Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT03573505
Status:
TERMINATED
Last Update Posted:
2020-12-11
First Post:
2018-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
An Efficacy and Safety Study of BG00011 in Participants With Idiopathic Pulmonary Fibrosis
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': 'US Biogen Clinical Trial Center', '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}, 'limitationsAndCaveats': {'description': 'The study was terminated early due to safety findings.'}}, 'adverseEventsModule': {'timeFrame': 'Up to 60 Weeks (End of Study)', 'description': 'The safety population included all the participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received BG00011-matching placebo, once weekly by subcutaneous (SC) injection up to a maximum of 46 weeks. Median exposure to placebo was 19.14 weeks.', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 31, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'BG00011', 'description': 'Participants received BG00011 56 milligram (mg), once weekly by SC injection up to a maximum of 46 weeks. Median exposure to BG00011 was 17.14 weeks.', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 40, 'seriousNumAtRisk': 54, 'deathsNumAffected': 4, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Idiopathic pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'seriousEvents': [{'term': 'Diverticulum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hip deformity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Ovarian adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Fallopian tube cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Idiopathic pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pneumothorax spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Steal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Forced (Expiratory) Vital Capacity (FVC) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00011-matching placebo, once weekly by subcutaneous (SC) injection up to a maximum of 46 weeks. Median exposure to placebo was 19.14 weeks.'}, {'id': 'OG001', 'title': 'BG00011', 'description': 'Participants received BG00011 56 milligram (mg), once weekly by SC injection up to a maximum of 46 weeks. Median exposure to BG00011 was 17.14 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.883', 'spread': '0.7037', 'groupId': 'OG000'}, {'value': '2.867', 'spread': '0.8607', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.308', 'spread': '0.1768', 'groupId': 'OG000'}, {'value': '-0.455', 'spread': '0.2849', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'FVC is the total amount of air exhaled during the forced expiratory volume test that is measured during spirometry and is the most important measurement of lung function. This test requires participant to breath into a tube connected to a machine that measures the amount of air that can be moved in and out of the lungs. Change from baseline is defined as post-baseline value minus baseline value. A negative change from baseline indicates decline.', 'unitOfMeasure': 'liters (L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "MITT population included all participants who were randomized and received at least 1 dose of study treatment (BG00011 or placebo). 'Number analyzed' at Week 52, are a few participants whose early termination visit fell into the analysis visit window of the Week 52 visit. No participant received Week 52 dosing."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in FVC, Expressed in Percent Predicted at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00011-matching placebo, once weekly by subcutaneous (SC) injection up to a maximum of 46 weeks. Median exposure to placebo was 19.14 weeks.'}, {'id': 'OG001', 'title': 'BG00011', 'description': 'Participants received BG00011 56 milligram (mg), once weekly by SC injection up to a maximum of 46 weeks. Median exposure to BG00011 was 17.14 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.1', 'spread': '15.46', 'groupId': 'OG000'}, {'value': '77.4', 'spread': '17.07', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.6', 'spread': '5.22', 'groupId': 'OG000'}, {'value': '-11.5', 'spread': '6.95', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': "FVC is the total amount of air exhaled during the forced expiratory volume test that is measured during spirometry and is the most important measurement of lung function. This test requires participant to breath into a tube connected to a machine that measures the amount of air that can be moved in and out of the lungs after taking an inhaled bronchodilator medicine which is used to dilate participant's bronchial (breathing) tubes. Percent predicted FVC (in %, here FVC was measured in litres) = \\[(observed FVC)/(predicted FVC)\\]\\*100. Change from baseline is defined as post-baseline value minus baseline value. A negative change from baseline indicates decline.", 'unitOfMeasure': 'percentage of predicted FVC', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "MITT population included all participants who were randomized and received at least 1 dose of study treatment (BG00011 or placebo). 'Number analyzed' at Week 52, are a few participants whose early termination visit fell into the analysis visit window of the Week 52 visit. No participant received Week 52 dosing."}, {'type': 'SECONDARY', 'title': 'Time to Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00011-matching placebo, once weekly by subcutaneous (SC) injection up to a maximum of 46 weeks. Median exposure to placebo was 19.14 weeks.'}, {'id': 'OG001', 'title': 'BG00011', 'description': 'Participants received BG00011 56 milligram (mg), once weekly by SC injection up to a maximum of 46 weeks. Median exposure to BG00011 was 17.14 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '127.5', 'groupId': 'OG000', 'lowerLimit': '29', 'upperLimit': '235'}, {'value': '119.0', 'groupId': 'OG001', 'lowerLimit': '28', 'upperLimit': '302'}]}]}], 'analyses': [{'pValue': '0.112', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.01', 'ciLowerLimit': '0.85', 'ciUpperLimit': '4.73', 'groupDescription': 'A cox proportional hazards model with terms for treatment (BG00011 vs. placebo) and randomization stratification factor is used. A stratified log-rank test is used to compare the 2 treatment groups using randomization stratus as the stratification factor. An HR (Hazard Ratio) \\< 1 indicates lower risk of event for the BG00011 group where HR is based on Cox proportional hazard model with treatment (Placebo, BG00011) as the categorical covariate.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Week 60 (End of Study)', 'description': 'Time to progression is defined by a composite endpoint, including any of the following events: Absolute decline of 10% predicted in FVC (FVC percent predicted (baseline) - FVC percent predicted (progression) ≥10%); Non-elective hospitalization for respiratory events; Lung transplantation or death. The earliest time to meet at least 1 composite criterion was calculated.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "MITT population included all participants who were randomized and received at least 1 dose of study treatment (BG00011 or placebo). 'Overall number of participants analyzed' are the participants who were assessed in this outcome measure."}, {'type': 'SECONDARY', 'title': 'Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00011-matching placebo, once weekly by subcutaneous (SC) injection up to a maximum of 46 weeks. Median exposure to placebo was 19.14 weeks.'}, {'id': 'OG001', 'title': 'BG00011', 'description': 'Participants received BG00011 56 milligram (mg), once weekly by SC injection up to a maximum of 46 weeks. Median exposure to BG00011 was 17.14 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '114.0', 'groupId': 'OG001', 'lowerLimit': '42', 'upperLimit': '223'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Early Termination Visit (Up to Week 52)', 'description': 'Time to first acute IPF exacerbation is defined as time from randomization to the first occurrence of acute IPF exacerbation. Acute IPF exacerbation is defined as a clinically significant deterioration of unidentifiable cause in a participant with underlying IPF. The diagnostic criteria for IPF used in this study were derived from evidence-based guidelines developed by the American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association (ATS/ERS/JRS/ALAT) joint task force for the diagnosis and management of IPF. Participants were assessed according to the modified 2007 diagnostic criteria for acute IPF exacerbation.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "MITT population included all participants who were randomized and received at least 1 dose of study treatment (BG00011 or placebo). 'Overall number of participants analyzed' are participants who had at least one acute IPF exacerbation."}, {'type': 'SECONDARY', 'title': 'Number of Participants With at Least One Acute IPF Exacerbation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00011-matching placebo, once weekly by subcutaneous (SC) injection up to a maximum of 46 weeks. Median exposure to placebo was 19.14 weeks.'}, {'id': 'OG001', 'title': 'BG00011', 'description': 'Participants received BG00011 56 milligram (mg), once weekly by SC injection up to a maximum of 46 weeks. Median exposure to BG00011 was 17.14 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Early Termination Visit (Up to Week 52)', 'description': 'Acute IPF exacerbation is defined as a clinically significant deterioration of unidentifiable cause in a participant with underlying IPF. The diagnostic criteria for IPF used in this study were derived from evidence-based guidelines developed by the American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association (ATS/ERS/JRS/ALAT) joint task force for the diagnosis and management of IPF. Participants were assessed according to the modified 2007 diagnostic criteria for acute IPF exacerbation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population included all participants who were randomized and received at least 1 dose of study treatment (BG00011 or placebo).'}, {'type': 'SECONDARY', 'title': 'Number of IPF Exacerbations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00011-matching placebo, once weekly by subcutaneous (SC) injection up to a maximum of 46 weeks. Median exposure to placebo was 19.14 weeks.'}, {'id': 'OG001', 'title': 'BG00011', 'description': 'Participants received BG00011 56 milligram (mg), once weekly by SC injection up to a maximum of 46 weeks. Median exposure to BG00011 was 17.14 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Early Termination Visit (Up to Week 52)', 'description': 'The IPF exacerbation is defined as a clinically significant deterioration of unidentifiable cause in a participant with underlying IPF. The diagnostic criteria for IPF used in this study were derived from evidence-based guidelines developed by the American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association (ATS/ERS/JRS/ALAT) joint task force for the diagnosis and management of IPF. Participants were assessed according to the modified 2007 diagnostic criteria for acute IPF exacerbation.', 'unitOfMeasure': 'exacerbations', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population included all participants who were randomized and received at least 1 dose of study treatment (BG00011 or placebo).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Absolute Decline of 10% Predicted in FVC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00011-matching placebo, once weekly by subcutaneous (SC) injection up to a maximum of 46 weeks. Median exposure to placebo was 19.14 weeks.'}, {'id': 'OG001', 'title': 'BG00011', 'description': 'Participants received BG00011 56 milligram (mg), once weekly by SC injection up to a maximum of 46 weeks. Median exposure to BG00011 was 17.14 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Early Termination Visit (Up to Week 52)', 'description': "FVC is the is the total amount of air exhaled during the forced expiratory volume test that is measured during spirometry and is the most important measurement of lung function. This test requires participant to breath into a tube connected to a machine that measures the amount of air that can be moved in and out of the lungs after taking an inhaled bronchodilator medicine which is used to dilate participant's bronchial (breathing) tubes. Absolute Decline of 10% = FVC percent predicted (baseline) - FVC percent predicted (progression) ≥10%.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population included all participants who were randomized and received at least 1 dose of study treatment (BG00011 or placebo).'}, {'type': 'SECONDARY', 'title': 'Time to Death or Lung Transplantation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00011-matching placebo, once weekly by subcutaneous (SC) injection up to a maximum of 46 weeks. Median exposure to placebo was 19.14 weeks.'}, {'id': 'OG001', 'title': 'BG00011', 'description': 'Participants received BG00011 56 milligram (mg), once weekly by SC injection up to a maximum of 46 weeks. Median exposure to BG00011 was 17.14 weeks.'}], 'classes': [{'title': 'Time to Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.0', 'groupId': 'OG001', 'lowerLimit': '60', 'upperLimit': '137'}]}]}, {'title': 'Time to Lung Transplantation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '155.0', 'groupId': 'OG001', 'lowerLimit': '155', 'upperLimit': '155'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Week 60 (End of Study)', 'description': 'Time to Death or Lung Transplantation is defined as the time from randomization to the first occurrence of any one of the event (death or lung transplantation).', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population included all participants who were randomized and received at least 1 dose of study treatment (BG00011 or Placebo).'}, {'type': 'SECONDARY', 'title': 'Time to All Non-elective Hospitalizations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00011-matching placebo, once weekly by subcutaneous (SC) injection up to a maximum of 46 weeks. Median exposure to placebo was 19.14 weeks.'}, {'id': 'OG001', 'title': 'BG00011', 'description': 'Participants received BG00011 56 milligram (mg), once weekly by SC injection up to a maximum of 46 weeks. Median exposure to BG00011 was 17.14 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '133.0', 'groupId': 'OG000', 'lowerLimit': '61', 'upperLimit': '235'}, {'value': '119.0', 'groupId': 'OG001', 'lowerLimit': '42', 'upperLimit': '302'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Week 60 (End of Study)', 'description': 'Time to all non-elective hospitalizations is defined as the time from randomization to the first occurrence of hospitalization which was not elected by the participant.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "The MITT population included all participants who were randomized and received at least 1 dose of study treatment (BG00011 or Placebo). 'Overall number of participants analyzed' are the participants who had at least one episode of non-elective hospitalization."}, {'type': 'SECONDARY', 'title': 'Time to All Non-Elective Respiratory Hospitalizations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00011-matching placebo, once weekly by subcutaneous (SC) injection up to a maximum of 46 weeks. Median exposure to placebo was 19.14 weeks.'}, {'id': 'OG001', 'title': 'BG00011', 'description': 'Participants received BG00011 56 milligram (mg), once weekly by SC injection up to a maximum of 46 weeks. Median exposure to BG00011 was 17.14 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '205.0', 'groupId': 'OG000', 'lowerLimit': '175', 'upperLimit': '235'}, {'value': '119.0', 'groupId': 'OG001', 'lowerLimit': '42', 'upperLimit': '223'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Week 60 (End of Study)', 'description': 'Time to all non-elective respiratory hospitalizations is defined as the time from randomization to the first occurrence of hospitalization due to respiratory problems, which was not elected by the participant.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "The MITT population included all participants who were randomized and received at least 1 dose of study treatment (BG00011 or Placebo). 'Overall number of participants analyzed' are the participants who had at least one episode of non-elective respiratory hospitalization."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Absolute FVC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00011-matching placebo, once weekly by subcutaneous (SC) injection up to a maximum of 46 weeks. Median exposure to placebo was 19.14 weeks.'}, {'id': 'OG001', 'title': 'BG00011', 'description': 'Participants received BG00011 56 milligram (mg), once weekly by SC injection up to a maximum of 46 weeks. Median exposure to BG00011 was 17.14 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.883', 'spread': '0.7037', 'groupId': 'OG000'}, {'value': '2.867', 'spread': '0.8607', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.006', 'spread': '0.1544', 'groupId': 'OG000'}, {'value': '0.032', 'spread': '0.1526', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.030', 'spread': '0.1575', 'groupId': 'OG000'}, {'value': '0.007', 'spread': '0.1513', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.020', 'spread': '0.1846', 'groupId': 'OG000'}, {'value': '0.000', 'spread': '0.2247', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.046', 'spread': '0.1819', 'groupId': 'OG000'}, {'value': '-0.042', 'spread': '0.2400', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.086', 'spread': '0.1921', 'groupId': 'OG000'}, {'value': '-0.121', 'spread': '0.3318', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.079', 'spread': '0.1949', 'groupId': 'OG000'}, {'value': '-0.069', 'spread': '0.3045', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.078', 'spread': '0.1979', 'groupId': 'OG000'}, {'value': '-0.152', 'spread': '0.3142', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 38', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.131', 'spread': '0.1847', 'groupId': 'OG000'}, {'value': '-0.275', 'spread': '0.3436', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.200', 'spread': '0.2153', 'groupId': 'OG000'}, {'value': '-0.485', 'spread': '0.3816', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 44', 'description': "FVC is the total amount of air exhaled during the forced expiratory volume test that is measured during spirometry and is the most important measurement of lung function. This test requires participant to breath into a tube connected to a machine that measures the amount of air that can be moved in and out of the lungs after taking an inhaled bronchodilator medicine which is used to dilate participant's bronchial (breathing) tubes. Change from baseline is defined as post-baseline value minus baseline value. A negative change from baseline indicates decline.", 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "MITT population included all participants who were randomized and received at least 1 dose of study treatment (BG00011 or placebo). 'Number Analyzed' are the participants who were assessed at the specified timepoint in this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Percent Predicted FVC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00011-matching placebo, once weekly by subcutaneous (SC) injection up to a maximum of 46 weeks. Median exposure to placebo was 19.14 weeks.'}, {'id': 'OG001', 'title': 'BG00011', 'description': 'Participants received BG00011 56 milligram (mg), once weekly by SC injection up to a maximum of 46 weeks. Median exposure to BG00011 was 17.14 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.1', 'spread': '15.46', 'groupId': 'OG000'}, {'value': '77.4', 'spread': '17.07', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '4.13', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '4.52', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '4.22', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '4.12', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '5.31', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '5.79', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '4.97', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '6.24', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.3', 'spread': '5.04', 'groupId': 'OG000'}, {'value': '-3.0', 'spread': '8.08', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '5.60', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '8.19', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '5.44', 'groupId': 'OG000'}, {'value': '-3.7', 'spread': '8.66', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 38', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.4', 'spread': '5.43', 'groupId': 'OG000'}, {'value': '-7.4', 'spread': '8.44', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.1', 'spread': '6.08', 'groupId': 'OG000'}, {'value': '-12.5', 'spread': '9.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 44', 'description': "FVC is the total amount of air exhaled during the forced expiratory volume test that is measured during spirometry and is the most important measurement of lung function. This test requires participant to breath into a tube connected to a machine that measures the amount of air that can be moved in and out of the lungs after taking an inhaled bronchodilator medicine which is used to dilate participant's bronchial (breathing) tubes. Percent predicted FVC (in %) = \\[(observed FVC)/(predicted FVC)\\]\\*100. Change from baseline is defined as post-baseline value minus baseline value. A negative change from baseline indicates decline.", 'unitOfMeasure': 'percentage of predicted FVC', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "MITT population included all participants who were randomized and received at least 1 dose of study treatment (BG00011 or placebo). 'Number Analyzed' are the participants who were assessed at the specified timepoint in this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Absolute Carbon Monoxide Diffusion Capacity (DLco)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00011-matching placebo, once weekly by subcutaneous (SC) injection up to a maximum of 46 weeks. Median exposure to placebo was 19.14 weeks.'}, {'id': 'OG001', 'title': 'BG00011', 'description': 'Participants received BG00011 56 milligram (mg), once weekly by SC injection up to a maximum of 46 weeks. Median exposure to BG00011 was 17.14 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.397', 'spread': '1.1853', 'groupId': 'OG000'}, {'value': '4.036', 'spread': '1.1043', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.094', 'spread': '0.4783', 'groupId': 'OG000'}, {'value': '0.019', 'spread': '0.4431', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.108', 'spread': '0.5583', 'groupId': 'OG000'}, {'value': '0.028', 'spread': '0.6078', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.205', 'spread': '0.6579', 'groupId': 'OG000'}, {'value': '-0.263', 'spread': '0.5472', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.074', 'spread': '0.7756', 'groupId': 'OG000'}, {'value': '-0.383', 'spread': '0.7427', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 38', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.025', 'spread': '0.5611', 'groupId': 'OG000'}, {'value': '-0.445', 'spread': '0.6153', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.228', 'spread': '0.1839', 'groupId': 'OG000'}, {'value': '-0.400', 'spread': '0.7921', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Early Termination Visit (Up to Week 52)', 'description': 'DLCO is a measurement of the ability of the lungs to transfer gases from the air to the blood. Evaluation of DLco was be performed by single-breath carbon monoxide diffusing capacity. DLCO was assessed in milliliters per minute per millimeter of mercury (mL/min/mmHg). Change from baseline is defined as post-baseline value minus baseline value. A negative change from baseline indicates decline.', 'unitOfMeasure': 'mL/min/mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "MITT population included all participants who were randomized and received at least 1 dose of study treatment (BG00011 or placebo). 'Number Analyzed' are the participants who were assessed at the specified timepoint in this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Percent Predicted Carbon Monoxide Diffusion Capacity (DLco)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00011-matching placebo, once weekly by subcutaneous (SC) injection up to a maximum of 46 weeks. Median exposure to placebo was 19.14 weeks.'}, {'id': 'OG001', 'title': 'BG00011', 'description': 'Participants received BG00011 56 milligram (mg), once weekly by SC injection up to a maximum of 46 weeks. Median exposure to BG00011 was 17.14 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.6', 'spread': '13.56', 'groupId': 'OG000'}, {'value': '49.1', 'spread': '11.15', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '5.62', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '5.08', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '6.75', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '7.78', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'spread': '7.48', 'groupId': 'OG000'}, {'value': '-3.1', 'spread': '6.49', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '9.10', 'groupId': 'OG000'}, {'value': '-4.8', 'spread': '8.78', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 38', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '6.42', 'groupId': 'OG000'}, {'value': '-5.5', 'spread': '6.82', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'spread': '1.82', 'groupId': 'OG000'}, {'value': '-4.0', 'spread': '9.56', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Early Termination Visit (Up to Week 52)', 'description': 'DLCO is a measurement of the ability of the lungs to transfer gases from the air to the blood. Evaluation of DLco was be performed by single-breath carbon monoxide diffusing capacity. Percent of predicted DLco (in %) = \\[(observed DLco)/(predicted DLco)\\]\\*100. Change from baseline is defined as post-baseline value minus baseline value. A negative change from baseline indicates decline.', 'unitOfMeasure': 'percentage of predicted DLco', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "MITT population included all participants who were randomized and received at least 1 dose of study treatment (BG00011 or placebo). 'Number Analyzed' are the participants who were assessed at the specified timepoint in this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Absolute Total Lung Capacity (TLC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00011-matching placebo, once weekly by subcutaneous (SC) injection up to a maximum of 46 weeks. Median exposure to placebo was 19.14 weeks.'}, {'id': 'OG001', 'title': 'BG00011', 'description': 'Participants received BG00011 56 milligram (mg), once weekly by SC injection up to a maximum of 46 weeks. Median exposure to BG00011 was 17.14 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.472', 'spread': '1.0497', 'groupId': 'OG000'}, {'value': '4.413', 'spread': '1.0560', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.090', 'spread': 'NA', 'comment': 'NA indicates that SD was not calculable as there was only 1 participant.', 'groupId': 'OG000'}, {'value': '-0.080', 'spread': '0.2276', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.010', 'spread': 'NA', 'comment': 'NA indicates that SD was not calculable as there was only 1 participant.', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.113', 'spread': '0.3272', 'groupId': 'OG000'}, {'value': '0.380', 'spread': 'NA', 'comment': 'NA indicates that SD was not calculable as there was only 1 participant.', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.060', 'spread': 'NA', 'comment': 'NA indicates that SD was not calculable as there was only 1 participant.', 'groupId': 'OG000'}, {'value': '-0.350', 'spread': '0.2131', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.002', 'spread': '0.2344', 'groupId': 'OG000'}, {'value': '-0.310', 'spread': '0.3476', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.103', 'spread': '0.2293', 'groupId': 'OG000'}, {'value': '-0.214', 'spread': '0.4403', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.370', 'spread': 'NA', 'comment': 'NA indicates that SD was not calculable as there was only 1 participant.', 'groupId': 'OG000'}, {'value': '0.140', 'spread': 'NA', 'comment': 'NA indicates that SD was not calculable as there was only 1 participant.', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 38', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.090', 'spread': '0.2263', 'groupId': 'OG000'}, {'value': '-0.023', 'spread': '0.4754', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.160', 'spread': '0.0283', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.197', 'spread': '0.3075', 'groupId': 'OG000'}, {'value': '-0.695', 'spread': '0.3465', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Early Termination Visit (Up to Week 52)', 'description': 'Total lung capacity is the measure of lung volume was measured by full-body plethysmography. Change from baseline is defined as post-baseline value minus baseline value. A negative change from baseline indicates decline.', 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "MITT population included all participants who were randomized and received at least 1 dose of study treatment (BG00011 or placebo). 'Number Analyzed' are the participants who were assessed at the specified timepoint in this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Percent Predicted TLC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00011-matching placebo, once weekly by subcutaneous (SC) injection up to a maximum of 46 weeks. Median exposure to placebo was 19.14 weeks.'}, {'id': 'OG001', 'title': 'BG00011', 'description': 'Participants received BG00011 56 milligram (mg), once weekly by SC injection up to a maximum of 46 weeks. Median exposure to BG00011 was 17.14 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.6', 'spread': '14.67', 'groupId': 'OG000'}, {'value': '67.7', 'spread': '12.74', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': 'NA', 'comment': 'NA indicates that SD was not calculable as there was only 1 participant.', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '3.50', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': 'NA', 'comment': 'NA indicates that SD was not calculable as there was only 1 participant.', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '4.93', 'groupId': 'OG000'}, {'value': '5.0', 'spread': 'NA', 'comment': 'NA indicates that SD was not calculable as there was only 1 participant.', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': 'NA', 'comment': 'NA indicates that SD was not calculable as there was only 1 participant.', 'groupId': 'OG000'}, {'value': '-4.8', 'spread': '2.75', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '3.81', 'groupId': 'OG000'}, {'value': '-5.8', 'spread': '5.76', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.6', 'spread': '3.78', 'groupId': 'OG000'}, {'value': '-3.0', 'spread': '6.12', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.0', 'spread': 'NA', 'comment': 'NA indicates that SD was not calculable as there was only 1 participant.', 'groupId': 'OG000'}, {'value': '3.0', 'spread': 'NA', 'comment': 'NA indicates that SD was not calculable as there was only 1 participant.', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 38', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '4.24', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '6.51', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.7', 'spread': '3.79', 'groupId': 'OG000'}, {'value': '-10.5', 'spread': '3.54', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Early Termination Visit (Up to Week 52)', 'description': 'Total lung capacity is the measure of lung volume was measured by full-body plethysmography. Percent predicted TLC (in %) = \\[(observed TLC)/(predicted TLC)\\]\\*100. Change from baseline is defined as post-baseline value minus baseline value. A negative change from baseline indicates decline.', 'unitOfMeasure': 'percentage of predicted TLC', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "MITT population included all participants who were randomized and received at least 1 dose of study treatment (BG00011 or placebo). 'Number Analyzed' are the participants who were assessed at the specified timepoint in this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 6 Minute Walk Test (6MWT) Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00011-matching placebo, once weekly by subcutaneous (SC) injection up to a maximum of 46 weeks. Median exposure to placebo was 19.14 weeks.'}, {'id': 'OG001', 'title': 'BG00011', 'description': 'Participants received BG00011 56 milligram (mg), once weekly by SC injection up to a maximum of 46 weeks. Median exposure to BG00011 was 17.14 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '458.4', 'spread': '115.33', 'groupId': 'OG000'}, {'value': '404.0', 'spread': '122.61', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.9', 'spread': '38.79', 'groupId': 'OG000'}, {'value': '-28.6', 'spread': '67.21', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.8', 'spread': '87.16', 'groupId': 'OG000'}, {'value': '-40.0', 'spread': '94.60', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 26 and Week 52', 'description': "The 6MWT measures the distance (in meters), a participant is able to walk in 6 minutes. This test measures the distance a person can walk quickly on a flat, hard surface in 6 minutes and reflects an individual's ability to perform daily physical activities.", 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "MITT population included all participants who were randomized and received at least 1 dose of study treatment (BG00011 or placebo). 'Number analyzed' are participants with data available for analyses at given timepoint. Participants at Week 52 are a few participants whose early termination visit fell into the analysis visit window of the Week 52 visit. No participant received Week 52 dosing."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00011-matching placebo, once weekly by subcutaneous (SC) injection up to a maximum of 46 weeks. Median exposure to placebo was 19.14 weeks.'}, {'id': 'OG001', 'title': 'BG00011', 'description': 'Participants received BG00011 56 milligram (mg), once weekly by SC injection up to a maximum of 46 weeks. Median exposure to BG00011 was 17.14 weeks.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 60 (End of Study)', 'description': 'An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death, requires inpatient hospitalization, results in persistent or significant disability and/or results in a congenital anomaly.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who were randomized and receive at least 1 dose of study treatment (BG00011 or placebo).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Anti-BG00011 Antibodies in the Serum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received BG00011-matching placebo, once weekly by subcutaneous (SC) injection up to a maximum of 46 weeks. Median exposure to placebo was 19.14 weeks.'}, {'id': 'OG001', 'title': 'BG00011', 'description': 'Participants received BG00011 56 milligram (mg), once weekly by SC injection up to a maximum of 46 weeks. Median exposure to BG00011 was 17.14 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 60 (End of Study)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The immunogenicity population defined as participants from mITT population who have at least 1 postdose immunogenicity sample evaluated for anti-BG00011 antibodies. 'Number of participants analyzed' are those who were assessed in this outcome measure."}, {'type': 'SECONDARY', 'title': 'Concentration of BG00011 in the Serum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BG00011', 'description': 'Participants received BG00011 56 milligram (mg), once weekly by SC injection up to a maximum of 46 weeks. Median exposure to BG00011 was 17.14 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2292.83', 'spread': '1778.376', 'groupId': 'OG000'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5323.08', 'spread': '3058.436', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7971.05', 'spread': '4912.091', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7768.33', 'spread': '5139.179', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6934.86', 'spread': '4288.642', 'groupId': 'OG000'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6614.24', 'spread': '4203.020', 'groupId': 'OG000'}]}]}, {'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8579.42', 'spread': '9754.642', 'groupId': 'OG000'}]}]}, {'title': 'Week 38', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3560.00', 'spread': '2771.630', 'groupId': 'OG000'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1085.33', 'spread': '455.978', 'groupId': 'OG000'}]}]}, {'title': 'Safety Follow-up Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '344.64', 'spread': '701.639', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose on Day 0, Day 5, Week 4, Week 8, Week 12, Week 26, Week 38, Week 52, and Safety Follow-up Visit (Up to Week 60)', 'unitOfMeasure': 'nanograms (ng)/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetics (PK) population included all participants who received at least 1 dose of study treatment and had at least one PK concentration measurement. Participants at Week 52 are a few participants whose early termination visit fell into the analysis visit window of the Week 52 visit. No participant received Week 52 dosing.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received BG00011-matching placebo, once weekly by subcutaneous (SC) injection up to a maximum of 46 weeks. Median exposure to placebo was 19.14 weeks.'}, {'id': 'FG001', 'title': 'BG00011', 'description': 'Participants received BG00011 56 milligram (mg), once weekly by SC injection up to a maximum of 46 weeks. Median exposure to BG00011 was 17.14 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Started=Participants who received at least one dose of treatment.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '54'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '54'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Consent withdrawn', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Site Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'Reason not specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'Participants were enrolled at 47 investigational sites in 16 countries from September 24, 2018 to November 14, 2019.', 'preAssignmentDetails': 'A total of 109 participants with Idiopathic pulmonary fibrosis (IPF) were enrolled and randomized in this study. Of which, 106 participants received at least one dose of study drug. The maximum length of the dosing period was up to Week 46. Participants were then followed-up for safety for up to Week 60.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received BG00011-matching placebo, once weekly by subcutaneous (SC) injection up to a maximum of 46 weeks. Median exposure to placebo was 19.14 weeks.'}, {'id': 'BG001', 'title': 'BG00011', 'description': 'Participants received BG00011 56 milligram (mg), once weekly by SC injection up to a maximum of 46 weeks. Median exposure to BG00011 was 17.14 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.50', 'spread': '6.652', 'groupId': 'BG000'}, {'value': '69.46', 'spread': '7.570', 'groupId': 'BG001'}, {'value': '68.99', 'spread': '7.117', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The modified intent-to-treat (MITT) population included all participants who were randomized and received at least 1 dose of study treatment (BG00011 or placebo).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-07-02', 'size': 3044705, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-10-29T05:03', 'hasProtocol': True}, {'date': '2017-11-20', 'size': 952280, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-10-29T05:03', 'hasProtocol': False}]}}, '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': 109}}, 'statusModule': {'whyStopped': 'Study was stopped because of safety concerns.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-09-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2019-11-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-10', 'studyFirstSubmitDate': '2018-06-19', 'resultsFirstSubmitDate': '2020-10-29', 'studyFirstSubmitQcDate': '2018-06-19', 'lastUpdatePostDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-29', 'studyFirstPostDateStruct': {'date': '2018-06-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Forced (Expiratory) Vital Capacity (FVC) at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'FVC is the total amount of air exhaled during the forced expiratory volume test that is measured during spirometry and is the most important measurement of lung function. This test requires participant to breath into a tube connected to a machine that measures the amount of air that can be moved in and out of the lungs. Change from baseline is defined as post-baseline value minus baseline value. A negative change from baseline indicates decline.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in FVC, Expressed in Percent Predicted at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': "FVC is the total amount of air exhaled during the forced expiratory volume test that is measured during spirometry and is the most important measurement of lung function. This test requires participant to breath into a tube connected to a machine that measures the amount of air that can be moved in and out of the lungs after taking an inhaled bronchodilator medicine which is used to dilate participant's bronchial (breathing) tubes. Percent predicted FVC (in %, here FVC was measured in litres) = \\[(observed FVC)/(predicted FVC)\\]\\*100. Change from baseline is defined as post-baseline value minus baseline value. A negative change from baseline indicates decline."}, {'measure': 'Time to Progression', 'timeFrame': 'Up to Week 60 (End of Study)', 'description': 'Time to progression is defined by a composite endpoint, including any of the following events: Absolute decline of 10% predicted in FVC (FVC percent predicted (baseline) - FVC percent predicted (progression) ≥10%); Non-elective hospitalization for respiratory events; Lung transplantation or death. The earliest time to meet at least 1 composite criterion was calculated.'}, {'measure': 'Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation', 'timeFrame': 'Up to Early Termination Visit (Up to Week 52)', 'description': 'Time to first acute IPF exacerbation is defined as time from randomization to the first occurrence of acute IPF exacerbation. Acute IPF exacerbation is defined as a clinically significant deterioration of unidentifiable cause in a participant with underlying IPF. The diagnostic criteria for IPF used in this study were derived from evidence-based guidelines developed by the American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association (ATS/ERS/JRS/ALAT) joint task force for the diagnosis and management of IPF. Participants were assessed according to the modified 2007 diagnostic criteria for acute IPF exacerbation.'}, {'measure': 'Number of Participants With at Least One Acute IPF Exacerbation', 'timeFrame': 'Up to Early Termination Visit (Up to Week 52)', 'description': 'Acute IPF exacerbation is defined as a clinically significant deterioration of unidentifiable cause in a participant with underlying IPF. The diagnostic criteria for IPF used in this study were derived from evidence-based guidelines developed by the American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association (ATS/ERS/JRS/ALAT) joint task force for the diagnosis and management of IPF. Participants were assessed according to the modified 2007 diagnostic criteria for acute IPF exacerbation.'}, {'measure': 'Number of IPF Exacerbations', 'timeFrame': 'Up to Early Termination Visit (Up to Week 52)', 'description': 'The IPF exacerbation is defined as a clinically significant deterioration of unidentifiable cause in a participant with underlying IPF. The diagnostic criteria for IPF used in this study were derived from evidence-based guidelines developed by the American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association (ATS/ERS/JRS/ALAT) joint task force for the diagnosis and management of IPF. Participants were assessed according to the modified 2007 diagnostic criteria for acute IPF exacerbation.'}, {'measure': 'Number of Participants With Absolute Decline of 10% Predicted in FVC', 'timeFrame': 'Up to Early Termination Visit (Up to Week 52)', 'description': "FVC is the is the total amount of air exhaled during the forced expiratory volume test that is measured during spirometry and is the most important measurement of lung function. This test requires participant to breath into a tube connected to a machine that measures the amount of air that can be moved in and out of the lungs after taking an inhaled bronchodilator medicine which is used to dilate participant's bronchial (breathing) tubes. Absolute Decline of 10% = FVC percent predicted (baseline) - FVC percent predicted (progression) ≥10%."}, {'measure': 'Time to Death or Lung Transplantation', 'timeFrame': 'Up to Week 60 (End of Study)', 'description': 'Time to Death or Lung Transplantation is defined as the time from randomization to the first occurrence of any one of the event (death or lung transplantation).'}, {'measure': 'Time to All Non-elective Hospitalizations', 'timeFrame': 'Up to Week 60 (End of Study)', 'description': 'Time to all non-elective hospitalizations is defined as the time from randomization to the first occurrence of hospitalization which was not elected by the participant.'}, {'measure': 'Time to All Non-Elective Respiratory Hospitalizations', 'timeFrame': 'Up to Week 60 (End of Study)', 'description': 'Time to all non-elective respiratory hospitalizations is defined as the time from randomization to the first occurrence of hospitalization due to respiratory problems, which was not elected by the participant.'}, {'measure': 'Change From Baseline in Absolute FVC', 'timeFrame': 'Up to Week 44', 'description': "FVC is the total amount of air exhaled during the forced expiratory volume test that is measured during spirometry and is the most important measurement of lung function. This test requires participant to breath into a tube connected to a machine that measures the amount of air that can be moved in and out of the lungs after taking an inhaled bronchodilator medicine which is used to dilate participant's bronchial (breathing) tubes. Change from baseline is defined as post-baseline value minus baseline value. A negative change from baseline indicates decline."}, {'measure': 'Change From Baseline in Percent Predicted FVC', 'timeFrame': 'Up to Week 44', 'description': "FVC is the total amount of air exhaled during the forced expiratory volume test that is measured during spirometry and is the most important measurement of lung function. This test requires participant to breath into a tube connected to a machine that measures the amount of air that can be moved in and out of the lungs after taking an inhaled bronchodilator medicine which is used to dilate participant's bronchial (breathing) tubes. Percent predicted FVC (in %) = \\[(observed FVC)/(predicted FVC)\\]\\*100. Change from baseline is defined as post-baseline value minus baseline value. A negative change from baseline indicates decline."}, {'measure': 'Change From Baseline in Absolute Carbon Monoxide Diffusion Capacity (DLco)', 'timeFrame': 'Up to Early Termination Visit (Up to Week 52)', 'description': 'DLCO is a measurement of the ability of the lungs to transfer gases from the air to the blood. Evaluation of DLco was be performed by single-breath carbon monoxide diffusing capacity. DLCO was assessed in milliliters per minute per millimeter of mercury (mL/min/mmHg). Change from baseline is defined as post-baseline value minus baseline value. A negative change from baseline indicates decline.'}, {'measure': 'Change From Baseline in Percent Predicted Carbon Monoxide Diffusion Capacity (DLco)', 'timeFrame': 'Up to Early Termination Visit (Up to Week 52)', 'description': 'DLCO is a measurement of the ability of the lungs to transfer gases from the air to the blood. Evaluation of DLco was be performed by single-breath carbon monoxide diffusing capacity. Percent of predicted DLco (in %) = \\[(observed DLco)/(predicted DLco)\\]\\*100. Change from baseline is defined as post-baseline value minus baseline value. A negative change from baseline indicates decline.'}, {'measure': 'Change From Baseline in Absolute Total Lung Capacity (TLC)', 'timeFrame': 'Up to Early Termination Visit (Up to Week 52)', 'description': 'Total lung capacity is the measure of lung volume was measured by full-body plethysmography. Change from baseline is defined as post-baseline value minus baseline value. A negative change from baseline indicates decline.'}, {'measure': 'Change From Baseline in Percent Predicted TLC', 'timeFrame': 'Up to Early Termination Visit (Up to Week 52)', 'description': 'Total lung capacity is the measure of lung volume was measured by full-body plethysmography. Percent predicted TLC (in %) = \\[(observed TLC)/(predicted TLC)\\]\\*100. Change from baseline is defined as post-baseline value minus baseline value. A negative change from baseline indicates decline.'}, {'measure': 'Change From Baseline in 6 Minute Walk Test (6MWT) Parameters', 'timeFrame': 'Baseline, Week 26 and Week 52', 'description': "The 6MWT measures the distance (in meters), a participant is able to walk in 6 minutes. This test measures the distance a person can walk quickly on a flat, hard surface in 6 minutes and reflects an individual's ability to perform daily physical activities."}, {'measure': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Up to Week 60 (End of Study)', 'description': 'An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death, requires inpatient hospitalization, results in persistent or significant disability and/or results in a congenital anomaly.'}, {'measure': 'Number of Participants With Anti-BG00011 Antibodies in the Serum', 'timeFrame': 'Up to Week 60 (End of Study)'}, {'measure': 'Concentration of BG00011 in the Serum', 'timeFrame': 'Predose on Day 0, Day 5, Week 4, Week 8, Week 12, Week 26, Week 38, Week 52, and Safety Follow-up Visit (Up to Week 60)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Idiopathic Pulmonary Fibrosis']}, 'referencesModule': {'references': [{'pmid': '35771569', 'type': 'DERIVED', 'citation': 'Raghu G, Mouded M, Chambers DC, Martinez FJ, Richeldi L, Lancaster LH, Hamblin MJ, Gibson KF, Rosas IO, Prasse A, Zhao G, Serenko M, Novikov N, McCurley A, Bansal P, Stebbins C, Arefayene M, Ibebunjo S, Violette SM, Gallagher D, Behr J. A Phase IIb Randomized Clinical Study of an Anti-alphavbeta6 Monoclonal Antibody in Idiopathic Pulmonary Fibrosis. Am J Respir Crit Care Med. 2022 Nov 1;206(9):1128-1139. doi: 10.1164/rccm.202112-2824OC.'}, {'pmid': '33463535', 'type': 'DERIVED', 'citation': 'Shenderov K, Collins SL, Powell JD, Horton MR. Immune dysregulation as a driver of idiopathic pulmonary fibrosis. J Clin Invest. 2021 Jan 19;131(2):e143226. doi: 10.1172/JCI143226.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the efficacy of BG00011 compared with placebo in participants with Idiopathic Pulmonary Fibrosis (IPF). The secondary objectives of this study are: to evaluate the efficacy of BG00011 compared with placebo in participants with IPF as determined by change in percent predicted forced (expiratory) vital capacity (FVC); to assess progression-free survival in participants who receive BG00011 compared with placebo; to assess the occurrence of IPF exacerbation in participants who receive BG00011 compared with placebo; to assess the incidence of absolute decline in FVC ≥10% in participants who receive BG00011 compared with placebo; to assess the time to death or lung transplantation in participants who receive BG00011 compared with placebo, and the transplant-free survival rate at Week 26 and Week 52; to assess the time to non-elective hospitalizations in participants who receive BG00011 compared with placebo; to assess additional pulmonary function test (PFT) findings in participants who receive BG00011 compared with placebo; To assess performance on the 6 minute walk test (6MWT) in participants who receive BG00011 compared with placebo; to evaluate the safety and tolerability of BG00011; and to evaluate the serum concentration of BG00011.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Female subjects must be surgically sterile, postmenopausal (minimum 1 year without menses), or agree to use 1 or more forms of highly effective contraception from the time of signing of the informed consent form (ICF) until 3 months after the last injection of study medication. Male subjects must also agree to use 1 or more forms of highly effective contraception for either themselves or their partners from signing of ICF until 4 months after last injection of study medication.\n* IPF diagnosed based on modified ATS/ERS/JRS/ALAT IPF guideline for diagnosis and management, within 3 years of Screening.\n* Combination of high-resolution computed tomography (HRCT) pattern and, if one has been obtained, surgical lung biopsy pattern, consistent with diagnosis of IPF.\n* Carbon monoxide diffusion capacity (DLco) (corrected for hemoglobin): 30% to 79% predicted of normal at Screening, with no clinically significant deterioration between the Screening Visit and randomization, as determined by the Investigator.\n* Forced (expiratory) vital capacity (FVC) ≥50% predicted of normal at Screening, with no clinically significant deterioration between the Screening Visit and randomization, as determined by the Investigator.\n* If a subject is taking nintedanib or pirfenidone, they must be on a stable dose for at least 8 weeks prior to randomization.\n\nKey Exclusion Criteria:\n\n* Unable to perform pulmonary functional tests (PFTs) or undergo HRCT procedure.\n* Peripheral capillary oxygen saturation (SpO2) \\<90% at rest (if on oxygen supplementation, must be ≤2 L/min at rest).\n* Airway obstruction (i.e., prebronchodilator FEV1/FVC \\<0.7) or evidence of a bronchodilator response as defined by an absolute increase of ≥12% and an increase of ≥200 milliliters (mL) in FEV1 or FVC, or both, after bronchodilator use, compared with the values before bronchodilator use at Screening.\n* End-stage fibrotic disease likely requiring organ transplantation within 12 months, or if the subject has initiated active evaluation for organ transplantation.\n* The extent of emphysema in the lungs exceeds fibrosis, based on central review of HRCT scans.\n* Body weight \\<60 kg at Screening.\n* History of or ongoing malignant disease, including solid tumors and hematologic malignancies, with the exception of basal cell carcinomas, squamous cell carcinomas, and carcinoma in situ of the cervix that have been completely excised and considered cured \\>2 years prior to Screening.\n* Significant cardiac disease (e.g., New York Heart Association Class 3 or 4; myocardial infarction within the past 6 months; unstable angina; coronary angioplasty or coronary artery bypass graft within the past 6 months; uncontrolled atrial or ventricular cardiac arrhythmias; or pulmonary hypertension requiring pharmacologic treatment).\n* Clinical diagnosis of any connective tissue disease (including but not limited to scleroderma, polymyositis/dermatomyositis, systemic lupus erythematosus, and rheumatoid arthritis) or a diagnosis of interstitial pneumonia with autoimmune features as determined by the Investigator.\n* Other disease that may interfere with testing procedures or, in the judgment of the Investigator, may interfere with study participation or may put the patient at risk when participating in this study.\n* Other unspecified reasons that, in the opinion of the Investigator or Biogen, make the subject unsuitable for enrollment.\n\nNOTE: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT03573505', 'acronym': 'SPIRIT', 'briefTitle': 'An Efficacy and Safety Study of BG00011 in Participants With Idiopathic Pulmonary Fibrosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis', 'orgStudyIdInfo': {'id': '203PF203'}, 'secondaryIdInfos': [{'id': '2017-003158-18', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BG00011', 'description': 'Participants will receive BG00011 56 mg once weekly by subcutaneous (SC) injection for 52 weeks.', 'interventionNames': ['Drug: BG00011']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive placebo once weekly by (SC) injection for 52 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'BG00011', 'type': 'DRUG', 'description': 'Administered as specified in the treatment arm.', 'armGroupLabels': ['BG00011']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered as specified in the treatment arm.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '06510-3221', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33125', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'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': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '63017', 'city': 'Chesterfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.66311, 'lon': -90.57707}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'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': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': 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