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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-24 @ 11:21 PM

Ignite Modification Date: 2026-01-01 @ 10:53 PM

Study NCT ID: NCT00804856

Status: COMPLETED

Last Update Posted: 2023-10-03

First Post: 2008-09-18

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: Phase I/IIa Trial to Investigate BI 6727 (Volasertib) as Monotherapy or in Combination With Cytarabine in Acute Myeloid Leukaemia

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C541363', 'term': 'BI 6727'}, {'id': 'D003561', 'term': 'Cytarabine'}], 'ancestors': [{'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1800-243-0127', 'title': 'Boehringer Ingelheim, Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 3325 days.', 'description': 'Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or Low-dose cytarabine (LDAC), including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.', 'eventGroups': [{'id': 'EG000', 'title': 'Phase II Schedule C. LDAC', 'description': 'Low-dose cytarabine (LDAC) monotherapy 2x20 milligram (mg) per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 45, 'otherNumAffected': 43, 'seriousNumAtRisk': 45, 'deathsNumAffected': 45, 'seriousNumAffected': 29}, {'id': 'EG001', 'title': 'Phase I Schedule A. Volasertib 150 mg+LDAC', 'description': 'Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 4, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Phase I Schedule A. Volasertib 200 mg+LDAC', 'description': 'Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 3, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Phase I Schedule A. Volasertib 250 mg+LDAC', 'description': 'Volasertib 250 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 4, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'Phase I Schedule A. Volasertib 300 mg+LDAC', 'description': 'Volasertib 300 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'deathsNumAffected': 9, 'seriousNumAffected': 7}, {'id': 'EG005', 'title': 'Phase I Schedule A. Volasertib 350 mg+LDAC', 'description': 'Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 8, 'seriousNumAffected': 6}, {'id': 'EG006', 'title': 'Phase II Schedule A. Volasertib 350 mg+LDAC', 'description': 'Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 41, 'seriousNumAtRisk': 42, 'deathsNumAffected': 38, 'seriousNumAffected': 34}, {'id': 'EG007', 'title': 'Phase I Schedule A. Volasertib 400 mg+LDAC', 'description': 'Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 3, 'seriousNumAffected': 3}, {'id': 'EG008', 'title': 'Phase I Schedule B. Volasertib 150 mg', 'description': 'Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'deathsNumAffected': 11, 'seriousNumAffected': 7}, {'id': 'EG009', 'title': 'Phase I Schedule B. Volasertib 200 mg', 'description': 'Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 2, 'seriousNumAffected': 1}, {'id': 'EG010', 'title': 'Phase I Schedule B. Volasertib 350 mg', 'description': 'Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 3, 'seriousNumAffected': 3}, {'id': 'EG011', 'title': 'Phase I Schedule B. Volasertib 400 mg', 'description': 'Phase I Schedule B. Volasertib 400 mg Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 6, 'seriousNumAffected': 3}, {'id': 'EG012', 'title': 'Phase I Schedule B. Volasertib 450 mg', 'description': 'Volasertib 450 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 23, 'seriousNumAtRisk': 23, 'deathsNumAffected': 21, 'seriousNumAffected': 16}, {'id': 'EG013', 'title': 'Phase I Schedule B. Volasertib 500 mg', 'description': 'Volasertib 500 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 5, 'seriousNumAffected': 3}, {'id': 'EG014', 'title': 'Phase I Schedule B. Volasertib 550 mg', 'description': 'Volasertib 550 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 4, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 14}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 2, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 5, 'numAffected': 5}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG012', 'numAtRisk': 23, 'numAffected': 11}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 4, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 8}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 23, 'numAffected': 4}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 23, 'numAffected': 7}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 11}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG012', 'numAtRisk': 23, 'numAffected': 12}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Splenomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 9}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 5}, {'groupId': 'EG009', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 5, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 23, 'numAffected': 12}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 4, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Aortic valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 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'MedDRA 19.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Blood chloride increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Blood creatine phosphokinase decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Blood creatinine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Blood creatinine decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 4, 'numAffected': 0}], 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2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Blood fibrinogen increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 4, 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4, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Blood iron decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Blood iron increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Blood lactate dehydrogenase decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 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'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Klebsiella sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Central nervous system leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Phase I: Maximum Tolerated Dose (MTD) of Volasertib in Combination With LDAC (Schedule A) and Volasertib Monotherapy (Schedule B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I Schedule A. Volasertib+LDAC', 'description': 'Patients were treated in the dose-escalation phase with Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and LDAC 2x20 milligram (mg) per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle until the patient met criteria for stopping study medication during the MTD evaluation period.'}, {'id': 'OG001', 'title': 'Phase I Schedule B. Volasertib', 'description': 'Patients were treated in the dose-escalation phase with Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) until the patient met criteria for stopping study medication during the MTD evaluation period'}], 'classes': [{'categories': [{'measurements': [{'value': '350', 'groupId': 'OG000'}, {'value': '450', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First Treatment cycle, up to 28 days.', 'description': 'To determine the Maximum tolerated dose (MTD), dose escalation was conducted following the 3+3 design with de-escalation. The MTD was defined as the highest dose at which 6 patients had been treated and less than 2 patients experienced a Dose limiting toxicity (DLT) within the first cycle of treatment. The MTD was defined based on safety data from the first cycle only.\n\nDLT is defined as drug related Common terminology criteria for adverse events (CTCAE) grade ≥ 3 nonhaematological toxicity (excluding: untreated nausea, untreated vomiting, CTCAE grade 3 untreated diarrhoea, CTCAE grade 3 "febrile neutropenia" and CTCAE grade 3 "infection with grade 3 or 4 neutrophils").\n\nIn patients with complete remission with incomplete blood count recovery (CRi) or partial remission (PR), persistent CTCAE grade 4 neutropenia or thrombocytopenia until three weeks after the end of the treatment cycle will be regarded a DLT.', 'unitOfMeasure': 'milligram (mg)', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib (BI 6727) or LDAC (Low-Dose Cytarabine), including patients who were replaced for any reason.'}, {'type': 'PRIMARY', 'title': 'Phase II: Number of Patients With Objective Response (Complete Remission (CR) + Complete Remission With Incomplete Blood Count Recovery (CRi))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II Schedule C. LDAC', 'description': 'Low-dose cytarabine (LDAC) monotherapy 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.'}, {'id': 'OG001', 'title': 'Phase II Schedule A. Volasertib 350 mg+LDAC', 'description': 'Volasertib 350 milligram (mg) on Days 1 and 15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0523', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.91', 'ciLowerLimit': '0.99', 'ciUpperLimit': '8.58', 'estimateComment': 'Ratio calculated as Phase II Schedule A Volasertib 350mg+LDAC divided by Phase II Schedule C LDAC.', 'groupDescription': 'Analysis for Objective Response', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'The best overall response recorded during the time period from the start of the treatment until end of the treatment period, progression or death (whichever was earlier), up to 869 days.', 'description': 'Phase II: Number of patients with Objective Response (Complete remission (CR) + Complete remission with incomplete blood count recovery (CRi)).\n\nComplete remission (CR): morphologically leukaemia-free state (i.e. bone marrow with \\<5% blasts by morphologic criteria and no Auer rods, no evidence of extramedullary leukaemia) and absolute neutrophil count ≥1,000/microliter (μL) and platelets \\>100,000/μL.\n\nComplete remission with incomplete blood count recovery ("incomplete" CR, CRi): all of the above criteria for CR were met except that neutrophils \\<1,000/μL or platelets \\<100,000/μL in the blood were not achieved.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set-phase II part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.'}, {'type': 'PRIMARY', 'title': 'Phase I: Number of Participants With Dose Limiting Toxicities (DLTs) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '32', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '23', 'groupId': 'OG011'}, {'value': '5', 'groupId': 'OG012'}, {'value': '4', 'groupId': 'OG013'}, {'value': '56', 'groupId': 'OG014'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I Schedule A. Volasertib 150 mg+LDAC', 'description': 'Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG001', 'title': 'Phase I Schedule A. Volasertib 200 mg+LDAC', 'description': 'Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG002', 'title': 'Phase I Schedule A. Volasertib 250 mg+LDAC', 'description': 'Volasertib 250 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG003', 'title': 'Phase I Schedule A. Volasertib 300 mg+LDAC', 'description': 'Volasertib 300 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG004', 'title': 'Phase I Schedule A. Volasertib 350 mg+LDAC', 'description': 'Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG005', 'title': 'Phase I Schedule A. Volasertib 400 mg+LDAC', 'description': 'Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG006', 'title': 'Total Phase I Combined. Schedule A.', 'description': 'Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps up to 400 mg, with a starting dose of 400 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes and LDAC 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG007', 'title': 'Phase I Schedule B. Volasertib 150 mg', 'description': 'Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG008', 'title': 'Phase I Schedule B. Volasertib 200 mg', 'description': 'Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG009', 'title': 'Phase I Schedule B. Volasertib 350 mg', 'description': 'Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG010', 'title': 'Phase I Schedule B. Volasertib 400 mg', 'description': 'Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG011', 'title': 'Phase I Schedule B. Volasertib 450 mg', 'description': 'Volasertib 450 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG012', 'title': 'Phase I Schedule B. Volasertib 500 mg', 'description': 'Volasertib 500 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG013', 'title': 'Phase I Schedule B. Volasertib 550 mg', 'description': 'Volasertib 550 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG014', 'title': 'Total Phase I Combined. Schedule B.', 'description': 'Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps from an initial starting dose of 150 mg. Dose was escalated up to 550 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}, {'value': '2', 'groupId': 'OG013'}, {'value': '7', 'groupId': 'OG014'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'First Treatment cycle, up to 28 days.', 'description': 'A DLT was defined as a drug related CTCAE (Common Toxicity Criteria for Adverse Events) Grade ≥3 non-haematological toxicity (excluding untreated nausea, untreated vomiting, Grade 3 untreated diarrhea, Grade 3 febrile neutropenia, and Grade 3 infection with Grade 3 or 4 neutrophils). In patients with CRi (Complete Remission with Incomplete Blood Count Recovery) or PR (Partial Remission), persistent Grade 4 neutropenia or thrombocytopenia for 3 weeks after the end of the treatment cycle was regarded as a DLT unless the respective Grade 4 cytopenia was preexistent. In patients who required platelet substitution to maintain a Grade \\<4 before treatment, a Grade 4 thrombocytopenia after treatment did not constitute a DLT.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set-Phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib (BI 6727) or LDAC (Low-Dose Cytarabine), including patients who were replaced for any reason.'}, {'type': 'SECONDARY', 'title': 'Best Overall Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '32', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '23', 'groupId': 'OG011'}, {'value': '5', 'groupId': 'OG012'}, {'value': '4', 'groupId': 'OG013'}, {'value': '56', 'groupId': 'OG014'}, {'value': '45', 'groupId': 'OG015'}, {'value': '42', 'groupId': 'OG016'}, {'value': '87', 'groupId': 'OG017'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I Schedule A. Volasertib 150 mg+LDAC', 'description': 'Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG001', 'title': 'Phase I Schedule A. Volasertib 200 mg+LDAC', 'description': 'Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG002', 'title': 'Phase I Schedule A. Volasertib 250 mg+LDAC', 'description': 'Volasertib 250 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG003', 'title': 'Phase I Schedule A. Volasertib 300 mg+LDAC', 'description': 'Volasertib 300 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG004', 'title': 'Phase I Schedule A. Volasertib 350 mg+LDAC', 'description': 'Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG005', 'title': 'Phase I Schedule A. Volasertib 400 mg+LDAC', 'description': 'Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG006', 'title': 'Total Phase I Combined. Schedule A.', 'description': 'Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps up to 400 mg, with a starting dose of 400 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes and LDAC 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG007', 'title': 'Phase I Schedule B. Volasertib 150 mg', 'description': 'Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG008', 'title': 'Phase I Schedule B. Volasertib 200 mg', 'description': 'Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG009', 'title': 'Phase I Schedule B. Volasertib 350 mg', 'description': 'Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG010', 'title': 'Phase I Schedule B. Volasertib 400 mg', 'description': 'Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG011', 'title': 'Phase I Schedule B. Volasertib 450 mg', 'description': 'Volasertib 450 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG012', 'title': 'Phase I Schedule B. Volasertib 500 mg', 'description': 'Volasertib 500 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG013', 'title': 'Phase I Schedule B. Volasertib 550 mg', 'description': 'Volasertib 550 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG014', 'title': 'Total Phase I Combined. Schedule B.', 'description': 'Volasertib escalating dose on Days 1 and15 (28-day cycle). Dose escalation in 50 milligram (mg) steps from an initial starting dose of 150 mg; dose escalation stopped at 200 mg and then restarted from the MTD dose in Schedule A (350 mg); dose was escalated up to 550 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes.'}, {'id': 'OG015', 'title': 'Phase II Schedule C. LDAC', 'description': 'Low-dose cytarabine (LDAC) monotherapy 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.'}, {'id': 'OG016', 'title': 'Phase II Schedule A. Volasertib 350 mg+LDAC', 'description': 'Volasertib 350 milligram (mg) on Days 1 and 15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.'}, {'id': 'OG017', 'title': 'Total Phase II Combined. Schedule A and C.', 'description': 'Volasertib escalating dose on Days 1 and 15 (28-day cycle). Dose escalation in 50 milligram (mg) steps up to 400 mg, with a starting dose of 150 mg. Volasertib 350 mg on Days 1+15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}], 'classes': [{'title': 'Complete remission', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '3', 'groupId': 'OG015'}, {'value': '6', 'groupId': 'OG016'}, {'value': '9', 'groupId': 'OG017'}]}]}, {'title': 'CRi', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '5', 'groupId': 'OG014'}, {'value': '3', 'groupId': 'OG015'}, {'value': '7', 'groupId': 'OG016'}, {'value': '10', 'groupId': 'OG017'}]}]}, {'title': 'Partial remission', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}, {'value': '4', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}, {'value': '2', 'groupId': 'OG016'}, {'value': '4', 'groupId': 'OG017'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '7', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '18', 'groupId': 'OG014'}, {'value': '18', 'groupId': 'OG015'}, {'value': '15', 'groupId': 'OG016'}, {'value': '33', 'groupId': 'OG017'}]}]}, {'title': 'Aplasia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}, {'value': '6', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}]}]}, {'title': 'Indeterminate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '1', 'groupId': 'OG014'}, {'value': '3', 'groupId': 'OG015'}, {'value': '5', 'groupId': 'OG016'}, {'value': '8', 'groupId': 'OG017'}]}]}, {'title': 'Progressive disease', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '7', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}, {'value': '19', 'groupId': 'OG014'}, {'value': '14', 'groupId': 'OG015'}, {'value': '7', 'groupId': 'OG016'}, {'value': '21', 'groupId': 'OG017'}]}]}, {'title': 'Not evaluable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}, {'value': '3', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '2', 'groupId': 'OG017'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'The best overall response recorded during the time period from the start of the treatment until end of the treatment period, progression or death (whichever was earlier), up to 869 days.', 'description': '* CR\n* CR+CRi\n* Partial remission: CR except bone marrow (BM) contained ≥5% but \\<25% blasts (or ≤50% initial blasts), or \\<5% blasts in presence of Auer rods or abnormal morphology.\n* No change: survived ≥7 days (d) after 1st cycle with persistent leukemia in last peripheral blood smear or BM, or with persistent extramedullary disease, without further deterioration due to leukemia or increase of blasts in BM or peripheral blood.\n* Aplasia: survived ≥7d after 1st cycle, died whilst cytopenic, with last post-treatment BM result aplastic or hypoplastic and without leukemia blasts.\n* Indeterminate: survived \\<7 d after 1st cycle or survived ≥7d after 1st cycle, died with no persistent leukemia in peripheral smear but no post-treatment BM examination or did not complete 1st cycle.\n* Progressive disease: survived ≥7d after 1st cycle with increase of blast population in BM or peripheral blood or aggravation or new extramedullary disease or further deterioration or death due to leukemia.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC, including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.'}, {'type': 'SECONDARY', 'title': 'Phase I: Number of Patients With Objective Response: Complete Remission or Complete Remission With Incomplete Blood Count Recovery (CR+CRi)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '32', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '23', 'groupId': 'OG011'}, {'value': '5', 'groupId': 'OG012'}, {'value': '4', 'groupId': 'OG013'}, {'value': '56', 'groupId': 'OG014'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I Schedule A. Volasertib 150 mg+LDAC', 'description': 'Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG001', 'title': 'Phase I Schedule A. Volasertib 200 mg+LDAC', 'description': 'Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG002', 'title': 'Phase I Schedule A. Volasertib 250 mg+LDAC', 'description': 'Volasertib 250 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG003', 'title': 'Phase I Schedule A. Volasertib 300 mg+LDAC', 'description': 'Volasertib 300 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG004', 'title': 'Phase I Schedule A. Volasertib 350 mg+LDAC', 'description': 'Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG005', 'title': 'Phase I Schedule A. Volasertib 400 mg+LDAC', 'description': 'Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG006', 'title': 'Total Phase I Combined. Schedule A.', 'description': 'Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps up to 400 mg, with a starting dose of 400 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes and LDAC 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG007', 'title': 'Phase I Schedule B. Volasertib 150 mg', 'description': 'Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG008', 'title': 'Phase I Schedule B. Volasertib 200 mg', 'description': 'Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG009', 'title': 'Phase I Schedule B. Volasertib 350 mg', 'description': 'Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG010', 'title': 'Phase I Schedule B. Volasertib 400 mg', 'description': 'Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG011', 'title': 'Phase I Schedule B. Volasertib 450 mg', 'description': 'Volasertib 450 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG012', 'title': 'Phase I Schedule B. Volasertib 500 mg', 'description': 'Volasertib 500 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG013', 'title': 'Phase I Schedule B. Volasertib 550 mg', 'description': 'Volasertib 550 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG014', 'title': 'Total Phase I Combined. Schedule B.', 'description': 'Volasertib escalating dose on Days 1 and15 (28-day cycle). Dose escalation in 50 milligram (mg) steps from an initial starting dose of 150 mg; dose escalation stopped at 200 mg and then restarted from the MTD dose in Schedule A (350 mg); dose was escalated up to 550 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '5', 'groupId': 'OG014'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'The best overall response recorded during the time period from the start of the treatment until end of the treatment period, progression or death (whichever was earlier), up to 594 days.', 'description': 'Phase I: Number of patients with Objective Response (Complete remission (CR) + Complete remission with incomplete blood count recovery (CRi)).\n\nComplete remission (CR): morphologically leukaemia-free state (i.e. bone marrow with \\<5% blasts by morphologic criteria and no Auer rods, no evidence of extramedullary leukaemia) and absolute neutrophil count ≥1,000/microliter (μL) and platelets \\>100,000/μL.\n\nComplete remission with incomplete blood count recovery ("incomplete" CR, CRi): all of the above criteria for CR were met except that neutrophils \\<1,000/μL or platelets \\<100,000/μL in the blood were not achieved.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set-phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC, including patients who were replaced for any reason.'}, {'type': 'SECONDARY', 'title': 'Phase II: Event Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II Schedule C. LDAC', 'description': 'Low-dose cytarabine (LDAC) monotherapy 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.'}, {'id': 'OG001', 'title': 'Phase II Schedule A. Volasertib 350 mg+LDAC', 'description': 'Volasertib 350 milligram (mg) on Days 1 and 15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '69.0', 'groupId': 'OG000', 'lowerLimit': '27', 'upperLimit': '215'}, {'value': '169.0', 'groupId': 'OG001', 'lowerLimit': '39', 'upperLimit': '470'}]}]}], 'analyses': [{'pValue': '0.0208', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.57', 'ciLowerLimit': '0.35', 'ciUpperLimit': '0.92', 'estimateComment': 'Ratio calculated as Phase II Schedule A Volasertib 350mg+LDAC divided by Phase II Schedule C LDAC.', 'groupDescription': 'An exploratory (non-stratified) logrank test was used to compare the different treatment arms.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'The patients that entered the trial, and measured from the date of randomization to the date of disease progression (treatment failure), relapse or death from any cause, whichever occurred first, up to 1000 days..', 'description': 'Event-free survival (EFS) \\[days\\] was the shortest duration of the following: (a) Date of assessment indicating PD on the response page of the eCRF (Electronic Case Report Form) - date of randomisation + 1 day (b) Date of assessment indicating clinical progressive disease (PD) on the disease or responses pages of the of eCRF- date of randomisation + 1 day (c) Date of assessment indicating PD on the patient status page of the eCRF - date of randomisation +1 day (for patients who had not been censored before this time point) (d) Death date - date of randomisation +1 day Patients not being assessed PD, clinical PD, or death during the trial were censored.\n\nEFS was analysed with the Kaplan-Meier method for each of the treatment arms.', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set-Phase II part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.'}, {'type': 'SECONDARY', 'title': 'Phase II: Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II Schedule C. LDAC', 'description': 'Low-dose cytarabine (LDAC) monotherapy 2x20 milligram (mg) per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.'}, {'id': 'OG001', 'title': 'Phase II Schedule A. Volasertib 350 mg+LDAC', 'description': 'Volasertib 350 milligram (mg) on Days 1 and 15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '158.0', 'groupId': 'OG000', 'lowerLimit': '78', 'upperLimit': '347'}, {'value': '245.0', 'groupId': 'OG001', 'lowerLimit': '73', 'upperLimit': '689'}]}]}], 'analyses': [{'pValue': '0.0465', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.63', 'ciLowerLimit': '0.40', 'ciUpperLimit': '1.00', 'estimateComment': 'Ratio calculated as Phase II Schedule A Volasertib 350mg+LDAC divided by Phase II Schedule C LDAC.', 'groupDescription': 'An exploratory (non-stratified) logrank test was used to compare the different treatment arms.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'The patients that entered the trial, and measured from the date of randomisation until death from any cause, up to 1100 days..', 'description': 'Overall survival \\[days\\] = (date of death - date of randomisation + 1 day), for patients with known date of death. Overall survival (censored) \\[days\\] = (date of last trial visit or follow-up - date of randomisation + 1 day), for patients who were still alive at time of database lock.\n\nOverall survival (OS) was analysed with the Kaplan-Meier method for each of the treatment arms.', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set-Phase II part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.'}, {'type': 'SECONDARY', 'title': 'Phase II: Relapse - Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II Schedule C. LDAC', 'description': 'Low-dose cytarabine (LDAC) monotherapy 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.'}, {'id': 'OG001', 'title': 'Phase II Schedule A. Volasertib 350 mg+LDAC', 'description': 'Volasertib 350 milligram (mg) on Days 1 and 15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '304.0', 'groupId': 'OG000', 'lowerLimit': '113', 'upperLimit': '367'}, {'value': '563.0', 'comment': '25% quartile not reached, not enough events occurred.', 'groupId': 'OG001', 'lowerLimit': '427', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'The patients who achieved CR or CRi, and was measured from the date of attaining CR or CRi until the date of disease recurrence or death from any cause, whichever occurred first, up to 900 days.', 'description': 'Relapse-free survival \\[days\\] = (date of first recurrence of disease or death after entering the trial - date of first occurrence of CR or CRi after entering the trial+ 1 day) for patients with a recurrence (this value should be positive).\n\nRelapse-free survival (censored) \\[days\\] = (date of last trial visit or follow-up - date of first occurrence of CR or CRi after entering the trial + 1 day) for patients who did not experience recurrence of disease or death at the time of analysis.', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients in Treated Set-Phase II with objective response. Treated Set-Phase II part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.'}, {'type': 'SECONDARY', 'title': 'Phase II: Remission Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II Schedule C. LDAC', 'description': 'Low-dose cytarabine (LDAC) monotherapy 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.'}, {'id': 'OG001', 'title': 'Phase II Schedule A. Volasertib 350 mg+LDAC', 'description': 'Volasertib 350 milligram (mg) on Days 1 and 15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '367.0', 'groupId': 'OG000', 'lowerLimit': '113', 'upperLimit': '367'}, {'value': '687.0', 'comment': '25% quartile not reached, not enough events occurred.', 'groupId': 'OG001', 'lowerLimit': '427', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'The patients who achieved CR or CRi, and was measured from the date of attaining CR or CRi until the date of disease recurrence (relapse), up to 900 days.', 'description': 'Remission duration analysis was defined only for patients who achieved Complete remission (CR) or Complete remission with incomplete blood count recovery (CRi), and was measured from the date of attaining CR or CRi until the date of disease recurrence (relapse). For patients who died without report of relapse, remission duration was censored on the date of death, regardless of cause.', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients in Treated Set-Phase II with objective response. Treated Set-Phase II part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.'}, {'type': 'SECONDARY', 'title': 'Phase II: Time to Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II Schedule C. LDAC', 'description': 'Low-dose cytarabine (LDAC) monotherapy 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.'}, {'id': 'OG001', 'title': 'Phase II Schedule A. Volasertib 350 mg+LDAC', 'description': 'Volasertib 350 milligram (mg) on Days 1 and 15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '63.5', 'groupId': 'OG000', 'lowerLimit': '30', 'upperLimit': '125'}, {'value': '71.0', 'groupId': 'OG001', 'lowerLimit': '29', 'upperLimit': '158'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'The patients who achieved CR or CRi, and was measured from the date of attaining CR or CRi until the date of disease recurrence (relapse), up to 158 days.', 'description': 'Time to remission \\[days\\] = (date of first occurrence of CR or CRi after entering the trial-date of randomisation + 1 day) for patients with an objective response.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients in Treated Set-Phase II with objective response. Treated Set-Phase II part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC.'}, {'type': 'SECONDARY', 'title': 'Best Eastern Co-operative Oncology Group (ECOG) Performance Score From Baseline Until End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '27', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '22', 'groupId': 'OG011'}, {'value': '5', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '53', 'groupId': 'OG014'}, {'value': '42', 'groupId': 'OG015'}, {'value': '39', 'groupId': 'OG016'}, {'value': '81', 'groupId': 'OG017'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I Schedule A. Volasertib 150 mg+LDAC', 'description': 'Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG001', 'title': 'Phase I Schedule A. Volasertib 200 mg+LDAC', 'description': 'Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG002', 'title': 'Phase I Schedule A. Volasertib 250 mg+LDAC', 'description': 'Volasertib 250 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG003', 'title': 'Phase I Schedule A. Volasertib 300 mg+LDAC', 'description': 'Volasertib 300 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG004', 'title': 'Phase I Schedule A. Volasertib 350 mg+LDAC', 'description': 'Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG005', 'title': 'Phase I Schedule A. Volasertib 400 mg+LDAC', 'description': 'Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG006', 'title': 'Total Phase I Combined. Schedule A.', 'description': 'Volasertib escalating dose on Days 1 and 15 (28-day cycle). Dose escalation in 50 milligram (mg) steps up to 400 mg, with a starting dose of 400 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG007', 'title': 'Phase I Schedule B. Volasertib 150 mg', 'description': 'Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG008', 'title': 'Phase I Schedule B. Volasertib 200 mg', 'description': 'Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG009', 'title': 'Phase I Schedule B. Volasertib 350 mg', 'description': 'Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG010', 'title': 'Phase I Schedule B. Volasertib 400 mg', 'description': 'Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG011', 'title': 'Phase I Schedule B. Volasertib 450 mg', 'description': 'Volasertib 450 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG012', 'title': 'Phase I Schedule B. Volasertib 500 mg', 'description': 'Volasertib 500 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG013', 'title': 'Phase I Schedule B. Volasertib 550 mg', 'description': 'Volasertib 550 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG014', 'title': 'Total Phase I Comined. Schedule B.', 'description': 'Volasertib escalating dose on Days 1 and 15 (28-day cycle). Dose escalation in 50 milligram (mg) steps from an initial starting dose of 550 mg. Dose was escalated up to 550 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes.'}, {'id': 'OG015', 'title': 'Phase II Schedule C. LDAC', 'description': 'Low-dose cytarabine (LDAC) monotherapy 2x20 milligram (mg) per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.'}, {'id': 'OG016', 'title': 'Phase II Schedule A. Volasertib 350 mg+LDAC', 'description': 'Volasertib 350 milligram (mg) on Days 1 and 15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.'}, {'id': 'OG017', 'title': 'Total Phase II. Schedule A and C.', 'description': 'Volasertib escalating dose on Days 1 and 15 (28-day cycle). Dose escalation in 50 milligram (mg) steps up to 400 mg, with a starting dose of 150 mg. Volasertib 350 mg on Days 1+15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}], 'classes': [{'title': 'Unchanged', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '14', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '33', 'groupId': 'OG014'}, {'value': '22', 'groupId': 'OG015'}, {'value': '15', 'groupId': 'OG016'}, {'value': '37', 'groupId': 'OG017'}]}]}, {'title': 'Improved', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '6', 'groupId': 'OG014'}, {'value': '8', 'groupId': 'OG015'}, {'value': '13', 'groupId': 'OG016'}, {'value': '21', 'groupId': 'OG017'}]}]}, {'title': 'Deteriorated', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '5', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '14', 'groupId': 'OG014'}, {'value': '12', 'groupId': 'OG015'}, {'value': '11', 'groupId': 'OG016'}, {'value': '23', 'groupId': 'OG017'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and End of Treatment (up to 869 days).', 'description': 'ECOG performance score change from baseline to last visit of last cycle = ECOG performance score at last visit of the last cycle - ECOG performance score at baseline. ECOG performance score changes from baseline were also categorised on a 3-point categorical scale: deteriorated (-1), unchanged (0), and improved (1). The number of participants for category of ECOG score change is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set-Phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC, including patients who were replaced for any reason. Phase II part, the Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC. Only participants with non-missing values are reported.'}, {'type': 'SECONDARY', 'title': 'Total Clearance (CL) of Volasertib in Plasma After i.v (Intravenous) Administration of Volasertib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '22', 'groupId': 'OG010'}, {'value': '5', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}, {'value': '31', 'groupId': 'OG013'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I Schedule A. Volasertib 150 mg+LDAC', 'description': 'Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG001', 'title': 'Phase I Schedule A. Volasertib 200 mg+LDAC', 'description': 'Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG002', 'title': 'Phase I Schedule A. Volasertib 250 mg+LDAC', 'description': 'Volasertib 250 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG003', 'title': 'Phase I Schedule A. Volasertib 300 mg+LDAC', 'description': 'Volasertib 300 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG004', 'title': 'Phase I Schedule A. Volasertib 350 mg+LDAC', 'description': 'Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG005', 'title': 'Phase I Schedule A. Volasertib 400 mg+LDAC', 'description': 'Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG006', 'title': 'Phase I Schedule B. Volasertib 150 mg', 'description': 'Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG007', 'title': 'Phase I Schedule B. Volasertib 200 mg', 'description': 'Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG008', 'title': 'Phase I Schedule B. Volasertib 350 mg', 'description': 'Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG009', 'title': 'Phase I Schedule B. Volasertib 400 mg', 'description': 'Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG010', 'title': 'Phase I Schedule B. Volasertib 450 mg', 'description': 'Volasertib 450 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG011', 'title': 'Phase I Schedule B. Volasertib 500 mg', 'description': 'Volasertib 500 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG012', 'title': 'Phase I Schedule B. Volasertib 550 mg', 'description': 'Volasertib 550 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG013', 'title': 'Phase II Schedule A. Volasertib 350 mg+LDAC.', 'description': 'Volasertib 350 mg on Days 1+15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and LDAC 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '1280', 'spread': '52.8', 'groupId': 'OG000'}, {'value': '972', 'spread': '26.6', 'groupId': 'OG001'}, {'value': '864', 'spread': '27.6', 'groupId': 'OG002'}, {'value': '1150', 'spread': '34.4', 'groupId': 'OG003'}, {'value': '1000', 'spread': '36.2', 'groupId': 'OG004'}, {'value': '852', 'spread': '49.6', 'groupId': 'OG005'}, {'value': '1330', 'spread': '29.3', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not calculable with one subject', 'groupId': 'OG007'}, {'value': '810', 'spread': '35.1', 'groupId': 'OG008'}, {'value': '1120', 'spread': '62.1', 'groupId': 'OG009'}, {'value': '920', 'spread': '36.2', 'groupId': 'OG010'}, {'value': '1140', 'spread': '38.5', 'groupId': 'OG011'}, {'value': '939', 'spread': '93.2', 'groupId': 'OG012'}, {'value': '897', 'spread': '42.8', 'groupId': 'OG013'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1: -0:05 hour (h), 0:30h, 1:00h, 1:30h, 2h, 3h, 4h, 24h, 96h, 216h, 335:55h, 336:30h, 337h, 337:30h, 338h, 339h, 340h, 648h after first drug administration.', 'description': 'Total Clearance (CL) of Volasertib in Plasma after Intravenous (i.v.) Administration of Volasertib.', 'unitOfMeasure': 'millilitre/minute (mL/min)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) set which included all patients in the treated set who had at least 1 evaluable blood sample during cycle 1. Phase I Schedule B Volasertib 200mg+LDAC was not analysed as there was not enough plasma concentrations at the terminal phase of the curve to calculate the half-life for one of the two subjects.'}, {'type': 'SECONDARY', 'title': 'Apparent Volume of Distribution of Volasertib at Steady State (VSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '22', 'groupId': 'OG010'}, {'value': '5', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}, {'value': '31', 'groupId': 'OG013'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I Schedule A. Volasertib 150 mg+LDAC', 'description': 'Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG001', 'title': 'Phase I Schedule A. Volasertib 200 mg+LDAC', 'description': 'Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG002', 'title': 'Phase I Schedule A. Volasertib 250 mg+LDAC', 'description': 'Volasertib 250 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG003', 'title': 'Phase I Schedule A. Volasertib 300 mg+LDAC', 'description': 'Volasertib 300 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG004', 'title': 'Phase I Schedule A. Volasertib 350 mg+LDAC', 'description': 'Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG005', 'title': 'Phase I Schedule A. Volasertib 400 mg+LDAC', 'description': 'Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG006', 'title': 'Phase I Schedule B. Volasertib 150 mg', 'description': 'Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG007', 'title': 'Phase I Schedule B. Volasertib 200 mg', 'description': 'Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG008', 'title': 'Phase I Schedule B. Volasertib 350 mg', 'description': 'Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG009', 'title': 'Phase I Schedule B. Volasertib 400 mg', 'description': 'Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG010', 'title': 'Phase I Schedule B. Volasertib 450 mg', 'description': 'Volasertib 450 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG011', 'title': 'Phase I Schedule B. Volasertib 500 mg', 'description': 'Volasertib 500 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG012', 'title': 'Phase I Schedule B. Volasertib 550 mg', 'description': 'Volasertib 550 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG013', 'title': 'Phase II Schedule A. Volasertib 350 mg+LDAC.', 'description': 'Volasertib 350 mg on Days 1+15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and LDAC 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '10600', 'spread': '111.0', 'groupId': 'OG000'}, {'value': '8640', 'spread': '14.1', 'groupId': 'OG001'}, {'value': '7000', 'spread': '26.6', 'groupId': 'OG002'}, {'value': '6320', 'spread': '35.9', 'groupId': 'OG003'}, {'value': '5270', 'spread': '58.2', 'groupId': 'OG004'}, {'value': '4830', 'spread': '56.7', 'groupId': 'OG005'}, {'value': '10300', 'spread': '36.3', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not calculable with one subject', 'groupId': 'OG007'}, {'value': '5800', 'spread': '35.1', 'groupId': 'OG008'}, {'value': '7150', 'spread': '70.6', 'groupId': 'OG009'}, {'value': '5740', 'spread': '38.7', 'groupId': 'OG010'}, {'value': '6360', 'spread': '50.1', 'groupId': 'OG011'}, {'value': '5680', 'spread': '81.9', 'groupId': 'OG012'}, {'value': '6130', 'spread': '42.0', 'groupId': 'OG013'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1: -0:05 hour (h), 0:30h, 1:00h, 1:30h, 2h, 3h, 4h, 24h, 96h, 216h, 335:55h, 336:30h, 337h, 337:30h, 338h, 339h, 340h, 648h after first drug administration.', 'description': 'Apparent Volume of Distribution of volasertib at steady state (VSS) following Intravenous (i.v.) administration.', 'unitOfMeasure': 'Liter (L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) set which included all patients in the treated set who had at least 1 evaluable blood sample during cycle 1. Phase I Schedule B Volasertib 200mg+LDAC was not analysed as there was not enough plasma concentrations at the terminal phase of the curve to calculate the half-life for one of the two subjects.'}, {'type': 'SECONDARY', 'title': 'Dose Normalized Maximum Measured Concentration of Cytarabine in Plasma (Cmax, Norm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Normalized Volasertib+LDAC(Phase I,Schedule A). 150 to 400 mg Volasertib.', 'description': 'Volasertib 150 to 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle. Dose groups of Phase I were combined by dose normalizing as pre specified in the study protocol.'}, {'id': 'OG001', 'title': 'Dose Normalized Volasertib+LDAC (Schedule A). Phase II. 350 mg Volasertib.', 'description': 'Volasertib 350 milligram (mg) on Days 1 and 15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.'}, {'id': 'OG002', 'title': 'Dose Normalized LDAC (Schedule C). Phase II. LDAC Monotherapy.', 'description': 'Low-dose cytarabine (LDAC) monotherapy 2x20 milligram (mg) per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.92', 'spread': '61.3', 'groupId': 'OG000'}, {'value': '2.83', 'spread': '52.8', 'groupId': 'OG001'}, {'value': '2.36', 'spread': '77.6', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1: -0:05 hour (h), 0:30h, 1:00h, 1:30h, 2h, 3h, 4h, 24h, 96h, 216h, 335:55h, 336:30h, 337h, 337:30h, 338h, 339h, 340h, 648h after first drug administration.', 'description': 'Cmax, norm: Maximum measured concentration of Cytarabine in plasma. The dose normalisation was done by dividing by the dose applied. Unit: nanogram/milliliter/milligram: ((ng/mL)/mg). Dose groups of Phase I were combined by dose normalizing as pre specified in the study protocol.', 'unitOfMeasure': '(ng/mL)/mg', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) set which included all patients in the treated set who had at least 1 evaluable blood sample during cycle 1, Only participants with non-missing values are reported.'}, {'type': 'SECONDARY', 'title': 'Dose Normalized Area Under the Concentration-Time Curve of Cytarabine in Plasma Over the Time Interval From 0 Extrapolated up to 4 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Normalized Volasertib+LDAC(Phase I,Schedule A). 150 to 400 mg Volasertib.', 'description': 'Volasertib 150 to 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle. Dose groups of Phase I were combined by dose normalizing as pre specified in the study protocol.'}, {'id': 'OG001', 'title': 'Dose Normalized Volasertib+LDAC (Schedule A). Phase II. 350 mg Volasertib.', 'description': 'Volasertib 350 milligram (mg) on Days 1 and 15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.'}, {'id': 'OG002', 'title': 'Dose Normalized LDAC (Schedule C). Phase II. LDAC Monotherapy.', 'description': 'Low-dose cytarabine (LDAC) monotherapy 2x20 milligram (mg) per day administered by subcutaneous injection on days 1-10 of each 28 days treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.84', 'spread': '30.6', 'groupId': 'OG000'}, {'value': '4.00', 'spread': '35.6', 'groupId': 'OG001'}, {'value': '3.94', 'spread': '43.8', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1: -0:05 hour (h), 0:30h, 1:00h, 1:30h, 2h, 3h, 4h after first drug administration.', 'description': 'AUC0-4,norm: Area under the concentration-time curve of Cytarabine in plasma over the time interval from zero extrapolated to 4 hours. The dose normalisation was done by dividing by dose applied. Unit: nanogram\\*hour/milliliter/milligram: ((ng\\*h/mL)/mg).\n\nDose groups of Phase I were combined by dose normalizing as pre specified in the study protocol.', 'unitOfMeasure': '(ng*h/mL)/mg', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) set which included all patients in the treated set who had at least 1 evaluable blood sample during cycle 1.'}, {'type': 'SECONDARY', 'title': "Absolute QTcF (QT Interval Corrected for Heart Rate Using Fridericia's Formula) Intervals", 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I+II Volasertib 350 mg+LDAC', 'description': 'Phase I+II: Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG001', 'title': 'Phase I Schedule B. Volasertib 450 mg', 'description': 'Volasertib 450 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}], 'classes': [{'title': 'Individual baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '411.6', 'spread': '20.7', 'groupId': 'OG000'}, {'value': '412.4', 'spread': '18.7', 'groupId': 'OG001'}]}]}, {'title': '1 hour after start of infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '430.0', 'spread': '20.4', 'groupId': 'OG000'}, {'value': '441.1', 'spread': '20.0', 'groupId': 'OG001'}]}]}, {'title': '24 hour after start of infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '414.0', 'spread': '21.3', 'groupId': 'OG000'}, {'value': '411.9', 'spread': '18.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Days -14 to -1) and day 1 (1 hour and 24 hours) after start of infusion.', 'description': "ECG (Electro Cardio Gram) Measurements: Absolute QTcF (QT Interval (interval from the beginning of the QRS complex to the end of the T wave) Corrected for Heart Rate Using Fridericia's Formula) Intervals. The 350 mg + LDAC arm of phase I and II were combined into one arm to provide maximum information on QT changes and presented together with the Phase I schedule B 450 mg arm, as pre specified in the study protocol.", 'unitOfMeasure': 'milliseconds (ms)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set-Phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC, including patients who were replaced for any reason. Only participants with non-missing values are reported.'}, {'type': 'SECONDARY', 'title': "QTcF (QT Interval Corrected for Heart Rate Using Fridericia's Formula) Change From Baseline at Cycle 1", 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I+II, Volasertib 350 mg+LDAC', 'description': 'Phase I+II: Volasertib 350 mg administered by Intravenous Infusion (IV) over 60 minutes on Days 1+15 (28-day cycle) and LDAC 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG001', 'title': 'Phase I Schedule B. Volasertib 450 mg', 'description': 'Volasertib 450 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}], 'classes': [{'title': 'Change from baseline after 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.5', 'spread': '10.4', 'groupId': 'OG000'}, {'value': '29.6', 'spread': '8.1', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline after 24 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '10.5', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '9.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Days -14 to -1) and day 1 (1 hour and 24 hours) after start of infusion.', 'description': 'ECG Measurements: QTcF (QT Interval (interval from the beginning of the QRS complex to the end of the T wave) changes from baseline at each time point: The QTcF post baseline measurement obtained at time t minus baseline QTcF measurement. The 350 mg + LDAC arm of phase I and II were combined into one arm to provide maximum information on QT changes and presented together with the Phase I schedule B 450 mg arm, as pre specified in the study protocol.', 'unitOfMeasure': 'millisecond (ms)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set-Phase I part: Treated Set was defined as all patients who received at least a single dose of either Volasertib or LDAC, including patients who were replaced for any reason. Only participants with non-missing values are reported.'}, {'type': 'SECONDARY', 'title': 'Phase I Schedule A: Number of Participants With Adverse Events (AEs) Graded According to Common Terminology Criteria for Adverse Events (CTCAE), Based on the Number of Patients With AEs With CTCAE Grade ≥3 During Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '32', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I Schedule A. Volasertib 150 mg+LDAC', 'description': 'Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG001', 'title': 'Phase I Schedule A. Volasertib 200 mg+LDAC', 'description': 'Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG002', 'title': 'Phase I Schedule A. Volasertib 250 mg+LDAC', 'description': 'Volasertib 250 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG003', 'title': 'Phase I Schedule A. Volasertib 300 mg+LDAC', 'description': 'Volasertib 300 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG004', 'title': 'Phase I Schedule A. Volasertib 350 mg+LDAC', 'description': 'Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG005', 'title': 'Phase I Schedule A. Volasertib 400 mg+LDAC', 'description': 'Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG006', 'title': 'Total Phase I Combined. Schedule A.', 'description': 'Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps up to 400 mg, with a starting dose of 400 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes and LDAC 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}], 'classes': [{'title': 'Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}]}]}, {'title': 'Grade 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'First treatment cycle, up to 28 days.', 'description': 'Number of patients with AEs following in the categories 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related AE) of CTCAE is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set-Phase I part: Treated set was defined as all patients in Phase I who received at least a single dose of either Volasertib or LDAC, including patients who were replaced for any reason.'}, {'type': 'SECONDARY', 'title': 'Phase I Schedule B: Number of Participants With Adverse Events (AEs) Graded According to Common Terminology Criteria for Adverse Events (CTCAE), Based on the Number of Patients With AEs With CTCAE Grade ≥3 During Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '56', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I Schedule B. Volasertib 150 mg', 'description': 'Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG001', 'title': 'Phase I Schedule B. Volasertib 200 mg', 'description': 'Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG002', 'title': 'Phase I Schedule B. Volasertib 350 mg', 'description': 'Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG003', 'title': 'Phase I Schedule B. Volasertib 400 mg', 'description': 'Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG004', 'title': 'Phase I Schedule B. Volasertib 450 mg', 'description': 'Volasertib 450 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG005', 'title': 'Phase I Schedule B. Volasertib 500 mg', 'description': 'Volasertib 500 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG006', 'title': 'Phase I Schedule B. Volasertib 550 mg', 'description': 'Volasertib 550 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG007', 'title': 'Total Phase I Schedule B.', 'description': 'Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps from an initial starting dose of 150 mg. Dose was escalated up to 550 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes.'}], 'classes': [{'title': 'Grade 3', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '30', 'groupId': 'OG007'}]}]}, {'title': 'Grade 5', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'First treatment cycle, up to 28 days.', 'description': 'Number of patients with AEs following in the categories 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related AE) of CTCAE is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set-Phase I part: Treated set was defined as all patients in Phase I who received at least a single dose of either Volasertib or LDAC, including patients who were replaced for any reason.'}, {'type': 'SECONDARY', 'title': 'Phase I Schedule A: Number of Participants With Adverse Events (AEs) Graded According to Common Terminology Criteria for Adverse Events (CTCAE), Based on the Number of Patients With AEs With CTCAE Grade ≥3 During All Cycles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '32', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I Schedule A. Volasertib 150 mg+LDAC', 'description': 'Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG001', 'title': 'Phase I Schedule A. Volasertib 200 mg+LDAC', 'description': 'Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG002', 'title': 'Phase I Schedule A. Volasertib 250 mg+LDAC', 'description': 'Volasertib 250 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG003', 'title': 'Phase I Schedule A. Volasertib 300 mg+LDAC', 'description': 'Volasertib 300 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG004', 'title': 'Phase I Schedule A. Volasertib 350 mg+LDAC', 'description': 'Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG005', 'title': 'Phase I Schedule A. Volasertib 400 mg+LDAC', 'description': 'Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'OG006', 'title': 'Total Phase I Combined. Schedule A.', 'description': 'Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps up to 400 mg, with a starting dose of 400 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes and LDAC 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}], 'classes': [{'title': 'Grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}]}]}, {'title': 'Grade 5', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 615 days.', 'description': 'Number of patients with AEs following in the categories 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related AE) of CTCAE is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set-Phase I part: Treated set was defined as all patients in Phase I who received at least a single dose of either Volasertib or LDAC, including patients who were replaced for any reason.'}, {'type': 'SECONDARY', 'title': 'Phase I Schedule B: Number of Participants With Adverse Events (AEs) Graded According to Common Terminology Criteria for Adverse Events (CTCAE), Based on the Number of Patients With AEs With CTCAE Grade ≥3 During All Cycles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '56', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I Schedule B. Volasertib 150 mg', 'description': 'Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG001', 'title': 'Phase I Schedule B. Volasertib 200 mg', 'description': 'Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG002', 'title': 'Phase I Schedule B. Volasertib 350 mg', 'description': 'Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG003', 'title': 'Phase I Schedule B. Volasertib 400 mg', 'description': 'Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG004', 'title': 'Phase I Schedule B. Volasertib 450 mg', 'description': 'Volasertib 450 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG005', 'title': 'Phase I Schedule B. Volasertib 500 mg', 'description': 'Volasertib 500 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG006', 'title': 'Phase I Schedule B. Volasertib 550 mg', 'description': 'Volasertib 550 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'OG007', 'title': 'Total Phase I Schedule B.', 'description': 'Volasertib escalating dose on Days 1+15 (28-day cycle). Dose escalation in 50 mg steps from an initial starting dose of 150 mg. Dose was escalated up to 550 mg. Volasertib administered by Intravenous Infusion (IV) over 60 minutes.'}], 'classes': [{'title': 'Grade 3', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '32', 'groupId': 'OG007'}]}]}, {'title': 'Grade 5', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 597 days.', 'description': 'Number of patients with AEs following in the categories 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related AE) of CTCAE is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set-Phase I part: the treated set was defined as all patients in Phase I who received at least a single dose of either Volasertib or LDAC, including patients who were replaced for any reason.'}, {'type': 'SECONDARY', 'title': 'Phase II: Number of Participants With Adverse Events (AEs) Graded According to Common Terminology Criteria for Adverse Events (CTCAE), Based on the Number of Patients With AEs With CTCAE Grade ≥3 During All Cycles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II Schedule C. LDAC', 'description': 'Low-dose cytarabine (LDAC) monotherapy 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.'}, {'id': 'OG001', 'title': 'Phase II Schedule A. Volasertib 350 mg+LDAC', 'description': 'Volasertib 350 milligram (mg) on Days 1 and 15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.'}], 'classes': [{'title': 'Grade 3', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Grade 5', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 890 days.', 'description': 'Number of patients with AEs following in the in the categories 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related AE) of CTCAE is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set-Phase II part: the treated set (Phase II) was defined as all patients in Phase II who received at least a single dose of either Volasertib or LDAC.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase I Schedule A. Volasertib 150 mg+LDAC', 'description': 'Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'FG001', 'title': 'Phase I Schedule A. Volasertib 200 mg+LDAC', 'description': 'Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'FG002', 'title': 'Phase I Schedule A. Volasertib 250 mg+LDAC', 'description': 'Volasertib 250 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'FG003', 'title': 'Phase I Schedule A. Volasertib 300 mg+LDAC', 'description': 'Volasertib 300 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'FG004', 'title': 'Phase I Schedule A. Volasertib 350 mg+LDAC', 'description': 'Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'FG005', 'title': 'Phase I Schedule A. Volasertib 400 mg+LDAC', 'description': 'Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'FG006', 'title': 'Phase I Schedule B. Volasertib 150 mg', 'description': 'Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'FG007', 'title': 'Phase I Schedule B. Volasertib 200 mg', 'description': 'Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'FG008', 'title': 'Phase I Schedule B. Volasertib 350 mg', 'description': 'Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'FG009', 'title': 'Phase I Schedule B. Volasertib 400 mg', 'description': 'Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'FG010', 'title': 'Phase I Schedule B. Volasertib 450 mg', 'description': 'Volasertib 450 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'FG011', 'title': 'Phase I Schedule B. Volasertib 500 mg', 'description': 'Volasertib 500 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'FG012', 'title': 'Phase I Schedule B. Volasertib 550 mg', 'description': 'Volasertib 550 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'FG013', 'title': 'Phase II Schedule C. LDAC', 'description': 'Low-dose cytarabine (LDAC) monotherapy 2x20 milligram (mg) per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.'}, {'id': 'FG014', 'title': 'Phase II Schedule A. Volasertib 350 mg+LDAC', 'description': 'Volasertib 350 milligram (mg) on Days 1 and 15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '11'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '5'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '23'}, {'groupId': 'FG011', 'numSubjects': '5'}, {'groupId': 'FG012', 'numSubjects': '4'}, {'groupId': 'FG013', 'numSubjects': '45'}, {'groupId': 'FG014', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '11'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '5'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '23'}, {'groupId': 'FG011', 'numSubjects': '5'}, {'groupId': 'FG012', 'numSubjects': '4'}, {'groupId': 'FG013', 'numSubjects': '45'}, {'groupId': 'FG014', 'numSubjects': '42'}]}], 'dropWithdraws': [{'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '8'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '4'}, {'groupId': 'FG009', 'numSubjects': '5'}, {'groupId': 'FG010', 'numSubjects': '12'}, {'groupId': 'FG011', 'numSubjects': '2'}, {'groupId': 'FG012', 'numSubjects': '2'}, {'groupId': 'FG013', 'numSubjects': '26'}, {'groupId': 'FG014', 'numSubjects': '20'}]}, {'type': 'Dose Limiting Toxicity (DLT)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '1'}]}, {'type': 'Other Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '5'}, {'groupId': 'FG011', 'numSubjects': '2'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '6'}, {'groupId': 'FG014', 'numSubjects': '13'}]}, {'type': 'Non compliance with protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '2'}, {'groupId': 'FG014', 'numSubjects': '0'}]}, {'type': 'Refused to continue medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '3'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '1'}, {'groupId': 'FG013', 'numSubjects': '1'}, {'groupId': 'FG014', 'numSubjects': '5'}]}, {'type': 'Other reason than listed above', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '3'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '1'}, {'groupId': 'FG013', 'numSubjects': '10'}, {'groupId': 'FG014', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Open-label, randomized, dose escalation study. In this trial 180 patients were entered and randomised. However 3 patients were entered but not treated in Phase I and 2 patients were not treated in Phase II. Thus total 175 patients were treated in this trial.', 'preAssignmentDetails': 'Patients were assigned to two treatment schedules (A and B) in the phase I part of the trial (dose escalation phase to determine maximum tolerated dose (MTD)). In the phase IIa part of the trial (after MTD was determined), patients were randomised to two treatment schedules (A and C).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '23', 'groupId': 'BG010'}, {'value': '5', 'groupId': 'BG011'}, {'value': '4', 'groupId': 'BG012'}, {'value': '45', 'groupId': 'BG013'}, {'value': '42', 'groupId': 'BG014'}, {'value': '175', 'groupId': 'BG015'}]}], 'groups': [{'id': 'BG000', 'title': 'Phase I Schedule A. Volasertib 150 mg+LDAC', 'description': 'Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'BG001', 'title': 'Phase I Schedule A. Volasertib 200 mg+LDAC', 'description': 'Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'BG002', 'title': 'Phase I Schedule A. Volasertib 250 mg+LDAC', 'description': 'Volasertib 250 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'BG003', 'title': 'Phase I Schedule A. Volasertib 300 mg+LDAC', 'description': 'Volasertib 300 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'BG004', 'title': 'Phase I Schedule A. Volasertib 350 mg+LDAC', 'description': 'Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'BG005', 'title': 'Phase I Schedule A. Volasertib 400 mg+LDAC', 'description': 'Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.'}, {'id': 'BG006', 'title': 'Phase I Schedule B. Volasertib 150 mg', 'description': 'Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'BG007', 'title': 'Phase I Schedule B. Volasertib 200 mg', 'description': 'Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'BG008', 'title': 'Phase I Schedule B. Volasertib 350 mg', 'description': 'Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'BG009', 'title': 'Phase I Schedule B. Volasertib 400 mg', 'description': 'Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'BG010', 'title': 'Phase I Schedule B. Volasertib 450 mg', 'description': 'Volasertib 450 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'BG011', 'title': 'Phase I Schedule B. Volasertib 500 mg', 'description': 'Volasertib 500 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'BG012', 'title': 'Phase I Schedule B. Volasertib 550 mg', 'description': 'Volasertib 550 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).'}, {'id': 'BG013', 'title': 'Phase II Schedule C. LDAC', 'description': 'Low-dose cytarabine (LDAC) monotherapy 2x20 milligram (mg) per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.'}, {'id': 'BG014', 'title': 'Phase II Schedule A. Volasertib 350 mg+LDAC', 'description': 'Volasertib 350 milligram (mg) on Days 1 and 15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.'}, {'id': 'BG015', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.5', 'spread': '12.1', 'groupId': 'BG000'}, {'value': '67.0', 'spread': '3.0', 'groupId': 'BG001'}, {'value': '71.2', 'spread': '6.8', 'groupId': 'BG002'}, {'value': '67.9', 'spread': '12.0', 'groupId': 'BG003'}, {'value': '72.5', 'spread': '6.1', 'groupId': 'BG004'}, {'value': '73.3', 'spread': '7.6', 'groupId': 'BG005'}, {'value': '73.5', 'spread': '3.9', 'groupId': 'BG006'}, {'value': '73.0', 'spread': '4.2', 'groupId': 'BG007'}, {'value': '70.6', 'spread': '2.9', 'groupId': 'BG008'}, {'value': '65.2', 'spread': '20.1', 'groupId': 'BG009'}, {'value': '68.2', 'spread': '7.7', 'groupId': 'BG010'}, {'value': '66.4', 'spread': '7.3', 'groupId': 'BG011'}, {'value': '69.8', 'spread': '4.1', 'groupId': 'BG012'}, {'value': '75.2', 'spread': '5.5', 'groupId': 'BG013'}, {'value': '75.6', 'spread': '4.9', 'groupId': 'BG014'}, {'value': '72.5', 'spread': '7.7', 'groupId': 'BG015'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '16', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '3', 'groupId': 'BG012'}, {'value': '20', 'groupId': 'BG013'}, {'value': '19', 'groupId': 'BG014'}, {'value': '79', 'groupId': 'BG015'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}, {'value': '7', 'groupId': 'BG010'}, {'value': '4', 'groupId': 'BG011'}, {'value': '1', 'groupId': 'BG012'}, {'value': '25', 'groupId': 'BG013'}, {'value': '23', 'groupId': 'BG014'}, {'value': '96', 'groupId': 'BG015'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '1', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '1', 'groupId': 'BG015'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '1', 'groupId': 'BG013'}, {'value': '1', 'groupId': 'BG014'}, {'value': '4', 'groupId': 'BG015'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '21', 'groupId': 'BG010'}, {'value': '5', 'groupId': 'BG011'}, {'value': '4', 'groupId': 'BG012'}, {'value': '35', 'groupId': 'BG013'}, {'value': '34', 'groupId': 'BG014'}, {'value': '153', 'groupId': 'BG015'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '8', 'groupId': 'BG013'}, {'value': '7', 'groupId': 'BG014'}, {'value': '17', 'groupId': 'BG015'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Treated Set: All patients in Phase I who received at least a single dose of either Volasertib or LDAC, including patients who were replaced for any reason. For the Phase II part, the treated set (Phase II) was defined as all patients in Phase II who received at least a single dose of either Volasertib or LDAC.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-02-19', 'size': 545481, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-03-14T04:32', 'hasProtocol': True}, {'date': '2012-01-23', 'size': 384632, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-03-14T04:32', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2021-04-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-02', 'studyFirstSubmitDate': '2008-09-18', 'resultsFirstSubmitDate': '2022-04-06', 'studyFirstSubmitQcDate': '2008-12-08', 'lastUpdatePostDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-12-02', 'studyFirstPostDateStruct': {'date': '2008-12-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-03-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase I: Maximum Tolerated Dose (MTD) of Volasertib in Combination With LDAC (Schedule A) and Volasertib Monotherapy (Schedule B)', 'timeFrame': 'First Treatment cycle, up to 28 days.', 'description': 'To determine the Maximum tolerated dose (MTD), dose escalation was conducted following the 3+3 design with de-escalation. The MTD was defined as the highest dose at which 6 patients had been treated and less than 2 patients experienced a Dose limiting toxicity (DLT) within the first cycle of treatment. The MTD was defined based on safety data from the first cycle only.\n\nDLT is defined as drug related Common terminology criteria for adverse events (CTCAE) grade ≥ 3 nonhaematological toxicity (excluding: untreated nausea, untreated vomiting, CTCAE grade 3 untreated diarrhoea, CTCAE grade 3 "febrile neutropenia" and CTCAE grade 3 "infection with grade 3 or 4 neutrophils").\n\nIn patients with complete remission with incomplete blood count recovery (CRi) or partial remission (PR), persistent CTCAE grade 4 neutropenia or thrombocytopenia until three weeks after the end of the treatment cycle will be regarded a DLT.'}, {'measure': 'Phase II: Number of Patients With Objective Response (Complete Remission (CR) + Complete Remission With Incomplete Blood Count Recovery (CRi))', 'timeFrame': 'The best overall response recorded during the time period from the start of the treatment until end of the treatment period, progression or death (whichever was earlier), up to 869 days.', 'description': 'Phase II: Number of patients with Objective Response (Complete remission (CR) + Complete remission with incomplete blood count recovery (CRi)).\n\nComplete remission (CR): morphologically leukaemia-free state (i.e. bone marrow with \\<5% blasts by morphologic criteria and no Auer rods, no evidence of extramedullary leukaemia) and absolute neutrophil count ≥1,000/microliter (μL) and platelets \\>100,000/μL.\n\nComplete remission with incomplete blood count recovery ("incomplete" CR, CRi): all of the above criteria for CR were met except that neutrophils \\<1,000/μL or platelets \\<100,000/μL in the blood were not achieved.'}, {'measure': 'Phase I: Number of Participants With Dose Limiting Toxicities (DLTs) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD)', 'timeFrame': 'First Treatment cycle, up to 28 days.', 'description': 'A DLT was defined as a drug related CTCAE (Common Toxicity Criteria for Adverse Events) Grade ≥3 non-haematological toxicity (excluding untreated nausea, untreated vomiting, Grade 3 untreated diarrhea, Grade 3 febrile neutropenia, and Grade 3 infection with Grade 3 or 4 neutrophils). In patients with CRi (Complete Remission with Incomplete Blood Count Recovery) or PR (Partial Remission), persistent Grade 4 neutropenia or thrombocytopenia for 3 weeks after the end of the treatment cycle was regarded as a DLT unless the respective Grade 4 cytopenia was preexistent. In patients who required platelet substitution to maintain a Grade \\<4 before treatment, a Grade 4 thrombocytopenia after treatment did not constitute a DLT.'}], 'secondaryOutcomes': [{'measure': 'Best Overall Response', 'timeFrame': 'The best overall response recorded during the time period from the start of the treatment until end of the treatment period, progression or death (whichever was earlier), up to 869 days.', 'description': '* CR\n* CR+CRi\n* Partial remission: CR except bone marrow (BM) contained ≥5% but \\<25% blasts (or ≤50% initial blasts), or \\<5% blasts in presence of Auer rods or abnormal morphology.\n* No change: survived ≥7 days (d) after 1st cycle with persistent leukemia in last peripheral blood smear or BM, or with persistent extramedullary disease, without further deterioration due to leukemia or increase of blasts in BM or peripheral blood.\n* Aplasia: survived ≥7d after 1st cycle, died whilst cytopenic, with last post-treatment BM result aplastic or hypoplastic and without leukemia blasts.\n* Indeterminate: survived \\<7 d after 1st cycle or survived ≥7d after 1st cycle, died with no persistent leukemia in peripheral smear but no post-treatment BM examination or did not complete 1st cycle.\n* Progressive disease: survived ≥7d after 1st cycle with increase of blast population in BM or peripheral blood or aggravation or new extramedullary disease or further deterioration or death due to leukemia.'}, {'measure': 'Phase I: Number of Patients With Objective Response: Complete Remission or Complete Remission With Incomplete Blood Count Recovery (CR+CRi)', 'timeFrame': 'The best overall response recorded during the time period from the start of the treatment until end of the treatment period, progression or death (whichever was earlier), up to 594 days.', 'description': 'Phase I: Number of patients with Objective Response (Complete remission (CR) + Complete remission with incomplete blood count recovery (CRi)).\n\nComplete remission (CR): morphologically leukaemia-free state (i.e. bone marrow with \\<5% blasts by morphologic criteria and no Auer rods, no evidence of extramedullary leukaemia) and absolute neutrophil count ≥1,000/microliter (μL) and platelets \\>100,000/μL.\n\nComplete remission with incomplete blood count recovery ("incomplete" CR, CRi): all of the above criteria for CR were met except that neutrophils \\<1,000/μL or platelets \\<100,000/μL in the blood were not achieved.'}, {'measure': 'Phase II: Event Free Survival', 'timeFrame': 'The patients that entered the trial, and measured from the date of randomization to the date of disease progression (treatment failure), relapse or death from any cause, whichever occurred first, up to 1000 days..', 'description': 'Event-free survival (EFS) \\[days\\] was the shortest duration of the following: (a) Date of assessment indicating PD on the response page of the eCRF (Electronic Case Report Form) - date of randomisation + 1 day (b) Date of assessment indicating clinical progressive disease (PD) on the disease or responses pages of the of eCRF- date of randomisation + 1 day (c) Date of assessment indicating PD on the patient status page of the eCRF - date of randomisation +1 day (for patients who had not been censored before this time point) (d) Death date - date of randomisation +1 day Patients not being assessed PD, clinical PD, or death during the trial were censored.\n\nEFS was analysed with the Kaplan-Meier method for each of the treatment arms.'}, {'measure': 'Phase II: Overall Survival', 'timeFrame': 'The patients that entered the trial, and measured from the date of randomisation until death from any cause, up to 1100 days..', 'description': 'Overall survival \\[days\\] = (date of death - date of randomisation + 1 day), for patients with known date of death. Overall survival (censored) \\[days\\] = (date of last trial visit or follow-up - date of randomisation + 1 day), for patients who were still alive at time of database lock.\n\nOverall survival (OS) was analysed with the Kaplan-Meier method for each of the treatment arms.'}, {'measure': 'Phase II: Relapse - Free Survival', 'timeFrame': 'The patients who achieved CR or CRi, and was measured from the date of attaining CR or CRi until the date of disease recurrence or death from any cause, whichever occurred first, up to 900 days.', 'description': 'Relapse-free survival \\[days\\] = (date of first recurrence of disease or death after entering the trial - date of first occurrence of CR or CRi after entering the trial+ 1 day) for patients with a recurrence (this value should be positive).\n\nRelapse-free survival (censored) \\[days\\] = (date of last trial visit or follow-up - date of first occurrence of CR or CRi after entering the trial + 1 day) for patients who did not experience recurrence of disease or death at the time of analysis.'}, {'measure': 'Phase II: Remission Duration', 'timeFrame': 'The patients who achieved CR or CRi, and was measured from the date of attaining CR or CRi until the date of disease recurrence (relapse), up to 900 days.', 'description': 'Remission duration analysis was defined only for patients who achieved Complete remission (CR) or Complete remission with incomplete blood count recovery (CRi), and was measured from the date of attaining CR or CRi until the date of disease recurrence (relapse). For patients who died without report of relapse, remission duration was censored on the date of death, regardless of cause.'}, {'measure': 'Phase II: Time to Remission', 'timeFrame': 'The patients who achieved CR or CRi, and was measured from the date of attaining CR or CRi until the date of disease recurrence (relapse), up to 158 days.', 'description': 'Time to remission \\[days\\] = (date of first occurrence of CR or CRi after entering the trial-date of randomisation + 1 day) for patients with an objective response.'}, {'measure': 'Best Eastern Co-operative Oncology Group (ECOG) Performance Score From Baseline Until End of Treatment', 'timeFrame': 'Baseline and End of Treatment (up to 869 days).', 'description': 'ECOG performance score change from baseline to last visit of last cycle = ECOG performance score at last visit of the last cycle - ECOG performance score at baseline. ECOG performance score changes from baseline were also categorised on a 3-point categorical scale: deteriorated (-1), unchanged (0), and improved (1). The number of participants for category of ECOG score change is reported.'}, {'measure': 'Total Clearance (CL) of Volasertib in Plasma After i.v (Intravenous) Administration of Volasertib', 'timeFrame': 'Cycle 1: -0:05 hour (h), 0:30h, 1:00h, 1:30h, 2h, 3h, 4h, 24h, 96h, 216h, 335:55h, 336:30h, 337h, 337:30h, 338h, 339h, 340h, 648h after first drug administration.', 'description': 'Total Clearance (CL) of Volasertib in Plasma after Intravenous (i.v.) Administration of Volasertib.'}, {'measure': 'Apparent Volume of Distribution of Volasertib at Steady State (VSS)', 'timeFrame': 'Cycle 1: -0:05 hour (h), 0:30h, 1:00h, 1:30h, 2h, 3h, 4h, 24h, 96h, 216h, 335:55h, 336:30h, 337h, 337:30h, 338h, 339h, 340h, 648h after first drug administration.', 'description': 'Apparent Volume of Distribution of volasertib at steady state (VSS) following Intravenous (i.v.) administration.'}, {'measure': 'Dose Normalized Maximum Measured Concentration of Cytarabine in Plasma (Cmax, Norm)', 'timeFrame': 'Cycle 1: -0:05 hour (h), 0:30h, 1:00h, 1:30h, 2h, 3h, 4h, 24h, 96h, 216h, 335:55h, 336:30h, 337h, 337:30h, 338h, 339h, 340h, 648h after first drug administration.', 'description': 'Cmax, norm: Maximum measured concentration of Cytarabine in plasma. The dose normalisation was done by dividing by the dose applied. Unit: nanogram/milliliter/milligram: ((ng/mL)/mg). Dose groups of Phase I were combined by dose normalizing as pre specified in the study protocol.'}, {'measure': 'Dose Normalized Area Under the Concentration-Time Curve of Cytarabine in Plasma Over the Time Interval From 0 Extrapolated up to 4 Hours', 'timeFrame': 'Cycle 1: -0:05 hour (h), 0:30h, 1:00h, 1:30h, 2h, 3h, 4h after first drug administration.', 'description': 'AUC0-4,norm: Area under the concentration-time curve of Cytarabine in plasma over the time interval from zero extrapolated to 4 hours. The dose normalisation was done by dividing by dose applied. Unit: nanogram\\*hour/milliliter/milligram: ((ng\\*h/mL)/mg).\n\nDose groups of Phase I were combined by dose normalizing as pre specified in the study protocol.'}, {'measure': "Absolute QTcF (QT Interval Corrected for Heart Rate Using Fridericia's Formula) Intervals", 'timeFrame': 'Baseline (Days -14 to -1) and day 1 (1 hour and 24 hours) after start of infusion.', 'description': "ECG (Electro Cardio Gram) Measurements: Absolute QTcF (QT Interval (interval from the beginning of the QRS complex to the end of the T wave) Corrected for Heart Rate Using Fridericia's Formula) Intervals. The 350 mg + LDAC arm of phase I and II were combined into one arm to provide maximum information on QT changes and presented together with the Phase I schedule B 450 mg arm, as pre specified in the study protocol."}, {'measure': "QTcF (QT Interval Corrected for Heart Rate Using Fridericia's Formula) Change From Baseline at Cycle 1", 'timeFrame': 'Baseline (Days -14 to -1) and day 1 (1 hour and 24 hours) after start of infusion.', 'description': 'ECG Measurements: QTcF (QT Interval (interval from the beginning of the QRS complex to the end of the T wave) changes from baseline at each time point: The QTcF post baseline measurement obtained at time t minus baseline QTcF measurement. The 350 mg + LDAC arm of phase I and II were combined into one arm to provide maximum information on QT changes and presented together with the Phase I schedule B 450 mg arm, as pre specified in the study protocol.'}, {'measure': 'Phase I Schedule A: Number of Participants With Adverse Events (AEs) Graded According to Common Terminology Criteria for Adverse Events (CTCAE), Based on the Number of Patients With AEs With CTCAE Grade ≥3 During Cycle 1', 'timeFrame': 'First treatment cycle, up to 28 days.', 'description': 'Number of patients with AEs following in the categories 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related AE) of CTCAE is reported.'}, {'measure': 'Phase I Schedule B: Number of Participants With Adverse Events (AEs) Graded According to Common Terminology Criteria for Adverse Events (CTCAE), Based on the Number of Patients With AEs With CTCAE Grade ≥3 During Cycle 1', 'timeFrame': 'First treatment cycle, up to 28 days.', 'description': 'Number of patients with AEs following in the categories 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related AE) of CTCAE is reported.'}, {'measure': 'Phase I Schedule A: Number of Participants With Adverse Events (AEs) Graded According to Common Terminology Criteria for Adverse Events (CTCAE), Based on the Number of Patients With AEs With CTCAE Grade ≥3 During All Cycles', 'timeFrame': 'From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 615 days.', 'description': 'Number of patients with AEs following in the categories 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related AE) of CTCAE is reported.'}, {'measure': 'Phase I Schedule B: Number of Participants With Adverse Events (AEs) Graded According to Common Terminology Criteria for Adverse Events (CTCAE), Based on the Number of Patients With AEs With CTCAE Grade ≥3 During All Cycles', 'timeFrame': 'From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 597 days.', 'description': 'Number of patients with AEs following in the categories 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related AE) of CTCAE is reported.'}, {'measure': 'Phase II: Number of Participants With Adverse Events (AEs) Graded According to Common Terminology Criteria for Adverse Events (CTCAE), Based on the Number of Patients With AEs With CTCAE Grade ≥3 During All Cycles', 'timeFrame': 'From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 890 days.', 'description': 'Number of patients with AEs following in the in the categories 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related AE) of CTCAE is reported.'}]}, 'conditionsModule': {'conditions': ['Leukemia, Myeloid, Acute']}, 'referencesModule': {'references': [{'pmid': '25006120', 'type': 'DERIVED', 'citation': 'Dohner H, Lubbert M, Fiedler W, Fouillard L, Haaland A, Brandwein JM, Lepretre S, Reman O, Turlure P, Ottmann OG, Muller-Tidow C, Kramer A, Raffoux E, Dohner K, Schlenk RF, Voss F, Taube T, Fritsch H, Maertens J. Randomized, phase 2 trial of low-dose cytarabine with or without volasertib in AML patients not suitable for induction therapy. Blood. 2014 Aug 28;124(9):1426-33. doi: 10.1182/blood-2014-03-560557. Epub 2014 Jul 8.'}], 'seeAlsoLinks': [{'url': 'http://www.mystudywindow.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The trial will be performed in two parts, a phase I part and a phase IIa part. In the phase I part of the trial, BI 6727 will be investigated as monotherapy and in combination with low dose cytarabine (LD-Ara-C) in patients with relapsed/refractory AML that are not eligible for intensive treatment. The dose of BI 6727 will be escalated to determine the maximum tolerated dose (MTD) of BI 6727 monotherapy and BI 6727 in combination with LD-Ara-C in AML patients. In the phase IIa part, the combination of BI 6727 at MTD with LD-Ara-C and LD-Ara-C monotherapy will be investigated to explore the efficacy of the combination schedule in comparison to LD-Ara-C monotherapy in previously untreated AML patients that are not eligible for intensive treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nMale or female adult with relapsed/refractory AML ineligible for intensive treatment (phase I part only) Male or female adult with previously untreated AML ineligible for intensive treatment (phase IIa part only) Confirmed diagnosis of AML according to the WHO definition (except for acute promyelocytic leukaemia, APL) Patient is eligible for LD-Ara-C treatment Life expectancy \\> 3 months Eastern co-operative oncology group (ECOG, R01-0787) performance score \\<=2 at screening Signed written informed consent consistent with international conference on harmonisation, good clinical practice (ICH-GCP) and local legislation\n\nExclusion criteria:\n\nPreviously untreated AML (phase I part only) Relapsed or treatment refractory AML (phase IIa part only) Patient with APL (AML subtype M3 according to the French-American-British (FAB) classification) Hypersensitivity to one of the trial drugs or the excipients Other malignancy requiring treatment Symptomatic central nervous system involvement Clinically relevant QT prolongation (e.g. long QT syndrome, QTcF\\>470 ms) Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (ULN), or AST or ALT greater than 5 times the ULN in case of known leukaemia liver involvement Prothrombin time (PT) \\> 1.5 x ULN for subjects not on therapeutic vitamin K antagonists (phenprocoumon, warfarin) Bilirubin greater than 1.5 mg/dl (\\> 26 mcmol/L) Serum creatinine greater than 2.0 mg/dl Concomitant intercurrent illness, which would compromise the evaluation of efficacy or safety of the trial drug, e.g. active severe infection, unstable angina pectoris, cardiac arrhythmia or severe heart failure/cardiac insufficiency.\n\nPsychiatric illness or social situation that would limit compliance with trial requirements Concomitant therapy, which is considered relevant for the evaluation of the efficacy or safety of the trial drug Contraindications for cytarabine treatment according to the SPC Female patients of childbearing potential who are sexually active and unwilling to use a medically acceptable method of contraception during the trial, i.e. combination of two forms of effective contraception (hormonal contraception, intrauterine device, condom with spermicide, etc.).\n\nMale patients with partners of childbearing potential who are unwilling to use condoms in combination with a second medically acceptable method of contraception during the trial Pregnant or nursing female patients Patient unable to comply with the protocol'}, 'identificationModule': {'nctId': 'NCT00804856', 'briefTitle': 'Phase I/IIa Trial to Investigate BI 6727 (Volasertib) as Monotherapy or in Combination With Cytarabine in Acute Myeloid Leukaemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'An Open Phase I/IIa Trial to Investigate the Maximum Tolerated Dose, Safety, Pharmacokinetics, and Efficacy of Intravenous BI 6727 as Monotherapy or in Combination With Subcutaneous Cytarabine in Patients With Acute Myeloid Leukaemia', 'orgStudyIdInfo': {'id': '1230.4'}, 'secondaryIdInfos': [{'id': '2008-003617-27', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase I Schedule A. Volasertib 150 mg+LDAC', 'description': 'Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.', 'interventionNames': ['Drug: Volasertib', 'Drug: Cytarabine']}, {'type': 'EXPERIMENTAL', 'label': 'Phase I Schedule A. Volasertib 200 mg+LDAC', 'description': 'Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.', 'interventionNames': ['Drug: Volasertib', 'Drug: Cytarabine']}, {'type': 'EXPERIMENTAL', 'label': 'Phase I Schedule A. Volasertib 250 mg+LDAC', 'description': 'Volasertib 250 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.', 'interventionNames': ['Drug: Volasertib', 'Drug: Cytarabine']}, {'type': 'EXPERIMENTAL', 'label': 'Phase I Schedule A. Volasertib 300 mg+LDAC', 'description': 'Volasertib 300 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.', 'interventionNames': ['Drug: Volasertib', 'Drug: Cytarabine']}, {'type': 'EXPERIMENTAL', 'label': 'Phase I Schedule A. Volasertib 350 mg+LDAC', 'description': 'Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.', 'interventionNames': ['Drug: Volasertib', 'Drug: Cytarabine']}, {'type': 'EXPERIMENTAL', 'label': 'Phase I Schedule A. Volasertib 400 mg+LDAC', 'description': 'Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle) and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.', 'interventionNames': ['Drug: Volasertib', 'Drug: Cytarabine']}, {'type': 'EXPERIMENTAL', 'label': 'Phase I Schedule B. Volasertib 150 mg', 'description': 'Volasertib 150 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).', 'interventionNames': ['Drug: Volasertib']}, {'type': 'EXPERIMENTAL', 'label': 'Phase I Schedule B. Volasertib 200 mg', 'description': 'Volasertib 200 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).', 'interventionNames': ['Drug: Volasertib']}, {'type': 'EXPERIMENTAL', 'label': 'Phase I Schedule B. Volasertib 350 mg', 'description': 'Volasertib 350 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).', 'interventionNames': ['Drug: Volasertib']}, {'type': 'EXPERIMENTAL', 'label': 'Phase I Schedule B. Volasertib 400 mg', 'description': 'Volasertib 400 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).', 'interventionNames': ['Drug: Volasertib']}, {'type': 'EXPERIMENTAL', 'label': 'Phase I Schedule B. Volasertib 450 mg', 'description': 'Volasertib 450 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).', 'interventionNames': ['Drug: Volasertib']}, {'type': 'EXPERIMENTAL', 'label': 'Phase I Schedule B. Volasertib 500 mg', 'description': 'Volasertib 500 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).', 'interventionNames': ['Drug: Volasertib']}, {'type': 'EXPERIMENTAL', 'label': 'Phase I Schedule B. Volasertib 550 mg', 'description': 'Volasertib 550 milligram (mg) administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).', 'interventionNames': ['Drug: Volasertib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Phase II Schedule C. LDAC', 'description': 'Low-dose cytarabine (LDAC) monotherapy 2x20 milligram (mg) per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.', 'interventionNames': ['Drug: Cytarabine']}, {'type': 'EXPERIMENTAL', 'label': 'Phase II Schedule A. Volasertib 350 mg+LDAC', 'description': 'Volasertib 350 milligram (mg) on Days 1 and 15 (28-day cycle) administered by Intravenous Infusion (IV) over 60 minutes and Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 days treatment cycle.', 'interventionNames': ['Drug: Volasertib', 'Drug: Cytarabine']}], 'interventions': [{'name': 'Volasertib', 'type': 'DRUG', 'description': 'Volasertib administered by Intravenous Infusion (IV) over 60 minutes on Days 1 and 15 (28-day cycle).', 'armGroupLabels': ['Phase I Schedule A. Volasertib 150 mg+LDAC', 'Phase I Schedule A. Volasertib 200 mg+LDAC', 'Phase I Schedule A. Volasertib 250 mg+LDAC', 'Phase I Schedule A. Volasertib 300 mg+LDAC', 'Phase I Schedule A. Volasertib 350 mg+LDAC', 'Phase I Schedule A. Volasertib 400 mg+LDAC', 'Phase I Schedule B. Volasertib 150 mg', 'Phase I Schedule B. Volasertib 200 mg', 'Phase I Schedule B. Volasertib 350 mg', 'Phase I Schedule B. Volasertib 400 mg', 'Phase I Schedule B. Volasertib 450 mg', 'Phase I Schedule B. Volasertib 500 mg', 'Phase I Schedule B. Volasertib 550 mg', 'Phase II Schedule A. Volasertib 350 mg+LDAC']}, {'name': 'Cytarabine', 'type': 'DRUG', 'description': 'Low-dose cytarabine (LDAC) 2x20mg per day administered by subcutaneous injection on days 1-10 of each 28 day treatment cycle.', 'armGroupLabels': ['Phase I Schedule A. Volasertib 150 mg+LDAC', 'Phase I Schedule A. Volasertib 200 mg+LDAC', 'Phase I Schedule A. Volasertib 250 mg+LDAC', 'Phase I Schedule A. Volasertib 300 mg+LDAC', 'Phase I Schedule A. Volasertib 350 mg+LDAC', 'Phase I Schedule A. Volasertib 400 mg+LDAC', 'Phase II Schedule A. Volasertib 350 mg+LDAC', 'Phase II Schedule C. LDAC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8036', 'city': 'Graz', 'country': 'Austria', 'facility': 'LKH-Univ. 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