{"analyses":[{"ciLowerLimit":"6.1","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"27.1","groupDescription":"In this trial, non-inferiority is defined as retaining 60% of the IV (active control) treatment effect as measured by ORR. The non-inferiority hypothesis can be stated as: H0: ORRSC - 0.60 ORRIV \\<0 vs. H1: ORRSC - 0.60 ORRIV ≥0 (non-inferiority).","groupIds":["OG000","OG001"],"nonInferiorityComment":"Assuming ORRs are 35.5% for both SC and IV, one-sided alpha level of 0.025, and approximately 80% power, approximately 216 subjects (144 SC:72 IV) are needed to show non-inferiority of SC to IV VELCADE.","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","pValue":"0.00201","paramType":"ORR_SQ - 0.6 ORR_IV","paramValue":"16.8","statisticalComment":"CONOR P. FARRINGTON AND GODFREY MANNING STATISTICS IN MEDICINE, VOL. 9, 1447-1454(1990).","statisticalMethod":"Farrrington and Manning","testedNonInferiority":true}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"31"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"145"},{"groupId":"OG001","value":"73"}],"units":"Participants"}],"description":"Disease response was measured according to European Group for Blood and Marrow Transplantation (EBMT) criteria with the addition of the response categories of nCR and VGPR.\n\nComplete response requires disappearance of monoclonal protein from the blood and urine and \\<5% plasma cells in the bone marrow on at least 2 determinations for a minimum of 6 weeks.\n\nPartial Response requires ≥50% reduction in serum m-protein for at least 2 determinations at least 6 weeks apart and if present, reduction in 24-hour urinary light chain excretion by either ≥90% or to \\<200 mg","groups":[{"description":"VELCADE 1.3 mg/m\\^2 administered by subcutaneous injection on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.","id":"OG000","title":"VELCADE Subcutaneuous"},{"description":"VELCADE 1.3 mg/m\\^2 administered by intravenous injection on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.","id":"OG001","title":"VELCADE Intravenous"}],"paramType":"NUMBER","populationDescription":"The response-evaluable population was defined as subjects who received at least 1 dose of study drug and had measurable, secretory multiple myeloma, defined as a serum monoclonal IgG or IgM of ≥10 g/L or a serum monoclonal IgA or IgE ≥5 g/L, or a serum monoclonal IgD of ≥0.5g/L, or urine M-protein of ≥200 mg/24 hours, at study entry.","reportingStatus":"POSTED","timeFrame":"Over 4 cycles (prior to the addition of dexamethasone)","title":"Number of Patients With Overall Response (Complete Response + Partial Response)","type":"PRIMARY","unitOfMeasure":"Participants"}