Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:56 PM
Study NCT ID:
NCT04419558
Status:
TERMINATED
Last Update Posted:
2024-08-12
First Post:
2020-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D054990', 'term': 'Idiopathic Pulmonary Fibrosis'}, {'id': 'D054988', 'term': 'Idiopathic Interstitial Pneumonias'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D011658', 'term': 'Pulmonary Fibrosis'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C560078', 'term': 'pamrevlumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'zephyrus@fibrogen.com', 'phone': '(415) 978-1427', 'title': 'Clinical Trial Information Desk', 'organization': 'FibroGen, Inc.'}, 'certainAgreement': {'otherDetails': 'The multisite consortium can publish any time after the data is collected and analyzed by FibroGen. The investigator can only publish after the multisite consortium publishes (or tries to publish and fails). FibroGen has 60 days to review a publication and can extend the embargo up to an additional 120 days (or 180 total).', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study drug up to Week 104', 'description': 'As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received any dose of study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'DB Period: Pamrevlumab', 'description': 'Participants received pamrevlumab 30 mg/kg, administered by IV infusion, every 3 weeks, for a total of up to 17 infusions over 48 weeks in the DB period.', 'otherNumAtRisk': 183, 'deathsNumAtRisk': 184, 'otherNumAffected': 83, 'seriousNumAtRisk': 183, 'deathsNumAffected': 16, 'seriousNumAffected': 38}, {'id': 'EG001', 'title': 'DB Period: Placebo', 'description': 'Participants received pamrevlumab-matching placebo, administered by IV infusion every 3 weeks for a total of up to 17 infusions over 48 weeks in the DB period.', 'otherNumAtRisk': 188, 'deathsNumAtRisk': 188, 'otherNumAffected': 74, 'seriousNumAtRisk': 188, 'deathsNumAffected': 15, 'seriousNumAffected': 37}, {'id': 'EG002', 'title': 'OLE Period: Pamrevlumab', 'description': 'Participants who completed the treatment in DB period and entered in the OLE period, received pamrevlumab 30 mg/kg administered by IV infusion, every 3 weeks for up to 48 weeks.', 'otherNumAtRisk': 86, 'deathsNumAtRisk': 86, 'otherNumAffected': 21, 'seriousNumAtRisk': 86, 'deathsNumAffected': 12, 'seriousNumAffected': 20}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Scleritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hepatic cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypertransaminasaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Empyema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Nasal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pulmonary sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Skin injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Thoracic vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Adenocarcinoma of colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Clear cell renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hepatocellular carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Intestinal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Metastases to liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Tumour haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cervicobrachial syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': "Parkinson's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Vertebrobasilar stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Autoimmune nephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'and mediastinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Chronic respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Idiopathic pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pneumothorax spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Peripheral artery aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'DB Period: Change From Baseline in FVC at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pamrevlumab', 'description': 'Participants received pamrevlumab 30 mg/kg, administered by IV infusion, every 3 weeks, for a total of up to 17 infusions over 48 weeks in the DB period. Participants who completed the treatment in DB period and entered in the OLE period, continued to receive pamrevlumab 30 mg/kg administered by IV infusion, every 3 weeks for up to 48 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received pamrevlumab-matching placebo, administered by IV infusion every 3 weeks for a total of up to 17 infusions over 48 weeks in the DB period. Participants who completed the treatment in DB period and entered in the OLE period, received pamrevlumab 30 mg/kg administered by IV infusion, every 3 weeks for up to 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.30', 'spread': '0.057', 'groupId': 'OG000'}, {'value': '-0.33', 'spread': '0.059', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6579', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.12', 'ciUpperLimit': '0.19', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.077', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 48', 'description': 'FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Least square (LS) mean and standard error (SE) were analyzed using mixed model repeated measures (MMRM).', 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'DB Period: Time to Disease Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pamrevlumab', 'description': 'Participants received pamrevlumab 30 mg/kg, administered by IV infusion, every 3 weeks, for a total of up to 17 infusions over 48 weeks in the DB period. Participants who completed the treatment in DB period and entered in the OLE period, continued to receive pamrevlumab 30 mg/kg administered by IV infusion, every 3 weeks for up to 48 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received pamrevlumab-matching placebo, administered by IV infusion every 3 weeks for a total of up to 17 infusions over 48 weeks in the DB period. Participants who completed the treatment in DB period and entered in the OLE period, received pamrevlumab 30 mg/kg administered by IV infusion, every 3 weeks for up to 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '59.0', 'comment': 'Due to smaller number of participants with an event, lower and upper limit of 95% confidence interval (CI) could not be calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Due to smaller number of participants with an event, median and upper limit of 95% CI could not be calculated.', 'groupId': 'OG001', 'lowerLimit': '49.4', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Week 48', 'description': "Time to disease progression was defined as time from randomization to either the first occurrence of an absolute FVC percent predicted (FVCpp) decline of ≥10% from baseline or death, whichever occurred first. 'Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. For an endpoint in which less than half of the participants have encountered the events, the 'Median Time to Event' might be longer than the reported timeframe of 48 weeks.", 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'DB Period: Change From Baseline in Quantitative Lung Fibrosis (QLF) Volume at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pamrevlumab', 'description': 'Participants received pamrevlumab 30 mg/kg, administered by IV infusion, every 3 weeks, for a total of up to 17 infusions over 48 weeks in the DB period. Participants who completed the treatment in DB period and entered in the OLE period, continued to receive pamrevlumab 30 mg/kg administered by IV infusion, every 3 weeks for up to 48 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received pamrevlumab-matching placebo, administered by IV infusion every 3 weeks for a total of up to 17 infusions over 48 weeks in the DB period. Participants who completed the treatment in DB period and entered in the OLE period, received pamrevlumab 30 mg/kg administered by IV infusion, every 3 weeks for up to 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '255.14', 'spread': '72.028', 'groupId': 'OG000'}, {'value': '269.15', 'spread': '60.898', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 48', 'description': 'The QLF volume is calculated as QLF=total lung capacity volume (TLC) \\* % of quantitative lung fibrosis for fibrosis of the whole lung. LS mean and SE were analyzed using MMRM.', 'unitOfMeasure': 'milliliters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'DB Period: Time to First Occurrence of Any Component of the Clinical Composite Endpoint, Whichever Occurred First', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pamrevlumab', 'description': 'Participants received pamrevlumab 30 mg/kg, administered by IV infusion, every 3 weeks, for a total of up to 17 infusions over 48 weeks in the DB period. Participants who completed the treatment in DB period and entered in the OLE period, continued to receive pamrevlumab 30 mg/kg administered by IV infusion, every 3 weeks for up to 48 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received pamrevlumab-matching placebo, administered by IV infusion every 3 weeks for a total of up to 17 infusions over 48 weeks in the DB period. Participants who completed the treatment in DB period and entered in the OLE period, received pamrevlumab 30 mg/kg administered by IV infusion, every 3 weeks for up to 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Due to smaller number of participants with an event, median and upper limit of 95% CI could not be calculated.', 'groupId': 'OG000', 'lowerLimit': '59.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Due to smaller number of participants with an event, median and 95% CI could not be calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Week 48', 'description': "The components of the clinical composite endpoints included acute idiopathic pulmonary fibrosis (IPF) exacerbation, respiratory hospitalization, or death. 'Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. For an endpoint in which less than half of the participants have encountered the events, the 'Median Time to Event' might be longer than the reported timeframe of 48 weeks.", 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'DB Period: Time to First Acute IPF Exacerbation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pamrevlumab', 'description': 'Participants received pamrevlumab 30 mg/kg, administered by IV infusion, every 3 weeks, for a total of up to 17 infusions over 48 weeks in the DB period. Participants who completed the treatment in DB period and entered in the OLE period, continued to receive pamrevlumab 30 mg/kg administered by IV infusion, every 3 weeks for up to 48 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received pamrevlumab-matching placebo, administered by IV infusion every 3 weeks for a total of up to 17 infusions over 48 weeks in the DB period. Participants who completed the treatment in DB period and entered in the OLE period, received pamrevlumab 30 mg/kg administered by IV infusion, every 3 weeks for up to 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Due to smaller number of participants with an event, data could not be calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Due to smaller number of participants with an event, data could not be calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Week 48', 'description': "'Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. For an endpoint in which less than half of the participants have encountered the events, the 'Median Time to Event' might be longer than the reported timeframe of 48 weeks.", 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'DB Period: Time to All-Cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pamrevlumab', 'description': 'Participants received pamrevlumab 30 mg/kg, administered by IV infusion, every 3 weeks, for a total of up to 17 infusions over 48 weeks in the DB period. Participants who completed the treatment in DB period and entered in the OLE period, continued to receive pamrevlumab 30 mg/kg administered by IV infusion, every 3 weeks for up to 48 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received pamrevlumab-matching placebo, administered by IV infusion every 3 weeks for a total of up to 17 infusions over 48 weeks in the DB period. Participants who completed the treatment in DB period and entered in the OLE period, received pamrevlumab 30 mg/kg administered by IV infusion, every 3 weeks for up to 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Due to smaller number of participants with an event, median and upper limit of 95% CI could not be calculated.', 'groupId': 'OG000', 'lowerLimit': '59.0', 'upperLimit': 'NA'}, {'value': '62.9', 'comment': 'Due to smaller number of participants with an event, lower and upper limit of 95% CI could not be calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Week 48', 'description': "'Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. For an endpoint in which less than half of the participants have encountered the events, the 'Median Time to Event' might be longer than the reported timeframe of 48 weeks.", 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'DB Period: Time to First Respiratory Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pamrevlumab', 'description': 'Participants received pamrevlumab 30 mg/kg, administered by IV infusion, every 3 weeks, for a total of up to 17 infusions over 48 weeks in the DB period. Participants who completed the treatment in DB period and entered in the OLE period, continued to receive pamrevlumab 30 mg/kg administered by IV infusion, every 3 weeks for up to 48 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received pamrevlumab-matching placebo, administered by IV infusion every 3 weeks for a total of up to 17 infusions over 48 weeks in the DB period. Participants who completed the treatment in DB period and entered in the OLE period, received pamrevlumab 30 mg/kg administered by IV infusion, every 3 weeks for up to 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Due to smaller number of participants with an event, data could not be calulated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Due to smaller number of participants with an event, data could not be calulated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Week 48', 'description': "'Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. For an endpoint in which less than half of the participants have encountered the events, the 'Median Time to Event' might be longer than the reported timeframe of 48 weeks.", 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomized participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pamrevlumab', 'description': 'Participants received pamrevlumab 30 milligrams (mg)/kilogram (kg), administered by intravenous (IV) infusion, every 3 weeks, for a total of up to 17 infusions over 48 weeks in the DB period. Participants who completed the treatment in DB period and entered in the OLE period, continued to receive pamrevlumab 30 mg/kg administered by IV infusion, every 3 weeks for up to 48 weeks.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants received pamrevlumab-matching placebo, administered by IV infusion every 3 weeks for a total of up to 17 infusions over 48 weeks in the DB period. Participants who completed the treatment in DB period and entered in the OLE period, received pamrevlumab 30 mg/kg administered by IV infusion, every 3 weeks for up to 48 weeks.'}], 'periods': [{'title': 'DB Period (48 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '184'}, {'groupId': 'FG001', 'numSubjects': '188'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '183'}, {'groupId': 'FG001', 'numSubjects': '188'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '137'}, {'groupId': 'FG001', 'numSubjects': '132'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Investigator Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '101'}]}, {'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Lung Transplant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Participant Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}, {'title': 'OLE Period (48 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '45'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'The study included a Double-blind (DB) Period and an Open-label Extension (OLE) Period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'BG000'}, {'value': '188', 'groupId': 'BG001'}, {'value': '372', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pamrevlumab', 'description': 'Participants received pamrevlumab 30 mg/kg, administered by IV infusion, every 3 weeks, for a total of up to 17 infusions over 48 weeks in the DB period. Participants who completed the treatment in DB period and entered in the OLE period, continued to receive pamrevlumab 30 mg/kg administered by IV infusion, every 3 weeks for up to 48 weeks.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants received pamrevlumab-matching placebo, administered by IV infusion every 3 weeks for a total of up to 17 infusions over 48 weeks in the DB period. Participants who completed the treatment in DB period and entered in the OLE period, received pamrevlumab 30 mg/kg administered by IV infusion, every 3 weeks for up to 48 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'BG000'}, {'value': '188', 'groupId': 'BG001'}, {'value': '372', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '70.2', 'spread': '7.8', 'groupId': 'BG000'}, {'value': '70.1', 'spread': '8.2', 'groupId': 'BG001'}, {'value': '70.1', 'spread': '8.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'BG000'}, {'value': '188', 'groupId': 'BG001'}, {'value': '372', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '139', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '283', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'BG000'}, {'value': '188', 'groupId': 'BG001'}, {'value': '372', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '266', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'BG000'}, {'value': '188', 'groupId': 'BG001'}, {'value': '372', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '225', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Forced Vital Capacity (FVC)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'BG000'}, {'value': '187', 'groupId': 'BG001'}, {'value': '371', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.4811', 'spread': '0.6477', 'groupId': 'BG000'}, {'value': '2.5097', 'spread': '0.6573', 'groupId': 'BG001'}, {'value': '2.4955', 'spread': '0.6518', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters.', 'unitOfMeasure': 'liters', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': "'Number analyzed' = participants evaluable for this baseline measure."}], 'populationDescription': 'The intent-to-treat (ITT) population included all randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-01-09', 'size': 1025995, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-06-26T13:54', 'hasProtocol': True}, {'date': '2023-10-16', 'size': 899633, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-06-26T13:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "During the Open-label extension phase, all participants will receive pamrevlumab in an open-label manner. No unblinding of participant's treatment assignment in the treatment phase (main study) will occur for purposes of open-label extension participation."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 372}}, 'statusModule': {'whyStopped': 'Sponsor Decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-09-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-08', 'studyFirstSubmitDate': '2020-06-03', 'resultsFirstSubmitDate': '2024-06-26', 'studyFirstSubmitQcDate': '2020-06-03', 'lastUpdatePostDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-08', 'studyFirstPostDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DB Period: Change From Baseline in FVC at Week 48', 'timeFrame': 'Baseline, Week 48', 'description': 'FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Least square (LS) mean and standard error (SE) were analyzed using mixed model repeated measures (MMRM).'}], 'secondaryOutcomes': [{'measure': 'DB Period: Time to Disease Progression', 'timeFrame': 'Up to Week 48', 'description': "Time to disease progression was defined as time from randomization to either the first occurrence of an absolute FVC percent predicted (FVCpp) decline of ≥10% from baseline or death, whichever occurred first. 'Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. For an endpoint in which less than half of the participants have encountered the events, the 'Median Time to Event' might be longer than the reported timeframe of 48 weeks."}, {'measure': 'DB Period: Change From Baseline in Quantitative Lung Fibrosis (QLF) Volume at Week 48', 'timeFrame': 'Baseline, Week 48', 'description': 'The QLF volume is calculated as QLF=total lung capacity volume (TLC) \\* % of quantitative lung fibrosis for fibrosis of the whole lung. LS mean and SE were analyzed using MMRM.'}, {'measure': 'DB Period: Time to First Occurrence of Any Component of the Clinical Composite Endpoint, Whichever Occurred First', 'timeFrame': 'Up to Week 48', 'description': "The components of the clinical composite endpoints included acute idiopathic pulmonary fibrosis (IPF) exacerbation, respiratory hospitalization, or death. 'Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. For an endpoint in which less than half of the participants have encountered the events, the 'Median Time to Event' might be longer than the reported timeframe of 48 weeks."}, {'measure': 'DB Period: Time to First Acute IPF Exacerbation', 'timeFrame': 'Up to Week 48', 'description': "'Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. For an endpoint in which less than half of the participants have encountered the events, the 'Median Time to Event' might be longer than the reported timeframe of 48 weeks."}, {'measure': 'DB Period: Time to All-Cause Mortality', 'timeFrame': 'Up to Week 48', 'description': "'Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. For an endpoint in which less than half of the participants have encountered the events, the 'Median Time to Event' might be longer than the reported timeframe of 48 weeks."}, {'measure': 'DB Period: Time to First Respiratory Hospitalization', 'timeFrame': 'Up to Week 48', 'description': "'Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. For an endpoint in which less than half of the participants have encountered the events, the 'Median Time to Event' might be longer than the reported timeframe of 48 weeks."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Idiopathic Pulmonary Fibrosis', 'IPF', 'Idiopathic Interstitial Pneumonia', 'Interstitial Lung Disease', 'Lung Fibrosis'], 'conditions': ['Idiopathic Pulmonary Fibrosis']}, 'descriptionModule': {'briefSummary': 'This is a Phase 3 trial to evaluate the efficacy and safety of 30 milligrams (mg)/kilogram (kg) intravenous (IV) infusions of pamrevlumab administered every 3 weeks as compared to placebo in participants with Idiopathic Pulmonary Fibrosis (IPF). There is a 48-week randomized treatment phase followed by an optional, open-label extension phase.', 'detailedDescription': "The intent of this study is to evaluate the efficacy and safety of pamrevlumab as monotherapy in participants with IPF. Participants who are not being treated with approved IPF therapies (that is, nintedanib or pirfenidone) may be eligible for screening. Examples of reasons participants may not be treated with approved IPF therapies include but are not limited to:\n\n* Intolerant or not responsive to approved IPF therapies\n* Ineligible to receive these therapies\n* Participant voluntarily declines to receive approved IPF therapies after being fully informed of the potential benefits/risks\n\nNOTE: No participant should discontinue an approved IPF therapy for the purpose of enrolling in this study.\n\nDuring the 48-week treatment phase of the study, co-administration of an approved IPF therapy (such as, pirfenidone or nintedanib) is acceptable if clinically indicated in the Investigator's opinion, after assessment of potential risks/benefits of such combination with blinded study treatment.\n\nParticipants who complete the 48-week study will be eligible for an optional, open-label extension phase with continued access to pamrevlumab, regardless of their randomized assignment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Diagnosis of IPF as defined by American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association (ATS/ERS/JRS/ALAT) guidelines within the past 7 years prior to study participation.\n2. High-resolution computed tomography (HRCT) scan at Screening, with ≥10% to \\<50% parenchymal fibrosis (reticulation) and \\<25% honeycombing.\n3. FVCpp value \\>45% and \\<95% at Screening and Day 1 (prior to randomization).\n4. Diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted ≥25% and ≤90%.\n5. Not currently receiving treatment for IPF with an approved therapy for IPF (such as, pirfenidone or nintedanib) for any reason, including prior intolerance or lack of response to an approved IPF therapy, or choice to forego treatment with an approved IPF therapy after a full discussion with the Investigator regarding risks/benefits of such therapy.\n\nKey Exclusion Criteria:\n\n1. Previous exposure to pamrevlumab.\n2. Evidence of significant obstructive lung disease, as evidenced by spirometry or HRCT.\n3. Female participants who are pregnant or nursing.\n4. Smoking within 3 months of Screening and/or unwilling to avoid smoking throughout the study.\n5. Interstitial lung disease other than IPF.\n6. Sustained improvement in the severity of IPF during the 12 months prior to screening.\n7. Other types of respiratory diseases that, in the opinion of the Investigator, would impact the primary protocol endpoint or otherwise preclude participation in the study, including diseases of the airways, lung parenchyma, pleural space, mediastinum, diaphragm, or chest wall.\n8. Certain medical conditions, that, in the opinion of the Investigator, would impact the primary protocol endpoint or otherwise preclude participation in the study (such as, myocardial infarction/stroke, severe chronic heart failure, pulmonary hypertension, or cancers).\n9. Acute IPF exacerbation during Screening or Randomization including hospitalization due to acute IPF exacerbation within 4 weeks prior to or during screening.\n10. Use of any investigational drugs or unapproved therapies, or participation in any clinical trial with an investigational new drug within 30 days prior to screening. Or use of approved IPF therapies (such as, pirfenidone or nintedanib) within 1 week prior to screening.\n11. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies, or to any component of the excipient.'}, 'identificationModule': {'nctId': 'NCT04419558', 'briefTitle': 'Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)', 'organization': {'class': 'INDUSTRY', 'fullName': 'FibroGen'}, 'officialTitle': 'Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects With Idiopathic Pulmonary Fibrosis (IPF)', 'orgStudyIdInfo': {'id': 'FGCL-3019-095'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pamrevlumab', 'description': 'Treatment phase: Pamrevlumab 30 mg/kg administered by IV infusion, every 3 weeks, for a total of up to 17 infusions over 48 weeks.\n\nOpen-label extension phase: Pamrevlumab 30 mg/kg administered by intravenous infusion, every 3 weeks for up to 48 weeks', 'interventionNames': ['Drug: Pamrevlumab']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo', 'description': 'Pamrevlumab-matching placebo administered by IV infusion every 3 weeks for a total of up to 17 infusions over 48 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Pamrevlumab', 'type': 'DRUG', 'otherNames': ['FG-3019'], 'description': 'Sterile solution for injection', 'armGroupLabels': ['Pamrevlumab']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Sterile solution for injection', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'UAB Lung Health Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UC San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80206', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'National Jewish Health', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33765', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'St. Francis Medical Center', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '34741', 'city': 'Kissimmee', 'state': 'Florida', 'country': 'United States', 'facility': 'Pulmonary Disease Specialists d/b/a PDS Research', 'geoPoint': {'lat': 28.30468, 'lon': -81.41667}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'TGH/USF Center for Advanced Lung Disease and Lung Transplant', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30324', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University/The Emory Clinic', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'The University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'The General Hospital Corporation d/b/a Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '49504', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Spectrum Health', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27403', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'PulmonIx, LLC', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '43221', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Milton S Hershey Medical 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