{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.0","upperLimit":"2.8","value":"1.4"},{"groupId":"OG001","lowerLimit":"0.0","upperLimit":"2.1","value":"0.7"}]}],"title":"Complete Response (CR)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0","upperLimit":"0","value":"0"},{"groupId":"OG001","lowerLimit":"0","upperLimit":"0","value":"0"}]}],"title":"Partial Response (PR)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"12.9","upperLimit":"21.8","value":"17.3"},{"groupId":"OG001","lowerLimit":"3.9","upperLimit":"13.2","value":"8.6"}]}],"title":"Marrow Complete Response (mCR)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.2","upperLimit":"5.3","value":"3.2"},{"groupId":"OG001","lowerLimit":"1.9","upperLimit":"9.6","value":"5.7"}]}],"title":"Hematological Improvement (HI)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.0","upperLimit":"2.2","value":"1.1"},{"groupId":"OG001","lowerLimit":"0.0","upperLimit":"4.5","value":"2.1"}]}],"title":"HI with Erythroid (HI-E)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.2","upperLimit":"3.3","value":"1.8"},{"groupId":"OG001","lowerLimit":"0.0","upperLimit":"4.5","value":"2.1"}]}],"title":"HI with Platelet (HI-P)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.0","upperLimit":"1.7","value":"0.7"},{"groupId":"OG001","lowerLimit":"0.0","upperLimit":"4.5","value":"2.1"}]}],"title":"HI with Neutrophil (HI-N)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"277"},{"groupId":"OG001","value":"140"}],"units":"Participants"}],"description":"DR: Complete Response(CR), Partial Response(PR),Marrow Complete Response(mCR), and Hematological Improvement(HI) including HI with Erythroid (HI-E), HI with Neutrophil (HI-N), or HI with Platelet (HI-P) based on IWG 2006 criteria. CR: BM:≤5% myeloblasts, Peripheral blood: Hgb≥11g/dL, Platelets(PLTs)≥100x10\\^9/L, Neutrophils≥1.0x10\\^9/L, Blasts 0%. PR: All CR criteria if abnormal before treatment except BM blasts decreased ≥50% over pretreatment but still\\>5%, Cellularity, morphology not relevant. HI responses:1) HI-E: Hgb increase ≥1.5g/dL, Relevant reduction of RBC units transfusions by absolute ≥4 RBC transfusions/8 week(wk) compared with pretreatment transfusion number previous 8wk. Only RBC transfusions given for Hgb≤9.0g/dL. 2) HI-P: Absolute increase≥30x10\\^9/L starting\\>20x10\\^9/L PLTs; Increase from\\<20x10\\^9/L to\\>20x10\\^9/L and by≥100%. 3) HI-N: ≥100% increase, absolute increase\\>0.5x10\\^9/L.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received Guadecitabine 60 mg/m\\^2, SC, on Days 1-5 of each 28-day cycle for at least 6 cycles in the absence of unacceptable toxicity or disease progression requiring alternative therapy. Participants received Guadecitabine treatment beyond 6 cycles as long as the participant continued to benefit based on investigator judgment and participant response and tolerability (or up to a maximum of 36 cycles).","id":"OG000","title":"Guadecitabine"},{"description":"Participants received one of the three treatment choice options:\n\n1. LDAC 20 mg/m\\^2 SC/IV once daily for 14 days of each 28-day cycles for at least 4 cycles in absence of disease progression or unacceptable toxicity.Participants who were responding or had stable disease were to continue treatment as per standard institutional practice.\n2. Standard IC of a 7+3 regimen:Cytarabine 100-200 mg/m\\^2/day given as continuous infusion for 7 days and anthracycline(daunorubicin(45-60 mg)/idarubicin(9-12 mg)/mitoxantrone(8-12 mg)/m\\^2) by IV infusion for 3 days of each 28-day cycles.\n3. BSC as needed during the treatment included,but was not limited to,blood transfusions(RBCs or platelets),growth factors including erythropoiesis stimulating agents,granulocyte stimulating factors,iron chelating therapy,and broad-spectrum antibiotics and/or antifungals.\n\nDuration for treatment choice was as per locally approved prescribing information and institutional standard practice or up to a maximum 30 cycles.","id":"OG001","title":"Treatment Choice"}],"paramType":"NUMBER","populationDescription":"The Efficacy Analysis Set included all participants randomly assigned to the study treatment. Participants who had multiple responses of HI (HI-E, HI-N and HI-P) were counted only once while calculating the total HI value in both treatment groups. Percentage of participants are rounded off to the nearest single decimal point.","reportingStatus":"POSTED","timeFrame":"Up to approximately 46.6 months","title":"Disease Response (DR) Rate","type":"SECONDARY","unitOfMeasure":"percentage of participants"}