{"classes":[{"categories":[{"measurements":[{"comment":"There were insufficient number of events so an upper limit could not be calculated","groupId":"OG000","lowerLimit":"2.66","upperLimit":"NA","value":"10.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"4"}],"units":"Participants"}],"description":"PFS is defined as the date of first dose of study treatment to the date of first documented evidence of progressive disease or death, whichever occurs first. PFS will be summarized using the Kaplan-Meier estimator. Median even-free survival will be reported and the corresponding 95% confidence interval will be calculated using Brookmeyer and Crowley method.","dispersionType":"95% Confidence Interval","groups":[{"description":"PRE-INDUCTION (CYCLE 0): Patients receive azacitidine IV on days -7 to -3 in absence of disease progression or unacceptable toxicity.\n\nINDUCTION (CYCLES 1-2): Patients receive azacitidine IV on days 22-26, dexamethasone IV or orally (PO), and daratumumab subcutaneously (SC) over 3-5 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity\n\nCONSOLIDATION (CYCLES 3-6): Patients receive azacitidine IV on days 22-26 of cycle 3 and on days 1-5 of cycles 5-6, dexamethasone IV or PO, and daratumumab SC over 3-5 minutes on days 1 and 15. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity\n\nMAINTENANCE (CYCLES 7+): Patients receive azacitidine IV on days 1-5, dexamethasone IV or PO, and daratumumab SC over 3-5 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity","id":"OG000","title":"Treatment (Azacitidine, Dexamethasone, Daratumumab)"}],"paramType":"MEDIAN","populationDescription":"One participant has insufficient imaging data required for efficacy evaluation and was excluded from this analysis","reportingStatus":"POSTED","timeFrame":"Up to 18 months","title":"Progression-free Survival (PFS)","type":"SECONDARY","unitOfMeasure":"months"}