Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-29 @ 5:09 PM
Study NCT ID:
NCT01448850
Status:
COMPLETED
Last Update Posted:
2017-01-30
First Post:
2011-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'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': 'vandermerwer@medimmune.com', 'phone': '301-398-0000', 'title': 'Rene van der Merwe, MBChB/Senior Director, Clinical Development', 'organization': 'MedImmune, LLC.'}, 'certainAgreement': {'otherDetails': 'MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 up to Week 69', 'eventGroups': [{'id': 'EG000', 'title': 'PLACEBO', 'description': 'Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.', 'otherNumAtRisk': 164, 'otherNumAffected': 127, 'seriousNumAtRisk': 164, 'seriousNumAffected': 35}, {'id': 'EG001', 'title': 'MEDI8968 300 mg', 'description': 'MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 5.', 'otherNumAtRisk': 160, 'otherNumAffected': 122, 'seriousNumAtRisk': 160, 'seriousNumAffected': 41}], 'otherEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 13, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dyslipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 27, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 138, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 112, 'numAffected': 64}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Adams-stokes syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Congestive cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Ventricular arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': "Ebstein's anomaly", 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hypoacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Impaired gastric emptying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pancreatitis necrotising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Atypical mycobacterial pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cholecystitis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Fungal oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Gastroenteritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pneumonia staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Comminuted fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'International normalised ratio increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Malignant neoplasm of unknown primary site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Metastatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cerebral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cerebral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Bronchitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 29, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 21, 'numAffected': 18}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.'}, {'id': 'OG001', 'title': 'MEDI8968 600 mg IV, 300 mg SC', 'description': 'MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.78', 'groupId': 'OG000', 'lowerLimit': '0.63', 'upperLimit': '0.96'}, {'value': '0.71', 'groupId': 'OG001', 'lowerLimit': '0.57', 'upperLimit': '0.90'}]}]}], 'analyses': [{'pValue': '0.645', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.92', 'ciLowerLimit': '0.68', 'ciUpperLimit': '1.25', 'pValueComment': 'Data was analyzed using Poisson regression with Pearson correction, adjusting for treatment, background therapy and history of previous exacerbations.', 'statisticalMethod': 'Poisson regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 up to 393', 'description': 'An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. The severity of an AECOPD is defined as: Moderate exacerbations require treatment with systemic corticosteroids, and or antibiotics. Severe exacerbations require hospitalization. The AECOPD rate was analyzed using a Poisson Regression model adjusted for over dispersion with number of exacerbations as the outcome and the log of follow-up time as an offset variable, with covariates for treatment group (MEDI8986, placebo), background maintenance therapy and previous exacerbations. Mean exacerbations were presented as number of exacerbations/year.', 'unitOfMeasure': 'AECOPD events/year', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population included all participants who were randomized into the study and received any investigational product.'}, {'type': 'SECONDARY', 'title': 'Mean Rate of Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.'}, {'id': 'OG001', 'title': 'MEDI8968 600 mg IV, 300 mg SC', 'description': 'MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.14', 'groupId': 'OG000', 'lowerLimit': '0.09', 'upperLimit': '0.21'}, {'value': '0.10', 'groupId': 'OG001', 'lowerLimit': '0.06', 'upperLimit': '0.16'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 up to 393', 'description': 'An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. Severe exacerbations require hospitalization. The AECOPD rate was analyzed using a Poisson Regression model adjusted for over dispersion with number of exacerbations as the outcome and the log of follow-up time as an offset variable, with covariates for treatment group (MEDI8986, placebo), background maintenance therapy and previous exacerbations. Mean exacerbations were presented as number of exacerbations/year.', 'unitOfMeasure': 'AECOPD events/year', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population included all participants who were randomized into the study and received any investigational product.'}, {'type': 'SECONDARY', 'title': 'Time to First Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.'}, {'id': 'OG001', 'title': 'MEDI8968 600 mg IV, 300 mg SC', 'description': 'MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and upper limit of 95% confidence interval (CI) were not evaluable as less than 50% of the participants had moderate or severe AECOPD.', 'groupId': 'OG000', 'lowerLimit': '173.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and upper limit of 95% confidence interval (CI) were not evaluable as less than 50% of the participants had moderate or severe AECOPD.', 'groupId': 'OG001', 'lowerLimit': '134.0', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 up to 393', 'description': 'Time to first worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. The severity of an AECOPD is defined as: Mild exacerbations require treatment with an increase in usual therapy, e.g., increase use of short acting bronchodilators. Moderate exacerbations require treatment with systemic corticosteroids, and or antibiotics. Severe exacerbations require hospitalization.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population included all participants who were randomized into the study and received any investigational product.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total and Subscales Scores at Week 53", 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.'}, {'id': 'OG001', 'title': 'MEDI8968 600 mg IV, 300 mg SC', 'description': 'MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.'}], 'classes': [{'title': 'Change at Week 53: Total Score (n=134, 123)', 'categories': [{'measurements': [{'value': '-2.76', 'spread': '1.069', 'groupId': 'OG000'}, {'value': '-2.22', 'spread': '1.101', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 53: Activity Score (n=134, 123)', 'categories': [{'measurements': [{'value': '-1.15', 'spread': '1.306', 'groupId': 'OG000'}, {'value': '-1.38', 'spread': '1.348', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 53: Impacts Score (n=134, 123)', 'categories': [{'measurements': [{'value': '-2.91', 'spread': '1.326', 'groupId': 'OG000'}, {'value': '-1.08', 'spread': '1.366', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 53: Symptoms Score (n=134, 123)', 'categories': [{'measurements': [{'value': '-5.60', 'spread': '1.279', 'groupId': 'OG000'}, {'value': '-6.81', 'spread': '1.325', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 53', 'description': "The SGRQ is a health related quality of life questionnaire consisting of 40 items in three domains: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). Each question's response has a unique empirically derived weight where lowest possible weight is zero and the highest is 100. The total score and domain score are derived from the relevant items and converted to a score of 0 to 100 with a higher score indicating poorer health status.", 'unitOfMeasure': 'units on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The mITT population included all participants who were randomized into the study and received any investigational product. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively."}, {'type': 'SECONDARY', 'title': "Percentage of Participants With Improvement in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.'}, {'id': 'OG001', 'title': 'MEDI8968 600 mg IV, 300 mg SC', 'description': 'MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.'}], 'classes': [{'title': 'Week 53: 4-point improvement (n=134,123)', 'categories': [{'measurements': [{'value': '45.5', 'groupId': 'OG000'}, {'value': '43.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 53: 12-point improvement (n=134,123)', 'categories': [{'measurements': [{'value': '17.9', 'groupId': 'OG000'}, {'value': '17.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 53', 'description': "The SGRQ is a health related quality of life questionnaire consisting of 40 items in three domains: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). Each question's response has a unique empirically derived weight where lowest possible weight is zero and the highest is 100. The total score and domain score are derived from the relevant items and converted to a score of 0 to 100 with a higher score indicating poorer health status. A 4-point change in total score demonstrates a clinically meaningful change, while an 8-point change and a 12-point change are interpreted as a moderate and large change in health status, respectively.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "The mITT population included all participants who were randomized into the study and received any investigational product. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Score at Week 53', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.'}, {'id': 'OG001', 'title': 'MEDI8968 600 mg IV, 300 mg SC', 'description': 'MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.27', 'spread': '0.107', 'groupId': 'OG000'}, {'value': '-0.08', 'spread': '0.110', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 53', 'description': 'The BODE index is a multi-dimension COPD grading system that incorporates body-mass index (B), degree of airflow obstruction (O), dyspnea (D), and exercise capacity (E) as measured by the modified medical research council (MMRC) dyspnea scale and the 6-minute walk test. The MMRC dyspnea scale is a 5-point scale that measures the level of dyspnea (trouble breathing) experienced by participants where score range is 0 (none) to 4 (very severe). BODE score is derived into a score range of 0 (healthy) to 10 (severe COPD).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The mITT population included all participants who were randomized into the study and received any investigational product. Here, 'N' signifies those participants evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Improvement in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.'}, {'id': 'OG001', 'title': 'MEDI8968 600 mg IV, 300 mg SC', 'description': 'MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.0', 'groupId': 'OG000'}, {'value': '33.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 53', 'description': 'The BODE index is a multi-dimension COPD grading system that incorporates body-mass index (B), degree of airflow obstruction (O), dyspnea (D), and exercise capacity (E) as measured by the modified medical research council (MMRC) dyspnea scale and the 6-minute walk test. The MMRC dyspnea scale is a 5-point scale that measures the level of dyspnea (trouble breathing) experienced by participants where score range is 0 (none) to 4 (very severe). BODE score is derived into a score range of 0 (healthy) to 10 (severe COPD). Negative change score signifies improvement compared to baseline. Number of participants with improvement in BODE score compared to baseline were reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "The mITT population included all participants who were randomized into the study and received any investigational product. Here, 'N' signifies those participants evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.'}, {'id': 'OG001', 'title': 'MEDI8968 600 mg IV, 300 mg SC', 'description': 'MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '130', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}]}, {'title': 'TESAEs', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to Week 69', 'description': 'An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and up to Week 69 that were absent before treatment or that worsened relative to pre-treatment state. TEAEs reported below included both SAEs and non-serious AEs.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who were randomized and received at least one dose of investigational product.'}, {'type': 'SECONDARY', 'title': 'Observed Serum Concentrations of MEDI8968', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI8968 600 mg IV, 300 mg SC', 'description': 'MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.'}], 'classes': [{'title': 'Baseline (n=145)', 'categories': [{'measurements': [{'value': '1.7', 'spread': '14.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 53 (n=120)', 'categories': [{'measurements': [{'value': '28555.7', 'spread': '27545.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (Baseline), Post-dose on Week 53', 'unitOfMeasure': 'nanogram per milliliters (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population included all participants who were randomized, received at least one dose of investigational product, and had at least one post-dose serum concentration.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Exhibiting Anti-Drug Antibodies for MEDI8968 at Any Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.'}, {'id': 'OG001', 'title': 'MEDI8968 600 mg IV, 300 mg SC', 'description': 'MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to Week 69', 'description': 'Anti-drug antibodies for MEDI8968 were analyzed for participants who received placebo or MEDI8968 as per planned analysis.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Immunogenicity (IM) population included all participants who were randomized, received at least one dose of investigational product, and had at least one post-dose serum sample for IM testing.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.'}, {'id': 'FG001', 'title': 'MEDI8968 600 mg IV, 300 mg SC', 'description': 'MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '164'}, {'groupId': 'FG001', 'numSubjects': '160'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '130'}, {'groupId': 'FG001', 'numSubjects': '120'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '40'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '12'}]}]}], 'preAssignmentDetails': 'A total of 464 participants were screened and 324 participants were randomized into the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '324', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.'}, {'id': 'BG001', 'title': 'MEDI8968 600 mg IV, 300 mg SC', 'description': 'MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.0', 'spread': '6.8', 'groupId': 'BG000'}, {'value': '62.8', 'spread': '6.7', 'groupId': 'BG001'}, {'value': '62.9', 'spread': '6.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Modified intent-to-treat (mITT) population included all participants who were randomized into the study and received any investigational product.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 464}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-30', 'studyFirstSubmitDate': '2011-10-06', 'resultsFirstSubmitDate': '2016-06-28', 'studyFirstSubmitQcDate': '2011-10-06', 'lastUpdatePostDateStruct': {'date': '2017-01-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-11-30', 'studyFirstPostDateStruct': {'date': '2011-10-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)', 'timeFrame': 'Day 1 up to 393', 'description': 'An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. The severity of an AECOPD is defined as: Moderate exacerbations require treatment with systemic corticosteroids, and or antibiotics. Severe exacerbations require hospitalization. The AECOPD rate was analyzed using a Poisson Regression model adjusted for over dispersion with number of exacerbations as the outcome and the log of follow-up time as an offset variable, with covariates for treatment group (MEDI8986, placebo), background maintenance therapy and previous exacerbations. Mean exacerbations were presented as number of exacerbations/year.'}], 'secondaryOutcomes': [{'measure': 'Mean Rate of Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)', 'timeFrame': 'Day 1 up to 393', 'description': 'An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. Severe exacerbations require hospitalization. The AECOPD rate was analyzed using a Poisson Regression model adjusted for over dispersion with number of exacerbations as the outcome and the log of follow-up time as an offset variable, with covariates for treatment group (MEDI8986, placebo), background maintenance therapy and previous exacerbations. Mean exacerbations were presented as number of exacerbations/year.'}, {'measure': 'Time to First Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)', 'timeFrame': 'Day 1 up to 393', 'description': 'Time to first worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. The severity of an AECOPD is defined as: Mild exacerbations require treatment with an increase in usual therapy, e.g., increase use of short acting bronchodilators. Moderate exacerbations require treatment with systemic corticosteroids, and or antibiotics. Severe exacerbations require hospitalization.'}, {'measure': "Change From Baseline in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total and Subscales Scores at Week 53", 'timeFrame': 'Baseline and Week 53', 'description': "The SGRQ is a health related quality of life questionnaire consisting of 40 items in three domains: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). Each question's response has a unique empirically derived weight where lowest possible weight is zero and the highest is 100. The total score and domain score are derived from the relevant items and converted to a score of 0 to 100 with a higher score indicating poorer health status."}, {'measure': "Percentage of Participants With Improvement in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total Score", 'timeFrame': 'Week 53', 'description': "The SGRQ is a health related quality of life questionnaire consisting of 40 items in three domains: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). Each question's response has a unique empirically derived weight where lowest possible weight is zero and the highest is 100. The total score and domain score are derived from the relevant items and converted to a score of 0 to 100 with a higher score indicating poorer health status. A 4-point change in total score demonstrates a clinically meaningful change, while an 8-point change and a 12-point change are interpreted as a moderate and large change in health status, respectively."}, {'measure': 'Change From Baseline in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Score at Week 53', 'timeFrame': 'Baseline and Week 53', 'description': 'The BODE index is a multi-dimension COPD grading system that incorporates body-mass index (B), degree of airflow obstruction (O), dyspnea (D), and exercise capacity (E) as measured by the modified medical research council (MMRC) dyspnea scale and the 6-minute walk test. The MMRC dyspnea scale is a 5-point scale that measures the level of dyspnea (trouble breathing) experienced by participants where score range is 0 (none) to 4 (very severe). BODE score is derived into a score range of 0 (healthy) to 10 (severe COPD).'}, {'measure': 'Percentage of Participants With Improvement in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Score', 'timeFrame': 'Baseline and Week 53', 'description': 'The BODE index is a multi-dimension COPD grading system that incorporates body-mass index (B), degree of airflow obstruction (O), dyspnea (D), and exercise capacity (E) as measured by the modified medical research council (MMRC) dyspnea scale and the 6-minute walk test. The MMRC dyspnea scale is a 5-point scale that measures the level of dyspnea (trouble breathing) experienced by participants where score range is 0 (none) to 4 (very severe). BODE score is derived into a score range of 0 (healthy) to 10 (severe COPD). Negative change score signifies improvement compared to baseline. Number of participants with improvement in BODE score compared to baseline were reported.'}, {'measure': 'Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)', 'timeFrame': 'Day 1 up to Week 69', 'description': 'An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and up to Week 69 that were absent before treatment or that worsened relative to pre-treatment state. TEAEs reported below included both SAEs and non-serious AEs.'}, {'measure': 'Observed Serum Concentrations of MEDI8968', 'timeFrame': 'Pre-dose (Baseline), Post-dose on Week 53'}, {'measure': 'Number of Participants Exhibiting Anti-Drug Antibodies for MEDI8968 at Any Visit', 'timeFrame': 'Day 1 up to Week 69', 'description': 'Anti-drug antibodies for MEDI8968 were analyzed for participants who received placebo or MEDI8968 as per planned analysis.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chronic Obstructive Pulmonary Disease (COPD)', 'MEDI8968'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '28793896', 'type': 'DERIVED', 'citation': 'Calverley PMA, Sethi S, Dawson M, Ward CK, Finch DK, Penney M, Newbold P, van der Merwe R. A randomised, placebo-controlled trial of anti-interleukin-1 receptor 1 monoclonal antibody MEDI8968 in chronic obstructive pulmonary disease. Respir Res. 2017 Aug 9;18(1):153. doi: 10.1186/s12931-017-0633-7.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of MEDI8968 on the rate of moderate or severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in adult subjects with symptomatic, moderate to very severe COPD (Global Initiative for Chronic Obstructive Lung Disease - GOLD stage II-IV) receiving standard maintenance therapy for the underlying disease condition.', 'detailedDescription': 'A Phase 2 double-blind, placebo-controlled study to evaluate the efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease. The study will have a screening phase of 23 days, treatment phase from Week 1 to 53 and follow-up phase from Week 53 to 69. Participants will receive either MEDI8968 600 milligram (mg) as intravenous (IV) infusion on Day 1 followed by 300 mg injection subcutaneously (SC) every 4 weeks up to Week 53 or matching placebo in the same fashion. Participants will primarily be assessed for incidence rate of moderate or severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD). Safety will be monitored throughout the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 45 through 75 years\n* Predicted (Global Initiative for Chronic Obstructive Lung Disease \\[GOLD\\] stage II, III, and IV) at Screening\n* History of previous acute exacerbations of chronic obstructive pulmonary disease (AECOPD) 12 months prior to Screening\n* Clinically stable and free from an AECOPD for 8 weeks prior to Day 1\n* Current smoker or ex-smoker with a tobacco history of more than or equal to (\\>=) 10 pack-years.\n\nExclusion Criteria:\n\n* Past or present disease or disorder,\n* Significant or unstable ischemic heart disease etc\n* Known history of allergy or reaction to any component of the investigational manufacturing product (IMP)\n* Past or current malignancy within the past 5 years\n* Subjects have had a chest x-ray or Computed Tomography (CT) scan suggestive of malignancy or tuberculosis (TB).\n* Use of immunosuppressive medication receipt of any biologic agent.'}, 'identificationModule': {'nctId': 'NCT01448850', 'acronym': 'SPRING', 'briefTitle': 'A Study to Evaluate the Efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'MedImmune LLC'}, 'officialTitle': 'A Phase 2 Double-blind, Placebo-controlled Study to Evaluate the Efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': 'CD-RI-MEDI8968-1103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo matched to MEDI8968 as IV infusion on Day 1 followed by SC injection every 4 weeks up to Week 53.', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'MEDI8968 600 mg IV, 300 mg SC', 'description': 'MEDI8968 600 milligram (mg) as intravenous (IV) infusion on Day 1 followed by 300 mg injection subcutaneously (SC) every 4 weeks up to Week 53.', 'interventionNames': ['Biological: MEDI8968 600 mg IV, 300 mg SC']}], 'interventions': [{'name': 'MEDI8968 600 mg IV, 300 mg SC', 'type': 'BIOLOGICAL', 'description': 'MEDI8968 600 mg as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.', 'armGroupLabels': ['MEDI8968 600 mg IV, 300 mg SC']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo matched to MEDI8968 as IV infusion on Day 1 followed by SC injection every 4 weeks up to Week 53.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'city': 'Duluth', 'state': 'Georgia', 'country': 'United 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