{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.75"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"4"}],"units":"Participants"}],"description":"ORR is defined as the proportion of participants with either a stringent complete response (sCR) + complete response (CR) + very good partial response + partial response (PR) as best response using International Myeloma Working Group (IMWG) Uniform Response Criteria for all subjects who have measurable disease and received at least 2 cycles of study treatment, and have at least 2 efficacy evaluation assessments.","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":"NUMBER","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":"Overall Response Rate (ORR)","type":"PRIMARY","unitOfMeasure":"proportion of participants"}