{"classes":[{"categories":[{"measurements":[{"comment":"Median and upper limit of confidence interval (CI) was not estimable due to insufficient number of participants with events.","groupId":"OG000","lowerLimit":"1.2","upperLimit":"NA","value":"NA"},{"comment":"Median and CI was not estimable due to insufficient number of participants with events.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Among the 3 participants on 16 mg/kg, only one participant had event, the median was set to this single uncensored value of \"time to event\" (defaults in PROC LIFETEST), no lower or upper bound of 95% CI calculated.","groupId":"OG002","lowerLimit":"NA","upperLimit":"NA","value":"8.4"},{"groupId":"OG003","lowerLimit":"0.5","upperLimit":"1.9","value":"1.9"}]}],"title":"Time to first response"},{"categories":[{"measurements":[{"comment":"Median and upper limit of CI was not estimable due to insufficient number of participants with events.","groupId":"OG000","lowerLimit":"1.2","upperLimit":"NA","value":"NA"},{"comment":"Median and CI was not estimable due to insufficient number of participants with events.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Among the 3 participants on 16 mg/kg, only one participant had event, the median was set to this single uncensored value of \"time to event\" (defaults in PROC LIFETEST), no lower or upper bound of 95% CI calculated.","groupId":"OG002","lowerLimit":"NA","upperLimit":"NA","value":"8.4"},{"groupId":"OG003","lowerLimit":"0.5","upperLimit":"1.9","value":"1.9"}]}],"title":"Time to best response"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"}],"units":"Participants"}],"description":"Time to first response was defined as the time from the date of first dose of daratumumab to the date of initial documentation of a response (PR or better). Time to best response was defined as the time between the date of first dose of daratumumab and the date of the initial evaluation of the best response (PR or better) to treatment. Kaplan-Meier method was used to estimate the distribution of time to response and time to best response.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants were administered with 7 full IV infusion of 4 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.","id":"OG000","title":"Part 1: Daratumumab 4 mg/kg"},{"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 participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions.","id":"OG001","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 participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.","id":"OG002","title":"Daratumumab 16 mg/kg"},{"description":"Participants were administered with 7 full IV infusion of 24 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.","id":"OG003","title":"Part 1:Daratumumab 24 mg/kg"}],"paramType":"MEDIAN","populationDescription":"All-Treated Analysis Set included all enrolled participants who received at least 1 dose of study drug. For Part 1, only participants treated with \\>= 4 mg/kg daratumumab were used for efficacy analyses and less than (\\<) 4 mg/kg doses were considered under the therapeutic levels.","reportingStatus":"POSTED","timeFrame":"Up to Week 28","title":"Part 1: Time to Response","type":"SECONDARY","unitOfMeasure":"months"}