{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"17.05","upperLimit":"35.71","value":"24.41"},{"groupId":"OG001","lowerLimit":"13.57","upperLimit":"21.98","value":"17.58"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"88"},{"groupId":"OG001","value":"105"}],"units":"Participants"}],"title":"PFS2"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.34","upperLimit":"19.32","value":"12.42"},{"groupId":"OG001","lowerLimit":"5.52","upperLimit":"9.26","value":"6.93"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"151"},{"groupId":"OG001","value":"153"}],"units":"Participants"}],"title":"Primary Efficacy of PFS"}],"denoms":[{"counts":[{"groupId":"OG000","value":"151"},{"groupId":"OG001","value":"153"}],"units":"Participants"}],"description":"Progression Free Survival (PFS) is defined as the time, in months, from randomization to the date of the first documented disease progression (PD) or death due to any cause, whichever comes first.\n\nPFS2 is defined as the time, in months, from randomization to the date of the first documented disease progression (PD) or death due to any cause, whichever comes first, after the next line of therapy.\n\nPD is assessed by the investigator based on the analysis of serum and urine protein electrophoresis (sPEP and uPEP), serum and urine immunofixation (sIFE and uIFE), serum free light chain protein (sFLC),corrected serum calcium assessment, imaging and bone marrow assessments as per modified IMWG guidelines.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients received Daratumumab subcutaneously (fixed dose of 1800 mg) or intravenously (16 mg/kg) weekly for cycles 1-2, every 2 weeks for cycles 3-6, and every 4 weeks thereafter. Pomalidomide was administered at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone at 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles..\n\nPomalidomide: Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle.\n\nDexamethasone: Dexamethasone will be administered at a 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.","id":"OG000","title":"Daratumumab+Pomalidomide+Dexamethasone"},{"description":"Patients received Pomalidomide at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles","id":"OG001","title":"Pomalidomide + Dexamethasone"}],"paramType":"MEDIAN","populationDescription":"The intent-to-treat (ITT) analysis set includes all participants who were randomly assigned to the pomalidomide, dexamethasone (Pd) or daratumumab, pomalidomide, dexamethasone (DPd) group.","reportingStatus":"POSTED","timeFrame":"PFS is assessed monthly from randomization until PD or death, whichever occurs first (approximately up to 3 years). PFS2 is assessed monthly from randomization until PD or death, whichever occurs first (approximately up to 5 years).","title":"Comparison of Progression Free Survival Between Treatment Arms (Daratumumab /Pomalidomide /Dexamethasone vs Pomalidomide / Dexamethasone)","type":"PRIMARY","unitOfMeasure":"months"}