{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.4","upperLimit":"3.5","value":"2.4"},{"comment":"Upper limit of CI was not estimable due to insufficient number of participants with events.","groupId":"OG001","lowerLimit":"4.7","upperLimit":"NA","value":"5.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"42"}],"units":"Participants"}],"description":"TTP was defined as the number of days from the date of first infusion (Day 1) to the date of first record of disease progression. Disease progression (IMWG criteria): increase of 25 percent (%) from lowest response level in Serum M-component and/or (the absolute increase must be \\>=0.5 g/dL); urine M-component and/or (the absolute increase must be \\>=200 mg/24 hour; only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels (absolute increase must be \\>10 mg/dL); Development of hypercalcemia (corrected serum calcium \\>11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder. Median TTP was estimated by using the Kaplan-Meier method.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants were administered with 8 mg/kg daratumumab weekly once for 8 weeks, then every 2 week (q2w) for 16 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions.","id":"OG000","title":"Daratumumab 8 mg/kg"},{"description":"Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.","id":"OG001","title":"Daratumumab 16 mg/kg"}],"paramType":"MEDIAN","populationDescription":"All-Treated Analysis Set included all enrolled participants who received at least 1 dose of study drug.","reportingStatus":"POSTED","timeFrame":"Up to Week 27","title":"Part 2: Time to Progression (TTP)","type":"SECONDARY","unitOfMeasure":"months"}