Ignite Creation Date:
2025-12-24 @ 10:18 PM
Ignite Modification Date:
2026-01-31 @ 4:33 AM
Study NCT ID:
NCT02157935
Status:
COMPLETED
Last Update Posted:
2017-11-07
First Post:
2014-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparing the Efficacy of Symbicort® pMDI and Formoterol Turbuhaler in Reducing Exacerbations in Patients With Cronic 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069502', 'term': 'Budesonide, Formoterol Fumarate Drug Combination'}], 'ancestors': [{'id': 'D000068759', 'term': 'Formoterol Fumarate'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D019819', 'term': 'Budesonide'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tor.skarby@astrazeneca.com', 'title': 'Tor Skärby', 'organization': 'AstraZeneca'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'During the randomized treatment period, ie from first treatment to one day after the last treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Formoterol 4.5 ug x2 Bid', 'otherNumAtRisk': 613, 'otherNumAffected': 56, 'seriousNumAtRisk': 613, 'seriousNumAffected': 63}, {'id': 'EG001', 'title': 'Symbicort 160/4.5 ug x2 Bid', 'otherNumAtRisk': 605, 'otherNumAffected': 38, 'seriousNumAtRisk': 605, 'seriousNumAffected': 49}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 35, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 34, 'numAffected': 30}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 31, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Retroperitoneal lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Sinoatrial block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Ventricular arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Vitreous haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Large intestine perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gastroenteritis salmonella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lower respiratory tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Orchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Salmonella bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Sepsis syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Extradural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Face injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Breast cancer female', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Chronic lymphocytic leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Plasma cell myeloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cerebrovascular insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Device malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bronchitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 29, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 22, 'numAffected': 20}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Chronic respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 605, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Rate of Moderate and Severe COPD Exacerbations Defined as: Worsening of ≥2 Major Symptoms or Worsening of 1 Major Symptom Together With ≥1 Minor Symptom for ≥2 Consecutive Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '606', 'groupId': 'OG000'}, {'value': '613', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort pMDI', 'description': 'Symbicort pMDI, budesonide/formoterol, 160/4.5 μg x 2 actuations BID, for oral inhalation'}, {'id': 'OG001', 'title': 'Formoterol Turbuhaler', 'description': 'Formoterol Turbuhaler, 4.5 μg x 2 actuations BID, for oral inhalation'}], 'classes': [{'categories': [{'measurements': [{'value': '0.85', 'groupId': 'OG000', 'lowerLimit': '0.70', 'upperLimit': '1.03'}, {'value': '1.12', 'groupId': 'OG001', 'lowerLimit': '0.93', 'upperLimit': '1.35'}]}]}], 'analyses': [{'pValue': '0.0059', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.76', 'ciLowerLimit': '0.62', 'ciUpperLimit': '0.92', 'statisticalMethod': 'Negative binomial model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Randomization at Week 0 to End of Treatment (EoT) W 26', 'description': 'The annual COPD exacerbation rate was analyzed and compared between two arms.\n\nAnnual exacerbation rate for each subject is defined as number of exacerbations divided by duration of randomized treatment period in years.\n\nThe annual COPD exacerbation rate of Symbicort group was compared with annual rate of Formoterol group. The rate ratio of Symbicort vs. Formoteroal was assessed by a negative binomial model.\n\nExacerbations, that met the modified Anthonisen criteria and duration ≥2 days were classified as moderate and severe exacerbations.\n\nModerate exacerbation: treatment of symptoms with systemic corticosteroids (≥3 days) and/or antibiotics.\n\nSevere exacerbation: symptoms that require hospitalization (including \\>24 hours in ED/urgent care setting).', 'unitOfMeasure': 'COPD exacerbations per year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set including all randomized subjects'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Moderate or Severe COPD Exacerbation.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '606', 'groupId': 'OG000'}, {'value': '613', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort pMDI', 'description': 'Symbicort pMDI, budesonide/formoterol, 160/4.5 μg x 2 actuations BID, for oral inhalation'}, {'id': 'OG001', 'title': 'Formoterol Turbuhaler', 'description': 'Formoterol Turbuhaler, 4.5 μg x 2 actuations BID, for oral inhalation'}], 'classes': [{'categories': [{'measurements': [{'value': '171', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0164', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.78', 'ciLowerLimit': '0.64', 'ciUpperLimit': '0.96', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomzation to EoT W 26', 'description': 'The number of patients who developed moderate or severe COPD exacerbation during treatment period were reported. Cox proportional hazards regression model was fitted to data to compare the two treatment arms .\n\nThe hazard ratio and 95% CI were estimated.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "St. George's Respiratory Questionnaire (SGRQ)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '589', 'groupId': 'OG000'}, {'value': '593', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort pMDI', 'description': 'Symbicort pMDI, budesonide/formoterol, 160/4.5 μg x 2 actuations BID, for oral inhalation'}, {'id': 'OG001', 'title': 'Formoterol Turbuhaler', 'description': 'Formoterol Turbuhaler, 4.5 μg x 2 actuations BID, for oral inhalation'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.855', 'spread': '8.941', 'groupId': 'OG000'}, {'value': '0.442', 'spread': '9.457', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0070', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.343', 'ciLowerLimit': '-2.318', 'ciUpperLimit': '-0.368', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'From Run-in W -4 to EoT W 26', 'description': 'SGRQ is a standardized, self-administered tool for measuring impaired health and perceived wellbeing in respiratory diseases; a validated electronic version of the questionnaire in the relevant validated languages was used in this study.\n\nThe questionnaire contains 50 items divided into three dimensions (Symptoms, Activity and Impact).\n\nEach of the three dimensions of the questionnaire is scored separately in the range from 0 to 100:\n\nzero (0) score indicating no impairment of quality of life.\n\nThe total SGRQ score ranging from 0 to 100 is a summary score utilizing responses to all items calculated using weights attached to each item of the questionnaire.\n\nHigher scores indicate poorer health and change of 4 units in the SGRQ has been determined to be the threshold for a clinically relevant change in health status.\n\nThe change from baseline was statistically summarized and compared between two arms in a mixed model.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The change from baseline in SGRQ were analyzed on randomized patients with a baseline SGRQ and at least one post-baseline value. Among 1219 patients who were randomized, only 589 patients in Symbicort group and 593 patients in Formoterol group had valid data and included in analysis.'}, {'type': 'SECONDARY', 'title': 'Pre-dose/Pre-bronchodilator FEV1 at the Study Site', 'denoms': [{'units': 'Participants', 'counts': [{'value': '588', 'groupId': 'OG000'}, {'value': '589', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort pMDI', 'description': 'Symbicort pMDI, budesonide/formoterol, 160/4.5 μg x 2 actuations BID, for oral inhalation'}, {'id': 'OG001', 'title': 'Formoterol Turbuhaler', 'description': 'Formoterol Turbuhaler, 4.5 μg x 2 actuations BID, for oral inhalation'}], 'classes': [{'categories': [{'measurements': [{'value': '0.008', 'spread': '0.210', 'groupId': 'OG000'}, {'value': '-0.025', 'spread': '0.198', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0091', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.030', 'ciLowerLimit': '0.008', 'ciUpperLimit': '0.053', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'From Run-in W -4 to EoT W 26', 'description': 'FEV1 from pre-dose spirometry is a measurement of lung function. The change from baseline on pre-dose FEV1 was summarized and compared between Symbicort and Formoterol groups using a mixed model.', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The change from baseline in pre-dose FEV1 were analyzed on randomized patients with a baseline pre-dose FEV1 and at least one post-baseline value. Among 1219 patients who were randomized, only 588 patients in Symbicort group and 589 patients in Formoterol group had valid data and included in analysis.'}, {'type': 'SECONDARY', 'title': 'Total Rescue Medication Use (Average Puffs/Day)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '602', 'groupId': 'OG000'}, {'value': '607', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort pMDI', 'description': 'Symbicort pMDI, budesonide/formoterol, 160/4.5 μg x 2 actuations BID, for oral inhalation'}, {'id': 'OG001', 'title': 'Formoterol Turbuhaler', 'description': 'Formoterol Turbuhaler, 4.5 μg x 2 actuations BID, for oral inhalation'}], 'classes': [{'categories': [{'measurements': [{'value': '0.135', 'spread': '1.248', 'groupId': 'OG000'}, {'value': '0.343', 'spread': '1.456', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0082', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.203', 'ciLowerLimit': '-0.353', 'ciUpperLimit': '-0.053', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'From Run-in W -4 to EoT W 26', 'description': 'Use of rescue medication is a measure of symptoms that need to be treated with a short-acting bronchodilator.\n\nThe average daily use across the observation period was used for analysis. Change from baseline was summarized and compared between two arms using a mixed model.', 'unitOfMeasure': 'puffs/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The change from baseline on rescue medication use were analyzed on randomized patients with a baseline and a post-baseline value. Among 1219 patients who were randomized, only 602 patients in Symbicort group and 607 patients in Formoterol group had valid data and included in analysis.'}, {'type': 'SECONDARY', 'title': 'Nights With Awakening Due to COPD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '603', 'groupId': 'OG000'}, {'value': '610', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort pMDI', 'description': 'Symbicort pMDI, budesonide/formoterol, 160/4.5 μg x 2 actuations BID, for oral inhalation'}, {'id': 'OG001', 'title': 'Formoterol Turbuhaler', 'description': 'Formoterol Turbuhaler, 4.5 μg x 2 actuations BID, for oral inhalation'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.007', 'spread': '0.173', 'groupId': 'OG000'}, {'value': '0.021', 'spread': '0.195', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0048', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.028', 'ciLowerLimit': '-0.048', 'ciUpperLimit': '-0.009', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'From Run-in W -4 to EoT W 26', 'description': 'Nighttime awakening due to COPD symptoms correspond to the severity of nocturnal symptoms from COPD.\n\nThe average number of awakening per night over the treatment period was analyzed. It was derived as the number of night with awakening divided by the total number of nights with data in the recording period. Change from baseline period on awakening was summarized and compared between two arms using a mixed model.', 'unitOfMeasure': 'awakening/night', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The change from baseline on awakening were analyzed on randomized patients with a baseline and a post-baseline value. Among 1219 patients who were randomized, only 603 patients in Symbicort group and 610 patients in Formoterol group had valid data and included in analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Symbicort pMDI', 'description': 'Symbicort pMDI, budesonide/formoterol, 160/4.5 μg x 2 actuations BID, for oral inhalation'}, {'id': 'FG001', 'title': 'Formoterol Turbuhaler', 'description': 'Formoterol Turbuhaler, 4.5 μg x 2 actuations BID, for oral inhalation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '606'}, {'groupId': 'FG001', 'numSubjects': '613'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '567'}, {'groupId': 'FG001', 'numSubjects': '548'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '65'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'Screen failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'preAssignmentDetails': 'The enrollment number in the protocol section denotes the number of patients screened into the trial. Out of these 2026 patients screened, 1219 patients were randomized into the trial. This explains the discrepancy in patient number.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '606', 'groupId': 'BG000'}, {'value': '613', 'groupId': 'BG001'}, {'value': '1219', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Symbicort pMDI', 'description': 'Symbicort pMDI, budesonide/formoterol, 160/4.5 μg x 2 actuations BID, for oral inhalation'}, {'id': 'BG001', 'title': 'Formoterol Turbuhaler', 'description': 'Formoterol Turbuhaler, 4.5 μg x 2 actuations BID, for oral inhalation'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.1', 'spread': '8.65', 'groupId': 'BG000'}, {'value': '63.9', 'spread': '8.67', 'groupId': 'BG001'}, {'value': '63.5', 'spread': '8.67', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '251', 'groupId': 'BG000'}, {'value': '270', 'groupId': 'BG001'}, {'value': '521', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '355', 'groupId': 'BG000'}, {'value': '343', 'groupId': 'BG001'}, {'value': '698', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'FEV1 post-bronchodilator categories', 'classes': [{'title': '<30%', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}]}, {'title': '>=30% to <50%', 'categories': [{'measurements': [{'value': '234', 'groupId': 'BG000'}, {'value': '247', 'groupId': 'BG001'}, {'value': '481', 'groupId': 'BG002'}]}]}, {'title': '>=50% to <=70%', 'categories': [{'measurements': [{'value': '307', 'groupId': 'BG000'}, {'value': '308', 'groupId': 'BG001'}, {'value': '615', 'groupId': 'BG002'}]}]}, {'title': '>70%', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Number of exacerbations during 2 - 52 weeks prior to enrollment', 'classes': [{'title': '1', 'categories': [{'measurements': [{'value': '430', 'groupId': 'BG000'}, {'value': '448', 'groupId': 'BG001'}, {'value': '878', 'groupId': 'BG002'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '253', 'groupId': 'BG002'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}, {'title': '4', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': '5', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': '6', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': '7', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set including all randomized patients'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2026}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2016-02-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-05', 'studyFirstSubmitDate': '2014-06-05', 'resultsFirstSubmitDate': '2016-12-15', 'studyFirstSubmitQcDate': '2014-06-05', 'lastUpdatePostDateStruct': {'date': '2017-11-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-12', 'studyFirstPostDateStruct': {'date': '2014-06-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-02-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Rate of Moderate and Severe COPD Exacerbations Defined as: Worsening of ≥2 Major Symptoms or Worsening of 1 Major Symptom Together With ≥1 Minor Symptom for ≥2 Consecutive Days', 'timeFrame': 'Randomization at Week 0 to End of Treatment (EoT) W 26', 'description': 'The annual COPD exacerbation rate was analyzed and compared between two arms.\n\nAnnual exacerbation rate for each subject is defined as number of exacerbations divided by duration of randomized treatment period in years.\n\nThe annual COPD exacerbation rate of Symbicort group was compared with annual rate of Formoterol group. The rate ratio of Symbicort vs. Formoteroal was assessed by a negative binomial model.\n\nExacerbations, that met the modified Anthonisen criteria and duration ≥2 days were classified as moderate and severe exacerbations.\n\nModerate exacerbation: treatment of symptoms with systemic corticosteroids (≥3 days) and/or antibiotics.\n\nSevere exacerbation: symptoms that require hospitalization (including \\>24 hours in ED/urgent care setting).'}], 'secondaryOutcomes': [{'measure': 'Number of Patients With Moderate or Severe COPD Exacerbation.', 'timeFrame': 'From randomzation to EoT W 26', 'description': 'The number of patients who developed moderate or severe COPD exacerbation during treatment period were reported. Cox proportional hazards regression model was fitted to data to compare the two treatment arms .\n\nThe hazard ratio and 95% CI were estimated.'}, {'measure': "St. George's Respiratory Questionnaire (SGRQ)", 'timeFrame': 'From Run-in W -4 to EoT W 26', 'description': 'SGRQ is a standardized, self-administered tool for measuring impaired health and perceived wellbeing in respiratory diseases; a validated electronic version of the questionnaire in the relevant validated languages was used in this study.\n\nThe questionnaire contains 50 items divided into three dimensions (Symptoms, Activity and Impact).\n\nEach of the three dimensions of the questionnaire is scored separately in the range from 0 to 100:\n\nzero (0) score indicating no impairment of quality of life.\n\nThe total SGRQ score ranging from 0 to 100 is a summary score utilizing responses to all items calculated using weights attached to each item of the questionnaire.\n\nHigher scores indicate poorer health and change of 4 units in the SGRQ has been determined to be the threshold for a clinically relevant change in health status.\n\nThe change from baseline was statistically summarized and compared between two arms in a mixed model.'}, {'measure': 'Pre-dose/Pre-bronchodilator FEV1 at the Study Site', 'timeFrame': 'From Run-in W -4 to EoT W 26', 'description': 'FEV1 from pre-dose spirometry is a measurement of lung function. The change from baseline on pre-dose FEV1 was summarized and compared between Symbicort and Formoterol groups using a mixed model.'}, {'measure': 'Total Rescue Medication Use (Average Puffs/Day)', 'timeFrame': 'From Run-in W -4 to EoT W 26', 'description': 'Use of rescue medication is a measure of symptoms that need to be treated with a short-acting bronchodilator.\n\nThe average daily use across the observation period was used for analysis. Change from baseline was summarized and compared between two arms using a mixed model.'}, {'measure': 'Nights With Awakening Due to COPD', 'timeFrame': 'From Run-in W -4 to EoT W 26', 'description': 'Nighttime awakening due to COPD symptoms correspond to the severity of nocturnal symptoms from COPD.\n\nThe average number of awakening per night over the treatment period was analyzed. It was derived as the number of night with awakening divided by the total number of nights with data in the recording period. Change from baseline period on awakening was summarized and compared between two arms using a mixed model.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD, turbuhaler, pMDI'], 'conditions': ['COPD Patients']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=2887&filename=Symbicort_RISE_Revised_CSP_3_4_FINAL_Redacted.pdf', 'label': 'Symbicort RISE Revised CSP 3 4 FINAL Redacted'}]}, 'descriptionModule': {'briefSummary': 'Comparing the efficacy of Symbicort® pMDI and Formoterol Turbuhaler in reducing exacerbations in patients with Chronic Obstructive Pulmonary Disease (COPD).', 'detailedDescription': 'A Phase IIIB, 6-Month, Double-blind, Double-dummy, Randomized, Parallel-group, Multicenter Exacerbation Study of Symbicort® pMDI 160/4.5 μg x 2 Actuations Twice-daily Compared to Formoterol Turbuhaler 4.5 μg x 2 Inhalations Twice-daily in COPD Patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n3\\. A current clinical diagnosis of COPD with COPD symptoms for more than 1 year, according to the GOLD guidelines.\n\n4\\. Current or previous smoker with a smoking history equivalent to 10 or more pack years (1 pack year = 20 cigarettes smoked per day for 1 year).\n\n5\\. Post-bronchodilator FEV1/forced vital capacity (FVC) \\<0.7 (70%) and FEV1 ≤70% of predicted normal (PN) value.\n\n6\\. Documented use of a short-acting inhaled bronchodilator (β2-agonists or anticholinergics) as rescue medication within 6 months prior to study start.\n\n7\\. A score of ≥2 on the modified medical research council (MMRC) dyspnea scale. 8. Documented history of ≥1 moderate or severe COPD exacerbation(s) that required treatment with systemic (oral, IM, IV) corticosteroids (a minimum 3 day course of an oral corticosteroid treatment or single depot corticosteroid injection), or hospitalization (defined as an inpatient stay or \\>24 hour stay in an observation area in the emergency department or other equivalent facility depending on the country and healthcare system) within 2-52 weeks before Visit 1 (i.e., not within the 14 days prior to Visit 1). A history of an exacerbation treated exclusively with antibiotics will not be considered adequate.\n\nExclusion Criteria:\n\n1. A history of asthma at or after 18 years of age.\n2. Subjects with significant or unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart failure (including significant cor pulmonale), uncontrolled hypertension as defined by the Investigator, or any other relevant cardiovascular disorder as judged by the Investigator.\n3. Known homozygous alpha-1 antitrypsin deficiency.\n4. Any significant disease or disorder (e.g., gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results of the study, or the subject's ability to participate in the study.\n5. A history of malignancy (except basal cell carcinoma) within the past 5 years.\n6. Active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, primary pulmonary hypertension, interstitial lung disease, or other active pulmonary diseases.\n7. Subjects who have needed additions or alterations to their usual maintenance or change in formulation of rescue therapy for COPD due to worsening symptoms within the 14 days prior to Visit 1 and up to Visit 3.\n8. CXR (frontal and lateral) with suspicion of pneumonia or other condition/abnormality that will require additional investigation/treatment, or put the subject at risk because of participation in the study.\n9. Risk factors for pneumonia: immune suppression (HIV, lupus) or other risk for pneumonia (e.g. neurological disorders affecting control of the upper airway, such as Parkinson's disease, myasthenia gravis, etc.).\n10. Pneumonia not resolved within 14 days of Visit 1.\n11. Moderate or severe COPD exacerbation that has not resolved within 14 days prior to Visit 1 or a moderate or severe COPD exacerbation that occurs between Visit 1 and Visit 2.\n12. Long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day.\n13. Subjects who are currently in the intensive rehabilitation phase or scheduled to begin new participation (intensive rehabilitation phase) in a pulmonary rehabilitation program during the study or have started a new pulmonary rehabilitation program within 60 days of Visit 1. Subjects in the maintenance phase of pulmonary rehabilitation program are not excluded.\n14. Treatment with oral, parenteral, or intra-articular corticosteroids within 4 weeks prior to Visit 1.\n15. Omalizumab or any other monoclonal or polyclonal antibody therapy taken for any reason within 6 months prior to Visit 1."}, 'identificationModule': {'nctId': 'NCT02157935', 'acronym': 'RISE', 'briefTitle': 'Comparing the Efficacy of Symbicort® pMDI and Formoterol Turbuhaler in Reducing Exacerbations in Patients With Cronic Obstructive Pulmonary Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase IIIB, 6-Month, Double-blind, Double-dummy, Randomized, Parallel-group, Multicenter Exacerbation Study of Symbicort® Pressurized Metered-Dose Inhaler (pMDI) 160/4.5 μg x 2 Actuations Twice-daily Compared to Formoterol Turbuhaler 4.5 μg x 2 Inhalations Twice-daily in Cronic Obstructive Pulmonary Disease (COPD) Patients.', 'orgStudyIdInfo': {'id': 'D589UC00001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Symbicort pMDI', 'description': 'Symbicort pMDI, budesonide/formoterol, 160/4.5 μg x 2 actuations BID, for oral inhalation', 'interventionNames': ['Drug: Symbicort', 'Other: Placebo for Symbicort pMDI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Formoterol Turbuhaler', 'description': 'Formoterol Turbuhaler, 4.5 μg x 2 actuations BID, for oral inhalation', 'interventionNames': ['Drug: Formoterol turbohaler', 'Other: Placebo for Formoterol Turbohaler']}], 'interventions': [{'name': 'Symbicort', 'type': 'DRUG', 'description': 'Budesonide/formoterol pMDI, 160/4.5 μg x 2 actuations BID, for oral inhalation, 120 doses', 'armGroupLabels': ['Symbicort pMDI']}, {'name': 'Formoterol turbohaler', 'type': 'DRUG', 'description': 'Formoterol Turbuhaler 4.5 μg x 2 actuations BID, for oral inhalation, 60 doses', 'armGroupLabels': ['Formoterol Turbuhaler']}, {'name': 'Placebo for Symbicort pMDI', 'type': 'OTHER', 'description': 'pMDI, aerosol for oral inhalation, placebo, 120 doses', 'armGroupLabels': ['Symbicort pMDI']}, {'name': 'Placebo for Formoterol Turbohaler', 'type': 'OTHER', 'description': 'PLacebo powder for oral inhalation, 60 doses', 'armGroupLabels': ['Formoterol Turbuhaler']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36420', 'city': 'Andalusia', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 31.30808, 'lon': -86.48243}}, {'city': 'Andalusia', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 31.30808, 'lon': -86.48243}}, {'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36535', 'city': 'Foley', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 30.40659, 'lon': -87.6836}}, {'city': 'Foley', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 30.40659, 'lon': -87.6836}}, {'zip': '35501', 'city': 'Jasper', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.83122, 'lon': -87.27751}}, {'city': 'Jasper', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.83122, 'lon': -87.27751}}, {'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.30616, 'lon': 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'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72204', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '93702', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '95670', 'city': 'Gold River', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.62629, 'lon': -121.24662}}, {'city': 'Gold River', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.62629, 'lon': -121.24662}}, {'zip': '90712', 'city': 'Lakewood', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.85363, 'lon': -118.13396}}, {'city': 'Lakewood', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.85363, 'lon': -118.13396}}, {'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '92270', 'city': 'Rancho Mirage', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.73974, 'lon': -116.41279}}, {'city': 'Rancho Mirage', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.73974, 'lon': -116.41279}}, {'zip': '95117', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '92683', 'city': 'Westminster', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.75918, 'lon': 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'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33134', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '33334', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33013', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'city': 'Hialeah', 'state': 'Florida', 'country': 'United 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