{"analyses":[{"ciLowerLimit":"0.3718","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.6991","estimateComment":"Confidence interval estimated using the Clopper Pearson method.","groupDescription":"A minimax 2-stage design was used to test the hypothesis that the CR+ rate less than or equal to 50%. Twenty-three evaluable subjects were enrolled in the first stage, followed by an additional 16 subjects for a total of 39 subjects. This design provided 90% power to detect a difference of 20% under the alternative hypothesis, assuming a one-sided alpha=0.10 significance level. If at least 24 of 39 participants had achieved CR or better to induction, the null hypothesis would have been rejected.","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY","pValue":"0.375","paramType":"Response rate","paramValue":"0.5385","statisticalMethod":"Fisher Exact"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"21"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"39"}],"units":"Participants"}],"description":"The primary endpoint is a binary variable determined for each subject indicating whether the subject achieved a complete response (CR) or stringent complete response (sCR) to induction treatment with KRd-Dara, as defined by the IMWG 2016 response criteria. Per IMWG 2016 criteria, CR is defined as negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, and \\<5% plasma cells in bone marrow aspirates. sCR is defined as CR plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry.","groups":[{"description":"Induction: Carfilzomib, lenalidomide, dexamethasone (KRd) + Daratumumab\n\nCarfilzomib, lenalidomide, dexamethasone (KRd) + Daratumumab: Experimental","id":"OG000","title":"KRd-Daratumumab"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The response evaluable population is defined as all subjects who initiate treatment with daratumumab and who have measurable disease at baseline.","reportingStatus":"POSTED","timeFrame":"From enrollment to best response determined at the end of induction (8 28-day cycles); the median length of induction was 32 weeks","title":"Number of Participants With Complete Response or Stringent Complete Response to Induction","type":"PRIMARY","unitOfMeasure":"Participants"}