{"analyses":[{"groupIds":["OG000","OG001","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.458","pValueComment":"The global difference among arms was based on the Wald test.","statisticalMethod":"Wald test","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"12.0","upperLimit":"18.6","value":"14.7"},{"groupId":"OG001","lowerLimit":"12.6","upperLimit":"24.2","value":"15.4"},{"groupId":"OG002","lowerLimit":"14.8","upperLimit":"20.3","value":"17.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"168"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"167"}],"units":"Participants"}],"description":"PFS is defined as the time from randomization to disease progression or death, whichever occurs first. Participants who did not progress and were still alive at the cut-off date were censored at the date of last contact. Response was assessed by the Investigator using the International Myeloma Working Group (IMWG) uniform response criteria.\n\nProgressive disease requires 1 of the following:\n\n* Increase of ≥ 25% from nadir in:\n\n  * Serum M-component (absolute increase ≥ 0.5 g/dl)\n  * Urine M-component (absolute increase ≥ 200 mg/24 hours)\n  * In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase \\> 100 mg/dl)\n  * Bone marrow plasma cell percentage (absolute % ≥ 10%)\n* Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas.\n* Development of hypercalcemia (corrected serum calcium \\> 11.5 mg/dl) attributed solely to plasma cell proliferative disease","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received bortezomib (Velcade) 1.3 mg/m\\^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).","id":"OG000","title":"Bortezomib and Dexamethasone"},{"description":"Participants received bortezomib 1.3 mg/m\\^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).","id":"OG001","title":"Bortezomib, Thalidomide, and Dexamethasone"},{"description":"Participants received bortezomib 1.3 mg/m\\^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m\\^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m\\^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).","id":"OG002","title":"Bortezomib, Melphalan and Prednisone"}],"paramType":"MEDIAN","populationDescription":"Intent-to-treat (all randomized participants)","reportingStatus":"POSTED","timeFrame":"From randomization until disease progression. Median follow-up time was 43 months.","title":"Progression Free Survival (PFS)","type":"PRIMARY","unitOfMeasure":"months"}