Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-03-08 @ 4:13 AM
Study NCT ID:
NCT02597933
Status:
COMPLETED
Last Update Posted:
2019-12-13
First Post:
2015-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012595', 'term': 'Scleroderma, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C530716', 'term': 'nintedanib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim, Call Center', 'organization': 'Boehringer Ingelheim'}, '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 date of first trial drug intake up to date of death or last contact date (ie., up to 100 weeks)', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Patients were administered orally placebo matching nintedanib 150 milligram (mg) soft gelatine capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events.', 'otherNumAtRisk': 288, 'deathsNumAtRisk': 288, 'otherNumAffected': 239, 'seriousNumAtRisk': 288, 'deathsNumAffected': 9, 'seriousNumAffected': 79}, {'id': 'EG001', 'title': 'Nintedanib', 'description': 'Patients were administered orally 150 milligram (mg) soft gelatin capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events.', 'otherNumAtRisk': 288, 'deathsNumAtRisk': 288, 'otherNumAffected': 270, 'seriousNumAtRisk': 288, 'deathsNumAffected': 10, 'seriousNumAffected': 88}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 36}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 92}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 218}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 96}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 78}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 33}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 43}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 39}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 28}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 22}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 16}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 19}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 39}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 28}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 23}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 20}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 34}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 41}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 23}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 56}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'seriousEvents': [{'term': 'Immune thrombocytopenic purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Thrombotic microangiopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Myocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pleuropericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Restrictive cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Right ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypertrophic cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Macular oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Retinal vein occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Rhegmatogenous retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Colitis ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Ileus paralytic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Intestinal mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Intestinal pseudo-obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Lower gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Brain death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Systemic inflammatory response syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Drug-induced liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hepatocellular injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Liver disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Anti-neutrophil cytoplasmic antibody positive vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Adenovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Campylobacter gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Systemic candida', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Postoperative ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cell marker increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Forced vital capacity decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Drooping shoulder syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Polymyalgia rheumatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Scleroderma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Systemic scleroderma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Benign mesothelioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Mesothelioma malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nasopharyngeal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Non-small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Sweat gland tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Carotid artery aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cerebral amyloid angiopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cerebral microhaemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cerebrovascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Major depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Bladder perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Scleroderma renal crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Urinary tract obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Vulvovaginal swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Acute lung injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Painful respiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pneumothorax spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pulmonary arterial hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Systemic sclerosis pulmonary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Actinic keratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Digital pitting scar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Petechiae', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Sclerema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Extremity necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Peripheral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': "Raynaud's phenomenon", 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Thrombophlebitis superficial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Vena cava thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients were administered orally placebo matching nintedanib 150 milligram (mg) soft gelatine capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events.'}, {'id': 'OG001', 'title': 'Nintedanib', 'description': 'Patients were administered orally 150 milligram (mg) soft gelatin capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events.'}], 'classes': [{'categories': [{'measurements': [{'value': '-93.3', 'spread': '13.5', 'groupId': 'OG000'}, {'value': '-52.4', 'spread': '13.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0350', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '40.95', 'ciLowerLimit': '2.88', 'ciUpperLimit': '79.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '19.38', 'estimateComment': 'The model assumed that data were missing at random \\& that patients who dropped out would have behaved similarly to those who remained in trial.', 'groupDescription': 'The primary analysis is a restricted maximum likelihood (REML) based approach using a random slope \\& intercept model. The analysis included the fixed, categorical effects of treatment, ATA status \\& gender, fixed continuous effects of time \\& baseline FVC (mL), age and height as well as the treatment-by time \\& baseline-by-time interactions. Random effects was included for patient response for both time \\& intercept.Within-patient errors are modelled by an unstructured variance-covariance matrix', 'statisticalMethod': 'random coefficient regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0378', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '43.13', 'ciLowerLimit': '2.44', 'ciUpperLimit': '83.83', 'groupDescription': 'This is a sensitivity analysis (SA) on primary endpoint including only on-trt measurements of FVC \\[mL\\]. The random coefficient model was used. The analysis included fixed, categorical effects of trt, ATA status \\& gender, fixed continuous effects of time \\& bl. FVC (mL), age, height, trt -by time \\& bl.-by-time interactions. Random effects included for patient response for both time \\& intercept.\n\nWithin-patient errors were modelled by an Unstructured variance-covariance matrix.', 'statisticalMethod': 'random coefficient regression', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'The model assumed that data were missing at random \\& that patients who dropped out would have behaved similarly to those who remained in trial.'}, {'pValue': '0.1046', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '30.00', 'ciLowerLimit': '-6.22', 'ciUpperLimit': '66.22', 'groupDescription': 'In multiple imputation SA 1, missing FVC values at wk 52 in pts who were alive at wk 52 were imputed assuming similar rate of FVC decline as in pts from corresponding trt group who prematurely disc. trial drug but had wk 52 FVC value. Missing FVC values at wk 52 in pts who died before wk 52 were imputed assuming similar rate of FVC decline as in pl. pts with wk 52 FVC value who prematurely disc. trial drug with most severe declines.The imputation model was similar to statistical model of PA.', 'statisticalMethod': 'random coefficient regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0740', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '32.93', 'ciLowerLimit': '-3.19', 'ciUpperLimit': '69.06', 'groupDescription': 'In multiple imputation SA 2, missing FVC values at wk 52 in pts who were alive at wk 52 were imputed assuming similar rate of FVC decline as in pts from pl. group who prematurely disc. trial drug but had a wk 52 FVC value. Missing FVC values at wk 52 in pts who died before wk 52 were imputed assuming similar rate of FVC decline as in pl. pts with a wk 52 FVC value who prematurely disc. trial drug with most severe declines. The imputation model was similar to the statistical model of the PA', 'statisticalMethod': 'random coefficient regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0644', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '33.86', 'ciLowerLimit': '-2.03', 'ciUpperLimit': '69.75', 'groupDescription': 'In multiple imputation SA 3, missing FVC values at wk 52 in pts who were alive at wk 52 were imputed assuming a similar rate of FVC decline as in all pts in the pl. group who were included in the PA. Missing FVC values at wk 52 in pts who died before wk 52 were imputed assuming a similar rate of FVC decline as in all placebo patients included in the primary analysis with the most severe declines. The imputation model was similar to the statistical model of the PA.', 'statisticalMethod': 'random coefficient regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0351', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '40.95', 'ciLowerLimit': '2.88', 'ciUpperLimit': '79.01', 'groupDescription': 'This is sensitivity analysis using the model similar to the primary analysis but including a different set of covariates: the fixed, categorical effects of treatment, ATA status, the fixed continuous effects of time, baseline FVC (mL), and the treatment-by-time and baseline-by-time interactions.Random effects was included for patient response for both time and intercept.', 'statisticalMethod': 'random coefficient regression', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0349', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '40.98', 'ciLowerLimit': '2.92', 'ciUpperLimit': '79.04', 'groupDescription': 'This is sensitivity analysis using the model similar to the primary analysis but including a different set of covariates: the fixed, categorical effects of treatment, ATA status (Positive / Negative), gender and mycophenolate mofetil /sodium background therapy use (Yes / No), fixed continuous effects of time, age , height and baseline FVC (mL), the treatment-by-time and baseline-by-time interactions. Random effects was included for patient response for both time and intercept', 'statisticalMethod': 'random coefficient regression', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'up to week (wk) 52 after the start of administration', 'description': 'Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test.\n\nFor this endpoint reported means represent the adjusted rate.', 'unitOfMeasure': 'millilitre (mL)/year (yr)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in the Modified Rodnan Skin Score (mRSS) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients were administered orally placebo matching nintedanib 150 milligram (mg) soft gelatine capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events.'}, {'id': 'OG001', 'title': 'Nintedanib', 'description': 'Patients were administered orally 150 milligram (mg) soft gelatin capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.96', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '-2.17', 'spread': '0.27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5785', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.21', 'ciLowerLimit': '-0.94', 'ciUpperLimit': '0.53', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.37', 'groupDescription': 'The mixed model repeated measures (MMRM) approach was used. The model assumed that data were missing at random \\& that patients who dropped out would have behaved similarly to those who remained in trial.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and up to 52 weeks after the start of administration', 'description': "This is the first key secondary endpoint.\n\nThe modified Rodnan Skin Score (mRSS) is an evaluation of the patient's skin thickness rated by clinical palpation using a 0 to 3 scale. The scale differentiates between 0 = normal skin, 1 = mild thickness, 2 = moderate thickness, and 3 = severe thickness with inability to pinch the skin into a fold.\n\nThe palpation is done for each of the 17 surface anatomic areas of the body: face, anterior chest, abdomen, fingers (right and left separately), forearms, upper arms, thighs, lower legs, dorsum of hands and feet. The sum of these individual values is defined as the total skin score. The mRSS has a range from 0 (no thickening) to 51 (severe thickening in all 17 areas). A high score corresponds to worse skin thickness.\n\nLeast square mean is actually the adjusted mean. Adjusted mean was based on all analysed patients in the model (not only patients with a baseline and measurement at Week 52).", 'unitOfMeasure': 'unit on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set'}, {'type': 'SECONDARY', 'title': "Absolute Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Week 52.", 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients were administered orally placebo matching nintedanib 150 milligram (mg) soft gelatine capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events.'}, {'id': 'OG001', 'title': 'Nintedanib', 'description': 'Patients were administered orally 150 milligram (mg) soft gelatin capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.88', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '0.81', 'spread': '0.88', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1711', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.69', 'ciLowerLimit': '-0.73', 'ciUpperLimit': '4.12', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.24', 'groupDescription': 'Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'The MMRM model assumed that data were missing at random \\& that patients who dropped out would have behaved similarly to those who remained in trial.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and up to 52 weeks after the start of administration', 'description': "This is the second key secondary endpoint.\n\nThe Saint George's Respiratory Questionnaire measures the health status in patients with chronic airflow limitation. It consists of 2 parts that cover 3 domains: symptoms, activities, and impacts. The symptom domain relates to the effect, frequency and severity of respiratory symptoms. The activity domain relates to activities that cause or are limited by breathlessness. The impact domain evaluates a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. The scores of these domains range from 0 (no impairment) to 100 (worst possible). The calculated total score summarises the impact of the disease on overall health status. A high score corresponds to worse health.\n\nLeast square mean is actually the adjusted mean. Adjusted mean was based on all analysed patients in the model (not only patients with a baseline and measurement at Week 52).", 'unitOfMeasure': 'unit on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Annual Rate of Decline in FVC in Percentage (%) Predicted Over 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients were administered orally placebo matching nintedanib 150 milligram (mg) soft gelatine capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events.'}, {'id': 'OG001', 'title': 'Nintedanib', 'description': 'Patients were administered orally 150 milligram (mg) soft gelatin capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.6', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0331', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '1.15', 'paramValue': '1.15', 'ciLowerLimit': '0.09', 'ciUpperLimit': '2.21', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.54', 'groupDescription': 'Based on a random coefficient regression with fixed categorical effects of treatment, ATA status, fixed continuous effects of time, baseline FVC \\[% pred\\], \\& including treatment-by-time and baseline-by-time interactions. Random effect was included for patient specific intercept \\& time.\n\nWithin-patient errors are modelled by an Unstructured variance-covariance matrix.\n\nInter-individual variability is modelled by a Variance-Components variance-covariance matrix.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'The model assumed that data were missing at random \\& that patients who dropped out would have behaved similarly to those who remained in trial.'}], 'paramType': 'MEAN', 'timeFrame': 'up to 52 weeks after the start of administration', 'description': 'Annual rate of decline in FVC in percentage (%) predicted over 52 weeks.\n\nFor this endpoint reported means represent the adjusted rate.', 'unitOfMeasure': '% predicted/yr', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in FVC in mL at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients were administered orally placebo matching nintedanib 150 milligram (mg) soft gelatine capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events.'}, {'id': 'OG001', 'title': 'Nintedanib', 'description': 'Patients were administered orally 150 milligram (mg) soft gelatin capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events.'}], 'classes': [{'categories': [{'measurements': [{'value': '-101.03', 'spread': '13.62', 'groupId': 'OG000'}, {'value': '-54.63', 'spread': '13.94', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0177', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '46.41', 'ciLowerLimit': '8.09', 'ciUpperLimit': '84.73', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '19.51', 'groupDescription': 'Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by-visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'The model assumed that data were missing at random \\& that patients who dropped out would have behaved similarly to those who remained in trial.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and up to 52 weeks after the start of administration', 'description': 'Absolute change from baseline in FVC in mL at Week 52. Least square mean is actually the adjusted mean. Adjusted mean was based on all analysed patients in the model (not only patients with a baseline and measurement at Week 52).', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set'}, {'type': 'SECONDARY', 'title': 'Relative Change From Baseline [%] of mRSS at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients were administered orally placebo matching nintedanib 150 milligram (mg) soft gelatine capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events.'}, {'id': 'OG001', 'title': 'Nintedanib', 'description': 'Patients were administered orally 150 milligram (mg) soft gelatin capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.92', 'spread': '5.89', 'groupId': 'OG000'}, {'value': '-10.20', 'spread': '5.98', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4547', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.28', 'ciLowerLimit': '-22.77', 'ciUpperLimit': '10.21', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.39', 'groupDescription': 'Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by-visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'The model assumed that data were missing at random \\& that patients who dropped out would have behaved similarly to those who remained in trial.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and up to 52 weeks after the start of administration', 'description': "Relative change from baseline \\[%\\] of mRSS at Week 52.\n\nThe modified Rodnan Skin Score (mRSS) is an evaluation of the patient's skin thickness rated by clinical palpation using a 0 to 3 scale. The scale differentiates between 0 = normal skin, 1 = mild thickness, 2 = moderate thickness, and 3 = severe thickness with inability to pinch the skin into a fold.\n\nThe palpation is done for each of the 17 surface anatomic areas of the body: face, anterior chest, abdomen, fingers (right and left separately), forearms, upper arms, thighs, lower legs, dorsum of hands and feet. The sum of these individual values is defined as the total skin score. The mRSS has a range from 0 (no thickening) to 51 (severe thickening in all 17 areas). A high score corresponds to worse skin thickness.\n\nLeast square mean is actually the adjusted mean. Adjusted mean was based on all analysed patients in the model (not only patients with a baseline and measurement at Week 52).", 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Time to Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients were administered orally placebo matching nintedanib 150 milligram (mg) soft gelatine capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events.'}, {'id': 'OG001', 'title': 'Nintedanib', 'description': 'Patients were administered orally 150 milligram (mg) soft gelatin capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7535', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.16', 'ciLowerLimit': '0.47', 'ciUpperLimit': '2.84', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER', 'statisticalComment': "Based on Cox's regression model (Wald test), stratified by ATA status."}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From date of first trial drug intake up to date of death or last contact date (ie., up to 100 weeks)', 'description': 'Time to event analysis of patients with death. The number of observed patients with death are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'The Percentage (%) of Responder Based on Combined Response Index in Systemic Sclerosis (CRISS) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients were administered orally placebo matching nintedanib 150 milligram (mg) soft gelatine capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events.'}, {'id': 'OG001', 'title': 'Nintedanib', 'description': 'Patients were administered orally 150 milligram (mg) soft gelatin capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000'}, {'value': '12.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9115', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.57', 'ciUpperLimit': '1.88', 'groupDescription': 'The comparison between both treatment groups was performed using a Cochran-Mantel-Haenszel test. CRISS score at Week 52 was transformed into 100 binary responder endpoints using multiple imputation. These were analyzed using a Cochran-Mantel-Haenszel test, stratified by ATA status OR and the 95% confidence interval (CI) as obtained from all 100 imputations were combined using Rubin´s rule.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Missing values were imputed using worst case, i.e. considered having disease progression.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': 'The percentage (%) of responder based on Combined Response Index in Systemic Sclerosis (CRISS) at Week 52.\n\nThis is a composite endpoint, based on the mRSS, FVC percent predicted, HAQ-DI, patient\'s global impression of overall health Visual Analogue Scale (VAS) and physician\'s global impression of patient\'s overall health VAS, as well as the absence of significant worsening of interstitial lung disease, a new scleroderma renal crisis, left ventricular failure or pulmonary arterial hypertension.\n\nThe CRISS index score represents a probability of improvement and ranges between 0 and 1.\n\nThis is a 2 stage process to predict probability of improvement:\n\nStep 1 - absence of major organ progression (SRC etc.) - score "0" Step 2 - predicted probability of improvement - (score "0 - 1")', 'unitOfMeasure': '(%) of responder based on CRISS', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco) in % Predicted at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients were administered orally placebo matching nintedanib 150 milligram (mg) soft gelatine capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events.'}, {'id': 'OG001', 'title': 'Nintedanib', 'description': 'Patients were administered orally 150 milligram (mg) soft gelatin capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.77', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '-3.21', 'spread': '0.54', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5668', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.44', 'ciLowerLimit': '-1.94', 'ciUpperLimit': '1.06', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.76', 'groupDescription': 'Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by-visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and up to 52 weeks after the start of administration', 'description': 'Absolute change from baseline in Carbon Monoxide Diffusion Capacity (DLco) in % predicted at Week 52.\n\nLeast square mean is actually the adjusted mean. Adjusted mean is based on all analysed patients in the model (not only patients with a baseline and measurement at week 52).', 'unitOfMeasure': '% predicted DLco', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Digital Ulcer Net Burden at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients were administered orally placebo matching nintedanib 150 milligram (mg) soft gelatine capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events.'}, {'id': 'OG001', 'title': 'Nintedanib', 'description': 'Patients were administered orally 150 milligram (mg) soft gelatin capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.06', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.05', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5914', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.09', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.06', 'groupDescription': 'Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by-visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and up to 52 weeks after the start of administration', 'description': 'Absolute change from baseline in digital ulcer net burden (defined as the number of new digital ulcers (DUs) plus the number of DUs that have been verified at any earlier assessment during the trial) at Week 52.\n\nIt is calculated at a visit by counting the total number of fingertips with ulcers (i.e. number of fingers with presence of digital ulcer ticked "Yes") at the corresponding visit\n\nLeast square mean is actually the adjusted mean. Adjusted mean is based on all analysed patients in the model (not only patients with a baseline and measurement at week 52).', 'unitOfMeasure': 'fingers', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients were administered orally placebo matching nintedanib 150 milligram (mg) soft gelatine capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events.'}, {'id': 'OG001', 'title': 'Nintedanib', 'description': 'Patients were administered orally 150 milligram (mg) soft gelatin capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.022', 'spread': '0.024', 'groupId': 'OG000'}, {'value': '0.054', 'spread': '0.024', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3447', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.032', 'ciLowerLimit': '-0.035', 'ciUpperLimit': '0.099', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.034', 'groupDescription': 'Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by-visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and up to 52 weeks after the start of administration', 'description': 'Absolute change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) score at Week 52.\n\nThe HAQ-DI score is calculated as follows:\n\nEach question is scored 0-3 (where 0= "without difficulty" \\& 3= "unable to do"). There are 8 categories (Dressing \\& Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, Activities), each including 2 or 3 questions. The score for each category corresponds to maximum question score within each category.\n\nFinally, HAQ-DI score corresponds to sum of the sub-scores of all 8 categories divided by number of categories completed. Please note that if there are fewer than 6 categories with responses, then a score cannot be calculated.\n\nThe HAQ-DI score scale has 25 possible values (i.e., 0, 0.125, 0.250, 0.375 … 3). A high score corresponds to worse impairment.\n\nLeast square mean is actually the adjusted mean. Adjusted mean is based on all analysed patients in the model (not only patients with a baseline and measurement at week 52).', 'unitOfMeasure': 'unit on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Dyspnoea Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients were administered orally placebo matching nintedanib 150 milligram (mg) soft gelatine capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events.'}, {'id': 'OG001', 'title': 'Nintedanib', 'description': 'Patients were administered orally 150 milligram (mg) soft gelatin capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.34', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '0.99', 'spread': '0.42', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2727', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.64', 'ciLowerLimit': '-0.51', 'ciUpperLimit': '1.79', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.58', 'groupDescription': 'Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by-visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and up to 52 weeks after the start of administration', 'description': 'Absolute change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT) dyspnoea score at Week 52.\n\nFACIT-Dyspnoea (Dyspnoea) 10 Item Short Form include a 4-point rating scale (no shortness of breath=0; mildly short of breath=1; moderately short of breath = 2; severely short of breath =3; or I did not do this in the past 7 days =4).\n\nA raw score is calculated as: Sum individual item scores \\* 10 / number of items answered. Raw scores are then converted to scale scores using the table included in the FACIT Dyspnoea Scale Short Form Scoring Guideline. FACIT dyspnea scale score ranges between 0 and 75.9.\n\nThe FACIT-Dyspnea short forms are scored such that a high score represents high levels of dyspnea.\n\nLeast square mean is actually the adjusted mean. Adjusted mean is based on all analysed patients in the model (not only patients with a baseline and measurement at week 52).', 'unitOfMeasure': 'Unit on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Patients were administered orally placebo matching nintedanib 150 milligram (mg) soft gelatine capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events.'}, {'id': 'FG001', 'title': 'Nintedanib', 'description': 'Patients were administered orally 150 milligram (mg) soft gelatin capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Started are randomised', 'groupId': 'FG000', 'numSubjects': '290'}, {'comment': 'Started are randomised', 'groupId': 'FG001', 'numSubjects': '290'}]}, {'type': 'Treated Patients', 'achievements': [{'groupId': 'FG000', 'numSubjects': '288'}, {'groupId': 'FG001', 'numSubjects': '288'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '252'}, {'groupId': 'FG001', 'numSubjects': '239'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '51'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'Not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Other than stated above', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '14'}]}]}], 'recruitmentDetails': 'This was a randomised, placebo-controlled, double-blind, parallel design trial.\n\nAbbreviation used:\n\ntreatment (trt) baseline (bl.) categorical (cat.) continuous (cont.) number (no.) patient (pt) Placebo (pl.) discontinued (disc.) primary analysis (PA) Antitopoisomerase Antibody (ATA)', 'preAssignmentDetails': 'All subjects were screened for eligibility to participate in trial. Subjects attended specialist sites to ensure that they (the subjects) met all implemented inclusion/exclusion criteria. Subjects were not to be randomised to trial drug if any of the specific entry criteria was violated'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'BG000'}, {'value': '288', 'groupId': 'BG001'}, {'value': '576', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Patients were administered orally placebo matching nintedanib 150 milligram (mg) soft gelatine capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events.'}, {'id': 'BG001', 'title': 'Nintedanib', 'description': 'Patients were administered orally 150 milligram (mg) soft gelatin capsules, twice daily with a possibility to interrupt treatment or to reduce to 100mg to manage adverse events.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.4', 'spread': '12.6', 'groupId': 'BG000'}, {'value': '54.6', 'spread': '11.8', 'groupId': 'BG001'}, {'value': '54.0', 'spread': '12.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '212', 'groupId': 'BG000'}, {'value': '221', 'groupId': 'BG001'}, {'value': '433', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '270', 'groupId': 'BG000'}, {'value': '266', 'groupId': 'BG001'}, {'value': '536', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '186', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '387', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline pulmonary efficacy variables - Forced Vital Capacity (FVC)', 'classes': [{'categories': [{'measurements': [{'value': '2541.0', 'spread': '815.5', 'groupId': 'BG000'}, {'value': '2458.5', 'spread': '735.9', 'groupId': 'BG001'}, {'value': '2499.7', 'spread': '777.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mL', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Treated set (TS): The treated set consisted of patients who were randomised to a treatment group and received at least 1 dose of trial medication.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-15', 'size': 1966089, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-10-28T12:44', 'hasProtocol': True}, {'date': '2018-07-26', 'size': 559400, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-10-28T12:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 580}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2018-11-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-26', 'studyFirstSubmitDate': '2015-10-08', 'resultsFirstSubmitDate': '2019-10-28', 'studyFirstSubmitQcDate': '2015-11-04', 'lastUpdatePostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-26', 'studyFirstPostDateStruct': {'date': '2015-11-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks', 'timeFrame': 'up to week (wk) 52 after the start of administration', 'description': 'Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test.\n\nFor this endpoint reported means represent the adjusted rate.'}], 'secondaryOutcomes': [{'measure': 'Absolute Change From Baseline in the Modified Rodnan Skin Score (mRSS) at Week 52', 'timeFrame': 'Baseline and up to 52 weeks after the start of administration', 'description': "This is the first key secondary endpoint.\n\nThe modified Rodnan Skin Score (mRSS) is an evaluation of the patient's skin thickness rated by clinical palpation using a 0 to 3 scale. The scale differentiates between 0 = normal skin, 1 = mild thickness, 2 = moderate thickness, and 3 = severe thickness with inability to pinch the skin into a fold.\n\nThe palpation is done for each of the 17 surface anatomic areas of the body: face, anterior chest, abdomen, fingers (right and left separately), forearms, upper arms, thighs, lower legs, dorsum of hands and feet. The sum of these individual values is defined as the total skin score. The mRSS has a range from 0 (no thickening) to 51 (severe thickening in all 17 areas). A high score corresponds to worse skin thickness.\n\nLeast square mean is actually the adjusted mean. Adjusted mean was based on all analysed patients in the model (not only patients with a baseline and measurement at Week 52)."}, {'measure': "Absolute Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Week 52.", 'timeFrame': 'Baseline and up to 52 weeks after the start of administration', 'description': "This is the second key secondary endpoint.\n\nThe Saint George's Respiratory Questionnaire measures the health status in patients with chronic airflow limitation. It consists of 2 parts that cover 3 domains: symptoms, activities, and impacts. The symptom domain relates to the effect, frequency and severity of respiratory symptoms. The activity domain relates to activities that cause or are limited by breathlessness. The impact domain evaluates a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. The scores of these domains range from 0 (no impairment) to 100 (worst possible). The calculated total score summarises the impact of the disease on overall health status. A high score corresponds to worse health.\n\nLeast square mean is actually the adjusted mean. Adjusted mean was based on all analysed patients in the model (not only patients with a baseline and measurement at Week 52)."}, {'measure': 'Annual Rate of Decline in FVC in Percentage (%) Predicted Over 52 Weeks', 'timeFrame': 'up to 52 weeks after the start of administration', 'description': 'Annual rate of decline in FVC in percentage (%) predicted over 52 weeks.\n\nFor this endpoint reported means represent the adjusted rate.'}, {'measure': 'Absolute Change From Baseline in FVC in mL at Week 52', 'timeFrame': 'Baseline and up to 52 weeks after the start of administration', 'description': 'Absolute change from baseline in FVC in mL at Week 52. Least square mean is actually the adjusted mean. Adjusted mean was based on all analysed patients in the model (not only patients with a baseline and measurement at Week 52).'}, {'measure': 'Relative Change From Baseline [%] of mRSS at Week 52', 'timeFrame': 'Baseline and up to 52 weeks after the start of administration', 'description': "Relative change from baseline \\[%\\] of mRSS at Week 52.\n\nThe modified Rodnan Skin Score (mRSS) is an evaluation of the patient's skin thickness rated by clinical palpation using a 0 to 3 scale. The scale differentiates between 0 = normal skin, 1 = mild thickness, 2 = moderate thickness, and 3 = severe thickness with inability to pinch the skin into a fold.\n\nThe palpation is done for each of the 17 surface anatomic areas of the body: face, anterior chest, abdomen, fingers (right and left separately), forearms, upper arms, thighs, lower legs, dorsum of hands and feet. The sum of these individual values is defined as the total skin score. The mRSS has a range from 0 (no thickening) to 51 (severe thickening in all 17 areas). A high score corresponds to worse skin thickness.\n\nLeast square mean is actually the adjusted mean. Adjusted mean was based on all analysed patients in the model (not only patients with a baseline and measurement at Week 52)."}, {'measure': 'Time to Death', 'timeFrame': 'From date of first trial drug intake up to date of death or last contact date (ie., up to 100 weeks)', 'description': 'Time to event analysis of patients with death. The number of observed patients with death are reported.'}, {'measure': 'The Percentage (%) of Responder Based on Combined Response Index in Systemic Sclerosis (CRISS) at Week 52', 'timeFrame': 'Week 52', 'description': 'The percentage (%) of responder based on Combined Response Index in Systemic Sclerosis (CRISS) at Week 52.\n\nThis is a composite endpoint, based on the mRSS, FVC percent predicted, HAQ-DI, patient\'s global impression of overall health Visual Analogue Scale (VAS) and physician\'s global impression of patient\'s overall health VAS, as well as the absence of significant worsening of interstitial lung disease, a new scleroderma renal crisis, left ventricular failure or pulmonary arterial hypertension.\n\nThe CRISS index score represents a probability of improvement and ranges between 0 and 1.\n\nThis is a 2 stage process to predict probability of improvement:\n\nStep 1 - absence of major organ progression (SRC etc.) - score "0" Step 2 - predicted probability of improvement - (score "0 - 1")'}, {'measure': 'Absolute Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco) in % Predicted at Week 52', 'timeFrame': 'Baseline and up to 52 weeks after the start of administration', 'description': 'Absolute change from baseline in Carbon Monoxide Diffusion Capacity (DLco) in % predicted at Week 52.\n\nLeast square mean is actually the adjusted mean. Adjusted mean is based on all analysed patients in the model (not only patients with a baseline and measurement at week 52).'}, {'measure': 'Absolute Change From Baseline in Digital Ulcer Net Burden at Week 52', 'timeFrame': 'Baseline and up to 52 weeks after the start of administration', 'description': 'Absolute change from baseline in digital ulcer net burden (defined as the number of new digital ulcers (DUs) plus the number of DUs that have been verified at any earlier assessment during the trial) at Week 52.\n\nIt is calculated at a visit by counting the total number of fingertips with ulcers (i.e. number of fingers with presence of digital ulcer ticked "Yes") at the corresponding visit\n\nLeast square mean is actually the adjusted mean. Adjusted mean is based on all analysed patients in the model (not only patients with a baseline and measurement at week 52).'}, {'measure': 'Absolute Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 52', 'timeFrame': 'Baseline and up to 52 weeks after the start of administration', 'description': 'Absolute change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) score at Week 52.\n\nThe HAQ-DI score is calculated as follows:\n\nEach question is scored 0-3 (where 0= "without difficulty" \\& 3= "unable to do"). There are 8 categories (Dressing \\& Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, Activities), each including 2 or 3 questions. The score for each category corresponds to maximum question score within each category.\n\nFinally, HAQ-DI score corresponds to sum of the sub-scores of all 8 categories divided by number of categories completed. Please note that if there are fewer than 6 categories with responses, then a score cannot be calculated.\n\nThe HAQ-DI score scale has 25 possible values (i.e., 0, 0.125, 0.250, 0.375 … 3). A high score corresponds to worse impairment.\n\nLeast square mean is actually the adjusted mean. Adjusted mean is based on all analysed patients in the model (not only patients with a baseline and measurement at week 52).'}, {'measure': 'Absolute Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Dyspnoea Score at Week 52', 'timeFrame': 'Baseline and up to 52 weeks after the start of administration', 'description': 'Absolute change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT) dyspnoea score at Week 52.\n\nFACIT-Dyspnoea (Dyspnoea) 10 Item Short Form include a 4-point rating scale (no shortness of breath=0; mildly short of breath=1; moderately short of breath = 2; severely short of breath =3; or I did not do this in the past 7 days =4).\n\nA raw score is calculated as: Sum individual item scores \\* 10 / number of items answered. Raw scores are then converted to scale scores using the table included in the FACIT Dyspnoea Scale Short Form Scoring Guideline. FACIT dyspnea scale score ranges between 0 and 75.9.\n\nThe FACIT-Dyspnea short forms are scored such that a high score represents high levels of dyspnea.\n\nLeast square mean is actually the adjusted mean. Adjusted mean is based on all analysed patients in the model (not only patients with a baseline and measurement at week 52).'}]}, 'conditionsModule': {'conditions': ['Scleroderma, Systemic']}, 'referencesModule': {'references': [{'pmid': '40233987', 'type': 'DERIVED', 'citation': 'Volkmann ER, Assassi S, Denton CP, Simonovska R, Sambevski S, Alves M, Bernstein EJ. Outcomes in Systemic Sclerosis-Associated Interstitial Lung Disease Based on Serological Profiles With a Focus on Anticentromere and Anti-RNA Polymerase III Antibodies. J Rheumatol. 2025 Sep 1;52(9):914-918. doi: 10.3899/jrheum.2024-1063.'}, {'pmid': '37357024', 'type': 'DERIVED', 'citation': 'Volkmann ER, McMahan ZH, Smith V, Jouneau S, Miede C, Alves M, Herrick AL; SENSCIS Trial Investigators. Risk of Malnutrition in Patients With Systemic Sclerosis-Associated Interstitial Lung Disease Treated With Nintedanib in the Randomized, Placebo-Controlled SENSCIS Trial. Arthritis Care Res (Hoboken). 2023 Dec;75(12):2501-2507. doi: 10.1002/acr.25176. Epub 2023 Aug 7.'}, {'pmid': '37294870', 'type': 'DERIVED', 'citation': 'Allanore Y, Khanna D, Smith V, Aringer M, Hoffmann-Vold AM, Kuwana M, Merkel PA, Stock C, Sambevski S, Denton CP; SENSCIS Trial Investigators. Effects of nintedanib in patients with limited cutaneous systemic sclerosis and interstitial lung disease. Rheumatology (Oxford). 2024 Mar 1;63(3):639-647. doi: 10.1093/rheumatology/kead280.'}, {'pmid': '36111858', 'type': 'DERIVED', 'citation': 'Denton CP, Goh NS, Humphries SM, Maher TM, Spiera R, Devaraj A, Ho L, Stock C, Erhardt E, Alves M, Wells AU. Extent of fibrosis and lung function decline in patients with systemic sclerosis and interstitial lung disease: data from the SENSCIS trial. Rheumatology (Oxford). 2023 May 2;62(5):1870-1876. doi: 10.1093/rheumatology/keac535.'}, {'pmid': '35790961', 'type': 'DERIVED', 'citation': 'Maher TM, Bourdin A, Volkmann ER, Vettori S, Distler JHW, Alves M, Stock C, Distler O. Decline in forced vital capacity in subjects with systemic sclerosis-associated interstitial lung disease in the SENSCIS trial compared with healthy reference subjects. Respir Res. 2022 Jul 5;23(1):178. doi: 10.1186/s12931-022-02095-6.'}, {'pmid': '35640959', 'type': 'DERIVED', 'citation': 'Kreuter M, Hoffmann-Vold AM, Matucci-Cerinic M, Saketkoo LA, Highland KB, Wilson H, Alves M, Erhardt E, Schoof N, Maher TM. Impact of lung function and baseline clinical characteristics on patient-reported outcome measures in systemic sclerosis-associated interstitial lung disease. Rheumatology (Oxford). 2023 Feb 6;62(SI):SI43-SI53. doi: 10.1093/rheumatology/keac325.'}, {'pmid': '35150246', 'type': 'DERIVED', 'citation': 'Volkmann ER, Kreuter M, Hoffmann-Vold AM, Wijsenbeek M, Smith V, Khanna D, Denton CP, Wuyts WA, Miede C, Alves M, Sambevski S, Allanore Y. Dyspnoea and cough in patients with systemic sclerosis-associated interstitial lung disease in the SENSCIS trial. Rheumatology (Oxford). 2022 Nov 2;61(11):4397-4408. doi: 10.1093/rheumatology/keac091.'}, {'pmid': '35012623', 'type': 'DERIVED', 'citation': 'Kreuter M, Del Galdo F, Miede C, Khanna D, Wuyts WA, Hummers LK, Alves M, Schoof N, Stock C, Allanore Y. Impact of lung function decline on time to hospitalisation events in systemic sclerosis-associated interstitial lung disease (SSc-ILD): a joint model analysis. Arthritis Res Ther. 2022 Jan 10;24(1):19. doi: 10.1186/s13075-021-02710-9.'}, {'pmid': '33412120', 'type': 'DERIVED', 'citation': 'Highland KB, Distler O, Kuwana M, Allanore Y, Assassi S, Azuma A, Bourdin A, Denton CP, Distler JHW, Hoffmann-Vold AM, Khanna D, Mayes MD, Raghu G, Vonk MC, Gahlemann M, Clerisme-Beaty E, Girard M, Stowasser S, Zoz D, Maher TM; SENSCIS trial investigators. Efficacy and safety of nintedanib in patients with systemic sclerosis-associated interstitial lung disease treated with mycophenolate: a subgroup analysis of the SENSCIS trial. Lancet Respir Med. 2021 Jan;9(1):96-106. doi: 10.1016/S2213-2600(20)30330-1.'}, {'pmid': '33328257', 'type': 'DERIVED', 'citation': 'Roennow A, Sauve M, Welling J, Riggs RJ, Kennedy AT, Galetti I, Brown E, Leite C, Gonzalez A, Portales Guiraud AP, Houyez F, Camp R, Gilbert A, Gahlemann M, Moros L, Luna Flores JL, Schmidt F, Sauter W, Finnern H. Collaboration between patient organisations and a clinical research sponsor in a rare disease condition: learnings from a community advisory board and best practice for future collaborations. BMJ Open. 2020 Dec 16;10(12):e039473. doi: 10.1136/bmjopen-2020-039473.'}, {'pmid': '33223487', 'type': 'DERIVED', 'citation': 'Azuma A, Chung L, Behera D, Chung M, Kondoh Y, Ogura T, Okamoto M, Swarnakar R, Zeng X, Zou H, Meng X, Gahlemann M, Alves M, Kuwana M; SENSCIS trial investigators. Efficacy and safety of nintedanib in Asian patients with systemic sclerosis-associated interstitial lung disease: Subgroup analysis of the SENSCIS trial. Respir Investig. 2021 Mar;59(2):252-259. doi: 10.1016/j.resinv.2020.10.005. Epub 2020 Nov 19.'}, {'pmid': '33142016', 'type': 'DERIVED', 'citation': 'Maher TM, Mayes MD, Kreuter M, Volkmann ER, Aringer M, Castellvi I, Cutolo M, Stock C, Schoof N, Alves M, Raghu G; SENSCIS Trial Investigators. Effect of Nintedanib on Lung Function in Patients With Systemic Sclerosis-Associated Interstitial Lung Disease: Further Analyses of a Randomized, Double-Blind, Placebo-Controlled Trial. Arthritis Rheumatol. 2021 Apr;73(4):671-676. doi: 10.1002/art.41576. Epub 2021 Mar 8.'}, {'pmid': '32243207', 'type': 'DERIVED', 'citation': 'Kuwana M, Ogura T, Makino S, Homma S, Kondoh Y, Saito A, Ugai H, Gahlemann M, Takehara K, Azuma A. Nintedanib in patients with systemic sclerosis-associated interstitial lung disease: A Japanese population analysis of the SENSCIS trial. Mod Rheumatol. 2021 Jan;31(1):141-150. doi: 10.1080/14397595.2020.1751402. Epub 2020 Apr 23.'}, {'pmid': '31112379', 'type': 'DERIVED', 'citation': 'Distler O, Highland KB, Gahlemann M, Azuma A, Fischer A, Mayes MD, Raghu G, Sauter W, Girard M, Alves M, Clerisme-Beaty E, Stowasser S, Tetzlaff K, Kuwana M, Maher TM; SENSCIS Trial Investigators. Nintedanib for Systemic Sclerosis-Associated Interstitial Lung Disease. N Engl J Med. 2019 Jun 27;380(26):2518-2528. doi: 10.1056/NEJMoa1903076. Epub 2019 May 20.'}, {'pmid': '28664834', 'type': 'DERIVED', 'citation': 'Distler O, Brown KK, Distler JHW, Assassi S, Maher TM, Cottin V, Varga J, Coeck C, Gahlemann M, Sauter W, Schmidt H, Highland KB; SENSCIS trial investigators. Design of a randomised, placebo-controlled clinical trial of nintedanib in patients with systemic sclerosis-associated interstitial lung disease (SENSCIS). Clin Exp Rheumatol. 2017 Sep-Oct;35 Suppl 106(4):75-81. Epub 2017 Jun 29.'}]}, 'descriptionModule': {'briefSummary': 'Systemic Sclerosis (SSc) is a devastating disease of unknown etiology. Patients suffer from multiple organ fibrosis whereas lung fibrosis (interstitial lung disease, ILD) is one of the main driver for mortality. There is preclinical evidence for efficacy of nintedanib in SSc and associated ILD (SSc-ILD) and the anti-fibrotic efficacy of nintedanib was proven in idiopathic pulmonary fibrosis patients, who are presenting a similar pattern regarding lung fibrosis. Hence it is the purpose of the trial to confirm the efficacy and safety of nintedanib 150 mg bid in treating patients with SSc-ILD, compared with placebo. The trial will be conducted as a double blind, randomised, placebo-controlled trial with primary efficacy evaluation at week 52 and placebo-controlled treatment until last patient out (up to a maximum of 100 weeks). Respiratory function is globally accepted for assessment of treatment effects in patients with lung fibrosis. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in patients with SSc-ILD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Age \\>= 18 years\n* 2013 American College of Rheumatology (ACR) / EULAR classification criteria for SSc fulfilled\n* SSc disease onset (defined by first non-Raynaud symptom) within 7 years\n* SSc related Interstitial Lung Disease confirmed by High Resolution Computer Tomography (HRCT); Extent of fibrotic disease in the lung \\>= 10%\n* FVC \\>= 40% of predicted normal\n* Carbon Monoxide Diffusion Capacity (DLCO) 30% to 89% of predicted normal\n\nExclusion criteria:\n\n* Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) \\>1.5 x ULN\n* Bilirubin \\>1.5 x ULN\n* Creatinine clearance \\<30 mL/min\n* Airway obstruction (pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1)/FVC \\<0.7)\n* Other clinically significant pulmonary abnormalities\n* Significant Pulmonary Hypertension (PH)\n* Cardiovascular diseases\n* More than 3 digital fingertip ulcers or a history of severe digital necrosis requiring hospitalization or severe other ulcers\n* Bleeding risk (such as predisposition to bleeding, fibrinolysis, full-dose anticoagulation, high dose antiplatelet therapy, history of hemorrhagic central nervous system (CNS) event within last year\n* international normalised ratio (INR) \\>2, prolongation of prothrombin time (PT) and partial thromboplastin time (PTT) by \\>1.5 x ULN)\n* History of thrombotic event within last year\n* Clinical signs of malabsorption or needing parenteral nutrition\n* Previous treatment with nintedanib or pirfenidone\n* Treatment with prednisone \\>10 mg/day, azathioprine, hydroxychloroquine, colchicine, D-penicillamine, sulfasalazine, cyclophosphamide, rituximab, tocilizumab, abatacept, leflunomide, tacrolimus, newer anti-arthritic treatments like tofacitinib and cyclosporine A, potassium para-aminobenzoate\n* Unstable background therapy with either mycophenolate mofetil or methotrexate\n* Previous or planned hematopoietic stem cell transplantation\n* Patients with underlying chronic liver disease (Child Pugh A, B, C hepatic impairment)'}, 'identificationModule': {'nctId': 'NCT02597933', 'briefTitle': 'A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung Fibrosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Double Blind, Randomised, Placebo-controlled Trial Evaluating Efficacy and Safety of Oral Nintedanib Treatment for at Least 52 Weeks in Patients With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)', 'orgStudyIdInfo': {'id': '1199.214'}, 'secondaryIdInfos': [{'id': '2015-000392-28', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nintedanib', 'description': 'patient receives capsules containing nintedanib twice a day', 'interventionNames': ['Drug: Nintedanib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'patient receives capsules identical to those containing active drug', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Nintedanib', 'type': 'DRUG', 'armGroupLabels': ['Nintedanib']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94305-5236', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Medical Center', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Denver', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida College of Medicine', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33125', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'The Emory Clinic', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane University Hospital and Clinic', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Health System', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota Masonic Cancer Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic-Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '63017', 'city': 'Chesterfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'The Lung Research Center, LLC', 'geoPoint': {'lat': 38.66311, 'lon': -90.57707}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Hospital for Special Surgery', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center-New York Presbyterian Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati Health', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43614', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Toledo', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Milton S. Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Temple University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29203', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'University of South Carolina', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '37232-5735', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt Pulmonary Clinic', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University Of Texas at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84108', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah Health Sciences Center', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '22042', 'city': 'Falls Church', 'state': 'Virginia', 'country': 'United States', 'facility': 'Inova Fairfax Medical Campus', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}, {'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Virginia Mason Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Froedtert and The Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': 'C1426BOR', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1046AAQ', 'city': 'Ciudad Autonoma Buenos Aires', 'country': 'Argentina', 'facility': 'APRILLUS-Asistencia e Investigación'}, {'zip': 'B1602DQD', 'city': 'Florida', 'country': 'Argentina', 'facility': 'CEMER-Centro Medico De Enfermedades Respiratorias', 'geoPoint': {'lat': -34.53258, 'lon': -58.49078}}, {'zip': '2050', 'city': 'Camperdown', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Royal Prince Alfred Hospital', 'geoPoint': {'lat': -33.88965, 'lon': 151.17642}}, {'zip': '2170', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Liverpool Hospital', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Royal Adelaide Hospital', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '3065', 'city': 'Fitzroy', 'state': 'Victoria', 'country': 'Australia', 'facility': "St Vincent's Hospital Melbourne", 'geoPoint': {'lat': -37.79839, 'lon': 144.97833}}, {'zip': '8036', 'city': 'Graz', 'country': 'Austria', 'facility': 'LKH-Univ. Hospital Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '6020', 'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Medical University of Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'ULB Hopital Erasme', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Brussels - UNIV Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'UNIV UZ Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'Centre Hospitalier Universitaire de Liège', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '80440-080', 'city': 'Curitiba', 'country': 'Brazil', 'facility': 'Edumed - Educacao e Saude SA', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'zip': 'L8N 4A6', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': "Saint Joseph's Healthcare", 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'M5T 3L9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H4J 1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'HSCM', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '4070038', 'city': 'Concepción', 'country': 'Chile', 'facility': 'Hospital Clínico Reg. de Concepción "Dr. G. Grant Benavente"', 'geoPoint': {'lat': -36.82699, 'lon': -73.04977}}, {'zip': '3465586', 'city': 'Talca', 'country': 'Chile', 'facility': 'Centro de Investigación del Maule', 'geoPoint': {'lat': -35.4232, 'lon': -71.64974}}, {'zip': '100032', 'city': 'Beijing', 'country': 'China', 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Chao-Yang Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Changchun', 'country': 'China', 'facility': 'First Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '610041', 'city': 'Chengdu', 'country': 'China', 'facility': 'West China Hospital', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '230022', 'city': 'Hefei', 'country': 'China', 'facility': 'The First Affiliated Hospital of Anhui Medical University', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '200040', 'city': 'Shanghai', 'country': 'China', 'facility': 'Huashan Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shenyang', 'country': 'China', 'facility': 'The First Hospital of Chinese Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '412007', 'city': 'Zhuzhou', 'country': 'China', 'facility': 'Zhuzhou Central Hospital', 'geoPoint': {'lat': 27.83333, 'lon': 113.15}}, {'zip': '12850', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Institute of Rheumathology Prague', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '14059', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Thomayer Hospital', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus Universitets Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '5000 C', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Odense Universitetshospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'zip': '00290', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'HYKS Keuhkosairauksien', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '20520', 'city': 'Turku', 'country': 'Finland', 'facility': 'TYKS, Keuhkosairauksien klinikka, Turku', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'zip': '93009', 'city': 'Bobigny', 'country': 'France', 'facility': 'HOP Avicenne', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'zip': '69677', 'city': 'Bron', 'country': 'France', 'facility': 'HOP Louis Pradel', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'HOP Calmette', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'HOP Claude Huriez', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'HOP Arnaud de Villeneuve', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '44000', 'city': 'Nantes', 'country': 'France', 'facility': 'HOP Hôtel-Dieu', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '06001', 'city': 'Nice', 'country': 'France', 'facility': 'HOP Pasteur', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'HOP Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75018', 'city': 'Paris', 'country': 'France', 'facility': 'HOP Bichat', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '35033', 'city': 'Rennes', 'country': 'France', 'facility': 'HOP Pontchaillou', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '76000', 'city': 'Rouen', 'country': 'France', 'facility': 'HOP Charles Nicolle', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'HOP Larrey', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'HOP Bretonneau', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '61231', 'city': 'Bad Nauheim', 'country': 'Germany', 'facility': 'Kerckhoff-Klinik, Bad Nauheim', 'geoPoint': {'lat': 50.36463, 'lon': 8.73859}}, {'zip': '50937', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Universitätsklinikum Köln (AöR)', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '93093', 'city': 'Donaustauf', 'country': 'Germany', 'facility': 'Klinik Donaustauf', 'geoPoint': {'lat': 49.03258, 'lon': 12.20459}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Universitätsklinikum Carl Gustav Carus Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '91054', 'city': 'Erlangen', 'country': 'Germany', 'facility': 'Universitätsklinikum Erlangen', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'zip': '17475', 'city': 'Greifswald', 'country': 'Germany', 'facility': 'Universitätsmedizin Greifswald', 'geoPoint': {'lat': 54.08905, 'lon': 13.40244}}, {'zip': '22763', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Asklepios Klinik Altona', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Medizinische Hochschule Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '69126', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '24105', 'city': 'Kiel', 'country': 'Germany', 'facility': 'Universitätsklinikum Schleswig-Holstein, Campus Kiel', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '80336', 'city': 'München', 'country': 'Germany', 'facility': 'Klinikum der Universität München - Campus Großhadern', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '48149', 'city': 'Münster', 'country': 'Germany', 'facility': 'Universitätsklinikum Münster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'Universitätsklinikum Tübingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'zip': '115 27', 'city': 'Athens', 'country': 'Greece', 'facility': 'General Hospital of Athens "Laiko"', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '11527', 'city': 'Athens', 'country': 'Greece', 'facility': 'General Hospital of Athens "Laiko"', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '1125', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Semmelweis University, Dept. Pulmonology', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '560 034', 'city': 'Bangalore', 'country': 'India', 'facility': "St John's Medical College", 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '560054', 'city': 'Bangalore', 'country': 'India', 'facility': 'Ramaiah Medical College and Hospitals', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '560099', 'city': 'Bangalore', 'country': 'India', 'facility': 'Mazumdar Shaw Medical centre', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '160012', 'city': 'Chandigarh', 'country': 'India', 'facility': 'Postgraduate Institute of Medical Education And Research', 'geoPoint': {'lat': 30.73629, 'lon': 76.7884}}, {'zip': '500034', 'city': 'Hyderabad', 'country': 'India', 'facility': 'Care Hospital', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'zip': '500082', 'city': 'Hyderabad', 'country': 'India', 'facility': "Nizam's Institute of Medical Sciences", 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'zip': '302039', 'city': 'Jaipur', 'country': 'India', 'facility': 'Asthma Bhawan', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}, {'zip': '400016', 'city': 'Mumbai', 'country': 'India', 'facility': 'P.D. Hinduja National Hospital', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '440012', 'city': 'Nagpur', 'country': 'India', 'facility': 'Getwell Hospital & Research Institute', 'geoPoint': {'lat': 21.14631, 'lon': 79.08491}}, {'zip': '110029', 'city': 'New Delhi', 'country': 'India', 'facility': 'All India Institute of Medical Science', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'zip': '110060', 'city': 'New Delhi', 'country': 'India', 'facility': 'Sir Gangaram Hospital', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'zip': '411 001', 'city': 'Pune', 'country': 'India', 'facility': 'Jehangir Clinical Development Centre Pvt. Ltd.', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'zip': '411001', 'city': 'Pune', 'country': 'India', 'facility': 'B.J. Medical College and Sasoon General Hospital', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'zip': '411040', 'city': 'Pune', 'country': 'India', 'facility': 'Inamdar Multispeciality Hospital', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'zip': '632 004', 'city': 'Vellore', 'country': 'India', 'facility': 'Christian Medical College', 'geoPoint': {'lat': 12.9184, 'lon': 79.13255}}, {'city': 'Cork', 'country': 'Ireland', 'facility': 'Cork University Hospital', 'geoPoint': {'lat': 51.89797, 'lon': -8.47061}}, {'city': 'Dublin', 'country': 'Ireland', 'facility': 'Mater Misericordiae University Hospital', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'zip': '31048', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Bnei Zion Medical Center, Haifa', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '3109601', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '49100', 'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'Rabin Medical Center Beilinson', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'zip': '64239', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Sourasky Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'zip': '60126', 'city': 'Ancona', 'country': 'Italy', 'facility': 'Az. Ospedaliere Umberto I di Ancona', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'zip': '16132', 'city': 'Genova', 'country': 'Italy', 'facility': 'Università degli Studi di Genova', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'zip': '20900', 'city': 'Monza', 'country': 'Italy', 'facility': 'A.O. San Gerardo di Monza', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'zip': '80138', 'city': 'Napoli', 'country': 'Italy', 'facility': 'A.O Universitaria - Università degli Studi della Campania Luigi Vanvitelli', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '35128', 'city': 'Padua', 'country': 'Italy', 'facility': 'Università degli Studi Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '00161', 'city': 'Roma', 'country': 'Italy', 'facility': "Azienda Universitaria-Universita' La Sapienza", 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '489-8642', 'city': 'Aichi, Seto', 'country': 'Japan', 'facility': 'Tosei General Hospital'}, {'zip': '830-0011', 'city': 'Fukuoka, Kurume', 'country': 'Japan', 'facility': 'Kurume University Hospital'}, {'zip': '060-8543', 'city': 'Hokkaido, Sapporo', 'country': 'Japan', 'facility': 'Sapporo Medical University Hospital', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '670-8520', 'city': 'Hyogo, Himeji', 'country': 'Japan', 'facility': 'National Hospital Organization Himeji Medical Center'}, {'zip': '020-8505', 'city': 'Iwate, Morioka', 'country': 'Japan', 'facility': 'Iwate Medical University Hospital'}, {'zip': '216-8511', 'city': 'Kanagawa, Kawasaki', 'country': 'Japan', 'facility': 'St. Marianna University School of Medicine Hospital'}, {'zip': '252-0375', 'city': 'Kanagawa, Sagamihara', 'country': 'Japan', 'facility': 'Kitasato University Hospital'}, {'zip': '236-0051', 'city': 'Kanagawa, Yokohama', 'country': 'Japan', 'facility': 'Kanagawa Cardiovascular and Respiratory Center'}, {'zip': '606-8507', 'city': 'Kyoto, Kyoto', 'country': 'Japan', 'facility': 'Kyoto University Hospital'}, {'zip': '852-8501', 'city': 'Nagasaki, Nagasaki', 'country': 'Japan', 'facility': 'Nagasaki University Hospital'}, {'zip': '589-8511', 'city': 'Osaka, Osakasayama', 'country': 'Japan', 'facility': 'Kindai University Hospital'}, {'zip': '591-8555', 'city': 'Osaka, Sakai', 'country': 'Japan', 'facility': 'National Hospital Organization Kinki-Chuo Chest Medical Center'}, {'zip': '569-8686', 'city': 'Osaka, Takatsuki', 'country': 'Japan', 'facility': 'Osaka Medical College Hospital'}, {'zip': '350-0495', 'city': 'Saitama, Iruma-gun', 'country': 'Japan', 'facility': 'Saitama Medical University Hospital', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'zip': '431-3192', 'city': 'Shizuoka, Hamamatsu', 'country': 'Japan', 'facility': 'Hamamatsu University Hospital'}, {'zip': '770-8503', 'city': 'Tokushima, Tokushima', 'country': 'Japan', 'facility': 'Tokushima University Hospital'}, {'zip': '113-8431', 'city': 'Tokyo, Bunkyo-Ku', 'country': 'Japan', 'facility': 'Juntendo University Hospital'}, {'zip': '113-8603', 'city': 'Tokyo, Bunkyo-Ku', 'country': 'Japan', 'facility': 'Nippon Medical School Hospital'}, {'zip': '143-8541', 'city': 'Tokyo, Ota-ku', 'country': 'Japan', 'facility': 'Toho University Omori Medical Center'}, {'zip': '162-0054', 'city': 'Tokyo, Shinjyuku-ku', 'country': 'Japan', 'facility': "Institute of Rheumatology Tokyo Women's Medical University", 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '59100', 'city': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'University Malaya Medical Centre', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'zip': '68100', 'city': 'Kuala Selangor', 'country': 'Malaysia', 'facility': 'Hospital Selayang', 'geoPoint': {'lat': 3.35, 'lon': 101.25}}, {'zip': '10990', 'city': 'Pulau Pinang', 'country': 'Malaysia', 'facility': 'Hospital Pulau Pinang', 'geoPoint': {'lat': 3.55, 'lon': 102.56667}}, {'zip': '70300', 'city': 'Seremban', 'country': 'Malaysia', 'facility': "Hospital Tuanku Ja'afar", 'geoPoint': {'lat': 2.7297, 'lon': 101.9381}}, {'zip': '14080', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '1081HV', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'VU Medisch Centrum', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '2333 ZA', 'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Leids Universitair Medisch Centrum (LUMC)', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': '6525 GA', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Radboud Universitair Medisch Centrum', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '3015 CE', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus Medisch Centrum', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': 'N-0372', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo Universitetssykehus HF, Rikshospitalet', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'zip': 'N-9038', 'city': 'Tromsø', 'country': 'Norway', 'facility': 'Universitetssykehuset Nord-Norge, Tromsø', 'geoPoint': {'lat': 69.6489, 'lon': 18.95508}}, {'zip': '85168', 'city': 'Bydgoszcz', 'country': 'Poland', 'facility': 'Dr.Biziel UnivHosp#2,Rheumat&Connec.Tissue Disease,Bydgoszcz', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '31011', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Dobry Lekarz,Spec.Med.Clinics,Private Prac,Krakow', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '35205', 'city': 'Rzeszów', 'country': 'Poland', 'facility': 'EMED, Center of Medical Services,Private Prac,Rzeszow', 'geoPoint': {'lat': 50.04132, 'lon': 21.99901}}, {'zip': '50 368', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Indep.Pblic Clin.Hosp#1,Dermatol,Venereol&Allerg.dep,Wroclaw', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '2801-951', 'city': 'Almada', 'country': 'Portugal', 'facility': 'Hospital Garcia de Orta, EPE', 'geoPoint': {'lat': 38.67902, 'lon': -9.1569}}, {'zip': '2720-276', 'city': 'Amadora', 'country': 'Portugal', 'facility': 'Hospital Fernando Fonseca, EPE', 'geoPoint': {'lat': 38.75382, 'lon': -9.23083}}, {'zip': '3000-075', 'city': 'Coimbra', 'country': 'Portugal', 'facility': 'CHUC - Centro Hospitalar e Universitário de Coimbra, EPE', 'geoPoint': {'lat': 40.20686, 'lon': -8.41996}}, {'zip': '4990-041', 'city': 'Ponte de Lima', 'country': 'Portugal', 'facility': 'ULSAM, EPE - Hospital Conde de Bertiandos', 'geoPoint': {'lat': 41.76719, 'lon': -8.58393}}, {'zip': '4200-319', 'city': 'Porto', 'country': 'Portugal', 'facility': 'Centro Hospitalar São João,EPE', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'zip': '4434-502', 'city': 'Vila Nova de Gaia', 'country': 'Portugal', 'facility': 'Centro Hospitalar de Vila Nova de Gaia', 'geoPoint': {'lat': 41.12401, 'lon': -8.61241}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08041', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28007', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital General Universitario Gregorio Marañón', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '39008', 'city': 'Santander', 'country': 'Spain', 'facility': 'Hospital Universitario Marqués de Valdecilla', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'zip': '46017', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Dr. Peset', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46026', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Politècnic La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '36312', 'city': 'Vigo', 'country': 'Spain', 'facility': 'Hospital Álvaro Cunqueiro', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}, {'zip': '413 45', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Clinical Rheumatology Research Center Sahlgrenska', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': '9007', 'city': 'Sankt Gallen', 'country': 'Switzerland', 'facility': 'Kantonspital St. Gallen, Rheumatologie Department', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}, {'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Universitätsspital Zürich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': '90110', 'city': 'Hat Yai', 'country': 'Thailand', 'facility': 'Songklanagarind Hospital', 'geoPoint': {'lat': 7.00836, 'lon': 100.47668}}, {'zip': '40002', 'city': 'Muang', 'country': 'Thailand', 'facility': 'Srinagarind Hospital'}, {'zip': '10400', 'city': 'Ratchathewi', 'country': 'Thailand', 'facility': 'Ramathibodi Hospital', 'geoPoint': {'lat': 13.759, 'lon': 100.53358}}, {'zip': 'G4 0SF', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Glasgow Royal Infirmary', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'NW3 2QG', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal Free Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE1 9RT', 'city': 'London', 'country': 'United Kingdom', 'facility': "Guy's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW3 6NP', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal Brompton Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M6 8HD', 'city': 'Salford', 'country': 'United Kingdom', 'facility': 'Salford Royal Hospital', 'geoPoint': {'lat': 53.48771, 'lon': -2.29042}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}