{"analyses":[{"groupDescription":"P-value tests the null hypothesis: CR+VGPR rate=27% in treatment arms obtained using the one-sided Chi-Square test with alpha=0.10.","groupIds":["OG000"],"nonInferiorityType":"OTHER","pValue":"0.4859","statisticalMethod":"Chi-squared"},{"groupDescription":"P-value tests the null hypothesis: CR+VGPR rate=27% in treatment arms obtained using the one-sided Chi-Square test with alpha=0.10.","groupIds":["OG001"],"nonInferiorityType":"OTHER","pValue":"0.6757","statisticalMethod":"Chi-squared"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"13","upperLimit":"46","value":"27"},{"groupId":"OG001","lowerLimit":"11","upperLimit":"41","value":"24"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"33"},{"groupId":"OG001","value":"34"}],"units":"Participants"}],"description":"Combined Response Rate is the percentage of participants with Complete Response (CR), including stringent Complete Response (sCR), and Very Good Partial Response (VGPR) according to the International Myeloma Working Group (IMWG) criteria during the Induction Phase (Cycles 1-13, 28-day cycles). CR=negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas and \\<5% plasma cells in bone marrow. VGPR=serum and urine M-component detectable by immunofixation but not on electrophoresis or 90% reduction in serum M-component plus urine M-component \\<100 mg/24 hour.","dispersionType":"95% Confidence Interval","groups":[{"description":"Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until progressive disease (PD)/death or unacceptable toxicity \\[13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months\\] and cyclophosphamide (CYC) 300 mg/m\\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \\>75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.","id":"OG000","title":"Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM)"},{"description":"Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until PD/death or unacceptable toxicity \\[13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months\\] and cyclophosphamide (CYC) 400 mg/m\\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \\>75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.","id":"OG001","title":"Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM)"}],"paramType":"NUMBER","populationDescription":"Response Evaluable Population was defined as participants who received at least 2 of the 3 ixazomib doses during Cycle 1, had measurable disease at Baseline, and at least 1 postbaseline response assessment.","reportingStatus":"POSTED","timeFrame":"Day 1 of Cycles 1-13, 28-day cycles (Up to 1 year)","title":"Combined Response Rate During the Induction Phase in Newly Diagnosed Multiple Myeloma (NDMM) Participants","type":"PRIMARY","unitOfMeasure":"percentage of participants"}