{"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":"FG000","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":"FG001","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":"FG002","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":"FG003","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":"FG004","title":"Volasertib 110 mg/m2 + Azacitidine (Escalation Cohort)- Part 2"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"1"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"0"}],"type":"Progressive disease / relapse"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"0"}],"type":"Other reason"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}],"type":"Protocol Violation"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"2"},{"groupId":"FG004","numSubjects":"1"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"2"},{"groupId":"FG004","numSubjects":"1"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Part 1:Starting dose of volasertib 250 mg administered on Day1 and Day15.The dose was escalated in 50 mg steps up to 300 mg.Flat dosing in Part 1. Part 2:volasertib dosing on Day1 in schedule A, on Day7 in schedule B, on Day1+ Day7 in schedule C.Body surface area (BSA) adapted dosing in Part 2. In each cycle, azacitidine was given from Day1 to 7","recruitmentDetails":"The trial had 2 parts."}