{"analyses":[{"groupIds":["OG000"],"nonInferiorityComment":"The PFS function was estimated using the Kaplan-Meier product-limit method, a non-parametric statistic.","nonInferiorityType":"OTHER","otherAnalysisDescription":"The PFS function was estimated using the Kaplan-Meier product-limit method. Median and one-sided confidence intervals (CIs) for PFS were computed and Kaplan-Meier plots of PFS were developed."}],"classes":[{"categories":[{"measurements":[{"comment":"The upper limit was not reached (NR).","groupId":"OG000","lowerLimit":"15.1","upperLimit":"NA","value":"28.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"18"}],"units":"Participants"}],"description":"Duration of response was restricted to the subjects that achieve a best objective response of PR or better. It was measured from the time, in months, that the criteria for objective response are first met until the date of a progression event (according to the primary definition of PFS).","dispersionType":"95% Confidence Interval","groups":[{"description":"Daratumumab:\n\nDaratumumab was given at a dose of 16 mg/kg administered as an intravenous (IV) infusion at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Dexamethasone was administered according to the standard recommended dose of 40 mg (20 mg for patients \\> 75 years of age) orally once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle. Subjects received pre-infusion medications before infusions to mitigate potential infused-related reactions (IRRs).\n\nDexamethasone:\n\nDexamethasone was administered at 40 mg (20 mg for patients \\> 75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.","id":"OG000","title":"Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD)"}],"paramType":"MEDIAN","reportingStatus":"POSTED","timeFrame":"Assessed monthly from first dose of Daratumumab until PD or death from any cause (approximately up to 30 months)","title":"Duration of Response in Patients With RI","type":"SECONDARY","unitOfMeasure":"Months"}