{"analyses":[{"ciLowerLimit":"1.9","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"17.1","estimateComment":"The Kaplan Meier method was used to estimate median PFS (in months). The Greenwood method was used to estimate confidence limits of median PFS.","groupIds":["OG000"],"nonInferiorityComment":"Estimation only","nonInferiorityType":"OTHER","paramType":"Median","paramValue":"10.9"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.9","upperLimit":"17.1","value":"10.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"15"}],"units":"Participants"}],"description":"PFS is defined as the duration of time from treatment start date to first occurrence of either progressive disease (PD) or death. PD must be objectively determined per IMWG 2016 criteria, where progression date is date of last assessment that identified PD. If subject died without documented PD, progression date will be death date. For surviving subjects who do not have PD, PFS will be censored at the date of last disease assessment. For subjects who received subsequent anti-cancer therapy prior to documented PD, PFS will be censored at the date of last disease assessment prior to commencement of subsequent therapy. Subjects who have an initial PFS event immediately following 2 or more consecutive missed assessments will be censored at date of last assessment prior to missed assessments.","dispersionType":"95% Confidence Interval","groups":[{"description":"Induction (4 28-day cycles):\n\nCarfilzomib (IV) @ 20 mg/m\\^2, Day 1 of Cycle 1; @ 56 mg/m\\^2, Day 8,15 of Cycle 1; @ 56 mg/m\\^2, Day 1,8,15 of Cycles 2-4\n\nLenalidomide (Oral) @ 25 mg, once daily at bedtime on Days 1-21 of each cycle (Cycles 1-4)\n\nDexamethasone @ 28 mg orally OR 8 mg IV, once weekly on Day 1,8,15,22 of Cycles 1-2; @28 mg orally OR 8 mg IV on Day 1 of Cycles 3-4\n\nElotuzumab (IV) @ 10 mg/kg, once weekly on Day 1,8,15,22 of Cycles 1-2; @ 20 mg/kg on Day 1 of Cycles 3-4\n\nMaintenance (28-day cycles):\n\nElotuzumab (IV) @ 20 mg/kg, Day 1 of each cycle (Cycles 1-n)\n\nLenalidomide (Oral) @ 15 mg (or last tolerated dose if \\<15 mg), once daily at bedtime on Days 1-21 of each cycle (Cycles 1-n)","id":"OG000","title":"KRd-Elotuzumab"}],"paramType":"MEDIAN","populationDescription":"The evaluable population consisted of all subjects who initiated Elo-KRd","reportingStatus":"POSTED","timeFrame":"From treatment start date to date of progression/death, or censored as described; assessed for approximately 3 years.","title":"Progression Free Survival (PFS)","type":"SECONDARY","unitOfMeasure":"months"}