{"analyses":[{"ciLowerLimit":"58.9","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"79.2","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"4.9","groupIds":["OG003"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"Significance level 5% one-tailed. Threshold response rate 35%","paramType":"Overall response rate (%)","paramValue":"69.8","statisticalMethod":"Binominal test","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"54.1","upperLimit":"100.0","value":"6"},{"groupId":"OG001","lowerLimit":"35.9","upperLimit":"99.6","value":"5"},{"groupId":"OG002","lowerLimit":"28.4","upperLimit":"99.5","value":"4"},{"groupId":"OG003","lowerLimit":"58.9","upperLimit":"79.2","value":"60"},{"groupId":"OG004","value":"71"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"86"},{"groupId":"OG004","value":"98"}],"units":"Participants"}],"description":"Response is evaluated as per the criteria for evaluating disease response and progression in patients with multiple myeloma treated by high-dose therapy and haemopoietic stem cell transplantation (Blade et al. 1998). CR: disappearance of the original 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; no increase in the size or number of lytic bone lesions; disappearance of soft tissue plasmacytomas for at least 6 weeks. PR: ≥50% reduction in the level of serum monoclonal protein for at least 2 determinations 6 weeks apart; If present, reduction in 24-hour urinary light chain excretion by either ≥90% or to \\<200 mg for at least 2 determinations 6 weeks apart; ≥50% reduction in the size of soft tissue plasmacytomas for at least 6 weeks; no increase in size or number of lytic bone lesions","groups":[{"description":"JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles","id":"OG000","title":"Phase I - JNJ-26866138 0.7 mg/m2 Group"},{"description":"JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles","id":"OG001","title":"Phase I - JNJ-26866138 1.0 mg/m2 Group"},{"description":"JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles","id":"OG002","title":"Phase I - JNJ-26866138 1.3 mg/m2 Group"},{"description":"JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5-9 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles","id":"OG003","title":"Phase II - JNJ-26866138 1.3 mg/m2 Group"},{"description":"Participants from both Phase I and Phase II","id":"OG004","title":"Total"}],"paramType":"NUMBER","populationDescription":"Full analysis set: All participants who received at least one dose of the study medication.","reportingStatus":"POSTED","timeFrame":"54 weeks","title":"Number of Participants With Overall Response (Complete Response [CR] + Partial Response [PR]) - Phase I and II","type":"PRIMARY","unitOfMeasure":"Participants"}