{"analyses":[{"ciLowerLimit":"0.69","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.45","estimateComment":"Odds ratio is from logistic regression model with prognostic factors: prior therapies (1, 2 or 3), proteasome inhibitor (exposed, naïve),and ISS Stage at Screening (I or II, III). Odds ratio \\> 1 favors Ixazomib.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.332","pValueComment":"P-value is from Cochran-Mantel-Haenszel stratified by: prior therapies (1, 2 or 3), proteasome inhibitor (exposed, naïve), and ISS Stage at Screening (I or II, III).","paramType":"Odds Ratio (OR)","paramValue":"1.30","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"72.0","upperLimit":"87.1","value":"80.3"},{"groupId":"OG001","lowerLimit":"66.8","upperLimit":"83.2","value":"75.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"117"},{"groupId":"OG001","value":"115"}],"units":"Participants"}],"description":"Data is reported for percentage of participants defined by polymorphism defined by polymorphisms in proteasome genes, such as polymorphism P11A in PSMB1 gene. Percentages are rounded off to single decimal.","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 progressive disease (PD) or unacceptable toxicity, whichever occurred first up to end of treatment (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 progressive disease (PD) or unacceptable toxicity, whichever occurred first up to (up to approximately 41 months).","id":"OG001","title":"Placebo + Lenalidomide + Dexamethasone"}],"paramType":"NUMBER","populationDescription":"ITT population included all randomized participants. Overall number analyzed is the number of participants available with data.","reportingStatus":"POSTED","timeFrame":"Day 1 of each cycle (every 4 weeks) until disease progression up to approximately 27 months (approximate median follow-up 15 months)","title":"Overall Response Rate in Participants Defined by Polymorphism","type":"SECONDARY","unitOfMeasure":"percentage of participants"}