{"analyses":[{"ciLowerLimit":"0.0006","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.1348","estimateComment":"Confidence interval estimated using the Clopper Pearson method.","groupIds":["OG000"],"nonInferiorityComment":"Estimation only.","nonInferiorityType":"OTHER","paramType":"Rate","paramValue":"0.0256"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"39"}],"units":"Participants"}],"description":"A binary variable will be determined for each participant indicating whether or not the subject died due to an adverse event during induction. This will include any grade 5 adverse event (according to NCI Common Terminology for Adverse Events version 4.03), regardless of causality","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 evaluable population is defined as all subjects who initiate treatment with daratumumab.","reportingStatus":"POSTED","timeFrame":"From enrollment to completion of induction; evaluated for approximately 32 weeks (8 28-day cycles).","title":"Number of Participants With Grade 5 Adverse Events During Induction","type":"OTHER_PRE_SPECIFIED","unitOfMeasure":"Participants"}