{"analyses":[{"ciLowerLimit":"0.0063","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.1732","estimateComment":"Confidence interval estimated using the Clopper Pearson method.","groupIds":["OG000"],"nonInferiorityComment":"Estimation only","nonInferiorityType":"OTHER","paramType":"Rate","paramValue":"0.0513"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"39"}],"units":"Participants"}],"description":"A binary variable will be determined for each subject indicating whether or not the subject experienced at least one grade 3 or higher study treatment-related cardiovascular or pulmonary-related adverse event according to the NCI Common Terminology for Adverse Events version 4.03 during induction. Only select CTCAE terms will be considered for this safety outcome including heart failure, pneumonia, dyspnea, peripheral edema, or hypertension.","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 3 or Higher Treatment-related Cardiovascular or Pulmonary-related Adverse Events During Induction","type":"OTHER_PRE_SPECIFIED","unitOfMeasure":"Participants"}