{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"33.3"},{"groupId":"OG001","value":"20.0"},{"groupId":"OG002","value":"0.0"},{"groupId":"OG003","value":"0.0"},{"groupId":"OG004","value":"0.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"1"}],"units":"Participants"}],"description":"OR was defined as best overall response of complete remission (CR) or partial remission (PR) defined according to the International Working Group (IWG) 2006 criteria.\n\nComplete remission (CR):\n\n* Bone marrow: \\<5 % myeloblasts with normal maturation of all cell lines\\*\n* Persistent dysplasia will be noted\\*\n* Peripheral blood:\n* hemoglobin (Hgb) \\> 11 Grams Per Decilitre (g/dL)\n* Platelets \\>100 x 109/L\n* Neutrophils \\> 1.0 x 109/L\n* Blasts 0 % \\*Dysplastic changes should consider the normal range of dysplastic changes\n\nPartial remission (PR):\n\nAll CR criteria if abnormal before treatment except:\n\n* Bone marrow blasts decreased by \\>50% to pre-treatment but still \\>5%\n* Cellularity and morphology not relevant","groups":[{"description":"Patients were intravenously administered escalating dose of volasertib 250 milligram (mg) (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 milligram / square meter (mg/m2) once daily on Days 1 to 7 (28- day cycle)","id":"OG000","title":"Volasertib 250 mg + Azacitidine (Escalation Cohort)-Part 1"},{"description":"Patients were intravenously administered escalating dose of volasertib 300 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)","id":"OG001","title":"Volasertib 300 mg + Azacitidine (Escalation Cohort)- Part 1"},{"description":"Patients were intravenously administered volasertib 250 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle) in the expansion cohort","id":"OG002","title":"Volasertib 250 mg + Azacitidine (Expansion Cohort)- Part 1"},{"description":"Patients were intravenously administered escalating dose of volasertib 170 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)","id":"OG003","title":"Volasertib 170 mg/m2 + Azacitidine (Escalation Cohort)- Part 2"},{"description":"Patients were intravenously administered escalating dose of volasertib 110 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day1 and Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)","id":"OG004","title":"Volasertib 110 mg/m2 + Azacitidine (Escalation Cohort)- Part 2"}],"paramType":"NUMBER","populationDescription":"Efficacy set (ES): All the treated patients without any protocol violations related to efficacy","reportingStatus":"POSTED","timeFrame":"From randomisation until data cut-off (16Dec2016); up to 159 weeks","title":"Percentage of Patients With Objective Response (OR)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}