{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.33","value":"71.24"},{"groupId":"OG001","spread":"18.32","value":"70.70"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"266"},{"groupId":"OG001","value":"119"}],"units":"Participants"}],"title":"Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"16.39","value":"-1.52"},{"groupId":"OG001","spread":"18.04","value":"-2.43"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"103"},{"groupId":"OG001","value":"40"}],"units":"Participants"}],"title":"Change from Baseline at Month 6"}],"denoms":[{"counts":[{"groupId":"OG000","value":"266"},{"groupId":"OG001","value":"119"}],"units":"Participants"}],"description":"The EQ-5D-5L is a self-reported health status questionnaire that consists of six questions used to calculate a health utility score for use in health economic analysis. The second component, EQ VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine).","dispersionType":"Standard Deviation","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":"MEAN","populationDescription":"The Efficacy Analysis Set included all participants randomly assigned to the study treatment. Overall number of participants analyzed are the number of participants with data available for analysis. 'Number Analyzed' indicates the number of participants with data available for analysis at the given timepoint. As pre-specified in the statistical analysis plan (SAP), the analysis included only the data collected for each participant during the first 6 months of study participation.","reportingStatus":"POSTED","timeFrame":"Baseline to Month 6","title":"Change From Baseline in Health-related QOL: EuroQOL Visual Analogue Scale (EQ-VAS) Score","type":"SECONDARY","unitOfMeasure":"score on a scale"}