Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-27 @ 11:52 AM
Study NCT ID:
NCT00876460
Status:
COMPLETED
Last Update Posted:
2016-11-17
First Post:
2009-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
BIBF 1120 + Docetaxel (Japan) in Patients With Advanced Non-small-cell Lung Cancer, Phase I
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days', 'eventGroups': [{'id': 'EG000', 'title': 'Nintedanib 100 mg + Docetaxel 60 mg/m2', 'description': 'Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)', 'description': 'Patients with body surface area (BSA) \\<1.5 m\\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.', 'otherNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)', 'description': 'Patients with body surface area ≥1.5 m\\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)', 'description': 'Patients with body surface area \\<1.5 m\\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)', 'description': 'Patients with body surface area ≥1.5 m\\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.', 'otherNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'seriousNumAffected': 4}, {'id': 'EG005', 'title': 'Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)', 'description': 'Patients with body surface area \\<1.5 m\\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)', 'description': 'Patients with body surface area ≥1.5 m\\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.', 'otherNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'seriousNumAffected': 3}, {'id': 'EG007', 'title': 'Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)', 'description': 'Patients with body surface area ≥1.5 m\\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 7}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 7}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Conjunctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Eye discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Retinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Anal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 4}, {'groupId': 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{'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Brain cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Peritumoural oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Experienced Dose Limited Toxicity in Combination Therapy of Nintedanib and Docetaxel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib 100 mg + Docetaxel 60 mg/m2', 'description': 'Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'OG001', 'title': 'Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)', 'description': 'Patients with body surface area (BSA) \\<1.5 m\\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'OG002', 'title': 'Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)', 'description': 'Patients with body surface area ≥1.5 m\\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'OG003', 'title': 'Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)', 'description': 'Patients with body surface area \\<1.5 m\\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'OG004', 'title': 'Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)', 'description': 'Patients with body surface area ≥1.5 m\\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'OG005', 'title': 'Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)', 'description': 'Patients with body surface area \\<1.5 m\\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'OG006', 'title': 'Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)', 'description': 'Patients with body surface area ≥1.5 m\\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'OG007', 'title': 'Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)', 'description': 'Patients with body surface area ≥1.5 m\\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the first treatment course, up to 3 weeks', 'description': 'Number of participants experienced Dose Limited Toxicity (DLT) in combination therapy of nintedanib and docetaxel.\n\nMaximum tolerated dose (MTD) of nintedanib combination with docetaxel were to be determined separately in the patient groups of body surface area (BSA) \\<1.5 m2 and BSA ≥1.5 m2. The MTD were to be determined as a combination of a dose equal to or less than 200 mg b.i.d. of nintedanib and 60 mg/m2 and 75 mg/m2 every 3 weeks of docetaxel at which either 0 out of 3, 1 out of 6, or 2 out of 6 patients experienced DLT.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (Patients eligible for DLT confirmation)'}, {'type': 'PRIMARY', 'title': 'Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 for All Courses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib 100 mg + Docetaxel 60 mg/m2', 'description': 'Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'OG001', 'title': 'Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)', 'description': 'Patients with body surface area (BSA) \\<1.5 m\\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'OG002', 'title': 'Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)', 'description': 'Patients with body surface area ≥1.5 m\\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'OG003', 'title': 'Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)', 'description': 'Patients with body surface area \\<1.5 m\\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'OG004', 'title': 'Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)', 'description': 'Patients with body surface area ≥1.5 m\\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'OG005', 'title': 'Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)', 'description': 'Patients with body surface area \\<1.5 m\\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'OG006', 'title': 'Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)', 'description': 'Patients with body surface area ≥1.5 m\\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'OG007', 'title': 'Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)', 'description': 'Patients with body surface area ≥1.5 m\\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}]}, {'title': 'Grade 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days', 'description': 'Number of participants with adverse events according to Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 for all courses.\n\nThe CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Objective Tumor Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib 100 mg + Docetaxel 60 mg/m2', 'description': 'Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'OG001', 'title': 'Nintedanib 150 mg + Docetaxel 60 mg/m2', 'description': 'Patients administered a soft gelatin capsule of nintedanib 150 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'OG002', 'title': 'Nintedanib 150 mg + Docetaxel 75 mg/m2', 'description': 'Patients administered a soft gelatin capsule of nintedanib 150 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'OG003', 'title': 'Nintedanib 200 mg + Docetaxel 60 mg/m2', 'description': 'Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'OG004', 'title': 'Nintedanib 200 mg + Docetaxel 75 mg/m2', 'description': 'Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days)', 'description': 'Number of participants with objective response defined as complete response (CR) or partial response (PR) according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who were treated with nintedanib and had both baseline and at least one post-treatment tumour measurement by computed tomography (CT) image'}, {'type': 'SECONDARY', 'title': 'Disease Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib 100 mg + Docetaxel 60 mg/m2', 'description': 'Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'OG001', 'title': 'Nintedanib 150 mg + Docetaxel 60 mg/m2', 'description': 'Patients administered a soft gelatin capsule of nintedanib 150 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'OG002', 'title': 'Nintedanib 150 mg + Docetaxel 75 mg/m2', 'description': 'Patients administered a soft gelatin capsule of nintedanib 150 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'OG003', 'title': 'Nintedanib 200 mg + Docetaxel 60 mg/m2', 'description': 'Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'OG004', 'title': 'Nintedanib 200 mg + Docetaxel 75 mg/m2', 'description': 'Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days)', 'description': 'Number of participants with disease control, defined as complete response (CR) or partial response (PR) or stable disease (SD) according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.0', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who treated with nintedanib and had both baseline and at least one post-treated tumour measurement by computed tomography (CT) image'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib 100 mg + Docetaxel 60 mg/m2', 'description': 'Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'OG001', 'title': 'Nintedanib 150 mg + Docetaxel 60 mg/m2', 'description': 'Patients administered a soft gelatin capsule of nintedanib 150 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'OG002', 'title': 'Nintedanib 150 mg + Docetaxel 75 mg/m2', 'description': 'Patients administered a soft gelatin capsule of nintedanib 150 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'OG003', 'title': 'Nintedanib 200 mg + Docetaxel 60 mg/m2', 'description': 'Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'OG004', 'title': 'Nintedanib 200 mg + Docetaxel 75 mg/m2', 'description': 'Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}], 'classes': [{'categories': [{'measurements': [{'value': '229.5', 'groupId': 'OG000', 'lowerLimit': '200.0', 'upperLimit': '259.0'}, {'value': '117.0', 'groupId': 'OG001', 'lowerLimit': '36.0', 'upperLimit': '267.0'}, {'value': '139.0', 'groupId': 'OG002', 'lowerLimit': '87.0', 'upperLimit': '262.0'}, {'value': '351.0', 'groupId': 'OG003', 'lowerLimit': '131.0', 'upperLimit': '614.0'}, {'value': '184.0', 'groupId': 'OG004', 'lowerLimit': '68.0', 'upperLimit': '884.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days)', 'description': 'For participants with known date of progression or death (of any cause): PFS \\[days\\] = earlier of date of progression or death - date the study treatment started + 1.\n\nFor participants known to be alive without progression by the end of trial or follow-up visit: PFS (censored) \\[days\\] = date of last imaging when the participant is known to be progression-free and alive - date the study treatment started + 1.\n\nProgression is assessed according to RECIST version 1.0.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Time to Treatment Failure (TTF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib 100 mg + Docetaxel 60 mg/m2', 'description': 'Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'OG001', 'title': 'Nintedanib 150 mg + Docetaxel 60 mg/m2', 'description': 'Patients administered a soft gelatin capsule of nintedanib 150 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'OG002', 'title': 'Nintedanib 150 mg + Docetaxel 75 mg/m2', 'description': 'Patients administered a soft gelatin capsule of nintedanib 150 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'OG003', 'title': 'Nintedanib 200 mg + Docetaxel 60 mg/m2', 'description': 'Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'OG004', 'title': 'Nintedanib 200 mg + Docetaxel 75 mg/m2', 'description': 'Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}], 'classes': [{'categories': [{'measurements': [{'value': '200.0', 'groupId': 'OG000', 'lowerLimit': '54.0', 'upperLimit': '259.0'}, {'value': '83.5', 'groupId': 'OG001', 'lowerLimit': '10.0', 'upperLimit': '187.0'}, {'value': '134.0', 'groupId': 'OG002', 'lowerLimit': '75.0', 'upperLimit': '178.0'}, {'value': '87.0', 'groupId': 'OG003', 'lowerLimit': '8.0', 'upperLimit': '212.0'}, {'value': '176.0', 'groupId': 'OG004', 'lowerLimit': '52.0', 'upperLimit': '884.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days)', 'description': 'For participants with known date of discontinuation of the study treatment (or progression \\[not necessarily confirmed by tumour imaging; can also be based on any clinical sign of tumour progression\\] or death): TTF \\[days\\] = earlier of date of discontinuation of the study treatment, progression, or death - date the study treatment started + 1.\n\nFor participants known to be alive without progression by the end of trial or follow-up visit: TTF (censored) \\[days\\] = date when the patient is known to be progression-free and alive - date the study treatment started + 1.\n\nProgression is assessed according to RECIST version 1.0.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Clinical Relevant Abnormalities in Laboratory Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib 100 mg + Docetaxel 60 mg/m2', 'description': 'Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'OG001', 'title': 'Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)', 'description': 'Patients with body surface area (BSA) \\<1.5 m\\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'OG002', 'title': 'Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)', 'description': 'Patients with body surface area ≥1.5 m\\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'OG003', 'title': 'Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)', 'description': 'Patients with body surface area \\<1.5 m\\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'OG004', 'title': 'Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)', 'description': 'Patients with body surface area ≥1.5 m\\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'OG005', 'title': 'Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)', 'description': 'Patients with body surface area \\<1.5 m\\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'OG006', 'title': 'Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)', 'description': 'Patients with body surface area ≥1.5 m\\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'OG007', 'title': 'Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)', 'description': 'Patients with body surface area ≥1.5 m\\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}], 'classes': [{'title': 'Alanine aminotransferase increased', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}]}, {'title': 'Aspartate aminotransferase increased', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}]}, {'title': 'Blood alkaline phosphatase increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}]}, {'title': 'Gamma-glutamyltransferase increased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}]}]}, {'title': 'Blood bilirubin increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Platelet count decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'White blood cell count decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}]}, {'title': 'Blood calcium decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Gamma-glutamyltransferase', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}]}, {'title': 'Blood chloride decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Blood thyroid stimulating hormone increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Blood urea increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'C-reactive protein increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'Haemoglobin decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'Lymphocyte count decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'Neutrophil count decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'Prothrombin level decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Tri-iodothyronine free decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Blood albumin decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Blood potassium decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Blood uric acid increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Blood urine', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Blood urine present', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Electrocardiogram QT prolonged', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days', 'description': 'Number of participants with clinically relevant abnormalities in laboratory parameters reported as adverse events', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'AUC0-inf of Nintedanib in Course 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib 100 mg', 'description': 'Patients with Nintedanib 100 mg b.i.d.'}, {'id': 'OG001', 'title': 'Nintedanib 150 mg', 'description': 'Patients with Nintedanib 150 mg b.i.d.'}, {'id': 'OG002', 'title': 'Nintedanib 200 mg', 'description': 'Patients with Nintedanib 200 mg b.i.d.'}], 'classes': [{'categories': [{'measurements': [{'value': '169', 'spread': '56.1', 'groupId': 'OG000'}, {'value': '260', 'spread': '50.1', 'groupId': 'OG001'}, {'value': '349', 'spread': '25.6', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '-0:05 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 7h, 10h and 23:55h after drug administration in course 1', 'description': 'AUC0-inf (area under the plasma concentration-time curve over the time interval from 0 extrapolated to infinity) after the first administration of nintedanib in course 1', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (AUC0-inf could not be calculated in 5 patients because the elimination phase was not observed in plasma concentration-time profiles in these patients.)'}, {'type': 'SECONDARY', 'title': 'Cmax of Nintedanib in Course 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib 100 mg', 'description': 'Patients with Nintedanib 100 mg b.i.d.'}, {'id': 'OG001', 'title': 'Nintedanib 150 mg', 'description': 'Patients with Nintedanib 150 mg b.i.d.'}, {'id': 'OG002', 'title': 'Nintedanib 200 mg', 'description': 'Patients with Nintedanib 200 mg b.i.d.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.3', 'spread': '60.0', 'groupId': 'OG000'}, {'value': '33.4', 'spread': '91.1', 'groupId': 'OG001'}, {'value': '59.9', 'spread': '43.9', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '-0:05h before drug administration and 1h, 2h, 3h, 4h, 6h, 7h, 10h and 23:55h after drug administration in course 1', 'description': 'Cmax (maximum measured plasma concentration) after the first administration of nintedanib in course 1', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'AUC0-inf of Docetaxel in Course 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel 60 mg/m2', 'description': 'Patients with Docetaxel 60 mg/m2'}, {'id': 'OG001', 'title': 'Docetaxel 75 mg/m2', 'description': 'Patients with Docetaxel 75 mg/m2'}], 'classes': [{'categories': [{'measurements': [{'value': '3270', 'spread': '35.6', 'groupId': 'OG000'}, {'value': '3810', 'spread': '22.7', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '-0:05h before drug administration and 1h, 1.5h, 2h, 3h, 4h, 7h, 23:55h and 47:55h after drug administration', 'description': 'AUC0-inf (area under the plasma concentration-time curve over the time interval from 0 extrapolated to infinity) after the first administration of docetaxel in course 1', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (1 patient was replaced after completion of first administration of docetaxel and before any nintedanib intake. Pharmacokinetic (PK) sampling of docetaxel for this patient was done and included in PK analysis.)'}, {'type': 'SECONDARY', 'title': 'Cmax of Docetaxel in Course 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel 60 mg/m2', 'description': 'Patients with Docetaxel 60 mg/m2'}, {'id': 'OG001', 'title': 'Docetaxel 75 mg/m2', 'description': 'Patients with Docetaxel 75 mg/m2'}], 'classes': [{'categories': [{'measurements': [{'value': '3150', 'spread': '42.8', 'groupId': 'OG000'}, {'value': '3550', 'spread': '32.2', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '-0:05h before drug administration and 1h, 1.5h, 2h, 3h, 4h, 7h, 23:55h and 47:55h after drug administration', 'description': 'Cmax (maximum measured plasma concentration) after the first administration of docetaxel in course 1', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (1 patient was replaced after completion of first administration of docetaxel and before any nintedanib intake. PK sampling of docetaxel for this patient was done and included in PK analysis.)'}, {'type': 'SECONDARY', 'title': 'AUC0-inf of Docetaxel in Course 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel 50 mg/m2', 'description': 'Patients with Docetaxel 50 mg/m2'}, {'id': 'OG001', 'title': 'Docetaxel 60 mg/m2', 'description': 'Patients with Docetaxel 60 mg/m2'}, {'id': 'OG002', 'title': 'Docetaxel 75 mg/m2', 'description': 'Patients with Docetaxel 75 mg/m2'}], 'classes': [{'categories': [{'measurements': [{'value': '2320', 'spread': '14.9', 'groupId': 'OG000'}, {'value': '3750', 'spread': '31.1', 'groupId': 'OG001'}, {'value': '4270', 'spread': '34.2', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '-0:05h before drug administration and 1h, 1.5h, 2h, 3h, 4h, 7h, 23:55h and 47:55h after drug administration', 'description': 'AUC0-inf (area under the plasma concentration-time curve over the time interval from 0 extrapolated to infinity) after the first administration of docetaxel in course 2.\n\nDocetaxel 50 mg/m2 patients were assigned to Docetaxel 60 mg/m2 in Cycle 1, but the dose was reduced to 50 mg/m2 in Cycle 2 as defined in the Clinical Trial Protocol.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (AUC0-inf could not be calculated in 1 patient because the elimination phase was not observed in plasma concentration-time profile in this patient.)'}, {'type': 'SECONDARY', 'title': 'Cmax of Docetaxel in Course 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Docetaxel 50 mg/m2', 'description': 'Patients with Docetaxel 50 mg/m2'}, {'id': 'OG001', 'title': 'Docetaxel 60 mg/m2', 'description': 'Patients with Docetaxel 60 mg/m2'}, {'id': 'OG002', 'title': 'Docetaxel 75 mg/m2', 'description': 'Patients with Docetaxel 75 mg/m2'}], 'classes': [{'categories': [{'measurements': [{'value': '1870', 'spread': '33.9', 'groupId': 'OG000'}, {'value': '3740', 'spread': '33.7', 'groupId': 'OG001'}, {'value': '4070', 'spread': '56.7', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '-0:05h before drug administration and 1h, 1.5h, 2h, 3h, 4h, 7h, 23:55h and 47:55h after drug administration', 'description': 'Cmax (maximum measured plasma concentration) after the first administration of docetaxel in course 2.\n\nDocetaxel 50 mg/m2 patients were assigned to Docetaxel 60 mg/m2 in Cycle 1, but the dose was reduced to 50 mg/m2 in Cycle 2 as defined in the Clinical Trial Protocol.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nintedanib 100 mg + Docetaxel 60 mg/m2', 'description': 'Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'FG001', 'title': 'Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)', 'description': 'Patients with body surface area (BSA) \\<1.5 m\\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'FG002', 'title': 'Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)', 'description': 'Patients with body surface area ≥1.5 m\\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'FG003', 'title': 'Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)', 'description': 'Patients with body surface area \\<1.5 m\\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'FG004', 'title': 'Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)', 'description': 'Patients with body surface area ≥1.5 m\\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'FG005', 'title': 'Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)', 'description': 'Patients with body surface area \\<1.5 m\\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'FG006', 'title': 'Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)', 'description': 'Patients with body surface area ≥1.5 m\\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'FG007', 'title': 'Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)', 'description': 'Patients with body surface area ≥1.5 m\\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}], 'periods': [{'title': 'Combination Therapy Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '8'}, {'groupId': 'FG007', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '8'}, {'groupId': 'FG007', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}]}, {'type': 'Dose limiting toxicity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Other reason not defined above', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '2'}]}, {'type': 'Not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}, {'title': 'Mono Therapy Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'One patient started mono therapy phase after discontinued from combination therapy phase.', 'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'comment': 'One patient started mono therapy phase after discontinued from combination therapy phase.', 'groupId': 'FG003', 'numSubjects': '1'}, {'comment': 'Two patients started mono therapy phase after discontinued from combination therapy phase.', 'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'comment': 'One patient started mono therapy phase after discontinued from combination therapy phase.', 'groupId': 'FG006', 'numSubjects': '1'}, {'comment': 'Three patients started mono therapy phase after discontinued from combination therapy phase.', 'groupId': 'FG007', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '43 patients entered.1 patient was replaced because he did not take any nintedanib(Nin) due to new brain metastasis after completion of first administration of docetaxel. Accordingly,42 patients treated with at least 1 dose of Nin in combination with docetaxel.Patients started mono therapy phase after discontinued from combination therapy phase .', 'preAssignmentDetails': 'In case a patient had to discontinue docetaxel for reasons other than progression disease, the patient could continue therapy with nintedanib if the patient had been treated with combination therapy with docetaxel during at least 4 treatment courses.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '42', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': 'Nintedanib 100 mg + Docetaxel 60 mg/m2', 'description': 'Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'BG001', 'title': 'Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)', 'description': 'Patients with body surface area (BSA) \\<1.5 m\\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'BG002', 'title': 'Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)', 'description': 'Patients with body surface area ≥1.5 m\\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'BG003', 'title': 'Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)', 'description': 'Patients with body surface area \\<1.5 m\\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'BG004', 'title': 'Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)', 'description': 'Patients with body surface area ≥1.5 m\\^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'BG005', 'title': 'Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)', 'description': 'Patients with body surface area \\<1.5 m\\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'BG006', 'title': 'Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)', 'description': 'Patients with body surface area ≥1.5 m\\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'BG007', 'title': 'Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)', 'description': 'Patients with body surface area ≥1.5 m\\^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.0', 'groupId': 'BG000', 'lowerLimit': '49', 'upperLimit': '58'}, {'value': '68.0', 'groupId': 'BG001', 'lowerLimit': '59', 'upperLimit': '71'}, {'value': '64.0', 'groupId': 'BG002', 'lowerLimit': '60', 'upperLimit': '69'}, {'value': '65.0', 'groupId': 'BG003', 'lowerLimit': '45', 'upperLimit': '70'}, {'value': '63.0', 'groupId': 'BG004', 'lowerLimit': '60', 'upperLimit': '73'}, {'value': '62.0', 'groupId': 'BG005', 'lowerLimit': '58', 'upperLimit': '72'}, {'value': '64.0', 'groupId': 'BG006', 'lowerLimit': '47', 'upperLimit': '72'}, {'value': '61.5', 'groupId': 'BG007', 'lowerLimit': '51', 'upperLimit': '72'}, {'value': '63.5', 'groupId': 'BG008', 'lowerLimit': '45', 'upperLimit': '73'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '13', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '29', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-27', 'studyFirstSubmitDate': '2009-03-03', 'resultsFirstSubmitDate': '2014-11-14', 'studyFirstSubmitQcDate': '2009-04-03', 'lastUpdatePostDateStruct': {'date': '2016-11-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-11-28', 'studyFirstPostDateStruct': {'date': '2009-04-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Experienced Dose Limited Toxicity in Combination Therapy of Nintedanib and Docetaxel', 'timeFrame': 'During the first treatment course, up to 3 weeks', 'description': 'Number of participants experienced Dose Limited Toxicity (DLT) in combination therapy of nintedanib and docetaxel.\n\nMaximum tolerated dose (MTD) of nintedanib combination with docetaxel were to be determined separately in the patient groups of body surface area (BSA) \\<1.5 m2 and BSA ≥1.5 m2. The MTD were to be determined as a combination of a dose equal to or less than 200 mg b.i.d. of nintedanib and 60 mg/m2 and 75 mg/m2 every 3 weeks of docetaxel at which either 0 out of 3, 1 out of 6, or 2 out of 6 patients experienced DLT.'}, {'measure': 'Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 for All Courses', 'timeFrame': 'Between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days', 'description': 'Number of participants with adverse events according to Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 for all courses.\n\nThe CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE).'}], 'secondaryOutcomes': [{'measure': 'Objective Tumor Response', 'timeFrame': 'Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days)', 'description': 'Number of participants with objective response defined as complete response (CR) or partial response (PR) according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0'}, {'measure': 'Disease Control', 'timeFrame': 'Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days)', 'description': 'Number of participants with disease control, defined as complete response (CR) or partial response (PR) or stable disease (SD) according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.0'}, {'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days)', 'description': 'For participants with known date of progression or death (of any cause): PFS \\[days\\] = earlier of date of progression or death - date the study treatment started + 1.\n\nFor participants known to be alive without progression by the end of trial or follow-up visit: PFS (censored) \\[days\\] = date of last imaging when the participant is known to be progression-free and alive - date the study treatment started + 1.\n\nProgression is assessed according to RECIST version 1.0.'}, {'measure': 'Time to Treatment Failure (TTF)', 'timeFrame': 'Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days)', 'description': 'For participants with known date of discontinuation of the study treatment (or progression \\[not necessarily confirmed by tumour imaging; can also be based on any clinical sign of tumour progression\\] or death): TTF \\[days\\] = earlier of date of discontinuation of the study treatment, progression, or death - date the study treatment started + 1.\n\nFor participants known to be alive without progression by the end of trial or follow-up visit: TTF (censored) \\[days\\] = date when the patient is known to be progression-free and alive - date the study treatment started + 1.\n\nProgression is assessed according to RECIST version 1.0.'}, {'measure': 'Clinical Relevant Abnormalities in Laboratory Parameters', 'timeFrame': 'Between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days', 'description': 'Number of participants with clinically relevant abnormalities in laboratory parameters reported as adverse events'}, {'measure': 'AUC0-inf of Nintedanib in Course 1', 'timeFrame': '-0:05 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 7h, 10h and 23:55h after drug administration in course 1', 'description': 'AUC0-inf (area under the plasma concentration-time curve over the time interval from 0 extrapolated to infinity) after the first administration of nintedanib in course 1'}, {'measure': 'Cmax of Nintedanib in Course 1', 'timeFrame': '-0:05h before drug administration and 1h, 2h, 3h, 4h, 6h, 7h, 10h and 23:55h after drug administration in course 1', 'description': 'Cmax (maximum measured plasma concentration) after the first administration of nintedanib in course 1'}, {'measure': 'AUC0-inf of Docetaxel in Course 1', 'timeFrame': '-0:05h before drug administration and 1h, 1.5h, 2h, 3h, 4h, 7h, 23:55h and 47:55h after drug administration', 'description': 'AUC0-inf (area under the plasma concentration-time curve over the time interval from 0 extrapolated to infinity) after the first administration of docetaxel in course 1'}, {'measure': 'Cmax of Docetaxel in Course 1', 'timeFrame': '-0:05h before drug administration and 1h, 1.5h, 2h, 3h, 4h, 7h, 23:55h and 47:55h after drug administration', 'description': 'Cmax (maximum measured plasma concentration) after the first administration of docetaxel in course 1'}, {'measure': 'AUC0-inf of Docetaxel in Course 2', 'timeFrame': '-0:05h before drug administration and 1h, 1.5h, 2h, 3h, 4h, 7h, 23:55h and 47:55h after drug administration', 'description': 'AUC0-inf (area under the plasma concentration-time curve over the time interval from 0 extrapolated to infinity) after the first administration of docetaxel in course 2.\n\nDocetaxel 50 mg/m2 patients were assigned to Docetaxel 60 mg/m2 in Cycle 1, but the dose was reduced to 50 mg/m2 in Cycle 2 as defined in the Clinical Trial Protocol.'}, {'measure': 'Cmax of Docetaxel in Course 2', 'timeFrame': '-0:05h before drug administration and 1h, 1.5h, 2h, 3h, 4h, 7h, 23:55h and 47:55h after drug administration', 'description': 'Cmax (maximum measured plasma concentration) after the first administration of docetaxel in course 2.\n\nDocetaxel 50 mg/m2 patients were assigned to Docetaxel 60 mg/m2 in Cycle 1, but the dose was reduced to 50 mg/m2 in Cycle 2 as defined in the Clinical Trial Protocol.'}]}, 'conditionsModule': {'conditions': ['Carcinoma, Non-Small-Cell Lung']}, 'descriptionModule': {'briefSummary': 'To confirm the safety of BIBF 1120 at a dose level up to 200 mg x 2/day (i.e., overseas recommended Phase III dose for combination treatment) with standard therapy of docetaxel (60 mg/m2 and 75 mg/m2) in Japanese advanced non small cell lung cancer (NSCLC) patients with stage IIIB/IV or recurrent after failure of first line chemotherapy and to determine the recommended dose for the Phase II trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n1. Histologically/cytologically confirmed, locally advanced/metastatic NSCLC of stage IIIB/IV or recurrent NSCLC (all histologies. Existence or nonexistence of measurable lesion according to RECIST is no object.)\n2. Patients with one prior chemotherapy regimen including platinum-containing drug.\n\n In case of recurrent disease, one additional prior regimen is allowed for adjuvant and/or neoadjuvant therapy. However monotherapy of EGFR-TKI (i.e. erlotinib/Tarceva® and gefitinib/Iressa®) is not counted as 'one regimen'.\n3. Male or female patients age \\>=20 years and =\\<74 years at the enrolment.\n4. Life expectancy of at least three (3) months after the start of administration of the investigational drug.\n5. Eastern Cooperative Oncology Group (ECOG) \\[R01-0787\\] performance Score 0 or 1.\n6. Patients retaining a significant physiological compensatory function and patients with sufficient baseline organ function as follows:\n\n * Haemoglobin count more than 9.0g/dL\n * Absolute neutrophil count more than 1500/mm3\n * Platelet count more than 100 000/mm3\n * Serum creatinine less than or equal to1.5x upper limit of normal range at the investigator site\n * Aspartate aminotransferase (AST) and / or alanine aminotransferase (ALT) less than or equal to 1.5x upper limit of normal range at the investigator site (It is the same if patients have liver metastases)\n * PaO2 or SpO2 more than 60torr or 92%\n7. Written informed consent that is consistent with ICH-GCP guidelines.\n\nExclusion criteria:\n\n1. Patients who have received chemotherapy (including other investigational drug), hormonal therapy and immune therapy =\\<4 weeks prior to registration or who have not recovered from side effects of such therapy.\n2. Patients who have received radiotherapy =\\<4 weeks (limited field (e.g brain or bone metastasis) radiation =\\<2 weeks) prior to registration.\n3. Patients who have active brain metastases. (Patients who have no symptoms and is not needed to receive therapy in the registration may participate in this trial)\n4. Patients with active double cancer. (Patients who have skin cancer that is not malignant melanoma and carcinoma in situ of uterine cervix may participate in this trial)\n5. Patients with distinct / suspected pulmonary fibrosis or interstitial lung disease by the chest radiographic findings, or patients with a previous history of.\n6. History of clinically significant haemoptysis within the past 3 months (more than one tea spoon of fresh blood per day)\n7. Therapeutic anticoagulation (except low dose heparin and/or heparin flush as needed for maintenance of an indwelling intravenous device) or antiplatelet therapy (except for chronic low-dose therapy with acetylsalicylic acid =\\<325 mg per day)\n8. History of major thrombotic or clinically relevant major bleeding event in the past 6 months prior to registration.\n9. Known inherited predisposition to bleeding or thrombosis.\n10. Significant cardiovascular diseases. (i.e. hypertension not controlled by medical therapy, unstable angina, history of myocardial infarction within the past 6 months, congestive heart failure \\> NYHA II, serious cardiac arrhythmia, pericardial effusion)\n11. Significant weight loss (\\> 10 %) within the past 6 weeks prior to registration in the this trial\n12. Current peripheral neuropathy \\>= CTCAE grade 2 except due to trauma.\n13. Accumulation of coelomic fluid (e.g. pleural effusion, ascites fluid, cardiac effusion) requiring treatment\n14. Major injuries and/or surgery within the past 10 days prior to registration with incomplete wound healing.\n15. Serious infections requiring systemic antibiotic (e.g antiviral, antimicrobial, antifungal) therapy.\n16. Decompensated diabetes mellitus or other contraindication to high dose corticosteroid therapy.\n17. Gastrointestinal disorders or abnormalities (e.g Crohn's disease, Colitis ulcerosa and extensive gastrectomy) that would interfere with absorption of the study drug.\n18. Patients with difficulty in swallowing study medication\n19. Patients with positive HBs antigen, HCV antibody, or HIV antibody test\n20. Serious illness or concomitant non-oncological disease such as neurologic-, psychiatric-, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may increase the risk associated with trial participation or investigational drug administration and in the judgment of the investigator would make the patient inappropriate for entry into the trial.\n21. Patients who are sexually active and unwilling to use a medically acceptable method of contraception (e.g. such as implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner for participating females, condoms for participating males) during the trial and for at least 12 months after end of active therapy\n22. Female patients who are pregnant, breast feeding and may become pregnant.\n23. Patients who have or is suspected of having active alcohol or drug abuse.\n24. Patient with clinically meaningful drug hypersensitivities.\n25. Patients with auto immune disease.\n26. Patients unable to comply with the protocol.\n27. Other patients judged ineligible for enrolment in the study by the investigator."}, 'identificationModule': {'nctId': 'NCT00876460', 'briefTitle': 'BIBF 1120 + Docetaxel (Japan) in Patients With Advanced Non-small-cell Lung Cancer, Phase I', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Phase I Study of Continuous, Concomitant Oral Treatment With BIBF 1120 and Docetaxel - a Phase I, Open-label, Dose-escalation Study in Japanese Patients With Stage IIIB/IV or Recurrent Non-small-cell Lung Cancer After Failure of Chemotherapy', 'orgStudyIdInfo': {'id': '1199.29'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BIBF 1120 + docetaxel', 'description': 'Low, medium and high dose of BIBF 1120 and 60 mg/m2, 75 mg/m2 docetaxel every 3 weeks', 'interventionNames': ['Drug: BIBF 1120 M + docetaxel M', 'Drug: BIBF 1120 M + docetaxel H', 'Drug: BIBF 1120 H + docetaxel H', 'Drug: BIBF 1120 L + docetaxel M', 'Drug: BIBF 1120 H + docetaxel M']}], 'interventions': [{'name': 'BIBF 1120 M + docetaxel M', 'type': 'DRUG', 'description': 'BIBF 1120 Medium dose bid + docetaxel 60 mg/m2', 'armGroupLabels': ['BIBF 1120 + docetaxel']}, {'name': 'BIBF 1120 M + docetaxel H', 'type': 'DRUG', 'description': 'BIBF 1120 Medium dose bid + docetaxel 75mg/m2', 'armGroupLabels': ['BIBF 1120 + docetaxel']}, {'name': 'BIBF 1120 H + docetaxel H', 'type': 'DRUG', 'description': 'BIBF 1120 HIgh dose bid + docetaxel 75 mg/m2', 'armGroupLabels': ['BIBF 1120 + docetaxel']}, {'name': 'BIBF 1120 L + docetaxel M', 'type': 'DRUG', 'description': 'BIBF 1120 Low dose bid + docetaxel 60 mg/m2', 'armGroupLabels': ['BIBF 1120 + docetaxel']}, {'name': 'BIBF 1120 H + docetaxel M', 'type': 'DRUG', 'description': 'BIBF 1120 HIgh dose bid + docetaxel 60 mg/m2', 'armGroupLabels': ['BIBF 1120 + docetaxel']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fukuoka, Fukuoka', 'country': 'Japan', 'facility': '1199.29.002 Boehringer Ingelheim Investigational Site'}, {'city': 'Osaka-Sayamashi, Osaka', 'country': 'Japan', 'facility': '1199.29.001 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}