{"denoms":[{"counts":[{"groupId":"BG000","value":"107"},{"groupId":"BG001","value":"109"},{"groupId":"BG002","value":"216"}],"units":"Participants"}],"groups":[{"description":"Participants received 300 mg oral azacitidine tablets daily (QD) on days 1 to 21 of each 28-day treatment cycle and best supportive care (BSC) which included and was not limited to packed RBC (packed red blood cell \\[pRBC\\] and whole blood), platelet transfusions (single donor or pooled donor), antibiotic, antiviral and/or antifungal therapy, nutritional support, and granulocyte colony stimulating factors (G-CSF) for participants who experienced neutropenic fever/infections.","id":"BG000","title":"Oral Azacitidine Plus Best Supportive Care"},{"description":"Participants received identically matching placebo tablets QD on days 1 to 21 of each 28-day treatment cycle and BSC which included but was not limited to, pRBC and whole blood, platelet transfusions (single donor or pooled donor), antibiotic, antiviral and/or antifungal therapy, nutritional support, and G-CSF for participants who experienced neutropenic fever/infections.","id":"BG001","title":"Placebo Plus Best Supportive Care"},{"description":"Total of all reporting groups","id":"BG002","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"9.23","value":"73.0"},{"groupId":"BG001","spread":"8.36","value":"73.1"},{"groupId":"BG002","spread":"8.78","value":"73.0"}]}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Age, Continuous","unitOfMeasure":"Years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"28"},{"groupId":"BG001","value":"30"},{"groupId":"BG002","value":"58"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"79"},{"groupId":"BG001","value":"79"},{"groupId":"BG002","value":"158"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"96"},{"groupId":"BG001","value":"99"},{"groupId":"BG002","value":"195"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"5"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Native Hawaiian or Other Pacific Islanders"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Japanese"},{"measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"15"}],"title":"Other"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race/Ethnicity, Customized","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"13"}],"title":"Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"91"},{"groupId":"BG001","value":"93"},{"groupId":"BG002","value":"184"}],"title":"Not Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"12"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"19"}],"title":"Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race/Ethnicity, Customized","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"7"}],"title":"RA = Refractory Anemia"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"RN = Refractory Neutropenia"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}],"title":"RT = Refractory Thrombocytopenia"},{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"5"}],"title":"RARS = RA with Ringed Sideroblasts"},{"measurements":[{"groupId":"BG000","value":"80"},{"groupId":"BG001","value":"73"},{"groupId":"BG002","value":"153"}],"title":"RCMD = R Cytopenia w/ Multilineage Dysplasia"},{"measurements":[{"groupId":"BG000","value":"17"},{"groupId":"BG001","value":"29"},{"groupId":"BG002","value":"46"}],"title":"RAEB-1 RA with Excess Blasts - 1"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"RAEB-2 RA with Excess Blasts - 2"},{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"4"}],"title":"MDS-U (MDS-unclassified)"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"del (5q) MDS Associated with Isolated del 5q"}]}],"description":"The WHO classification recognizes eight subtypes of MDS that are distinguished by the percentage of myeloblasts, presence or absence of ringed sideroblasts (i.e., erythroid precursors with iron deposits surrounding the nucleus), presence of a monocytosis or a deletion 5q.","paramType":"COUNT_OF_PARTICIPANTS","title":"Myelodysplastic Syndrome (MDS) World Health Organization (WHO) 2008 Classification","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Low"},{"measurements":[{"groupId":"BG000","value":"106"},{"groupId":"BG001","value":"109"},{"groupId":"BG002","value":"215"}],"title":"Intermediate 1 (0.5-1.0)"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}],"title":"Intermediate 2 (1.5-2.0)"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"High"}]}],"description":"The international prognostic scoring system (IPSS) is a standard for risk assessment in primary myelodysplastic syndromes (MDS) that categorizes prognoses taking into account cytogenetics, cytopenias, blasts and blood counts. The IPSS prognostic subgroups consist of low-, intermediate-1-, intermediate-2-, and high-risk groups. The scale is 0-3.5 at 0.5 increments. Scores of 0=Low; 0.5-1.0=Int-1; 1.5-2.0=Int-2; 2.5-3.5=High risk which corresponds to poorer prognosis.","paramType":"COUNT_OF_PARTICIPANTS","title":"International Prognostic Scoring System (IPSS)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"1.3","upperLimit":"10.0","value":"3.33"},{"groupId":"BG001","lowerLimit":"1.3","upperLimit":"9.5","value":"3.33"},{"groupId":"BG002","lowerLimit":"1.3","upperLimit":"10.0","value":"3.33"}]}]}],"description":"The average red blood cell (RBC) transfusion units per 28 days is derived using transfusion records before randomization date to randomization date - 84 days (if enrolled under original protocol or protocol amendment 1), or to randomization date - 56 days (if enrolled under protocol 2).","dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Average Red Blood Cell Transfusion Requirement (units per 28 days)","unitOfMeasure":"units per 28 days"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"0.988","value":"8.22"},{"groupId":"BG001","spread":"0.960","value":"8.04"},{"groupId":"BG002","spread":"0.976","value":"8.13"}]}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Hemoglobin","unitOfMeasure":"g/dL"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"15.97","value":"27.0"},{"groupId":"BG001","spread":"18.11","value":"27.9"},{"groupId":"BG002","spread":"17.05","value":"27.5"}]}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Platelet Count","unitOfMeasure":"10^9 cells/L"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"30"},{"groupId":"BG001","value":"35"},{"groupId":"BG002","value":"65"}],"title":"Dependent"},{"measurements":[{"groupId":"BG000","value":"77"},{"groupId":"BG001","value":"74"},{"groupId":"BG002","value":"151"}],"title":"Independent"}]}],"description":"Participants with thrombocytopenia were defined by 2 platelet counts that were ≤ 75 × 10\\^9/cells/L with a platelet measurement ≥ 21 days apart. For those who were platelet transfusion-dependent at baseline and did not achieve platelet transfusion independence (TI) ≥ 56 days (8 weeks) during study treatment were considered as non-responders. For participants who were not platelet transfusion-dependent at baseline, development of platelet transfusion dependence, ie, ≥ 2 platelet transfusions in any 56-day (8 week) period during study treatment and were considered worse outcome.","paramType":"COUNT_OF_PARTICIPANTS","title":"Platelet Transfusion Status","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"91"},{"groupId":"BG001","value":"94"},{"groupId":"BG002","value":"185"}],"title":"Grade 0-1"},{"measurements":[{"groupId":"BG000","value":"16"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"31"}],"title":"Grade 2"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Grade 3"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Grade 4"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Grade 5"}]}],"description":"ECOG performance status is used to describe a patient's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability (walking, working, etc.). The scale ranges from 0 to 5: 0 = Fully active, no restrictions; 1 = Restricted activity but ambulatory, able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care but unable to carry out work activities; 3 = Capable to only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled, no self-care, confined to bed or chair; 5 = Dead.","paramType":"COUNT_OF_PARTICIPANTS","title":"Eastern Cooperative Oncology Group (ECOG) Performance Status","unitOfMeasure":"Participants"}],"populationDescription":"The intent-to-treat (ITT) population included all participants who were randomized, regardless of whether they received treatment or not."}