{"analyses":[{"ciLowerLimit":"0.43","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.19","groupDescription":"Null Hypothesis: The (median) time to progression is equal in both treatment groups","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.196","paramType":"Hazard Ratio (HR)","paramValue":"0.71","statisticalMethod":"Regression, Cox","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"9.83","upperLimit":"14.43","value":"12.6"},{"groupId":"OG001","lowerLimit":"8.60","upperLimit":"11.40","value":"9.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"47"}],"units":"Participants"}],"description":"'Median time to progression of disease is assessed according to International Myeloma Working Group (IMWG) criteria or death from any cause. IMWG criteria: increase of \\>=25% from lowest level in Serum M-component or (the absolute increase must be \\>=0.5 gram per deciliter \\[g/dL\\]); Urine M component or (the absolute increase must be \\>=200 milligram per 24 hour. Only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels. The absolute increase \\>10 mg/dL. Bone marrow plasma cell percentage \\>=10%. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing. Development of hypercalcemia. Participants who died or dropped out due to any reason without progression will be censored with the day of death or drop-out, respectively and who are alive at the end of the study without any progression was censored with the last available date.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle.","id":"OG000","title":"Vd (Bortezomib + Dexamethasone)"},{"description":"Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle and single oral doses of 50 mg cyclophosphamide on a once daily basis from Day 1, Cycle 1 continuously until Day 21, Cycle 8.","id":"OG001","title":"Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide)"}],"paramType":"MEDIAN","populationDescription":"Intent-to-treat (ITT): Participants who received at least one dose of study medication and in whom the primary efficacy parameter could be assessed at least once under study medication.","reportingStatus":"POSTED","timeFrame":"From the date of randomization until the disease progression or participant's death from any cause whichever occurred first, as assessed up to 72 weeks after end of treatment visit (ie, 46 days after last dose of study medication)","title":"Time to Progression of Disease","type":"PRIMARY","unitOfMeasure":"Months"}