked a central laboratory result but with known del (17) by local laboratory. Participants without documentation of death at the time of the analysis were censored at the date when they were last known to be alive. Data is only reported high-risk participants with Del(17).","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. Overall number analyzed is the number of participants available for analysis.","reportingStatus":"POSTED","timeFrame":"From the time of screening until disease progression and thereafter every 12 weeks until death or study termination (up to approximately 97 months)","title":"Overall Survival in High-Risk Participants Carrying Deletion 17 [Del(17)]","type":"SECONDARY","unitOfMeasure":"months"}