Ignite Creation Date:
2025-12-24 @ 7:37 PM
Ignite Modification Date:
2025-12-29 @ 11:20 PM
Study NCT ID:
NCT01004003
Status:
COMPLETED
Last Update Posted:
2017-10-26
First Post:
2009-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase I/II Comparison of Efficacy and Safety of BIBF 1120 and Sorafenib in Patients With Advanced Hepatocellular Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Slovakia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077157', 'term': 'Sorafenib'}, {'id': 'C530716', 'term': 'nintedanib'}], 'ancestors': [{'id': 'D010671', 'term': 'Phenylurea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009536', 'term': 'Niacinamide'}, {'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days', 'eventGroups': [{'id': 'EG000', 'title': 'Phase 1 Group 1, 100mg Nintedanib Bid', 'description': 'Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD). Group 1 patients had a baseline Child-Pugh score of 5 or 6, and aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤2 times the upper limit of normal (ULN).', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Phase I Group 1, 150mg Nintedanib Bid', 'description': 'Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Phase I Group 1, 200mg Nintedanib Bid', 'description': 'Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).', 'otherNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Phase I Group 2, 50mg Nintedanib Bid', 'description': 'Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \\>2 to ≤5 times ULN.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'Phase I Group 2, 100mg Nintedanib Bid', 'description': 'Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \\>2 to ≤5 times ULN.', 'otherNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': 'Phase I Group 2, 150mg Nintedanib Bid', 'description': 'Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \\>2 to ≤5 times ULN.', 'otherNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'seriousNumAffected': 3}, {'id': 'EG006', 'title': 'Phase I Group 2, 200mg Nintedanib Bid', 'description': 'Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \\>2 to ≤5 times ULN.', 'otherNumAtRisk': 8, 'otherNumAffected': 7, 'seriousNumAtRisk': 8, 'seriousNumAffected': 4}, {'id': 'EG007', 'title': 'Phase II, 200 mg Nintedanib Bid', 'description': 'Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).', 'otherNumAtRisk': 62, 'otherNumAffected': 61, 'seriousNumAtRisk': 62, 'seriousNumAffected': 34}, {'id': 'EG008', 'title': 'Phase II, 400 mg Sorafenib Bid', 'description': 'Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).', 'otherNumAtRisk': 31, 'otherNumAffected': 31, 'seriousNumAtRisk': 31, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cerumen impaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Deafness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Eye discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 15}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 16}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abdominal tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Anorectal varices', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 9}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 43}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 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'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Respiratory alkalosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Stevens-Johnson syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hepatectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Bleeding varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Tolerated Dose in Phase I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN)'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Patients had a baseline Child-Pugh score of 7, or AST or ALT \\>2 to ≤5 times ULN.'}], 'classes': [{'categories': [{'measurements': [{'value': '200', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': 'The MTD was defined as the highest dose studied for which the incidence of dose limiting toxicities (DLTs) was 0/3 or less than 2/6 patients during the first treatment course.', 'unitOfMeasure': 'mg bid', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set which included all patients who received at least one single dose of trial medication, including phase I patients from the dose escalation part that were not replaced for MTD determination.'}, {'type': 'PRIMARY', 'title': 'Time to Progression (TTP) in Phase II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II, 200 mg Nintedanib Bid', 'description': 'Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).'}, {'id': 'OG001', 'title': 'Phase II, 400 mg Sorafenib Bid', 'description': 'Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).'}], 'classes': [{'categories': [{'measurements': [{'value': '5.45', 'groupId': 'OG000', 'lowerLimit': '2.69', 'upperLimit': '9.20'}, {'value': '4.63', 'groupId': 'OG001', 'lowerLimit': '2.79', 'upperLimit': '20.40'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.437', 'ciLowerLimit': '0.805', 'ciUpperLimit': '2.565', 'estimateComment': 'Hazard ratio (HR) from Cox proportional hazards model stratified by macroscopic vacular invasion, extrahepatic spread, or both present vs both absent.\n\nHR below 1 favors Nintedanib.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization until data cut-off (15 July 2014); Up to 1031 days', 'description': 'TTP according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.0 criteria based on central independent review. TTP RECIST 1.0 was defined as the time from randomisation to disease progression according to RECIST 1.0.', 'unitOfMeasure': 'months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set, only phase II participants.'}, {'type': 'SECONDARY', 'title': 'Incidence of Dose Limiting Toxicity in Phase I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I Group I, 100 mg Nintedanib Bid', 'description': 'Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).\n\nPhase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD).\n\nGroup 1 patients had a baseline Child-Pugh score of 5 or 6, and AST (aspartate aminotransferase ) and ALT (alanine transaminase) ≤2 times the upper limit of normal (ULN).'}, {'id': 'OG001', 'title': 'Phase I Group 1, 150 mg Nintedanib Bid', 'description': 'Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).\n\nPhase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).'}, {'id': 'OG002', 'title': 'Phase I Group 1, 200 mg Nintedanib Bid', 'description': 'Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid).\n\nPhase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).'}, {'id': 'OG003', 'title': 'Phase I Group 2, 50 mg Nintedanib Bid', 'description': 'Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid).\n\nPhase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \\>2 to ≤5 times ULN.'}, {'id': 'OG004', 'title': 'Phase I Group 2, 100 mg Nintedanib Bid', 'description': 'Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).\n\nPhase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \\>2 to ≤5 times ULN.'}, {'id': 'OG005', 'title': 'Phase I Group 2, 150 mg Nintedanib Bid', 'description': 'Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).\n\nPhase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \\>2 to ≤5 times ULN.'}, {'id': 'OG006', 'title': 'Phase I Group 2, 200 mg Nintedanib Bid', 'description': 'Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg)twice daily (bid).\n\nPhase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \\>2 to ≤5 times ULN.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': 'Number of patients with dose limiting toxicity are presented', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (Phase I patients from the dose escalation part that were not replaced for MTD determination).'}, {'type': 'SECONDARY', 'title': 'Objective Tumour Response by RECIST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II, 200 mg Nintedanib Bid', 'description': 'Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).'}, {'id': 'OG001', 'title': 'Phase II, 400 mg Sorafenib Bid', 'description': 'Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '8.7'}, {'value': '6.5', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '21.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization until data cut-off (15 July 2014); Up to 1031 days', 'description': "Objective RECIST 1.0 tumour response was defined as Complete Response (CR) or Partial Response (PR) and was derived from the patient's best objective RECIST 1.0 response based on central independent review.\n\n95% Confidence Interval presented below are computed by Clopper and Pearson method.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set, phase II participants only'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II, 200 mg Nintedanib Bid', 'description': 'Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).'}, {'id': 'OG001', 'title': 'Phase II, 400 mg Sorafenib Bid', 'description': 'Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).'}], 'classes': [{'categories': [{'measurements': [{'value': '5.32', 'groupId': 'OG000', 'lowerLimit': '2.69', 'upperLimit': '9.20'}, {'value': '3.94', 'groupId': 'OG001', 'lowerLimit': '2.33', 'upperLimit': '7.36'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.351', 'ciLowerLimit': '0.779', 'ciUpperLimit': '2.343', 'estimateComment': 'Hazard ratio from Cox proportional hazards model stratified by macroscopic vacular invasion, extrahepatic spread, or both present vs both absent.\n\nHR below 1 favors Nintedanib.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization until data cut-off (15 July 2014); Up to 1031 days', 'description': 'PFS by RECIST 1.0 was defined as the duration from date of randomisation to date of progression or death, whichever occurred earlier, based on central independent review.', 'unitOfMeasure': 'months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set, only phase II participants'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II, 200 mg Nintedanib Bid', 'description': 'Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).'}, {'id': 'OG001', 'title': 'Phase II, 400 mg Sorafenib Bid', 'description': 'Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).'}], 'classes': [{'categories': [{'measurements': [{'value': '11.86', 'groupId': 'OG000', 'lowerLimit': '6.60', 'upperLimit': '25.46'}, {'value': '11.40', 'groupId': 'OG001', 'lowerLimit': '6.51', 'upperLimit': '17.25'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.877', 'ciLowerLimit': '0.522', 'ciUpperLimit': '1.473', 'estimateComment': 'Hazard ratio from Cox proportional hazards model stratified by macroscopic vacular invasion, extrahepatic spread, or both present vs both absent.\n\nHR below 1 favors Nintedanib.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization until data cut-off (15 July 2014); Up to 1031 days', 'description': 'Overall survival was defined as the duration from date of randomisation to the date of death.', 'unitOfMeasure': 'months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set, only phase II participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase 1 Group 1, 100mg Nintedanib Bid', 'description': 'Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD). Group 1 patients had a baseline Child-Pugh score of 5 or 6, and aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤2 times the upper limit of normal (ULN).'}, {'id': 'FG001', 'title': 'Phase I Group 1, 150mg Nintedanib Bid', 'description': 'Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).'}, {'id': 'FG002', 'title': 'Phase I Group 1, 200mg Nintedanib Bid', 'description': 'Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).'}, {'id': 'FG003', 'title': 'Phase I Group 2, 50mg Nintedanib Bid', 'description': 'Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \\>2 to ≤5 times ULN.'}, {'id': 'FG004', 'title': 'Phase I Group 2, 100mg Nintedanib Bid', 'description': 'Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \\>2 to ≤5 times ULN.'}, {'id': 'FG005', 'title': 'Phase I Group 2, 150mg Nintedanib Bid', 'description': 'Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \\>2 to ≤5 times ULN.'}, {'id': 'FG006', 'title': 'Phase I Group 2, 200mg Nintedanib Bid', 'description': 'Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \\>2 to ≤5 times ULN.'}, {'id': 'FG007', 'title': 'Phase II, 200 mg Nintedanib Bid', 'description': 'Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).'}, {'id': 'FG008', 'title': 'Phase II, 400 mg Sorafenib Bid', 'description': 'Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). 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Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).'}, {'id': 'BG008', 'title': 'Phase II, 400 mg Sorafenib Bid', 'description': 'Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).'}, {'id': 'BG009', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.7', 'spread': '6.8', 'groupId': 'BG000'}, {'value': '65.0', 'spread': '7.8', 'groupId': 'BG001'}, {'value': '66.5', 'spread': '4.0', 'groupId': 'BG002'}, {'value': '72.3', 'spread': '11.7', 'groupId': 'BG003'}, {'value': '56.3', 'spread': '6.4', 'groupId': 'BG004'}, {'value': '59.3', 'spread': '13.9', 'groupId': 'BG005'}, {'value': '57.0', 'spread': '11.0', 'groupId': 'BG006'}, {'value': '65.4', 'spread': '10.0', 'groupId': 'BG007'}, {'value': '63.1', 'spread': '11.8', 'groupId': 'BG008'}, {'value': '64.2', 'spread': '10.5', 'groupId': 'BG009'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '14', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '24', 'groupId': 'BG009'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '48', 'groupId': 'BG007'}, {'value': '26', 'groupId': 'BG008'}, {'value': '101', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Treated set which included all patients who received at least one single dose of trial medication.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'dispFirstSubmitDate': '2014-08-18', 'completionDateStruct': {'date': '2016-10-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-25', 'studyFirstSubmitDate': '2009-10-12', 'dispFirstSubmitQcDate': '2014-08-18', 'resultsFirstSubmitDate': '2015-07-09', 'studyFirstSubmitQcDate': '2009-10-28', 'dispFirstPostDateStruct': {'date': '2014-08-20', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-10-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-07-09', 'studyFirstPostDateStruct': {'date': '2009-10-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Tolerated Dose in Phase I', 'timeFrame': '4 weeks', 'description': 'The MTD was defined as the highest dose studied for which the incidence of dose limiting toxicities (DLTs) was 0/3 or less than 2/6 patients during the first treatment course.'}, {'measure': 'Time to Progression (TTP) in Phase II', 'timeFrame': 'From randomization until data cut-off (15 July 2014); Up to 1031 days', 'description': 'TTP according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.0 criteria based on central independent review. TTP RECIST 1.0 was defined as the time from randomisation to disease progression according to RECIST 1.0.'}], 'secondaryOutcomes': [{'measure': 'Incidence of Dose Limiting Toxicity in Phase I', 'timeFrame': '4 weeks', 'description': 'Number of patients with dose limiting toxicity are presented'}, {'measure': 'Objective Tumour Response by RECIST', 'timeFrame': 'From randomization until data cut-off (15 July 2014); Up to 1031 days', 'description': "Objective RECIST 1.0 tumour response was defined as Complete Response (CR) or Partial Response (PR) and was derived from the patient's best objective RECIST 1.0 response based on central independent review.\n\n95% Confidence Interval presented below are computed by Clopper and Pearson method."}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'From randomization until data cut-off (15 July 2014); Up to 1031 days', 'description': 'PFS by RECIST 1.0 was defined as the duration from date of randomisation to date of progression or death, whichever occurred earlier, based on central independent review.'}, {'measure': 'Overall Survival', 'timeFrame': 'From randomization until data cut-off (15 July 2014); Up to 1031 days', 'description': 'Overall survival was defined as the duration from date of randomisation to the date of death.'}]}, 'conditionsModule': {'conditions': ['Carcinoma, Hepatocellular']}, 'descriptionModule': {'briefSummary': 'The study aim is to determine maximally tolerated dose (MTD) of BIBF 1120 in HCC (hepatocellular cancer) and compare efficacy of BIBF 1120 to Sorafenib in HCC patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Histologically or cytologically confirmed diagnosis of hepatocellular carcinoma (HCC) not amenable to curative surgery or loco-regional therapy (RFA, percutaneous ethanol injection (PEI), TACE)\n* Age 18 years or older\n* Eastern Cooperative Oncology Group performance score of 2 or less\n* Child-Pugh score A (score 5-6)\n* At least one measurable lesion according to RECIST 1.0 (this criterion is limited to phase II only)\n* In case a measurable lesion was previously treated by loco-regional therapy (RFA, PEI, TACE or RT) , this lesion must have to be documented as progression according to RECIST 1.0 by CT or MRI (this criterion is limited to phase II only).\n* Time interval from last local therapy (e.g. radiofrequency ablation, percutaneous ethanol injection, radiotherapy, transarterial chemoembolization) more than 4 weeks prior to start of study treatment\n* Written informed consent consistent with International Conference on Harmonisation/ Good Clinical Practice (ICH-GCP) and local legislation\n\nExclusion criteria:\n\n* Prior systemic therapy for HCC\n* Fibrolamellar hepatocellular carcinoma (HCC)\n* Bilirubin greater than 1.5 times ULN\n* AST or ALT greater than 2 times ULN\n* Uncontrolled or refractory ascites to adequate medical therapy\n* Hepatic encephalopathy more than grade 1 according to Child-Pugh criteria\n* Prothrombin time international normalized ratio greater than 2.3, or prothrombin time more than 6 seconds prolonged than control\n* Absolute neutrophil count less than 1000 /µL\n* Platelet count less than 60000 /µL\n* Hemoglobin less than 9 g/dL\n* Serum creatinine greater than 1.5 times Upper Limit of Normal (ULN)\n* Proteinuria of Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or greater\n* Variceal bleeding within last 6 months prior to start of study treatment\n* History of major thrombotic (except portal vein thrombosis) or clinically relevant major bleeding event in the past 6 months\n* Known inherited predisposition to bleeding or thrombosis\n* Significant cardiovascular diseases (i.e. hypertension not controlled by medical therapy, blood pressure \\> 150/90 mmHg), unstable angina, history of myocardial infarction within the past 6 months, congestive heart failure \\> class II according to New York Heart Association (NYHA), serious cardiac arrhythmia, pericardial effusion)\n* Therapeutic anticoagulation (except low dose heparin and/or heparin flush as needed for maintenance of an indwelling intravenous device) or antiplatelet therapy (except for chronic low-dose therapy with acetylsalicylic acid =\\< 325mg per day)\n* Major surgery within 4 weeks prior to start of study treatment\n* Treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial (except for present trial drug)\n* Known serious illness or concomitant non-oncological disease such as neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may increase the risk associated with study participation or study drug administration and in the judgment of the investigator would make the patient inappropriate for entry into the study\n* Patients who are sexually active and unwilling to use a medically acceptable method of contraception (e.g. such as implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner for participating females, condoms for participating males) during the trial and for at least twelve months after end of active therapy\n* Current alcohol abuse or drug abuse that would limit pt ability to comply with protocol\n* Symptomatic central nervous system (CNS) metastasis\n* Life expectancy less than 12 weeks\n* Patient unable to take oral medication'}, 'identificationModule': {'nctId': 'NCT01004003', 'briefTitle': 'Phase I/II Comparison of Efficacy and Safety of BIBF 1120 and Sorafenib in Patients With Advanced Hepatocellular Carcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Multicenter, Open Label, Phase I /Randomised Phase II Study to Evaluate Safety, 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