{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"7"}]}],"title":"Hematologic Improvement"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}],"title":"Complete Remission"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Partial Remission"},{"categories":[{"measurements":[{"groupId":"OG000","value":"9"}]}],"title":"Stable Disease"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"}]}],"title":"Disease Progression"}],"denoms":[{"counts":[{"groupId":"OG000","value":"25"}],"units":"Participants"}],"description":"Complete Response (CR) include less than 5% marrow blasts without evidence of dysplasia and normalization of peripheral blood counts, including a hemoglobin level of 110 g/L or more, a neutrophil count of 1.5 × 109/L or more, and a platelet count of 100 × 109/L or more. For PR, patients must demonstrate all CR criteria if abnormal before treatment except that marrow blasts should decrease by 50% or more compared with pretreatment levels, or patients may demonstrate a less-advanced MDS disease category than prior to treatment. Stable disease (SD) is defined by failure to achieve at least a partial response but no evidence of progression. Disease progression (DP) includes at least 50% decrease from maximum remission in granulocytes or platelets, reduction in hemoglobin by greater than or equal to 2g/dL, or transfusion dependence. Hematologic improvement (HI) includes hemoglobin increase by at least 1.5g/dL, reduction in transfusions, increase of platelets, increase of neutrophil count","groups":[{"description":"INDUCTION PHASE: Patients receive decitabine subcutaneously (SQ) twice weekly for 4 weeks or thrice weekly until achieving bone marrow blasts \\< 5%. MAINTENANCE PHASE: Patients then receive decitabine SQ twice weekly for up to 52 weeks in the absence of disease progression or unacceptable toxicity.","id":"OG000","title":"Arm I: Decitabine 0.2mg/kg"}],"paramType":"NUMBER","populationDescription":"All patients enrolled and that received any treatment.","reportingStatus":"POSTED","timeFrame":"Formal assessment at week 12 for study primary end-point (hematologic improvement).","title":"Number of Patients With Response as Defined by IWG (International Working Group) Criteria for Myelodysplasia","type":"PRIMARY","unitOfMeasure":"participants"}