Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-02-22 @ 6:44 PM
Study NCT ID:
NCT02161757
Status:
COMPLETED
Last Update Posted:
2018-08-28
First Post:
2014-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C574065', 'term': 'tralokinumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialTransparency@astrazeneca.com', 'phone': '+1 301-398-0582', 'title': 'Global Clinical Lead', 'organization': 'AstraZeneca'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Serious and Other (non-serious) adverse event (AE) data reported for the treatment period, from baseline (Week 0) to end of treatment (Week 52). All-Cause mortality is reported for the overall study period (including the extended follow-up period), up to Week 72.', 'description': "Treatment-emergent AEs were defined with an onset date ≥ the first day of IP and ≤ (the last day of IP + dosing frequency). 'Dosing frequency' was 2 or 4 weeks depending on whether patients were randomised to Q2W or Q4W dosing regimens. Patient population was safety analysis set which included all patients who received at least one dose of any IP.", 'eventGroups': [{'id': 'EG000', 'title': 'Tralo 300 mg Q2W', 'description': 'Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.', 'otherNumAtRisk': 398, 'deathsNumAtRisk': 398, 'otherNumAffected': 134, 'seriousNumAtRisk': 398, 'deathsNumAffected': 2, 'seriousNumAffected': 40}, {'id': 'EG001', 'title': 'Tralo 300 mg Q4W', 'description': 'Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.', 'otherNumAtRisk': 404, 'deathsNumAtRisk': 404, 'otherNumAffected': 145, 'seriousNumAtRisk': 404, 'deathsNumAffected': 1, 'seriousNumAffected': 39}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.', 'otherNumAtRisk': 400, 'deathsNumAtRisk': 400, 'otherNumAffected': 107, 'seriousNumAtRisk': 400, 'deathsNumAffected': 1, 'seriousNumAffected': 48}], 'otherEvents': [{'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 58, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 29, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 29, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 27, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 24, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 40, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 61, 'numAffected': 48}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 73, 'numAffected': 36}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 62, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 67, 'numAffected': 48}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 55, 'numAffected': 37}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 35, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 42, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 28, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 55, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 43, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 45, 'numAffected': 28}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Sinus node dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Chronic sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Facial bones fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cerebrovascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Erosive duodenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Swollen tongue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Eosinophilic granulomatosis with polyangiitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Diarrhoea infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 0, 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'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pneumonia viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 0, 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{'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Uterine cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Haemorrhagic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vascular encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vertebrobasilar insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Metrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 15, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 23, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 39, 'numAffected': 25}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pharyngeal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 404, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 400, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Annualised Asthma Exacerbation Rate (AAER) up to Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '404', 'groupId': 'OG001'}, {'value': '400', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tralo 300 mg Q2W', 'description': 'Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.'}, {'id': 'OG001', 'title': 'Tralo 300 mg Q4W', 'description': 'Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.56', 'groupId': 'OG000', 'lowerLimit': '0.46', 'upperLimit': '0.67'}, {'value': '0.54', 'groupId': 'OG001', 'lowerLimit': '0.45', 'upperLimit': '0.65'}, {'value': '0.60', 'groupId': 'OG002', 'lowerLimit': '0.50', 'upperLimit': '0.72'}]}]}], 'analyses': [{'pValue': '0.5859', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.72', 'ciUpperLimit': '1.21', 'estimateComment': 'Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.', 'groupDescription': 'Comparison of AAER (rate ratio): Tralo 300 mg Q2W vs placebo.', 'statisticalMethod': 'Negative binomial', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.'}, {'pValue': '0.4406', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.70', 'ciUpperLimit': '1.17', 'estimateComment': 'Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.', 'groupDescription': 'Comparison of AAER (rate ratio): Tralo 300 mg Q4W vs placebo.', 'statisticalMethod': 'Negative binomial', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.'}, {'pValue': '0.5859', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Rate reduction', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.01', 'ciLowerLimit': '-20.76', 'ciUpperLimit': '28.39', 'estimateComment': 'Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.', 'groupDescription': 'Comparison of AAER (rate reduction): Tralo 300 mg Q2W vs placebo.', 'statisticalMethod': 'Negative binominal', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.'}, {'pValue': '0.4406', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Rate reduction', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.76', 'ciLowerLimit': '-17.16', 'ciUpperLimit': '30.50', 'estimateComment': 'Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.', 'groupDescription': 'Comparison of AAER (rate reduction): Tralo 300 mg Q4W vs placebo.', 'statisticalMethod': 'Negative binominal', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Week 0) up to Week 52', 'description': 'Asthma exacerbation was defined as a worsening of asthma that led to any of the following:\n\n* Use of systemic corticosteroids for at least 3 days; a single depo-injectable dose of corticosteroids was considered equivalent to a 3-day course of systemic corticosteroids.\n* An emergency room (ER) or urgent care (UC) visit (defined as evaluation and treatment for \\<24 hours in an ER or UC centre) due to asthma that required systemic corticosteroids (see above).\n* An inpatient hospitalisation (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥24 hours) due to asthma.\n\nAAER = number of exacerbations\\*365.25 / (follow-up date - date of randomisation + 1) (where maximum follow-up time for a patient was approximately 52 weeks).\n\nAAER in the tralokinumab group was compared to that seen in the placebo group up to Week 52 using a negative binomial model; rate ratios and rate reductions are both presented for comparative statistical analyses.', 'unitOfMeasure': 'Events/year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 52 in Pre-dose/Pre-bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '373', 'groupId': 'OG001'}, {'value': '363', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tralo 300 mg Q2W', 'description': 'Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.'}, {'id': 'OG001', 'title': 'Tralo 300 mg Q4W', 'description': 'Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.366', 'spread': '27.349', 'groupId': 'OG000'}, {'value': '12.099', 'spread': '26.253', 'groupId': 'OG001'}, {'value': '10.136', 'spread': '24.206', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square (LS) Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.03', 'ciLowerLimit': '2.34', 'ciUpperLimit': '9.73', 'estimateComment': 'Fixed categorical effects of treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.', 'groupDescription': 'Comparison of percent change from baseline in pre-dose/pre-BD FEV1 at Week 52: Tralo 300 mg Q2W vs placebo.\n\nRestricted maximum likelihood (REML) based repeated measures analysis performed on patients with a baseline pre-dose/pre-BD FEV1 assessment.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.10', 'ciLowerLimit': '-1.58', 'ciUpperLimit': '5.77', 'estimateComment': 'Fixed categorical effects of treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.', 'groupDescription': 'Comparison of percent change from baseline in pre-dose/pre-BD FEV1 at Week 52: Tralo 300 mg Q4W vs placebo.\n\nREML based repeated measures analysis performed on patients with a baseline pre-dose/pre-BD FEV1 assessment.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0) and Week 52', 'description': 'Lung function was assessed by FEV1 which was measured by spirometry. Spirometry was performed by the Investigator or authorised delegate according to American Thoracic Society/European Respiratory Society guidelines. The mean percent change from baseline in pre-BD FEV1 at Week 52 is presented.', 'unitOfMeasure': 'Percent change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 52 in Total Asthma Symptom Score (Bi-weekly Means)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '313', 'groupId': 'OG000'}, {'value': '313', 'groupId': 'OG001'}, {'value': '312', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tralo 300 mg Q2W', 'description': 'Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.'}, {'id': 'OG001', 'title': 'Tralo 300 mg Q4W', 'description': 'Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.09', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '-1.00', 'spread': '1.11', 'groupId': 'OG001'}, {'value': '-1.03', 'spread': '1.13', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.23', 'ciUpperLimit': '0.04', 'estimateComment': 'Fixed categorical effects of baseline asthma symptom score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.', 'groupDescription': 'Comparison of mean change from baseline in total asthma symptom score at Week 52: Tralo 300 mg Q2W vs placebo.\n\nREML based repeated measures analysis.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '0.12', 'estimateComment': 'Fixed categorical effects of baseline asthma symptom score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.', 'groupDescription': 'Comparison of mean change from baseline in total asthma symptom score at Week 52: Tralo 300 mg Q4W vs placebo.\n\nREML based repeated measures analysis.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0) and Week 52', 'description': 'Asthma symptoms during night-time and daytime were recorded by the patient each morning and evening in the Asthma Daily Diary. Symptoms were recorded using a 4-point response scale, which ranged from 0 to 3, where 0 indicated no asthma symptoms. Asthma symptom daytime score (recorded in the evening), night-time score (recorded in the morning), and total score were calculated separately. The daily asthma symptom total score was calculated by taking the sum of the night-time and daytime asthma symptom scores recorded each day, ranging from 0 to 6. A lower symptom score indicated a better outcome. The change from baseline in bi-weekly mean daily asthma symptom total score is presented.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}, {'value': '315', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tralo 300 mg Q2W', 'description': 'Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.'}, {'id': 'OG001', 'title': 'Tralo 300 mg Q4W', 'description': 'Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.18', 'spread': '1.17', 'groupId': 'OG000'}, {'value': '1.16', 'spread': '1.14', 'groupId': 'OG001'}, {'value': '1.03', 'spread': '1.24', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.15', 'ciLowerLimit': '-0.01', 'ciUpperLimit': '0.31', 'estimateComment': 'Fixed categorical effects of baseline AQLQ(S)+12 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.', 'groupDescription': 'Comparison of change in mean score from baseline for AQLQ(S)+12 at Week 52: Tralo 300 mg Q2W vs placebo.\n\nREML based repeated measures analysis.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '-0.03', 'ciUpperLimit': '0.28', 'estimateComment': 'Fixed categorical effects of baseline AQLQ(S)+12 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.', 'groupDescription': 'Comparison of change in mean score from baseline for AQLQ(S)+12 at Week 52: Tralo 300 mg Q4W vs placebo.\n\nREML based repeated measures analysis.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0) and Week 52', 'description': 'The AQLQ(S)+12 is a questionnaire that measures health-related quality of life for patients with asthma aged 12 and older. The questionnaire comprises 32 questions and has 4 separate domains (asthma symptoms, activity limitations, emotional function and environmental stimuli). Patients were asked to recall their experiences during the previous 2 weeks and to score each of the questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The total score was calculated as the mean response to all questions, ranging from 1 (severe impairment) to 7 (no impairment). Individual AQLQ(S)+12 total score changes of ≥0.5 were considered to be clinically meaningful. The mean change from baseline in AQLQ(S)+12 score at Week 52 is presented.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 52 in Asthma Control Questionnaire-6 (ACQ-6) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '344', 'groupId': 'OG001'}, {'value': '329', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tralo 300 mg Q2W', 'description': 'Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.'}, {'id': 'OG001', 'title': 'Tralo 300 mg Q4W', 'description': 'Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.19', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '-1.12', 'spread': '1.03', 'groupId': 'OG001'}, {'value': '-1.02', 'spread': '1.14', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.29', 'ciUpperLimit': '-0.02', 'estimateComment': 'Fixed categorical effects of baseline ACQ-6 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.', 'groupDescription': 'Comparison of change in mean score from baseline for ACQ-6 at Week 52: Tralo 300 mg Q2W vs placebo.\n\nREML based repeated measures analysis.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-0.26', 'ciUpperLimit': '0.01', 'estimateComment': 'Fixed categorical effects of baseline ACQ-6 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.', 'groupDescription': 'Comparison of change in mean score from baseline for ACQ-6 at Week 52: Tralo 300 mg Q4W vs placebo.\n\nREML based repeated measures analysis.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0) and Week 52', 'description': 'The ACQ-6 questionnaire is a shortened version of the ACQ (omitting FEV1 measurement) that assesses asthma symptoms (night-time awakenings, symptoms on waking, activity limitation, dyspnoea, wheezing) and rescue short-acting β2-agonists medication use during the past week. Questions were weighted equally and scored on a 7-point scale from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-6 score was the mean of the responses, ranging from 0 (totally controlled) to 6 (severely uncontrolled). Mean scores of ≤0.75 indicate well-controlled asthma, scores between 0.75 and ≤1.5 indicate partly controlled asthma and a score \\>1.5 indicates not well-controlled asthma. Individual changes of at least 0.5 were considered to be clinically meaningful. The mean change from baseline in ACQ-6 score at Week 52 is presented.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'AAER Associated With an ER/UC Visit, or a Hospitalisation up to Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '404', 'groupId': 'OG001'}, {'value': '400', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tralo 300 mg Q2W', 'description': 'Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.'}, {'id': 'OG001', 'title': 'Tralo 300 mg Q4W', 'description': 'Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.04', 'groupId': 'OG000', 'lowerLimit': '0.02', 'upperLimit': '0.06'}, {'value': '0.06', 'groupId': 'OG001', 'lowerLimit': '0.04', 'upperLimit': '0.09'}, {'value': '0.07', 'groupId': 'OG002', 'lowerLimit': '0.05', 'upperLimit': '0.11'}]}]}], 'analyses': [{'pValue': '0.0369', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.54', 'ciLowerLimit': '0.30', 'ciUpperLimit': '0.96', 'estimateComment': 'Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations resulting in hospitalisation or ER treatment (yes/no) in the year before the study.', 'groupDescription': 'Comparison of AAER associated with an ER/UC visit or hospitalisation: Tralo 300 mg Q2W vs placebo.', 'statisticalMethod': 'Negative binomial', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3603', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.78', 'ciLowerLimit': '0.46', 'ciUpperLimit': '1.33', 'estimateComment': 'Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations resulting in hospitalisation or ER treatment (yes/no) in the year before the study.', 'groupDescription': 'Comparison of AAER associated with an ER/UC visit or hospitalisation: Tralo 300 mg Q4W vs placebo.', 'statisticalMethod': 'Negative binomial', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Week 0) up to Week 52', 'description': 'The annual rate of exacerbations associated with an ER/UC visit or hospitalisation up to Week 52 are presented for non-adjudicated data (i.e. events assessed by the Investigator and recorded in the electronic case report form).\n\nAAER = Number of Exacerbations\\*365.25 / (Follow-up date - Date of randomisation + 1) (where maximum follow-up time for a patient was approximately 52 weeks).', 'unitOfMeasure': 'Events/year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in European Quality of Life - 5 Dimension 5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Scores at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}, {'value': '319', 'groupId': 'OG001'}, {'value': '324', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tralo 300 mg Q2W', 'description': 'Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.'}, {'id': 'OG001', 'title': 'Tralo 300 mg Q4W', 'description': 'Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.68', 'spread': '20.33', 'groupId': 'OG000'}, {'value': '9.00', 'spread': '18.99', 'groupId': 'OG001'}, {'value': '10.06', 'spread': '18.92', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0) and Week 52', 'description': 'The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The patient was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. The questionnaire also included a VAS, where the patient was asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state. The mean change from baseline in EQ-5D-5L VAS scores at Week 52 is presented.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Asthma Rescue Medication Use at Week 52 (Bi-weekly Means)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '313', 'groupId': 'OG000'}, {'value': '313', 'groupId': 'OG001'}, {'value': '312', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tralo 300 mg Q2W', 'description': 'Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.'}, {'id': 'OG001', 'title': 'Tralo 300 mg Q4W', 'description': 'Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.18', 'spread': '3.46', 'groupId': 'OG000'}, {'value': '-2.15', 'spread': '3.69', 'groupId': 'OG001'}, {'value': '-2.04', 'spread': '3.84', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.51', 'ciUpperLimit': '0.29', 'estimateComment': 'Fixed categorical effects of baseline rescue medication use, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.', 'groupDescription': 'Comparison of mean change from baseline in rescue medication use at Week 52: Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.56', 'ciUpperLimit': '0.24', 'estimateComment': 'Fixed categorical effects of baseline rescue medication use, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.', 'groupDescription': 'Comparison of mean change from baseline in rescue medication use at Week 52: Tralo 300 mg Q4W vs placebo. REML based repeated measures analysis.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0) and Week 52', 'description': 'Salbutamol, albuterol or levalbuterol were used as rescue medication during the study in the event of a worsening of asthma symptoms. Rescue medication use was measured by the bi-weekly mean number of inhalations (puffs) per day, calculated as: total morning puffs + total evening puffs + 2\\*(total morning nebuliser use + total evening nebuliser use)/ total number of days with data in bi-weekly period. The change from baseline in bi-weekly mean total asthma rescue medication use at Week 52 is presented.', 'unitOfMeasure': 'Puffs/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Home Peak Expiratory Flow (PEF) (Morning and Evening) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}, {'value': '329', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tralo 300 mg Q2W', 'description': 'Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.'}, {'id': 'OG001', 'title': 'Tralo 300 mg Q4W', 'description': 'Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.'}], 'classes': [{'title': 'Morning PEF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}, {'value': '329', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12.95', 'spread': '85.66', 'groupId': 'OG000'}, {'value': '7.55', 'spread': '74.97', 'groupId': 'OG001'}, {'value': '5.23', 'spread': '74.10', 'groupId': 'OG002'}]}]}, {'title': 'Evening PEF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}, {'value': '319', 'groupId': 'OG001'}, {'value': '326', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.89', 'spread': '83.02', 'groupId': 'OG000'}, {'value': '0.68', 'spread': '73.19', 'groupId': 'OG001'}, {'value': '-0.28', 'spread': '76.05', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.25', 'ciLowerLimit': '-3.53', 'ciUpperLimit': '16.03', 'estimateComment': 'Fixed categorical effects of baseline PEF (morning), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.', 'groupDescription': 'Comparison of mean change from baseline in morning PEF at Week 52: Tralo 300 mg Q2W vs placebo.\n\nREML based repeated measures analysis.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.77', 'ciLowerLimit': '-7.99', 'ciUpperLimit': '11.53', 'estimateComment': 'Fixed categorical effects of baseline PEF (morning), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.', 'groupDescription': 'Comparison of mean change from baseline in morning PEF at Week 52: Tralo 300 mg Q4W vs placebo.\n\nREML based repeated measures analysis.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.14', 'ciLowerLimit': '-2.60', 'ciUpperLimit': '16.87', 'estimateComment': 'Fixed categorical effects of baseline PEF (evening), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.', 'groupDescription': 'Comparison of mean change from baseline in evening PEF at Week 52: Tralo 300 mg Q2W vs placebo.\n\nREML based repeated measures analysis.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.61', 'ciLowerLimit': '-9.13', 'ciUpperLimit': '10.35', 'estimateComment': 'Fixed categorical effects of baseline PEF (evening), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.', 'groupDescription': 'Comparison of mean change from baseline in evening PEF at Week 52: Tralo 300 mg Q4W vs placebo.\n\nREML based repeated measures analysis.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0) and Week 52', 'description': 'Home PEF testing was performed by the patient using an electronic, hand-held spirometer (peak flow meter) and was performed in the morning upon awakening (prior to taking their morning asthma controller) and in the evening at bedtime (prior to taking their evening asthma controller). The mean change from baseline in home PEF values at Week 52 are presented separately for morning and evening.', 'unitOfMeasure': 'L/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Night-time Awakenings Due to Asthma Requiring Rescue Medication Use at Week 52 (Bi-weekly Means [Percentage])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '346', 'groupId': 'OG000'}, {'value': '357', 'groupId': 'OG001'}, {'value': '357', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tralo 300 mg Q2W', 'description': 'Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.'}, {'id': 'OG001', 'title': 'Tralo 300 mg Q4W', 'description': 'Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.'}], 'classes': [{'categories': [{'measurements': [{'value': '-37.63', 'spread': '37.27', 'groupId': 'OG000'}, {'value': '-35.17', 'spread': '37.49', 'groupId': 'OG001'}, {'value': '-36.00', 'spread': '36.69', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.80', 'ciLowerLimit': '-5.29', 'ciUpperLimit': '1.69', 'estimateComment': 'Fixed categorical effects of baseline number (%) of awakenings, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.', 'groupDescription': 'Comparison of mean change from baseline in number (%) of awakenings at Week 52: Tralo 300 mg Q2W vs placebo.\n\nREML based repeated measures analysis.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.36', 'ciLowerLimit': '-5.84', 'ciUpperLimit': '1.12', 'estimateComment': 'Fixed categorical effects of baseline number (%) of awakenings, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.', 'groupDescription': 'Comparison of mean change from baseline in number (%) of awakenings at Week 52: Tralo 300 mg Q4W vs placebo.\n\nREML based repeated measures analysis.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0) and Week 52', 'description': 'The patient captured night-time awakenings (yes/no) and the use of rescue medication during these awakenings (yes/no) each morning in the Asthma Daily Diary. Night-time awakenings (percentage) was defined as the number of nights with awakenings due to asthma and requiring rescue medication divided by number of nights with data. The change from baseline in bi-weekly means (percentage) night-time awakenings due to asthma requiring rescue medication use at Week 52 is presented.', 'unitOfMeasure': 'Percentage of nights with awakenings', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With ≥1 Asthma Exacerbation up to Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '404', 'groupId': 'OG001'}, {'value': '400', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tralo 300 mg Q2W', 'description': 'Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.'}, {'id': 'OG001', 'title': 'Tralo 300 mg Q4W', 'description': 'Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.'}], 'classes': [{'categories': [{'measurements': [{'value': '128', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.732', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.71', 'ciUpperLimit': '1.28', 'estimateComment': 'The estimate of each odds ratio was obtained from two separate models, from a Cochran-Mantel-Haenszel test controlling for geographical region, age group and periostin group at baseline.', 'groupDescription': 'Comparison of number of patients with ≥ 1 asthma exacerbations up to Week 52: Tralo 300 mg Q2W vs placebo.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.421', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.65', 'ciUpperLimit': '1.19', 'estimateComment': 'The estimate of each odds ratio was obtained from two separate models, from a Cochran-Mantel-Haenszel test controlling for geographical region, age group and periostin group at baseline.', 'groupDescription': 'Comparison of number of patients with ≥ 1 asthma exacerbations up to Week 52: Tralo 300 mg Q4W vs placebo.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Week 0) up to Week 52', 'description': 'The number of patients with ≥1 asthma exacerbation up to Week 52 is presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study.'}, {'type': 'SECONDARY', 'title': 'Work Productivity and Activity Impairment Questionnaire and Classroom Impairment Questions (WPAI+CIQ): Productivity Loss at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '137', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tralo 300 mg Q2W', 'description': 'Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.'}, {'id': 'OG001', 'title': 'Tralo 300 mg Q4W', 'description': 'Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.'}], 'classes': [{'title': 'Productivity loss - currently employed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '27.71', 'spread': '24.06', 'groupId': 'OG000'}, {'value': '28.48', 'spread': '25.11', 'groupId': 'OG001'}, {'value': '31.25', 'spread': '25.34', 'groupId': 'OG002'}]}]}, {'title': 'Productivity loss - currently in school', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '33.13', 'spread': '28.03', 'groupId': 'OG000'}, {'value': '31.79', 'spread': '34.28', 'groupId': 'OG001'}, {'value': '32.31', 'spread': '28.46', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 52', 'description': "The WPAI+CIQ consists of questions about how asthma and asthma-related issues impact a patient's ability to work, attend classes and perform regular daily activities. The questionnaire contains 10 questions relating to the patient's experience over the previous 7 days. The WPAI+CIQ outcomes for productivity loss are presented separately for those currently employed and for those currently in school and are expressed as mean productivity loss (percentage) at Week 52, with higher numbers indicating less productivity.\n\nWork Productivity Loss = {Q2/(Q2+Q4)+\\[(1-Q2/(Q2+Q4))x(Q5/10)\\]}\\*100 (Absenteeism = Q2/(Q2+Q4)\\*100; Presenteeism = (Q5/10)\\*100).\n\nClass Productivity Loss = {Q7/(Q7+Q8) + \\[(1-Q7/(Q7+Q8))x(Q9/10)\\]}\\*100 (Absenteeism = Q7/ (Q7+Q8)\\*100; Presenteeism = (Q9/10)\\*100).\n\nNote: QX refers to response to question number X on WPAI+CIQ questionnaire.", 'unitOfMeasure': 'Percent productivity loss', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoint of testing were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'WPAI+CIQ: Activity Impairment at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tralo 300 mg Q2W', 'description': 'Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.'}, {'id': 'OG001', 'title': 'Tralo 300 mg Q4W', 'description': 'Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.'}], 'classes': [{'title': 'Activity Impairment - currently employed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '23.25', 'spread': '21.31', 'groupId': 'OG000'}, {'value': '23.53', 'spread': '22.57', 'groupId': 'OG001'}, {'value': '27.01', 'spread': '23.21', 'groupId': 'OG002'}]}]}, {'title': 'Activity Impairment - currently in school', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '29.29', 'spread': '20.56', 'groupId': 'OG000'}, {'value': '27.50', 'spread': '29.55', 'groupId': 'OG001'}, {'value': '28.95', 'spread': '23.07', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 52', 'description': "The WPAI+CIQ consists of questions about how asthma and asthma-related issues impact a patient's ability to work, attend classes and perform regular daily activities. The questionnaire contains 10 questions relating to the patient's experience over the previous 7 days.\n\nThe WPAI+CIQ outcomes for activity impairment are presented separately for those currently employed and for those currently in school and are expressed as mean impairment percentages at Week 52, with higher numbers indicating greater impairment.\n\nActivity impairment = (Q10/10)\\*100. Note: QX refers to response to question number X on WPAI+CIQ questionnaire.", 'unitOfMeasure': 'Percent Impairment', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoint of testing were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Asthma-related Healthcare Encounters by Type up to Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '404', 'groupId': 'OG001'}, {'value': '400', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tralo 300 mg Q2W', 'description': 'Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.'}, {'id': 'OG001', 'title': 'Tralo 300 mg Q4W', 'description': 'Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.'}], 'classes': [{'title': 'Ambulance transport', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}, {'title': 'Emergency room visits', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}]}]}, {'title': 'Unscheduled outpatient visits', 'categories': [{'measurements': [{'value': '1750', 'groupId': 'OG000'}, {'value': '1786', 'groupId': 'OG001'}, {'value': '1705', 'groupId': 'OG002'}]}]}, {'title': 'Home visits', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Telephone calls', 'categories': [{'measurements': [{'value': '515', 'groupId': 'OG000'}, {'value': '463', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}]}, {'title': 'Advanced pulmonary function test', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Week 0) up to Week 52', 'description': "Broad-based healthcare utilisation asthma-related event information was collected by the Investigator/authorised delegate at each visit. At Visit 1, healthcare resource utilisation information was collected with a 1-year recall period; subsequent visits collected information with a recall period of 'since the last scheduled visit'. Total number of times the healthcare encounter occurred was calculated across all patients for each of the following categories:\n\n* Ambulance transport,\n* Emergency room visits,\n* Unscheduled outpatient visits (visit to specialist and/or visit to primary healthcare physician and/or other healthcare visit),\n* Home visits (home visit, physician and/or other healthcare professional),\n* Telephone calls (telephone calls to physician and/or nurse), and\n* Advanced pulmonary function test.", 'unitOfMeasure': 'Encounters', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study.'}, {'type': 'SECONDARY', 'title': 'Asthma-related Healthcare Encounters by Type up to Week 52: Hospitalisations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '404', 'groupId': 'OG001'}, {'value': '400', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tralo 300 mg Q2W', 'description': 'Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.'}, {'id': 'OG001', 'title': 'Tralo 300 mg Q4W', 'description': 'Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.'}], 'classes': [{'categories': [{'measurements': [{'value': '270', 'groupId': 'OG000'}, {'value': '345', 'groupId': 'OG001'}, {'value': '482', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Week 0) up to Week 52', 'description': "Broad-based healthcare utilisation asthma-related event information was collected by the Investigator/authorised delegate at each visit. At Visit 1, healthcare resource utilisation information was collected with a 1-year recall period; subsequent visits collected information with a recall period of 'since the last scheduled visit'. Total number of days spent in hospital was calculated across all patients for the following healthcare encounter category:\n\n• Hospitalisations (hospitalisations, intensive care and/or general care).", 'unitOfMeasure': 'Days', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study.'}, {'type': 'SECONDARY', 'title': 'Asthma-related Healthcare Encounters by Type up to Week 52: Spirometry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '404', 'groupId': 'OG001'}, {'value': '400', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tralo 300 mg Q2W', 'description': 'Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.'}, {'id': 'OG001', 'title': 'Tralo 300 mg Q4W', 'description': 'Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.'}], 'classes': [{'categories': [{'measurements': [{'value': '489', 'groupId': 'OG000'}, {'value': '520', 'groupId': 'OG001'}, {'value': '502', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Week 0) up to Week 52', 'description': "Broad-based healthcare utilisation asthma-related event information was collected by the Investigator/authorised delegate at each visit. At Visit 1, healthcare resource utilisation information was collected with a 1-year recall period; subsequent visits collected information with a recall period of 'since the last scheduled visit'. Total number of assessments was calculated across all patients for the following healthcare encounter category:\n\n• Spirometry.", 'unitOfMeasure': 'Assessments', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study.'}, {'type': 'SECONDARY', 'title': 'Serum Trough Concentration (Ctrough) of Tralokinumab During the Study Period up to Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '394', 'groupId': 'OG000'}, {'value': '401', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tralo 300 mg Q2W', 'description': 'Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.'}, {'id': 'OG001', 'title': 'Tralo 300 mg Q4W', 'description': 'Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '394', 'groupId': 'OG000'}, {'value': '401', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Value was not calculable since below level of detection.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Value was not calculable since below level of detection.', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.690', 'spread': '199.269', 'groupId': 'OG000'}, {'value': '13.151', 'spread': '188.026', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '358', 'groupId': 'OG000'}, {'value': '366', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55.262', 'spread': '159.824', 'groupId': 'OG000'}, {'value': '19.243', 'spread': '112.830', 'groupId': 'OG001'}]}]}, {'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '358', 'groupId': 'OG000'}, {'value': '370', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.766', 'spread': '257.341', 'groupId': 'OG000'}, {'value': '30.305', 'spread': '255.039', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '373', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.074', 'spread': '675.764', 'groupId': 'OG000'}, {'value': '14.290', 'spread': '437.472', 'groupId': 'OG001'}]}]}, {'title': 'Week 72 (follow-up)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '356', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.419', 'spread': '238.749', 'groupId': 'OG000'}, {'value': '0.172', 'spread': '171.973', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Blood samples were collected pre-dose at Baseline (Week 0), and at Week 4, Week 8, Week 26, Week 52 and Week 72 (follow-up)', 'description': 'To evaluate the pharmacokinetics (PK), pre-dose blood samples were collected at each visit and tralokinumab concentrations in serum were determined. Mean Ctrough concentrations are presented at each indicated visit up to Week 72.', 'unitOfMeasure': 'micrograms/millilitre', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients in the FAS who received tralokinumab and who had PK blood samples were included in the PK analysis set. Only patients with data available at the timepoints of testing were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Patients Positive for Anti-drug Antibodies (ADAs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '373', 'groupId': 'OG000'}, {'value': '382', 'groupId': 'OG001'}, {'value': '374', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tralo 300 mg Q2W', 'description': 'Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.'}, {'id': 'OG001', 'title': 'Tralo 300 mg Q4W', 'description': 'Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.'}], 'classes': [{'title': 'ADA prevalence', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'ADA incidence', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'ADA positive at baseline', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'ADA positive post-baseline', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'ADA pos post-baseline and pos at baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'ADA pos post-baseline and not detected at baseline', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'ADA not detected post-baseline and pos at baseline', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Persistent Positive', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Transient Positive', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Treatment-boosted ADA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'nAB positive at any visit', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Week 0), Week 26, Week 56 (follow-up) and Week 72 (follow-up)', 'description': "ADA assessments performed using a tiered approach (screening, confirmatory and titering assays). Confirmed ADA positive samples were also tested for neutralising antibodies (nAb). ADA prevalence defined as proportion of study population with drug-reactive antibodies at any point in time. ADA incidence (treatment-emergent ADA) defined as sum of treatment-induced (post-baseline ADA positive only) and treatment-boosted ADA. Persistently positive defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive defined as having ≥1 post-baseline ADA positive assessment and not fulfilling conditions of persistently positive. Treatment-boosted ADA defined as baseline positive ADA titer boosted to a 4-fold or higher level following drug administration. In some category titles 'positive' is denoted by 'pos'.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ADA evaluable population included all patients in the safety analysis set (i.e. those who had received any IP) who had non-missing baseline ADA and at least 1 non-missing post-baseline ADA result.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tralo 300 mg Q2W', 'description': 'Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.'}, {'id': 'FG001', 'title': 'Tralo 300 mg Q4W', 'description': 'Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.'}], 'periods': [{'title': 'Randomised Through Start Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '401'}, {'groupId': 'FG001', 'numSubjects': '406'}, {'groupId': 'FG002', 'numSubjects': '400'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '398'}, {'groupId': 'FG001', 'numSubjects': '404'}, {'groupId': 'FG002', 'numSubjects': '400'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Did not receive treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Treatment Through Study Completion', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '398'}, {'groupId': 'FG001', 'numSubjects': '404'}, {'groupId': 'FG002', 'numSubjects': '400'}]}, {'type': 'Completed Treatment for Week 52 Cut-off', 'achievements': [{'groupId': 'FG000', 'numSubjects': '332'}, {'groupId': 'FG001', 'numSubjects': '355'}, {'groupId': 'FG002', 'numSubjects': '360'}]}, {'type': 'COMPLETED', 'comment': 'Completed the study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '341'}, {'groupId': 'FG001', 'numSubjects': '361'}, {'groupId': 'FG002', 'numSubjects': '361'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '39'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'First patient enrolled: 13 Jun 2014; Week 52 cut-off: 28 Feb 2017; Last Patient Last Visit Week 72: 18 Jul 2017. Study performed at 254 sites in 14 countries.\n\nPatients were maintained on currently prescribed inhaled corticosteroid long-acting β2-agonist therapy + any additional maintenance asthma controller medications throughout the study period.', 'preAssignmentDetails': '2248 patients signed informed consent, 1669 entered screening/run-in period, 1207 patients were randomised to receive treatment with tralokinumab 300 milligrams (mg), or placebo, every 2 weeks (Q2W) or every 4 weeks (Q4W). Of the 1207 patients randomised, 1202 received investigational product (IP).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'BG000'}, {'value': '404', 'groupId': 'BG001'}, {'value': '400', 'groupId': 'BG002'}, {'value': '1202', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Tralo 300 mg Q2W', 'description': 'Tralokinumab 300 mg administered subcutaneously Q2W over a 52-week treatment period (up to 26 doses). Follow-up visits were conducted at Weeks 56 and 72.'}, {'id': 'BG001', 'title': 'Tralo 300 mg Q4W', 'description': 'Tralokinumab 300 mg administered subcutaneously Q4W over a 52-week treatment period (up to 13 doses). Follow-up visits were conducted at Weeks 56 and 72.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo was administered subcutaneously over a 52-week treatment period. The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W) where the 2 placebo cohorts were given weights proportional to the number of patients in each cohort. Follow-up visits were conducted at Weeks 56 and 72.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.4', 'spread': '14.3', 'groupId': 'BG000'}, {'value': '51.1', 'spread': '13.9', 'groupId': 'BG001'}, {'value': '51.4', 'spread': '14.3', 'groupId': 'BG002'}, {'value': '50.6', 'spread': '14.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '252', 'groupId': 'BG000'}, {'value': '281', 'groupId': 'BG001'}, {'value': '265', 'groupId': 'BG002'}, {'value': '798', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '146', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}, {'value': '404', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '163', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '285', 'groupId': 'BG000'}, {'value': '297', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}, {'value': '870', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All patients in the full analysis set (FAS) who received at least one dose of IP (tralokinumab or placebo) were included in the baseline analysis.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-26', 'size': 1166283, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-06-05T04:53', 'hasProtocol': True}, {'date': '2018-02-26', 'size': 991702, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-06-05T04:53', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1207}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2017-07-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-30', 'studyFirstSubmitDate': '2014-06-05', 'resultsFirstSubmitDate': '2017-12-21', 'studyFirstSubmitQcDate': '2014-06-10', 'lastUpdatePostDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-04-13', 'studyFirstPostDateStruct': {'date': '2014-06-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Annualised Asthma Exacerbation Rate (AAER) up to Week 52', 'timeFrame': 'Baseline (Week 0) up to Week 52', 'description': 'Asthma exacerbation was defined as a worsening of asthma that led to any of the following:\n\n* Use of systemic corticosteroids for at least 3 days; a single depo-injectable dose of corticosteroids was considered equivalent to a 3-day course of systemic corticosteroids.\n* An emergency room (ER) or urgent care (UC) visit (defined as evaluation and treatment for \\<24 hours in an ER or UC centre) due to asthma that required systemic corticosteroids (see above).\n* An inpatient hospitalisation (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥24 hours) due to asthma.\n\nAAER = number of exacerbations\\*365.25 / (follow-up date - date of randomisation + 1) (where maximum follow-up time for a patient was approximately 52 weeks).\n\nAAER in the tralokinumab group was compared to that seen in the placebo group up to Week 52 using a negative binomial model; rate ratios and rate reductions are both presented for comparative statistical analyses.'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline to Week 52 in Pre-dose/Pre-bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1)', 'timeFrame': 'Baseline (Week 0) and Week 52', 'description': 'Lung function was assessed by FEV1 which was measured by spirometry. Spirometry was performed by the Investigator or authorised delegate according to American Thoracic Society/European Respiratory Society guidelines. The mean percent change from baseline in pre-BD FEV1 at Week 52 is presented.'}, {'measure': 'Change From Baseline to Week 52 in Total Asthma Symptom Score (Bi-weekly Means)', 'timeFrame': 'Baseline (Week 0) and Week 52', 'description': 'Asthma symptoms during night-time and daytime were recorded by the patient each morning and evening in the Asthma Daily Diary. Symptoms were recorded using a 4-point response scale, which ranged from 0 to 3, where 0 indicated no asthma symptoms. Asthma symptom daytime score (recorded in the evening), night-time score (recorded in the morning), and total score were calculated separately. The daily asthma symptom total score was calculated by taking the sum of the night-time and daytime asthma symptom scores recorded each day, ranging from 0 to 6. A lower symptom score indicated a better outcome. The change from baseline in bi-weekly mean daily asthma symptom total score is presented.'}, {'measure': 'Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) Total Score', 'timeFrame': 'Baseline (Week 0) and Week 52', 'description': 'The AQLQ(S)+12 is a questionnaire that measures health-related quality of life for patients with asthma aged 12 and older. The questionnaire comprises 32 questions and has 4 separate domains (asthma symptoms, activity limitations, emotional function and environmental stimuli). Patients were asked to recall their experiences during the previous 2 weeks and to score each of the questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The total score was calculated as the mean response to all questions, ranging from 1 (severe impairment) to 7 (no impairment). Individual AQLQ(S)+12 total score changes of ≥0.5 were considered to be clinically meaningful. The mean change from baseline in AQLQ(S)+12 score at Week 52 is presented.'}, {'measure': 'Change From Baseline to Week 52 in Asthma Control Questionnaire-6 (ACQ-6) Score', 'timeFrame': 'Baseline (Week 0) and Week 52', 'description': 'The ACQ-6 questionnaire is a shortened version of the ACQ (omitting FEV1 measurement) that assesses asthma symptoms (night-time awakenings, symptoms on waking, activity limitation, dyspnoea, wheezing) and rescue short-acting β2-agonists medication use during the past week. Questions were weighted equally and scored on a 7-point scale from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-6 score was the mean of the responses, ranging from 0 (totally controlled) to 6 (severely uncontrolled). Mean scores of ≤0.75 indicate well-controlled asthma, scores between 0.75 and ≤1.5 indicate partly controlled asthma and a score \\>1.5 indicates not well-controlled asthma. Individual changes of at least 0.5 were considered to be clinically meaningful. The mean change from baseline in ACQ-6 score at Week 52 is presented.'}, {'measure': 'AAER Associated With an ER/UC Visit, or a Hospitalisation up to Week 52', 'timeFrame': 'Baseline (Week 0) up to Week 52', 'description': 'The annual rate of exacerbations associated with an ER/UC visit or hospitalisation up to Week 52 are presented for non-adjudicated data (i.e. events assessed by the Investigator and recorded in the electronic case report form).\n\nAAER = Number of Exacerbations\\*365.25 / (Follow-up date - Date of randomisation + 1) (where maximum follow-up time for a patient was approximately 52 weeks).'}, {'measure': 'Change From Baseline in European Quality of Life - 5 Dimension 5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Scores at Week 52', 'timeFrame': 'Baseline (Week 0) and Week 52', 'description': 'The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The patient was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. The questionnaire also included a VAS, where the patient was asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state. The mean change from baseline in EQ-5D-5L VAS scores at Week 52 is presented.'}, {'measure': 'Change From Baseline in Total Asthma Rescue Medication Use at Week 52 (Bi-weekly Means)', 'timeFrame': 'Baseline (Week 0) and Week 52', 'description': 'Salbutamol, albuterol or levalbuterol were used as rescue medication during the study in the event of a worsening of asthma symptoms. Rescue medication use was measured by the bi-weekly mean number of inhalations (puffs) per day, calculated as: total morning puffs + total evening puffs + 2\\*(total morning nebuliser use + total evening nebuliser use)/ total number of days with data in bi-weekly period. The change from baseline in bi-weekly mean total asthma rescue medication use at Week 52 is presented.'}, {'measure': 'Change From Baseline in Home Peak Expiratory Flow (PEF) (Morning and Evening) at Week 52', 'timeFrame': 'Baseline (Week 0) and Week 52', 'description': 'Home PEF testing was performed by the patient using an electronic, hand-held spirometer (peak flow meter) and was performed in the morning upon awakening (prior to taking their morning asthma controller) and in the evening at bedtime (prior to taking their evening asthma controller). The mean change from baseline in home PEF values at Week 52 are presented separately for morning and evening.'}, {'measure': 'Change From Baseline in Night-time Awakenings Due to Asthma Requiring Rescue Medication Use at Week 52 (Bi-weekly Means [Percentage])', 'timeFrame': 'Baseline (Week 0) and Week 52', 'description': 'The patient captured night-time awakenings (yes/no) and the use of rescue medication during these awakenings (yes/no) each morning in the Asthma Daily Diary. Night-time awakenings (percentage) was defined as the number of nights with awakenings due to asthma and requiring rescue medication divided by number of nights with data. The change from baseline in bi-weekly means (percentage) night-time awakenings due to asthma requiring rescue medication use at Week 52 is presented.'}, {'measure': 'Number of Patients With ≥1 Asthma Exacerbation up to Week 52', 'timeFrame': 'Baseline (Week 0) up to Week 52', 'description': 'The number of patients with ≥1 asthma exacerbation up to Week 52 is presented.'}, {'measure': 'Work Productivity and Activity Impairment Questionnaire and Classroom Impairment Questions (WPAI+CIQ): Productivity Loss at Week 52', 'timeFrame': 'At Week 52', 'description': "The WPAI+CIQ consists of questions about how asthma and asthma-related issues impact a patient's ability to work, attend classes and perform regular daily activities. The questionnaire contains 10 questions relating to the patient's experience over the previous 7 days. The WPAI+CIQ outcomes for productivity loss are presented separately for those currently employed and for those currently in school and are expressed as mean productivity loss (percentage) at Week 52, with higher numbers indicating less productivity.\n\nWork Productivity Loss = {Q2/(Q2+Q4)+\\[(1-Q2/(Q2+Q4))x(Q5/10)\\]}\\*100 (Absenteeism = Q2/(Q2+Q4)\\*100; Presenteeism = (Q5/10)\\*100).\n\nClass Productivity Loss = {Q7/(Q7+Q8) + \\[(1-Q7/(Q7+Q8))x(Q9/10)\\]}\\*100 (Absenteeism = Q7/ (Q7+Q8)\\*100; Presenteeism = (Q9/10)\\*100).\n\nNote: QX refers to response to question number X on WPAI+CIQ questionnaire."}, {'measure': 'WPAI+CIQ: Activity Impairment at Week 52', 'timeFrame': 'At Week 52', 'description': "The WPAI+CIQ consists of questions about how asthma and asthma-related issues impact a patient's ability to work, attend classes and perform regular daily activities. The questionnaire contains 10 questions relating to the patient's experience over the previous 7 days.\n\nThe WPAI+CIQ outcomes for activity impairment are presented separately for those currently employed and for those currently in school and are expressed as mean impairment percentages at Week 52, with higher numbers indicating greater impairment.\n\nActivity impairment = (Q10/10)\\*100. Note: QX refers to response to question number X on WPAI+CIQ questionnaire."}, {'measure': 'Asthma-related Healthcare Encounters by Type up to Week 52', 'timeFrame': 'Baseline (Week 0) up to Week 52', 'description': "Broad-based healthcare utilisation asthma-related event information was collected by the Investigator/authorised delegate at each visit. At Visit 1, healthcare resource utilisation information was collected with a 1-year recall period; subsequent visits collected information with a recall period of 'since the last scheduled visit'. Total number of times the healthcare encounter occurred was calculated across all patients for each of the following categories:\n\n* Ambulance transport,\n* Emergency room visits,\n* Unscheduled outpatient visits (visit to specialist and/or visit to primary healthcare physician and/or other healthcare visit),\n* Home visits (home visit, physician and/or other healthcare professional),\n* Telephone calls (telephone calls to physician and/or nurse), and\n* Advanced pulmonary function test."}, {'measure': 'Asthma-related Healthcare Encounters by Type up to Week 52: Hospitalisations', 'timeFrame': 'Baseline (Week 0) up to Week 52', 'description': "Broad-based healthcare utilisation asthma-related event information was collected by the Investigator/authorised delegate at each visit. At Visit 1, healthcare resource utilisation information was collected with a 1-year recall period; subsequent visits collected information with a recall period of 'since the last scheduled visit'. Total number of days spent in hospital was calculated across all patients for the following healthcare encounter category:\n\n• Hospitalisations (hospitalisations, intensive care and/or general care)."}, {'measure': 'Asthma-related Healthcare Encounters by Type up to Week 52: Spirometry', 'timeFrame': 'Baseline (Week 0) up to Week 52', 'description': "Broad-based healthcare utilisation asthma-related event information was collected by the Investigator/authorised delegate at each visit. At Visit 1, healthcare resource utilisation information was collected with a 1-year recall period; subsequent visits collected information with a recall period of 'since the last scheduled visit'. Total number of assessments was calculated across all patients for the following healthcare encounter category:\n\n• Spirometry."}, {'measure': 'Serum Trough Concentration (Ctrough) of Tralokinumab During the Study Period up to Week 72', 'timeFrame': 'Blood samples were collected pre-dose at Baseline (Week 0), and at Week 4, Week 8, Week 26, Week 52 and Week 72 (follow-up)', 'description': 'To evaluate the pharmacokinetics (PK), pre-dose blood samples were collected at each visit and tralokinumab concentrations in serum were determined. Mean Ctrough concentrations are presented at each indicated visit up to Week 72.'}, {'measure': 'Number of Patients Positive for Anti-drug Antibodies (ADAs)', 'timeFrame': 'Baseline (Week 0), Week 26, Week 56 (follow-up) and Week 72 (follow-up)', 'description': "ADA assessments performed using a tiered approach (screening, confirmatory and titering assays). Confirmed ADA positive samples were also tested for neutralising antibodies (nAb). ADA prevalence defined as proportion of study population with drug-reactive antibodies at any point in time. ADA incidence (treatment-emergent ADA) defined as sum of treatment-induced (post-baseline ADA positive only) and treatment-boosted ADA. Persistently positive defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive defined as having ≥1 post-baseline ADA positive assessment and not fulfilling conditions of persistently positive. Treatment-boosted ADA defined as baseline positive ADA titer boosted to a 4-fold or higher level following drug administration. In some category titles 'positive' is denoted by 'pos'."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Asthma', 'Reactive Airways', 'Respiratory Tract Disease', 'Obstructive Lung Disease', 'Lung Diseases'], 'conditions': ['Uncontrolled Asthma']}, 'referencesModule': {'references': [{'pmid': '31315668', 'type': 'DERIVED', 'citation': 'Gottlow M, Svensson DJ, Lipkovich I, Huhn M, Bowen K, Wessman P, Colice G. Application of structured statistical analyses to identify a biomarker predictive of enhanced tralokinumab efficacy in phase III clinical trials for severe, uncontrolled asthma. BMC Pulm Med. 2019 Jul 17;19(1):129. doi: 10.1186/s12890-019-0889-4.'}, {'pmid': '30649752', 'type': 'DERIVED', 'citation': 'Carlsson M, Braddock M, Li Y, Wang J, Xu W, White N, Megally A, Hunter G, Colice G. Evaluation of Antibody Properties and Clinically Relevant Immunogenicity, Anaphylaxis, and Hypersensitivity Reactions in Two Phase III Trials of Tralokinumab in Severe, Uncontrolled Asthma. Drug Saf. 2019 Jun;42(6):769-784. doi: 10.1007/s40264-018-00788-w.'}, {'pmid': '29792288', 'type': 'DERIVED', 'citation': 'Panettieri RA Jr, Sjobring U, Peterffy A, Wessman P, Bowen K, Piper E, Colice G, Brightling CE. Tralokinumab for severe, uncontrolled asthma (STRATOS 1 and STRATOS 2): two randomised, double-blind, placebo-controlled, phase 3 clinical trials. Lancet Respir Med. 2018 Jul;6(7):511-525. doi: 10.1016/S2213-2600(18)30184-X. Epub 2018 May 20.'}, {'pmid': '29536781', 'type': 'DERIVED', 'citation': 'Panettieri RA Jr, Wang M, Braddock M, Bowen K, Colice G. Tralokinumab for the treatment of severe, uncontrolled asthma: the ATMOSPHERE clinical development program. Immunotherapy. 2018 Mar 1;10(6):473-490. doi: 10.2217/imt-2017-0191. Epub 2018 Mar 14.'}]}, 'descriptionModule': {'briefSummary': 'A 52-Week, Multicentre, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents with Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist', 'detailedDescription': 'This is a randomized, double-blind, parallel group, placebo-controlled study designed to evaluate efficacy and safety of tralokinumab administered subcutaneously in subjects with uncontrolled asthma on inhaled corticosteroid plus long-acting β2-agonist and having a history of asthma exacerbations.\n\nApproximately 1140 subjects will be randomized globally. Subjects will receive tralokinumab, or placebo, administered via subcutaneous injection at the study site, over a 52-week treatment period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 12 -75\n2. Documented physician-diagnosed asthma.\n3. Documented treatment with ICS at a total daily dose corresponding to ≥500μg fluticasone propionate dry powder formulation equivalents) and a LABA\n4. Morning pre-BD FEV1 value of ≥40 and \\<80% value (\\<90% for patients 12 to 17 years of age) of their PNV.\n5. Post-BD reversibility of ≥12% and ≥200 mL in FEV1\n6. ACQ-6 score ≥1.5\n\nExclusion Criteria:\n\n1. Pulmonary disease other than asthma\n2. History of anaphylaxis following any biologic therapy\n3. Hepatitis B, C or HIV\n4. Pregnant or breastfeeding\n5. History of cancer\n6. Current tobacco smoking or a history of tobacco smoking for ≥ 10 pack-years\n7. Previous receipt of tralokinumab'}, 'identificationModule': {'nctId': 'NCT02161757', 'acronym': 'STRATOS1', 'briefTitle': 'A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist.', 'orgStudyIdInfo': {'id': 'D2210C00007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tralokinumab Dose Regimen 1', 'description': 'Tralokinumab subcutaneous injection', 'interventionNames': ['Biological: Tralokinumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Dose Regimen 1', 'description': 'Placebo subcutaneous injection', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Tralokinumab Dose Regimen 2', 'description': 'Tralokinumab subcutaneous injection', 'interventionNames': ['Biological: Tralokinumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Dose Regimen 2', 'description': 'Placebo subcutaneous injection', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Tralokinumab', 'type': 'BIOLOGICAL', 'description': 'Subcutaneous injection', 'armGroupLabels': ['Tralokinumab Dose Regimen 1', 'Tralokinumab Dose Regimen 2']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Subcutaneous injection', 'armGroupLabels': ['Placebo Dose Regimen 1', 'Placebo Dose Regimen 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85018', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '91007', 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