Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-27 @ 7:18 AM
Study NCT ID:
NCT01914757
Status:
COMPLETED
Last Update Posted:
2017-01-25
First Post:
2013-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety Study of Benralizumab in Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}], 'ancestors': [{'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C571386', 'term': 'benralizumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Mitchell.Goldman@astrazeneca.com', 'phone': '+1 301 398 0323', 'title': 'Mitchell Goldman, Medical Science Director', 'organization': 'AstraZeneca'}, 'certainAgreement': {'otherDetails': "≥ 60 days prior to submission of material for publication/presentation, Institution and PI shall jointly provide AZ with material for review. No publication/presentation may include any of AZ's Confidential Information without AZ's written approval. AZ can request Inst. and PI to withhold material from submission for publication/presentation for an additional 90 days to allow AZ to establish and preserve its proprietary rights in the material being submitted for publication or presentation.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Benralizumab 30 mg q.4 Weeks', 'description': 'Benralizumab administered subcutaneously every 4 weeks', 'otherNumAtRisk': 438, 'otherNumAffected': 244, 'seriousNumAtRisk': 438, 'seriousNumAffected': 46}, {'id': 'EG001', 'title': 'Benralizumab 30 mg q.8 Weeks', 'description': 'Benralizumab administered subcutaneously every 8 weeks', 'otherNumAtRisk': 428, 'otherNumAffected': 232, 'seriousNumAtRisk': 428, 'seriousNumAffected': 41}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously', 'otherNumAtRisk': 440, 'otherNumAffected': 264, 'seriousNumAtRisk': 440, 'seriousNumAffected': 61}], 'otherEvents': [{'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 20, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 19, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 51, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 54, 'numAffected': 45}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 72, 'numAffected': 54}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 27, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 17, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 27, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 132, 'numAffected': 90}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 131, 'numAffected': 82}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 147, 'numAffected': 92}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 21, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 24, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 22, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 31, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 30, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 56, 'numAffected': 39}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 35, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 53, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 53, 'numAffected': 42}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 14, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Back pain', 'stats': 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'numAffected': 52}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 18, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 12, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 25, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 19, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 28, 'numAffected': 24}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 23, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 24, 'numAffected': 22}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastroduodenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rectal polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cholecystitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hepatitis alcoholic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Bacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Bronchitis haemophilus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and 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'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urticaria papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 440, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils >=300/uL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}, {'value': '248', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Benralizumab 30 mg q.4 Weeks', 'description': 'Benralizumab administered subcutaneously every 4 weeks'}, {'id': 'OG001', 'title': 'Benralizumab 30 mg q.8 Weeks', 'description': 'Benralizumab administered subcutaneously every 8 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.48', 'upperLimit': '0.74'}, {'value': '0.66', 'groupId': 'OG001', 'lowerLimit': '0.54', 'upperLimit': '0.82'}, {'value': '0.93', 'groupId': 'OG002', 'lowerLimit': '0.77', 'upperLimit': '1.12'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.64', 'ciLowerLimit': '0.49', 'ciUpperLimit': '0.85', 'statisticalMethod': 'Negative Binomial', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids', 'testedNonInferiority': False}, {'pValue': '0.019', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.72', 'ciLowerLimit': '0.54', 'ciUpperLimit': '0.95', 'statisticalMethod': 'Negative Binomial', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Immediately following the first administration of study drug through Study Week 56.', 'description': 'The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF.', 'unitOfMeasure': 'Events/year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, Baseline eosinophils \\>=300/uL, High-dose ICS.'}, {'type': 'SECONDARY', 'title': 'Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils <300/uL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Benralizumab 30 mg q.4 Weeks', 'description': 'Benralizumab administered subcutaneously every 4 weeks'}, {'id': 'OG001', 'title': 'Benralizumab 30 mg q.8 Weeks', 'description': 'Benralizumab administered subcutaneously every 8 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '0.78', 'groupId': 'OG000', 'lowerLimit': '0.59', 'upperLimit': '1.02'}, {'value': '0.73', 'groupId': 'OG001', 'lowerLimit': '0.55', 'upperLimit': '0.95'}, {'value': '1.21', 'groupId': 'OG002', 'lowerLimit': '0.96', 'upperLimit': '1.52'}]}]}], 'analyses': [{'pValue': '0.015', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.64', 'ciLowerLimit': '0.45', 'ciUpperLimit': '0.92', 'statisticalMethod': 'Negative Binomial', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids', 'testedNonInferiority': False}, {'pValue': '0.005', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '0.42', 'ciUpperLimit': '0.86', 'statisticalMethod': 'Negative Binomial', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes covariates treatment group, region, number of 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'Benralizumab administered subcutaneously every 4 weeks'}, {'id': 'OG001', 'title': 'Benralizumab 30 mg q.8 Weeks', 'description': 'Benralizumab administered subcutaneously every 8 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '0.34', 'spread': '0.469', 'groupId': 'OG000'}, {'value': '0.332', 'spread': '0.518', 'groupId': 'OG001'}, {'value': '0.206', 'spread': '0.471', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.125', 'ciLowerLimit': '0.037', 'ciUpperLimit': '0.213', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit, and treatment by visit', 'testedNonInferiority': False}, {'pValue': '0.01', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.116', 'ciLowerLimit': '0.028', 'ciUpperLimit': '0.204', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit, and treatment by visit', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Immediately following the first administration of study drug through Study Week 56.', 'unitOfMeasure': 'Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, Baseline eosinophils \\>=300/uL, High-dose ICS'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline Eosinophils <300/uL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Benralizumab 30 mg q.4 Weeks', 'description': 'Benralizumab administered subcutaneously every 4 weeks'}, {'id': 'OG001', 'title': 'Benralizumab 30 mg q.8 Weeks', 'description': 'Benralizumab administered subcutaneously every 8 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '0.221', 'spread': '0.441', 'groupId': 'OG000'}, {'value': '0.164', 'spread': '0.358', 'groupId': 'OG001'}, {'value': '0.135', 'spread': '0.437', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.268', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.064', 'ciLowerLimit': '-0.049', 'ciUpperLimit': '0.176', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit, and treatment by visit', 'testedNonInferiority': False}, {'pValue': '0.786', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.015', 'ciLowerLimit': '-0.127', 'ciUpperLimit': '0.096', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit, and treatment by visit', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Immediately following the first administration of study drug through Study Week 56.', 'unitOfMeasure': 'Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, Baseline eosinophils \\<300/uL, High-dose ICS'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Week 56 Asthma Symptoms Score for Patients With Baseline Eosinophils >=300/uL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Benralizumab 30 mg q.4 Weeks', 'description': 'Benralizumab administered subcutaneously every 4 weeks'}, {'id': 'OG001', 'title': 'Benralizumab 30 mg q.8 Weeks', 'description': 'Benralizumab administered subcutaneously every 8 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.33', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '1.17', 'groupId': 'OG001'}, {'value': '-1.2', 'spread': '1.19', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.224', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '0.07', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes treatment, baseline Asthma symptom score, region, use of OCS, visit, and visit by treatment.', 'testedNonInferiority': False}, {'pValue': '0.019', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.23', 'ciLowerLimit': '-0.43', 'ciUpperLimit': '-0.04', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes treatment, baseline Asthma symptom score, region, use of OCS, visit, and visit by treatment.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Immediately following the first administration of study drug through Study Week 56.', 'description': 'Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma). Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each timepoint is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, Baseline eosinophils \\>=300/uL, High-dose ICS'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Week 56 Asthma Symptoms Score for Patients With Baseline Eosinophils <300/uL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Benralizumab 30 mg q.4 Weeks', 'description': 'Benralizumab administered subcutaneously every 4 weeks'}, {'id': 'OG001', 'title': 'Benralizumab 30 mg q.8 Weeks', 'description': 'Benralizumab administered subcutaneously every 8 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.05', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '-0.95', 'spread': '1.13', 'groupId': 'OG001'}, {'value': '-0.88', 'spread': '1.12', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.287', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.44', 'ciUpperLimit': '0.13', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes treatment, baseline Asthma symptom score, region, use of OCS, visit, and visit by treatment.', 'testedNonInferiority': False}, {'pValue': '0.966', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '0.29', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes treatment, baseline Asthma symptom score, region, use of OCS, visit, and visit by treatment.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Immediately following the first administration of study drug through Study Week 56.', 'description': 'Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma). Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each timepoint is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, Baseline eosinophils \\<300/uL, High-dose ICS'}, {'type': 'SECONDARY', 'title': 'Change in Asthma Rescue Medication Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Benralizumab 30 mg q.4 Weeks', 'description': 'Benralizumab administered subcutaneously every 4 weeks'}, {'id': 'OG001', 'title': 'Benralizumab 30 mg q.8 Weeks', 'description': 'Benralizumab administered subcutaneously every 8 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.0', 'spread': '3.64', 'groupId': 'OG000'}, {'value': '-2.92', 'spread': '3.60', 'groupId': 'OG001'}, {'value': '-2.65', 'spread': '9.57', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.603', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.21', 'ciLowerLimit': '-0.58', 'ciUpperLimit': '0.99', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes treatment, baseline Asthma rescue medication use, region, use of OCS, visit, and visit by treatment.', 'testedNonInferiority': False}, {'pValue': '0.209', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-1.29', 'ciUpperLimit': '0.28', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes treatment, baseline Asthma medication use, region, use of OCS, visit, and visit by treatment.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Immediately following the first administration of study drug through Study Week 56.', 'description': 'Change from Baseline to Week 56 in number of Rescue medication use (puffs/day)', 'unitOfMeasure': 'Puffs per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, Baseline eosinophils \\>=300/uL, High-dose ICS'}, {'type': 'SECONDARY', 'title': 'Home Lung Function Assessments Based on PEF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}, {'value': '248', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Benralizumab 30 mg q.4 Weeks', 'description': 'Benralizumab administered subcutaneously every 4 weeks'}, {'id': 'OG001', 'title': 'Benralizumab 30 mg q.8 Weeks', 'description': 'Benralizumab administered subcutaneously every 8 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously'}], 'classes': [{'title': 'Change at Week 56, Morning (n=194, 193, 197)', 'categories': [{'measurements': [{'value': '41.745', 'spread': '78.534', 'groupId': 'OG000'}, {'value': '43.375', 'spread': '91.865', 'groupId': 'OG001'}, {'value': '23.961', 'spread': '71.509', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 56, Evening (n=194, 192, 197)', 'categories': [{'measurements': [{'value': '35.142', 'spread': '75.489', 'groupId': 'OG000'}, {'value': '39.270', 'spread': '89.772', 'groupId': 'OG001'}, {'value': '15.448', 'spread': '78.341', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.029', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.86', 'ciLowerLimit': '1.59', 'ciUpperLimit': '30.12', 'groupDescription': 'Morning PEF Change from Baseline to Week 56', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes treatment, baseline morning PEF, region, use of OCS, visit, and visit by treatment.', 'testedNonInferiority': False}, {'pValue': '0.037', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.27', 'ciLowerLimit': '0.9', 'ciUpperLimit': '29.64', 'groupDescription': 'Morning PEF Change from Baseline to Week 56', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes treatment, baseline morning PEF, region, use of OCS, visit, and visit by treatment.', 'testedNonInferiority': False}, {'pValue': '0.018', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.54', 'ciLowerLimit': '3.07', 'ciUpperLimit': '32', 'groupDescription': 'Evening PEF Change from Baseline to Week 56', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes treatment, baseline evening PEF, region, use of OCS, visit, and visit by treatment.', 'testedNonInferiority': False}, {'pValue': '0.004', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.22', 'ciLowerLimit': '6.65', 'ciUpperLimit': '35.79', 'groupDescription': 'Evening PEF Change from Baseline to Week 56', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes treatment, baseline evening PEF, region, use of OCS, visit, and visit by treatment.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Immediately following the first administration of study drug through Study Week 56.', 'description': 'Change from Baseline to Week 56 in Home lung function (morning and evening Peak expiratory flow \\[PEF\\])', 'unitOfMeasure': 'L/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, Baseline eosinophils \\>=300/uL, High-dose ICS'}, {'type': 'SECONDARY', 'title': 'Proportion of Nights With Awakening Due to Asthma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}, {'value': '203', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Benralizumab 30 mg q.4 Weeks', 'description': 'Benralizumab administered subcutaneously every 4 weeks'}, {'id': 'OG001', 'title': 'Benralizumab 30 mg q.8 Weeks', 'description': 'Benralizumab administered subcutaneously every 8 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.373', 'spread': '0.388', 'groupId': 'OG000'}, {'value': '-0.431', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '-0.372', 'spread': '0.405', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.4', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.06', 'ciUpperLimit': '0.03', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes treatment, baseline prop of nights with nocturnal wakening, region, use of OCS, visit, and visit by treatment.', 'testedNonInferiority': False}, {'pValue': '0.146', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '0.01', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes treatment, baseline prop of nights with nocturnal wakening, region, use of OCS, visit, and visit by treatment.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Immediately following the first administration of study drug through Study Week 56.', 'description': 'Change from Baseline to Week 56 on Proportion of Nights with awakening due to asthma', 'unitOfMeasure': 'Proportion of nights', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, Baseline eosinophils \\>=300/uL, High-dose ICS'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Week 56 in ACQ-6 for Patients With Baseline Eosinophils >=300/uL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}, {'value': '197', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Benralizumab 30 mg q.4 Weeks', 'description': 'Benralizumab administered subcutaneously every 4 weeks'}, {'id': 'OG001', 'title': 'Benralizumab 30 mg q.8 Weeks', 'description': 'Benralizumab administered subcutaneously every 8 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.34', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '-1.49', 'spread': '1.13', 'groupId': 'OG001'}, {'value': '-1.21', 'spread': '1.12', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.043', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.19', 'ciLowerLimit': '-0.38', 'ciUpperLimit': '-0.01', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit, and visit by treatment.', 'testedNonInferiority': False}, {'pValue': '0.008', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.25', 'ciLowerLimit': '-0.44', 'ciUpperLimit': '-0.07', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit, and visit by treatment.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Immediately following the first administration of study drug through Study Week 56.', 'description': 'ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Mean scores of \\<=0.75 indicates well-controlled asthma, scores between 0.75 to \\<=1.5 indicate partly controlled asthma, and \\>1.5 indicates not well controlled asthma.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, Baseline eosinophils \\>=300/uL, High-dose ICS'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Week 56 in ACQ-6 for Patients With Baseline Eosinophils <300/uL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Benralizumab 30 mg q.4 Weeks', 'description': 'Benralizumab administered subcutaneously every 4 weeks'}, {'id': 'OG001', 'title': 'Benralizumab 30 mg q.8 Weeks', 'description': 'Benralizumab administered subcutaneously every 8 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.22', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '-1.06', 'spread': '1.02', 'groupId': 'OG001'}, {'value': '-0.83', 'spread': '1.07', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.078', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.24', 'ciLowerLimit': '-0.51', 'ciUpperLimit': '0.03', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit, and visit by treatment.', 'testedNonInferiority': False}, {'pValue': '0.449', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.37', 'ciUpperLimit': '0.16', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit, and visit by treatment.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Immediately following the first administration of study drug through Study Week 56.', 'description': 'ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Mean scores of \\<=0.75 indicates well-controlled asthma, scores between 0.75 to \\<=1.5 indicate partly controlled asthma, and \\>1.5 indicates not well controlled asthma.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, Baseline eosinophils \\<300/uL, High-dose ICS'}, {'type': 'SECONDARY', 'title': 'Number of Patients With >=1 Asthma Exacerbation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}, {'value': '248', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Benralizumab 30 mg q.4 Weeks', 'description': 'Benralizumab administered subcutaneously every 4 weeks'}, {'id': 'OG001', 'title': 'Benralizumab 30 mg q.8 Weeks', 'description': 'Benralizumab administered subcutaneously every 8 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.46', 'ciLowerLimit': '0.31', 'ciUpperLimit': '0.69', 'groupDescription': 'Proportion of patients with \\>=1 asthma exacerbation', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Controlling for region, number of exacerbations in the previous year, use of OCS', 'testedNonInferiority': False}, {'pValue': '0.023', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.65', 'ciLowerLimit': '0.45', 'ciUpperLimit': '0.95', 'groupDescription': 'Proportion of patients with \\>=1 asthma exacerbation', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Controlling for region, number of exacerbations in the previous year, use of OCS', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Immediately following the first administration of study drug through Study Week 56', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, Baseline eosinophils \\>=300/uL, High-dose ICS'}, {'type': 'SECONDARY', 'title': 'Time to First Asthma Exacerbation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}, {'value': '248', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Benralizumab 30 mg q.4 Weeks', 'description': 'Benralizumab administered subcutaneously every 4 weeks'}, {'id': 'OG001', 'title': 'Benralizumab 30 mg q.8 Weeks', 'description': 'Benralizumab administered subcutaneously every 8 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.61', 'ciLowerLimit': '0.46', 'ciUpperLimit': '0.80', 'groupDescription': 'Time to first Exacerbation', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes treatment, region, number of exacerbations in the previous year, use of OCS', 'testedNonInferiority': False}, {'pValue': '0.018', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.73', 'ciLowerLimit': '0.55', 'ciUpperLimit': '0.95', 'groupDescription': 'Time to first asthma exacerbation', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes treatment, region, number of exacerbations in the previous year, use of OCS', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Immediately following the first administration of study drug through Study Week 56', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, Baseline eosinophils \\>=300/uL, High-dose ICS'}, {'type': 'SECONDARY', 'title': 'Annual Rate of Asthma Exacerbation Resulting Emergency Room Visits and Hospitalizations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}, {'value': '248', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Benralizumab 30 mg q.4 Weeks', 'description': 'Benralizumab administered subcutaneously every 4 weeks'}, {'id': 'OG001', 'title': 'Benralizumab 30 mg q.8 Weeks', 'description': 'Benralizumab administered subcutaneously every 8 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '0.04', 'groupId': 'OG000', 'lowerLimit': '0.02', 'upperLimit': '0.06'}, {'value': '0.05', 'groupId': 'OG001', 'lowerLimit': '0.03', 'upperLimit': '0.08'}, {'value': '0.04', 'groupId': 'OG002', 'lowerLimit': '0.02', 'upperLimit': '0.07'}]}]}], 'analyses': [{'pValue': '0.837', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.48', 'ciUpperLimit': '1.82', 'statisticalMethod': 'negative binomial', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes treatment, region, any prior exacerbation resulting ER/Hospitalization, use of OCS', 'testedNonInferiority': False}, {'pValue': '0.538', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.23', 'ciLowerLimit': '0.64', 'ciUpperLimit': '2.35', 'statisticalMethod': 'negative binomial', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes treatment, region, any prior exacerbation resulting ER/Hospitalization, use of OCS', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Immediately following the first administration of study drug through Study Week 56.', 'description': 'Annual rate of asthma exacerbations that are associated with an emergency room visit or a hospitalization (adjudicated)', 'unitOfMeasure': 'Events/year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, Baseline eosinophils \\>=300/uL, High-dose ICS'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics of Benralizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '435', 'groupId': 'OG000'}, {'value': '424', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Benralizumab 30 mg q.4 Weeks', 'description': 'Benralizumab administered subcutaneously every 4 weeks'}, {'id': 'OG001', 'title': 'Benralizumab 30 mg q.8 Weeks', 'description': 'Benralizumab administered subcutaneously every 8 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously'}], 'classes': [{'title': 'Baseline (n=435, 419)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Value is less than lower limit of quantification', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Value is less than lower limit of quantification', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=430, 416)', 'categories': [{'measurements': [{'value': '650.04', 'spread': '154.61', 'groupId': 'OG000'}, {'value': '703.16', 'spread': '89.48', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 (n=414, 395)', 'categories': [{'measurements': [{'value': '894.86', 'spread': '148.91', 'groupId': 'OG000'}, {'value': '939.45', 'spread': '98.99', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n=390, 378)', 'categories': [{'measurements': [{'value': '936.43', 'spread': '247.46', 'groupId': 'OG000'}, {'value': '252.54', 'spread': '274.74', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 (n=388, 361)', 'categories': [{'measurements': [{'value': '827.09', 'spread': '370.64', 'groupId': 'OG000'}, {'value': '188.99', 'spread': '308.38', 'groupId': 'OG001'}]}]}, {'title': 'Week 32 (n=345, 323)', 'categories': [{'measurements': [{'value': '823.21', 'spread': '362.43', 'groupId': 'OG000'}, {'value': '166.53', 'spread': '289.34', 'groupId': 'OG001'}]}]}, {'title': 'Week 40 (n=370, 338)', 'categories': [{'measurements': [{'value': '859.69', 'spread': '364.28', 'groupId': 'OG000'}, {'value': '172.28', 'spread': '298.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 (n=355, 337)', 'categories': [{'measurements': [{'value': '888.09', 'spread': '333.98', 'groupId': 'OG000'}, {'value': '186.5', 'spread': '290.28', 'groupId': 'OG001'}]}]}, {'title': 'Week 56 (n=358, 344)', 'categories': [{'measurements': [{'value': '763.98', 'spread': '309.18', 'groupId': 'OG000'}, {'value': '173.41', 'spread': '235.86', 'groupId': 'OG001'}]}]}, {'title': 'Week 60 (n=49, 45)', 'categories': [{'measurements': [{'value': '53.63', 'spread': '1782.96', 'groupId': 'OG000'}, {'value': '18.63', 'spread': '756.47', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48, Week 56, Week 60', 'description': 'Mean PK Concentration at each visit', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set'}, {'type': 'SECONDARY', 'title': 'Immunogenicity of Benralizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '438', 'groupId': 'OG000'}, {'value': '427', 'groupId': 'OG001'}, {'value': '440', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Benralizumab 30 mg q.4 Weeks', 'description': 'Benralizumab administered subcutaneously every 4 weeks'}, {'id': 'OG001', 'title': 'Benralizumab 30 mg q.8 Weeks', 'description': 'Benralizumab administered subcutaneously every 8 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously'}], 'classes': [{'title': 'Positive at any visit (n=438, 427, 440)', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'Base- and Post-baseline Postive (n=431, 414, 430)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Only post-baseline positive (n=431, 420, 436)', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Persistently positive (n=431, 420, 436)', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Transient positive (n=431, 420, 436)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Only baseline positive (n=438, 421, 434)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Pre-treatment until end of follow-up', 'description': 'Anti-drug antibodies (ADA) responses at baseline and post baseline. Persistently positive is 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 is defined as having at least one post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set'}, {'type': 'SECONDARY', 'title': 'Extent of Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '438', 'groupId': 'OG000'}, {'value': '428', 'groupId': 'OG001'}, {'value': '440', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Benralizumab 30 mg q.4 Weeks', 'description': 'Benralizumab administered subcutaneously every 4 weeks'}, {'id': 'OG001', 'title': 'Benralizumab 30 mg q.8 Weeks', 'description': 'Benralizumab administered subcutaneously every 8 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '344.14', 'spread': '73.129', 'groupId': 'OG000'}, {'value': '331.64', 'spread': '88.839', 'groupId': 'OG001'}, {'value': '336.69', 'spread': '82.148', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately following the first administration of study drug through Study Week 56', 'description': 'Extent of exposure is defined as the duration of treatment in days', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Week 56 in AQLQ(S)+12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}, {'value': '191', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Benralizumab 30 mg q.4 Weeks', 'description': 'Benralizumab administered subcutaneously every 4 weeks'}, {'id': 'OG001', 'title': 'Benralizumab 30 mg q.8 Weeks', 'description': 'Benralizumab administered subcutaneously every 8 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '1.44', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '1.61', 'spread': '1.24', 'groupId': 'OG001'}, {'value': '1.32', 'spread': '1.19', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.119', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.16', 'ciLowerLimit': '-0.04', 'ciUpperLimit': '0.37', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes treatment, baseline AQLQ score, region, use of OCS, visit, visit by treatment.', 'testedNonInferiority': False}, {'pValue': '0.019', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.24', 'ciLowerLimit': '0.04', 'ciUpperLimit': '0.45', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model includes treatment, baseline AQLQ score, region, use of OCS, visit, visit by treatment.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Immediately following the first administration of study drug through Study Week 56', 'description': 'AQLQ(S)+12 overall score is defined as the average of all 32 questions in the AQLQ(S)+12 questionnaire. AQLQ(S)+12 is a 7-point scale questionnaire, ranging from 7 (no impairment) to 1 (severe impairment). Total or domain score change of \\>=0.5 are considered clinically meaningful.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, Baseline eosinophils \\>=300/uL, High-dose ICS'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 56 in EQ-5D-5L VAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}, {'value': '191', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Benralizumab 30 mg q.4 Weeks', 'description': 'Benralizumab administered subcutaneously every 4 weeks'}, {'id': 'OG001', 'title': 'Benralizumab 30 mg q.8 Weeks', 'description': 'Benralizumab administered subcutaneously every 8 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '13.8', 'spread': '21.52', 'groupId': 'OG000'}, {'value': '15.5', 'spread': '20.36', 'groupId': 'OG001'}, {'value': '12.1', 'spread': '20.13', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately following the first administration of study drug through Study Week 56', 'description': 'EQ-5D-5L VAS is to rate current health status on a scale of 0-100, with 0 being the worst imaginable health state.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, Baseline eosinophils \\>=300/uL, High-dose ICS'}, {'type': 'SECONDARY', 'title': 'Mean Work Productivity Loss Due to Asthma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Benralizumab 30 mg q.4 Weeks', 'description': 'Benralizumab administered subcutaneously every 4 weeks'}, {'id': 'OG001', 'title': 'Benralizumab 30 mg q.8 Weeks', 'description': 'Benralizumab administered subcutaneously every 8 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '26.56', 'spread': '25.589', 'groupId': 'OG000'}, {'value': '24.44', 'spread': '24.689', 'groupId': 'OG001'}, {'value': '27.29', 'spread': '25.802', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately following the first administration of study drug through Study Week 56', 'description': 'WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Work productivity loss is derived by sum of percentage of missed work due to asthma and product of percentage of actual working hours times degree of asthma affecting work productivity while working. Percentage of missed work due to asthma is calculated by number of hours missed work due to asthma divided by total number of hours missed work plus number of hours actually worked. This is only applicable to patients who were employed.', 'unitOfMeasure': 'Percent of productivity loss', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, Baseline eosinophils \\>=300/uL, High-dose ICS, who were employed'}, {'type': 'SECONDARY', 'title': 'Mean Productivity Loss Due to Asthma in Classroom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Benralizumab 30 mg q.4 Weeks', 'description': 'Benralizumab administered subcutaneously every 4 weeks'}, {'id': 'OG001', 'title': 'Benralizumab 30 mg q.8 Weeks', 'description': 'Benralizumab administered subcutaneously every 8 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '19.92', 'spread': '23.765', 'groupId': 'OG000'}, {'value': '14', 'spread': '16.733', 'groupId': 'OG001'}, {'value': '33.5', 'spread': '25.593', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately following the first administration of study drug through Study Week 56', 'description': 'WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Classroom productivity loss is derived by sum of percentage of missed classes due to asthma and product of percentage of actual hours attending classes times degree of asthma affecting classroom productivity. Percentage of missed classes due to asthma is calculated by number of hours missed classes due to asthma divided by total number of hours missed classes plus number of hours actually attending classes. This is only applicable for patients who took classes.', 'unitOfMeasure': 'percent of productivity loss', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, Baseline eosinophils \\>=300/uL, High-dose ICS, who took classes'}, {'type': 'SECONDARY', 'title': 'Number of Participants That Utilized Health Care Resources', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}, {'value': '248', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Benralizumab 30 mg q.4 Weeks', 'description': 'Benralizumab administered subcutaneously every 4 weeks'}, {'id': 'OG001', 'title': 'Benralizumab 30 mg q.8 Weeks', 'description': 'Benralizumab administered subcutaneously every 8 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously'}], 'classes': [{'title': 'Hospitalizations', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'Emergency department visits', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'Unscheduled outpatient visits', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}]}, {'title': 'Home visits', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Telephone calls', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}]}, {'title': 'Ambulance transports', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Immediately following the first administration of study drug through Study Week 56', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, Baseline eosinophils \\>=300/uL, High-dose ICS'}, {'type': 'SECONDARY', 'title': 'Patient and Clinician Assessment of Response to Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}, {'value': '248', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Benralizumab 30 mg q.4 Weeks', 'description': 'Benralizumab administered subcutaneously every 4 weeks'}, {'id': 'OG001', 'title': 'Benralizumab 30 mg q.8 Weeks', 'description': 'Benralizumab administered subcutaneously every 8 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously'}], 'classes': [{'title': 'CGIC, Improved', 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}]}, {'title': 'CGIC, Much Improved', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}]}, {'title': 'CGIC, Very Much Improved', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'CGIC, Total', 'categories': [{'measurements': [{'value': '217', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}]}]}, {'title': 'PGIC, Improved', 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}]}]}, {'title': 'PGIC, Much Improved', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}]}, {'title': 'PGIC, Very Much Improved', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}, {'title': 'PGIC, Total', 'categories': [{'measurements': [{'value': '226', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}, {'value': '182', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Immediately following the first administration of study drug through Study Week 56', 'description': 'CGIC (clinician global impression of change), and PGIC (patient global impression of change) are overall evaluation of response to treatment, conducted separately by investigator and patient using a 7-point rating scale, ranging from 1 (Very much Improved), to 7 (Very much Worse). This endpoint was added after the second protocol amendment, thus not all patients had data to be analyzed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, Baseline eosinophils \\>=300/uL, High-dose ICS'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Benralizumab 30 mg q.4 Weeks', 'description': 'Benralizumab administered subcutaneously every 4 weeks'}, {'id': 'FG001', 'title': 'Benralizumab 30 mg q.8 Weeks', 'description': 'Benralizumab administered subcutaneously every 8 weeks'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '425'}, {'groupId': 'FG001', 'numSubjects': '441'}, {'groupId': 'FG002', 'numSubjects': '440'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '389'}, {'groupId': 'FG001', 'numSubjects': '390'}, {'groupId': 'FG002', 'numSubjects': '402'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '38'}]}], 'dropWithdraws': [{'type': 'Severe non-compliance to protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '19'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Study specific withdrawal criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Eligibility criteria not fulfilled', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Other reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}], 'preAssignmentDetails': '2505 participants signed informed consent, 2181 entered screening/run-in period, 1306 participants were randomised to receive treatment with benralizumab 30 mg Q4W, Q8W, or placebo. Of the 1306 patients randomised, all (100.0%) received treatment with study drug.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '425', 'groupId': 'BG000'}, {'value': '441', 'groupId': 'BG001'}, {'value': '440', 'groupId': 'BG002'}, {'value': '1306', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Benralizumab 30 mg q.4 Weeks', 'description': 'Benralizumab administered subcutaneously every 4 weeks'}, {'id': 'BG001', 'title': 'Benralizumab 30 mg q.8 Weeks', 'description': 'Benralizumab administered subcutaneously every 8 weeks'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo administered subcutaneously'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.0', 'spread': '13.6', 'groupId': 'BG000'}, {'value': '49', 'spread': '14.3', 'groupId': 'BG001'}, {'value': '48.8', 'spread': '15.1', 'groupId': 'BG002'}, {'value': '49.2', 'spread': '14.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '270', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '264', 'groupId': 'BG002'}, {'value': '807', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '155', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '176', 'groupId': 'BG002'}, {'value': '499', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, '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': 2508}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-30', 'studyFirstSubmitDate': '2013-07-31', 'resultsFirstSubmitDate': '2016-09-08', 'studyFirstSubmitQcDate': '2013-07-31', 'lastUpdatePostDateStruct': {'date': '2017-01-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-11-30', 'studyFirstPostDateStruct': {'date': '2013-08-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils >=300/uL', 'timeFrame': 'Immediately following the first administration of study drug through Study Week 56.', 'description': 'The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF.'}], 'secondaryOutcomes': [{'measure': 'Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils <300/uL', 'timeFrame': 'Immediately following the first administration of study drug through Study Week 56.', 'description': 'The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF.'}, {'measure': 'Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline Eosinophils >=300/uL', 'timeFrame': 'Immediately following the first administration of study drug through Study Week 56.'}, {'measure': 'Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline Eosinophils <300/uL', 'timeFrame': 'Immediately following the first administration of study drug through Study Week 56.'}, {'measure': 'Mean Change From Baseline to Week 56 Asthma Symptoms Score for Patients With Baseline Eosinophils >=300/uL', 'timeFrame': 'Immediately following the first administration of study drug through Study Week 56.', 'description': 'Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma). Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each timepoint is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better.'}, {'measure': 'Mean Change From Baseline to Week 56 Asthma Symptoms Score for Patients With Baseline Eosinophils <300/uL', 'timeFrame': 'Immediately following the first administration of study drug through Study Week 56.', 'description': 'Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma). Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each timepoint is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better.'}, {'measure': 'Change in Asthma Rescue Medication Use', 'timeFrame': 'Immediately following the first administration of study drug through Study Week 56.', 'description': 'Change from Baseline to Week 56 in number of Rescue medication use (puffs/day)'}, {'measure': 'Home Lung Function Assessments Based on PEF', 'timeFrame': 'Immediately following the first administration of study drug through Study Week 56.', 'description': 'Change from Baseline to Week 56 in Home lung function (morning and evening Peak expiratory flow \\[PEF\\])'}, {'measure': 'Proportion of Nights With Awakening Due to Asthma', 'timeFrame': 'Immediately following the first administration of study drug through Study Week 56.', 'description': 'Change from Baseline to Week 56 on Proportion of Nights with awakening due to asthma'}, {'measure': 'Mean Change From Baseline to Week 56 in ACQ-6 for Patients With Baseline Eosinophils >=300/uL', 'timeFrame': 'Immediately following the first administration of study drug through Study Week 56.', 'description': 'ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Mean scores of \\<=0.75 indicates well-controlled asthma, scores between 0.75 to \\<=1.5 indicate partly controlled asthma, and \\>1.5 indicates not well controlled asthma.'}, {'measure': 'Mean Change From Baseline to Week 56 in ACQ-6 for Patients With Baseline Eosinophils <300/uL', 'timeFrame': 'Immediately following the first administration of study drug through Study Week 56.', 'description': 'ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Mean scores of \\<=0.75 indicates well-controlled asthma, scores between 0.75 to \\<=1.5 indicate partly controlled asthma, and \\>1.5 indicates not well controlled asthma.'}, {'measure': 'Number of Patients With >=1 Asthma Exacerbation', 'timeFrame': 'Immediately following the first administration of study drug through Study Week 56'}, {'measure': 'Time to First Asthma Exacerbation', 'timeFrame': 'Immediately following the first administration of study drug through Study Week 56'}, {'measure': 'Annual Rate of Asthma Exacerbation Resulting Emergency Room Visits and Hospitalizations', 'timeFrame': 'Immediately following the first administration of study drug through Study Week 56.', 'description': 'Annual rate of asthma exacerbations that are associated with an emergency room visit or a hospitalization (adjudicated)'}, {'measure': 'Pharmacokinetics of Benralizumab', 'timeFrame': 'Baseline, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48, Week 56, Week 60', 'description': 'Mean PK Concentration at each visit'}, {'measure': 'Immunogenicity of Benralizumab', 'timeFrame': 'Pre-treatment until end of follow-up', 'description': 'Anti-drug antibodies (ADA) responses at baseline and post baseline. Persistently positive is 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 is defined as having at least one post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive.'}, {'measure': 'Extent of Exposure', 'timeFrame': 'Immediately following the first administration of study drug through Study Week 56', 'description': 'Extent of exposure is defined as the duration of treatment in days'}, {'measure': 'Mean Change From Baseline to Week 56 in AQLQ(S)+12', 'timeFrame': 'Immediately following the first administration of study drug through Study Week 56', 'description': 'AQLQ(S)+12 overall score is defined as the average of all 32 questions in the AQLQ(S)+12 questionnaire. AQLQ(S)+12 is a 7-point scale questionnaire, ranging from 7 (no impairment) to 1 (severe impairment). Total or domain score change of \\>=0.5 are considered clinically meaningful.'}, {'measure': 'Change From Baseline to Week 56 in EQ-5D-5L VAS', 'timeFrame': 'Immediately following the first administration of study drug through Study Week 56', 'description': 'EQ-5D-5L VAS is to rate current health status on a scale of 0-100, with 0 being the worst imaginable health state.'}, {'measure': 'Mean Work Productivity Loss Due to Asthma', 'timeFrame': 'Immediately following the first administration of study drug through Study Week 56', 'description': 'WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Work productivity loss is derived by sum of percentage of missed work due to asthma and product of percentage of actual working hours times degree of asthma affecting work productivity while working. Percentage of missed work due to asthma is calculated by number of hours missed work due to asthma divided by total number of hours missed work plus number of hours actually worked. This is only applicable to patients who were employed.'}, {'measure': 'Mean Productivity Loss Due to Asthma in Classroom', 'timeFrame': 'Immediately following the first administration of study drug through Study Week 56', 'description': 'WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Classroom productivity loss is derived by sum of percentage of missed classes due to asthma and product of percentage of actual hours attending classes times degree of asthma affecting classroom productivity. Percentage of missed classes due to asthma is calculated by number of hours missed classes due to asthma divided by total number of hours missed classes plus number of hours actually attending classes. This is only applicable for patients who took classes.'}, {'measure': 'Number of Participants That Utilized Health Care Resources', 'timeFrame': 'Immediately following the first administration of study drug through Study Week 56'}, {'measure': 'Patient and Clinician Assessment of Response to Treatment', 'timeFrame': 'Immediately following the first administration of study drug through Study Week 56', 'description': 'CGIC (clinician global impression of change), and PGIC (patient global impression of change) are overall evaluation of response to treatment, conducted separately by investigator and patient using a 7-point rating scale, ranging from 1 (Very much Improved), to 7 (Very much Worse). This endpoint was added after the second protocol amendment, thus not all patients had data to be analyzed.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive Lung Diseases'], 'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '35287231', 'type': 'DERIVED', 'citation': 'Menzies-Gow A, Hoyte FL, Price DB, Cohen D, Barker P, Kreindler J, Jison M, Brooks CL, Papeleu P, Katial R. Clinical Remission in Severe Asthma: A Pooled Post Hoc Analysis of the Patient Journey with Benralizumab. Adv Ther. 2022 May;39(5):2065-2084. doi: 10.1007/s12325-022-02098-1. Epub 2022 Mar 14.'}, {'pmid': '32334141', 'type': 'DERIVED', 'citation': 'Lugogo NL, Kreindler JL, Martin UJ, Cook B, Hirsch I, Trudo FJ. Blood eosinophil count group shifts and kinetics in severe eosinophilic asthma. Ann Allergy Asthma Immunol. 2020 Aug;125(2):171-176. doi: 10.1016/j.anai.2020.04.011. Epub 2020 Apr 22.'}, {'pmid': '31836949', 'type': 'DERIVED', 'citation': 'Jackson DJ, Humbert M, Hirsch I, Newbold P, Garcia Gil E. Ability of Serum IgE Concentration to Predict Exacerbation Risk and Benralizumab Efficacy for Patients with Severe Eosinophilic Asthma. Adv Ther. 2020 Feb;37(2):718-729. doi: 10.1007/s12325-019-01191-2. Epub 2019 Dec 14.'}, {'pmid': '31626906', 'type': 'DERIVED', 'citation': 'Chipps BE, Hirsch I, Trudo F, Alacqua M, Zangrilli JG. Benralizumab efficacy for patients with fixed airflow obstruction and severe, uncontrolled eosinophilic asthma. Ann Allergy Asthma Immunol. 2020 Jan;124(1):79-86. doi: 10.1016/j.anai.2019.10.006. Epub 2019 Oct 15.'}, {'pmid': '30802500', 'type': 'DERIVED', 'citation': 'Chupp G, Lugogo NL, Kline JN, Ferguson GT, Hirsch I, Goldman M, Zangrilli JG, Trudo F. Rapid onset of effect of benralizumab on morning peak expiratory flow in severe, uncontrolled asthma. Ann Allergy Asthma Immunol. 2019 May;122(5):478-485. doi: 10.1016/j.anai.2019.02.016. Epub 2019 Feb 23.'}, {'pmid': '30139780', 'type': 'DERIVED', 'citation': 'Bleecker ER, Wechsler ME, FitzGerald JM, Menzies-Gow A, Wu Y, Hirsch I, Goldman M, Newbold P, Zangrilli JG. Baseline patient factors impact on the clinical efficacy of benralizumab for severe asthma. Eur Respir J. 2018 Oct 18;52(4):1800936. doi: 10.1183/13993003.00936-2018. Print 2018 Oct.'}, {'pmid': '30077185', 'type': 'DERIVED', 'citation': 'DuBuske L, Newbold P, Wu Y, Trudo F. Seasonal variability of exacerbations of severe, uncontrolled eosinophilic asthma and clinical benefits of benralizumab. Allergy Asthma Proc. 2018 Sep 4;39(5):345-349. doi: 10.2500/aap.2018.39.4162. Epub 2018 Aug 4.'}, {'pmid': '29409951', 'type': 'DERIVED', 'citation': 'Chipps BE, Newbold P, Hirsch I, Trudo F, Goldman M. Benralizumab efficacy by atopy status and serum immunoglobulin E for patients with severe, uncontrolled asthma. Ann Allergy Asthma Immunol. 2018 May;120(5):504-511.e4. doi: 10.1016/j.anai.2018.01.030. Epub 2018 Feb 1.'}, {'pmid': '29128192', 'type': 'DERIVED', 'citation': 'Ohta K, Adachi M, Tohda Y, Kamei T, Kato M, Mark Fitzgerald J, Takanuma M, Kakuno T, Imai N, Wu Y, Aurivillius M, Goldman M. Efficacy and safety of benralizumab in Japanese patients with severe, uncontrolled eosinophilic asthma. Allergol Int. 2018 Apr;67(2):266-272. doi: 10.1016/j.alit.2017.10.004. Epub 2017 Nov 8.'}, {'pmid': '27609406', 'type': 'DERIVED', 'citation': 'FitzGerald JM, Bleecker ER, Nair P, Korn S, Ohta K, Lommatzsch M, Ferguson GT, Busse WW, Barker P, Sproule S, Gilmartin G, Werkstrom V, Aurivillius M, Goldman M; CALIMA study investigators. Benralizumab, an anti-interleukin-5 receptor alpha monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2016 Oct 29;388(10056):2128-2141. doi: 10.1016/S0140-6736(16)31322-8. Epub 2016 Sep 5.'}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1823&filename=d3250c00018_Revised_CSP_CALIMA..pdf', 'label': 'D3250C00018CSP3redacted'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Benralizumab reduces the exacerbation rate in patients with a history of asthma exacerbations and uncontrolled asthma receiving ICS-LABA with or without oral corticosteroids and additional asthma controllers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Provision of informed consent prior to any study specific procedures\n2. Female and male aged 12 to 75 years, inclusively, at the time of Visit 1\n3. History of physician-diagnosed asthma requiring treatment with medium-to-high dose ICS (\\>250µg fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 months prior to Visit 1.\n4. Documented treatment with ICS and LABA for at least 3 months prior to Visit 1 with or without oral corticosteroids and additional asthma controllers. The ICS and LABA can be parts of a combination product or given by separate inhalers. The ICS dose must be greater than or equal to 500 μg/day fluticasone propionate dry powder formulation or equivalent daily. For ICS/LABA combination preparations, the mid-strength approved maintenance dose in the local country will meet this ICS criterion.\n\nExclusion criteria:\n\n1. Clinically important pulmonary disease other than asthma (e.g. active lung infection, COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (e.g. allergic bronchopulmonary aspergillosis/mycosis, Churg- Strauss syndrome, hypereosinophilic syndrome)\n2. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could:\n\n * Affect the safety of the patient throughout the study\n * Influence the findings of the studies or their interpretations\n * Impede the patient's ability to complete the entire duration of study\n3. Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period\n4. Any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry, or urinalysis during screening/run-in period, which in the opinion of the Investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patient's ability to complete entire duration of the study"}, 'identificationModule': {'nctId': 'NCT01914757', 'briefTitle': 'Efficacy and Safety Study of Benralizumab in Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Multicentre, Randomized, Double-blind, Parallel Group, Placebocontrolled, Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab in Asthmatic Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist (CALIMA)', 'orgStudyIdInfo': {'id': 'D3250C00018'}}, 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