Ignite Creation Date:
2025-12-24 @ 7:15 PM
Ignite Modification Date:
2025-12-25 @ 4:52 PM
Study NCT ID:
NCT00715403
Status:
COMPLETED
Last Update Posted:
2014-12-02
First Post:
2008-07-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Phase I/II Open Label Extension Study of BIBF 1120 Administered Orally Once or Twice Daily to Establish Safety, Pharmacokinetics and Efficacy in Patients With Advanced Solid Tumours and Clinical Benefit From Previous Therapy With BIBF 1120
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C530716', 'term': 'nintedanib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim Pharmaceuticals'}, '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 the first intake of trial medication until 28 days after last intake of medication, up to 1119 days', 'eventGroups': [{'id': 'EG000', 'title': '50mg QD', 'description': 'Patients were treated with 50 mg Nintedanib once daily in the morning.', 'otherNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '200mg QD', 'description': 'Patients were treated with 200 mg Nintedanib once daily in the morning.', 'otherNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '100mg BID', 'description': 'Patients were treated with 100 mg Nintedanib twice daily.', 'otherNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '150mg BID', 'description': 'Patients were treated with 150 mg Nintedanib twice daily.', 'otherNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': '200mg BID', 'description': 'Patients were treated with 200 mg Nintedanib twice daily.', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': '250mg BID', 'description': 'Patients were treated with 250 mg Nintedanib twice daily.', 'otherNumAtRisk': 19, 'otherNumAffected': 17, 'seriousNumAtRisk': 19, 'seriousNumAffected': 9}, {'id': 'EG006', 'title': '300mg BID', 'description': 'Patients were treated with 300 mg Nintedanib twice daily.', 'otherNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 12.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 12.0'}, {'term': 'Neutropenia', 'stats': 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 12.0'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 12.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 12.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 12.0'}, {'term': 'Eye disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 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'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 12.0'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 12.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 12.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 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0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 12.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 12}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 12.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, 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1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 12.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 12.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 12.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 6}, {'groupId': 'EG006', 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'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 12.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 12.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 12.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 12.0'}, 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'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Chest pain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Chills', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Hepatic pain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Urinary tract infection', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Weight decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Hyperglycaemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Muscular weakness', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Back pain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Joint swelling', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Dysgeusia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Peripheral sensory neuropathy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Insomnia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Haematuria', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Incontinence', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Cough', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Alopecia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Dry skin', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Pruritus', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Conjunctivitis', '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': '100', 'groupId': 'OG006'}]}]}, {'title': 'Haemoptysis', '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': '100', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From signing the informed consent until final follow-up, up to 991 days', 'description': 'All patients who had grade 1 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Clinically Relevant Abnormalities for Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': '50mg QD', 'description': 'Patients were treated with 50 mg Nintedanib once daily in the morning.'}, {'id': 'OG001', 'title': '200mg QD', 'description': 'Patients were treated with 200 mg Nintedanib once daily in the morning.'}, {'id': 'OG002', 'title': '100mg BID', 'description': 'Patients were treated with 100 mg Nintedanib twice daily.'}, {'id': 'OG003', 'title': '150mg BID', 'description': 'Patients were treated with 150 mg Nintedanib twice daily.'}, {'id': 'OG004', 'title': '200mg BID', 'description': 'Patients were treated with 200 mg Nintedanib twice daily.'}, {'id': 'OG005', 'title': '250mg BID', 'description': 'Patients were treated with 250 mg Nintedanib twice daily.'}, {'id': 'OG006', 'title': '300mg BID', 'description': 'Patients were treated with 300 mg Nintedanib twice daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline until final follow-up, up to 991 days', 'description': 'Clinically relevant abnormalities for Vital Signs (systolic blood pressure, diastolic blood pressure, and pulse rate). New abnormal findings or worsening of baseline conditions were reported as Adverse Events.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Pre-dose Concentration of Nintedanib in Plasma at Steady-state (Cpre,ss)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': '50mg QD', 'description': 'Patients were treated with 50 mg Nintedanib once daily in the morning.'}, {'id': 'OG001', 'title': '200mg QD', 'description': 'Patients were treated with 200 mg Nintedanib once daily in the morning.'}, {'id': 'OG002', 'title': '100mg BID', 'description': 'Patients were treated with 100 mg Nintedanib twice daily.'}, {'id': 'OG003', 'title': '150mg BID', 'description': 'Patients were treated with 150 mg Nintedanib twice daily.'}, {'id': 'OG004', 'title': '200mg BID', 'description': 'Patients were treated with 200 mg Nintedanib twice daily.'}, {'id': 'OG005', 'title': '250mg BID', 'description': 'Patients were treated with 250 mg Nintedanib twice daily.'}, {'id': 'OG006', 'title': '300mg BID', 'description': 'Patients were treated with 300 mg Nintedanib twice daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.54', 'spread': '48.3', 'groupId': 'OG003'}, {'value': '11.8', 'spread': '33.5', 'groupId': 'OG004'}, {'value': '11.0', 'spread': '48.5', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Just before drug administration every 28±7 days after day 29', 'description': 'Cpre,ss represents the pre-dose concentration of Nintedanib in Plasma at steady-state at day 29', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set. No descriptive statistics could be calculated for the dosing groups 50 mg and 200 mg QD; 100 mg and 300 mg BID due to insufficient patients.'}, {'type': 'SECONDARY', 'title': 'Unconfirmed Best Overall Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': '50mg QD', 'description': 'Patients were treated with 50 mg Nintedanib once daily in the morning.'}, {'id': 'OG001', 'title': '200mg QD', 'description': 'Patients were treated with 200 mg Nintedanib once daily in the morning.'}, {'id': 'OG002', 'title': '100mg BID', 'description': 'Patients were treated with 100 mg Nintedanib twice daily.'}, {'id': 'OG003', 'title': '150mg BID', 'description': 'Patients were treated with 150 mg Nintedanib twice daily.'}, {'id': 'OG004', 'title': '200mg BID', 'description': 'Patients were treated with 200 mg Nintedanib twice daily.'}, {'id': 'OG005', 'title': '250mg BID', 'description': 'Patients were treated with 250 mg Nintedanib twice daily.'}, {'id': 'OG006', 'title': '300mg BID', 'description': 'Patients were treated with 300 mg Nintedanib twice daily.'}], 'classes': [{'title': 'Complete response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Partial response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Stable disease', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Non-evaluable, clinically non-progressive disease', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '83', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'PD or non-evaluable , clinically PD', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}, {'value': '100', 'groupId': 'OG006'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '42', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline until end of treatment, up to 991 days', 'description': 'Unconfirmed best overall response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0).\n\nPD = Progressive disease.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set.'}, {'type': 'SECONDARY', 'title': 'Unconfirmed Best Objective Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': '50mg QD', 'description': 'Patients were treated with 50 mg Nintedanib once daily in the morning.'}, {'id': 'OG001', 'title': '200mg QD', 'description': 'Patients were treated with 200 mg Nintedanib once daily in the morning.'}, {'id': 'OG002', 'title': '100mg BID', 'description': 'Patients were treated with 100 mg Nintedanib twice daily.'}, {'id': 'OG003', 'title': '150mg BID', 'description': 'Patients were treated with 150 mg Nintedanib twice daily.'}, {'id': 'OG004', 'title': '200mg BID', 'description': 'Patients were treated with 200 mg Nintedanib twice daily.'}, {'id': 'OG005', 'title': '250mg BID', 'description': 'Patients were treated with 250 mg Nintedanib twice daily.'}, {'id': 'OG006', 'title': '300mg BID', 'description': 'Patients were treated with 300 mg Nintedanib twice daily.'}], 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}, {'value': '53', 'groupId': 'OG005'}, {'value': '100', 'groupId': 'OG006'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '42', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline until end of treatment, up to 991 days', 'description': 'Unconfirmed best objective response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set.'}, {'type': 'SECONDARY', 'title': 'Clinical Benefit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': '50mg QD', 'description': 'Patients were treated with 50 mg Nintedanib once daily in the morning.'}, {'id': 'OG001', 'title': '200mg QD', 'description': 'Patients were treated with 200 mg Nintedanib once daily in the morning.'}, {'id': 'OG002', 'title': '100mg BID', 'description': 'Patients were treated with 100 mg Nintedanib twice daily.'}, {'id': 'OG003', 'title': '150mg BID', 'description': 'Patients were treated with 150 mg Nintedanib twice daily.'}, {'id': 'OG004', 'title': '200mg BID', 'description': 'Patients were treated with 200 mg Nintedanib twice daily.'}, {'id': 'OG005', 'title': '250mg BID', 'description': 'Patients were treated with 250 mg Nintedanib twice daily.'}, {'id': 'OG006', 'title': '300mg BID', 'description': 'Patients were treated with 300 mg Nintedanib twice daily.'}], 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}, {'value': '89', 'groupId': 'OG005'}, {'value': '100', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline until end of treatment, up to 991 days', 'description': 'Clinical benefit was defined as the absence of disease progression (no PD or nonevaluable clinically progressive disease) determined by RECIST (version 1.0).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set.'}, {'type': 'SECONDARY', 'title': 'Confirmed Objective Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': '50mg QD', 'description': 'Patients were treated with 50 mg Nintedanib once daily in the morning.'}, {'id': 'OG001', 'title': '200mg QD', 'description': 'Patients were treated with 200 mg Nintedanib once daily in the morning.'}, {'id': 'OG002', 'title': '100mg BID', 'description': 'Patients were treated with 100 mg Nintedanib twice daily.'}, {'id': 'OG003', 'title': '150mg BID', 'description': 'Patients were treated with 150 mg Nintedanib twice daily.'}, {'id': 'OG004', 'title': '200mg BID', 'description': 'Patients were treated with 200 mg Nintedanib twice daily.'}, {'id': 'OG005', 'title': '250mg BID', 'description': 'Patients were treated with 250 mg Nintedanib twice daily.'}, {'id': 'OG006', 'title': '300mg BID', 'description': 'Patients were treated with 300 mg Nintedanib twice daily.'}], 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}, {'value': '58', 'groupId': 'OG005'}, {'value': '100', 'groupId': 'OG006'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '42', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline until end of treatment, up to 991 days', 'description': 'Confirmed objective response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': '50mg QD', 'description': 'Patients were treated with 50 mg Nintedanib once daily in the morning.'}, {'id': 'OG001', 'title': '200mg QD', 'description': 'Patients were treated with 200 mg Nintedanib once daily in the morning.'}, {'id': 'OG002', 'title': '100mg BID', 'description': 'Patients were treated with 100 mg Nintedanib twice daily.'}, {'id': 'OG003', 'title': '150mg BID', 'description': 'Patients were treated with 150 mg Nintedanib twice daily.'}, {'id': 'OG004', 'title': '200mg BID', 'description': 'Patients were treated with 200 mg Nintedanib twice daily.'}, {'id': 'OG005', 'title': '250mg BID', 'description': 'Patients were treated with 250 mg Nintedanib twice daily.'}, {'id': 'OG006', 'title': '300mg BID', 'description': 'Patients were treated with 300 mg Nintedanib twice daily.'}], 'classes': [{'title': 'Progression (RECIST)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '42', 'groupId': 'OG005'}, {'value': '100', 'groupId': 'OG006'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'No progressive disease (RECIST) or death', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '67', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First drug administration (in previous trial) until end of treatment, up to 1230 days', 'description': 'Percentage of participants that experienced progression free survival (PFS), assessed by RECIST (Response Evaluation Criteria In Solid Tumours) (version 1.0), by day 1230. Progression was defined as progressive disease (PD) or non-evaluable clinically progressive disease.\n\nPFS was defined for patients without PD at screening as the time from first treatment with the trial drug in the previous trial until onset of PD or death, whatever comes earlier.\n\nPatients with PD could enter the trial if they showed signs of clinical benefit. For patients with PD at screening, the RECIST assessment at screening was used as a new baseline value and PFS was the time from first treatment with the trial drug in this trial until the onset of progressive disease in this trial or death, whatever comes first.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set. Data for category'}, {'type': 'PRIMARY', 'title': 'Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': '50mg QD', 'description': 'Patients were treated with 50 mg Nintedanib once daily in the morning.'}, {'id': 'OG001', 'title': '200mg QD', 'description': 'Patients were treated with 200 mg Nintedanib once daily in the morning.'}, {'id': 'OG002', 'title': '100mg BID', 'description': 'Patients were treated with 100 mg Nintedanib twice daily.'}, {'id': 'OG003', 'title': '150mg BID', 'description': 'Patients were treated with 150 mg Nintedanib twice daily.'}, {'id': 'OG004', 'title': '200mg BID', 'description': 'Patients were treated with 200 mg Nintedanib twice daily.'}, {'id': 'OG005', 'title': '250mg BID', 'description': 'Patients were treated with 250 mg Nintedanib twice daily.'}, {'id': 'OG006', 'title': '300mg BID', 'description': 'Patients were treated with 300 mg Nintedanib twice daily.'}], 'classes': [{'title': 'Fatigue', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Anorexia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Diarrhoea', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Bronchitis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Nausea', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Abdominal pain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Asthenia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Gastrointestinal infection', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Bone pain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Arthralgia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Musculoskeletal chest pain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Constipation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Flatulence', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Musculoskeletal pain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Sciatica', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Dyspnoea', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Chest pain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Urinary tract infection', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Weight decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Back pain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Peripheral sensory neuropathy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Cough', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Haemoptysis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Osteoarthritis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Parotitis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Osteolysis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Abdominal pain upper', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Gastrointestinal disorder', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Groin pain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Anaemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Neutropenia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Oedema peripheral', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Gamma-glutamyltransferase increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Dehydration', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Productive cough', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Deep vein thrombosis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Phlebitis superficial', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From signing the informed consent until final follow-up, up to 991 days', 'description': 'All patients who had grade 2 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'PRIMARY', 'title': 'Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': '50mg QD', 'description': 'Patients were treated with 50 mg Nintedanib once daily in the morning.'}, {'id': 'OG001', 'title': '200mg QD', 'description': 'Patients were treated with 200 mg Nintedanib once daily in the morning.'}, {'id': 'OG002', 'title': '100mg BID', 'description': 'Patients were treated with 100 mg Nintedanib twice daily.'}, {'id': 'OG003', 'title': '150mg BID', 'description': 'Patients were treated with 150 mg Nintedanib twice daily.'}, {'id': 'OG004', 'title': '200mg BID', 'description': 'Patients were treated with 200 mg Nintedanib twice daily.'}, {'id': 'OG005', 'title': '250mg BID', 'description': 'Patients were treated with 250 mg Nintedanib twice daily.'}, {'id': 'OG006', 'title': '300mg BID', 'description': 'Patients were treated with 300 mg Nintedanib twice daily.'}], 'classes': [{'title': 'Gamma-glutamyltransferase increased', 'categories': [{'measurements': [{'value': '100', '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'}]}]}, {'title': 'Diarrhoea', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Diarrhoea infectious', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Dyspnoea', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Lymphopenia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Constipation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Haemorrhoids', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Ileus', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Subileus', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Pneumonia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Convulsion', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Renal failure', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Urinary tract obstruction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Pleural effusion', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From signing the informed consent until final follow-up, up to 991 days', 'description': 'All patients who had grade 3 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'PRIMARY', 'title': 'Incidence and Intensity of Adverse Events With Highest CTCAE Grade 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': '50mg QD', 'description': 'Patients were treated with 50 mg Nintedanib once daily in the morning.'}, {'id': 'OG001', 'title': '200mg QD', 'description': 'Patients were treated with 200 mg Nintedanib once daily in the morning.'}, {'id': 'OG002', 'title': '100mg BID', 'description': 'Patients were treated with 100 mg Nintedanib twice daily.'}, {'id': 'OG003', 'title': '150mg BID', 'description': 'Patients were treated with 150 mg Nintedanib twice daily.'}, {'id': 'OG004', 'title': '200mg BID', 'description': 'Patients were treated with 200 mg Nintedanib twice daily.'}, {'id': 'OG005', 'title': '250mg BID', 'description': 'Patients were treated with 250 mg Nintedanib twice daily.'}, {'id': 'OG006', 'title': '300mg BID', 'description': 'Patients were treated with 300 mg Nintedanib twice daily.'}], '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': 'From signing the informed consent until final follow-up, up to 991 days', 'description': 'All patients who had grade 4 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'PRIMARY', 'title': 'Incidence and Intensity of Adverse Events With Highest CTCAE Grade 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': '50mg QD', 'description': 'Patients were treated with 50 mg Nintedanib once daily in the morning.'}, {'id': 'OG001', 'title': '200mg QD', 'description': 'Patients were treated with 200 mg Nintedanib once daily in the morning.'}, {'id': 'OG002', 'title': '100mg BID', 'description': 'Patients were treated with 100 mg Nintedanib twice daily.'}, {'id': 'OG003', 'title': '150mg BID', 'description': 'Patients were treated with 150 mg Nintedanib twice daily.'}, {'id': 'OG004', 'title': '200mg BID', 'description': 'Patients were treated with 200 mg Nintedanib twice daily.'}, {'id': 'OG005', 'title': '250mg BID', 'description': 'Patients were treated with 250 mg Nintedanib twice daily.'}, {'id': 'OG006', 'title': '300mg BID', 'description': 'Patients were treated with 300 mg Nintedanib twice daily.'}], 'classes': [{'title': 'Subdural Haematoma', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Malignant neoplasm progression', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From signing the informed consent until final follow-up, up to 991 days', 'description': 'All patients who had grade 5 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'PRIMARY', 'title': 'Difference From Baseline for Liver Enzymes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': '50mg QD', 'description': 'Patients were treated with 50 mg Nintedanib once daily in the morning.'}, {'id': 'OG001', 'title': '200mg QD', 'description': 'Patients were treated with 200 mg Nintedanib once daily in the morning.'}, {'id': 'OG002', 'title': '100mg BID', 'description': 'Patients were treated with 100 mg Nintedanib twice daily.'}, {'id': 'OG003', 'title': '150mg BID', 'description': 'Patients were treated with 150 mg Nintedanib twice daily.'}, {'id': 'OG004', 'title': '200mg BID', 'description': 'Patients were treated with 200 mg Nintedanib twice daily.'}, {'id': 'OG005', 'title': '250mg BID', 'description': 'Patients were treated with 250 mg Nintedanib twice daily.'}, {'id': 'OG006', 'title': '300mg BID', 'description': 'Patients were treated with 300 mg Nintedanib twice daily.'}], 'classes': [{'title': 'Alkaline phosphatase', 'categories': [{'measurements': [{'value': '127.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '11.9', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '-39.0', 'spread': '70.5', 'groupId': 'OG002'}, {'value': '-21.2', 'spread': '96.4', 'groupId': 'OG003'}, {'value': '-11.7', 'spread': '81.0', 'groupId': 'OG004'}, {'value': '16.0', 'spread': '180.9', 'groupId': 'OG005'}, {'value': '7.2', 'spread': '0.0', 'groupId': 'OG006'}]}]}, {'title': 'Aspartate aminotransferase', 'categories': [{'measurements': [{'value': '14.3', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '13.7', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '9.6', 'spread': '18.0', 'groupId': 'OG002'}, {'value': '6.8', 'spread': '9.1', 'groupId': 'OG003'}, {'value': '4.3', 'spread': '41.0', 'groupId': 'OG004'}, {'value': '15.9', 'spread': '35.1', 'groupId': 'OG005'}, {'value': '7.6', 'spread': '0.0', 'groupId': 'OG006'}]}]}, {'title': 'Alanine aminotransferase', 'categories': [{'measurements': [{'value': '10.6', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '11.1', 'groupId': 'OG002'}, {'value': '-1.6', 'spread': '18.8', 'groupId': 'OG003'}, {'value': '9.1', 'spread': '45.4', 'groupId': 'OG004'}, {'value': '17.0', 'spread': '33.6', 'groupId': 'OG005'}, {'value': '12.4', 'spread': '0.0', 'groupId': 'OG006'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From signing the informed consent until end of treatment, up to 991 days', 'description': 'Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set.'}, {'type': 'PRIMARY', 'title': 'Difference From Baseline for Bilirubin, Creatinine and Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': '50mg QD', 'description': 'Patients were treated with 50 mg Nintedanib once daily in the morning.'}, {'id': 'OG001', 'title': '200mg QD', 'description': 'Patients were treated with 200 mg Nintedanib once daily in the morning.'}, {'id': 'OG002', 'title': '100mg BID', 'description': 'Patients were treated with 100 mg Nintedanib twice daily.'}, {'id': 'OG003', 'title': '150mg BID', 'description': 'Patients were treated with 150 mg Nintedanib twice daily.'}, {'id': 'OG004', 'title': '200mg BID', 'description': 'Patients were treated with 200 mg Nintedanib twice daily.'}, {'id': 'OG005', 'title': '250mg BID', 'description': 'Patients were treated with 250 mg Nintedanib twice daily.'}, {'id': 'OG006', 'title': '300mg BID', 'description': 'Patients were treated with 300 mg Nintedanib twice daily.'}], 'classes': [{'title': 'Bilirubin (total)', 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.2', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '0.3', 'groupId': 'OG003'}, {'value': '0.1', 'spread': '0.1', 'groupId': 'OG004'}, {'value': '0.1', 'spread': '0.3', 'groupId': 'OG005'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG006'}]}]}, {'title': 'Creatinine', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.2', 'groupId': 'OG002'}, {'value': '-0.1', 'spread': '0.0', 'groupId': 'OG003'}, {'value': '-0.1', 'spread': '0.2', 'groupId': 'OG004'}, {'value': '-0.1', 'spread': '0.3', 'groupId': 'OG005'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG006'}]}]}, {'title': 'Glucose (N=1,1,3,9,4,14,1)', 'categories': [{'measurements': [{'value': '-60.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '28.9', 'spread': '126.1', 'groupId': 'OG002'}, {'value': '-11.3', 'spread': '75.1', 'groupId': 'OG003'}, {'value': '-76.5', 'spread': '75.9', 'groupId': 'OG004'}, {'value': '-23.3', 'spread': '52.2', 'groupId': 'OG005'}, {'value': '-40.0', 'spread': '0.0', 'groupId': 'OG006'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From signing the informed consent until end of treatment, up to 991 days', 'description': 'Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set.'}, {'type': 'PRIMARY', 'title': 'Difference From Baseline for Haemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': '50mg QD', 'description': 'Patients were treated with 50 mg Nintedanib once daily in the morning.'}, {'id': 'OG001', 'title': '200mg QD', 'description': 'Patients were treated with 200 mg Nintedanib once daily in the morning.'}, {'id': 'OG002', 'title': '100mg BID', 'description': 'Patients were treated with 100 mg Nintedanib twice daily.'}, {'id': 'OG003', 'title': '150mg BID', 'description': 'Patients were treated with 150 mg Nintedanib twice daily.'}, {'id': 'OG004', 'title': '200mg BID', 'description': 'Patients were treated with 200 mg Nintedanib twice daily.'}, {'id': 'OG005', 'title': '250mg BID', 'description': 'Patients were treated with 250 mg Nintedanib twice daily.'}, {'id': 'OG006', 'title': '300mg BID', 'description': 'Patients were treated with 300 mg Nintedanib twice daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.8', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '2.3', 'groupId': 'OG002'}, {'value': '1.0', 'spread': '1.3', 'groupId': 'OG003'}, {'value': '1.2', 'spread': '0.7', 'groupId': 'OG004'}, {'value': '-0.2', 'spread': '2.1', 'groupId': 'OG005'}, {'value': '1.1', 'spread': '0.0', 'groupId': 'OG006'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From baseline until end of treatment, up to 991 days', 'description': 'Difference from baseline for Haemoglobin (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set.'}, {'type': 'PRIMARY', 'title': 'Difference From Baseline for Haematology and Differentials Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': '50mg QD', 'description': 'Patients were treated with 50 mg Nintedanib once daily in the morning.'}, {'id': 'OG001', 'title': '200mg QD', 'description': 'Patients were treated with 200 mg Nintedanib once daily in the morning.'}, {'id': 'OG002', 'title': '100mg BID', 'description': 'Patients were treated with 100 mg Nintedanib twice daily.'}, {'id': 'OG003', 'title': '150mg BID', 'description': 'Patients were treated with 150 mg Nintedanib twice daily.'}, {'id': 'OG004', 'title': '200mg BID', 'description': 'Patients were treated with 200 mg Nintedanib twice daily.'}, {'id': 'OG005', 'title': '250mg BID', 'description': 'Patients were treated with 250 mg Nintedanib twice daily.'}, {'id': 'OG006', 'title': '300mg BID', 'description': 'Patients were treated with 300 mg Nintedanib twice daily.'}], 'classes': [{'title': 'Platelets', 'categories': [{'measurements': [{'value': '42.2', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '11.1', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '83.7', 'groupId': 'OG002'}, {'value': '-2.5', 'spread': '25.2', 'groupId': 'OG003'}, {'value': '-38.1', 'spread': '39.9', 'groupId': 'OG004'}, {'value': '11.2', 'spread': '65.9', 'groupId': 'OG005'}, {'value': '-27.1', 'spread': '0.0', 'groupId': 'OG006'}]}]}, {'title': 'White blood cell count', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '2.9', 'groupId': 'OG002'}, {'value': '-0.8', 'spread': '2.6', 'groupId': 'OG003'}, {'value': '-0.1', 'spread': '5.6', 'groupId': 'OG004'}, {'value': '0.7', 'spread': '2.9', 'groupId': 'OG005'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG006'}]}]}, {'title': 'Lymphocytes (N=1,1,4,9,4,17,1)', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '2.0', 'groupId': 'OG002'}, {'value': '1.0', 'spread': '1.1', 'groupId': 'OG003'}, {'value': '0.0', 'spread': '1.6', 'groupId': 'OG004'}, {'value': '0.6', 'spread': '0.6', 'groupId': 'OG005'}, {'value': '1.1', 'spread': '0.0', 'groupId': 'OG006'}]}]}, {'title': 'Neutrophils (N=1,1,4,9,6,17,1)', 'categories': [{'measurements': [{'value': '-4.1', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '-4.7', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '3.7', 'groupId': 'OG002'}, {'value': '-1.0', 'spread': '5.6', 'groupId': 'OG003'}, {'value': '-2.4', 'spread': '10.0', 'groupId': 'OG004'}, {'value': '-0.5', 'spread': '3.0', 'groupId': 'OG005'}, {'value': '-1.2', 'spread': '0.0', 'groupId': 'OG006'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From signing the informed consent until end of treatment, up to 991 days', 'description': 'Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.', 'unitOfMeasure': '10^9 /L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set.'}, {'type': 'PRIMARY', 'title': 'Difference From Baseline for Coagulation Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': '50mg QD', 'description': 'Patients were treated with 50 mg Nintedanib once daily in the morning.'}, {'id': 'OG001', 'title': '200mg QD', 'description': 'Patients were treated with 200 mg Nintedanib once daily in the morning.'}, {'id': 'OG002', 'title': '100mg BID', 'description': 'Patients were treated with 100 mg Nintedanib twice daily.'}, {'id': 'OG003', 'title': '150mg BID', 'description': 'Patients were treated with 150 mg Nintedanib twice daily.'}, {'id': 'OG004', 'title': '200mg BID', 'description': 'Patients were treated with 200 mg Nintedanib twice daily.'}, {'id': 'OG005', 'title': '250mg BID', 'description': 'Patients were treated with 250 mg Nintedanib twice daily.'}, {'id': 'OG006', 'title': '300mg BID', 'description': 'Patients were treated with 300 mg Nintedanib twice daily.'}], 'classes': [{'title': 'PT-INR (N=1,1,3,7,5,14,1)', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '0.6', 'groupId': 'OG002'}, {'value': '0.1', 'spread': '0.1', 'groupId': 'OG003'}, {'value': '0.2', 'spread': '0.5', 'groupId': 'OG004'}, {'value': '-0.0', 'spread': '0.1', 'groupId': 'OG005'}, {'value': '0.1', 'spread': '0.0', 'groupId': 'OG006'}]}]}, {'title': 'Partial thromboplastin time (N=1,1,3,9,4,14,1)', 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '-3.6', 'spread': '6.7', 'groupId': 'OG002'}, {'value': '1.9', 'spread': '4.3', 'groupId': 'OG003'}, {'value': '1.9', 'spread': '4.3', 'groupId': 'OG004'}, {'value': '1.5', 'spread': '4.7', 'groupId': 'OG005'}, {'value': '-2.9', 'spread': '0.0', 'groupId': 'OG006'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From signing the informed consent until end of treatment, up to 991 days', 'description': 'Difference from baseline (normalized value) in coagulation parameters Prothrombin time, international normalised ratio (PT-INR) and partial thromboplastin time. Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.', 'unitOfMeasure': 'sec', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set.'}, {'type': 'PRIMARY', 'title': 'Difference From Baseline for Electrolytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': '50mg QD', 'description': 'Patients were treated with 50 mg Nintedanib once daily in the morning.'}, {'id': 'OG001', 'title': '200mg QD', 'description': 'Patients were treated with 200 mg Nintedanib once daily in the morning.'}, {'id': 'OG002', 'title': '100mg BID', 'description': 'Patients were treated with 100 mg Nintedanib twice daily.'}, {'id': 'OG003', 'title': '150mg BID', 'description': 'Patients were treated with 150 mg Nintedanib twice daily.'}, {'id': 'OG004', 'title': '200mg BID', 'description': 'Patients were treated with 200 mg Nintedanib twice daily.'}, {'id': 'OG005', 'title': '250mg BID', 'description': 'Patients were treated with 250 mg Nintedanib twice daily.'}, {'id': 'OG006', 'title': '300mg BID', 'description': 'Patients were treated with 300 mg Nintedanib twice daily.'}], 'classes': [{'title': 'Potassium (N=1,1,4,9,6,18,1)', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '2.1', 'groupId': 'OG002'}, {'value': '0.1', 'spread': '0.4', 'groupId': 'OG003'}, {'value': '-0.0', 'spread': '1.1', 'groupId': 'OG004'}, {'value': '0.1', 'spread': '0.9', 'groupId': 'OG005'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG006'}]}]}, {'title': 'Sodium (N=1,1,4,9,6,18,1)', 'categories': [{'measurements': [{'value': '2.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '5.2', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '1.5', 'groupId': 'OG003'}, {'value': '1.5', 'spread': '6.0', 'groupId': 'OG004'}, {'value': '-1.3', 'spread': '5.5', 'groupId': 'OG005'}, {'value': '5.0', 'spread': '0.0', 'groupId': 'OG006'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From signing the informed consent until end of treatment, up to 991 days', 'description': 'Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '50mg QD', 'description': 'Patients were treated with 50 mg Nintedanib once daily (QD) in the morning.'}, {'id': 'FG001', 'title': '200mg QD', 'description': 'Patients were treated with 200 mg Nintedanib once daily in the morning.'}, {'id': 'FG002', 'title': '100mg BID', 'description': 'Patients were treated with 100 mg Nintedanib twice daily (BID).'}, {'id': 'FG003', 'title': '150mg BID', 'description': 'Patients were treated with 150 mg Nintedanib twice daily.'}, {'id': 'FG004', 'title': '200mg BID', 'description': 'Patients were treated with 200 mg Nintedanib twice daily.'}, {'id': 'FG005', 'title': '250mg BID', 'description': 'Patients were treated with 250 mg Nintedanib twice daily.'}, {'id': 'FG006', 'title': '300mg BID', 'description': 'Patients were treated with 300 mg Nintedanib twice daily.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '19'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'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'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '19'}, {'groupId': 'FG006', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '14'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Dose limiting Toxicity (DLT)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Other Adverse Event than DLT', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Other reason not defined above', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This was a multinational, open-label, uncontrolled, extension trial with Nintedanib in patients who had experienced a clinical benefit with Nintedanib (objective tumour response or disease stabilisation and/or symptom improvement) in either one out of five phase I or phase I/IIA clinical trials for advanced solid tumours at study entry.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '19', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '41', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': '50mg QD', 'description': 'Patients were treated with 50 mg Nintedanib once daily in the morning.'}, {'id': 'BG001', 'title': '200mg QD', 'description': 'Patients were treated with 200 mg Nintedanib once daily in the morning.'}, {'id': 'BG002', 'title': '100mg BID', 'description': 'Patients were treated with 100 mg Nintedanib twice daily.'}, {'id': 'BG003', 'title': '150mg BID', 'description': 'Patients were treated with 150 mg Nintedanib twice daily.'}, {'id': 'BG004', 'title': '200mg BID', 'description': 'Patients were treated with 200 mg Nintedanib twice daily.'}, {'id': 'BG005', 'title': '250mg BID', 'description': 'Patients were treated with 250 mg Nintedanib twice daily.'}, {'id': 'BG006', 'title': '300mg BID', 'description': 'Patients were treated with 300 mg Nintedanib twice daily.'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '75.0', 'groupId': 'BG000', 'lowerLimit': '75', 'upperLimit': '75'}, {'value': '47.0', 'groupId': 'BG001', 'lowerLimit': '47', 'upperLimit': '47'}, {'value': '65.5', 'groupId': 'BG002', 'lowerLimit': '52', 'upperLimit': '75'}, {'value': '66.0', 'groupId': 'BG003', 'lowerLimit': '52', 'upperLimit': '78'}, {'value': '63.5', 'groupId': 'BG004', 'lowerLimit': '45', 'upperLimit': '74'}, {'value': '66.0', 'groupId': 'BG005', 'lowerLimit': '41', 'upperLimit': '80'}, {'value': '67.0', 'groupId': 'BG006', 'lowerLimit': '67', 'upperLimit': '67'}, {'value': '66.0', 'groupId': 'BG007', 'lowerLimit': '41', 'upperLimit': '80'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '33', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Treated set which comprised of all patients who received at least one dose of Nintedanib in both their previous Nintedanib trial and in this extension trial'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'lastUpdateSubmitDate': '2014-11-24', 'studyFirstSubmitDate': '2008-07-11', 'resultsFirstSubmitDate': '2014-11-14', 'studyFirstSubmitQcDate': '2008-07-14', 'lastUpdatePostDateStruct': {'date': '2014-12-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-11-24', 'studyFirstPostDateStruct': {'date': '2008-07-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1', 'timeFrame': 'From signing the informed consent until final follow-up, up to 991 days', 'description': 'All patients who had grade 1 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).'}, {'measure': 'Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2', 'timeFrame': 'From signing the informed consent until final follow-up, up to 991 days', 'description': 'All patients who had grade 2 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).'}, {'measure': 'Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3', 'timeFrame': 'From signing the informed consent until final follow-up, up to 991 days', 'description': 'All patients who had grade 3 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).'}, {'measure': 'Incidence and Intensity of Adverse Events With Highest CTCAE Grade 4', 'timeFrame': 'From signing the informed consent until final follow-up, up to 991 days', 'description': 'All patients who had grade 4 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).'}, {'measure': 'Incidence and Intensity of Adverse Events With Highest CTCAE Grade 5', 'timeFrame': 'From signing the informed consent until final follow-up, up to 991 days', 'description': 'All patients who had grade 5 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).'}, {'measure': 'Difference From Baseline for Liver Enzymes', 'timeFrame': 'From signing the informed consent until end of treatment, up to 991 days', 'description': 'Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.'}, {'measure': 'Difference From Baseline for Bilirubin, Creatinine and Glucose', 'timeFrame': 'From signing the informed consent until end of treatment, up to 991 days', 'description': 'Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.'}, {'measure': 'Difference From Baseline for Haemoglobin', 'timeFrame': 'From baseline until end of treatment, up to 991 days', 'description': 'Difference from baseline for Haemoglobin (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.'}, {'measure': 'Difference From Baseline for Haematology and Differentials Parameters', 'timeFrame': 'From signing the informed consent until end of treatment, up to 991 days', 'description': 'Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.'}, {'measure': 'Difference From Baseline for Coagulation Parameters', 'timeFrame': 'From signing the informed consent until end of treatment, up to 991 days', 'description': 'Difference from baseline (normalized value) in coagulation parameters Prothrombin time, international normalised ratio (PT-INR) and partial thromboplastin time. Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.'}, {'measure': 'Difference From Baseline for Electrolytes', 'timeFrame': 'From signing the informed consent until end of treatment, up to 991 days', 'description': 'Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.'}], 'secondaryOutcomes': [{'measure': 'Clinically Relevant Abnormalities for Vital Signs', 'timeFrame': 'From baseline until final follow-up, up to 991 days', 'description': 'Clinically relevant abnormalities for Vital Signs (systolic blood pressure, diastolic blood pressure, and pulse rate). New abnormal findings or worsening of baseline conditions were reported as Adverse Events.'}, {'measure': 'Pre-dose Concentration of Nintedanib in Plasma at Steady-state (Cpre,ss)', 'timeFrame': 'Just before drug administration every 28±7 days after day 29', 'description': 'Cpre,ss represents the pre-dose concentration of Nintedanib in Plasma at steady-state at day 29'}, {'measure': 'Unconfirmed Best Overall Response', 'timeFrame': 'Baseline until end of treatment, up to 991 days', 'description': 'Unconfirmed best overall response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0).\n\nPD = Progressive disease.'}, {'measure': 'Unconfirmed Best Objective Response', 'timeFrame': 'Baseline until end of treatment, up to 991 days', 'description': 'Unconfirmed best objective response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0)'}, {'measure': 'Clinical Benefit', 'timeFrame': 'Baseline until end of treatment, up to 991 days', 'description': 'Clinical benefit was defined as the absence of disease progression (no PD or nonevaluable clinically progressive disease) determined by RECIST (version 1.0).'}, {'measure': 'Confirmed Objective Response', 'timeFrame': 'Baseline until end of treatment, up to 991 days', 'description': 'Confirmed objective response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0)'}, {'measure': 'Progression Free Survival', 'timeFrame': 'First drug administration (in previous trial) until end of treatment, up to 1230 days', 'description': 'Percentage of participants that experienced progression free survival (PFS), assessed by RECIST (Response Evaluation Criteria In Solid Tumours) (version 1.0), by day 1230. Progression was defined as progressive disease (PD) or non-evaluable clinically progressive disease.\n\nPFS was defined for patients without PD at screening as the time from first treatment with the trial drug in the previous trial until onset of PD or death, whatever comes earlier.\n\nPatients with PD could enter the trial if they showed signs of clinical benefit. For patients with PD at screening, the RECIST assessment at screening was used as a new baseline value and PFS was the time from first treatment with the trial drug in this trial until the onset of progressive disease in this trial or death, whatever comes first.'}]}, 'conditionsModule': {'conditions': ['Neoplasms']}, 'descriptionModule': {'briefSummary': 'The primary objective of this trial is to evaluate the long-term safety of BIBF 1120 in terms of incidence and intensity of Adverse Events and changes in safety laboratory parameters.\n\nSecondary objectives are the collection of further safety data (vital signs), efficacy data and the determination of pharmacokinetic characteristics during long-term therapy with BIBF 1120.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female patients with advanced solid tumours who have completed a previous study with BIBF 1120. The patients should not have progression of their underlying tumour disease unless there is evidence for significant clinical benefit (e.g. symptom improvement) from treatment with BIBF 1120.\n2. Age 18 years or older\n3. Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score \\<= 2\n4. Patients must have given written informed consent (which must be consistent with ICH-GCP and local legislation)\n\nExclusion Criteria:\n\n1. Time elapsed from last administration of BIBF 1120 in the previous trial to start of treatment in the present trial exceeds four weeks\n2. Presence of drug related toxicity \\> grade 2 CTC from previous therapy with BIBF 1120 or presence of drug related continuous toxicity of grade 2 for seven or more consecutive days which would preclude ongoing chronic therapy with BIBF 1120\n3. Active ulcers (gastro-intestinal tract, skin)\n4. Major injuries and surgery within the past three weeks with incomplete wound healing\n5. Hypersensitivity to BIBF 1120 or the excipients of the trial drug\n6. Known secondary malignancy requiring therapy\n7. Active infectious disease\n8. Significant cardiovascular diseases (i.e. uncontrolled severe hypertension, unstable angina pectoris, history of myocardial infarction, congestive heart failure \\> NYHA II)\n9. Gastrointestinal disorders anticipated to interfere with the resorption of the study drug\n10. Brain metastases requiring therapy\n11. Absolute neutrophil count less than 1,500/mm3\n12. Platelet count less than 100,000/mm3\n13. Bilirubin greater than 1.5 mg/dl (\\> 26 µmol/L)\n14. Aspartate amino transferase (AST) and/or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal)\n15. Serum creatinine greater than 2 mg/dl (\\> 176 µmol/L)\n16. Concomitant non-oncological diseases which are considered relevant for the evaluation of the safety of the trial drug\n17. Chemo-, radio-, or immunotherapy within the past four weeks prior to treatment with the trial drug\n18. Patients who are sexually active and unwilling to use a medically acceptable method of contraception\n19. Pregnancy or lactation\n20. Treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy (visit 2) or concomitantly with this trial (except for a previous study with BIBF 1120)\n21. Patients unable to comply with the protocol\n22. Active alcohol or drug abuse'}, 'identificationModule': {'nctId': 'NCT00715403', 'briefTitle': 'A Phase I/II Open Label Extension Study of BIBF 1120 Administered Orally Once or Twice Daily to Establish Safety, Pharmacokinetics and Efficacy in Patients With Advanced Solid Tumours and Clinical Benefit From Previous Therapy With BIBF 1120', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Extension Study to Establish Safety, Pharmacokinetics and Efficacy of BIBF 1120 in Patients With Previous Clinical Benefit From BIBF 1120', 'orgStudyIdInfo': {'id': '1199.16'}}, 'armsInterventionsModule': {'interventions': [{'name': 'BIBF 1120', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bordeaux', 'country': 'France', 'facility': '1199.16.3306A Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Clichy', 'country': 'France', 'facility': '1199.16.3311A Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}, {'city': 'Clichy', 'country': 'France', 'facility': '1199.16.3311B Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}, {'city': 'Paris', 'country': 'France', 'facility': '1199.16.3302A Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': '1199.16.3312A Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': '1199.16.3313A Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': '1199.16.3313E Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Freiburg/Breisgau', 'country': 'Germany', 'facility': '1199.16.49001 Boehringer Ingelheim Investigational Site'}, {'city': 'Großhansdorf', 'country': 'Germany', 'facility': '1199.16.49004 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 53.66528, 'lon': 10.28552}}, {'city': 'Tübingen', 'country': 'Germany', 'facility': '1199.16.49008 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'city': 'Wiesbaden', 'country': 'Germany', 'facility': '1199.16.49005 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 50.08601, 'lon': 8.24435}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Boehringer Ingelheim, Study Chair', 'oldOrganization': 'Boehringer Ingelheim'}}}}