{"analyses":[{"ciLowerLimit":"0.365","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.466","estimateComment":"Odds ratio and CI are based on a logistic regression model with treatment group as a categorical predictor variable and pre-induction regimen, pre-induction ISS, and response after transplantation at screening as covariates.","groupDescription":"CR","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.370","pValueComment":"P-value is based on Cochran-Mantel-Haenszel (CMH) test stratified by pre-induction regimen, pre-induction international staging system (ISS), and response after transplantation at screening.","paramType":"Odds Ratio (OR)","paramValue":"0.732","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"12"}]}],"title":"PR"},{"categories":[{"measurements":[{"groupId":"OG000","value":"45"},{"groupId":"OG001","value":"40"}]}],"title":"VGPR"},{"categories":[{"measurements":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"44"}]}],"title":"CR"}],"denoms":[{"counts":[{"groupId":"OG000","value":"261"},{"groupId":"OG001","value":"395"}],"units":"Participants"}],"description":"Response was assessed according to IMWG criteria. Best response includes partial response (PR), very good partial response (VGPR) and complete response (CR). PR as per IMWG criteria is 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to less than (\\<)200 milligrams (mg) per 24 hours. VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein plus urine M-protein level \\<100 mg per 24 hours. CR is negative immunofixation of serum and urine and disappearance of soft tissue plasmacytomas and \\<5% plasma cells in bone marrow. Stringent CR (sCR) is CR and normal FLC ratio and absence of clonal plasma cells (PCs) by immunohistochemistry or 2- to 4-color flow cytometry. The decimal values of percentages were subjected to rounding off.","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":"NUMBER","populationDescription":"ITT population was defined as all participants who were randomized and had post randomization data.","reportingStatus":"POSTED","timeFrame":"Randomization up to EOT (up to 24 months) and thereafter every 4 weeks until initiation of the next line of therapy (up to 107 months)","title":"Percentage of Participants With Any Best Response Category Before PD or Subsequent Therapy","type":"SECONDARY","unitOfMeasure":"percentage of participants"}