Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-31 @ 3:11 PM
Study NCT ID:
NCT01371305
Status:
COMPLETED
Last Update Posted:
2020-02-28
First Post:
2011-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054990', 'term': 'Idiopathic Pulmonary Fibrosis'}], 'ancestors': [{'id': 'D011658', 'term': 'Pulmonary Fibrosis'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@biogen.com', 'phone': '866-633-4636', 'title': 'Biogen Study Medical Director', 'organization': 'Biogen'}, 'certainAgreement': {'otherDetails': "Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to Week 19', 'description': 'The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo.\n\nThe "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.', 'eventGroups': [{'id': 'EG000', 'title': 'BG00011 0.015 mg', 'description': 'Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'BG00011 0.1 mg', 'description': 'Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'BG00011 0.3 mg', 'description': 'Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'BG00011 1.0 mg', 'description': 'Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 4, 'seriousNumAtRisk': 7, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'BG00011 3.0 mg', 'description': 'Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Matching Placebo', 'description': 'Participants with IPF received SC injection of BG00011 matching placebo once weekly for 8 doses.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Viral Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Hepatic Enzyme Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Idiopathic Pulmonary Fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Onychoclasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Phlebitis Superficial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Viral Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Productive Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Rhinitis Allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Upper-Airway Cough Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Increased Bronchial Secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Lung Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Nasal Discharge Discoloration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Sinus Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Sleep Apnoea Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Sputum Discolored', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Chest Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Infusion Site Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Injection Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Injection Site Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Non-Cardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 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'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Atrioventricular Block Second Degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Seasonal Allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Squamous Cell Carcinoma of Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}], 'seriousEvents': [{'term': 'Atrioventricular Block Complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Idiopathic Pulmonary Fibrosis Exacerbation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Type II Second-Degree Atrioventricular Block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Jaw fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'BG00011 0.015 mg', 'description': 'Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.'}, {'id': 'OG001', 'title': 'BG00011 0.1 mg', 'description': 'Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'OG002', 'title': 'BG00011 0.3 mg', 'description': 'Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'OG003', 'title': 'BG00011 1.0 mg', 'description': 'Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'OG004', 'title': 'BG00011 3.0 mg', 'description': 'Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'OG005', 'title': 'Matching Placebo', 'description': 'Participants with IPF received SC injection of BG00011 matching placebo once weekly for 8 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to Week 19', 'description': 'An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Observed Serum Concentration (Tmax) of BG00011', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'BG00011 0.015 mg', 'description': 'Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.'}, {'id': 'OG001', 'title': 'BG00011 0.1 mg', 'description': 'Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'OG002', 'title': 'BG00011 0.3 mg', 'description': 'Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'OG003', 'title': 'BG00011 1.0 mg', 'description': 'Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'OG004', 'title': 'BG00011 3.0 mg', 'description': 'Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '168', 'spread': 'NA', 'comment': 'Insufficient data to perform analysis.', 'groupId': 'OG000'}, {'value': '101', 'spread': '42.9', 'groupId': 'OG001'}, {'value': '132', 'spread': '39.4', 'groupId': 'OG002'}, {'value': '134', 'spread': '60.5', 'groupId': 'OG003'}, {'value': '96.4', 'spread': '53.5', 'groupId': 'OG004'}]}]}, {'title': 'Day 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '42.7', 'spread': '61.9', 'groupId': 'OG000'}, {'value': '64.0', 'spread': '24.8', 'groupId': 'OG001'}, {'value': '64.0', 'spread': '51.8', 'groupId': 'OG002'}, {'value': '32.0', 'spread': '19.6', 'groupId': 'OG003'}, {'value': '38.0', 'spread': '39.4', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) population = Safety population.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Serum Concentration (Cmax) of BG00011', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'BG00011 0.015 mg', 'description': 'Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.'}, {'id': 'OG001', 'title': 'BG00011 0.1 mg', 'description': 'Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'OG002', 'title': 'BG00011 0.3 mg', 'description': 'Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'OG003', 'title': 'BG00011 1.0 mg', 'description': 'Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'OG004', 'title': 'BG00011 3.0 mg', 'description': 'Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '71.3', 'spread': 'NA', 'comment': 'Insufficient data to perform analysis.', 'groupId': 'OG000'}, {'value': '335', 'spread': '178', 'groupId': 'OG001'}, {'value': '716', 'spread': '281', 'groupId': 'OG002'}, {'value': '4370', 'spread': '1350', 'groupId': 'OG003'}, {'value': '12900', 'spread': '3130', 'groupId': 'OG004'}]}]}, {'title': 'Day 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '134', 'spread': '44.6', 'groupId': 'OG000'}, {'value': '1080', 'spread': '676', 'groupId': 'OG001'}, {'value': '3170', 'spread': '1380', 'groupId': 'OG002'}, {'value': '15400', 'spread': '5180', 'groupId': 'OG003'}, {'value': '52800', 'spread': '17600', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population = Safety population.'}, {'type': 'SECONDARY', 'title': 'Area Under the Serum Concentration Time Curve From Time 0 to Last Quantifiable Observed Concentration AUC(0-t) of BG00011', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'BG00011 0.015 mg', 'description': 'Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.'}, {'id': 'OG001', 'title': 'BG00011 0.1 mg', 'description': 'Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'OG002', 'title': 'BG00011 0.3 mg', 'description': 'Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'OG003', 'title': 'BG00011 1.0 mg', 'description': 'Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'OG004', 'title': 'BG00011 3.0 mg', 'description': 'Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '9200', 'spread': 'NA', 'comment': 'Insufficient data to perform analysis.', 'groupId': 'OG000'}, {'value': '44800', 'spread': '24800', 'groupId': 'OG001'}, {'value': '92600', 'spread': '40500', 'groupId': 'OG002'}, {'value': '513000', 'spread': '264000', 'groupId': 'OG003'}, {'value': '1730000', 'spread': '525000', 'groupId': 'OG004'}]}]}, {'title': 'Day 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '44600', 'spread': '39400', 'groupId': 'OG000'}, {'value': '344000', 'spread': '169000', 'groupId': 'OG001'}, {'value': '1080000', 'spread': '554000', 'groupId': 'OG002'}, {'value': '6370000', 'spread': '3980000', 'groupId': 'OG003'}, {'value': '25700000', 'spread': '17700000', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50', 'unitOfMeasure': 'hours nanogram per milliliter (hr*ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population = Safety population.'}, {'type': 'SECONDARY', 'title': 'Area Under the Serum Concentration-Time Curve From Time 0 to 168 Hours AUC(0-168) of BG00011', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'BG00011 0.015 mg', 'description': 'Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.'}, {'id': 'OG001', 'title': 'BG00011 0.1 mg', 'description': 'Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'OG002', 'title': 'BG00011 0.3 mg', 'description': 'Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'OG003', 'title': 'BG00011 1.0 mg', 'description': 'Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'OG004', 'title': 'BG00011 3.0 mg', 'description': 'Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '9200', 'spread': 'NA', 'comment': 'Insufficient data to perform analysis.', 'groupId': 'OG000'}, {'value': '44800', 'spread': '24800', 'groupId': 'OG001'}, {'value': '92600', 'spread': '40500', 'groupId': 'OG002'}, {'value': '497000', 'spread': '242000', 'groupId': 'OG003'}, {'value': '1690000', 'spread': '438000', 'groupId': 'OG004'}]}]}, {'title': 'Day 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '21000', 'spread': '8250', 'groupId': 'OG000'}, {'value': '159000', 'spread': '91200', 'groupId': 'OG001'}, {'value': '465000', 'spread': '209000', 'groupId': 'OG002'}, {'value': '2290000', 'spread': '769000', 'groupId': 'OG003'}, {'value': '8310000', 'spread': '2840000', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population = Safety population.'}, {'type': 'SECONDARY', 'title': 'Apparent Terminal Elimination Half Life (T1/2) of BG00011', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'BG00011 0.015 mg', 'description': 'Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.'}, {'id': 'OG001', 'title': 'BG00011 0.1 mg', 'description': 'Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'OG002', 'title': 'BG00011 0.3 mg', 'description': 'Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'OG003', 'title': 'BG00011 1.0 mg', 'description': 'Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'OG004', 'title': 'BG00011 3.0 mg', 'description': 'Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Day 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '178', 'spread': 'NA', 'comment': 'Insufficient data to perform analysis.', 'groupId': 'OG000'}, {'value': '177', 'spread': '123', 'groupId': 'OG001'}, {'value': '168', 'spread': '56.8', 'groupId': 'OG002'}, {'value': '178', 'spread': '60.9', 'groupId': 'OG003'}, {'value': '250', 'spread': 'NA', 'comment': 'Insufficient data to perform analysis.', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50', 'unitOfMeasure': 'hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population = Safety population. Data for this outcome measure was not collected at Day 1.'}, {'type': 'SECONDARY', 'title': 'Apparent Terminal Rate Constant [λz]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'BG00011 0.015 mg', 'description': 'Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.'}, {'id': 'OG001', 'title': 'BG00011 0.1 mg', 'description': 'Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'OG002', 'title': 'BG00011 0.3 mg', 'description': 'Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'OG003', 'title': 'BG00011 1.0 mg', 'description': 'Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'OG004', 'title': 'BG00011 3.0 mg', 'description': 'Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Day 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.00390', 'spread': 'NA', 'comment': 'Insufficient data to perform analysis.', 'groupId': 'OG000'}, {'value': '0.00508', 'spread': '0.00226', 'groupId': 'OG001'}, {'value': '0.00442', 'spread': '0.00112', 'groupId': 'OG002'}, {'value': '0.00423', 'spread': '0.00123', 'groupId': 'OG003'}, {'value': '0.00286', 'spread': 'NA', 'comment': 'Insufficient data to perform analysis.', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50', 'unitOfMeasure': 'hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population = Safety population. Data for this outcome measure was not collected at Day 1.'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration Versus Time Curve From Time Zero to Infinity AUC(0-inf) of BG00011', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'BG00011 0.015 mg', 'description': 'Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.'}, {'id': 'OG001', 'title': 'BG00011 0.1 mg', 'description': 'Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'OG002', 'title': 'BG00011 0.3 mg', 'description': 'Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'OG003', 'title': 'BG00011 1.0 mg', 'description': 'Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'OG004', 'title': 'BG00011 3.0 mg', 'description': 'Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Day 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '41900', 'spread': 'NA', 'comment': 'Insufficient data to perform analysis.', 'groupId': 'OG000'}, {'value': '362000', 'spread': '173000', 'groupId': 'OG001'}, {'value': '1190000', 'spread': '690000', 'groupId': 'OG002'}, {'value': '7250000', 'spread': '4230000', 'groupId': 'OG003'}, {'value': '24300000', 'spread': 'NA', 'comment': 'Insufficient data to perform analysis.', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population = Safety population. Data for this outcome measure was not collected at Day 1.'}, {'type': 'SECONDARY', 'title': 'Apparent Clearance (CL/F) of BG00011', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'BG00011 0.015 mg', 'description': 'Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.'}, {'id': 'OG001', 'title': 'BG00011 0.1 mg', 'description': 'Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'OG002', 'title': 'BG00011 0.3 mg', 'description': 'Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'OG003', 'title': 'BG00011 1.0 mg', 'description': 'Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'OG004', 'title': 'BG00011 3.0 mg', 'description': 'Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Day 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.913', 'spread': 'NA', 'comment': 'Insufficient data to perform analysis.', 'groupId': 'OG000'}, {'value': '0.758', 'spread': '0.290', 'groupId': 'OG001'}, {'value': '0.801', 'spread': '0.441', 'groupId': 'OG002'}, {'value': '0.501', 'spread': '0.172', 'groupId': 'OG003'}, {'value': '0.486', 'spread': 'NA', 'comment': 'Insufficient data to perform analysis.', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50', 'unitOfMeasure': 'milliliter/hour/kilogram (mL/hr/kg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population = Safety population. Data for this outcome measure was not collected at Day 1.'}, {'type': 'SECONDARY', 'title': 'Apparent Volume of Distribution (Vd/F) of BG00011', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'BG00011 0.015 mg', 'description': 'Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.'}, {'id': 'OG001', 'title': 'BG00011 0.1 mg', 'description': 'Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'OG002', 'title': 'BG00011 0.3 mg', 'description': 'Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'OG003', 'title': 'BG00011 1.0 mg', 'description': 'Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'OG004', 'title': 'BG00011 3.0 mg', 'description': 'Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Day 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '234', 'spread': 'NA', 'comment': 'Insufficient data to perform analysis.', 'groupId': 'OG000'}, {'value': '183', 'spread': '96.0', 'groupId': 'OG001'}, {'value': '183', 'spread': '88.0', 'groupId': 'OG002'}, {'value': '120', 'spread': '29.8', 'groupId': 'OG003'}, {'value': '168', 'spread': 'NA', 'comment': 'Insufficient data to perform analysis.', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50', 'unitOfMeasure': 'milliliter per kilogram (mL/kg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population = safety population. Data for this outcome measure was not analysed on day 1.'}, {'type': 'SECONDARY', 'title': 'Percentage Change (PC) From Baseline in Biomarkers Isolated From Bronchoalveolar Lavage (BAL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'BG00011 0.015 mg', 'description': 'Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.'}, {'id': 'OG001', 'title': 'BG00011 0.1 mg', 'description': 'Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'OG002', 'title': 'BG00011 0.3 mg', 'description': 'Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'OG003', 'title': 'BG00011 1.0 mg', 'description': 'Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'OG004', 'title': 'BG00011 3.0 mg', 'description': 'Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'OG005', 'title': 'Matching Placebo', 'description': 'Participants with IPF received matching placebo.'}], 'classes': [{'title': 'ALOX5; PC at Day 8 (Follow Up)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '4.39', 'spread': '16.560', 'groupId': 'OG000'}, {'value': '-0.25', 'spread': '11.154', 'groupId': 'OG001'}, {'value': '-5.16', 'spread': '23.074', 'groupId': 'OG002'}, {'value': '-51.07', 'spread': '22.942', 'groupId': 'OG003'}, {'value': '-70.90', 'spread': '14.633', 'groupId': 'OG004'}, {'value': '-7.87', 'spread': '15.793', 'groupId': 'OG005'}]}]}, {'title': 'FN1; PC at Day 8 (Follow Up)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.42', 'spread': '20.776', 'groupId': 'OG000'}, {'value': '-4.83', 'spread': '22.035', 'groupId': 'OG001'}, {'value': '-16.84', 'spread': '15.424', 'groupId': 'OG002'}, {'value': '-65.41', 'spread': '16.174', 'groupId': 'OG003'}, {'value': '-77.42', 'spread': '17.989', 'groupId': 'OG004'}, {'value': '-8.27', 'spread': '23.881', 'groupId': 'OG005'}]}]}, {'title': 'OLR1; PC at Day 8 (Follow Up)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-4.79', 'spread': '31.104', 'groupId': 'OG000'}, {'value': '-1.58', 'spread': '16.207', 'groupId': 'OG001'}, {'value': '-15.09', 'spread': '25.235', 'groupId': 'OG002'}, {'value': '-63.64', 'spread': '18.657', 'groupId': 'OG003'}, {'value': '-77.97', 'spread': '14.602', 'groupId': 'OG004'}, {'value': '-3.56', 'spread': '21.215', 'groupId': 'OG005'}]}]}, {'title': 'PAI-1; aka SERPINE 1; PC at Day 8 (Follow Up)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '26.98', 'spread': '55.559', 'groupId': 'OG000'}, {'value': '-28.27', 'spread': '10.055', 'groupId': 'OG001'}, {'value': '7.83', 'spread': '30.064', 'groupId': 'OG002'}, {'value': '-26.06', 'spread': '38.247', 'groupId': 'OG003'}, {'value': '71.44', 'spread': '115.042', 'groupId': 'OG004'}, {'value': '-1.40', 'spread': '59.537', 'groupId': 'OG005'}]}]}, {'title': 'TGM2; PC at Day 8 (Follow Up)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.71', 'spread': '31.009', 'groupId': 'OG000'}, {'value': '-3.06', 'spread': '41.757', 'groupId': 'OG001'}, {'value': '-13.17', 'spread': '35.547', 'groupId': 'OG002'}, {'value': '-53.15', 'spread': '28.412', 'groupId': 'OG003'}, {'value': '-71.35', 'spread': '17.449', 'groupId': 'OG004'}, {'value': '15.06', 'spread': '59.874', 'groupId': 'OG005'}]}]}, {'title': 'TREM1; PC at Day 8 (Follow Up)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-3.71', 'spread': '20.135', 'groupId': 'OG000'}, {'value': '-2.01', 'spread': '16.654', 'groupId': 'OG001'}, {'value': '-7.66', 'spread': '21.151', 'groupId': 'OG002'}, {'value': '-48.33', 'spread': '23.511', 'groupId': 'OG003'}, {'value': '-63.13', 'spread': '13.700', 'groupId': 'OG004'}, {'value': '-12.83', 'spread': '17.397', 'groupId': 'OG005'}]}]}, {'title': 'ETS1; PC at Day 8 (Follow Up)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '3.16', 'spread': '53.425', 'groupId': 'OG000'}, {'value': '-11.52', 'spread': '26.342', 'groupId': 'OG001'}, {'value': '-10.54', 'spread': '43.866', 'groupId': 'OG002'}, {'value': '240.59', 'spread': '245.766', 'groupId': 'OG003'}, {'value': '103.16', 'spread': '152.301', 'groupId': 'OG004'}, {'value': '65.10', 'spread': '146.690', 'groupId': 'OG005'}]}]}, {'title': 'pSMAD2 to tSMAD2; PC at Day 8 (Follow Up)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '23.91', 'spread': '54.293', 'groupId': 'OG000'}, {'value': '-3.33', 'spread': '29.724', 'groupId': 'OG001'}, {'value': '-39.82', 'spread': '24.675', 'groupId': 'OG002'}, {'value': '-63.74', 'spread': '34.674', 'groupId': 'OG003'}, {'value': '-76.20', 'spread': '14.834', 'groupId': 'OG004'}, {'value': '28.59', 'spread': '52.270', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 8 (Follow up)', 'description': 'The expression level of 7 genes; Arachidonate 5-lipoxygenase (ALOX5), fibronectin 1 (FN1), Oxidized low density lipoprotein receptor 1 (OLR1), Plasminogen activator inhibitor-1 (PAI-1; aka SERPINE 1), Transglutaminase 2 (TGM2), Triggering receptor expressed on myeloid cells 1 (TREM1), and v-ets erythroblastosis virus E26 oncogene homolog 1 (ETS1) were assessed via BAL as well as a ratio of pSMAD2 to tSMAD2 levels.', 'unitOfMeasure': 'Percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The "Pharmacodynamic" population consisted of all participants who received at least 1 multiple dose injection of BG00011 and have a corresponding sample collected for BAL and/or blood biomarkers.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Antibodies to BG00011', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'BG00011 0.015 mg', 'description': 'Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.'}, {'id': 'OG001', 'title': 'BG00011 0.1 mg', 'description': 'Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'OG002', 'title': 'BG00011 0.3 mg', 'description': 'Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'OG003', 'title': 'BG00011 1.0 mg', 'description': 'Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'OG004', 'title': 'BG00011 3.0 mg', 'description': 'Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'OG005', 'title': 'Matching Placebo', 'description': 'Participants with IPF received SC injection of BG00011 matching placebo once weekly for 8 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 19', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BG00011 0.015 mg', 'description': 'Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.'}, {'id': 'FG001', 'title': 'BG00011 0.1 mg', 'description': 'Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'FG002', 'title': 'BG00011 0.3 mg', 'description': 'Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'FG003', 'title': 'BG00011 1.0 mg', 'description': 'Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'FG004', 'title': 'BG00011 3.0 mg', 'description': 'Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'FG005', 'title': 'Matching Placebo', 'description': 'Participants with IPF received SC injection of BG00011 matching placebo once weekly for 8 doses.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Subject request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The participants were enrolled across 10 sites in the US.', 'preAssignmentDetails': 'Forty-one participants were randomized and received at least one dose in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '41', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'BG00011 0.015 mg', 'description': 'Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.'}, {'id': 'BG001', 'title': 'BG00011 0.1 mg', 'description': 'Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'BG002', 'title': 'BG00011 0.3 mg', 'description': 'Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'BG003', 'title': 'BG00011 1.0 mg', 'description': 'Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'BG004', 'title': 'BG00011 3.0 mg', 'description': 'Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.'}, {'id': 'BG005', 'title': 'Matching Placebo', 'description': 'Participants with IPF received SC injection of BG00011 matching placebo once weekly for 8 doses.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68', 'spread': '2.7', 'groupId': 'BG000'}, {'value': '68', 'spread': '5.9', 'groupId': 'BG001'}, {'value': '65', 'spread': '9.6', 'groupId': 'BG002'}, {'value': '70', 'spread': '4.0', 'groupId': 'BG003'}, {'value': '72', 'spread': '9.7', 'groupId': 'BG004'}, {'value': '72', 'spread': '7.4', 'groupId': 'BG005'}, {'value': '69', 'spread': '7.1', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '35', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '41', 'groupId': 'BG006'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '41', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population: The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-05-23', 'size': 342609, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-02-12T11:37', 'hasProtocol': False}, {'date': '2015-07-16', 'size': 1786833, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-02-12T11:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'dispFirstSubmitDate': '2018-03-23', 'completionDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-12', 'studyFirstSubmitDate': '2011-06-03', 'dispFirstSubmitQcDate': '2018-03-23', 'resultsFirstSubmitDate': '2020-02-12', 'studyFirstSubmitQcDate': '2011-06-09', 'dispFirstPostDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-12', 'studyFirstPostDateStruct': {'date': '2011-06-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events (AEs)', 'timeFrame': 'up to Week 19', 'description': 'An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment.'}], 'secondaryOutcomes': [{'measure': 'Time to Reach Maximum Observed Serum Concentration (Tmax) of BG00011', 'timeFrame': 'Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50'}, {'measure': 'Maximum Observed Serum Concentration (Cmax) of BG00011', 'timeFrame': 'Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50'}, {'measure': 'Area Under the Serum Concentration Time Curve From Time 0 to Last Quantifiable Observed Concentration AUC(0-t) of BG00011', 'timeFrame': 'Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50'}, {'measure': 'Area Under the Serum Concentration-Time Curve From Time 0 to 168 Hours AUC(0-168) of BG00011', 'timeFrame': 'Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50'}, {'measure': 'Apparent Terminal Elimination Half Life (T1/2) of BG00011', 'timeFrame': 'Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50'}, {'measure': 'Apparent Terminal Rate Constant [λz]', 'timeFrame': 'Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50'}, {'measure': 'Area Under the Concentration Versus Time Curve From Time Zero to Infinity AUC(0-inf) of BG00011', 'timeFrame': 'Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50'}, {'measure': 'Apparent Clearance (CL/F) of BG00011', 'timeFrame': 'Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50'}, {'measure': 'Apparent Volume of Distribution (Vd/F) of BG00011', 'timeFrame': 'Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50'}, {'measure': 'Percentage Change (PC) From Baseline in Biomarkers Isolated From Bronchoalveolar Lavage (BAL)', 'timeFrame': 'Baseline, Day 8 (Follow up)', 'description': 'The expression level of 7 genes; Arachidonate 5-lipoxygenase (ALOX5), fibronectin 1 (FN1), Oxidized low density lipoprotein receptor 1 (OLR1), Plasminogen activator inhibitor-1 (PAI-1; aka SERPINE 1), Transglutaminase 2 (TGM2), Triggering receptor expressed on myeloid cells 1 (TREM1), and v-ets erythroblastosis virus E26 oncogene homolog 1 (ETS1) were assessed via BAL as well as a ratio of pSMAD2 to tSMAD2 levels.'}, {'measure': 'Number of Participants With Treatment Emergent Antibodies to BG00011', 'timeFrame': 'Up to Week 19'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Idiopathic Pulmonary Fibrosis (IPF)']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the safety and tolerability of subcutaneously (SC) administered multiple, escalating doses of BG00011 (a humanized monoclonal antibody directed against the alpha v beta 6 (αvβ6) integrin, formerly known as STX-100) in participants with IPF. The Secondary objectives are to estimate the pharmacokinetic (PK) parameters after the 1st dose and after the last dose of multiple, escalating doses of BG00011 in participants with IPF, to assess the immunogenicity of BG00011 in participants with IPF, and to assess the effect of BG00011 on biomarkers isolated from bronchoalveolar lavage (BAL) and peripheral blood in participants with IPF.', 'detailedDescription': 'This study was previously posted by Stromedix, Inc. In April, 2014, sponsorship of the trial was transferred to Biogen. The study drug name was changed from STX-100 to BG00011 and the study number was changed from STX-003 to 203PF201, to align with sponsor conventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '84 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n1. Clinical features consistent with IPF prior to screening (based on the American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) consensus criteria for the diagnosis of IPF).\n2. Forced (expiratory) Vital Capacity (FVC) ≥ 50% of predicted value.\n3. DLco (corrected for hemoglobin) ≥ 30% predicted value.\n4. Oxygen saturation \\> 90% at rest by pulse oximetry while breathing ambient air or receiving ≤2 L/minute of supplemental oxygen.\n5. Residual volume ≤ 120% predicted value.\n6. Ratio of Forced Expiratory Volume over 1 second (FEV1) to FVC ≥ 0.65 after the use of a bronchodilator.\n7. Other known causes of interstitial lung disease have been excluded (e.g., drug toxicities, environmental exposures, connective tissue diseases).\n8. High Resolution Computed Tomography (HRCT) image fulfills the criteria for 'Usual Interstitial Pneumonia (UIP) pattern'.\n9. If the HRCT image does not fulfill the criteria for 'UIP pattern' a surgical lung biopsy is necessary for the diagnosis of IPF (lung biopsy performed prior to screening is acceptable). If a lung biopsy has been performed, it must fulfill the histopathological criteria for either 'UIP pattern' or 'probable UIP pattern' with the appropriate HRCT correlate.\n10. Adequate bone marrow and liver function.\n11. Patient has a life expectancy of at least 12 months.\n\nKey Exclusion Criteria:\n\n1. Findings that are diagnostic of a condition other than UIP on surgical lung biopsy (performed either before or after screening), HRCT imaging, transbronchial lung biopsy, or bronchoalveolar lavage (BAL).\n2. Serious local infection or systemic infection within 3 months prior to screening.\n3. Treatment with another investigational drug, investigational device, or approved therapy for investigational use within 4 weeks of initial screening.\n4. Currently receiving high dose corticosteroid, cytotoxic therapy (e.g., chlorambucil, azathioprine, cyclophosphamide, methotrexate), nintedanib (Ofev®), vasodilator therapy for pulmonary hypertension (e.g., bosentan), unapproved and/or investigational therapy for IPF or administration of such therapeutics within 5 half-lives of the agent prior to initial screening in this study.\n5. End-stage fibrotic disease requiring organ transplantation within 6 months\n\nNOTE: Other protocol defined Inclusion/Exclusion Criteria may apply."}, 'identificationModule': {'nctId': 'NCT01371305', 'briefTitle': 'STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': 'Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Dose-Escalation Study of STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)', 'orgStudyIdInfo': {'id': '203PF201'}, 'secondaryIdInfos': [{'id': 'STX-003', 'type': 'OTHER', 'domain': 'Stromedix, Inc.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BG00011', 'description': 'Participants will receive 8 consecutive weekly doses of BG00011', 'interventionNames': ['Drug: BG00011']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive 8 consecutive weekly doses of placebo.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'BG00011', 'type': 'DRUG', 'otherNames': ['STX-100'], 'description': 'BG00011 will be administered at varying doses via subcutaneous (SC) injection', 'armGroupLabels': ['BG00011']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Sterile normal saline (0.9% Sodium Chloride for Injection) via Subcutaneous (SC) injections.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Biogen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biogen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}