Ignite Creation Date:
2025-12-24 @ 1:05 PM
Ignite Modification Date:
2025-12-28 @ 2:37 AM
Study NCT ID:
NCT01238861
Status:
COMPLETED
Last Update Posted:
2016-11-17
First Post:
2010-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Efficacy and Safety of MEDI-563 in Adults With Uncontrolled Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['South Africa']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'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': 'vandermerwer@medimmune.com', 'phone': '301-398-0000', 'title': 'Rene van der Merwe, MBChB, MFPM, Medical Officer', 'organization': 'MedImmune, LLC'}, 'certainAgreement': {'otherDetails': 'MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From initiation of investigational product administration up to Week 92', 'description': 'The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .', 'eventGroups': [{'id': 'EG000', 'title': 'EOS POS Placebo', 'description': 'EOS+ participants received two placebo injections subcutaneously.', 'otherNumAtRisk': 80, 'otherNumAffected': 44, 'seriousNumAtRisk': 80, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'EOS POS Benralizumab 2 mg', 'description': 'EOS+ participants received single benralizumab 2 milligram (mg) injection followed by a single placebo injection subcutaneously.', 'otherNumAtRisk': 81, 'otherNumAffected': 54, 'seriousNumAtRisk': 81, 'seriousNumAffected': 10}, {'id': 'EG002', 'title': 'EOS POS Benralizumab 20 mg', 'description': 'EOS+ participants received single benralizumab 20 mg injection followed by a single placebo injection subcutaneously.', 'otherNumAtRisk': 81, 'otherNumAffected': 57, 'seriousNumAtRisk': 81, 'seriousNumAffected': 6}, {'id': 'EG003', 'title': 'EOS POS Benralizumab 100 mg', 'description': 'EOS+ participants received two benralizumab 50 mg injections subcutaneously.', 'otherNumAtRisk': 82, 'otherNumAffected': 68, 'seriousNumAtRisk': 82, 'seriousNumAffected': 6}, {'id': 'EG004', 'title': 'EOS NEG Placebo', 'description': 'EOS- participants received two placebo injections subcutaneously.', 'otherNumAtRisk': 141, 'otherNumAffected': 94, 'seriousNumAtRisk': 141, 'seriousNumAffected': 16}, {'id': 'EG005', 'title': 'EOS NEG Benralizumab 100 mg', 'description': 'EOS- participants received two benralizumab 50 mg injections subcutaneously.', 'otherNumAtRisk': 141, 'otherNumAffected': 93, 'seriousNumAtRisk': 141, 'seriousNumAffected': 18}], 'otherEvents': [{'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 17, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 17, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 141, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 141, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 141, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 17, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 141, 'numEvents': 12, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 141, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 141, 'numEvents': 20, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 13, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 19, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 13, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 141, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 17, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 141, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 141, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 7, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Upper respiratory tract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 12, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 141, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 14, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 141, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 13, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 13, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 141, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 17, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 51, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 59, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 42, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 36, 'numAffected': 26}, {'groupId': 'EG004', 'numAtRisk': 141, 'numEvents': 67, 'numAffected': 42}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 77, 'numAffected': 42}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 13, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 141, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 11, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 141, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'seriousEvents': [{'term': 'Acute myocardial infarct', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Supraventricular tachyca', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 4, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastrooesophageal reflux', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, 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{'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Lower respiratory tract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Post procedural cellulit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Postoperative wound infe', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Tonsillitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Ulna fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Interstitial lung diseas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Polyarteritis nodosa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Annual Asthma Exacerbation Rate (AER) for Eosinophilic Phenotype (EOS+) Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Eosinophilic Phenotype (EOS+) Placebo', 'description': "EOS+ (defined as ELEN Index \\[proprietary mathematical algorithm to predict sputum eosinophil's greater than or equal to 2 percent\\] positive and/or FeNO \\[fraction of exhaled nitric oxide\\] greater than or equal to \\[\\>=\\] 50 parts per billion \\[ppb\\]) participants received matching placebo subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40."}, {'id': 'OG001', 'title': 'EOS+ Benralizumab, 2 mg', 'description': 'EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'OG002', 'title': 'EOS+ Benralizumab, 20 mg', 'description': 'EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'OG003', 'title': 'EOS+ Benralizumab, 100 mg', 'description': 'EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.57', 'groupId': 'OG000'}, {'value': '0.65', 'groupId': 'OG001'}, {'value': '0.37', 'groupId': 'OG002'}, {'value': '0.34', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.781', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.09', 'ciLowerLimit': '0.74', 'ciUpperLimit': '1.59', 'estimateComment': 'The p-value was calculated by Poisson regression with over-dispersion adjustment factor. The correction for potential over dispersion was made by Pearson chi-square.', 'statisticalMethod': 'Poisson Regression Method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.173', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.64', 'ciLowerLimit': '0.42', 'ciUpperLimit': '0.97', 'estimateComment': 'The p-value was calculated by Poisson regression with over-dispersion adjustment factor. The correction for potential over dispersion was made by Pearson chi-square.', 'statisticalMethod': 'Poisson Regression Method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.096', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.59', 'ciLowerLimit': '0.40', 'ciUpperLimit': '0.89', 'estimateComment': 'The p-value was calculated by Poisson regression with over-dispersion adjustment factor. The correction for potential over dispersion was made by Pearson chi-square.', 'statisticalMethod': 'Poisson Regression Method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 1 up to Week 52', 'description': 'The annual asthma exacerbation rate (AER) was calculated as the total number of observed exacerbations in each group up to week 52, divided by total duration of person-year follow-up in each group. An asthma exacerbation is defined as a progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 days as prescribed or administered by the investigator or healthcare provider; or 2) participant initiation of systemic corticosteroids (tablets, suspension or injection) for a duration of at least 3 days as outlined in the Asthma Action Plan provided to the participant by the investigator on Day 1.', 'unitOfMeasure': 'AER events/person-year', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified intent-to-treat (mITT) population included all randomized participants who received any dose of investigational product.'}, {'type': 'SECONDARY', 'title': 'Dose Response in EOS+ Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'EOS+ Placebo', 'description': 'EOS+ participants received two placebo injections subcutaneously.'}, {'id': 'OG001', 'title': 'EOS+ Benralizumab, 2 mg', 'description': 'EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'OG002', 'title': 'EOS+ Benralizumab, 20 mg', 'description': 'EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'OG003', 'title': 'EOS+ Benralizumab, 100 mg', 'description': 'EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}], 'timeFrame': 'Baseline up to Week 66', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to change in planned analysis after unblinding of study data, dose response was not performed.'}, {'type': 'SECONDARY', 'title': 'Minimum Observed Serum Trough Concentration for Benralizumab at Steady-State (Ctrough, ss)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '223', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'EOS+ Benralizumab, 2 mg', 'description': 'EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'OG001', 'title': 'EOS+ Benralizumab, 20 mg', 'description': 'EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'OG002', 'title': 'Benralizumab, 100 mg', 'description': 'EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.7', 'spread': '131', 'groupId': 'OG000'}, {'value': '182', 'spread': '180', 'groupId': 'OG001'}, {'value': '869', 'spread': '665', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (0 hour), Post-dose on Day 1, 6, Week 4, 16, 24, 32, 40, and 52', 'unitOfMeasure': 'microgram per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic (PK) Population included all participants who received at least one dose of benralizumab and had at least one quantifiable PK observation. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for PK in the 100 mg benralizumab group.'}, {'type': 'SECONDARY', 'title': 'Dose-Normalized Minimum Observed Serum Trough Concentration for Benralizumab at Steady-State (Ctrough, ssD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '223', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'EOS+ Benralizumab, 2 mg', 'description': 'EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'OG001', 'title': 'EOS+ Benralizumab, 20 mg', 'description': 'EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'OG002', 'title': 'Benralizumab, 100 mg', 'description': 'EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.3', 'spread': '65.3', 'groupId': 'OG000'}, {'value': '9.10', 'spread': '9.02', 'groupId': 'OG001'}, {'value': '8.69', 'spread': '6.65', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (0 hour), Post-dose on Day 1, 6, Week 4, 16, 24, 32, 40, and 52', 'unitOfMeasure': 'microgram per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK Population included all participants who received at least one dose of benralizumab and had at least one quantifiable PK observation. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for PK in the 100 mg benralizumab group.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Anti-Drug Antibodies (ADA) to Benralizumab in Eosinophilic Phenotype (EOS+) Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'EOS+ Placebo', 'description': 'EOS+ participants received two placebo injections subcutaneously.'}, {'id': 'OG001', 'title': 'EOS+ Benralizumab, 2 mg', 'description': 'EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'OG002', 'title': 'EOS+ Benralizumab, 20 mg', 'description': 'EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'OG003', 'title': 'EOS+ Benralizumab, 100 mg', 'description': 'EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '42.0', 'groupId': 'OG001'}, {'value': '30.9', 'groupId': 'OG002'}, {'value': '25.6', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 92', 'description': 'Immunogenicity assessment included determination of anti-drug (benralizumab) antibodies in serum samples. ADA positive was defined as a titer \\>=50 at any point in the study. It was observed at baseline and any visit during the study.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population included all randomized participants who received any dose of investigational product.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Asthma Control Questionnaire (6-items) (ACQ-6) Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}, {'value': '142', 'groupId': 'OG004'}, {'value': '140', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'EOS+ Placebo', 'description': 'EOS+ participants received two placebo injections subcutaneously.'}, {'id': 'OG001', 'title': 'EOS+ Benralizumab, 2 mg', 'description': 'EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'OG002', 'title': 'EOS+ Benralizumab, 20 mg', 'description': 'EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'OG003', 'title': 'EOS+ Benralizumab, 100 mg', 'description': 'EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'OG004', 'title': 'EOS- Placebo', 'description': 'EOS- (defined as ELEN Index negative and FeNO \\<50 ppb) participants received matching placebo subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'OG005', 'title': 'EOS- Benralizumab, 100 mg', 'description': 'EOS- participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}], 'classes': [{'title': 'Baseline (n=80,80,80,82,142,140)', 'categories': [{'measurements': [{'value': '2.7479', 'spread': '0.9762', 'groupId': 'OG000'}, {'value': '2.6479', 'spread': '0.9908', 'groupId': 'OG001'}, {'value': '2.4750', 'spread': '0.9106', 'groupId': 'OG002'}, {'value': '2.5346', 'spread': '0.9728', 'groupId': 'OG003'}, {'value': '2.4742', 'spread': '0.8408', 'groupId': 'OG004'}, {'value': '2.6381', 'spread': '0.8330', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 52 (n=34,42,40,39,64,73)', 'categories': [{'measurements': [{'value': '-0.8922', 'spread': '1.1969', 'groupId': 'OG000'}, {'value': '-1.1032', 'spread': '1.1207', 'groupId': 'OG001'}, {'value': '-1.2500', 'spread': '1.2247', 'groupId': 'OG002'}, {'value': '-1.1239', 'spread': '1.2852', 'groupId': 'OG003'}, {'value': '-0.8418', 'spread': '1.1343', 'groupId': 'OG004'}, {'value': '-1.1295', 'spread': '1.1301', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.125', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value was calculated by analysis of covariance (ANCOVA) with treatment, baseline inhaled steroid status and baseline observed value as covariates.', 'testedNonInferiority': False}, {'pValue': '0.074', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.', 'testedNonInferiority': False}, {'pValue': '0.057', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.', 'testedNonInferiority': False}, {'pValue': '0.010', 'groupIds': ['OG004', 'OG005'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 52', 'description': 'Asthma Control Questionnaire (ACQ) is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score was the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Data collected on Day 1 prior to dosing was considered as baseline. Results were reported for overall ACQ score. ACQ-6 score was summarized together for all participants.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population included all randomized participants who received any dose of investigational product. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Total Nasal Symptoms Score (TNSS) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '222', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'EOS+ and EOS- participants received two placebo injections subcutaneously.'}, {'id': 'OG001', 'title': 'EOS+ Benralizumab, 2 mg', 'description': 'EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'OG002', 'title': 'EOS+ Benralizumab, 20 mg', 'description': 'EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'OG003', 'title': 'Benralizumab (100 mg)', 'description': 'EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.'}], 'classes': [{'title': 'Baseline (n=71,27,25,81)', 'categories': [{'measurements': [{'value': '4.3', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '5.3', 'spread': '1.8', 'groupId': 'OG002'}, {'value': '4.4', 'spread': '2.1', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 52 (n=89,39,39,106)', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '2.90', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '2.01', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '2.96', 'groupId': 'OG002'}, {'value': '-0.8', 'spread': '2.24', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 52', 'description': 'Total Nasal Symptoms Score (TNSS) is a 3-item questionnaire, the sum of nasal symptoms, namely, nasal obstruction (rhinorrhea), nasal congestion, and nasal itching/sneezing. Each symptom was rated on a scale from 0-3, with 0 representing no symptoms, 1 mild, 2 moderate, and 3 severe symptoms. TNSS score was a summation of the 3 individual nasal symptom. TNSS score could range from 0 to 9 where higher score indicates worsening. Data was summarized by each treatment group. In addition, data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population included all randomized participants who received any dose of investigational product. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Asthma Symptom Diary Score at Week 51-52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '222', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received two placebo injections subcutaneously.'}, {'id': 'OG001', 'title': 'EOS+ Benralizumab, 2 mg', 'description': 'EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'OG002', 'title': 'EOS+ Benralizumab, 20 mg', 'description': 'EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'OG003', 'title': 'Benralizumab (100 mg)', 'description': 'EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.'}], 'classes': [{'title': 'Baseline (n=204,72,74,210)', 'categories': [{'measurements': [{'value': '1.58', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '1.65', 'spread': '0.65', 'groupId': 'OG001'}, {'value': '1.60', 'spread': '0.61', 'groupId': 'OG002'}, {'value': '1.60', 'spread': '0.62', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 51-52 (n=111,36,39,111)', 'categories': [{'measurements': [{'value': '-0.37', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '-0.56', 'spread': '0.76', 'groupId': 'OG001'}, {'value': '-0.56', 'spread': '0.69', 'groupId': 'OG002'}, {'value': '-0.53', 'spread': '0.67', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.131', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.182', 'ciLowerLimit': '-0.336', 'ciUpperLimit': '-0.028', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.', 'testedNonInferiority': False}, {'pValue': '0.126', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.173', 'ciLowerLimit': '-0.317', 'ciUpperLimit': '-0.028', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.', 'testedNonInferiority': False}, {'pValue': '0.097', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.140', 'ciLowerLimit': '-0.247', 'ciUpperLimit': '-0.032', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 51-52', 'description': 'Asthma Symptom Diary included 7 questions about the participant symptom and the overall impact of treatment on the disease during the study period. Mean scores of the 7 questions were calculated to identify asthma symptom-free days. Asthma Symptom Diary Scores were analyzed on a bi-weekly basis and compared to baseline scores. Overall symptom score=(daytime frequency score + daytime severity score + nighttime severity score)/3, where total score ranges from 0 to 9. Higher score represents worsening. Mean asthma symptom diary score were summarized together for all participants. Mean asthma symptom diary score were summarized together for all participants. In addition, data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population included all randomized participants who received any dose of investigational product. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Rescue Medication Use at Week 51-52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '222', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received two placebo injections subcutaneously.'}, {'id': 'OG001', 'title': 'EOS+ Benralizumab, 2 mg', 'description': 'EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'OG002', 'title': 'EOS+ Benralizumab, 20 mg', 'description': 'EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'OG003', 'title': 'Benralizumab (100 mg)', 'description': 'EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.'}], 'classes': [{'title': 'Baseline without prophylactic (n=204,72,74,210)', 'categories': [{'measurements': [{'value': '3.09', 'spread': '2.55', 'groupId': 'OG000'}, {'value': '3.57', 'spread': '3.67', 'groupId': 'OG001'}, {'value': '3.82', 'spread': '4.34', 'groupId': 'OG002'}, {'value': '3.16', 'spread': '2.82', 'groupId': 'OG003'}]}]}, {'title': 'Baseline with prophylactic (n=204,72,74,210)', 'categories': [{'measurements': [{'value': '4.07', 'spread': '3.34', 'groupId': 'OG000'}, {'value': '4.71', 'spread': '5.56', 'groupId': 'OG001'}, {'value': '5.24', 'spread': '6.40', 'groupId': 'OG002'}, {'value': '4.22', 'spread': '3.90', 'groupId': 'OG003'}]}]}, {'title': 'Change Week 51-52 -prophylactic(n=111,36,39,111)', 'categories': [{'measurements': [{'value': '-1.2540', 'spread': '2.4571', 'groupId': 'OG000'}, {'value': '-1.4116', 'spread': '2.8722', 'groupId': 'OG001'}, {'value': '-1.8804', 'spread': '5.3129', 'groupId': 'OG002'}, {'value': '-1.1589', 'spread': '2.0086', 'groupId': 'OG003'}]}]}, {'title': 'Change Week 51-52 +prophylactic(n=111,36,39,111)', 'categories': [{'measurements': [{'value': '-1.6855', 'spread': '3.2875', 'groupId': 'OG000'}, {'value': '-1.6810', 'spread': '4.2247', 'groupId': 'OG001'}, {'value': '-2.5118', 'spread': '7.6814', 'groupId': 'OG002'}, {'value': '-1.4693', 'spread': '2.5603', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.642', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.174', 'ciLowerLimit': '-0.654', 'ciUpperLimit': '0.306', 'groupDescription': 'Analysis reported for rescue medication use without prophylactic at Week 51-52.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.', 'testedNonInferiority': False}, {'pValue': '0.824', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.111', 'ciLowerLimit': '-0.533', 'ciUpperLimit': '0.756', 'groupDescription': 'Analysis reported for rescue medication use without prophylactic at Week 51-52.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.', 'testedNonInferiority': False}, {'pValue': '0.910', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.029', 'ciLowerLimit': '-0.297', 'ciUpperLimit': '0.355', 'groupDescription': 'Analysis reported for rescue medication use without prophylactic at Week 51-52.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.', 'testedNonInferiority': False}, {'pValue': '0.992', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.004', 'ciLowerLimit': '-0.602', 'ciUpperLimit': '0.593', 'groupDescription': 'Analysis reported for rescue medication use with prophylactic at Week 51-52.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.', 'testedNonInferiority': False}, {'pValue': '0.624', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.337', 'ciLowerLimit': '-0.548', 'ciUpperLimit': '1.222', 'groupDescription': 'Analysis reported for rescue medication use with prophylactic at Week 51-52.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.', 'testedNonInferiority': False}, {'pValue': '0.645', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.150', 'ciLowerLimit': '-0.267', 'ciUpperLimit': '0.567', 'groupDescription': 'Analysis reported for rescue medication use with prophylactic at Week 51-52.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 51-52', 'description': 'Participants were provided inhalers of the same dose (medium- or high-dose) inhaled corticosteroid (ICS) plus long-acting beta antagonist (LABA) combination product as baseline prophylactic medication and continued with same dose throughout the study. Rescue medications such as short-term beta2 agonists were used as first-line treatment for worsening asthma symptoms. Investigator prescribed additional short term asthma controller medications included additional ICS, theophylline, inhaled cromones or antimuscarinics; if asthma symptoms remained mild but not resolved. If asthma symptoms worsened, participants received an oral corticosteroid burst. All rescue medications use with prophylactic medication (+ prophylactic) and without prophylactic medication (- prophylactic) was recorded in asthma symptom dairy by participant. Rescue medication use was analyzed on a bi-weekly basis and compared to baseline scores.', 'unitOfMeasure': 'rescue medication per 2 weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population included all randomized participants who received any dose of investigational product. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively. Data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '222', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received two placebo injections subcutaneously.'}, {'id': 'OG001', 'title': 'EOS+ Benralizumab, 2 mg', 'description': 'EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'OG002', 'title': 'EOS+ Benralizumab, 20 mg', 'description': 'EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'OG003', 'title': 'Benralizumab (100 mg)', 'description': 'EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.'}], 'classes': [{'title': 'Baseline (n=215,80,81,218)', 'categories': [{'measurements': [{'value': '2.033', 'spread': '0.669', 'groupId': 'OG000'}, {'value': '1.978', 'spread': '0.701', 'groupId': 'OG001'}, {'value': '2.080', 'spread': '0.751', 'groupId': 'OG002'}, {'value': '2.012', 'spread': '0.672', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 52 (n=150,51,58,160)', 'categories': [{'measurements': [{'value': '0.0098', 'spread': '0.3615', 'groupId': 'OG000'}, {'value': '0.1631', 'spread': '0.4691', 'groupId': 'OG001'}, {'value': '0.1847', 'spread': '0.5234', 'groupId': 'OG002'}, {'value': '0.0998', 'spread': '0.3541', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.014', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.157', 'ciLowerLimit': '0.076', 'ciUpperLimit': '0.237', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.', 'testedNonInferiority': False}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.184', 'ciLowerLimit': '0.102', 'ciUpperLimit': '0.266', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.', 'testedNonInferiority': False}, {'pValue': '0.026', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.091', 'ciLowerLimit': '0.039', 'ciUpperLimit': '0.143', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 52', 'description': 'FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Data was summarized by each treatment group. In addition, data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms.', 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population included all randomized participants who received any dose of investigational product. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Forced Vital Capacity (FVC) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}, {'value': '142', 'groupId': 'OG004'}, {'value': '140', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'EOS+ Placebo', 'description': 'EOS+ participants received two placebo injections subcutaneously.'}, {'id': 'OG001', 'title': 'EOS+ Benralizumab, 2 mg', 'description': 'EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'OG002', 'title': 'EOS+ Benralizumab, 20 mg', 'description': 'EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'OG003', 'title': 'EOS+ Benralizumab, 100 mg', 'description': 'EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'OG004', 'title': 'EOS- Placebo', 'description': 'EOS- (defined as ELEN Index negative and FeNO \\<50 ppb) participants received matching placebo subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'OG005', 'title': 'EOS- Benralizumab, 100 mg', 'description': 'EOS- participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}], 'classes': [{'title': 'Baseline (n=80,80,81,82,135,136)', 'categories': [{'measurements': [{'value': '3.282', 'spread': '1.030', 'groupId': 'OG000'}, {'value': '3.069', 'spread': '0.957', 'groupId': 'OG001'}, {'value': '3.285', 'spread': '1.028', 'groupId': 'OG002'}, {'value': '3.110', 'spread': '0.851', 'groupId': 'OG003'}, {'value': '3.043', 'spread': '0.864', 'groupId': 'OG004'}, {'value': '3.126', 'spread': '0.981', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 52 (n=51,51,58,59,99,101)', 'categories': [{'measurements': [{'value': '0.029', 'spread': '0.514', 'groupId': 'OG000'}, {'value': '0.129', 'spread': '0.565', 'groupId': 'OG001'}, {'value': '0.190', 'spread': '0.586', 'groupId': 'OG002'}, {'value': '0.166', 'spread': '0.445', 'groupId': 'OG003'}, {'value': '-0.030', 'spread': '0.426', 'groupId': 'OG004'}, {'value': '0.056', 'spread': '0.371', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.384', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.', 'testedNonInferiority': False}, {'pValue': '0.092', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.', 'testedNonInferiority': False}, {'pValue': '0.134', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.', 'testedNonInferiority': False}, {'pValue': '0.129', 'groupIds': ['OG004', 'OG005'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 52', 'description': 'Forced Vital Capacity (FVC) was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.', 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population included all randomized participants who received any dose of investigational product. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Peak Expiratory Flow (PEF) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '222', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received two placebo injections subcutaneously.'}, {'id': 'OG001', 'title': 'EOS+ Benralizumab, 2 mg', 'description': 'EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'OG002', 'title': 'EOS+ Benralizumab, 20 mg', 'description': 'EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'OG003', 'title': 'Benralizumab (100 mg)', 'description': 'EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.'}], 'classes': [{'title': 'Baseline (n=215,80,81,218)', 'categories': [{'measurements': [{'value': '319.3', 'spread': '104.7', 'groupId': 'OG000'}, {'value': '325.5', 'spread': '101.6', 'groupId': 'OG001'}, {'value': '323.1', 'spread': '100.8', 'groupId': 'OG002'}, {'value': '323.8', 'spread': '101.7', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 52 (n=150,51,58,160)', 'categories': [{'measurements': [{'value': '13.0', 'spread': '64.6', 'groupId': 'OG000'}, {'value': '29.0', 'spread': '64.1', 'groupId': 'OG001'}, {'value': '45.9', 'spread': '95.5', 'groupId': 'OG002'}, {'value': '26.6', 'spread': '66.3', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 52', 'description': 'The PEF is a participant\'s maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed while sitting or standing prior to using any medication (if needed) for asthma. Home PEF was determined separately for morning and evening, and were averaged for each participant. Data was summarized by each treatment group. In addition, data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms.', 'unitOfMeasure': 'liters per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population included all randomized participants who received any dose of investigational product. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '222', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received two placebo injections subcutaneously.'}, {'id': 'OG001', 'title': 'EOS+ Benralizumab, 2 mg', 'description': 'EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'OG002', 'title': 'EOS+ Benralizumab, 20 mg', 'description': 'EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'OG003', 'title': 'Benralizumab (100 mg)', 'description': 'EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.'}], 'classes': [{'title': 'Baseline (n=214,78,80,217)', 'categories': [{'measurements': [{'value': '3.72', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '3.72', 'spread': '1.17', 'groupId': 'OG001'}, {'value': '3.79', 'spread': '1.06', 'groupId': 'OG002'}, {'value': '3.72', 'spread': '1.01', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 52 (n=88,39,38,105)', 'categories': [{'measurements': [{'value': '0.9634', 'spread': '1.3342', 'groupId': 'OG000'}, {'value': '1.2612', 'spread': '1.2082', 'groupId': 'OG001'}, {'value': '1.4474', 'spread': '1.4262', 'groupId': 'OG002'}, {'value': '1.1223', 'spread': '1.2636', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.069', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.404', 'ciLowerLimit': '0.121', 'ciUpperLimit': '0.687', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.', 'testedNonInferiority': False}, {'pValue': '0.049', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.462', 'ciLowerLimit': '0.163', 'ciUpperLimit': '0.761', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.', 'testedNonInferiority': False}, {'pValue': '0.168', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.238', 'ciLowerLimit': '0.017', 'ciUpperLimit': '0.459', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 52', 'description': 'AQLQ: a 32-item questionnaire evaluating quality of life of participants with asthma including 4 domains (symptoms, activity limitations, emotional function, and environmental stimuli). Participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score was calculated as the mean response to all questions. The 4 domain scores were the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment). The AQLQ(S) responses were categorized as improvement (defined as change from baseline \\>=0.5), no change (defined as change from baseline \\>= -0.5 to less than \\[\\<\\] 0.5), and worse (defined as change from baseline \\< -0.5). Data was summarized by each treatment group.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population included all randomized participants who received any dose of investigational product. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively. Data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in European Quality of Life - 5 Dimensions (EQ-5D) Health State Evaluation at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '222', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received two placebo injections subcutaneously.'}, {'id': 'OG001', 'title': 'EOS+ Benralizumab, 2 mg', 'description': 'EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'OG002', 'title': 'EOS+ Benralizumab, 20 mg', 'description': 'EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'OG003', 'title': 'Benralizumab (100 mg)', 'description': 'EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.'}], 'classes': [{'title': 'Baseline (n=213,79,74,209)', 'categories': [{'measurements': [{'value': '0.7629', 'spread': '0.2153', 'groupId': 'OG000'}, {'value': '0.7418', 'spread': '0.2376', 'groupId': 'OG001'}, {'value': '0.7877', 'spread': '0.1878', 'groupId': 'OG002'}, {'value': '0.7679', 'spread': '0.1623', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 52 (n=148,58,53,161)', 'categories': [{'measurements': [{'value': '0.0853', 'spread': '0.2096', 'groupId': 'OG000'}, {'value': '0.0822', 'spread': '0.3137', 'groupId': 'OG001'}, {'value': '0.1223', 'spread': '0.2132', 'groupId': 'OG002'}, {'value': '0.0824', 'spread': '0.2179', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.510', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.020', 'ciLowerLimit': '-0.058', 'ciUpperLimit': '0.019', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.', 'testedNonInferiority': False}, {'pValue': '0.113', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.041', 'ciLowerLimit': '0.008', 'ciUpperLimit': '0.074', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.', 'testedNonInferiority': False}, {'pValue': '0.599', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.011', 'ciLowerLimit': '-0.016', 'ciUpperLimit': '0.038', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 52', 'description': 'The utility-based EQ-5D questionnaire comprises of two parts and provides a generic measure of health for clinical and economic appraisal. The health state valuation was the summary score of mobility, self-care, usual activities, pain/discomfort and anxiety/depression on a 3 category scale (no problem, moderate problem, severe problems). Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Data was summarized by each treatment group. In addition, data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population included all randomized participants who received any dose of investigational product. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EQ-5D Visual Analog Scale (VAS) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '222', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received two placebo injections subcutaneously.'}, {'id': 'OG001', 'title': 'EOS+ Benralizumab, 2 mg', 'description': 'EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'OG002', 'title': 'EOS+ Benralizumab, 20 mg', 'description': 'EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'OG003', 'title': 'Benralizumab (100 mg)', 'description': 'EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.'}], 'classes': [{'title': 'Baseline (n=213,79,74,208)', 'categories': [{'measurements': [{'value': '65.0798', 'spread': '17.8903', 'groupId': 'OG000'}, {'value': '65.4937', 'spread': '18.5063', 'groupId': 'OG001'}, {'value': '64.3378', 'spread': '18.1427', 'groupId': 'OG002'}, {'value': '64.6250', 'spread': '19.7778', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 52 (n=148,58,53,161)', 'categories': [{'measurements': [{'value': '12.8041', 'spread': '19.1036', 'groupId': 'OG000'}, {'value': '12.5517', 'spread': '20.8008', 'groupId': 'OG001'}, {'value': '15.4906', 'spread': '21.7297', 'groupId': 'OG002'}, {'value': '13.7391', 'spread': '20.5139', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.871', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.373', 'ciLowerLimit': '-3.333', 'ciUpperLimit': '2.586', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.', 'testedNonInferiority': False}, {'pValue': '0.227', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '2.857', 'ciLowerLimit': '-0.175', 'ciUpperLimit': '5.889', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.', 'testedNonInferiority': False}, {'pValue': '0.503', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.139', 'ciLowerLimit': '-1.041', 'ciUpperLimit': '3.319', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 52', 'description': 'The utility-based EQ-5D questionnaire comprises of two parts and provides a generic measure of health for clinical and economic appraisal. The EQ-5D VAS was measured from 0 (worst imaginable health state) to 100 (best imaginable health state). Data was summarized by each treatment group. In addition, data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population included all randomized participants who received any dose of investigational product. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Percentage of Nocturnal Awakening-Free Nights at Week 51-52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '222', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received two placebo injections subcutaneously.'}, {'id': 'OG001', 'title': 'EOS+ Benralizumab, 2 mg', 'description': 'EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'OG002', 'title': 'EOS+ Benralizumab, 20 mg', 'description': 'EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'OG003', 'title': 'Benralizumab (100 mg)', 'description': 'EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.'}], 'classes': [{'title': 'Baseline (n=204,72,74,210)', 'categories': [{'measurements': [{'value': '52.05', 'spread': '36.96', 'groupId': 'OG000'}, {'value': '45.07', 'spread': '40.04', 'groupId': 'OG001'}, {'value': '51.57', 'spread': '39.72', 'groupId': 'OG002'}, {'value': '50.92', 'spread': '37.72', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 51-52 (n=111,36,39,111)', 'categories': [{'measurements': [{'value': '19.7595', 'spread': '39.1388', 'groupId': 'OG000'}, {'value': '27.1749', 'spread': '41.7342', 'groupId': 'OG001'}, {'value': '29.6181', 'spread': '38.4315', 'groupId': 'OG002'}, {'value': '23.3054', 'spread': '36.2761', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.550', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '3.907', 'ciLowerLimit': '-4.483', 'ciUpperLimit': '12.297', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.', 'testedNonInferiority': False}, {'pValue': '0.215', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '7.659', 'ciLowerLimit': '-0.262', 'ciUpperLimit': '15.579', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.', 'testedNonInferiority': False}, {'pValue': '0.413', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '3.540', 'ciLowerLimit': '-2.006', 'ciUpperLimit': '9.086', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 51-52', 'description': 'Percentage of nocturnal awakening-free nights were analyzed on a bi-weekly basis and compared to baseline scores. Data was summarized by each treatment group. In addition, data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms.', 'unitOfMeasure': 'percent nocturnal awakening-free nights', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population included all randomized participants who received any dose of investigational product. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Fraction Exhaled Nitric Oxide (FeNO) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '222', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received two placebo injections subcutaneously.'}, {'id': 'OG001', 'title': 'EOS+ Benralizumab, 2 mg', 'description': 'EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'OG002', 'title': 'EOS+ Benralizumab, 20 mg', 'description': 'EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'OG003', 'title': 'Benralizumab (100 mg)', 'description': 'EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.'}], 'classes': [{'title': 'Baseline (n=222,81,81,222)', 'categories': [{'measurements': [{'value': '26.88', 'spread': '23.57', 'groupId': 'OG000'}, {'value': '39.52', 'spread': '32.67', 'groupId': 'OG001'}, {'value': '40.79', 'spread': '31.03', 'groupId': 'OG002'}, {'value': '26.68', 'spread': '23.10', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 52 (n=148,57,56,157)', 'categories': [{'measurements': [{'value': '1.2523', 'spread': '16.0200', 'groupId': 'OG000'}, {'value': '-3.2222', 'spread': '33.2543', 'groupId': 'OG001'}, {'value': '-6.1905', 'spread': '30.1103', 'groupId': 'OG002'}, {'value': '1.4384', 'spread': '28.9090', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.896', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.', 'testedNonInferiority': False}, {'pValue': '0.944', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.', 'testedNonInferiority': False}, {'pValue': '0.667', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 52', 'description': 'Data was summarized by each treatment group. In addition, data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms.', 'unitOfMeasure': 'parts per billion', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population included all randomized participants who received any dose of investigational product. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Eosinophilic Phenotype (EOS+) Placebo', 'description': "EOS+ (defined as ELEN Index \\[proprietary mathematical algorithm to predict sputum eosinophil's greater than or equal to 2 percent\\] positive and/or FeNO \\[fraction of exhaled nitric oxide\\] greater than or equal to \\[\\>=\\] 50 parts per billion \\[ppb\\]) participants received matching placebo subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40."}, {'id': 'FG001', 'title': 'EOS+ Benralizumab, 2 mg', 'description': 'EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'FG002', 'title': 'EOS+ Benralizumab, 20 mg', 'description': 'EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'FG003', 'title': 'EOS+ Benralizumab, 100 mg', 'description': 'EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'FG004', 'title': 'Non-eosinophil Phenotype (EOS-) Placebo', 'description': 'EOS- (defined as ELEN Index negative and FeNO \\<50 ppb) participants received matching placebo subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'FG005', 'title': 'EOS- Benralizumab, 100 mg', 'description': 'EOS- participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '81'}, {'groupId': 'FG002', 'numSubjects': '81'}, {'groupId': 'FG003', 'numSubjects': '82'}, {'groupId': 'FG004', 'numSubjects': '142'}, {'groupId': 'FG005', 'numSubjects': '140'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '73'}, {'groupId': 'FG002', 'numSubjects': '70'}, {'groupId': 'FG003', 'numSubjects': '69'}, {'groupId': 'FG004', 'numSubjects': '129'}, {'groupId': 'FG005', 'numSubjects': '125'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '13'}, {'groupId': 'FG005', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Unplanned surgery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Did not meet entry ACQ-6 criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Incorrect enrollment/randomization', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Subject traveled to Argentina by 1 year', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Subject moved out of state/area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Strongyloides stercoralis antibodies +', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Personal problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Unable to continue visits', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Serious adverse event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Lack of compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '9'}]}]}], 'preAssignmentDetails': 'Participants were stratified based on the protocol defined eosinophilic phenotype (EOS+ versus EOS-) and inhaled corticosteroid (ICS) use during a 3-week screening period. A total of 964 participants were screened out of which 609 were randomized in the study, and of which 606 participants received at least one dose of investigational product.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}, {'value': '82', 'groupId': 'BG003'}, {'value': '142', 'groupId': 'BG004'}, {'value': '140', 'groupId': 'BG005'}, {'value': '606', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Eosinophilic Phenotype (EOS+) Placebo', 'description': "EOS+ (defined as ELEN Index \\[proprietary mathematical algorithm to predict sputum eosinophil's greater than or equal to 2 percent\\] positive and/or FeNO \\[fraction of exhaled nitric oxide\\] greater than or equal to \\[\\>=\\] 50 parts per billion \\[ppb\\]) participants received matching placebo subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40."}, {'id': 'BG001', 'title': 'EOS+ Benralizumab, 2 mg', 'description': 'EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'BG002', 'title': 'EOS+ Benralizumab, 20 mg', 'description': 'EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'BG003', 'title': 'EOS+ Benralizumab, 100 mg', 'description': 'EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'BG004', 'title': 'Non-eosinophil Phenotype (EOS-) Placebo', 'description': 'EOS- (defined as ELEN Index negative and FeNO \\<50 ppb) participants received matching placebo subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'BG005', 'title': 'EOS- Benralizumab, 100 mg', 'description': 'EOS- participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.6', 'spread': '11.7', 'groupId': 'BG000'}, {'value': '47.1', 'spread': '12.8', 'groupId': 'BG001'}, {'value': '46.6', 'spread': '13.2', 'groupId': 'BG002'}, {'value': '47.8', 'spread': '12.9', 'groupId': 'BG003'}, {'value': '50.0', 'spread': '12.3', 'groupId': 'BG004'}, {'value': '50.0', 'spread': '11.5', 'groupId': 'BG005'}, {'value': '48.3', 'spread': '12.4', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}, {'value': '98', 'groupId': 'BG005'}, {'value': '417', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '42', 'groupId': 'BG004'}, {'value': '42', 'groupId': 'BG005'}, {'value': '189', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The modified intent-to-treat (mITT) population included all randomized participants who received any dose of investigational product.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 964}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-28', 'studyFirstSubmitDate': '2010-11-09', 'resultsFirstSubmitDate': '2016-05-31', 'studyFirstSubmitQcDate': '2010-11-09', 'lastUpdatePostDateStruct': {'date': '2016-11-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-09-28', 'studyFirstPostDateStruct': {'date': '2010-11-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Annual Asthma Exacerbation Rate (AER) for Eosinophilic Phenotype (EOS+) Participants', 'timeFrame': 'Week 1 up to Week 52', 'description': 'The annual asthma exacerbation rate (AER) was calculated as the total number of observed exacerbations in each group up to week 52, divided by total duration of person-year follow-up in each group. An asthma exacerbation is defined as a progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 days as prescribed or administered by the investigator or healthcare provider; or 2) participant initiation of systemic corticosteroids (tablets, suspension or injection) for a duration of at least 3 days as outlined in the Asthma Action Plan provided to the participant by the investigator on Day 1.'}], 'secondaryOutcomes': [{'measure': 'Dose Response in EOS+ Participants', 'timeFrame': 'Baseline up to Week 66'}, {'measure': 'Minimum Observed Serum Trough Concentration for Benralizumab at Steady-State (Ctrough, ss)', 'timeFrame': 'Pre-dose (0 hour), Post-dose on Day 1, 6, Week 4, 16, 24, 32, 40, and 52'}, {'measure': 'Dose-Normalized Minimum Observed Serum Trough Concentration for Benralizumab at Steady-State (Ctrough, ssD)', 'timeFrame': 'Pre-dose (0 hour), Post-dose on Day 1, 6, Week 4, 16, 24, 32, 40, and 52'}, {'measure': 'Percentage of Participants With Anti-Drug Antibodies (ADA) to Benralizumab in Eosinophilic Phenotype (EOS+) Participants', 'timeFrame': 'Baseline up to Week 92', 'description': 'Immunogenicity assessment included determination of anti-drug (benralizumab) antibodies in serum samples. ADA positive was defined as a titer \\>=50 at any point in the study. It was observed at baseline and any visit during the study.'}, {'measure': 'Change From Baseline in Asthma Control Questionnaire (6-items) (ACQ-6) Score at Week 52', 'timeFrame': 'Baseline up to Week 52', 'description': 'Asthma Control Questionnaire (ACQ) is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score was the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Data collected on Day 1 prior to dosing was considered as baseline. Results were reported for overall ACQ score. ACQ-6 score was summarized together for all participants.'}, {'measure': 'Change From Baseline in Mean Total Nasal Symptoms Score (TNSS) at Week 52', 'timeFrame': 'Baseline up to Week 52', 'description': 'Total Nasal Symptoms Score (TNSS) is a 3-item questionnaire, the sum of nasal symptoms, namely, nasal obstruction (rhinorrhea), nasal congestion, and nasal itching/sneezing. Each symptom was rated on a scale from 0-3, with 0 representing no symptoms, 1 mild, 2 moderate, and 3 severe symptoms. TNSS score was a summation of the 3 individual nasal symptom. TNSS score could range from 0 to 9 where higher score indicates worsening. Data was summarized by each treatment group. In addition, data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms.'}, {'measure': 'Change From Baseline in Mean Asthma Symptom Diary Score at Week 51-52', 'timeFrame': 'Baseline up to Week 51-52', 'description': 'Asthma Symptom Diary included 7 questions about the participant symptom and the overall impact of treatment on the disease during the study period. Mean scores of the 7 questions were calculated to identify asthma symptom-free days. Asthma Symptom Diary Scores were analyzed on a bi-weekly basis and compared to baseline scores. Overall symptom score=(daytime frequency score + daytime severity score + nighttime severity score)/3, where total score ranges from 0 to 9. Higher score represents worsening. Mean asthma symptom diary score were summarized together for all participants. Mean asthma symptom diary score were summarized together for all participants. In addition, data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms.'}, {'measure': 'Change From Baseline in Rescue Medication Use at Week 51-52', 'timeFrame': 'Baseline up to Week 51-52', 'description': 'Participants were provided inhalers of the same dose (medium- or high-dose) inhaled corticosteroid (ICS) plus long-acting beta antagonist (LABA) combination product as baseline prophylactic medication and continued with same dose throughout the study. Rescue medications such as short-term beta2 agonists were used as first-line treatment for worsening asthma symptoms. Investigator prescribed additional short term asthma controller medications included additional ICS, theophylline, inhaled cromones or antimuscarinics; if asthma symptoms remained mild but not resolved. If asthma symptoms worsened, participants received an oral corticosteroid burst. All rescue medications use with prophylactic medication (+ prophylactic) and without prophylactic medication (- prophylactic) was recorded in asthma symptom dairy by participant. Rescue medication use was analyzed on a bi-weekly basis and compared to baseline scores.'}, {'measure': 'Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 52', 'timeFrame': 'Baseline and Week 52', 'description': 'FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Data was summarized by each treatment group. In addition, data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms.'}, {'measure': 'Change From Baseline in Mean Forced Vital Capacity (FVC) at Week 52', 'timeFrame': 'Baseline and Week 52', 'description': 'Forced Vital Capacity (FVC) was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.'}, {'measure': 'Change From Baseline in Peak Expiratory Flow (PEF) at Week 52', 'timeFrame': 'Baseline and Week 52', 'description': 'The PEF is a participant\'s maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed while sitting or standing prior to using any medication (if needed) for asthma. Home PEF was determined separately for morning and evening, and were averaged for each participant. Data was summarized by each treatment group. In addition, data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms.'}, {'measure': 'Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Score at Week 52', 'timeFrame': 'Baseline and Week 52', 'description': 'AQLQ: a 32-item questionnaire evaluating quality of life of participants with asthma including 4 domains (symptoms, activity limitations, emotional function, and environmental stimuli). Participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score was calculated as the mean response to all questions. The 4 domain scores were the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment). The AQLQ(S) responses were categorized as improvement (defined as change from baseline \\>=0.5), no change (defined as change from baseline \\>= -0.5 to less than \\[\\<\\] 0.5), and worse (defined as change from baseline \\< -0.5). Data was summarized by each treatment group.'}, {'measure': 'Change From Baseline in European Quality of Life - 5 Dimensions (EQ-5D) Health State Evaluation at Week 52', 'timeFrame': 'Baseline and Week 52', 'description': 'The utility-based EQ-5D questionnaire comprises of two parts and provides a generic measure of health for clinical and economic appraisal. The health state valuation was the summary score of mobility, self-care, usual activities, pain/discomfort and anxiety/depression on a 3 category scale (no problem, moderate problem, severe problems). Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Data was summarized by each treatment group. In addition, data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms.'}, {'measure': 'Change From Baseline in EQ-5D Visual Analog Scale (VAS) at Week 52', 'timeFrame': 'Baseline and Week 52', 'description': 'The utility-based EQ-5D questionnaire comprises of two parts and provides a generic measure of health for clinical and economic appraisal. The EQ-5D VAS was measured from 0 (worst imaginable health state) to 100 (best imaginable health state). Data was summarized by each treatment group. In addition, data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms.'}, {'measure': 'Change From Baseline in Percentage of Nocturnal Awakening-Free Nights at Week 51-52', 'timeFrame': 'Baseline up to Week 51-52', 'description': 'Percentage of nocturnal awakening-free nights were analyzed on a bi-weekly basis and compared to baseline scores. Data was summarized by each treatment group. In addition, data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms.'}, {'measure': 'Change From Baseline in Mean Fraction Exhaled Nitric Oxide (FeNO) at Week 52', 'timeFrame': 'Baseline up to Week 52', 'description': 'Data was summarized by each treatment group. In addition, data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Asthma', 'Benralizumab', 'MEDI-563'], 'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '25306557', 'type': 'RESULT', 'citation': 'Castro M, Wenzel SE, Bleecker ER, Pizzichini E, Kuna P, Busse WW, Gossage DL, Ward CK, Wu Y, Wang B, Khatry DB, van der Merwe R, Kolbeck R, Molfino NA, Raible DG. Benralizumab, an anti-interleukin 5 receptor alpha monoclonal antibody, versus placebo for uncontrolled eosinophilic asthma: a phase 2b randomised dose-ranging study. Lancet Respir Med. 2014 Nov;2(11):879-890. doi: 10.1016/S2213-2600(14)70201-2. Epub 2014 Oct 8.'}, {'pmid': '30658649', 'type': 'DERIVED', 'citation': 'Sridhar S, Liu H, Pham TH, Damera G, Newbold P. Modulation of blood inflammatory markers by benralizumab in patients with eosinophilic airway diseases. Respir Res. 2019 Jan 18;20(1):14. doi: 10.1186/s12931-018-0968-8.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to evaluate the effect of multiple-dose subcutaneous administrations of MEDI-563 on adults with uncontrolled asthma.', 'detailedDescription': 'This is a Phase 2b, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of multiple-dose (7 doses) subcutaneous administration of benralizumab (MEDI-563) in adult subjects with uncontrolled asthma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 through 75 years at the time of screening\n* Adequate contraception from screening through end of trial\n* Weight of more than (\\>) 45 kilogram (kg) but less than or equal to (\\<=) 150 kg (\\>100 pound \\[lb\\] but \\<=330 lb)\n* History of physician-diagnosed asthma for at least 12 months prior to screening\n* Physician prescribed daily use of medium-dose or high-dose inhaled corticosteroid(s) (ICS) plus long-acting beta 2 agonist (LABA) for at least 12 months prior to screening\n* Willingness to switch to an ICS/LABA combination product\n* Dose of other asthma controller medications must be stable for at least 30 days prior to screening\n* At least 2 documented asthma exacerbations in the 12 months prior to screening that required use of a systemic corticosteroid burst\n* For subjects 65 years of age or older, a chest x-ray (CXR) or chest computed tomography (CT) that is normal for an asthmatic population\n* Ability and willingness to complete the study to Week 66, and if needed to Week 92.\n\nExclusion Criteria:\n\n* Known history of allergy or reaction to any component of the investigational product formulation\n* History of anaphylaxis to any biologic therapy\n* Unexplained diarrhea within 30 days prior to screening or diagnosis of helminth parasitic infestation within 6 months prior to screening\n* Use of immunosuppressive medication within 3 months prior to screening. Chronic oral prednisone or equivalent up to 10 milligram (mg) daily or 20 mg every other day for asthma is allowed\n* Oral corticosteroid burst or short-acting systemic corticosteroid within 30 days prior to screening or during the screening/run-in period\n* Acute upper or lower respiratory infections requiring antibiotics or antiviral medications within 30 days prior to the screening or during the screening/run-in period\n* Receipt of immunoglobulin or blood products within 30 days prior to screening\n* Receipt of any marketed or investigational biologic within 4 months or 5 half-lives prior to screening, whichever is longer\n* Receipt of any investigational nonbiologic within 30 days or 5 half-lives prior to screening, whichever is longer\n* Previously received MEDI-563\n* Any clinically relevant abnormal findings in physical examination\n* Past history of clinically significant cardiac disease or any electrocardiogram (ECG) abnormality\n* Breastfeeding or lactating women\n* History of alcohol or drug abuse within 12 months prior to screening\n* History of any known primary immunodeficiency disorder\n* Positive medical history for hepatitis B or C. Subjects with a history of hepatitis B vaccination without history of hepatitis B are allowed to enrol\n* A positive human immunodeficiency virus (HIV) test or subject taking antiretroviral medications\n* History of cigarette smoking more than or equal to (\\>=) 10 pack-years or smoking within 12 months prior to screening.\n* Known exposure to inhaled occupational agents or fumes with an established diagnosis of occupational asthma\n* History of cancer, except for basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy \\>=12 months prior to screening or other malignancies treated with apparent success with curative therapy \\>=5 years prior to screening\n* Stable dose of allergy vaccination regimen for less than 30 days prior to screening\n* Subjects unable to demonstrate acceptable inhaler and peak flow meter techniques.'}, 'identificationModule': {'nctId': 'NCT01238861', 'briefTitle': 'Study to Evaluate the Efficacy and Safety of MEDI-563 in Adults With Uncontrolled Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'MedImmune LLC'}, 'officialTitle': 'A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of MEDI-563 in Adults With Uncontrolled Asthma', 'orgStudyIdInfo': {'id': 'MI-CP220'}, 'secondaryIdInfos': [{'id': '2010-020126-17', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Eosinophilic phenotype (EOS+) Placebo', 'description': "EOS+ (defined as ELEN Index \\[proprietary mathematical algorithm to predict sputum eosinophil's greater than or equal to 2 percent\\] positive and/or FeNO \\[fraction of exhaled nitric oxide\\] greater than or equal to \\[\\>=\\] 50 parts per billion \\[ppb\\]) participants received matching placebo injections subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.", 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'EOS+ Benralizumab (2 mg)', 'description': 'EOS+ participants received single benralizumab 2 milligram (mg) injection subcutaneously every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.', 'interventionNames': ['Biological: Benralizumab 2 mg']}, {'type': 'EXPERIMENTAL', 'label': 'EOS+ Benralizumab (20 mg)', 'description': 'EOS+ participants received single benralizumab 20 mg injection subcutaneously every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.', 'interventionNames': ['Biological: Benralizumab 20 mg']}, {'type': 'EXPERIMENTAL', 'label': 'EOS+ Benralizumab (100 mg)', 'description': 'EOS+ participants received benralizumab 50 mg as two injections subcutaneously every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.', 'interventionNames': ['Biological: Benralizumab 100 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Non-eosinophil phenotype (EOS-) Placebo', 'description': 'EOS- (defined as ELEN Index negative and FeNO \\<50 ppb) participants received matching placebo subcutaneous every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'EOS- Benralizumab (100 mg)', 'description': 'EOS- participants received benralizumab 50 mg as two injections subcutaneously every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.', 'interventionNames': ['Biological: Benralizumab 100 mg']}], 'interventions': [{'name': 'Benralizumab 2 mg', 'type': 'BIOLOGICAL', 'otherNames': ['MEDI-563'], 'description': 'EOS+ participants received single benralizumab 2 milligram (mg) injection followed by a single placebo injection subcutaneously.', 'armGroupLabels': ['EOS+ Benralizumab (2 mg)']}, {'name': 'Benralizumab 20 mg', 'type': 'BIOLOGICAL', 'otherNames': ['MEDI-563'], 'description': 'EOS+ participants received single benralizumab 20 mg injection followed by a single placebo injection subcutaneously.', 'armGroupLabels': ['EOS+ Benralizumab (20 mg)']}, {'name': 'Benralizumab 100 mg', 'type': 'BIOLOGICAL', 'otherNames': ['MEDI-563'], 'description': 'EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.', 'armGroupLabels': ['EOS+ Benralizumab (100 mg)', 'EOS- Benralizumab (100 mg)']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'EOS+ and EOS- participants received two placebo injections subcutaneously.', 'armGroupLabels': ['Eosinophilic phenotype (EOS+) Placebo', 'Non-eosinophil phenotype (EOS-) Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Orange', 'state': 'California', 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