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

Ignite Creation Date: 2025-12-25 @ 1:41 AM

Ignite Modification Date: 2025-12-25 @ 11:57 PM

Study NCT ID: NCT00805194

Status: COMPLETED

Last Update Posted: 2018-12-05

First Post: 2008-12-08

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: LUME-Lung 1: BIBF 1120 Plus Docetaxel as Compared to Placebo Plus Docetaxel in 2nd Line Non Small Cell Lung Cancer

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'C530716', 'term': 'nintedanib'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the first drug administration until 28 days after the last drug administration, up to 42 months', 'description': 'Number of participants at risk corresponds to all randomised patients who were documented to have taken at least 1 dose of study medication. Patients were allocated to the treatment groups according to the treatment actually received.', 'eventGroups': [{'id': 'EG000', 'title': 'Nintedanib Plus Docetaxel', 'description': 'Nintedanib 200 mg twice daily administered orally in the form of a soft gelatin capsule plus docetaxel 75 milligram (mg)/square meter (m2) once every 3 weeks administered via intravenous infusion over 1 hour (h).', 'otherNumAtRisk': 652, 'deathsNumAtRisk': 652, 'otherNumAffected': 569, 'seriousNumAtRisk': 652, 'deathsNumAffected': 107, 'seriousNumAffected': 224}, {'id': 'EG001', 'title': 'Placebo Plus Docetaxel', 'description': 'Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).', 'otherNumAtRisk': 655, 'deathsNumAtRisk': 655, 'otherNumAffected': 547, 'seriousNumAtRisk': 655, 'deathsNumAffected': 77, 'seriousNumAffected': 206}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 43}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 73}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 37}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 76}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 260}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 130}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 158}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 117}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 54}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 102}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 54}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 60}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 54}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 191}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 175}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 42}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 89}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 184}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 55}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 145}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 43}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 77}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 236}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 232}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 157}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 158}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 144}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 101}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 46}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 44}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 45}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 41}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 34}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 34}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 42}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 47}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 38}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 96}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 108}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 100}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 80}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 107}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 119}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 19}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 21}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Tachyarrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Ventricular arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Diverticulum intestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Duodenal ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Gastric perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Gastritis erosive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Gastrointestinal necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Haemorrhoidal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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{'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Personality change', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Bladder perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Alveolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Bronchial haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Bronchial secretion retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Bronchostenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 30}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Lung infiltration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Obstructive airways disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pleuritic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pulmonary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Respiratory depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Stridor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Tracheal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Subclavian artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Superior vena cava syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 652, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression Free Survival (PFS) as Assessed by Central Independent Review', 'denoms': [{'units': 'Participants', 'counts': [{'value': '565', 'groupId': 'OG000'}, {'value': '569', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib Plus Docetaxel', 'description': 'Nintedanib 200 mg twice daily administered orally in the form of a soft gelatin capsule plus docetaxel 75 milligram (mg)/square meter (m2) once every 3 weeks administered via intravenous infusion over 1 hour (h).'}, {'id': 'OG001', 'title': 'Placebo Plus Docetaxel', 'description': 'Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '5.7'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '4.6'}]}]}], 'analyses': [{'pValue': '0.0019', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.79', 'ciLowerLimit': '0.68', 'ciUpperLimit': '0.92', 'estimateComment': 'Hazard Ratio (HR) below 1 favors nintedanib', 'groupDescription': 'HR, Confidence Interval (CI) and p-value obtained from the proportional hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation until cut-off date 2 November 2010 (when 713 PFS events were observed)', 'description': 'Progression Free Survival (PFS) as assessed by central independent review according to the modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) . Progression free survival (PFS) is defined as the duration of time from date of randomisation to date of progression or death (whatever occurs earlier).\n\nMedian, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.', 'unitOfMeasure': 'months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomised Set'}, {'type': 'SECONDARY', 'title': 'Overall Survival (Key Secondary Endpoint)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '655', 'groupId': 'OG000'}, {'value': '659', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib Plus Docetaxel', 'description': 'Nintedanib 200 mg twice daily administered orally in the form of a soft gelatin capsule plus docetaxel 75 milligram (mg)/square meter (m2) once every 3 weeks administered via intravenous infusion over 1 hour (h).'}, {'id': 'OG001', 'title': 'Placebo Plus Docetaxel', 'description': 'Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).'}], 'classes': [{'title': 'Adenocarcinoma and <9 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.9', 'groupId': 'OG000', 'lowerLimit': '5.1', 'upperLimit': '21.9'}, {'value': '7.9', 'groupId': 'OG001', 'lowerLimit': '4.5', 'upperLimit': '14.5'}]}]}, {'title': 'Adenocarcinoma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'OG000'}, {'value': '336', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.6', 'groupId': 'OG000', 'lowerLimit': '5.5', 'upperLimit': '24.2'}, {'value': '10.3', 'groupId': 'OG001', 'lowerLimit': '5.5', 'upperLimit': '19.9'}]}]}, {'title': 'All patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '655', 'groupId': 'OG000'}, {'value': '659', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '19.4'}, {'value': '9.1', 'groupId': 'OG001', 'lowerLimit': '4.8', 'upperLimit': '17.2'}]}]}], 'analyses': [{'pValue': '0.0073', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.75', 'ciLowerLimit': '0.60', 'ciUpperLimit': '0.92', 'pValueComment': 'HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs 1 - one pat. had 2), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)', 'estimateComment': "The overall alpha level followed a Lan-DeMets spending function with O'Brien-Fleming shape parameter to preserve an overall 2-sided alpha level of 0.05.\n\nHR below 1 favors nintedanib", 'groupDescription': 'Hierarchical testing was tested in a fixed sequence of statistical hypotheses in (1) patients with adenocarcinoma and \\<9 months since start of first-line therapy, (2) patients with adenocarcinoma, and (3) all patients. Each hypothesis could be only tested at the pre-specified alpha level if the previous null hypothesis in the testing sequence had been rejected.\n\nOverall survival for patients with adenocarcinoma and \\<9 months since start of first line therapy.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0359', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.70', 'ciUpperLimit': '0.99', 'pValueComment': 'HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs 1 - one pat. had 2), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)', 'estimateComment': "The overall alpha level followed a Lan-DeMets spending function with O'Brien-Fleming shape parameter to preserve an overall 2-sided alpha level of 0.05.\n\nHR below 1 favors nintedanib", 'groupDescription': 'Hierarchical testing was tested in a fixed sequence of statistical hypotheses in (1) patients with adenocarcinoma and \\<9 months since start of first-line therapy, (2) patients with adenocarcinoma, and (3) all patients. Each hypothesis could be only tested at the pre-specified alpha level if the previous null hypothesis in the testing sequence had been rejected.\n\nOverall survival for patients with adenocarcinoma.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.2720', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.05', 'pValueComment': 'HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs 1 - one pat. had 2), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)', 'estimateComment': "The overall alpha level followed a Lan-DeMets spending function with O'Brien-Fleming shape parameter to preserve an overall 2-sided alpha level of 0.05. HR below 1 favors nintedanib", 'groupDescription': 'Hierarchical testing was tested in a fixed sequence of statistical hypotheses in (1) patients with adenocarcinoma and \\<9 months since start of first-line therapy, (2) patients with adenocarcinoma, and (3) all patients. Each hypothesis could be only tested at the pre-specified alpha level if the previous null hypothesis in the testing sequence had been rejected.\n\nOverall survival for all patients.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation until cut-off date 15 February 2013 (approximately 48 months or 1151 deaths among all patients )', 'description': 'Overall Survival (OS) defined as the duration from randomisation to death (irrespective of the reason of death). Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.\n\nA fixed-sequence-testing was implemented for key secondary endpoint if both the primary and the follow-up analysis showed a treatment benefit (P\\<0.05) of nintedanib over placebo. In this case, the OS would be tested using hierarchical testing of statistical hypotheses in (1) patients with adenocarcinoma and \\<9 months since start of first-line therapy, (2) patients with adenocarcinoma, and (3) all patients. Each hypothesis could be only tested at the pre-specified alpha level if the previous null hypothesis in the testing sequence had been.', 'unitOfMeasure': 'months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomised Set'}, {'type': 'SECONDARY', 'title': 'Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Central Independent Review', 'denoms': [{'units': 'Participants', 'counts': [{'value': '655', 'groupId': 'OG000'}, {'value': '659', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib Plus Docetaxel', 'description': 'Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).'}, {'id': 'OG001', 'title': 'Placebo Plus Docetaxel', 'description': 'Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '5.7'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '5.5'}]}]}], 'analyses': [{'pValue': '0.0070', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.85', 'ciLowerLimit': '0.75', 'ciUpperLimit': '0.96', 'pValueComment': 'HR, CI and p-value obtained from the proportional hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)', 'estimateComment': 'HR below 1 favors nintedanib', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation until cut-off date 15 February 2013', 'description': 'Follow-up analysis was conducted at the time of overall survival analysis. Progression Free Survival (PFS) as assessed by central independent review according to the modified RECIST (version 1.0) criteria.\n\nMedian, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.', 'unitOfMeasure': 'months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomised Set'}, {'type': 'SECONDARY', 'title': 'Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '655', 'groupId': 'OG000'}, {'value': '659', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib Plus Docetaxel', 'description': 'Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).'}, {'id': 'OG001', 'title': 'Placebo Plus Docetaxel', 'description': 'Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).'}], 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '7.1'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '5.7'}]}]}], 'analyses': [{'pValue': '0.0012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '0.73', 'ciUpperLimit': '0.93', 'pValueComment': 'HR, CI and p-value obtained from the proportional hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)', 'estimateComment': 'HR below 1 favors nintedanib', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation until cut-off date 15 February 2013', 'description': 'Follow-up analysis was conducted at the time of overall survival analysis. Progression Free Survival (PFS) as assessed by investigator according to the modified RECIST (version 1.0) criteria.\n\nMedian, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.', 'unitOfMeasure': 'months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomised Set'}, {'type': 'SECONDARY', 'title': 'Objective Tumour Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '655', 'groupId': 'OG000'}, {'value': '659', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib Plus Docetaxel', 'description': 'Nintedanib 200 mg twice daily administered orally in the form of a soft gelatin capsule plus docetaxel 75 milligram (mg)/square meter (m2) once every 3 weeks administered via intravenous infusion over 1 hour (h).'}, {'id': 'OG001', 'title': 'Placebo Plus Docetaxel', 'description': 'Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).'}], 'classes': [{'title': 'central independent reviewer', 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000'}, {'value': '3.3', 'groupId': 'OG001'}]}]}, {'title': 'investigator assessment', 'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000'}, {'value': '7.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3067', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.34', 'ciLowerLimit': '0.76', 'ciUpperLimit': '2.39', 'pValueComment': 'Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)', 'estimateComment': 'An odds ratio \\>1 indicates a benefit to nintedanib', 'groupDescription': 'Analysis based on the central independent review', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0761', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.41', 'ciLowerLimit': '0.96', 'ciUpperLimit': '2.08', 'pValueComment': 'Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)', 'estimateComment': 'An odds ratio \\>1 indicates a benefit to nintedanib', 'groupDescription': "Analysis based on the investigator's assessment", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomisation until cut-off date 15 February 2013', 'description': 'Confirmed objective response is defined as confirmed Complete Response (CR) and Partial Response (PR) and evaluated according to the modified RECIST criteria version 1.0.\n\nAs per RECIST v1.0, Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions.\n\nThis endpoint was analysed based on the central independent reviewer as well as the investigator.', 'unitOfMeasure': '% of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomised Set'}, {'type': 'SECONDARY', 'title': 'Duration of Confirmed Objective Tumour Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '655', 'groupId': 'OG000'}, {'value': '659', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib Plus Docetaxel', 'description': 'Nintedanib 200 mg twice daily administered orally in the form of a soft gelatin capsule plus docetaxel 75 milligram (mg)/square meter (m2) once every 3 weeks administered via intravenous infusion over 1 hour (h).'}, {'id': 'OG001', 'title': 'Placebo Plus Docetaxel', 'description': 'Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).'}], 'classes': [{'title': 'central independent reviewer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '5.7'}, {'value': '4.3', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '8.5'}]}]}, {'title': 'investigator assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '10.0'}, {'value': '5.5', 'groupId': 'OG001', 'lowerLimit': '3.9', 'upperLimit': '9.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation until cut-off date 15 February 2013', 'description': 'The duration of objective response is the time from first documented (CR) or (PR) to the time of progression or death and evaluated according to the modified RECIST criteria version 1.0.\n\nAs per RECIST v1.0, Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions.\n\nMedian, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.\n\nThis endpoint was analysed based on the central independent reviewer as well as the investigator.', 'unitOfMeasure': 'months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomised Set'}, {'type': 'SECONDARY', 'title': 'Time to Confirmed Objective Tumour Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '655', 'groupId': 'OG000'}, {'value': '659', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib Plus Docetaxel', 'description': 'Nintedanib 200 mg twice daily administered orally in the form of a soft gelatin capsule plus docetaxel 75 milligram (mg)/square meter (m2) once every 3 weeks administered via intravenous infusion over 1 hour (h).'}, {'id': 'OG001', 'title': 'Placebo Plus Docetaxel', 'description': 'Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).'}], 'classes': [{'title': 'central independent reviewer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '3.0'}, {'value': '2.9', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '5.6'}]}]}, {'title': 'investigator assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '4.0'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '4.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation until cut-off date 15 February 2013', 'description': 'Time to confirmed objective response is defined as time from randomisation to the date of first documented (CR) or (PR) and evaluated according to the modified RECIST criteria version 1.0.\n\nMedian, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.\n\nThis endpoint was analysed based on the central independent reviewer as well as the investigator.', 'unitOfMeasure': 'months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomised Set'}, {'type': 'SECONDARY', 'title': 'Disease Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '655', 'groupId': 'OG000'}, {'value': '659', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib Plus Docetaxel', 'description': 'Nintedanib 200 mg twice daily administered orally in the form of a soft gelatin capsule plus docetaxel 75 milligram (mg)/square meter (m2) once every 3 weeks administered via intravenous infusion over 1 hour (h).'}, {'id': 'OG001', 'title': 'Placebo Plus Docetaxel', 'description': 'Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 (with dose reduction to 60 mg/m2 if required) once every 3 weeks administered via intravenous infusion over 1 hour (h).'}], 'classes': [{'title': 'central independent reviewer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '272', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.0', 'groupId': 'OG000'}, {'value': '41.3', 'groupId': 'OG001'}]}]}, {'title': 'investigator assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '415', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '63.4', 'groupId': 'OG000'}, {'value': '51.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.68', 'ciLowerLimit': '1.35', 'ciUpperLimit': '2.09', 'pValueComment': 'Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)', 'estimateComment': 'An odds ratio \\>1 indicates a benefit to nintedanib', 'groupDescription': 'Analysis based on the central independent review', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.64', 'ciLowerLimit': '1.31', 'ciUpperLimit': '2.05', 'pValueComment': 'Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)', 'estimateComment': 'An odds ratio \\>1 indicates a benefit to nintedanib', 'groupDescription': "Analysis based on investigator's assessment", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomisation until cut-off date 15 February 2013', 'description': 'Disease control was defined as a best overall response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) and evaluated according to the modified RECIST criteria version 1.0.\n\nAs per RECIST v1.0 for target lesions : Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions; progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.\n\nThis endpoint was analysed based on the central independent reviewer as well as the investigator.', 'unitOfMeasure': '% of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomised Set'}, {'type': 'SECONDARY', 'title': 'Duration of Disease Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '655', 'groupId': 'OG000'}, {'value': '659', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib Plus Docetaxel', 'description': 'Nintedanib 200 mg twice daily administered orally in the form of a soft gelatin capsule plus docetaxel 75 milligram (mg)/square meter (m2) once every 3 weeks administered via intravenous infusion over 1 hour (h).'}, {'id': 'OG001', 'title': 'Placebo Plus Docetaxel', 'description': 'Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).'}], 'classes': [{'title': 'central independent reviewer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '272', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '7.1'}, {'value': '5.6', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '8.2'}]}]}, {'title': 'investigator assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '415', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': '8.4'}, {'value': '5.6', 'groupId': 'OG001', 'lowerLimit': '4.1', 'upperLimit': '8.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation until cut-off date 15 February 2013', 'description': 'The duration of disease control was defined as the time from randomisation to the date of disease progression or death (which ever occurs first) for patients with disease control.\n\nMedian, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.\n\nThis endpoint was analysed based on the central independent reviewer as well as the investigator.', 'unitOfMeasure': 'months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomised Set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Tumour Size', 'denoms': [{'units': 'Participants', 'counts': [{'value': '655', 'groupId': 'OG000'}, {'value': '659', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib Plus Docetaxel', 'description': 'Nintedanib 200 mg twice daily administered orally in the form of a soft gelatin capsule plus docetaxel 75 milligram (mg)/square meter (m2) once every 3 weeks administered via intravenous infusion over 1 hour (h).'}, {'id': 'OG001', 'title': 'Placebo Plus Docetaxel', 'description': 'Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).'}], 'classes': [{'title': 'central independent reviewer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '582', 'groupId': 'OG000'}, {'value': '570', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.87', 'groupId': 'OG000', 'lowerLimit': '-6.62', 'upperLimit': '-3.12'}, {'value': '0.58', 'groupId': 'OG001', 'lowerLimit': '-1.19', 'upperLimit': '2.35'}]}]}, {'title': 'investigator assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '603', 'groupId': 'OG000'}, {'value': '596', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.34', 'groupId': 'OG000', 'lowerLimit': '-12.58', 'upperLimit': '-8.11'}, {'value': '-2.14', 'groupId': 'OG001', 'lowerLimit': '-4.39', 'upperLimit': '0.10'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value generated from ANOVA model adjusted for baseline ECOG PS (0 vs. 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)', 'groupDescription': 'Analysis based on the central independent review', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value generated from ANOVA model adjusted for baseline ECOG PS (0 vs. 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)', 'groupDescription': "Analysis based on the investigator's assessment", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'From randomisation until cut-off date 15 February 2013', 'description': 'Percentage change from baseline in tumour size is defined as decrease in the sum of the longest diameter of the target lesion.\n\nPresented means are in fact adjusted best means percentage changes generated from ANOVA model adjusted for baseline ECOG PS (0 vs. 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)\n\nThis endpoint was analysed based on the central independent reviewer as well as the investigator.', 'unitOfMeasure': 'percentage of change in tumor size in mm', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomised Set'}, {'type': 'SECONDARY', 'title': 'Clinical Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '655', 'groupId': 'OG000'}, {'value': '659', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nitedanib Plus Docetaxel', 'description': 'Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).'}, {'id': 'OG001', 'title': 'Placebo Plus Docetaxel', 'description': 'Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).'}], 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '22.7'}, {'value': '5.2', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '19.2'}]}]}], 'analyses': [{'pValue': '0.7282', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.21', 'pValueComment': 'HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs 1 - one pat.had 2), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)', 'estimateComment': 'HR below 1 favors nintedanib', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation until cut-off date 15 February 2013', 'description': 'Clinical improvement was defined as the time from randomisation to deterioration in body weight and/or Eastern Cooperative Oncology group performance score (ECOG PS) whichever occurred first.\n\nMedian, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.', 'unitOfMeasure': 'months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomised set'}, {'type': 'SECONDARY', 'title': 'Quality of Life (QoL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '655', 'groupId': 'OG000'}, {'value': '659', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nitedanib Plus Docetaxel', 'description': 'Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).'}, {'id': 'OG001', 'title': 'Placebo Plus Docetaxel', 'description': 'Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).'}], 'classes': [{'title': 'Time to deterioration of cough', 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '11.8'}, {'value': '3.5', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '12.6'}]}]}, {'title': 'Time to deterioration of dyspnoea', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '4.2'}, {'value': '2.1', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '4.5'}]}]}, {'title': 'Time to deterioration of pain', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '6.5'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '5.8'}]}]}], 'analyses': [{'pValue': '0.1858', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.05', 'pValueComment': 'HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs \\>=1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)', 'estimateComment': 'HR below 1 favors nintedanib', 'groupDescription': 'Analysis evaluating the time to deterioration of cough', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.5203', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.91', 'ciUpperLimit': '1.20', 'pValueComment': 'HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs \\>=1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)', 'estimateComment': 'HR below 1 favors nintedanib', 'groupDescription': 'Analysis evaluating the time to deterioration of dyspnoea', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.4373', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.09', 'pValueComment': 'HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs \\>= 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)', 'estimateComment': 'HR below 1 favors nintedanib', 'groupDescription': 'Analysis evaluating the time to deterioration of pain', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation until cut-off date 15 February 2013', 'description': 'Quality of life (QoL) was measured by standardised questionnaires (Health Status Self-Assessment Questionnaire (EQ-5D), EORTC Quality of life questionnaire - Core 30 (EORTC QLQ-C30), Quality of life questionnaire - lung cancer module (EORTC QLQ-LC13). The EORTC QLQ-C30 comprises of 30 questions, using both multi-item scales and single-item measures. EORTC LC-13 comprises of 13 questions incorporating 1 multi-item scale and a series of single items.\n\nThe following were the main points of interest:\n\nTime to deterioration of cough (EORTC QLQ-LC13 question 1), Time to deterioration of dyspnoea (QLQ-LC13, composite of questions 3 to 5), Time to deterioration of pain (QLQ- C30, composite of questions 9 and 19).\n\nTime to deterioration of cough, dyspnoea and pain was defined as the time to a 10-point increase from the baseline score.\n\nMedian, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve', 'unitOfMeasure': 'months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomised set'}, {'type': 'SECONDARY', 'title': 'Dose Normalised Predose Plasma Concentration at Steady State (Cpre,ss,Norm) of Nintedanib and of Its Metabolites BIBF 1202 and BIBF 1202 Glucuronide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '454', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nitedanib 200 mg Bid Plus Docetaxel', 'description': 'Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).'}, {'id': 'OG001', 'title': 'Nintedanib 150 Bid mg Plus Docetaxel', 'description': 'Nintedanib 150 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).'}], 'classes': [{'title': 'nintedanib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '453', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0707', 'spread': '77.7', 'groupId': 'OG000'}, {'value': '0.106', 'spread': '52.6', 'groupId': 'OG001'}]}]}, {'title': 'metabolite BIBF 1202', 'denoms': [{'units': 'Participants', 'counts': [{'value': '454', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0907', 'spread': '127', 'groupId': 'OG000'}, {'value': '0.190', 'spread': '152', 'groupId': 'OG001'}]}]}, {'title': 'metabolite BIBF 1202 glucuronide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '429', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.04', 'spread': '153', 'groupId': 'OG000'}, {'value': '1.94', 'spread': '135', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before the administration of nintedanib or placebo and between a window of 30 mins to an hour after administration of trial drug during Course 2 and between 1 and 3 hours after administration of trial drug during Course 3', 'description': 'Geometric mean of dose normalised predose plasma concentration (Cpre,ss,norm) of nintedanib and of its metabolites BIBF 1202 and BIBF 1202 glucuronide evaluated at steady state based on course 2 and 3. If only one value was available and valid, then this value was used for calculation of Cpre,ss,norm.', 'unitOfMeasure': 'ng/mL/mg', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic set- all patients in the treated set who were documented to have received at least 1 dose of nintedanib and who had at least 1 valid drug plasma concentration available'}, {'type': 'SECONDARY', 'title': 'Incidence and Intensity of Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '652', 'groupId': 'OG000'}, {'value': '655', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nitedanib Plus Docetaxel', 'description': 'Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).'}, {'id': 'OG001', 'title': 'Placebo Plus Docetaxel', 'description': 'Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).'}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000'}, {'value': '8.2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '16.6', 'groupId': 'OG000'}, {'value': '20.5', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '21.2', 'groupId': 'OG000'}, {'value': '21.2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '33.7', 'groupId': 'OG000'}, {'value': '31.3', 'groupId': 'OG001'}]}]}, {'title': 'Grade 5', 'categories': [{'measurements': [{'value': '16.4', 'groupId': 'OG000'}, {'value': '11.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the first drug administration until 28 days after the last drug administration, up to 42 months', 'description': 'Incidence and intensity of adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The worst CTCAE grade per patient is reported and MedDRA version 15.1 used.\n\nSerious signs and symptoms of progressive disease were reported as an adverse event in analysis of this endpoint.', 'unitOfMeasure': '% of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set- all randomised patients who were documented to have taken at least 1 dose of study medication . Patients were allocated to the treatment groups according to the treatment actually received.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nintedanib Plus Docetaxel', 'description': 'Nintedanib 200 mg twice daily administered orally in the form of a soft gelatin capsule plus docetaxel 75 milligram (mg)/square meter (m2) once every 3 weeks administered via intravenous infusion over 1 hour (h).'}, {'id': 'FG001', 'title': 'Placebo Plus Docetaxel', 'description': 'Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'randomised patients', 'groupId': 'FG000', 'numSubjects': '655'}, {'comment': 'randomised patients', 'groupId': 'FG001', 'numSubjects': '659'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '649'}, {'groupId': 'FG001', 'numSubjects': '654'}]}], 'dropWithdraws': [{'type': 'Progressive disease (modified RECIST)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '404'}, {'groupId': 'FG001', 'numSubjects': '435'}]}, {'type': 'Worsening or AE of underlying disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'Other AE', 'reasons': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '73'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'Not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Reasons other than stated above', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '16'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '655', 'groupId': 'BG000'}, {'value': '659', 'groupId': 'BG001'}, {'value': '1314', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Nintedanib Plus Docetaxel', 'description': 'Nintedanib 200 mg twice daily administered orally in the form of a soft gelatin capsule plus docetaxel 75 milligram (mg)/square meter (m2) once every 3 weeks administered via intravenous infusion over 1 hour (h).'}, {'id': 'BG001', 'title': 'Placebo Plus Docetaxel', 'description': 'Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '655', 'groupId': 'BG000'}, {'value': '659', 'groupId': 'BG001'}, {'value': '1314', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '59.7', 'spread': '9.7', 'groupId': 'BG000'}, {'value': '59.8', 'spread': '9.0', 'groupId': 'BG001'}, {'value': '59.7', 'spread': '9.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '655', 'groupId': 'BG000'}, {'value': '659', 'groupId': 'BG001'}, {'value': '1314', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '179', 'groupId': 'BG000'}, {'value': '180', 'groupId': 'BG001'}, {'value': '359', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '476', 'groupId': 'BG000'}, {'value': '479', 'groupId': 'BG001'}, {'value': '955', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Tumour histology', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '655', 'groupId': 'BG000'}, {'value': '659', 'groupId': 'BG001'}, {'value': '1314', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Adenocarcinoma', 'measurements': [{'value': '322', 'groupId': 'BG000'}, {'value': '336', 'groupId': 'BG001'}, {'value': '658', 'groupId': 'BG002'}]}, {'title': 'Squamous cell carcinoma', 'measurements': [{'value': '276', 'groupId': 'BG000'}, {'value': '279', 'groupId': 'BG001'}, {'value': '555', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of patients with adenocarcinoma and time since first line therapy in categories', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'BG000'}, {'value': '336', 'groupId': 'BG001'}, {'value': '658', 'groupId': 'BG002'}]}], 'categories': [{'title': '<9 month', 'measurements': [{'value': '206', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '405', 'groupId': 'BG002'}]}, {'title': '>=9 month', 'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '246', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Randomised patients with adenocarcinoma and time since first line therapy.'}], 'populationDescription': 'Randomised Set (RS)- Includes all randomised patients, whether patients had received study treatment or not'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1314}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2017-11-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-09', 'studyFirstSubmitDate': '2008-12-08', 'resultsFirstSubmitDate': '2014-11-14', 'studyFirstSubmitQcDate': '2008-12-08', 'lastUpdatePostDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-11-27', 'studyFirstPostDateStruct': {'date': '2008-12-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival (PFS) as Assessed by Central Independent Review', 'timeFrame': 'From randomisation until cut-off date 2 November 2010 (when 713 PFS events were observed)', 'description': 'Progression Free Survival (PFS) as assessed by central independent review according to the modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) . Progression free survival (PFS) is defined as the duration of time from date of randomisation to date of progression or death (whatever occurs earlier).\n\nMedian, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (Key Secondary Endpoint)', 'timeFrame': 'From randomisation until cut-off date 15 February 2013 (approximately 48 months or 1151 deaths among all patients )', 'description': 'Overall Survival (OS) defined as the duration from randomisation to death (irrespective of the reason of death). Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.\n\nA fixed-sequence-testing was implemented for key secondary endpoint if both the primary and the follow-up analysis showed a treatment benefit (P\\<0.05) of nintedanib over placebo. In this case, the OS would be tested using hierarchical testing of statistical hypotheses in (1) patients with adenocarcinoma and \\<9 months since start of first-line therapy, (2) patients with adenocarcinoma, and (3) all patients. Each hypothesis could be only tested at the pre-specified alpha level if the previous null hypothesis in the testing sequence had been.'}, {'measure': 'Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Central Independent Review', 'timeFrame': 'From randomisation until cut-off date 15 February 2013', 'description': 'Follow-up analysis was conducted at the time of overall survival analysis. Progression Free Survival (PFS) as assessed by central independent review according to the modified RECIST (version 1.0) criteria.\n\nMedian, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.'}, {'measure': 'Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Investigator', 'timeFrame': 'From randomisation until cut-off date 15 February 2013', 'description': 'Follow-up analysis was conducted at the time of overall survival analysis. Progression Free Survival (PFS) as assessed by investigator according to the modified RECIST (version 1.0) criteria.\n\nMedian, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.'}, {'measure': 'Objective Tumour Response', 'timeFrame': 'From randomisation until cut-off date 15 February 2013', 'description': 'Confirmed objective response is defined as confirmed Complete Response (CR) and Partial Response (PR) and evaluated according to the modified RECIST criteria version 1.0.\n\nAs per RECIST v1.0, Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions.\n\nThis endpoint was analysed based on the central independent reviewer as well as the investigator.'}, {'measure': 'Duration of Confirmed Objective Tumour Response', 'timeFrame': 'From randomisation until cut-off date 15 February 2013', 'description': 'The duration of objective response is the time from first documented (CR) or (PR) to the time of progression or death and evaluated according to the modified RECIST criteria version 1.0.\n\nAs per RECIST v1.0, Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions.\n\nMedian, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.\n\nThis endpoint was analysed based on the central independent reviewer as well as the investigator.'}, {'measure': 'Time to Confirmed Objective Tumour Response', 'timeFrame': 'From randomisation until cut-off date 15 February 2013', 'description': 'Time to confirmed objective response is defined as time from randomisation to the date of first documented (CR) or (PR) and evaluated according to the modified RECIST criteria version 1.0.\n\nMedian, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.\n\nThis endpoint was analysed based on the central independent reviewer as well as the investigator.'}, {'measure': 'Disease Control', 'timeFrame': 'From randomisation until cut-off date 15 February 2013', 'description': 'Disease control was defined as a best overall response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) and evaluated according to the modified RECIST criteria version 1.0.\n\nAs per RECIST v1.0 for target lesions : Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions; progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.\n\nThis endpoint was analysed based on the central independent reviewer as well as the investigator.'}, {'measure': 'Duration of Disease Control', 'timeFrame': 'From randomisation until cut-off date 15 February 2013', 'description': 'The duration of disease control was defined as the time from randomisation to the date of disease progression or death (which ever occurs first) for patients with disease control.\n\nMedian, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.\n\nThis endpoint was analysed based on the central independent reviewer as well as the investigator.'}, {'measure': 'Change From Baseline in Tumour Size', 'timeFrame': 'From randomisation until cut-off date 15 February 2013', 'description': 'Percentage change from baseline in tumour size is defined as decrease in the sum of the longest diameter of the target lesion.\n\nPresented means are in fact adjusted best means percentage changes generated from ANOVA model adjusted for baseline ECOG PS (0 vs. 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)\n\nThis endpoint was analysed based on the central independent reviewer as well as the investigator.'}, {'measure': 'Clinical Improvement', 'timeFrame': 'From randomisation until cut-off date 15 February 2013', 'description': 'Clinical improvement was defined as the time from randomisation to deterioration in body weight and/or Eastern Cooperative Oncology group performance score (ECOG PS) whichever occurred first.\n\nMedian, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.'}, {'measure': 'Quality of Life (QoL)', 'timeFrame': 'From randomisation until cut-off date 15 February 2013', 'description': 'Quality of life (QoL) was measured by standardised questionnaires (Health Status Self-Assessment Questionnaire (EQ-5D), EORTC Quality of life questionnaire - Core 30 (EORTC QLQ-C30), Quality of life questionnaire - lung cancer module (EORTC QLQ-LC13). The EORTC QLQ-C30 comprises of 30 questions, using both multi-item scales and single-item measures. EORTC LC-13 comprises of 13 questions incorporating 1 multi-item scale and a series of single items.\n\nThe following were the main points of interest:\n\nTime to deterioration of cough (EORTC QLQ-LC13 question 1), Time to deterioration of dyspnoea (QLQ-LC13, composite of questions 3 to 5), Time to deterioration of pain (QLQ- C30, composite of questions 9 and 19).\n\nTime to deterioration of cough, dyspnoea and pain was defined as the time to a 10-point increase from the baseline score.\n\nMedian, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve'}, {'measure': 'Dose Normalised Predose Plasma Concentration at Steady State (Cpre,ss,Norm) of Nintedanib and of Its Metabolites BIBF 1202 and BIBF 1202 Glucuronide', 'timeFrame': 'Before the administration of nintedanib or placebo and between a window of 30 mins to an hour after administration of trial drug during Course 2 and between 1 and 3 hours after administration of trial drug during Course 3', 'description': 'Geometric mean of dose normalised predose plasma concentration (Cpre,ss,norm) of nintedanib and of its metabolites BIBF 1202 and BIBF 1202 glucuronide evaluated at steady state based on course 2 and 3. If only one value was available and valid, then this value was used for calculation of Cpre,ss,norm.'}, {'measure': 'Incidence and Intensity of Adverse Events', 'timeFrame': 'From the first drug administration until 28 days after the last drug administration, up to 42 months', 'description': 'Incidence and intensity of adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The worst CTCAE grade per patient is reported and MedDRA version 15.1 used.\n\nSerious signs and symptoms of progressive disease were reported as an adverse event in analysis of this endpoint.'}]}, 'conditionsModule': {'conditions': ['Carcinoma, Non-Small-Cell Lung']}, 'referencesModule': {'references': [{'pmid': '28702806', 'type': 'DERIVED', 'citation': 'Gottfried M, Bennouna J, Bondarenko I, Douillard JY, Heigener DF, Krzakowski M, Mellemgaard A, Novello S, Orlov S, Summers Y, von Pawel J, Stohr J, Kaiser R, Reck M. Efficacy and Safety of Nintedanib Plus Docetaxel in Patients with Advanced Lung Adenocarcinoma: Complementary and Exploratory Analyses of the Phase III LUME-Lung 1 Study. Target Oncol. 2017 Aug;12(4):475-485. doi: 10.1007/s11523-017-0517-2.'}, {'pmid': '24411639', 'type': 'DERIVED', 'citation': 'Reck M, Kaiser R, Mellemgaard A, Douillard JY, Orlov S, Krzakowski M, von Pawel J, Gottfried M, Bondarenko I, Liao M, Gann CN, Barrueco J, Gaschler-Markefski B, Novello S; LUME-Lung 1 Study Group. Docetaxel plus nintedanib versus docetaxel plus placebo in patients with previously treated non-small-cell lung cancer (LUME-Lung 1): a phase 3, double-blind, randomised controlled trial. Lancet Oncol. 2014 Feb;15(2):143-55. doi: 10.1016/S1470-2045(13)70586-2. Epub 2014 Jan 9.'}]}, 'descriptionModule': {'briefSummary': 'The present trial will be performed to evaluate whether BIBF 1120 in combination with standard therapy of docetaxel in patients with stage IIIB/IV or recurrent NSCLC is more effective as compared to placebo in combination with standard therapy of docetaxel. A secondary aim is to obtain safety information as well as information on quality of life of patients treated with BIBF 1120 in combination to standard therapy with docetaxel. In addition, blood will be collected for pharmacokinetic analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* male or female patient aged 18 years or older;\n* histologically or cytologically confirmed, locally advanced and/or metastatic NSCLC of stage IIIB or IV or recurrent NSCLC;\n* relapse or failure of one first line prior chemotherapy;\n* at least one target tumour lesion that has not been irradiated within the past three months and that can accurately be measured ;\n* life expectancy of at least three months;\n* Eastern Cooperative Oncology group (ECOG) score of 0 or 1;\n* patient has given written informed consent\n\nExclusion criteria:\n\n* more than one prior chemotherapy regimen for advanced and/or metastatic or recurrent NSCLC;\n* more than one chemotherapy treatment regimen (either neoadjuvant or adjuvant or neoadjuvant plus adjuvant) prior to first line chemotherapy;\n* previous therapy with other VEGFR inhibitors (other than bevacizumab) or docetaxel for treatment of NSCLC;\n* persistence of clinically relevant therapy related toxicities from previous chemotherapy and/or radiotherapy;\n* treatment with other investigational drugs or other anti-cancer therapy or treatment in another clinical trial within the past four weeks before start of - therapy or concomitantly with this trial ;\n* radiotherapy (except extremities and brain) within the past three months prior to baseline imaging;\n* active brain metastases or leptomeningeal disease;\n* radiographic evidence of cavitary or necrotic tumours;\n* centrally located tumours with radiographic evidence (CT or MRI) of local invasion of major blood vessels;\n* history of clinically significant haemoptysis within the past 3 months;\n* therapeutic anticoagulation (except low dose heparin) or antiplatelet therapy;\n* history of major thrombotic or clinically relevant major bleeding event in the past 6 months;\n* known inherited predisposition to bleeding or thrombosis;\n* significant cardiovascular diseases ;\n* inadequate safety laboratory parameters;\n* significant weight loss (\\> 10 %) within the past 6 weeks;\n* current peripheral neuropathy greater than CTCAE grade 2 except due to trauma;\n* preexisting ascites and/or clinically significant pleural effusion;\n* major injuries and/or surgery within the past ten days prior to randomisation with incomplete wound healing;\n* serious infections requiring systemic antibiotic therapy;\n* decompensated diabetes mellitus or other contraindication to high dose corticosteroid therapy;\n* gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug;\n* active or chronic hepatitis C and/or B infection;\n* serious illness or concomitant non-oncological disease or laboratory abnormality that may increase the risk associated with study participation or study drug administration;\n* patients who are sexually active and unwilling to use a medically acceptable method of contraception during the trial and for at least twelve months after end of active therapy;\n* pregnancy or breast feeding;\n* psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule;\n* patients unable to comply with the protocol;\n* active alcohol or drug abuse;\n* other malignancy within the past three years other than basal cell skin cancer, or carcinoma in situ of the cervix;\n* any contraindications for therapy with docetaxel;\n* history of severe hypersensitivity reactions to docetaxel or other drugs formulated with polysorbate 80 (Tween 80);\n* hypersensitivity to BIBF 1120 and/or the excipients of the trial drugs;\n* hypersensitivity to contrast media'}, 'identificationModule': {'nctId': 'NCT00805194', 'briefTitle': 'LUME-Lung 1: BIBF 1120 Plus Docetaxel as Compared to Placebo Plus Docetaxel in 2nd Line Non Small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Multicentre, Randomised, Double-blind, Phase III Trial to Investigate the Efficacy and Safety of Oral BIBF 1120 Plus Standard Docetaxel Therapy Compared to Placebo Plus Standard Docetaxel Therapy in Patients With Stage IIIB/IV or Recurrent Non Small Cell Lung Cancer After Failure of First Line Chemotherapy', 'orgStudyIdInfo': {'id': '1199.13'}, 'secondaryIdInfos': [{'id': '2007-004803-36', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BIBF 1120 plus docetaxel', 'description': 'BIBF 1120 2 times daily along with standard therapy of docetaxel', 'interventionNames': ['Drug: BIBF 1120 plus docetaxel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo plus docetaxel', 'description': 'Placebo matching BIBF 1120 2 times daily along with standard therapy of docetaxel', 'interventionNames': ['Drug: placebo plus docetaxel']}], 'interventions': [{'name': 'placebo plus docetaxel', 'type': 'DRUG', 'description': 'placebo matching BIBF 1120 2 times daily along with standard therapy of docetaxel', 'armGroupLabels': ['Placebo plus docetaxel']}, {'name': 'BIBF 1120 plus docetaxel', 'type': 'DRUG', 'description': 'BIBF 1120 2 times daily along with standard therapy of docetaxel', 'armGroupLabels': ['BIBF 1120 plus docetaxel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8036', 'city': 'Graz', 'country': 'Austria', 'facility': 'LKH-Univ. 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