Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2026-01-03 @ 9:22 AM
Study NCT ID:
NCT01296932
Status:
COMPLETED
Last Update Posted:
2020-08-20
First Post:
2011-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
BI836826 Dose Escalation in Relapsed Chronic Lymphocytic Leukaemia (CLL)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}], 'ancestors': [{'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'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'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000626798', 'term': 'BI 836826'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim, Call Centre', '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}, 'limitationsAndCaveats': {'description': 'The trial was discontinued due to lack of recruitment before a formal maximum tolerated dose (MTD) was established based on the number of patients with Dose Limiting Toxicities (DLTs) in the first treatment cycle.'}}, 'adverseEventsModule': {'timeFrame': 'From the first dose of study medication until 6 weeks after last administration of BI 836826, up to 136 weeks', 'description': 'The Treated set (TS) was used for adverse event reporting. (TS: This patient set consists of all patients who received at least one application of the BI drug BI 836826.)', 'eventGroups': [{'id': 'EG000', 'title': 'BI 836826 1 Milligram', 'description': 'Patients were administered BI 836826-1 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'BI 836826 3 Milligram', 'description': 'Patients were administered BI 836826-3 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'BI 836826 9 Milligram', 'description': 'Patients were administered BI 836826-9 milligram solution for infusion after dilution intravenously as one or two doses within the first cycle followed by single doses within all following 14-day cycles', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'BI 836826 25 Milligram', 'description': 'Patients were administered BI 836826-25 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'BI 836826 50 Milligram', 'description': 'Patients were administered BI 836826-50 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'BI 836826 100 Milligram', 'description': 'Patients were administered BI 836826-100 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'BI 836826 200 Milligram', 'description': 'Patients were administered BI 836826-200 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG007', 'title': 'BI 836826 400 Milligram', 'description': 'Patients were administered BI 836826-400 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG008', 'title': 'BI 836826 800 Milligram', 'description': 'Patients were administered BI 836826-800 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Eosinophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lymph node pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Aortic valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Diastolic dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypertensive heart disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Mitral valve calcification', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Tricuspid valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 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{'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Vena cava thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Best Percentage Change From Baseline in Number of Lymphocytes in the Peripheral Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 836826 1 Milligram', 'description': 'Patients were administered BI 836826-1 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle'}, {'id': 'OG001', 'title': 'BI 836826 3 Milligram', 'description': 'Patients were administered BI 836826-3 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle'}, {'id': 'OG002', 'title': 'BI 836826 9 Milligram', 'description': 'Patients were administered BI 836826-9 milligram solution for infusion after dilution intravenously as one or two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG003', 'title': 'BI 836826 25 Milligram', 'description': 'Patients were administered BI 836826-25 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG004', 'title': 'BI 836826 50 Milligram', 'description': 'Patients were administered BI 836826-50 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG005', 'title': 'BI 836826 100 Milligram', 'description': 'Patients were administered BI 836826-100 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG006', 'title': 'BI 836826 200 Milligram', 'description': 'Patients were administered BI 836826-200 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG007', 'title': 'BI 836826 400 Milligram', 'description': 'Patients were administered BI 836826-400 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG008', 'title': 'BI 836826 800 Milligram', 'description': 'Patients were administered BI 836826-800 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.39', 'spread': '31.39', 'groupId': 'OG000'}, {'value': '-21.20', 'spread': '10.08', 'groupId': 'OG001'}, {'value': '-48.21', 'spread': '57.39', 'groupId': 'OG002'}, {'value': '-48.15', 'spread': '34.01', 'groupId': 'OG003'}, {'value': '-49.35', 'spread': '31.44', 'groupId': 'OG004'}, {'value': '-81.81', 'spread': '11.03', 'groupId': 'OG005'}, {'value': '-79.22', 'spread': '39.94', 'groupId': 'OG006'}, {'value': '-93.40', 'spread': '9.76', 'groupId': 'OG007'}, {'value': '-47.14', 'spread': '103.29', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and ≥8 day after a completed infusion of a cycle and before Chronic Lymphocytic Leukemia (CLL) therapy; data collected up to cut-off date 26Oct2016, Up to 1809 days', 'description': 'In most patients with relapsed or refractory chronic lymphocytic leukaemia (CLL), malignant B-cells represent the majority of lymphocytes in the peripheral blood. Reduction of CLL-cells was assessed in the peripheral blood by absolute lymphocyte count, and flow cytometry. The number of lymphocytes in the peripheral blood was analysed in terms of the best percentage change from baseline until start of subsequent CLL therapy or progressive disease (PD).', 'unitOfMeasure': 'Percentage of change (%)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who received at least one application of the drug BI 836826, had a baseline and at least one post-baseline assessment of the number of lymphocytes in the peripheral blood.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Improved Haemoglobin Count for at Least Two Subsequent Response Assessments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 836826 1 Milligram', 'description': 'Patients were administered BI 836826-1 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle'}, {'id': 'OG001', 'title': 'BI 836826 3 Milligram', 'description': 'Patients were administered BI 836826-3 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle'}, {'id': 'OG002', 'title': 'BI 836826 9 Milligram', 'description': 'Patients were administered BI 836826-9 milligram solution for infusion after dilution intravenously as one or two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG003', 'title': 'BI 836826 25 Milligram', 'description': 'Patients were administered BI 836826-25 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG004', 'title': 'BI 836826 50 Milligram', 'description': 'Patients were administered BI 836826-50 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG005', 'title': 'BI 836826 100 Milligram', 'description': 'Patients were administered BI 836826-100 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG006', 'title': 'BI 836826 200 Milligram', 'description': 'Patients were administered BI 836826-200 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG007', 'title': 'BI 836826 400 Milligram', 'description': 'Patients were administered BI 836826-400 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG008', 'title': 'BI 836826 800 Milligram', 'description': 'Patients were administered BI 836826-800 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}], 'classes': [{'categories': [{'title': 'NO', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}]}, {'title': 'YES', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '≥8 day after a completed infusion of a cycle and before Chronic Lymphocytic Leukemia (CLL) therapy; data collected up to cut-off date 26Oct2016, Up to 1809 days', 'description': 'In patients with haemoglobin counts below the limits of normal at baseline, improvement in this count during therapy potentially indicated a benefit for the patient. Number of patients with improved haemoglobin count for at least two subsequent response assessments which fulfil International Workshop on Chronic Lymphocytic Leukemia (IWCLL) response criteria for Complete Remission (CR) or Partial Remission (PR). The response was assessed before Progressive Disease (PD) or start of new Chronic Lymphocytic Leukaemia (CLL) therapy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set (TS): All patients who received at least one application of the drug BI 836826.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Improved Platelet Count for at Least Two Subsequent Response Assessments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 836826 1 Milligram', 'description': 'Patients were administered BI 836826-1 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle'}, {'id': 'OG001', 'title': 'BI 836826 3 Milligram', 'description': 'Patients were administered BI 836826-3 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle'}, {'id': 'OG002', 'title': 'BI 836826 9 Milligram', 'description': 'Patients were administered BI 836826-9 milligram solution for infusion after dilution intravenously as one or two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG003', 'title': 'BI 836826 25 Milligram', 'description': 'Patients were administered BI 836826-25 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG004', 'title': 'BI 836826 50 Milligram', 'description': 'Patients were administered BI 836826-50 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG005', 'title': 'BI 836826 100 Milligram', 'description': 'Patients were administered BI 836826-100 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG006', 'title': 'BI 836826 200 Milligram', 'description': 'Patients were administered BI 836826-200 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG007', 'title': 'BI 836826 400 Milligram', 'description': 'Patients were administered BI 836826-400 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG008', 'title': 'BI 836826 800 Milligram', 'description': 'Patients were administered BI 836826-800 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}], 'classes': [{'categories': [{'title': 'NO', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}]}, {'title': 'YES', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '≥8 day after a completed infusion of a cycle and before Chronic Lymphocytic Leukemia (CLL) therapy; data collected up to cut-off date 26Oct2016, Up to 1809 days', 'description': 'In patients with platelet counts below the limits of normal at baseline, improvement in this count during therapy potentially indicated a benefit for the patient. Number of patients with improved platelet count for at least two subsequent response assessments which fulfil International Workshop on Chronic Lymphocytic Leukemia (IWCLL) response criteria for Complete Remission (CR) or Partial Remission (PR). The response was assessed before Progressive Disease (PD) or start of new Chronic Lymphocytic Leukaemia (CLL) therapy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'TS'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Improved Neutrophil Count for at Least Two Subsequent Response Assessments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 836826 1 Milligram', 'description': 'Patients were administered BI 836826-1 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle'}, {'id': 'OG001', 'title': 'BI 836826 3 Milligram', 'description': 'Patients were administered BI 836826-3 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle'}, {'id': 'OG002', 'title': 'BI 836826 9 Milligram', 'description': 'Patients were administered BI 836826-9 milligram solution for infusion after dilution intravenously as one or two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG003', 'title': 'BI 836826 25 Milligram', 'description': 'Patients were administered BI 836826-25 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG004', 'title': 'BI 836826 50 Milligram', 'description': 'Patients were administered BI 836826-50 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG005', 'title': 'BI 836826 100 Milligram', 'description': 'Patients were administered BI 836826-100 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG006', 'title': 'BI 836826 200 Milligram', 'description': 'Patients were administered BI 836826-200 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG007', 'title': 'BI 836826 400 Milligram', 'description': 'Patients were administered BI 836826-400 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG008', 'title': 'BI 836826 800 Milligram', 'description': 'Patients were administered BI 836826-800 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}], 'classes': [{'categories': [{'title': 'YES', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}, {'title': 'NO', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '≥8 day after a completed infusion of a cycle and before Chronic Lymphocytic Leukemia (CLL) therapy; data collected up to cut-off date 26Oct2016, Up to 1809 days', 'description': 'In patients with neutrophil count below the limits of normal at baseline, improvement in this count during therapy potentially indicated a benefit for the patient. Number of patients with improved neutrophil count for at least two subsequent response assessments which fulfil International Workshop on Chronic Lymphocytic Leukemia (IWCLL) response criteria for Complete Remission (CR) or Partial Remission (PR). The response was assessed before Progressive Disease (PD) or start of new Chronic Lymphocytic Leukaemia (CLL) therapy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'TS'}, {'type': 'SECONDARY', 'title': "Best Overall Response According to 'International Workshop on Chronic Lymphocytic Leukemia' (IWCLL) Criteria", 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 836826 1 Milligram', 'description': 'Patients were administered BI 836826-1 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle'}, {'id': 'OG001', 'title': 'BI 836826 3 Milligram', 'description': 'Patients were administered BI 836826-3 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle'}, {'id': 'OG002', 'title': 'BI 836826 9 Milligram', 'description': 'Patients were administered BI 836826-9 milligram solution for infusion after dilution intravenously as one or two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG003', 'title': 'BI 836826 25 Milligram', 'description': 'Patients were administered BI 836826-25 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG004', 'title': 'BI 836826 50 Milligram', 'description': 'Patients were administered BI 836826-50 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG005', 'title': 'BI 836826 100 Milligram', 'description': 'Patients were administered BI 836826-100 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG006', 'title': 'BI 836826 200 Milligram', 'description': 'Patients were administered BI 836826-200 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG007', 'title': 'BI 836826 400 Milligram', 'description': 'Patients were administered BI 836826-400 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG008', 'title': 'BI 836826 800 Milligram', 'description': 'Patients were administered BI 836826-800 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}], 'classes': [{'categories': [{'title': 'Complete remission', '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'}]}, {'title': 'Complete remission with incomplete marrow recovery', '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'}]}, {'title': 'Partial remission', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}]}, {'title': 'Stable disease', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}]}, {'title': 'Progressive disease', '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'}]}, {'title': 'Not evaluable', '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': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Data collected up to cut-off date 26Oct2016 until Progressive disease (PD) to start of next Chronic Lymphocytic Leukaemia (CLL) therapy, Up to 1809 days.', 'description': 'Response was assessed according to the IWCLL (International Workshop on Chronic Lymphocytic Leukemia) guidelines based on laboratory data from the peripheral blood and clinical examination by the investigator after each cycle prior to administration of the next dose of BI 836826, at the end of the treatment (EOT) visit, and at all Follow-up Visits. Best overall response will be analysed descriptively. Frequency distributions will be used to examine this endpoint.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'TS'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 836826 1 Milligram', 'description': 'Patients were administered BI 836826-1 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle'}, {'id': 'OG001', 'title': 'BI 836826 3 Milligram', 'description': 'Patients were administered BI 836826-3 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle'}, {'id': 'OG002', 'title': 'BI 836826 9 Milligram', 'description': 'Patients were administered BI 836826-9 milligram solution for infusion after dilution intravenously as one or two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG003', 'title': 'BI 836826 25 Milligram', 'description': 'Patients were administered BI 836826-25 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG004', 'title': 'BI 836826 50 Milligram', 'description': 'Patients were administered BI 836826-50 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG005', 'title': 'BI 836826 100 Milligram', 'description': 'Patients were administered BI 836826-100 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG006', 'title': 'BI 836826 200 Milligram', 'description': 'Patients were administered BI 836826-200 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG007', 'title': 'BI 836826 400 Milligram', 'description': 'Patients were administered BI 836826-400 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG008', 'title': 'BI 836826 800 Milligram', 'description': 'Patients were administered BI 836826-800 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '57.0', 'groupId': 'OG000', 'lowerLimit': '15.0', 'upperLimit': '316.0'}, {'value': '86.0', 'groupId': 'OG001', 'lowerLimit': '59.0', 'upperLimit': '141.0'}, {'value': '133.5', 'groupId': 'OG002', 'lowerLimit': '79.0', 'upperLimit': '281.0'}, {'value': '81.0', 'groupId': 'OG003', 'lowerLimit': '29.0', 'upperLimit': '134.0'}, {'value': '85.0', 'groupId': 'OG004', 'lowerLimit': '16.0', 'upperLimit': '106.0'}, {'value': '114.0', 'groupId': 'OG005', 'lowerLimit': '44.0', 'upperLimit': '133.0'}, {'value': '196.5', 'groupId': 'OG006', 'lowerLimit': '98.0', 'upperLimit': '247.0'}, {'value': '113.0', 'groupId': 'OG007', 'lowerLimit': '106.0', 'upperLimit': '799.0'}, {'value': '68.0', 'groupId': 'OG008', 'lowerLimit': '51.0', 'upperLimit': '74.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Data collected up to cut-off date 26Oct2016, Up to 1809 days.', 'description': 'Progression-free survival (PFS) was defined as the time from the first administration of BI 836826 until disease progression or death, whichever occurred first. Disease progression= At least one of the following:\n\n* 50+% increase in blood lymphocytes over baseline with an absolute number of B-lymphocytes of at least 5x109/L\n* Progression of lymphadenopathy\n* 50+% increase in the previously noted enlargement of the liver or new appearance of hepatomegaly\n* 50+% increase in the previously noted enlargement of the spleen or new appearance of splenomegaly\n* 50+% Decrease of platelet counts or to less than 100x109/L secondary to CLL and unrelated to autoimmune cytopenia\n* Decrease of haemoglobin levels by more than 20 g/L, or to less than 100 g/L secondary to CLL and unrelated to autoimmune cytopenia T Transformation to a more aggressive histology, e.g. Richter syndrome.', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'TS'}, {'type': 'SECONDARY', 'title': 'Failure-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 836826 1 Milligram', 'description': 'Patients were administered BI 836826-1 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle'}, {'id': 'OG001', 'title': 'BI 836826 3 Milligram', 'description': 'Patients were administered BI 836826-3 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle'}, {'id': 'OG002', 'title': 'BI 836826 9 Milligram', 'description': 'Patients were administered BI 836826-9 milligram solution for infusion after dilution intravenously as one or two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG003', 'title': 'BI 836826 25 Milligram', 'description': 'Patients were administered BI 836826-25 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG004', 'title': 'BI 836826 50 Milligram', 'description': 'Patients were administered BI 836826-50 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG005', 'title': 'BI 836826 100 Milligram', 'description': 'Patients were administered BI 836826-100 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG006', 'title': 'BI 836826 200 Milligram', 'description': 'Patients were administered BI 836826-200 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG007', 'title': 'BI 836826 400 Milligram', 'description': 'Patients were administered BI 836826-400 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG008', 'title': 'BI 836826 800 Milligram', 'description': 'Patients were administered BI 836826-800 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '57.0', 'groupId': 'OG000', 'lowerLimit': '29.0', 'upperLimit': '316.0'}, {'value': '106.0', 'groupId': 'OG001', 'lowerLimit': '59.0', 'upperLimit': '141.0'}, {'value': '152.5', 'groupId': 'OG002', 'lowerLimit': '85.0', 'upperLimit': '281.0'}, {'value': '81.0', 'groupId': 'OG003', 'lowerLimit': '29.0', 'upperLimit': '134.0'}, {'value': '85.0', 'groupId': 'OG004', 'lowerLimit': '25.0', 'upperLimit': '106.0'}, {'value': '114.0', 'groupId': 'OG005', 'lowerLimit': '54.0', 'upperLimit': '133.0'}, {'value': '196.5', 'groupId': 'OG006', 'lowerLimit': '127.0', 'upperLimit': '247.0'}, {'value': '149.0', 'groupId': 'OG007', 'lowerLimit': '120.0', 'upperLimit': '799.0'}, {'value': '100.0', 'groupId': 'OG008', 'lowerLimit': '68.0', 'upperLimit': '141.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Data collected up to cut-off date 26Oct2016, Up to 1809 days.', 'description': 'Failure-free survival (FFS) was defined as the time from the first administration of BI 836826 until disease progression or death, or start of next Chronic Lymphocytic Leukemia (CLL) therapy, whichever occurred first. Disease progression= At least one of the following:\n\n* 50+% increase in blood lymphocytes over baseline with an absolute number of B-lymphocytes of at least 5x109/L\n* Progression of lymphadenopathy\n* 50+% increase in the previously noted enlargement of the liver or new appearance of hepatomegaly\n* 50+% increase in the previously noted enlargement of the spleen or new appearance of splenomegaly\n* 50+% Decrease of platelet counts or to less than 100x109/L secondary to CLL and unrelated to autoimmune cytopenia\n* Decrease of haemoglobin levels by more than 20 g/L, or to less than 100 g/L secondary to CLL and unrelated to autoimmune cytopenia T Transformation to a more aggressive histology, e.g. Richter syndrome.', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'TS'}, {'type': 'PRIMARY', 'title': 'Number of Patients With Dose-Limiting Toxicities Adverse Events (DLTs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 836826 1 Milligram', 'description': 'Patients were administered BI 836826-1 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle'}, {'id': 'OG001', 'title': 'BI 836826 3 Milligram', 'description': 'Patients were administered BI 836826-3 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle'}, {'id': 'OG002', 'title': 'BI 836826 9 Milligram', 'description': 'Patients were administered BI 836826-9 milligram solution for infusion after dilution intravenously as one or two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG003', 'title': 'BI 836826 25 Milligram', 'description': 'Patients were administered BI 836826-25 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG004', 'title': 'BI 836826 50 Milligram', 'description': 'Patients were administered BI 836826-50 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG005', 'title': 'BI 836826 100 Milligram', 'description': 'Patients were administered BI 836826-100 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG006', 'title': 'BI 836826 200 Milligram', 'description': 'Patients were administered BI 836826-200 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG007', 'title': 'BI 836826 400 Milligram', 'description': 'Patients were administered BI 836826-400 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'OG008', 'title': 'BI 836826 800 Milligram', 'description': 'Patients were administered BI 836826-800 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}], 'classes': [{'categories': [{'title': 'Total with dose limiting toxicities adverse events', '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': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14 days after first administration of BI836826 (MTD evaluation period)', 'description': 'Dose-Limiting Toxicities (DLTs) were defined as any drug-related non-haematologic adverse event of Common Terminology Criteria for AE (CTCAE) Grade 3 or higher, except infusion related reactions associated with the administration of BI 836826. In addition complications due to haematologic AEs were considered as DLTs and were added in more detail in an amendment later on.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The maximum tolerated dose (MTD) evaluation set: This includes all patients who were documented to have received at least one dose of trial medication and were not replaced for the MTD evaluation.'}, {'type': 'PRIMARY', 'title': 'Maximum Tolerated Dose (MTD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 836826', 'description': 'Patients were administered BI 836826 solution for infusion after dilution intravenously as one or two doses within the first cycle followed by a single doses within all following 14-day cycles in the higher dose groups (\\>9 milligram BI 836826).'}], 'timeFrame': '14 days after first administration of BI836826 (MTD evaluation period)', 'description': 'The maximum tolerated dose (MTD) was defined as the highest dose of BI 836826 studied for which the incidence of DLT was no more than 17% (i.e. 1 out of 6 patients) during the first treatment cycle. For those patients who received more than 1 cycle of BI 836826, all AEs corresponding to the DLT were considered for the purpose of confirming the MTD and for the selection of the recommended dose for treatment of the expansion cohort and for further development. All DLTs, occurring during the first or repeated treatment cycle were reported as significant AEs. As it was not possible to recruit a sufficient number of patients whilst the first part of the trial was still in progress, the recruitment was ended by the sponsor before the MTD or optimal biological dose (OBD) was reached.', 'reportingStatus': 'POSTED', 'populationDescription': 'The trial was discontinued prematurely due to lack of recruitment before the MTD based on the frequency of patients with DLTs in the first treatment cycle was reached.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BI 836826 1 Milligram', 'description': 'Patients were administered BI 836826-1 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle'}, {'id': 'FG001', 'title': 'BI 836826 3 Milligram', 'description': 'Patients were administered BI 836826-3 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle'}, {'id': 'FG002', 'title': 'BI 836826 9 Milligram', 'description': 'Patients were administered BI 836826-9 milligram solution for infusion after dilution intravenously as one or two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'FG003', 'title': 'BI 836826 25 Milligram', 'description': 'Patients were administered BI 836826-25 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'FG004', 'title': 'BI 836826 50 Milligram', 'description': 'Patients were administered BI 836826-50 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'FG005', 'title': 'BI 836826 100 Milligram', 'description': 'Patients were administered BI 836826-100 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'FG006', 'title': 'BI 836826 200 Milligram', 'description': 'Patients were administered BI 836826-200 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'FG007', 'title': 'BI 836826 400 Milligram', 'description': 'Patients were administered BI 836826-400 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'FG008', 'title': 'BI 836826 800 Milligram', 'description': 'Patients were administered BI 836826-800 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '4'}]}, {'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': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Dose limiting toxicity', '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': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}]}, {'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}]}, {'type': 'Investigator decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}]}, {'type': 'No clinical benefit anymore', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'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'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'IV problems, administration not possible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'per protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Low benefit and too many side effects', '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': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'No adequate treatment response', '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': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Dosage already reduced, AE still present', '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': '1'}]}]}], 'recruitmentDetails': 'This was a Phase-1,single arm,open-label,dose escalation trial, patients with advanced chronic lymphocytic leukemia. While the first part of the trial was still in progress, recruitment was ended by the sponsor before the maximum tolerated dose(MTD) or Optimal Biological Dose(OBD) was reached.', 'preAssignmentDetails': 'All patients were screened for eligibility to participate in the trial. Patients attended specialist sites to ensure that all patients met all inclusion/exclusion criteria. Patients were not to be entered to trial treatment if any one of the specific entry criteria were not met.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}, {'value': '37', 'groupId': 'BG009'}]}], 'groups': [{'id': 'BG000', 'title': 'BI 836826 1 Milligram', 'description': 'Patients were administered BI 836826-1 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle'}, {'id': 'BG001', 'title': 'BI 836826 3 Milligram', 'description': 'Patients were administered BI 836826-3 milligram solution for infusion after dilution intravenously as one single dose within a 14-day cycle'}, {'id': 'BG002', 'title': 'BI 836826 9 Milligram', 'description': 'Patients were administered BI 836826-9 milligram solution for infusion after dilution intravenously as one or two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'BG003', 'title': 'BI 836826 25 Milligram', 'description': 'Patients were administered BI 836826-25 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'BG004', 'title': 'BI 836826 50 Milligram', 'description': 'Patients were administered BI 836826-50 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'BG005', 'title': 'BI 836826 100 Milligram', 'description': 'Patients were administered BI 836826-100 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'BG006', 'title': 'BI 836826 200 Milligram', 'description': 'Patients were administered BI 836826-200 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'BG007', 'title': 'BI 836826 400 Milligram', 'description': 'Patients were administered BI 836826-400 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'BG008', 'title': 'BI 836826 800 Milligram', 'description': 'Patients were administered BI 836826-800 milligram solution for infusion after dilution intravenously as two doses within the first cycle followed by single doses within all following 14-day cycles'}, {'id': 'BG009', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.7', 'spread': '8.4', 'groupId': 'BG000'}, {'value': '74.3', 'spread': '5.7', 'groupId': 'BG001'}, {'value': '63.3', 'spread': '10.0', 'groupId': 'BG002'}, {'value': '58.7', 'spread': '9.6', 'groupId': 'BG003'}, {'value': '63.3', 'spread': '13.2', 'groupId': 'BG004'}, {'value': '61.0', 'spread': '17.0', 'groupId': 'BG005'}, {'value': '73.3', 'spread': '5.4', 'groupId': 'BG006'}, {'value': '70.7', 'spread': '11.4', 'groupId': 'BG007'}, {'value': '69.5', 'spread': '6.5', 'groupId': 'BG008'}, {'value': '66.5', 'spread': '10.2', 'groupId': 'BG009'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '11', 'groupId': 'BG009'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '26', 'groupId': 'BG009'}]}]}], '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'}]}, {'title': 'Asian', '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'}]}, {'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'}]}, {'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'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '21', 'groupId': 'BG009'}]}, {'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'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '16', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Ethnicity data were not collected for the study. Race was not collected in France due to law (These are the missing/unknown).', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Treated Set (TS): All patients who received at least one application of the drug BI 836826.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-10-13', 'size': 383883, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-12-07T05:03', 'hasProtocol': False}, {'date': '2015-03-04', 'size': 934881, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-12-07T05:03', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2017-07-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-10', 'studyFirstSubmitDate': '2011-02-15', 'resultsFirstSubmitDate': '2018-12-11', 'studyFirstSubmitQcDate': '2011-02-15', 'lastUpdatePostDateStruct': {'date': '2020-08-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-10', 'studyFirstPostDateStruct': {'date': '2011-02-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients With Dose-Limiting Toxicities Adverse Events (DLTs)', 'timeFrame': '14 days after first administration of BI836826 (MTD evaluation period)', 'description': 'Dose-Limiting Toxicities (DLTs) were defined as any drug-related non-haematologic adverse event of Common Terminology Criteria for AE (CTCAE) Grade 3 or higher, except infusion related reactions associated with the administration of BI 836826. In addition complications due to haematologic AEs were considered as DLTs and were added in more detail in an amendment later on.'}, {'measure': 'Maximum Tolerated Dose (MTD)', 'timeFrame': '14 days after first administration of BI836826 (MTD evaluation period)', 'description': 'The maximum tolerated dose (MTD) was defined as the highest dose of BI 836826 studied for which the incidence of DLT was no more than 17% (i.e. 1 out of 6 patients) during the first treatment cycle. For those patients who received more than 1 cycle of BI 836826, all AEs corresponding to the DLT were considered for the purpose of confirming the MTD and for the selection of the recommended dose for treatment of the expansion cohort and for further development. All DLTs, occurring during the first or repeated treatment cycle were reported as significant AEs. As it was not possible to recruit a sufficient number of patients whilst the first part of the trial was still in progress, the recruitment was ended by the sponsor before the MTD or optimal biological dose (OBD) was reached.'}], 'secondaryOutcomes': [{'measure': 'Best Percentage Change From Baseline in Number of Lymphocytes in the Peripheral Blood', 'timeFrame': 'baseline and ≥8 day after a completed infusion of a cycle and before Chronic Lymphocytic Leukemia (CLL) therapy; data collected up to cut-off date 26Oct2016, Up to 1809 days', 'description': 'In most patients with relapsed or refractory chronic lymphocytic leukaemia (CLL), malignant B-cells represent the majority of lymphocytes in the peripheral blood. Reduction of CLL-cells was assessed in the peripheral blood by absolute lymphocyte count, and flow cytometry. The number of lymphocytes in the peripheral blood was analysed in terms of the best percentage change from baseline until start of subsequent CLL therapy or progressive disease (PD).'}, {'measure': 'Number of Patients With Improved Haemoglobin Count for at Least Two Subsequent Response Assessments', 'timeFrame': '≥8 day after a completed infusion of a cycle and before Chronic Lymphocytic Leukemia (CLL) therapy; data collected up to cut-off date 26Oct2016, Up to 1809 days', 'description': 'In patients with haemoglobin counts below the limits of normal at baseline, improvement in this count during therapy potentially indicated a benefit for the patient. Number of patients with improved haemoglobin count for at least two subsequent response assessments which fulfil International Workshop on Chronic Lymphocytic Leukemia (IWCLL) response criteria for Complete Remission (CR) or Partial Remission (PR). The response was assessed before Progressive Disease (PD) or start of new Chronic Lymphocytic Leukaemia (CLL) therapy.'}, {'measure': 'Number of Patients With Improved Platelet Count for at Least Two Subsequent Response Assessments', 'timeFrame': '≥8 day after a completed infusion of a cycle and before Chronic Lymphocytic Leukemia (CLL) therapy; data collected up to cut-off date 26Oct2016, Up to 1809 days', 'description': 'In patients with platelet counts below the limits of normal at baseline, improvement in this count during therapy potentially indicated a benefit for the patient. Number of patients with improved platelet count for at least two subsequent response assessments which fulfil International Workshop on Chronic Lymphocytic Leukemia (IWCLL) response criteria for Complete Remission (CR) or Partial Remission (PR). The response was assessed before Progressive Disease (PD) or start of new Chronic Lymphocytic Leukaemia (CLL) therapy.'}, {'measure': 'Number of Patients With Improved Neutrophil Count for at Least Two Subsequent Response Assessments', 'timeFrame': '≥8 day after a completed infusion of a cycle and before Chronic Lymphocytic Leukemia (CLL) therapy; data collected up to cut-off date 26Oct2016, Up to 1809 days', 'description': 'In patients with neutrophil count below the limits of normal at baseline, improvement in this count during therapy potentially indicated a benefit for the patient. Number of patients with improved neutrophil count for at least two subsequent response assessments which fulfil International Workshop on Chronic Lymphocytic Leukemia (IWCLL) response criteria for Complete Remission (CR) or Partial Remission (PR). The response was assessed before Progressive Disease (PD) or start of new Chronic Lymphocytic Leukaemia (CLL) therapy.'}, {'measure': "Best Overall Response According to 'International Workshop on Chronic Lymphocytic Leukemia' (IWCLL) Criteria", 'timeFrame': 'Data collected up to cut-off date 26Oct2016 until Progressive disease (PD) to start of next Chronic Lymphocytic Leukaemia (CLL) therapy, Up to 1809 days.', 'description': 'Response was assessed according to the IWCLL (International Workshop on Chronic Lymphocytic Leukemia) guidelines based on laboratory data from the peripheral blood and clinical examination by the investigator after each cycle prior to administration of the next dose of BI 836826, at the end of the treatment (EOT) visit, and at all Follow-up Visits. Best overall response will be analysed descriptively. Frequency distributions will be used to examine this endpoint.'}, {'measure': 'Progression-free Survival', 'timeFrame': 'Data collected up to cut-off date 26Oct2016, Up to 1809 days.', 'description': 'Progression-free survival (PFS) was defined as the time from the first administration of BI 836826 until disease progression or death, whichever occurred first. Disease progression= At least one of the following:\n\n* 50+% increase in blood lymphocytes over baseline with an absolute number of B-lymphocytes of at least 5x109/L\n* Progression of lymphadenopathy\n* 50+% increase in the previously noted enlargement of the liver or new appearance of hepatomegaly\n* 50+% increase in the previously noted enlargement of the spleen or new appearance of splenomegaly\n* 50+% Decrease of platelet counts or to less than 100x109/L secondary to CLL and unrelated to autoimmune cytopenia\n* Decrease of haemoglobin levels by more than 20 g/L, or to less than 100 g/L secondary to CLL and unrelated to autoimmune cytopenia T Transformation to a more aggressive histology, e.g. Richter syndrome.'}, {'measure': 'Failure-free Survival', 'timeFrame': 'Data collected up to cut-off date 26Oct2016, Up to 1809 days.', 'description': 'Failure-free survival (FFS) was defined as the time from the first administration of BI 836826 until disease progression or death, or start of next Chronic Lymphocytic Leukemia (CLL) therapy, whichever occurred first. Disease progression= At least one of the following:\n\n* 50+% increase in blood lymphocytes over baseline with an absolute number of B-lymphocytes of at least 5x109/L\n* Progression of lymphadenopathy\n* 50+% increase in the previously noted enlargement of the liver or new appearance of hepatomegaly\n* 50+% increase in the previously noted enlargement of the spleen or new appearance of splenomegaly\n* 50+% Decrease of platelet counts or to less than 100x109/L secondary to CLL and unrelated to autoimmune cytopenia\n* Decrease of haemoglobin levels by more than 20 g/L, or to less than 100 g/L secondary to CLL and unrelated to autoimmune cytopenia T Transformation to a more aggressive histology, e.g. Richter syndrome.'}]}, 'conditionsModule': {'conditions': ['Leukemia, Lymphocytic, Chronic, B-Cell']}, 'descriptionModule': {'briefSummary': 'Adult patients with chronic lymphocytic leukaemia who experience a relapse after at least two prior treatment regimens may be enrolled in this trial. The trial will examine whether monotherapy with BI 836826 is safe and tolerable at escalating dose levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Diagnosis of relapsed or refractory chronic lymphocytic leukaemia.\n2. At least two prior treatment regimens for chronic lymphocytic leukaemia.\n3. At least one criterion for active disease as defined by the International Workshop on CLL.\n4. Absolute lymphocyte count lower than 200 x 10\\^9/l .\n5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2.\n6. Age 18 years or older.\n7. Written informed consent which is consistent with International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) guidelines and local legislation.\n\nExclusion criteria:\n\n1. Treatment with anti Cluster of Differentiation (CD) 20 therapy within 4 weeks, or alemtuzumab within 8 weeks, or any cytotoxic antileukemia therapy within 2 weeks, Ibrutinib or Idelalisib within 1 week prior to the first administration of the trial drug.\n2. Prior allogeneic stem cell transplantation.\n3. Active autoimmune haemolytic anemia.\n4. Active autoimmune thrombocytopenia.\n5. Known transformation to an aggressive B-cell malignancy.\n6. Concurrent treatment with relevant doses of systemic glucocorticosteroids.\n7. Prior history of malignancy other than chronic lymphocytic leukaemia (exceptions to this rule are defined in the clinical trial protocol).\n8. Aspartate aminotransferase or alanine aminotransferase \\> 2.5 x upper limit of normal.\n9. Total bilirubin \\> 1.5 x upper limit of normal.\n10. Absolute Neutrophil Count \\< 1.000/µl.\n11. Platelets \\< 25.000/µL.\n12. Estimated Glomerular Filtration Rate \\<45 mL/min.\n13. Proteinuria Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or higher.\n14. Significant concurrent disease.\n15. Any infectious disease requiring treatment at the time of enrolment or within the previous 2 weeks.\n16. Hepatitis B or C.\n17. Human Immunodeficiency Virus (HIV) infection.\n18. Cytomegalovirus (CMV) viremia.\n19. Women of childbearing potential not using a highly effective method of birth control during the trial until one year after the last dose.\n20. Pregnancy or breast feeding.\n21. Known or suspected active alcohol or drug abuse.\n22. Treatment with another investigational drug within the past four weeks before start of therapy or concomitantly with this trial.\n23. Prior treatment with BI 836826.\n24. Patients unable to comply with the protocol'}, 'identificationModule': {'nctId': 'NCT01296932', 'briefTitle': 'BI836826 Dose Escalation in Relapsed Chronic Lymphocytic Leukaemia (CLL)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Phase I, Open, Dose Escalation Trial With BI 836826 in Patients With Advanced Chronic Lymphocytic Leukaemia', 'orgStudyIdInfo': {'id': '1270.1'}, 'secondaryIdInfos': [{'id': '2010-021488-34', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with relapsed CLL', 'description': 'Patients with relapsed CLL after at least two prior treatment regimens will receive BI 836826.', 'interventionNames': ['Drug: BI 836826']}], 'interventions': [{'name': 'BI 836826', 'type': 'DRUG', 'description': 'Monotherapy with BI 836826 at escalating dose levels administered as an intravenous infusion.', 'armGroupLabels': ['Patients with relapsed CLL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Brussels - UNIV Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '2650', 'city': 'Edegem', 'country': 'Belgium', 'facility': 'Edegem - UNIV UZ Antwerpen', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'UNIV UZ Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '13273', 'city': 'Marseille', 'country': 'France', 'facility': 'INS Paoli-Calmettes', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'CTR Investigation Clinique, onco, Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'INS Universitaire du Cancer', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '50937', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Universitätsklinikum Köln (AöR)', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '60590', 'city': 'Frankfurt am Main', 'country': 'Germany', 'facility': 'Universitätsklinikum Frankfurt', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Universitätsklinikum Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '89081', 'city': 'Ulm', 'country': 'Germany', 'facility': 'Universitätsklinikum Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}