{"analyses":[{"ciLowerLimit":"0.43","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.19","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":"PFS is defined as time from randomization to myeloma progression according to International Myeloma Working Group (IMWG) criteria or death from any cause. IMWG criteria: increase of ≥25 percent from lowest response level in Serum M-component and/or (the absolute increase must be ≥0.5 g/dL) Urine M-component and/or (the absolute increase must be ≥200 mg/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 must be \\>10 mg/dL. Bone marrow plasma cell percentage: the absolute percent must be ≥10 percent. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia (corrected serum calcium \\>11.5 mg/dL or 2.65mmol/L) that can be attributed solely to the plasma cell proliferative disorder. PFS included disease progression as well as death.","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): all 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. Participants without progression and who are still alive at the end of the study or dropped out will be censored with the last available date.","reportingStatus":"POSTED","timeFrame":"From the date of randomization until the disease progression or participant's death from any cause whichever occured first, as assessed up to 72 weeks after end of treatment visit (ie, 46 days after last dose of study medication)","title":"Progression-Free Survival (PFS)","type":"SECONDARY","unitOfMeasure":"Months"}