{"analyses":[{"ciLowerLimit":"0.5","ciPctValue":"95","ciUpperLimit":"10","estimateComment":"95% Confidence intervals were calculated for the true confirmed response rate using properties of the binomial distribution.","groupDescription":"Proportion of confirmed responses to Anakinra alone was estimated by the number of patients who achieved a confirmed response divided by the total number of assessable patients.","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","paramType":"Proportion of confirmed responses (%)","paramValue":"1.8"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.5","upperLimit":"10","value":"1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"54"}],"units":"Participants"}],"description":"Response Definitions:\n\n* Complete Response(CR):disappearance of M-Protein from serum \\& urine and immunofixation, \\<5% bone marrow(BM) plasma cells \\& disappearance of soft tissue plasmacytomas(STP);\n* Very Good Partial Response(VGPR):\\>=90% decrease in serum M-Protein, Urine M-protein \\<100 mg/24 hours, \\<=5% BM plasma cells, disappearance of STP;\n* Partial response(PR):\\>=50% reduction in serum M-protein, \\>=90% decrease in Urine M-protein or \\<200 mg/24 hours \\& \\>=50% decrease in STP;\n* Minor response(MR):25-49% decrease in serum M-protein, 50-89% decrease in urine M-protein \\& 25-49% decrease in STP","groups":[{"description":"Patients in this outcome received only Anakinra (100mg daily subcutaneously administered).","id":"OG000","title":"Anakinra Without Dexamethasone"}],"paramType":"NUMBER","populationDescription":"Participants who met the eligibility criteria, signed the consent form and have began treatment were considered evaluable.","reportingStatus":"POSTED","timeFrame":"6 months","title":"Patients With Confirmed Response (Complete Response, Very Good Partial Response, Partial Response, or Minimal Response) on 2 Consecutive Months During the First 6 Months of Treatment With Anakinra Alone","type":"PRIMARY","unitOfMeasure":"participants"}