Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-02-28 @ 8:47 PM
Study NCT ID:
NCT02155660
Status:
COMPLETED
Last Update Posted:
2019-06-26
First Post:
2014-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With Exacerbation History
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}], 'ancestors': [{'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ulbaldo.martin@astrazeneca.com', 'phone': '1.301.398.0163', 'title': 'Ulbaldo Martin', 'organization': 'AstraZeneca'}, 'certainAgreement': {'otherDetails': "≥ 60 days prior to submission of material for publication/presentation, Institution and PI shall jointly provide AZ with material for review. No publication/presentation may include any of AZ's Confidential Information without AZ's written approval. AZ can request Inst. and PI to withhold material from submission for publication/presentation for an additional 90 days to allow AZ to establish and preserve its proprietary rights in the material being submitted for publication or presentation.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the time patient signed informed consent throughout the treatment period to the follow-up visit (week 60).', 'description': 'Adverse events are presented according to the actual treatment the participants received. One participant randomized to Benra 10 mg was treated with Benra 30 mg, thus this participant is counted in Benra 30 mg group, and hence one less participant in Benra 10 mg, compared with patient flow summary (where participants are summarized per randomized treatment group).', 'eventGroups': [{'id': 'EG000', 'title': 'Benra 10 mg', 'description': 'Every 8 weeks administered subcutaneously', 'otherNumAtRisk': 561, 'deathsNumAtRisk': 561, 'otherNumAffected': 251, 'seriousNumAtRisk': 561, 'deathsNumAffected': 17, 'seriousNumAffected': 144}, {'id': 'EG001', 'title': 'Benra 30 mg', 'description': 'Every 8 weeks administered subcutaneously', 'otherNumAtRisk': 563, 'deathsNumAtRisk': 563, 'otherNumAffected': 233, 'seriousNumAtRisk': 563, 'deathsNumAffected': 21, 'seriousNumAffected': 177}, {'id': 'EG002', 'title': 'Benra 100 mg', 'description': 'Every 8 weeks administered subcutaneously', 'otherNumAtRisk': 562, 'deathsNumAtRisk': 562, 'otherNumAffected': 238, 'seriousNumAtRisk': 562, 'deathsNumAffected': 17, 'seriousNumAffected': 127}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Every 8 weeks administered subcutaneously', 'otherNumAtRisk': 568, 'deathsNumAtRisk': 568, 'otherNumAffected': 260, 'seriousNumAtRisk': 568, 'deathsNumAffected': 19, 'seriousNumAffected': 158}], 'otherEvents': [{'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 94, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 100, 'numAffected': 70}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 87, 'numAffected': 63}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 88, 'numAffected': 66}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 22, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 27, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 29, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 27, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 25, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 20, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 17, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 18, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 19, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 21, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 24, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 109, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 98, 'numAffected': 71}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 92, 'numAffected': 67}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 89, 'numAffected': 65}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 34, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 26, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 32, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 22, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 73, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 68, 'numAffected': 47}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 92, 'numAffected': 60}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 93, 'numAffected': 70}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 20, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 20, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 34, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 36, 'numAffected': 24}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 24, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 34, 'numAffected': 24}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 22, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 22, 'numAffected': 21}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Haemorrhagic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Polycythaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Aortic valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cor pulmonale', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Right ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Henoch-Schonlein purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Accelerated hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Aortic dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Penetrating aortic ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 561, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 563, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 562, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 568, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '377', 'groupId': 'OG000'}, {'value': '394', 'groupId': 'OG001'}, {'value': '386', 'groupId': 'OG002'}, {'value': '388', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Benralizumab 10 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG001', 'title': 'Benralizumab 30 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG002', 'title': 'Benralizumab 100 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Every 8 weeks administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '0.99', 'groupId': 'OG000', 'lowerLimit': '0.87', 'upperLimit': '1.13'}, {'value': '1.21', 'groupId': 'OG001', 'lowerLimit': '1.08', 'upperLimit': '1.37'}, {'value': '1.09', 'groupId': 'OG002', 'lowerLimit': '0.96', 'upperLimit': '1.23'}, {'value': '1.17', 'groupId': 'OG003', 'lowerLimit': '1.04', 'upperLimit': '1.32'}]}]}], 'analyses': [{'pValue': '0.0638', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.85', 'ciLowerLimit': '0.71', 'ciUpperLimit': '1.01', 'statisticalMethod': 'Negative binomial', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.'}, {'pValue': '0.6575', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.23', 'statisticalMethod': 'Negative binomial', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.'}, {'pValue': '0.3988', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.78', 'ciUpperLimit': '1.10', 'statisticalMethod': 'Negative binomial', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Immediately following the first IP dose through week 56', 'description': 'A COPD exacerbation is defined by symptomatic worsening of COPD requiring:\n\n* Use of systemic corticosteroids for at least 3 days; a single depot injectable dose of corticosteroids will be considered equivalent to a 3-day course of systemic corticosteroids; and/or\n* Use of antibiotics; and/or\n* An inpatient hospitalization or death due to COPD Annual COPD exacerbation rate is the number of exacerbations per year. Its raw rate is calculated by number of exacerbations divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model.', 'unitOfMeasure': 'Exacerbations per year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, baseline EOS\\>=220/uL'}, {'type': 'SECONDARY', 'title': 'Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS<220/uL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Benralizumab 10 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG001', 'title': 'Benralizumab 30 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG002', 'title': 'Benralizumab 100 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Every 8 weeks administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '1.23', 'groupId': 'OG000', 'lowerLimit': '1.03', 'upperLimit': '1.46'}, {'value': '1.27', 'groupId': 'OG001', 'lowerLimit': '1.05', 'upperLimit': '1.53'}, {'value': '1.21', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '1.45'}, {'value': '1.18', 'groupId': 'OG003', 'lowerLimit': '0.98', 'upperLimit': '1.41'}]}]}], 'analyses': [{'pValue': '0.7564', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.32', 'statisticalMethod': 'Negative binomial', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model includes treatment group, region, background therapy, number of exacerbations in the previous year.'}, {'pValue': '0.5573', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.37', 'statisticalMethod': 'Negative binomial', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model includes treatment group, region, background therapy, number of exacerbations in the previous year.'}, {'pValue': '0.8644', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.30', 'statisticalMethod': 'Negative binomial', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model includes treatment group, region, background therapy, number of exacerbations in the previous year.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Immediately following the first IP dose through week 56', 'description': 'A COPD exacerbation is defined by symptomatic worsening of COPD requiring:\n\n* Use of systemic corticosteroids for at least 3 days; a single depot injectable dose of corticosteroids will be considered equivalent to a 3-day course of systemic corticosteroids; and/or\n* Use of antibiotics; and/or\n* An inpatient hospitalization or death due to COPD Annual COPD exacerbation rate is the number of exacerbations per year. Its raw rate is calculated by number of exacerbations divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model.', 'unitOfMeasure': 'Exacerbations per year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, baseline EOS\\<220/uL'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline EOS>=220/uL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '347', 'groupId': 'OG002'}, {'value': '344', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Benralizumab 10 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG001', 'title': 'Benralizumab 30 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG002', 'title': 'Benralizumab 100 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Every 8 weeks administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '0.021', 'spread': '0.346', 'groupId': 'OG000'}, {'value': '0.011', 'spread': '0.289', 'groupId': 'OG001'}, {'value': '0.033', 'spread': '0.291', 'groupId': 'OG002'}, {'value': '0.016', 'spread': '0.292', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.5043', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.015', 'ciLowerLimit': '-0.029', 'ciUpperLimit': '0.059', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model includes treatment group, baseline FEV1 value, EOS cohort, region, background therapy, visit, and treatment by visit interaction.'}, {'pValue': '0.7691', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.007', 'ciLowerLimit': '-0.051', 'ciUpperLimit': '0.037', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model includes treatment group, baseline FEV1 value, EOS cohort, region, background therapy, visit, and treatment by visit interaction.'}, {'pValue': '0.3767', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.024', 'ciUpperLimit': '0.064', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model includes treatment group, baseline FEV1 value, EOS cohort, region, background therapy, visit, and treatment by visit interaction.'}], 'paramType': 'MEAN', 'timeFrame': 'First IP up to end of treatment Week 56', 'description': 'Pre-bronchodilator FEV1 (L) is collected at Weeks 0, 4, 8, 16, 24, 32, 40, 48, and 56. Baseline is the last non-missing value with quality (acceptable or borderline quality grade) prior to the first dose of study treatment.', 'unitOfMeasure': 'Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, baseline EOS\\>=220/uL'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in SGRQ Total Score for Patients With Baseline EOS>=220/uL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}, {'value': '354', 'groupId': 'OG002'}, {'value': '349', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Benralizumab 10 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG001', 'title': 'Benralizumab 30 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG002', 'title': 'Benralizumab 100 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Every 8 weeks administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.733', 'spread': '14.996', 'groupId': 'OG000'}, {'value': '-8.674', 'spread': '17.910', 'groupId': 'OG001'}, {'value': '-7.257', 'spread': '15.989', 'groupId': 'OG002'}, {'value': '-6.863', 'spread': '16.344', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.3636', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.011', 'ciLowerLimit': '-3.192', 'ciUpperLimit': '1.171', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model includes treatment group, baseline SGRQ score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.'}, {'pValue': '0.2106', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.388', 'ciLowerLimit': '-3.562', 'ciUpperLimit': '0.786', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model includes treatment group, baseline SGRQ score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.'}, {'pValue': '0.5851', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.602', 'ciLowerLimit': '-2.763', 'ciUpperLimit': '1.560', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model includes treatment group, baseline SGRQ score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.'}], 'paramType': 'MEAN', 'timeFrame': 'First IP up to Week 56', 'description': 'SGRQ is from 50-item PRO instrument. The SGRQ total score is expressed as a percentage of overall impairment, in which 100% means the worst possible health status and 0 indicates the best possible health status.', 'unitOfMeasure': 'Percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, baseline EOS\\>=220/uL'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in CAT Total Score for Patients With Baseline EOS>=220/uL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '332', 'groupId': 'OG000'}, {'value': '331', 'groupId': 'OG001'}, {'value': '354', 'groupId': 'OG002'}, {'value': '350', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Benralizumab 10 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG001', 'title': 'Benralizumab 30 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG002', 'title': 'Benralizumab 100 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Every 8 weeks administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.18', 'spread': '6.78', 'groupId': 'OG000'}, {'value': '-2.43', 'spread': '7.18', 'groupId': 'OG001'}, {'value': '-2.36', 'spread': '6.67', 'groupId': 'OG002'}, {'value': '-2.36', 'spread': '6.54', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.8525', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.09', 'ciLowerLimit': '-0.82', 'ciUpperLimit': '0.99', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model includes treatment group, baseline CAT total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.'}, {'pValue': '0.9870', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.91', 'ciUpperLimit': '0.89', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model includes treatment group, baseline CAT total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.'}, {'pValue': '0.8204', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-1.00', 'ciUpperLimit': '0.79', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model includes treatment group, baseline CAT total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.'}], 'paramType': 'MEAN', 'timeFrame': 'First IP up to Week 56', 'description': 'CAT is an 8-item PRO developed to measure the impact of COPD on health status. The instrument uses semantic differential six-point response scales. A CAT total score is the sum of item responses. Score ranges from 0 to 40 with higher scores indicative of greater COPD impact on health status.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, baseline EOS\\>=220/uL'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in E-RS: COPD Total Score for Patients With Baseline EOS>=220/uL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'OG000'}, {'value': '302', 'groupId': 'OG001'}, {'value': '317', 'groupId': 'OG002'}, {'value': '325', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Benralizumab 10 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG001', 'title': 'Benralizumab 30 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG002', 'title': 'Benralizumab 100 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Every 8 weeks administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.657', 'spread': '5.701', 'groupId': 'OG000'}, {'value': '-2.219', 'spread': '6.381', 'groupId': 'OG001'}, {'value': '-1.593', 'spread': '5.665', 'groupId': 'OG002'}, {'value': '-1.137', 'spread': '5.935', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.2636', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.102', 'ciUpperLimit': '0.301', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model includes treatment group, baseline total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.'}, {'pValue': '0.4087', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.296', 'ciLowerLimit': '-0.998', 'ciUpperLimit': '0.406', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model includes treatment group, baseline total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.'}, {'pValue': '0.2336', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.425', 'ciLowerLimit': '-1.125', 'ciUpperLimit': '0.275', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model includes treatment group, baseline total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.'}], 'paramType': 'MEAN', 'timeFrame': 'First IP up to Week 56', 'description': 'The E-RS: COPD is an 11-item PRO developed to evaluate the severity of respiratory symptoms of COPD. Summation of E-RS: COPD item responses produces a total score ranging from 0 to 40, with higher scores indicating greater severity.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, baseline EOS\\>=220/uL'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Total Rescue Medication Use (Number of Puffs Per Day) for Patients With Baseline EOS>=220/uL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}, {'value': '310', 'groupId': 'OG002'}, {'value': '314', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Benralizumab 10 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG001', 'title': 'Benralizumab 30 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG002', 'title': 'Benralizumab 100 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Every 8 weeks administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.36', 'spread': '3.04', 'groupId': 'OG000'}, {'value': '-0.24', 'spread': '3.36', 'groupId': 'OG001'}, {'value': '-0.17', 'spread': '3.02', 'groupId': 'OG002'}, {'value': '0.23', 'spread': '3.55', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0012', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.642', 'ciLowerLimit': '-1.029', 'ciUpperLimit': '-0.254', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model includes treatment group, baseline rescue med. use, EOS cohort, region, background therapy, visit, and treatment by visit interaction.'}, {'pValue': '0.0852', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.340', 'ciLowerLimit': '-0.727', 'ciUpperLimit': '0.047', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model includes treatment group, baseline rescue med. use, EOS cohort, region, background therapy, visit, and treatment by visit interaction.'}, {'pValue': '0.0650', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.364', 'ciLowerLimit': '-0.750', 'ciUpperLimit': '0.023', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model includes treatment group, baseline rescue med. use, EOS cohort, region, background therapy, visit, and treatment by visit interaction.'}], 'paramType': 'MEAN', 'timeFrame': 'First IP up to Week 56', 'description': 'The number of rescue medication inhalations and nebulizer treatments taken are recorded by the patient in the eDiary twice daily. Total rescue medication use is the sum of daytime and night-time use.', 'unitOfMeasure': 'Puffs/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, baseline EOS\\>=220/uL'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Proportion of Nights With Awakenings Due to Respiratory Symptoms for Patients With Baseline EOS>=220/uL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '321', 'groupId': 'OG002'}, {'value': '322', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Benralizumab 10 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG001', 'title': 'Benralizumab 30 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG002', 'title': 'Benralizumab 100 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Every 8 weeks administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.092', 'spread': '0.297', 'groupId': 'OG000'}, {'value': '-0.131', 'spread': '0.332', 'groupId': 'OG001'}, {'value': '-0.084', 'spread': '0.334', 'groupId': 'OG002'}, {'value': '-0.053', 'spread': '0.345', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0415', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.041', 'ciLowerLimit': '-0.081', 'ciUpperLimit': '-0.002', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model includes treatment group, baseline prop. of nights awakens., EOS cohort, region, background therapy, visit, and treatment by visit interaction.'}, {'pValue': '0.0069', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.055', 'ciLowerLimit': '-0.094', 'ciUpperLimit': '-0.015', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model includes treatment group, baseline prop. of nights awakens., EOS cohort, region, background therapy, visit, and treatment by visit interaction.'}, {'pValue': '0.2008', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.026', 'ciLowerLimit': '-0.065', 'ciUpperLimit': '0.014', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model includes treatment group, baseline prop. of nights awakens., EOS cohort, region, background therapy, visit, and treatment by visit interaction.'}], 'paramType': 'MEAN', 'timeFrame': 'First IP up to Week 56', 'description': 'Change from baseline to Week 56 in proportion of nights with awakenings due to respiratory symptoms.', 'unitOfMeasure': 'Proportion of nights', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, baseline EOS\\>=220/uL'}, {'type': 'SECONDARY', 'title': 'Number of Participants by Number of COPD Exacerbations Based on EXACT-PRO for Patients With Baseline EOS>=220/uL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '377', 'groupId': 'OG000'}, {'value': '394', 'groupId': 'OG001'}, {'value': '385', 'groupId': 'OG002'}, {'value': '388', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Benralizumab 10 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG001', 'title': 'Benralizumab 30 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG002', 'title': 'Benralizumab 100 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Every 8 weeks administered subcutaneously'}], 'classes': [{'categories': [{'title': '0', 'measurements': [{'value': '166', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '162', 'groupId': 'OG002'}, {'value': '159', 'groupId': 'OG003'}]}, {'title': '1', 'measurements': [{'value': '108', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}, {'value': '119', 'groupId': 'OG003'}]}, {'title': '2', 'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}, {'title': '3', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}, {'title': '4', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}, {'title': '5', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}, {'title': '6', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}, {'title': '7', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}, {'title': '8', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': '9', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': '10', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': '11', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Immediately following first IP up to week 56', 'description': 'The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while considering their experiences "today". The daily EXACT-PRO total score is recorded and has a range of 0-100 with higher scores indicative of greater severity. COPD exacerbation event frequency is calculated based on comparison of the baseline score with daily total scores. An increase of EXACT-PRO total score ≥9 for 3 days or ≥12 for 2 days indicates a COPD exacerbation event has occurred.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, EOS\\>=220/uL'}, {'type': 'SECONDARY', 'title': 'Severity of EXACT-PRO for Patients With Baseline EOS>=220/uL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}, {'value': '223', 'groupId': 'OG002'}, {'value': '229', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Benralizumab 10 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG001', 'title': 'Benralizumab 30 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG002', 'title': 'Benralizumab 100 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Every 8 weeks administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '50.3', 'spread': '12.30', 'groupId': 'OG000'}, {'value': '52.1', 'spread': '11.3', 'groupId': 'OG001'}, {'value': '51.2', 'spread': '11.0', 'groupId': 'OG002'}, {'value': '51.0', 'spread': '11.7', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately following first IP up to week 56', 'description': 'The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while considering their experiences "today". The daily EXACT-PRO total score has a range of 0-100 with higher scores indicative of greater severity. Severity of the study is the highest score of EXACT-PRO.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, baseline EOS\\>=220/uL'}, {'type': 'SECONDARY', 'title': 'Duration of COPD Exacerbation Based on EXACT-PRO Score for Patients With Baseline EOS>=220/uL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}, {'value': '223', 'groupId': 'OG002'}, {'value': '229', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Benralizumab 10 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG001', 'title': 'Benralizumab 30 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG002', 'title': 'Benralizumab 100 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Every 8 weeks administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '110.1', 'spread': '114.0', 'groupId': 'OG000'}, {'value': '96.1', 'spread': '109.3', 'groupId': 'OG001'}, {'value': '99.8', 'spread': '114.8', 'groupId': 'OG002'}, {'value': '99.9', 'spread': '113.9', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately following first IP up to week 56', 'description': 'The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while considering their experiences "today". The daily EXACT-PRO total score has a range of 0-100 with higher scores indicative of greater severity. COPD exacerbation event frequency is identified by comparing the baseline score with daily total scores. An increase in EXACT-PRO total score ≥9 for 3 days or ≥12 for 2 days indicate an event has occurred. Event duration is calculated after identification of the following five parameters: 1) onset; 2) three-day rolling average; 3) maximum observed value; 4) threshold for improvement; and 5) recovery. That is, duration of the exacerbation is the time elapse between onset and recovery of the event.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, baseline EOS\\>=220/uL'}, {'type': 'SECONDARY', 'title': 'Annual EXACT-PRO Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '377', 'groupId': 'OG000'}, {'value': '394', 'groupId': 'OG001'}, {'value': '385', 'groupId': 'OG002'}, {'value': '388', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Benralizumab 10 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG001', 'title': 'Benralizumab 30 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG002', 'title': 'Benralizumab 100 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Every 8 weeks administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '1.20', 'groupId': 'OG000', 'lowerLimit': '1.05', 'upperLimit': '1.37'}, {'value': '1.21', 'groupId': 'OG001', 'lowerLimit': '1.06', 'upperLimit': '1.37'}, {'value': '1.13', 'groupId': 'OG002', 'lowerLimit': '0.99', 'upperLimit': '1.29'}, {'value': '1.23', 'groupId': 'OG003', 'lowerLimit': '1.08', 'upperLimit': '1.40'}]}]}], 'analyses': [{'pValue': '0.8158', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.18', 'statisticalMethod': 'Negative binomial', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.'}, {'pValue': '0.8378', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.18', 'statisticalMethod': 'Negative binomial', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.'}, {'pValue': '0.3759', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.11', 'statisticalMethod': 'Negative binomial', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Immediately following the first IP dose through week 56', 'description': 'The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while considering their experiences "today". The daily EXACT-PRO total score has a range of 0-100 with higher scores indicative of greater severity. Event frequency is calculated by comparing the baseline with daily total scores. An increase in EXACT-PRO total score ≥9 for 3 days or ≥12 for 2 days indicate an event has occurred. Annual EXACT-PRO exacerbation rate is the number of exacerbations per year. Its raw rate is calculated by number of exacerbations divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model.', 'unitOfMeasure': 'Exacerbations per year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, baseline EOS\\>=220/uL'}, {'type': 'SECONDARY', 'title': 'Number of Participants Having at Least 1 COPD Exacerbation for Patients With Baseline EOS>=220/uL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '377', 'groupId': 'OG000'}, {'value': '394', 'groupId': 'OG001'}, {'value': '386', 'groupId': 'OG002'}, {'value': '388', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Benralizumab 10 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG001', 'title': 'Benralizumab 30 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG002', 'title': 'Benralizumab 100 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Every 8 weeks administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '203', 'groupId': 'OG000'}, {'value': '241', 'groupId': 'OG001'}, {'value': '214', 'groupId': 'OG002'}, {'value': '208', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.9141', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.36', 'groupDescription': 'Proportion of participants with \\>=1 COPD exacerbation.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'CMH test controlling for EOS cohort, region, and background therapy.'}, {'pValue': '0.0323', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.39', 'ciLowerLimit': '1.03', 'ciUpperLimit': '1.87', 'groupDescription': 'Proportion of participants with \\>=1 COPD exacerbation.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'CMH test controlling for EOS cohort, region, and background therapy.'}, {'pValue': '0.5109', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.10', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.48', 'groupDescription': 'Proportion of participants with \\>=1 COPD exacerbation.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'CMH test controlling for EOS cohort, region, and background therapy.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Immediately following first IP dose up to week 56', 'description': 'A COPD exacerbation is defined by symptomatic worsening COPD requiring systemic corticosteroids, antibiotics, or an inpatient hospitalization/death due to COPD.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, baseline EOS\\>=220/uL'}, {'type': 'SECONDARY', 'title': 'Time to First COPD Exacerbation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '377', 'groupId': 'OG000'}, {'value': '394', 'groupId': 'OG001'}, {'value': '386', 'groupId': 'OG002'}, {'value': '388', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Benralizumab 10 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG001', 'title': 'Benralizumab 30 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG002', 'title': 'Benralizumab 100 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Every 8 weeks administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '315', 'groupId': 'OG000', 'lowerLimit': '244', 'upperLimit': '380'}, {'value': '260', 'groupId': 'OG001', 'lowerLimit': '225', 'upperLimit': '291'}, {'value': '322', 'groupId': 'OG002', 'lowerLimit': '278', 'upperLimit': '373'}, {'value': '337', 'groupId': 'OG003', 'lowerLimit': '261', 'upperLimit': '400'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Immediately following IP dose to Week 56', 'description': 'Time to first COPD exacerbation is from the randomization date to the first occurrence of COPD exacerbation.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, baseline EOS\\>=220/uL'}, {'type': 'SECONDARY', 'title': 'Annual COPD Exacerbation Rate Associated With ER or Hospitalization Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '377', 'groupId': 'OG000'}, {'value': '394', 'groupId': 'OG001'}, {'value': '386', 'groupId': 'OG002'}, {'value': '388', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Benralizumab 10 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG001', 'title': 'Benralizumab 30 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG002', 'title': 'Benralizumab 100 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Every 8 weeks administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '0.22', 'groupId': 'OG000', 'lowerLimit': '0.17', 'upperLimit': '0.29'}, {'value': '0.29', 'groupId': 'OG001', 'lowerLimit': '0.23', 'upperLimit': '0.36'}, {'value': '0.22', 'groupId': 'OG002', 'lowerLimit': '0.17', 'upperLimit': '0.28'}, {'value': '0.32', 'groupId': 'OG003', 'lowerLimit': '0.26', 'upperLimit': '0.40'}]}]}], 'analyses': [{'pValue': '0.0287', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '0.49', 'ciUpperLimit': '0.96', 'statisticalMethod': 'Negative binomial', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model includes treatment group, EOS cohort, region, background therapy, previous year exacerbations associated with hospitalization (Y/N).'}, {'pValue': '0.4631', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.65', 'ciUpperLimit': '1.22', 'statisticalMethod': 'Negative binomial', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model includes treatment group, EOS cohort, region, background therapy, previous year exacerbations associated with hospitalization (Y/N).'}, {'pValue': '0.0185', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.67', 'ciLowerLimit': '0.48', 'ciUpperLimit': '0.94', 'statisticalMethod': 'Negative binomial', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model includes treatment group, EOS cohort, region, background therapy, previous year exacerbations associated with hospitalization (Y/N).'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Immediately following the first IP dose through week 56', 'description': 'Annual COPD exacerbations rate that result in ER or hospitalization is calculated by number of exacerbations resulting ER or hospitalization divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model.', 'unitOfMeasure': 'Exacerbations per year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, baseline EOS\\>=220/uL'}, {'type': 'SECONDARY', 'title': 'Number of Participants Had COPD-related Healthcare Encounter for Patient With Baseline EOS>=220/uL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '377', 'groupId': 'OG000'}, {'value': '394', 'groupId': 'OG001'}, {'value': '386', 'groupId': 'OG002'}, {'value': '388', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Benralizumab 10 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG001', 'title': 'Benralizumab 30 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG002', 'title': 'Benralizumab 100 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Every 8 weeks administered subcutaneously'}], 'classes': [{'title': 'Hospitalisations', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}]}, {'title': 'Emergency department', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}]}, {'title': 'Unscheduled outpatient visits', 'categories': [{'measurements': [{'value': '208', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '225', 'groupId': 'OG002'}, {'value': '211', 'groupId': 'OG003'}]}]}, {'title': 'Home visits', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}, {'title': 'Telephone calls', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '114', 'groupId': 'OG003'}]}]}, {'title': 'Ambulance transports', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Immediately following first IP dose up to Week 56', 'description': 'Types of healthcare encounter: Hospitalisations (inc. intensive care and/or general care), Emergency department visits, Unscheduled outpatients visits, Home visits, Telephone calls, and ambulance transports.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, baseline EOS\\>=220/uL'}, {'type': 'SECONDARY', 'title': 'Duration of Study Treatment Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '561', 'groupId': 'OG000'}, {'value': '563', 'groupId': 'OG001'}, {'value': '562', 'groupId': 'OG002'}, {'value': '568', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Benralizumab 10 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG001', 'title': 'Benralizumab 30 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG002', 'title': 'Benralizumab 100 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Every 8 weeks administered subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '307.4', 'spread': '80.38', 'groupId': 'OG000'}, {'value': '302.2', 'spread': '84.62', 'groupId': 'OG001'}, {'value': '303.0', 'spread': '88.48', 'groupId': 'OG002'}, {'value': '308.8', 'spread': '78.95', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From first dose date to last dose date, 48 weeks per protocol.', 'description': 'Duration of study treatment is calculated from first dose date to last dose date + 1 day.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set'}, {'type': 'SECONDARY', 'title': 'Serum Concentration of Benralizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '558', 'groupId': 'OG000'}, {'value': '560', 'groupId': 'OG001'}, {'value': '552', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Benralizumab 10 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG001', 'title': 'Benralizumab 30 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG002', 'title': 'Benralizumab 100 mg', 'description': 'Every 8 weeks administered subcutaneously'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '555', 'groupId': 'OG000'}, {'value': '559', 'groupId': 'OG001'}, {'value': '548', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': '\\<LLOQ (Lower limit of quantification)', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': '\\<LLOQ (Lower limit of quantification)', 'groupId': 'OG001'}, {'value': 'NA', 'spread': '51.95', 'comment': '\\<LLOQ (Lower limit of quantification)', 'groupId': 'OG002'}]}]}, {'title': 'Week 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '399', 'groupId': 'OG000'}, {'value': '370', 'groupId': 'OG001'}, {'value': '384', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '42.51', 'spread': '384.81', 'groupId': 'OG000'}, {'value': '222.92', 'spread': '248.24', 'groupId': 'OG001'}, {'value': '594.33', 'spread': '321.66', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-first dose and pre-dose at end of treatment (week 56).', 'description': 'PK serum samples were collected pre-dose at each visit.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set'}, {'type': 'SECONDARY', 'title': 'Immunogenicity of Benralizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '561', 'groupId': 'OG000'}, {'value': '563', 'groupId': 'OG001'}, {'value': '562', 'groupId': 'OG002'}, {'value': '568', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Benralizumab 10 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG001', 'title': 'Benralizumab 30 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG002', 'title': 'Benralizumab 100 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Every 8 weeks administered subcutaneously'}], 'classes': [{'title': 'ADA prevalence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '561', 'groupId': 'OG000'}, {'value': '563', 'groupId': 'OG001'}, {'value': '562', 'groupId': 'OG002'}, {'value': '568', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}]}, {'title': 'ADA incidence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '554', 'groupId': 'OG000'}, {'value': '554', 'groupId': 'OG001'}, {'value': '542', 'groupId': 'OG002'}, {'value': '555', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}]}, {'title': 'Both base/post-baseline positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '554', 'groupId': 'OG000'}, {'value': '554', 'groupId': 'OG001'}, {'value': '542', 'groupId': 'OG002'}, {'value': '555', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'Only post baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '556', 'groupId': 'OG000'}, {'value': '556', 'groupId': 'OG001'}, {'value': '547', 'groupId': 'OG002'}, {'value': '561', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}, {'title': 'Only baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '559', 'groupId': 'OG000'}, {'value': '561', 'groupId': 'OG001'}, {'value': '557', 'groupId': 'OG002'}, {'value': '562', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'ADA persistently positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '554', 'groupId': 'OG000'}, {'value': '554', 'groupId': 'OG001'}, {'value': '542', 'groupId': 'OG002'}, {'value': '555', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'ADA transiently positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '554', 'groupId': 'OG000'}, {'value': '554', 'groupId': 'OG001'}, {'value': '542', 'groupId': 'OG002'}, {'value': '555', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'nAb prevalence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '561', 'groupId': 'OG000'}, {'value': '563', 'groupId': 'OG001'}, {'value': '562', 'groupId': 'OG002'}, {'value': '568', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': 'nAb incidence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '554', 'groupId': 'OG000'}, {'value': '554', 'groupId': 'OG001'}, {'value': '542', 'groupId': 'OG002'}, {'value': '555', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Pre-treatment until end of follow-up, week 60 per protocol.', 'description': 'Anti-drug antibody (ADA) responses such as ADA prevalence, ADA incidence, ADA persistently positive counts, etc. were presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set. For each parameter, the number of subjects at risk is to be analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Benralizumab 10 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'FG001', 'title': 'Benralizumab 30 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'FG002', 'title': 'Benralizumab 100 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Every 8 weeks administered subcutaneously'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '562'}, {'groupId': 'FG001', 'numSubjects': '562'}, {'groupId': 'FG002', 'numSubjects': '562'}, {'groupId': 'FG003', 'numSubjects': '568'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '504'}, {'groupId': 'FG001', 'numSubjects': '489'}, {'groupId': 'FG002', 'numSubjects': '502'}, {'groupId': 'FG003', 'numSubjects': '507'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '73'}, {'groupId': 'FG002', 'numSubjects': '60'}, {'groupId': 'FG003', 'numSubjects': '61'}]}], 'dropWithdraws': [{'type': 'Other Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'Study-specific withdrawal criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Severe non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '19'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '21'}]}]}], 'preAssignmentDetails': '2255 patients signed informed consent and were randomized to received treatment with benralizumab 10 mg,30 mg, 100 mg or placebo. One participant was excluded from the analysis. Therefore results are provided for 2254 participants.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '562', 'groupId': 'BG000'}, {'value': '562', 'groupId': 'BG001'}, {'value': '562', 'groupId': 'BG002'}, {'value': '568', 'groupId': 'BG003'}, {'value': '2254', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Benralizumab 10 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'BG001', 'title': 'Benralizumab 30 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'BG002', 'title': 'Benralizumab 100 mg', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Every 8 weeks administered subcutaneously'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.7', 'spread': '8.47', 'groupId': 'BG000'}, {'value': '65.6', 'spread': '8.61', 'groupId': 'BG001'}, {'value': '65.0', 'spread': '8.23', 'groupId': 'BG002'}, {'value': '65.3', 'spread': '8.44', 'groupId': 'BG003'}, {'value': '65.2', 'spread': '8.44', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Full analysis set'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '196', 'groupId': 'BG000'}, {'value': '194', 'groupId': 'BG001'}, {'value': '207', 'groupId': 'BG002'}, {'value': '209', 'groupId': 'BG003'}, {'value': '806', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '366', 'groupId': 'BG000'}, {'value': '368', 'groupId': 'BG001'}, {'value': '355', 'groupId': 'BG002'}, {'value': '359', 'groupId': 'BG003'}, {'value': '1448', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Full analysis set'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '441', 'groupId': 'BG000'}, {'value': '444', 'groupId': 'BG001'}, {'value': '443', 'groupId': 'BG002'}, {'value': '446', 'groupId': 'BG003'}, {'value': '1774', 'groupId': 'BG004'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '55', 'groupId': 'BG004'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '273', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '152', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'populationDescription': 'Full analysis set'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-07-06', 'size': 1011082, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-03-13T03:35', 'hasProtocol': True}, {'date': '2018-05-11', 'size': 994761, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-03-13T03:36', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2255}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-07', 'studyFirstSubmitDate': '2014-05-20', 'resultsFirstSubmitDate': '2019-03-18', 'studyFirstSubmitQcDate': '2014-06-02', 'lastUpdatePostDateStruct': {'date': '2019-06-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-06-07', 'studyFirstPostDateStruct': {'date': '2014-06-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL', 'timeFrame': 'Immediately following the first IP dose through week 56', 'description': 'A COPD exacerbation is defined by symptomatic worsening of COPD requiring:\n\n* Use of systemic corticosteroids for at least 3 days; a single depot injectable dose of corticosteroids will be considered equivalent to a 3-day course of systemic corticosteroids; and/or\n* Use of antibiotics; and/or\n* An inpatient hospitalization or death due to COPD Annual COPD exacerbation rate is the number of exacerbations per year. Its raw rate is calculated by number of exacerbations divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model.'}], 'secondaryOutcomes': [{'measure': 'Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS<220/uL', 'timeFrame': 'Immediately following the first IP dose through week 56', 'description': 'A COPD exacerbation is defined by symptomatic worsening of COPD requiring:\n\n* Use of systemic corticosteroids for at least 3 days; a single depot injectable dose of corticosteroids will be considered equivalent to a 3-day course of systemic corticosteroids; and/or\n* Use of antibiotics; and/or\n* An inpatient hospitalization or death due to COPD Annual COPD exacerbation rate is the number of exacerbations per year. Its raw rate is calculated by number of exacerbations divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model.'}, {'measure': 'Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline EOS>=220/uL', 'timeFrame': 'First IP up to end of treatment Week 56', 'description': 'Pre-bronchodilator FEV1 (L) is collected at Weeks 0, 4, 8, 16, 24, 32, 40, 48, and 56. Baseline is the last non-missing value with quality (acceptable or borderline quality grade) prior to the first dose of study treatment.'}, {'measure': 'Mean Change From Baseline in SGRQ Total Score for Patients With Baseline EOS>=220/uL', 'timeFrame': 'First IP up to Week 56', 'description': 'SGRQ is from 50-item PRO instrument. The SGRQ total score is expressed as a percentage of overall impairment, in which 100% means the worst possible health status and 0 indicates the best possible health status.'}, {'measure': 'Mean Change From Baseline in CAT Total Score for Patients With Baseline EOS>=220/uL', 'timeFrame': 'First IP up to Week 56', 'description': 'CAT is an 8-item PRO developed to measure the impact of COPD on health status. The instrument uses semantic differential six-point response scales. A CAT total score is the sum of item responses. Score ranges from 0 to 40 with higher scores indicative of greater COPD impact on health status.'}, {'measure': 'Mean Change From Baseline in E-RS: COPD Total Score for Patients With Baseline EOS>=220/uL', 'timeFrame': 'First IP up to Week 56', 'description': 'The E-RS: COPD is an 11-item PRO developed to evaluate the severity of respiratory symptoms of COPD. Summation of E-RS: COPD item responses produces a total score ranging from 0 to 40, with higher scores indicating greater severity.'}, {'measure': 'Mean Change From Baseline in Total Rescue Medication Use (Number of Puffs Per Day) for Patients With Baseline EOS>=220/uL', 'timeFrame': 'First IP up to Week 56', 'description': 'The number of rescue medication inhalations and nebulizer treatments taken are recorded by the patient in the eDiary twice daily. Total rescue medication use is the sum of daytime and night-time use.'}, {'measure': 'Mean Change From Baseline in Proportion of Nights With Awakenings Due to Respiratory Symptoms for Patients With Baseline EOS>=220/uL', 'timeFrame': 'First IP up to Week 56', 'description': 'Change from baseline to Week 56 in proportion of nights with awakenings due to respiratory symptoms.'}, {'measure': 'Number of Participants by Number of COPD Exacerbations Based on EXACT-PRO for Patients With Baseline EOS>=220/uL', 'timeFrame': 'Immediately following first IP up to week 56', 'description': 'The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while considering their experiences "today". The daily EXACT-PRO total score is recorded and has a range of 0-100 with higher scores indicative of greater severity. COPD exacerbation event frequency is calculated based on comparison of the baseline score with daily total scores. An increase of EXACT-PRO total score ≥9 for 3 days or ≥12 for 2 days indicates a COPD exacerbation event has occurred.'}, {'measure': 'Severity of EXACT-PRO for Patients With Baseline EOS>=220/uL', 'timeFrame': 'Immediately following first IP up to week 56', 'description': 'The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while considering their experiences "today". The daily EXACT-PRO total score has a range of 0-100 with higher scores indicative of greater severity. Severity of the study is the highest score of EXACT-PRO.'}, {'measure': 'Duration of COPD Exacerbation Based on EXACT-PRO Score for Patients With Baseline EOS>=220/uL', 'timeFrame': 'Immediately following first IP up to week 56', 'description': 'The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while considering their experiences "today". The daily EXACT-PRO total score has a range of 0-100 with higher scores indicative of greater severity. COPD exacerbation event frequency is identified by comparing the baseline score with daily total scores. An increase in EXACT-PRO total score ≥9 for 3 days or ≥12 for 2 days indicate an event has occurred. Event duration is calculated after identification of the following five parameters: 1) onset; 2) three-day rolling average; 3) maximum observed value; 4) threshold for improvement; and 5) recovery. That is, duration of the exacerbation is the time elapse between onset and recovery of the event.'}, {'measure': 'Annual EXACT-PRO Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL', 'timeFrame': 'Immediately following the first IP dose through week 56', 'description': 'The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while considering their experiences "today". The daily EXACT-PRO total score has a range of 0-100 with higher scores indicative of greater severity. Event frequency is calculated by comparing the baseline with daily total scores. An increase in EXACT-PRO total score ≥9 for 3 days or ≥12 for 2 days indicate an event has occurred. Annual EXACT-PRO exacerbation rate is the number of exacerbations per year. Its raw rate is calculated by number of exacerbations divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model.'}, {'measure': 'Number of Participants Having at Least 1 COPD Exacerbation for Patients With Baseline EOS>=220/uL', 'timeFrame': 'Immediately following first IP dose up to week 56', 'description': 'A COPD exacerbation is defined by symptomatic worsening COPD requiring systemic corticosteroids, antibiotics, or an inpatient hospitalization/death due to COPD.'}, {'measure': 'Time to First COPD Exacerbation', 'timeFrame': 'Immediately following IP dose to Week 56', 'description': 'Time to first COPD exacerbation is from the randomization date to the first occurrence of COPD exacerbation.'}, {'measure': 'Annual COPD Exacerbation Rate Associated With ER or Hospitalization Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL', 'timeFrame': 'Immediately following the first IP dose through week 56', 'description': 'Annual COPD exacerbations rate that result in ER or hospitalization is calculated by number of exacerbations resulting ER or hospitalization divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model.'}, {'measure': 'Number of Participants Had COPD-related Healthcare Encounter for Patient With Baseline EOS>=220/uL', 'timeFrame': 'Immediately following first IP dose up to Week 56', 'description': 'Types of healthcare encounter: Hospitalisations (inc. intensive care and/or general care), Emergency department visits, Unscheduled outpatients visits, Home visits, Telephone calls, and ambulance transports.'}, {'measure': 'Duration of Study Treatment Administration', 'timeFrame': 'From first dose date to last dose date, 48 weeks per protocol.', 'description': 'Duration of study treatment is calculated from first dose date to last dose date + 1 day.'}, {'measure': 'Serum Concentration of Benralizumab', 'timeFrame': 'Pre-first dose and pre-dose at end of treatment (week 56).', 'description': 'PK serum samples were collected pre-dose at each visit.'}, {'measure': 'Immunogenicity of Benralizumab', 'timeFrame': 'Pre-treatment until end of follow-up, week 60 per protocol.', 'description': 'Anti-drug antibody (ADA) responses such as ADA prevalence, ADA incidence, ADA persistently positive counts, etc. were presented.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Obstructive Lung Diseases', 'Chronic Obstructive Pulmonary Disease', 'Lung Disease', 'Bronchial Diseases', 'COPD Exacerbation', 'Respiratory Tract Diseases'], 'conditions': ['Moderate to Very Severe Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '31575508', 'type': 'DERIVED', 'citation': 'Criner GJ, Celli BR, Singh D, Agusti A, Papi A, Jison M, Makulova N, Shih VH, Brooks L, Barker P, Martin UJ, Newbold P. Predicting response to benralizumab in chronic obstructive pulmonary disease: analyses of GALATHEA and TERRANOVA studies. Lancet Respir Med. 2020 Feb;8(2):158-170. doi: 10.1016/S2213-2600(19)30338-8. Epub 2019 Sep 28.'}, {'pmid': '31112385', 'type': 'DERIVED', 'citation': "Criner GJ, Celli BR, Brightling CE, Agusti A, Papi A, Singh D, Sin DD, Vogelmeier CF, Sciurba FC, Bafadhel M, Backer V, Kato M, Ramirez-Venegas A, Wei YF, Bjermer L, Shih VH, Jison M, O'Quinn S, Makulova N, Newbold P, Goldman M, Martin UJ; GALATHEA Study Investigators; TERRANOVA Study Investigators. Benralizumab for the Prevention of COPD Exacerbations. N Engl J Med. 2019 Sep 12;381(11):1023-1034. doi: 10.1056/NEJMoa1905248. Epub 2019 May 20."}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=2563&filename=D3251C00004%20-%20%20%20Statistical%20Analysis%20Plan_Redacted.pdf', 'label': 'Related Info'}, {'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=2563&filename=Terranova%20CSP%20and%20last%20amendment_Redacted.pdf', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine if benralizumab reduces COPD exacerbation rate in symptomatic patients with moderate to very severe COPD who are receiving standard of care therapies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:.\n\n* Informed consent.\n* Subjects 40-85 y.o.\n* Moderate to very severe COPD with Post Bronchodilator (BD) FEV1\\>20% and ≤65%.\n\n -≥2 moderate or ≥1 severe COPD exacerbation(s) required treatment or hospitalization within 2-52 weeks prior to Visit1.\n* Modified Medical Research Council (mMRC) score ≥1 at Visit 1.\n* Treatment with double or triple therapy throughout the year prior to Visit 1, constant 2 weeks prior to Visit 1.\n* Tobacco history of ≥10 pack-years.\n* Women of childbearing potential must use a highly effective form of birth control from Visit 1 until 16 weeks after their last dose, and negative serum pregnancy test result at Visit 1.\n* Male subjects who are sexually active must be surgically sterile one year prior to Visit 1 or use an adequate method of contraception from the first Investigational Product (IP) dose until 16 weeks after their last dose.\n* Compliance with maintenance therapy during run-in ≥70%.\n* Blood eosinophils due to subject's stratification and cap for blood eosinophil levels.When any eosinophil cohort is full, subjects in the completed cohort will not be randomised and will be withdrawn from the study.\n\nExclusion criteria:\n\n* Clinically important pulmonary disease other than COPD or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.\n* Any disorder or major physical impairment that is not stable by Investigator opinion and/or could affect: - subject safety-study findings or their interpretation or subject's ability to complete the entire study duration.\n* Unstable ischemic heart disease, arrhythmia, cardiomyopathy, or other relevant cardiovascular disorder that in Investigator's judgment may put the patient at risk or negatively affect the study outcome.\n* Treatment with systemic corticosteroids and/or antibiotics, and/or hospitalization for a COPD exacerbation within 2 weeks prior to Visit1 or during the enrolment and run-in period.\n* Acute upper or lower respiratory infection requiring antibiotics within 2 weeks prior to Visit1 or during the enrolment and run-in period.\n* Pneumonia within 8 weeks prior to Visit1 or during the enrolment and run-in period.\n* Pregnant, breastfeeding, or lactating women.\n* Risk factors for pneumonia\n* History of anaphylaxis to any other biologic therapy.\n* Long term oxygen therapy with signs and/or symptoms of cor pulmonale, right ventricular failure.\n* Use of immunosuppressive medication within 2 weeks prior to Visit1 and/or during the enrolment and run-in period.\n* Receipt of any investigational non-biologic product within 30 days or 5 half-lives prior to Visit 1.\n* Evidence of active tuberculosis (TB) without an appropriate course of treatment.\n* Lung volume reduction surgery within the 6 months prior to Visit 1. History of partial or total lung resection (single lobe or segmentectomy is acceptable).\n* Asthma as a primary or main diagnosis according to the Global Initiative for Asthma (GINA) guidelines or other accepted guidelines.\n* Previous treatment with benralizumab.\n* Helminth parasitic infection diagnosed within 24 weeks prior to Visit 1."}, 'identificationModule': {'nctId': 'NCT02155660', 'acronym': 'TERRANOVA', 'briefTitle': 'Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With Exacerbation History', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Randomised, Double-blind, Double Dummy, 56 Week Placebo-controlled, Multicentre, Parallel Group, Phase 3 Study Evaluating Efficacy/Safety of 3 Benralizumab Doses in Patients With Moderate to Very Severe COPD With Previous Exacerbations.', 'orgStudyIdInfo': {'id': 'D3251C00004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Benralizumab Arm A', 'description': 'Benralizumab administered subcutaneously', 'interventionNames': ['Drug: Benralizumab Arm A']}, {'type': 'EXPERIMENTAL', 'label': 'Benralizumab Arm B', 'description': 'Benralizumab administered subcutaneously', 'interventionNames': ['Drug: Benralizumab Arm B']}, {'type': 'EXPERIMENTAL', 'label': 'Benralizumab Arm C', 'description': 'Benralizumab administered subcutaneously', 'interventionNames': ['Drug: Benralizumab Arm C']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo administered subcutaneously', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Benralizumab Arm A', 'type': 'DRUG', 'description': 'Benralizumab subcutaneously on study week 0 until study week 48 inclusive', 'armGroupLabels': ['Benralizumab Arm A']}, {'name': 'Benralizumab Arm B', 'type': 'DRUG', 'description': 'Benralizumab subcutaneously on study week 0 until study week 48 inclusive', 'armGroupLabels': ['Benralizumab Arm B']}, {'name': 'Benralizumab Arm C', 'type': 'DRUG', 'description': 'Benralizumab subcutaneously on study week 0 until study week 48 inclusive', 'armGroupLabels': ['Benralizumab Arm C']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Benralizumab subcutaneously on study week 0 until study week 48 inclusive', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35216', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36542', 'city': 'Gulf Shores', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 30.24604, 'lon': -87.70082}}, {'zip': '36117', 'city': 'Montgomery', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.36681, 'lon': -86.29997}}, {'zip': '86001', 'city': 'Flagstaff', 'state': 'Arizona', 'country': 'United States', 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