Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-02-23 @ 8:06 PM
Study NCT ID:
NCT01629667
Status:
TERMINATED
Last Update Posted:
2017-05-15
First Post:
2012-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase 2, Randomized Dose-ranging Study to Evaluate the Efficacy of Tralokinumab in Adults 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C574065', 'term': 'tralokinumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '1-877-240-9479', 'title': 'AstraZeneca Clinical Study Information Center', 'organization': 'MedImmune, LLC'}, 'certainAgreement': {'otherDetails': 'MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Study was early terminated due to lack of efficacy.'}}, 'adverseEventsModule': {'timeFrame': 'From the start of study treatment through Week 88 or at the time of early termination from the study', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.', 'otherNumAtRisk': 57, 'otherNumAffected': 51, 'seriousNumAtRisk': 57, 'seriousNumAffected': 13}, {'id': 'EG001', 'title': 'Tralokinumab 400 Milligram (mg)', 'description': 'Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.', 'otherNumAtRisk': 57, 'otherNumAffected': 45, 'seriousNumAtRisk': 57, 'seriousNumAffected': 16}, {'id': 'EG002', 'title': 'Tralokinumab 800 mg', 'description': 'Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.', 'otherNumAtRisk': 59, 'otherNumAffected': 50, 'seriousNumAtRisk': 59, 'seriousNumAffected': 17}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 20, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 19, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 22, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 7, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 16, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 20, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 14, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 12, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 12, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 9, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 28, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 12, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 14, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Idiopathic pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 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'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pruritus allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.'}, {'id': 'OG001', 'title': 'Tralokinumab 400 Milligram (mg)', 'description': 'Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.'}, {'id': 'OG002', 'title': 'Tralokinumab 800 mg', 'description': 'Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.'}], 'classes': [{'title': 'Baseline (n=57,57,59)', 'categories': [{'measurements': [{'value': '70.30', 'spread': '12.04', 'groupId': 'OG000'}, {'value': '68.54', 'spread': '14.26', 'groupId': 'OG001'}, {'value': '70.60', 'spread': '13.37', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 52 (n=36,32,35)', 'categories': [{'measurements': [{'value': '-4.08', 'spread': '6.85', 'groupId': 'OG000'}, {'value': '-6.10', 'spread': '6.98', 'groupId': 'OG001'}, {'value': '-6.07', 'spread': '5.14', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.140', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.77', 'ciLowerLimit': '-4.13', 'ciUpperLimit': '0.59', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.234', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.41', 'ciLowerLimit': '-3.73', 'ciUpperLimit': '0.91', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 52', 'description': 'Forced vital capacity (FVC) is a standard pulmonary function test used to monitor disease progression in IPF. FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in litres. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) \\* 100%.', 'unitOfMeasure': 'Percentage of predicted FVC', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "n" is number of participants analysed at given time point.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.'}, {'id': 'OG001', 'title': 'Tralokinumab 400 Milligram (mg)', 'description': 'Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.'}, {'id': 'OG002', 'title': 'Tralokinumab 800 mg', 'description': 'Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.'}], 'classes': [{'title': 'TEAE', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}]}, {'title': 'TESAE', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the start of study treatment through Week 88', 'description': 'Any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received Tralokinumab. Treatment-emergent were events between administration of investigational product and Week 88 that were absent before treatment or that worsened relative to pretreatment state.', 'unitOfMeasure': 'Participant', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received any study investigational product and participants were analysed according to the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.'}, {'id': 'OG001', 'title': 'Tralokinumab 400 Milligram (mg)', 'description': 'Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.'}, {'id': 'OG002', 'title': 'Tralokinumab 800 mg', 'description': 'Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.'}], 'classes': [{'title': 'Anaemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Haemoglobin decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypovolaemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'ALT increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'AST increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Blood glucose increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Diabetes mellitus', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Diabetes mellitus inadequate control', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Type 2 diabetes mellitus', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Gout', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Hepatic steatosis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Liver function test abnormal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'GGT increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Hyperlipidaemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Hyperglycaemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypokalaemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypertriglyceridaemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hyponatraemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypophosphataemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Iron deficiency', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Vitamin D deficiency', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Vitamin D decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the start of study treatment through Week 88', 'description': 'An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent were events between administration of investigational product and Week 88 that were absent before treatment or that worsened relative to pre-treatment state. Laboratory evaluations (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.', 'unitOfMeasure': 'Participant', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received any study investigational product and participants were analysed according to the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.'}, {'id': 'OG001', 'title': 'Tralokinumab 400 Milligram (mg)', 'description': 'Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.'}, {'id': 'OG002', 'title': 'Tralokinumab 800 mg', 'description': 'Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.'}], 'classes': [{'title': 'Hypertension', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Pulmonary hypertension', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Pyrexia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Hypotension', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Blood pressure increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Atrial fibrillation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Atrial flutter', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Arrhythmia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Bradycardia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Heart rate increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Palpitations', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Sinus tachycardia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Supraventricular tachycardia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Tachyarrhythmia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Weight decreased', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the start of study treatment through Week 88', 'description': 'Vital signs parameters included heart rate, blood pressure, temperature, weight, pulse oximetry and respiratory rate. Treatment-emergent were events between administration of investigational product and Week 88 that were absent before treatment or that worsened relative to pre-treatment state.', 'unitOfMeasure': 'Participant', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received any study investigational product and participants were analysed according to the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Electrocardiogram Abnormalities Reported as Treatment-emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.'}, {'id': 'OG001', 'title': 'Tralokinumab 400 Milligram (mg)', 'description': 'Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.'}, {'id': 'OG002', 'title': 'Tralokinumab 800 mg', 'description': 'Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the start of study treatment through Week 88', 'description': 'AEs observed in participants with clinically significant ECG abnormalities were assessed. Tricuspid valve incompetence was the only abnormality reported as TEAE. ECG parameters included heart rate, PR, QRS, QT, and QTc intervals. Treatment-emergent were events between administration of investigational product and Week 88 that were absent before treatment or that worsened relative to pre-treatment state.', 'unitOfMeasure': 'Participant', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received any study investigational product and participants were analysed according to the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Disease Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.'}, {'id': 'OG001', 'title': 'Tralokinumab 400 Milligram (mg)', 'description': 'Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.'}, {'id': 'OG002', 'title': 'Tralokinumab 800 mg', 'description': 'Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.'}], 'classes': [{'title': 'At Week 52', 'categories': [{'measurements': [{'value': '35.1', 'groupId': 'OG000'}, {'value': '35.1', 'groupId': 'OG001'}, {'value': '28.8', 'groupId': 'OG002'}]}]}, {'title': 'At Week 72', 'categories': [{'measurements': [{'value': '42.1', 'groupId': 'OG000'}, {'value': '42.1', 'groupId': 'OG001'}, {'value': '44.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52 and 72', 'description': 'Progression-free Survival (PFS) was used to evaluate disease progression and the percentage of participants with disease progression. A participant was classified as having disease progression if at least one of the following criteria were met:• Adjudicated respiratory-related mortality. •Adjudicated hospitalization due to IPF exacerbation. •Confirmed decline in percent-predicted FVC of greater than or equal to (\\>=) 10%. •Confirmed decline in 6 minute walk test (6MWT) \\>= 50 meters.', 'unitOfMeasure': 'Percentage of Participant', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Haemoglobin (Hb) Corrected Percent-predicted Diffusion Capacity for Carbon Monoxide (DLco) Through Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.'}, {'id': 'OG001', 'title': 'Tralokinumab 400 Milligram (mg)', 'description': 'Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.'}, {'id': 'OG002', 'title': 'Tralokinumab 800 mg', 'description': 'Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.'}], 'classes': [{'title': 'Baseline (n=57,57,59)', 'categories': [{'measurements': [{'value': '46.962', 'spread': '13.796', 'groupId': 'OG000'}, {'value': '49.389', 'spread': '16.029', 'groupId': 'OG001'}, {'value': '47.509', 'spread': '12.524', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 52 (n=34,30,32)', 'categories': [{'measurements': [{'value': '-3.963', 'spread': '8.777', 'groupId': 'OG000'}, {'value': '-5.233', 'spread': '9.597', 'groupId': 'OG001'}, {'value': '-6.356', 'spread': '8.588', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 72 (n=23,21,22)', 'categories': [{'measurements': [{'value': '-8.322', 'spread': '9.538', 'groupId': 'OG000'}, {'value': '-9.962', 'spread': '10.362', 'groupId': 'OG001'}, {'value': '-10.382', 'spread': '12.372', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52 and 72', 'description': 'The single breath technique was used to determine the DLco. The test was performed by qualified pulmonary function technicians with experience performing this study. Acceptable test criteria included:• An inspiratory volume of more than 85% of vital capacity. • A stable breath hold of 10 seconds (+/- 2 seconds) with no leaks, Valsalva or Mueller maneuvers. • Expiration in less than 4 seconds with appropriate clearance of dead space. The average of the two best acceptable maneuvers was used. There must be a minimum of 4 minutes between the performances of each test.', 'unitOfMeasure': 'Percent predicted DLco', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "n" is number of participants analysed at given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 6 Minute Walk Test (6MWT) Distance Through Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.'}, {'id': 'OG001', 'title': 'Tralokinumab 400 Milligram (mg)', 'description': 'Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.'}, {'id': 'OG002', 'title': 'Tralokinumab 800 mg', 'description': 'Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.'}], 'classes': [{'title': 'Baseline (n=55,57,56)', 'categories': [{'measurements': [{'value': '391.07', 'spread': '112.06', 'groupId': 'OG000'}, {'value': '391.69', 'spread': '102.46', 'groupId': 'OG001'}, {'value': '383.22', 'spread': '93.99', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 52 (n=31,31,29)', 'categories': [{'measurements': [{'value': '19.49', 'spread': '71.36', 'groupId': 'OG000'}, {'value': '22.96', 'spread': '52.38', 'groupId': 'OG001'}, {'value': '-12.40', 'spread': '55.81', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 72 (n=21,24,19)', 'categories': [{'measurements': [{'value': '18.76', 'spread': '54.83', 'groupId': 'OG000'}, {'value': '7.85', 'spread': '78.12', 'groupId': 'OG001'}, {'value': '-30.25', 'spread': '78.07', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52 and 72', 'description': 'The 6MWT measures the distance that a participant can walk on a measured, flat hard surface in a period of 6 minutes. The 6MWT evaluates the global and integrated responses of all body systems involved during walking.', 'unitOfMeasure': 'Meter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "n" is number of participants analysed at given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Oxygen Saturation by Pulse Oximetry at Week 68', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.'}, {'id': 'OG001', 'title': 'Tralokinumab 400 Milligram (mg)', 'description': 'Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.'}, {'id': 'OG002', 'title': 'Tralokinumab 800 mg', 'description': 'Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.'}], 'classes': [{'title': 'Baseline (n=57,57,59)', 'categories': [{'measurements': [{'value': '96.2', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '95.6', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '95.4', 'spread': '2.9', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 52 (n=30,28,29)', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '1.7', 'groupId': 'OG001'}, {'value': '-0.7', 'spread': '2.7', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 68 (n=23,25,22)', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '2.4', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '2.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 68', 'description': 'Participants transcutaneous oxygen saturation were observed by pulse oximetry.', 'unitOfMeasure': 'Percent of oxygen saturation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "n" is number of participants analysed at given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Lung Volumes Through Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.'}, {'id': 'OG001', 'title': 'Tralokinumab 400 Milligram (mg)', 'description': 'Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.'}, {'id': 'OG002', 'title': 'Tralokinumab 800 mg', 'description': 'Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.'}], 'classes': [{'title': 'Baseline (n=53,50,53)', 'categories': [{'measurements': [{'value': '4.105', 'spread': '0.905', 'groupId': 'OG000'}, {'value': '3.870', 'spread': '0.905', 'groupId': 'OG001'}, {'value': '4.060', 'spread': '1.192', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 52 (n=32,29,28)', 'categories': [{'measurements': [{'value': '0.891', 'spread': '5.150', 'groupId': 'OG000'}, {'value': '-0.212', 'spread': '0.645', 'groupId': 'OG001'}, {'value': '-0.264', 'spread': '0.442', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 72 (n=24,22,19)', 'categories': [{'measurements': [{'value': '-0.139', 'spread': '0.635', 'groupId': 'OG000'}, {'value': '-0.274', 'spread': '0.705', 'groupId': 'OG001'}, {'value': '-0.417', 'spread': '0.468', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52 and 72', 'description': 'Lung volumes were evaluated by total lung capacity (TLC), residual volume (RV), and vital capacity (VC). Lung volumes were determined by body plethysmography.', 'unitOfMeasure': 'Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "n" is number of participants analysed at given time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Idiopathic Pulmonary Fibrosis (IPF) Exacerbations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.'}, {'id': 'OG001', 'title': 'Tralokinumab 400 Milligram (mg)', 'description': 'Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.'}, {'id': 'OG002', 'title': 'Tralokinumab 800 mg', 'description': 'Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.'}], 'classes': [{'title': 'At Week 52', 'categories': [{'measurements': [{'value': '12.3', 'groupId': 'OG000'}, {'value': '12.3', 'groupId': 'OG001'}, {'value': '8.5', 'groupId': 'OG002'}]}]}, {'title': 'At Week 72', 'categories': [{'measurements': [{'value': '12.3', 'groupId': 'OG000'}, {'value': '17.5', 'groupId': 'OG001'}, {'value': '11.9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52 and 72', 'description': 'The IPF exacerbations is defined as an acute, clinically significant, deterioration of unidentifiable cause in a participant with underlying IPF. Exacerbations of IPF were adjudicated according to the protocol definition by an independent committee as follows:\n\n1\\. Confirmed acute IPF exacerbation, 2. Suspected acute IPF exacerbation, 3. Not an IPF exacerbation with an alternative diagnosis provided if possible, and 4. Undetermined due to insufficient information.', 'unitOfMeasure': 'Percentage of participant', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adjudicated Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.'}, {'id': 'OG001', 'title': 'Tralokinumab 400 Milligram (mg)', 'description': 'Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.'}, {'id': 'OG002', 'title': 'Tralokinumab 800 mg', 'description': 'Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.'}], 'classes': [{'title': 'At Week 52', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000'}, {'value': '7.0', 'groupId': 'OG001'}, {'value': '5.1', 'groupId': 'OG002'}]}]}, {'title': 'At Week 72', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000'}, {'value': '8.8', 'groupId': 'OG001'}, {'value': '5.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52 and 72', 'description': 'Participants all cause mortality were observed. Events that resulted in participant death were adjudicated into respiratory-related mortality or all other cause mortality by an independent committee.', 'unitOfMeasure': 'Percentage of participant', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adjudicated Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.'}, {'id': 'OG001', 'title': 'Tralokinumab 400 Milligram (mg)', 'description': 'Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.'}, {'id': 'OG002', 'title': 'Tralokinumab 800 mg', 'description': 'Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.'}], 'classes': [{'title': 'At Week 52', 'categories': [{'measurements': [{'value': '21.1', 'groupId': 'OG000'}, {'value': '24.6', 'groupId': 'OG001'}, {'value': '16.9', 'groupId': 'OG002'}]}]}, {'title': 'At Week 72', 'categories': [{'measurements': [{'value': '21.1', 'groupId': 'OG000'}, {'value': '24.6', 'groupId': 'OG001'}, {'value': '23.7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52 and 72', 'description': 'Participants who were hospitalized due to IPF exacerbation were observed. All events that resulted in the hospitalization of participants were adjudicated by an independent committee to determine if the event was due to an IPF exacerbation as follows: 1. Exacerbation or progression of IPF, 2. Result of a complication of IPF, 3. Not related to IPF (alternative diagnosis provided), and 4. Undetermined due to insufficient information.', 'unitOfMeasure': 'Percentage of participant', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Through Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.'}, {'id': 'OG001', 'title': 'Tralokinumab 400 Milligram (mg)', 'description': 'Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.'}, {'id': 'OG002', 'title': 'Tralokinumab 800 mg', 'description': 'Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.'}], 'classes': [{'title': 'Baseline (n=57,57,59)', 'categories': [{'measurements': [{'value': '2.199', 'spread': '0.500', 'groupId': 'OG000'}, {'value': '2.025', 'spread': '0.495', 'groupId': 'OG001'}, {'value': '2.144', 'spread': '0.564', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 52 (n=36,32,35)', 'categories': [{'measurements': [{'value': '-0.120', 'spread': '0.259', 'groupId': 'OG000'}, {'value': '-0.148', 'spread': '0.200', 'groupId': 'OG001'}, {'value': '-0.179', 'spread': '0.134', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 72 (n=26,26,23)', 'categories': [{'measurements': [{'value': '-0.260', 'spread': '0.261', 'groupId': 'OG000'}, {'value': '-0.152', 'spread': '0.317', 'groupId': 'OG001'}, {'value': '-0.222', 'spread': '0.166', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52 and 72', 'description': 'FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.', 'unitOfMeasure': 'Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "n" is number of participants analysed at given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Percent-predicted FEV1 Through Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.'}, {'id': 'OG001', 'title': 'Tralokinumab 400 Milligram (mg)', 'description': 'Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.'}, {'id': 'OG002', 'title': 'Tralokinumab 800 mg', 'description': 'Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.'}], 'classes': [{'title': 'Baseline (n=57,57,59)', 'categories': [{'measurements': [{'value': '78.56', 'spread': '13.05', 'groupId': 'OG000'}, {'value': '77.88', 'spread': '14.88', 'groupId': 'OG001'}, {'value': '78.94', 'spread': '14.58', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 52 (n=36,32,35)', 'categories': [{'measurements': [{'value': '-4.16', 'spread': '8.50', 'groupId': 'OG000'}, {'value': '-5.78', 'spread': '8.11', 'groupId': 'OG001'}, {'value': '-7.01', 'spread': '5.33', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 72 (n=26,26,23)', 'categories': [{'measurements': [{'value': '-8.77', 'spread': '8.99', 'groupId': 'OG000'}, {'value': '-6.42', 'spread': '11.13', 'groupId': 'OG001'}, {'value': '-8.61', 'spread': '6.61', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52 and 72', 'description': 'FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Predicted FEV1 is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FEV1 = (observed value)/(predicted value) \\* 100%.', 'unitOfMeasure': 'Percent of predicted FEV1', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "n" is number of participants analysed at given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Absolute Forced Vital Capacity (FVC) Through Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.'}, {'id': 'OG001', 'title': 'Tralokinumab 400 Milligram (mg)', 'description': 'Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.'}, {'id': 'OG002', 'title': 'Tralokinumab 800 mg', 'description': 'Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.'}], 'classes': [{'title': 'Baseline (n=57,57,59)', 'categories': [{'measurements': [{'value': '2.662', 'spread': '0.649', 'groupId': 'OG000'}, {'value': '2.406', 'spread': '0.664', 'groupId': 'OG001'}, {'value': '2.593', 'spread': '0.711', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 52 (n=36,32,35)', 'categories': [{'measurements': [{'value': '-0.162', 'spread': '0.278', 'groupId': 'OG000'}, {'value': '-0.205', 'spread': '0.224', 'groupId': 'OG001'}, {'value': '-0.209', 'spread': '0.168', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 72 (n=26,26,23)', 'categories': [{'measurements': [{'value': '-0.322', 'spread': '0.297', 'groupId': 'OG000'}, {'value': '-0.186', 'spread': '0.325', 'groupId': 'OG001'}, {'value': '-0.282', 'spread': '0.242', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52 and 72', 'description': 'Forced vital capacity (FVC) is a standard pulmonary function test used to monitor disease progression in IPF. FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in litres.', 'unitOfMeasure': 'Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "n" is number of participants analysed at given time point.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinical Global Impression of Severity Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.'}, {'id': 'OG001', 'title': 'Tralokinumab 400 Milligram (mg)', 'description': 'Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.'}, {'id': 'OG002', 'title': 'Tralokinumab 800 mg', 'description': 'Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.'}], 'classes': [{'title': 'Very mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Very severe', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 72', 'description': "The CGI-S is a single, clinician completed, item designed to capture the clinician's impression of the participants IPF severity. Clinicians were asked to consider their experience in this participant population and rate the overall IPF severity of the participant using a 5-point scale (1 = very mild, 5 = very severe).", 'unitOfMeasure': 'Participant', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "N" is number of participants analysed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinical Global Impression of Change Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.'}, {'id': 'OG001', 'title': 'Tralokinumab 400 Milligram (mg)', 'description': 'Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.'}, {'id': 'OG002', 'title': 'Tralokinumab 800 mg', 'description': 'Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.'}], 'classes': [{'title': 'Very much improved', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Much improved', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Slightly improved', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Slightly worse', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Much worse', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Very much worse', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 72', 'description': 'The CGI-C is a single, clinician completed, item designed to capture the clinicians overall impression of change in IPF severity from the baseline state at Screening. Clinicians were asked to rate the participants IPF severity relative to their state at baseline using a 7-point scale (-3 = very much worse, 0 = no change, about the same, 3 = very much improved).', 'unitOfMeasure': 'Participant', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "N" is number of participants analysed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ) Total Score at Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.'}, {'id': 'OG001', 'title': 'Tralokinumab 400 Milligram (mg)', 'description': 'Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.'}, {'id': 'OG002', 'title': 'Tralokinumab 800 mg', 'description': 'Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.'}], 'classes': [{'title': 'Baseline (n=56,55,58)', 'categories': [{'measurements': [{'value': '40.9', 'spread': '22.8', 'groupId': 'OG000'}, {'value': '36.5', 'spread': '21.0', 'groupId': 'OG001'}, {'value': '45.9', 'spread': '20.4', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 72 (n=24,21,21)', 'categories': [{'measurements': [{'value': '12.9', 'spread': '14.7', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '18.0', 'groupId': 'OG001'}, {'value': '10.9', 'spread': '23.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 72', 'description': 'The UCSD SOBQ is a 24-item questionnaire designed to capture patient-reported shortness of breath. Respondents were asked to rate their breathlessness during 21 activities of daily living using a 6-point scale (0 = not at all breathless, 5 = maximally breathless or too breathless to do this activity). In addition to the 21 activity items, the UCSD SOBQ includes 3 additional questions about limitations due to shortness of breath, fear of harm from overexertion, and fear of shortness of breath. The UCSD SOBQ was scored by summing responses across all 24 items to form a total score. Scores range from 0-120 with higher scores indicative of greater shortness of breath.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "n" is number of participants analysed at given time point.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 72", 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.'}, {'id': 'OG001', 'title': 'Tralokinumab 400 Milligram (mg)', 'description': 'Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.'}, {'id': 'OG002', 'title': 'Tralokinumab 800 mg', 'description': 'Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.'}], 'classes': [{'title': 'Baseline (n=57,57,59)', 'categories': [{'measurements': [{'value': '47.24', 'spread': '18.86', 'groupId': 'OG000'}, {'value': '44.80', 'spread': '18.91', 'groupId': 'OG001'}, {'value': '51.39', 'spread': '15.64', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 72 (n=24,24,23)', 'categories': [{'measurements': [{'value': '2.91', 'spread': '14.92', 'groupId': 'OG000'}, {'value': '3.16', 'spread': '15.11', 'groupId': 'OG001'}, {'value': '3.38', 'spread': '14.88', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 72', 'description': 'The SGRQ is a 50-item Patient-reported outcome (PRO) instrument developed to measure respiratory-related health status via 76 weighted responses. The SGRQ is divided into two parts. Part 1 asks respondents to consider the last 3 months and report on their respiratory symptoms using 5-point Likert scales. Part 2 asks respondents to consider their current state and respond to a series of dichotomous yes/no items related to their activities (activities that cause or were limited by breathlessness) and impacts (social functioning, psychological disturbances resulting from airways disease). Total scores and domain scores (symptoms, activities, and impact on daily life) were scored from 0-100, where lower scores indicate better health status.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "n" is number of participants analysed at given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Exacerbations of Chronic Pulmonary Disease (EXACT IPF) Total Score Through Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.'}, {'id': 'OG001', 'title': 'Tralokinumab 400 Milligram (mg)', 'description': 'Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.'}, {'id': 'OG002', 'title': 'Tralokinumab 800 mg', 'description': 'Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.'}], 'classes': [{'title': 'Baseline (n=55,51,56)', 'categories': [{'measurements': [{'value': '16.24', 'spread': '9.44', 'groupId': 'OG000'}, {'value': '15.87', 'spread': '8.38', 'groupId': 'OG001'}, {'value': '17.89', 'spread': '9.72', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 52 (n=31,27,30)', 'categories': [{'measurements': [{'value': '1.47', 'spread': '5.75', 'groupId': 'OG000'}, {'value': '1.61', 'spread': '7.21', 'groupId': 'OG001'}, {'value': '1.40', 'spread': '10.18', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 72 (n=23,23,20)', 'categories': [{'measurements': [{'value': '1.95', 'spread': '7.46', 'groupId': 'OG000'}, {'value': '0.63', 'spread': '7.50', 'groupId': 'OG001'}, {'value': '1.81', 'spread': '10.00', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52 and 72', 'description': 'The EXACT-IPF is a 14-item daily dairy used to capture the IPF related symptoms completed by the participants using an eDiary. The EXACT-IPF total score is the sum of all items ranged from 1 to 14. EXACT-IPF is an interval-level scale ranging from 0 to 100, where the higher scores indicate more severe condition. The EXACT-IPF used Likert scales (with 3 to 6 response options each) to capture participant reported IPF-related symptoms. The scores are the simple sum of item responses for each domain or single item.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "n" is number of participants analysed at given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in European Quality of Life-5-Dimension 3 Level Version (EQ-5D-3L) (Including Visual Analog Scale [VAS]) at Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.'}, {'id': 'OG001', 'title': 'Tralokinumab 400 Milligram (mg)', 'description': 'Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.'}, {'id': 'OG002', 'title': 'Tralokinumab 800 mg', 'description': 'Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.'}], 'classes': [{'title': 'Baseline (n=57,57,59)', 'categories': [{'measurements': [{'value': '70.5', 'spread': '19.1', 'groupId': 'OG000'}, {'value': '70.5', 'spread': '18.1', 'groupId': 'OG001'}, {'value': '66.6', 'spread': '14.9', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 72 (n=24,24,23)', 'categories': [{'measurements': [{'value': '-3.0', 'spread': '17.9', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '20.9', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '14.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 72', 'description': "The EQ-5D-3L is a standardized PRO used to capture respondent's general health status. The questionnaire assesses 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 response options (no problem, some or moderate problems, and unable or extreme problems) that reflect increasing levels of difficulty. The questionnaire also includes a visual analog scale, where the participants were asked to rate their current health on a scale of 0-100, with 0 being the worst imaginable health state.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "n" is number of participants analysed at given time point.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Patient Global Impression of Severity (PGI-S) for Idiopathic Pulmonary Fibrosis (IPF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.'}, {'id': 'OG001', 'title': 'Tralokinumab 400 Milligram (mg)', 'description': 'Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.'}, {'id': 'OG002', 'title': 'Tralokinumab 800 mg', 'description': 'Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.'}], 'classes': [{'title': 'Very mild', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Very severe', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 72', 'description': 'The PGI-S is a single-item, global assessment of participant-perceived IPF severity. The assessment was designed to capture participant perceived IPF-related health status. Participants rate their IPF severity using a 5-point scale (1 = very mild, 5 = very severe).', 'unitOfMeasure': 'Participant', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "N" is number of participants analysed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Patient Global Impression of Change (PGI-C) for Idiopathic Pulmonary Fibrosis (IPF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.'}, {'id': 'OG001', 'title': 'Tralokinumab 400 Milligram (mg)', 'description': 'Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.'}, {'id': 'OG002', 'title': 'Tralokinumab 800 mg', 'description': 'Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.'}], 'classes': [{'title': 'Very much improved', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Much improved', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Slightly improved', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Slightly worse', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Much worse', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Very much worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 72', 'description': 'The PGI-C is a single-item, global assessment designed to capture participant-perceived change in their IPF health condition using a 7-point scale (-3 = very much improved, 0 = no change, about the same, 3 = very much worse).', 'unitOfMeasure': 'Participant', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, "N" is number of participants analysed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Mean Serum Concentration of Tralokinumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tralokinumab 400 Milligram (mg)', 'description': 'Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.'}, {'id': 'OG001', 'title': 'Tralokinumab 800 mg', 'description': 'Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.'}], 'classes': [{'title': 'Week 0: predose (n=50,56)', 'categories': [{'measurements': [{'value': '3.520', 'spread': '23.885', 'groupId': 'OG000'}, {'value': '6.151', 'spread': '45.560', 'groupId': 'OG001'}]}]}, {'title': 'Week 0: 0 hour postdose (n=53,57)', 'categories': [{'measurements': [{'value': '176.047', 'spread': '125.991', 'groupId': 'OG000'}, {'value': '311.105', 'spread': '88.229', 'groupId': 'OG001'}]}]}, {'title': 'Week 0: 2 hour postdose (n=53,56)', 'categories': [{'measurements': [{'value': '172.108', 'spread': '46.423', 'groupId': 'OG000'}, {'value': '301.321', 'spread': '60.520', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=57,57)', 'categories': [{'measurements': [{'value': '30.155', 'spread': '20.164', 'groupId': 'OG000'}, {'value': '57.914', 'spread': '45.326', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 (n=33,39)', 'categories': [{'measurements': [{'value': '44.653', 'spread': '40.584', 'groupId': 'OG000'}, {'value': '80.553', 'spread': '67.187', 'groupId': 'OG001'}]}]}, {'title': 'Week 72 (n=24,21)', 'categories': [{'measurements': [{'value': '41.583', 'spread': '24.723', 'groupId': 'OG000'}, {'value': '76.224', 'spread': '54.045', 'groupId': 'OG001'}]}]}, {'title': 'Week 82 (n=15,12)', 'categories': [{'measurements': [{'value': '3.651', 'spread': '3.547', 'groupId': 'OG000'}, {'value': '11.442', 'spread': '13.846', 'groupId': 'OG001'}]}]}, {'title': 'Week 88 (n=12,10)', 'categories': [{'measurements': [{'value': '0.493', 'spread': '0.490', 'groupId': 'OG000'}, {'value': '10.585', 'spread': '19.084', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose, 0 hour, and 2 hour postdose on Week 0; predose on Week 4, 48, 72, 82 and 88', 'description': 'The mean serum concentration of Tralokinumab were observed.', 'unitOfMeasure': 'microgram per milliliter (mcg/ml)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic population included all participants who received at least one dose of tralokinumab and had at least one detectable trough (Weeks 4, 48 or 72 only) serum concentration measurement. Here, "n" is number of participants analysed at given time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Positive for Anti-Drug Antibodies to Tralokinumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.'}, {'id': 'OG001', 'title': 'Tralokinumab 400 Milligram (mg)', 'description': 'Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.'}, {'id': 'OG002', 'title': 'Tralokinumab 800 mg', 'description': 'Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.'}], 'classes': [{'title': 'Baseline (n=54,54,58)', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '1.9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 0, Day 1 (n=1,3,1)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 48 (n=35,32,36)', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 72 (n=2,1,1)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 82 (n=13,15,12)', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 88 (n=10,13,11)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the start of study treatment through Week 88', 'description': 'A participant was considered ADA-positive across the study if they had a positive reading at any time point during the study.', 'unitOfMeasure': 'Percentage of participant', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received any study investigational product and participants were analysed according to the treatment they actually received. Here, "n" is number of participants analysed at given time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.'}, {'id': 'FG001', 'title': 'Tralokinumab 400 Milligram (mg)', 'description': 'Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.'}, {'id': 'FG002', 'title': 'Tralokinumab 800 mg', 'description': 'Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '58'}, {'groupId': 'FG002', 'numSubjects': '59'}]}, {'type': 'Randomized and Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '57'}, {'groupId': 'FG002', 'numSubjects': '59'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '45'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '28'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Randomized, not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Ongoing AE worsening right heart failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Requiring lung transplant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Early tretmt termntd, cmpltd safety f-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Started other medicine', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Site error in safety follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Enrolled in another clinical study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Code break', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 409 participants participated in the study. Of which, 176 participants were randomized into the study at 48 sites including 17 sites in the USA, 9 sites in Australia, 7 sites in Peru, 6 sites in Israel, 5 sites in Canada, and 4 sites in South Korea.', 'preAssignmentDetails': 'A total of 176 participants were randomized into the study. Three participants who were randomized did not receive treatment; therefore, 173 participants were randomized and treated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '173', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.'}, {'id': 'BG001', 'title': 'Tralokinumab 400 Milligram (mg)', 'description': 'Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.'}, {'id': 'BG002', 'title': 'Tralokinumab 800 mg', 'description': 'Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.5', 'spread': '6.1', 'groupId': 'BG000'}, {'value': '67.3', 'spread': '7.7', 'groupId': 'BG001'}, {'value': '67.9', 'spread': '6.7', 'groupId': 'BG002'}, {'value': '67.6', 'spread': '6.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '133', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The intent-to-treat (ITT) population is all randomized participants who receive any study investigational product and participants were analysed according to the randomization.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 409}}, 'statusModule': {'whyStopped': 'Early termination of the study due to lack of efficacy.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-28', 'studyFirstSubmitDate': '2012-06-12', 'resultsFirstSubmitDate': '2017-01-19', 'studyFirstSubmitQcDate': '2012-06-26', 'lastUpdatePostDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-28', 'studyFirstPostDateStruct': {'date': '2012-06-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 52', 'timeFrame': 'Baseline and Week 52', 'description': 'Forced vital capacity (FVC) is a standard pulmonary function test used to monitor disease progression in IPF. FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in litres. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) \\* 100%.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)', 'timeFrame': 'From the start of study treatment through Week 88', 'description': 'Any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received Tralokinumab. Treatment-emergent were events between administration of investigational product and Week 88 that were absent before treatment or that worsened relative to pretreatment state.'}, {'measure': 'Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events', 'timeFrame': 'From the start of study treatment through Week 88', 'description': 'An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent were events between administration of investigational product and Week 88 that were absent before treatment or that worsened relative to pre-treatment state. Laboratory evaluations (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.'}, {'measure': 'Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events', 'timeFrame': 'From the start of study treatment through Week 88', 'description': 'Vital signs parameters included heart rate, blood pressure, temperature, weight, pulse oximetry and respiratory rate. Treatment-emergent were events between administration of investigational product and Week 88 that were absent before treatment or that worsened relative to pre-treatment state.'}, {'measure': 'Number of Participants With Electrocardiogram Abnormalities Reported as Treatment-emergent Adverse Events', 'timeFrame': 'From the start of study treatment through Week 88', 'description': 'AEs observed in participants with clinically significant ECG abnormalities were assessed. Tricuspid valve incompetence was the only abnormality reported as TEAE. ECG parameters included heart rate, PR, QRS, QT, and QTc intervals. Treatment-emergent were events between administration of investigational product and Week 88 that were absent before treatment or that worsened relative to pre-treatment state.'}, {'measure': 'Percentage of Participants With Disease Progression', 'timeFrame': 'Week 52 and 72', 'description': 'Progression-free Survival (PFS) was used to evaluate disease progression and the percentage of participants with disease progression. A participant was classified as having disease progression if at least one of the following criteria were met:• Adjudicated respiratory-related mortality. •Adjudicated hospitalization due to IPF exacerbation. •Confirmed decline in percent-predicted FVC of greater than or equal to (\\>=) 10%. •Confirmed decline in 6 minute walk test (6MWT) \\>= 50 meters.'}, {'measure': 'Change From Baseline in Haemoglobin (Hb) Corrected Percent-predicted Diffusion Capacity for Carbon Monoxide (DLco) Through Week 72', 'timeFrame': 'Baseline, Week 52 and 72', 'description': 'The single breath technique was used to determine the DLco. The test was performed by qualified pulmonary function technicians with experience performing this study. Acceptable test criteria included:• An inspiratory volume of more than 85% of vital capacity. • A stable breath hold of 10 seconds (+/- 2 seconds) with no leaks, Valsalva or Mueller maneuvers. • Expiration in less than 4 seconds with appropriate clearance of dead space. The average of the two best acceptable maneuvers was used. There must be a minimum of 4 minutes between the performances of each test.'}, {'measure': 'Change From Baseline in 6 Minute Walk Test (6MWT) Distance Through Week 72', 'timeFrame': 'Baseline, Week 52 and 72', 'description': 'The 6MWT measures the distance that a participant can walk on a measured, flat hard surface in a period of 6 minutes. The 6MWT evaluates the global and integrated responses of all body systems involved during walking.'}, {'measure': 'Change From Baseline in Oxygen Saturation by Pulse Oximetry at Week 68', 'timeFrame': 'Baseline and Week 68', 'description': 'Participants transcutaneous oxygen saturation were observed by pulse oximetry.'}, {'measure': 'Change From Baseline in Lung Volumes Through Week 72', 'timeFrame': 'Baseline, Week 52 and 72', 'description': 'Lung volumes were evaluated by total lung capacity (TLC), residual volume (RV), and vital capacity (VC). Lung volumes were determined by body plethysmography.'}, {'measure': 'Percentage of Participants With Idiopathic Pulmonary Fibrosis (IPF) Exacerbations', 'timeFrame': 'Week 52 and 72', 'description': 'The IPF exacerbations is defined as an acute, clinically significant, deterioration of unidentifiable cause in a participant with underlying IPF. Exacerbations of IPF were adjudicated according to the protocol definition by an independent committee as follows:\n\n1\\. Confirmed acute IPF exacerbation, 2. Suspected acute IPF exacerbation, 3. Not an IPF exacerbation with an alternative diagnosis provided if possible, and 4. Undetermined due to insufficient information.'}, {'measure': 'Percentage of Participants With Adjudicated Mortality', 'timeFrame': 'Week 52 and 72', 'description': 'Participants all cause mortality were observed. Events that resulted in participant death were adjudicated into respiratory-related mortality or all other cause mortality by an independent committee.'}, {'measure': 'Percentage of Participants With Adjudicated Hospitalization', 'timeFrame': 'Week 52 and 72', 'description': 'Participants who were hospitalized due to IPF exacerbation were observed. All events that resulted in the hospitalization of participants were adjudicated by an independent committee to determine if the event was due to an IPF exacerbation as follows: 1. Exacerbation or progression of IPF, 2. Result of a complication of IPF, 3. Not related to IPF (alternative diagnosis provided), and 4. Undetermined due to insufficient information.'}, {'measure': 'Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Through Week 72', 'timeFrame': 'Baseline, Week 52 and 72', 'description': 'FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.'}, {'measure': 'Change From Baseline in Percent-predicted FEV1 Through Week 72', 'timeFrame': 'Baseline, Week 52 and 72', 'description': 'FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Predicted FEV1 is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FEV1 = (observed value)/(predicted value) \\* 100%.'}, {'measure': 'Change From Baseline in Absolute Forced Vital Capacity (FVC) Through Week 72', 'timeFrame': 'Baseline, Week 52 and 72', 'description': 'Forced vital capacity (FVC) is a standard pulmonary function test used to monitor disease progression in IPF. FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in litres.'}, {'measure': 'Number of Participants With Clinical Global Impression of Severity Scores', 'timeFrame': 'Week 72', 'description': "The CGI-S is a single, clinician completed, item designed to capture the clinician's impression of the participants IPF severity. Clinicians were asked to consider their experience in this participant population and rate the overall IPF severity of the participant using a 5-point scale (1 = very mild, 5 = very severe)."}, {'measure': 'Number of Participants With Clinical Global Impression of Change Scores', 'timeFrame': 'Week 72', 'description': 'The CGI-C is a single, clinician completed, item designed to capture the clinicians overall impression of change in IPF severity from the baseline state at Screening. Clinicians were asked to rate the participants IPF severity relative to their state at baseline using a 7-point scale (-3 = very much worse, 0 = no change, about the same, 3 = very much improved).'}, {'measure': 'Change From Baseline in University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ) Total Score at Week 72', 'timeFrame': 'Baseline and Week 72', 'description': 'The UCSD SOBQ is a 24-item questionnaire designed to capture patient-reported shortness of breath. Respondents were asked to rate their breathlessness during 21 activities of daily living using a 6-point scale (0 = not at all breathless, 5 = maximally breathless or too breathless to do this activity). In addition to the 21 activity items, the UCSD SOBQ includes 3 additional questions about limitations due to shortness of breath, fear of harm from overexertion, and fear of shortness of breath. The UCSD SOBQ was scored by summing responses across all 24 items to form a total score. Scores range from 0-120 with higher scores indicative of greater shortness of breath.'}, {'measure': "Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 72", 'timeFrame': 'Baseline and Week 72', 'description': 'The SGRQ is a 50-item Patient-reported outcome (PRO) instrument developed to measure respiratory-related health status via 76 weighted responses. The SGRQ is divided into two parts. Part 1 asks respondents to consider the last 3 months and report on their respiratory symptoms using 5-point Likert scales. Part 2 asks respondents to consider their current state and respond to a series of dichotomous yes/no items related to their activities (activities that cause or were limited by breathlessness) and impacts (social functioning, psychological disturbances resulting from airways disease). Total scores and domain scores (symptoms, activities, and impact on daily life) were scored from 0-100, where lower scores indicate better health status.'}, {'measure': 'Change From Baseline in Exacerbations of Chronic Pulmonary Disease (EXACT IPF) Total Score Through Week 72', 'timeFrame': 'Baseline, Week 52 and 72', 'description': 'The EXACT-IPF is a 14-item daily dairy used to capture the IPF related symptoms completed by the participants using an eDiary. The EXACT-IPF total score is the sum of all items ranged from 1 to 14. EXACT-IPF is an interval-level scale ranging from 0 to 100, where the higher scores indicate more severe condition. The EXACT-IPF used Likert scales (with 3 to 6 response options each) to capture participant reported IPF-related symptoms. The scores are the simple sum of item responses for each domain or single item.'}, {'measure': 'Change From Baseline in European Quality of Life-5-Dimension 3 Level Version (EQ-5D-3L) (Including Visual Analog Scale [VAS]) at Week 72', 'timeFrame': 'Baseline and Week 72', 'description': "The EQ-5D-3L is a standardized PRO used to capture respondent's general health status. The questionnaire assesses 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 response options (no problem, some or moderate problems, and unable or extreme problems) that reflect increasing levels of difficulty. The questionnaire also includes a visual analog scale, where the participants were asked to rate their current health on a scale of 0-100, with 0 being the worst imaginable health state."}, {'measure': 'Number of Participants With Patient Global Impression of Severity (PGI-S) for Idiopathic Pulmonary Fibrosis (IPF)', 'timeFrame': 'Week 72', 'description': 'The PGI-S is a single-item, global assessment of participant-perceived IPF severity. The assessment was designed to capture participant perceived IPF-related health status. Participants rate their IPF severity using a 5-point scale (1 = very mild, 5 = very severe).'}, {'measure': 'Number of Participants With Patient Global Impression of Change (PGI-C) for Idiopathic Pulmonary Fibrosis (IPF)', 'timeFrame': 'Week 72', 'description': 'The PGI-C is a single-item, global assessment designed to capture participant-perceived change in their IPF health condition using a 7-point scale (-3 = very much improved, 0 = no change, about the same, 3 = very much worse).'}, {'measure': 'Mean Serum Concentration of Tralokinumab', 'timeFrame': 'Predose, 0 hour, and 2 hour postdose on Week 0; predose on Week 4, 48, 72, 82 and 88', 'description': 'The mean serum concentration of Tralokinumab were observed.'}, {'measure': 'Percentage of Participants Positive for Anti-Drug Antibodies to Tralokinumab', 'timeFrame': 'From the start of study treatment through Week 88', 'description': 'A participant was considered ADA-positive across the study if they had a positive reading at any time point during the study.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Idiopathic Pulmonary Fibrosis']}, 'referencesModule': {'references': [{'pmid': '28787186', 'type': 'DERIVED', 'citation': 'Parker JM, Glaspole IN, Lancaster LH, Haddad TJ, She D, Roseti SL, Fiening JP, Grant EP, Kell CM, Flaherty KR. A Phase 2 Randomized Controlled Study of Tralokinumab in Subjects with Idiopathic Pulmonary Fibrosis. Am J Respir Crit Care Med. 2018 Jan 1;197(1):94-103. doi: 10.1164/rccm.201704-0784OC.'}]}, 'descriptionModule': {'briefSummary': 'To study the safety and effectiveness of multiple-doses of tralokinumab on pulmonary function in adults with mild to moderate idiopathic pulmonary fibrosis (IPF). IPF is a chronic, progressive, irreversible, and usually fatal lung disease of unknown cause.', 'detailedDescription': 'The primary objective of this study is to determine the effect of multiple doses of tralokinumab on pulmonary function in adults with mild to moderate IPF'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* 1\\) IPF diagnosis for \\<= 5 years prior to Visit 1 (screening). Confirmation of diagnosis of IPF in accordance is required for subject inclusion 2) Confirmed diagnosis of IPF by clinical characteristics, HRCT and surgical lung biopsy (if required) 3)Mild to moderate IPF to include all of the following at screening:\n\n 1. FVC \\>= 50% predicted normal\n 2. Partial pressure of oxygen in arterial blood (PaO2) of \\>= 55 mmHg on room air or 50 mmHg at high altitude (\\> 1500 meters), or oxygen saturation by pulse oximetry (SpO2) of \\>= 90%on room air at rest\n 3. Hemoglobin-corrected diffusion capacity for carbon monoxide (DLCO) \\>= 30% predicted normal 4) Be able to walk \\>= 100 meters unassisted\n\nKey Exclusion Criteria:\n\n1. A FEV1/FVC ratio less than 0.70 at the time of screening (postbronchodilator)\n2. The extent of emphysema on the HRCT is greater than the extent of fibrosis.\n3. Currently listed for lung transplantation\n4. Use of the following medications:\n\n 1. Immunosuppressive medications (eg, methotrexate, cyclosporine, azathioprine, intramuscular long-acting depot corticosteroid) within 3 months prior to Visit 1 (screening). Oral prednisone \\<= 15 mg/day (or equivalent oral corticosteroid) is allowed for chronic use if subject was on a stable dose at least 30 days prior to Visit 1 (screening)\n 2. Pirfenidone within 4 weeks prior to Visit 1 (screening)\n 3. N-acetylcysteine within 4 weeks prior to Visit 1 (screening)\n 4. Live attenuated vaccines within 4 weeks prior to Visit 1 (screening)'}, 'identificationModule': {'nctId': 'NCT01629667', 'briefTitle': 'A Phase 2, Randomized Dose-ranging Study to Evaluate the Efficacy of Tralokinumab in Adults With Idiopathic Pulmonary Fibrosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'MedImmune LLC'}, 'officialTitle': 'A Phase 2, Randomized Dose-ranging Study to Evaluate the Efficacy of Tralokinumab in Adults With Idiopathic Pulmonary Fibrosis', 'orgStudyIdInfo': {'id': 'CD-RI-CAT-354-1066'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tralokinumab 400 milligram (mg)', 'description': 'Participants will receive Tralokinumab 400 mg intravenous (IV) infusion Q4W for 68 Weeks.', 'interventionNames': ['Biological: Tralokinumab']}, {'type': 'EXPERIMENTAL', 'label': 'Tralokinumab 800 mg', 'description': 'Participants will receive Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.', 'interventionNames': ['Biological: Tralokinumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive placebo IV once every 4 Weeks (Q4W) for 68 Weeks.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Tralokinumab', 'type': 'BIOLOGICAL', 'description': 'Participants will receive Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.', 'armGroupLabels': ['Tralokinumab 400 milligram (mg)']}, {'name': 'Tralokinumab', 'type': 'BIOLOGICAL', 'description': 'Participants will receive Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.', 'armGroupLabels': ['Tralokinumab 800 mg']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Participants will receive placebo IV once every 4 Weeks (Q4W) for 68 Weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'city': 'Winter Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 28.6, 'lon': -81.33924}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'city': 'Chesterfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.66311, 'lon': -90.57707}}, {'city': 'Summit', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.71562, 'lon': -74.36468}}, {'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 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