Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2026-02-25 @ 5:48 PM
Study NCT ID:
NCT02766608
Status:
COMPLETED
Last Update Posted:
2019-09-24
First Post:
2016-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Assess Efficacy and Safety of PT009 Compared to PT005, PT008, and Symbicort® Turbuhaler® on Lung Function Over 24-Weeks in Subjects With Moderate to Very Severe COPD
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': 'D019819', 'term': 'Budesonide'}, {'id': 'C494814', 'term': 'BID protein, human'}], 'ancestors': [{'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'paul.dorinsky1@astrazeneca.com', 'phone': '650-305-2600', 'title': 'Paul M. Dorinsky, MD', 'organization': 'Pearl Therapeutics, a Member of the AstraZeneca Group'}, 'certainAgreement': {'otherDetails': "Drafts of any and all publications or presentations of this study must be submitted at least 30 days prior to submission for publication or presentation to Pearl Therapeutics for review, approval, and to ensure consistency. Pearl Therapeutics has the right to request appropriate modification to correct facts and to represent it's opinions, or the opinions of the publication committee, if these differ with the proposed publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug', 'description': 'Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).', 'eventGroups': [{'id': 'EG000', 'title': 'BFF MDI 320/9.6 μg', 'description': 'Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg', 'otherNumAtRisk': 655, 'deathsNumAtRisk': 655, 'otherNumAffected': 240, 'seriousNumAtRisk': 655, 'deathsNumAffected': 3, 'seriousNumAffected': 42}, {'id': 'EG001', 'title': 'BFF MDI 160/9.6 μg', 'description': 'Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg', 'otherNumAtRisk': 637, 'deathsNumAtRisk': 637, 'otherNumAffected': 201, 'seriousNumAtRisk': 637, 'deathsNumAffected': 2, 'seriousNumAffected': 45}, {'id': 'EG002', 'title': 'FF MDI 9.6 μg', 'description': 'Formoterol Fumarate Metered Dose Inhalation 9.6 μg', 'otherNumAtRisk': 644, 'deathsNumAtRisk': 644, 'otherNumAffected': 219, 'seriousNumAtRisk': 644, 'deathsNumAffected': 2, 'seriousNumAffected': 72}, {'id': 'EG003', 'title': 'BD MDI 320 μg', 'description': 'Budesonide Metered Dose Inhalation 320 μg', 'otherNumAtRisk': 206, 'deathsNumAtRisk': 206, 'otherNumAffected': 75, 'seriousNumAtRisk': 206, 'deathsNumAffected': 0, 'seriousNumAffected': 15}, {'id': 'EG004', 'title': 'Symbicort TBH 400/12 μg', 'description': 'Symbicort Turbuhaler 400/12 μg', 'otherNumAtRisk': 219, 'deathsNumAtRisk': 219, 'otherNumAffected': 57, 'seriousNumAtRisk': 219, 'deathsNumAffected': 2, 'seriousNumAffected': 20}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 46, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 44, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 46, 'numAffected': 43}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 18, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 27, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 24, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 36, 'numAffected': 30}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 21, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 27, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 35, 'numAffected': 29}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Congestive cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal hernia gangrenous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Breast abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Embolic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Intracranial aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRa'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Colitis ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRa'}, {'term': 'Diverticulum intestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastrointestinal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Inflammatory bowel disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Strangulated umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acetabulum fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dural tear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Forearm fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vascular pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Adenocarcinoma of colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Brain cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Breast cancer male', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchial carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastric neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Mesothelioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Metastases to liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Metastatic carcinoma of the bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Non-small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pancreatic carcinoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Peripheral artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thrombophlebitis superficial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Incarcerated hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sudden cardiac death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cachexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diabetes with hyperosmolarity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Electrolyte imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertonic bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal tubular necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Device battery issue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Prostatic haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Skull fractured base', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 637, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 644, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 219, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 (BFF MDI Versus FF MDI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '571', 'groupId': 'OG000'}, {'value': '564', 'groupId': 'OG001'}, {'value': '550', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BFF MDI 320/9.6 μg', 'description': 'Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg'}, {'id': 'OG001', 'title': 'BFF MDI 160/9.6 μg', 'description': 'Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg'}, {'id': 'OG002', 'title': 'FF MDI 9.6 μg', 'description': 'Formoterol Fumarate Metered Dose Inhalation 9.6 μg'}], 'classes': [{'categories': [{'measurements': [{'value': '0.036', 'groupId': 'OG000', 'lowerLimit': '0.019', 'upperLimit': '0.053'}, {'value': '0.017', 'groupId': 'OG001', 'lowerLimit': '0.000', 'upperLimit': '0.034'}, {'value': '-0.003', 'groupId': 'OG002', 'lowerLimit': '-0.020', 'upperLimit': '0.015'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'at Week 24', 'description': 'Change from baseline in morning pre-dose trough FEV1 (Forced expiratory volume in 1 second) at Week 24 (BFF MDI versus FF MDI)', 'unitOfMeasure': 'Liter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in FEV1 AUC0-4 (BFF MDI vs BD MDI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '571', 'groupId': 'OG000'}, {'value': '565', 'groupId': 'OG001'}, {'value': '549', 'groupId': 'OG002'}, {'value': '168', 'groupId': 'OG003'}, {'value': '189', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'BFF MDI 320/9.6 μg', 'description': 'Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg'}, {'id': 'OG001', 'title': 'BFF MDI 160/9.6 μg', 'description': 'Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg'}, {'id': 'OG002', 'title': 'FF MDI 9.6 ug', 'description': 'Formoterol Fumarate Metered Dose Inhalation 9.6 μg'}, {'id': 'OG003', 'title': 'BD MDI 320 ug', 'description': 'Budesonide Metered Dose Inhalation 320 μg'}, {'id': 'OG004', 'title': 'Symbicort TBH 400/12 ug', 'description': 'Symbicort Turbuhaler 400/12 ug'}], 'classes': [{'categories': [{'measurements': [{'value': '0.194', 'groupId': 'OG000', 'lowerLimit': '0.177', 'upperLimit': '0.212'}, {'value': '0.179', 'groupId': 'OG001', 'lowerLimit': '0.161', 'upperLimit': '0.197'}, {'value': '0.161', 'groupId': 'OG002', 'lowerLimit': '0.143', 'upperLimit': '0.179'}, {'value': '0.022', 'groupId': 'OG003', 'lowerLimit': '-0.011', 'upperLimit': '0.054'}, {'value': '0.187', 'groupId': 'OG004', 'lowerLimit': '0.157', 'upperLimit': '0.218'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'at Week 24', 'description': 'Changes from baseline in FEV1 AUC0-4 were normalized by taking the area under the curve value and dividing by the length of time under consideration (usually 4 hours). This normalization represents a weighted average of the change from baseline in FEV1 over the 4-hour period.', 'unitOfMeasure': 'Liter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'SECONDARY', 'title': 'Time to First Moderate or Severe COPD Exacerbation (BFF MDI vs FF MDI).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '655', 'groupId': 'OG000'}, {'value': '637', 'groupId': 'OG001'}, {'value': '644', 'groupId': 'OG002'}, {'value': '206', 'groupId': 'OG003'}, {'value': '219', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'BFF MDI 320/9.6 μg', 'description': 'Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg'}, {'id': 'OG001', 'title': 'BFF MDI 160/9.6 μg', 'description': 'Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg'}, {'id': 'OG002', 'title': 'FF MDI 9.6 μg', 'description': 'Formoterol Fumarate Metered Dose Inhalation 9.6 μg'}, {'id': 'OG003', 'title': 'BD MDI 320 μg', 'description': 'Budesonide Metered Dose Inhalation 320 μg'}, {'id': 'OG004', 'title': 'Symbicort TBH 400/12 ug', 'description': 'Symbicort Turbuhaler 400/12 ug'}], 'classes': [{'title': 'Percentage of Subjects to Exacerbate at 4 Weeks', 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '4.9'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '2.2', 'upperLimit': '5.1'}, {'value': '5.5', 'groupId': 'OG002', 'lowerLimit': '4.0', 'upperLimit': '7.6'}, {'value': '7.0', 'groupId': 'OG003', 'lowerLimit': '4.2', 'upperLimit': '11.5'}, {'value': '1.8', 'groupId': 'OG004', 'lowerLimit': '0.7', 'upperLimit': '4.8'}]}]}, {'title': 'Percentage of Subjects to Exacerbate at 12 Weeks', 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000', 'lowerLimit': '7.7', 'upperLimit': '12.4'}, {'value': '9.9', 'groupId': 'OG001', 'lowerLimit': '7.8', 'upperLimit': '12.5'}, {'value': '15.0', 'groupId': 'OG002', 'lowerLimit': '12.4', 'upperLimit': '18.1'}, {'value': '14.9', 'groupId': 'OG003', 'lowerLimit': '10.6', 'upperLimit': '20.7'}, {'value': '8.6', 'groupId': 'OG004', 'lowerLimit': '5.5', 'upperLimit': '13.3'}]}]}, {'title': 'Percentage of Subjects to Exacerbate at 20 Weeks', 'categories': [{'measurements': [{'value': '14.4', 'groupId': 'OG000', 'lowerLimit': '11.9', 'upperLimit': '17.4'}, {'value': '18.5', 'groupId': 'OG001', 'lowerLimit': '15.6', 'upperLimit': '21.8'}, {'value': '20.5', 'groupId': 'OG002', 'lowerLimit': '17.5', 'upperLimit': '23.9'}, {'value': '17.7', 'groupId': 'OG003', 'lowerLimit': '13.0', 'upperLimit': '23.9'}, {'value': '13.1', 'groupId': 'OG004', 'lowerLimit': '9.2', 'upperLimit': '18.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'over 24 Weeks (timepoints of 4, 12 & 20 weeks)', 'description': 'Time to first moderate or severe COPD (Chronic Obstructive Pulmonary Disease) exacerbation (BFF MDI vs FF MDI).', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving an MCID (Minimal Clinically Important Difference) of 4 Units or More in SGRQ at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '649', 'groupId': 'OG000'}, {'value': '635', 'groupId': 'OG001'}, {'value': '640', 'groupId': 'OG002'}, {'value': '204', 'groupId': 'OG003'}, {'value': '217', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'BFF MDI 320/9.6 μg', 'description': 'Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg'}, {'id': 'OG001', 'title': 'BFF MDI 160/9.6 μg', 'description': 'Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg'}, {'id': 'OG002', 'title': 'FF MDI 9.6 μg', 'description': 'Formoterol Fumarate Metered Dose Inhalation 9.6 μg'}, {'id': 'OG003', 'title': 'BD MDI 320 μg', 'description': 'Budesonide Metered Dose Inhalation 320 μg'}, {'id': 'OG004', 'title': 'Symbicort TBH 400/12 μg', 'description': 'Symbicort Turbuhaler 400/12 μg'}], 'classes': [{'categories': [{'measurements': [{'value': '48.12', 'groupId': 'OG000'}, {'value': '47.22', 'groupId': 'OG001'}, {'value': '41.59', 'groupId': 'OG002'}, {'value': '43.62', 'groupId': 'OG003'}, {'value': '53.78', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at Week 24', 'description': "The SGRQ (St. George's Respiratory Questionnaire) is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of BFF MDI, FF MDI, BD MDI, \\& Symbicort TBH on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life.", 'unitOfMeasure': 'Percentage of Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 (BFF MDI vs BD MDI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '571', 'groupId': 'OG000'}, {'value': '564', 'groupId': 'OG001'}, {'value': '550', 'groupId': 'OG002'}, {'value': '168', 'groupId': 'OG003'}, {'value': '189', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'BFF MDI 320/9.6 μg', 'description': 'Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg'}, {'id': 'OG001', 'title': 'BFF MDI 160/9.6 μg', 'description': 'Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg'}, {'id': 'OG002', 'title': 'FF MDI 9.6 μg', 'description': 'Formoterol Fumarate Metered Dose Inhalation 9.6 μg'}, {'id': 'OG003', 'title': 'BD MDI 320 μg', 'description': 'Budesonide Metered Dose Inhalation 320 μg'}, {'id': 'OG004', 'title': 'Symbicort TBH 400/12 μg', 'description': 'Symbicort Turbuhaler 400/12 μg'}], 'classes': [{'categories': [{'measurements': [{'value': '0.036', 'groupId': 'OG000', 'lowerLimit': '0.019', 'upperLimit': '0.053'}, {'value': '0.017', 'groupId': 'OG001', 'lowerLimit': '0.000', 'upperLimit': '0.034'}, {'value': '-0.003', 'groupId': 'OG002', 'lowerLimit': '-0.020', 'upperLimit': '0.015'}, {'value': '-0.028', 'groupId': 'OG003', 'lowerLimit': '-0.060', 'upperLimit': '0.003'}, {'value': '0.039', 'groupId': 'OG004', 'lowerLimit': '0.009', 'upperLimit': '0.069'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'at Week 24', 'description': 'Change from baseline in morning pre-dose trough FEV1(Forced Expiratory Volume in 1 second) at Week 24 (BFF MDI vs BD MDI)', 'unitOfMeasure': 'Liter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'SECONDARY', 'title': 'Peak Change From Baseline in FEV1 at Week 24 (BFF MDI vs BD MDI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '571', 'groupId': 'OG000'}, {'value': '565', 'groupId': 'OG001'}, {'value': '549', 'groupId': 'OG002'}, {'value': '168', 'groupId': 'OG003'}, {'value': '189', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'BFF MDI 320/9.6 μg', 'description': 'Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg'}, {'id': 'OG001', 'title': 'BFF MDI 160/9.6 μg', 'description': 'Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg'}, {'id': 'OG002', 'title': 'FF MDI 9.6 μg', 'description': 'Formoterol Fumarate Metered Dose Inhalation 9.6 μg'}, {'id': 'OG003', 'title': 'BD MDI 320 μg', 'description': 'Budesonide Metered Dose Inhalation 320 μg'}, {'id': 'OG004', 'title': 'Symbicort TBH 400/12 μg', 'description': 'Symbicort Turbuhaler 400/12 μg'}], 'classes': [{'categories': [{'measurements': [{'value': '0.272', 'groupId': 'OG000', 'lowerLimit': '0.254', 'upperLimit': '0.291'}, {'value': '0.258', 'groupId': 'OG001', 'lowerLimit': '0.239', 'upperLimit': '0.276'}, {'value': '0.243', 'groupId': 'OG002', 'lowerLimit': '0.224', 'upperLimit': '0.261'}, {'value': '0.116', 'groupId': 'OG003', 'lowerLimit': '0.082', 'upperLimit': '0.150'}, {'value': '0.267', 'groupId': 'OG004', 'lowerLimit': '0.253', 'upperLimit': '0.299'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'at Week 24', 'description': 'Peak change from baseline in FEV1 (Forced Expiratory Volume in 1 second) at Week 24 (BFF MDI vs BD MDI)', 'unitOfMeasure': 'Liter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Average Daily Rescue Ventolin HFA Use Over 24 Weeks (BFF MDI vs BD MDI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '654', 'groupId': 'OG000'}, {'value': '636', 'groupId': 'OG001'}, {'value': '641', 'groupId': 'OG002'}, {'value': '206', 'groupId': 'OG003'}, {'value': '218', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'BFF MDI 320/9.6 μg', 'description': 'Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg'}, {'id': 'OG001', 'title': 'BFF MDI 160/9.6 μg', 'description': 'Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg'}, {'id': 'OG002', 'title': 'FF MDI 9.6 μg', 'description': 'Formoterol Fumarate Metered Dose Inhalation 9.6 μg'}, {'id': 'OG003', 'title': 'BD MDI 320 μg', 'description': 'Budesonide Metered Dose Inhalation 320 μg'}, {'id': 'OG004', 'title': 'Symbicort TBH 400/12 μg', 'description': 'Symbicort Turbuhaler 400/12 μg'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.3', 'groupId': 'OG000', 'lowerLimit': '-1.5', 'upperLimit': '-1.1'}, {'value': '-1.3', 'groupId': 'OG001', 'lowerLimit': '-1.4', 'upperLimit': '-1.1'}, {'value': '-1.1', 'groupId': 'OG002', 'lowerLimit': '-1.2', 'upperLimit': '-0.9'}, {'value': '-0.6', 'groupId': 'OG003', 'lowerLimit': '-0.9', 'upperLimit': '-0.3'}, {'value': '-1.2', 'groupId': 'OG004', 'lowerLimit': '-1.5', 'upperLimit': '-0.9'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'over 24 Weeks', 'description': 'Change from baseline in average daily rescue Ventolin HFA use over 24 weeks (BFF MDI vs BD MDI)', 'unitOfMeasure': 'Puffs per day', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'SECONDARY', 'title': 'FEV1 on Day 1, 5 Minutes, Time to Onset of Action Determination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '535', 'groupId': 'OG000'}, {'value': '536', 'groupId': 'OG001'}, {'value': '534', 'groupId': 'OG002'}, {'value': '171', 'groupId': 'OG003'}, {'value': '173', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'BFF MDI 320/9.6 μg', 'description': 'Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg'}, {'id': 'OG001', 'title': 'BFF MDI 160/9.6 μg', 'description': 'Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg'}, {'id': 'OG002', 'title': 'FF MDI 9.6 μg', 'description': 'Formoterol Fumarate Metered Dose Inhalation 9.6 μg'}, {'id': 'OG003', 'title': 'BD MDI 320 μg', 'description': 'Budesonide Metered Dose Inhalation 320 μg'}, {'id': 'OG004', 'title': 'Symbicort TBH 400/12 μg', 'description': 'Symbicort Turbuhaler 400/12 μg'}], 'classes': [{'categories': [{'measurements': [{'value': '0.157', 'groupId': 'OG000', 'lowerLimit': '0.148', 'upperLimit': '0.166'}, {'value': '0.151', 'groupId': 'OG001', 'lowerLimit': '0.142', 'upperLimit': '0.161'}, {'value': '0.160', 'groupId': 'OG002', 'lowerLimit': '0.150', 'upperLimit': '0.169'}, {'value': '0.025', 'groupId': 'OG003', 'lowerLimit': '0.009', 'upperLimit': '0.041'}, {'value': '0.131', 'groupId': 'OG004', 'lowerLimit': '0.115', 'upperLimit': '0.148'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 - 5 Minutes', 'description': 'Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.', 'unitOfMeasure': 'Liter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'SECONDARY', 'title': 'FEV1 on Day 1, 15 Minutes, Time to Onset of Action Determination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '624', 'groupId': 'OG000'}, {'value': '615', 'groupId': 'OG001'}, {'value': '612', 'groupId': 'OG002'}, {'value': '203', 'groupId': 'OG003'}, {'value': '211', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'BFF MDI 320/9.6 μg', 'description': 'Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg'}, {'id': 'OG001', 'title': 'BFF MDI 160/9.6 μg', 'description': 'Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg'}, {'id': 'OG002', 'title': 'FF MDI 9.6 μg', 'description': 'Formoterol Fumarate Metered Dose Inhalation 9.6 μg'}, {'id': 'OG003', 'title': 'BD MDI 320 μg', 'description': 'Budesonide Metered Dose Inhalation 320 μg'}, {'id': 'OG004', 'title': 'Symbicort TBH 400/12 μg', 'description': 'Symbicort Turbuhaler 400/12 μg'}], 'classes': [{'categories': [{'measurements': [{'value': '0.190', 'groupId': 'OG000', 'lowerLimit': '0.180', 'upperLimit': '0.200'}, {'value': '0.186', 'groupId': 'OG001', 'lowerLimit': '0.176', 'upperLimit': '0.196'}, {'value': '0.201', 'groupId': 'OG002', 'lowerLimit': '0.191', 'upperLimit': '0.211'}, {'value': '0.040', 'groupId': 'OG003', 'lowerLimit': '0.022', 'upperLimit': '0.058'}, {'value': '0.167', 'groupId': 'OG004', 'lowerLimit': '0.149', 'upperLimit': '0.184'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 - 15 Minutes', 'description': 'Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.', 'unitOfMeasure': 'Liter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'SECONDARY', 'title': 'FEV1 on Day 1, 30 Minutes, Time to Onset of Action Determination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '648', 'groupId': 'OG000'}, {'value': '627', 'groupId': 'OG001'}, {'value': '638', 'groupId': 'OG002'}, {'value': '203', 'groupId': 'OG003'}, {'value': '214', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'BFF MDI 320/9.6 μg', 'description': 'Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg'}, {'id': 'OG001', 'title': 'BFF MDI 160/9.6 μg', 'description': 'Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg'}, {'id': 'OG002', 'title': 'FF MDI 9.6 μg', 'description': 'Formoterol Fumarate Metered Dose Inhalation 9.6 μg'}, {'id': 'OG003', 'title': 'BD MDI 320 μg', 'description': 'Budesonide Metered Dose Inhalation 320 μg'}, {'id': 'OG004', 'title': 'Symbicort TBH 400/12 μg', 'description': 'Symbicort Turbuhaler 400/12 μg'}], 'classes': [{'categories': [{'measurements': [{'value': '0.207', 'groupId': 'OG000', 'lowerLimit': '0.196', 'upperLimit': '0.217'}, {'value': '0.207', 'groupId': 'OG001', 'lowerLimit': '0.196', 'upperLimit': '0.218'}, {'value': '0.215', 'groupId': 'OG002', 'lowerLimit': '0.205', 'upperLimit': '0.226'}, {'value': '0.047', 'groupId': 'OG003', 'lowerLimit': '0.028', 'upperLimit': '0.066'}, {'value': '0.190', 'groupId': 'OG004', 'lowerLimit': '0.172', 'upperLimit': '0.209'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 - 30 Minutes', 'description': 'Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.', 'unitOfMeasure': 'Liter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'SECONDARY', 'title': 'FEV1 on Day 1, 1 Hour, Time to Onset of Action Determination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '649', 'groupId': 'OG000'}, {'value': '628', 'groupId': 'OG001'}, {'value': '640', 'groupId': 'OG002'}, {'value': '204', 'groupId': 'OG003'}, {'value': '215', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'BFF MDI 320/9.6 μg', 'description': 'Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg'}, {'id': 'OG001', 'title': 'BFF MDI 160/9.6 μg', 'description': 'Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg'}, {'id': 'OG002', 'title': 'FF MDI 9.6 μg', 'description': 'Formoterol Fumarate Metered Dose Inhalation 9.6 μg'}, {'id': 'OG003', 'title': 'BD MDI 320 μg', 'description': 'Budesonide Metered Dose Inhalation 320 μg'}, {'id': 'OG004', 'title': 'Symbicort TBH 400/12 μg', 'description': 'Symbicort Turbuhaler 400/12 μg'}], 'classes': [{'categories': [{'measurements': [{'value': '0.225', 'groupId': 'OG000', 'lowerLimit': '0.213', 'upperLimit': '0.236'}, {'value': '0.221', 'groupId': 'OG001', 'lowerLimit': '0.210', 'upperLimit': '0.233'}, {'value': '0.236', 'groupId': 'OG002', 'lowerLimit': '0.225', 'upperLimit': '0.248'}, {'value': '0.053', 'groupId': 'OG003', 'lowerLimit': '0.033', 'upperLimit': '0.073'}, {'value': '0.211', 'groupId': 'OG004', 'lowerLimit': '0.191', 'upperLimit': '0.231'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 - 1 Hour', 'description': 'Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.', 'unitOfMeasure': 'Liter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'SECONDARY', 'title': 'FEV1 on Day 1, 2 Hours, Time to Onset of Action Determination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '649', 'groupId': 'OG000'}, {'value': '629', 'groupId': 'OG001'}, {'value': '636', 'groupId': 'OG002'}, {'value': '205', 'groupId': 'OG003'}, {'value': '217', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'BFF MDI 320/9.6 μg', 'description': 'Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg'}, {'id': 'OG001', 'title': 'BFF MDI 160/9.6 μg', 'description': 'Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg'}, {'id': 'OG002', 'title': 'FF MDI 9.6 μg', 'description': 'Formoterol Fumarate Metered Dose Inhalation 9.6 μg'}, {'id': 'OG003', 'title': 'BD MDI 320 μg', 'description': 'Budesonide Metered Dose Inhalation 320 μg'}, {'id': 'OG004', 'title': 'Symbicort TBH 400/12 μg', 'description': 'Symbicort Turbuhaler 400/12 μg'}], 'classes': [{'categories': [{'measurements': [{'value': '0.253', 'groupId': 'OG000', 'lowerLimit': '0.241', 'upperLimit': '0.265'}, {'value': '0.234', 'groupId': 'OG001', 'lowerLimit': '0.222', 'upperLimit': '0.247'}, {'value': '0.244', 'groupId': 'OG002', 'lowerLimit': '0.231', 'upperLimit': '0.256'}, {'value': '0.063', 'groupId': 'OG003', 'lowerLimit': '0.042', 'upperLimit': '0.085'}, {'value': '0.221', 'groupId': 'OG004', 'lowerLimit': '0.200', 'upperLimit': '0.243'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 - 2 Hours', 'description': 'Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.', 'unitOfMeasure': 'Liter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'SECONDARY', 'title': 'FEV1 on Day 1, 4 Hours, Time to Onset of Action Determination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '651', 'groupId': 'OG000'}, {'value': '630', 'groupId': 'OG001'}, {'value': '634', 'groupId': 'OG002'}, {'value': '201', 'groupId': 'OG003'}, {'value': '217', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'BFF MDI 320/9.6 μg', 'description': 'Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg'}, {'id': 'OG001', 'title': 'BFF MDI 160/9.6 μg', 'description': 'Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg'}, {'id': 'OG002', 'title': 'FF MDI 9.6 μg', 'description': 'Formoterol Fumarate Metered Dose Inhalation 9.6 μg'}, {'id': 'OG003', 'title': 'BD MDI 320 μg', 'description': 'Budesonide Metered Dose Inhalation 320 μg'}, {'id': 'OG004', 'title': 'Symbicort TBH 400/12 μg', 'description': 'Symbicort Turbuhaler 400/12 μg'}], 'classes': [{'categories': [{'measurements': [{'value': '0.230', 'groupId': 'OG000', 'lowerLimit': '0.216', 'upperLimit': '0.243'}, {'value': '0.215', 'groupId': 'OG001', 'lowerLimit': '0.202', 'upperLimit': '0.229'}, {'value': '0.212', 'groupId': 'OG002', 'lowerLimit': '0.199', 'upperLimit': '0.226'}, {'value': '0.073', 'groupId': 'OG003', 'lowerLimit': '0.049', 'upperLimit': '0.097'}, {'value': '0.209', 'groupId': 'OG004', 'lowerLimit': '0.186', 'upperLimit': '0.232'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 - 4 Hours', 'description': 'Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.', 'unitOfMeasure': 'Liter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Substudy: 12-hour PFT Endpoint FEV1 AUC0-12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}, {'value': '189', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BFF MDI 320/9.6 μg', 'description': 'Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg'}, {'id': 'OG001', 'title': 'BFF MDI 160/9.6 μg', 'description': 'Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg'}, {'id': 'OG002', 'title': 'FF MDI 9.6 μg', 'description': 'Formoterol Fumarate Metered Dose Inhalation 9.6 μg'}, {'id': 'OG003', 'title': 'BD MDI 320 μg', 'description': 'Budesonide Metered Dose Inhalation 320 μg'}], 'classes': [{'categories': [{'measurements': [{'value': '0.135', 'groupId': 'OG000', 'lowerLimit': '0.107', 'upperLimit': '0.163'}, {'value': '0.124', 'groupId': 'OG001', 'lowerLimit': '0.097', 'upperLimit': '0.152'}, {'value': '0.117', 'groupId': 'OG002', 'lowerLimit': '0.089', 'upperLimit': '0.145'}, {'value': '0.024', 'groupId': 'OG003', 'lowerLimit': '-0.028', 'upperLimit': '0.075'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'at Week 12', 'description': 'Substudy: 12-hour PFT (Pulmonary Function Test) endpoint FEV1 (Forced Expiratory Volume) AUC0-12 (Area under the Curve 0-12). Changes from baseline in FEV1 AUC0-12 were normalized by taking the area under the curve value and dividing by the length of time under consideration. This normalization represents a weighted average of the change from baseline in FEV1 over the 12-hour period.', 'unitOfMeasure': 'Liter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BFF MDI 320/9.6 μg', 'description': 'Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg'}, {'id': 'FG001', 'title': 'BFF MDI 160/9.6 μg', 'description': 'Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg'}, {'id': 'FG002', 'title': 'FF MDI 9.6 μg', 'description': 'Formoterol Fumarate Metered Dose Inhalation 9.6 μg'}, {'id': 'FG003', 'title': 'BD MDI 320 μg', 'description': 'Budesonide Metered Dose Inhalation 320 μg'}, {'id': 'FG004', 'title': 'Symbicort TBH 400/12 μg', 'description': 'Symbicort Turbuhaler 400/12 μg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'mITT Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '655'}, {'groupId': 'FG001', 'numSubjects': '637'}, {'groupId': 'FG002', 'numSubjects': '644'}, {'groupId': 'FG003', 'numSubjects': '206'}, {'groupId': 'FG004', 'numSubjects': '219'}]}, {'type': 'COMPLETED', 'comment': 'Completed Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '576'}, {'groupId': 'FG001', 'numSubjects': '567'}, {'groupId': 'FG002', 'numSubjects': '554'}, {'groupId': 'FG003', 'numSubjects': '169'}, {'groupId': 'FG004', 'numSubjects': '190'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '70'}, {'groupId': 'FG002', 'numSubjects': '90'}, {'groupId': 'FG003', 'numSubjects': '37'}, {'groupId': 'FG004', 'numSubjects': '29'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '12'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '10'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '32'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Protocol disc criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Administrative Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study randomized subjects at 244 study centers in 7 countries, from June 2016 and November 2017. The study period was scheduled to take up to approximately 30 weeks for each individual subject from the time of screening through the follow-up period.', 'preAssignmentDetails': 'Subjects were randomized in a 3:3:3:1:1 ratio to BFF 320/9.6, BFF 160/9.6, FF 9.6, BD 320, and Symbicort.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '664', 'groupId': 'BG000'}, {'value': '649', 'groupId': 'BG001'}, {'value': '648', 'groupId': 'BG002'}, {'value': '209', 'groupId': 'BG003'}, {'value': '219', 'groupId': 'BG004'}, {'value': '2389', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'BFF MDI 320/9.6 μg', 'description': 'Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg'}, {'id': 'BG001', 'title': 'BFF MDI 160/9.6 μg', 'description': 'Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg'}, {'id': 'BG002', 'title': 'FF MDI 9.6 μg', 'description': 'Formoterol Fumarate Metered Dose Inhalation 9.6 μg'}, {'id': 'BG003', 'title': 'BD MDI 320 μg', 'description': 'Budesonide Metered Dose Inhalation 320 μg'}, {'id': 'BG004', 'title': 'Symbicort TBH 400/12 μg', 'description': 'Symbicort Turbuhaler 400/12 μg'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '655', 'groupId': 'BG000'}, {'value': '637', 'groupId': 'BG001'}, {'value': '644', 'groupId': 'BG002'}, {'value': '206', 'groupId': 'BG003'}, {'value': '219', 'groupId': 'BG004'}, {'value': '2361', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '64.2', 'spread': '7.7', 'groupId': 'BG000'}, {'value': '64.3', 'spread': '7.6', 'groupId': 'BG001'}, {'value': '64.1', 'spread': '8.0', 'groupId': 'BG002'}, {'value': '64.2', 'spread': '7.4', 'groupId': 'BG003'}, {'value': '65.3', 'spread': '7.0', 'groupId': 'BG004'}, {'value': '64.3', 'spread': '7.7', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'mITT'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Values listed are mITT population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '655', 'groupId': 'BG000'}, {'value': '637', 'groupId': 'BG001'}, {'value': '644', 'groupId': 'BG002'}, {'value': '206', 'groupId': 'BG003'}, {'value': '219', 'groupId': 'BG004'}, {'value': '2361', 'groupId': 'BG005'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '253', 'groupId': 'BG000'}, {'value': '260', 'groupId': 'BG001'}, {'value': '261', 'groupId': 'BG002'}, {'value': '81', 'groupId': 'BG003'}, {'value': '78', 'groupId': 'BG004'}, {'value': '933', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '402', 'groupId': 'BG000'}, {'value': '377', 'groupId': 'BG001'}, {'value': '383', 'groupId': 'BG002'}, {'value': '125', 'groupId': 'BG003'}, {'value': '141', 'groupId': 'BG004'}, {'value': '1428', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'mITT'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'Values listed are mITT population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '655', 'groupId': 'BG000'}, {'value': '637', 'groupId': 'BG001'}, {'value': '644', 'groupId': 'BG002'}, {'value': '206', 'groupId': 'BG003'}, {'value': '219', 'groupId': 'BG004'}, {'value': '2361', 'groupId': 'BG005'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '69', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '637', 'groupId': 'BG000'}, {'value': '616', 'groupId': 'BG001'}, {'value': '623', 'groupId': 'BG002'}, {'value': '198', 'groupId': 'BG003'}, {'value': '212', 'groupId': 'BG004'}, {'value': '2286', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'mITT'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'Values listed are mITT population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '655', 'groupId': 'BG000'}, {'value': '637', 'groupId': 'BG001'}, {'value': '644', 'groupId': 'BG002'}, {'value': '206', 'groupId': 'BG003'}, {'value': '219', 'groupId': 'BG004'}, {'value': '2361', 'groupId': 'BG005'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '71', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '633', 'groupId': 'BG000'}, {'value': '619', 'groupId': 'BG001'}, {'value': '622', 'groupId': 'BG002'}, {'value': '197', 'groupId': 'BG003'}, {'value': '210', 'groupId': 'BG004'}, {'value': '2281', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'mITT'}], 'populationDescription': 'The Modified Intent-To-Treat (mITT) Population is a subset of the ITT Population, and is defined as all subjects with post-randomization data obtained prior to discontinuation from treatment. The Intent-To-Treat (ITT) Population is defined as all subjects who were randomized to treatment and received any amount of the study treatment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-10-24', 'size': 12568853, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-01-30T15:04', 'hasProtocol': True}, {'date': '2017-12-11', 'size': 1169244, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-06-21T10:28', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2389}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-03', 'studyFirstSubmitDate': '2016-05-06', 'resultsFirstSubmitDate': '2018-11-30', 'studyFirstSubmitQcDate': '2016-05-06', 'lastUpdatePostDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-03', 'studyFirstPostDateStruct': {'date': '2016-05-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Substudy: 12-hour PFT Endpoint FEV1 AUC0-12', 'timeFrame': 'at Week 12', 'description': 'Substudy: 12-hour PFT (Pulmonary Function Test) endpoint FEV1 (Forced Expiratory Volume) AUC0-12 (Area under the Curve 0-12). Changes from baseline in FEV1 AUC0-12 were normalized by taking the area under the curve value and dividing by the length of time under consideration. This normalization represents a weighted average of the change from baseline in FEV1 over the 12-hour period.'}], 'primaryOutcomes': [{'measure': 'Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 (BFF MDI Versus FF MDI)', 'timeFrame': 'at Week 24', 'description': 'Change from baseline in morning pre-dose trough FEV1 (Forced expiratory volume in 1 second) at Week 24 (BFF MDI versus FF MDI)'}, {'measure': 'Change From Baseline in FEV1 AUC0-4 (BFF MDI vs BD MDI)', 'timeFrame': 'at Week 24', 'description': 'Changes from baseline in FEV1 AUC0-4 were normalized by taking the area under the curve value and dividing by the length of time under consideration (usually 4 hours). This normalization represents a weighted average of the change from baseline in FEV1 over the 4-hour period.'}], 'secondaryOutcomes': [{'measure': 'Time to First Moderate or Severe COPD Exacerbation (BFF MDI vs FF MDI).', 'timeFrame': 'over 24 Weeks (timepoints of 4, 12 & 20 weeks)', 'description': 'Time to first moderate or severe COPD (Chronic Obstructive Pulmonary Disease) exacerbation (BFF MDI vs FF MDI).'}, {'measure': 'Percentage of Subjects Achieving an MCID (Minimal Clinically Important Difference) of 4 Units or More in SGRQ at Week 24', 'timeFrame': 'at Week 24', 'description': "The SGRQ (St. George's Respiratory Questionnaire) is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of BFF MDI, FF MDI, BD MDI, \\& Symbicort TBH on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life."}, {'measure': 'Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 (BFF MDI vs BD MDI)', 'timeFrame': 'at Week 24', 'description': 'Change from baseline in morning pre-dose trough FEV1(Forced Expiratory Volume in 1 second) at Week 24 (BFF MDI vs BD MDI)'}, {'measure': 'Peak Change From Baseline in FEV1 at Week 24 (BFF MDI vs BD MDI)', 'timeFrame': 'at Week 24', 'description': 'Peak change from baseline in FEV1 (Forced Expiratory Volume in 1 second) at Week 24 (BFF MDI vs BD MDI)'}, {'measure': 'Change From Baseline in Average Daily Rescue Ventolin HFA Use Over 24 Weeks (BFF MDI vs BD MDI)', 'timeFrame': 'over 24 Weeks', 'description': 'Change from baseline in average daily rescue Ventolin HFA use over 24 weeks (BFF MDI vs BD MDI)'}, {'measure': 'FEV1 on Day 1, 5 Minutes, Time to Onset of Action Determination', 'timeFrame': 'Day 1 - 5 Minutes', 'description': 'Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.'}, {'measure': 'FEV1 on Day 1, 15 Minutes, Time to Onset of Action Determination', 'timeFrame': 'Day 1 - 15 Minutes', 'description': 'Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.'}, {'measure': 'FEV1 on Day 1, 30 Minutes, Time to Onset of Action Determination', 'timeFrame': 'Day 1 - 30 Minutes', 'description': 'Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.'}, {'measure': 'FEV1 on Day 1, 1 Hour, Time to Onset of Action Determination', 'timeFrame': 'Day 1 - 1 Hour', 'description': 'Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.'}, {'measure': 'FEV1 on Day 1, 2 Hours, Time to Onset of Action Determination', 'timeFrame': 'Day 1 - 2 Hours', 'description': 'Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.'}, {'measure': 'FEV1 on Day 1, 4 Hours, Time to Onset of Action Determination', 'timeFrame': 'Day 1 - 4 Hours', 'description': 'Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['COPD'], 'conditions': ['Chronic Obstructive Pulmonary Disorder']}, 'referencesModule': {'references': [{'pmid': '35815359', 'type': 'DERIVED', 'citation': 'Singh D, Hurst JR, Martinez FJ, Rabe KF, Bafadhel M, Jenkins M, Salazar D, Dorinsky P, Darken P. Predictive modeling of COPD exacerbation rates using baseline risk factors. Ther Adv Respir Dis. 2022 Jan-Dec;16:17534666221107314. doi: 10.1177/17534666221107314.'}, {'pmid': '30220648', 'type': 'DERIVED', 'citation': 'Ferguson GT, Papi A, Anzueto A, Kerwin EM, Cappelletti C, Duncan EA, Nyberg J, Dorinsky P. Budesonide/formoterol MDI with co-suspension delivery technology in COPD: the TELOS study. Eur Respir J. 2018 Sep 16;52(3):1801334. doi: 10.1183/13993003.01334-2018. Print 2018 Sep.'}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4181&filename=PT009002_TELOS_PROTOCOL_REDACTED_07AUG2018_PDFA.pdf', 'label': 'Related Info'}, {'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4181&filename=d7820c00001-12-1-09-Final_sap_PDFA.pdf', 'label': 'Related Info'}, {'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4181&filename=PT009002_TELOS_PROTOCOL_REDACTED_PDFA.pdf', 'label': 'Related Info'}, {'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4181&filename=PT009002_Final_sap_Redacted_PDFA.pdf', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase III randomized, double-blind, parallel group, multi-center, 24-week lung function study with BFF MDI (320/9.6 μg and 160/9.6 μg) compared to FF MDI 9.6 μg, BD MDI 320 μg, and open-label Symbicort® TBH (200/6 μg) administered BID.', 'detailedDescription': 'This is a Phase III randomized, double-blind, parallel group, multi-center, 24-week lung function study with BFF MDI (320/9.6 μg and 160/9.6 μg) compared to FF MDI 9.6 μg, BD MDI 320 μg, and open-label Symbicort® TBH (200/6 μg) administered BID. Subjects will undergo a 1- to 4-week Screening Period. Subjects who successfully complete the Screening Period will be to one of the following five treatment groups:BFF MDI 320/9.6 μg BID (N=660), BFF MDI 160/9.6 μg BID, FF MDI 9.6 μg BID, BD MDI 320 μg BID, Symbicort®, TBH 400/12 μg BID. Following randomization, subjects will enter the Treatment Period and undergo additional treatment visits over 24 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Give their signed written informed consent to participate\n2. Are at least 40 years of age and no older than 80 years\n3. COPD patients who are symptomatic\n4. Must be receiving one or more inhaled bronchodilators as maintenance therapy\n\nExclusion Criteria:\n\n1. Current diagnosis of asthma,\n2. COPD due to α1-Antitrypsin Deficiency\n3. Known active tuberculosis, lung cancer, cystic fibrosis, significant bronchiectasis, Pulmonary resection or Lung Volume Reduction Surgery during the past 6 months\n4. Long-term-oxygen therapy (≥ 12 hours a day).'}, 'identificationModule': {'nctId': 'NCT02766608', 'acronym': 'telos', 'briefTitle': 'Study to Assess Efficacy and Safety of PT009 Compared to PT005, PT008, and Symbicort® Turbuhaler® on Lung Function Over 24-Weeks in Subjects With Moderate to Very Severe COPD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pearl Therapeutics, Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT009 Compared to PT005, PT008, and Open-label Symbicort® Turbuhaler®, as an Active Control, on Lung Function Over a 24-Week Treatment Period in Subjects With Moderate to Very Severe COPD', 'orgStudyIdInfo': {'id': 'PT009002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BFF MDI 320/9.6 μg', 'description': 'Budesonide and Formoterol Fumarate Inhalation Aerosol 160/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID', 'interventionNames': ['Drug: BFF MDI 320/9.6 μg']}, {'type': 'EXPERIMENTAL', 'label': 'BFF MDI 160/9.6 μg', 'description': 'Budesonide and Formoterol Fumarate Inhalation Aerosol-80/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID', 'interventionNames': ['Drug: BFF MDI 160/9.6 μg']}, {'type': 'EXPERIMENTAL', 'label': 'FF MDI 9.6 μg', 'description': 'Formoterol Fumarate Inhalation Aerosol-4.8 μg per actuation MDI/ 120 inhalations Taken as 2 inhalations BID', 'interventionNames': ['Drug: FF MDI 9.6 μg']}, {'type': 'EXPERIMENTAL', 'label': 'BD MDI 320 μg', 'description': 'Budesonide inhalation Aerosol 160 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID', 'interventionNames': ['Drug: BD MDI 320 μg']}, {'type': 'OTHER', 'label': 'Symbicort® TBH 400/12 μg', 'description': 'Symbicort Turbuhaler 400/12 μg Taken as 2 inhalations BID', 'interventionNames': ['Drug: Symbicort® TBH 400/12 μg BID']}], 'interventions': [{'name': 'BFF MDI 320/9.6 μg', 'type': 'DRUG', 'otherNames': ['Budesonide and Formoterol Fumarate Inhalation Aerosol'], 'description': 'Blinded Treatment', 'armGroupLabels': ['BFF MDI 320/9.6 μg']}, {'name': 'BFF MDI 160/9.6 μg', 'type': 'DRUG', 'otherNames': ['Budesonide and Formoterol Fumarate Inhalation Aerosol'], 'description': 'Blinded Treatment', 'armGroupLabels': ['BFF MDI 160/9.6 μg']}, {'name': 'FF MDI 9.6 μg', 'type': 'DRUG', 'otherNames': ['Formoterol Fumarate Inhalation Aerosol'], 'description': 'Blinded Treatment', 'armGroupLabels': ['FF MDI 9.6 μg']}, {'name': 'BD MDI 320 μg', 'type': 'DRUG', 'otherNames': ['Budesonide Inhalation Aerosol'], 'description': 'Blinded Treatment', 'armGroupLabels': ['BD MDI 320 μg']}, {'name': 'Symbicort® TBH 400/12 μg BID', 'type': 'DRUG', 'otherNames': ['Symbicort® Turbuhaler'], 'description': 'Open Label', 'armGroupLabels': ['Symbicort® TBH 400/12 μg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35611', 'city': 'Athens', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.80243, 'lon': -86.97219}}, {'zip': '35243', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36305', 'city': 'Dothan', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 31.22323, 'lon': -85.39049}}, {'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85020', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85745', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '95670', 'city': 'Gold River', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.62629, 'lon': -121.24662}}, {'zip': '92262', 'city': 'Palm Springs', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.8303, 'lon': -116.54529}}, {'zip': '95823', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92120', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80301', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}, {'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80127', 'city': 'Littleton', 'state': 'Colorado', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.61332, 'lon': -105.01665}}, {'zip': '06517', 'city': 'Hamden', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.39593, 'lon': -72.89677}}, {'zip': '33756', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33765', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '32720', 'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'zip': '33016', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33134', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33175', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33186', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32405', 'city': 'Panama City', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 30.15946, 'lon': -85.65983}}, {'zip': '32127', 'city': 'Port Orange', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.13832, 'lon': -80.99561}}, {'zip': '32129', 'city': 'Port Orange', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.13832, 'lon': -80.99561}}, {'zip': '33603', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '32789-4681', 'city': 'Winter Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 28.6, 'lon': -81.33924}}, {'zip': '30513', 'city': 'Blue Ridge', 'state': 'Georgia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.86397, 'lon': -84.32409}}, {'zip': '83646', 'city': 'Meridian', 'state': 'Idaho', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 43.61211, 'lon': -116.39151}}, {'zip': '21204', 'city': 'Towson', 'state': 'Maryland', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.4015, 'lon': -76.60191}}, {'zip': '21157', 'city': 'Westminster', 'state': 'Maryland', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.57538, 'lon': -76.99581}}, {'zip': '02747', 'city': 'North Dartmouth', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.63899, 'lon': -70.97032}}, {'zip': '48336', 'city': 'Farmington Hills', 'state': 'Michigan', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.48531, 'lon': -83.37716}}, {'zip': '55435', 'city': 'Edina', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 44.88969, 'lon': -93.34995}}, {'zip': '55432', 'city': 'Fridley', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 45.08608, 'lon': -93.26328}}, {'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55125', 'city': 'Woodbury', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 44.92386, 'lon': -92.95938}}, {'zip': '63301', 'city': 'Saint Charles', 'state': 'Missouri', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.78394, 'lon': -90.48123}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '89014', 'city': 'Henderson', 'state': 'Nevada', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 36.0397, 'lon': -114.98194}}, {'zip': '89052', 'city': 'Henderson', 'state': 'Nevada', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 36.0397, 'lon': -114.98194}}, {'zip': '89118', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '11236', 'city': 'Jackson Heights', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.75566, 'lon': -73.88541}}, {'zip': '10803', 'city': 'Larchmont', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.92788, 'lon': -73.7518}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28054', 'city': 'Gastonia', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.26208, 'lon': -81.1873}}, {'zip': '27408', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '28078', 'city': 'Huntersville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.41069, 'lon': -80.84285}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '58103', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '43213', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43215', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '45459', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '43016', 'city': 'Dublin', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.09923, 'lon': -83.11408}}, {'zip': '43123', 'city': 'Grove City', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.88145, 'lon': -83.09296}}, {'zip': '73103', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97504', 'city': 'Medford', 'state': 'Oregon', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.32652, 'lon': -122.87559}}, {'zip': '15236', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15243', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29621', 'city': 'Anderson', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.50344, 'lon': -82.65013}}, {'zip': '29640', 'city': 'Easley', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.82984, 'lon': -82.60152}}, {'zip': '29341', 'city': 'Gaffney', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.07179, 'lon': -81.64982}}, {'zip': '29615', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '29464', 'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'zip': '29707', 'city': 'Old Point Station', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.95987, 'lon': -81.04869}}, {'zip': '29732', 'city': 'Rock Hill', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.92487, 'lon': -81.02508}}, {'zip': '29678', 'city': 'Seneca', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.68566, 'lon': -82.9532}}, {'zip': '29303', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'zip': '29379', 'city': 'Union', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.71541, 'lon': -81.62371}}, {'zip': '37601', 'city': 'Johnson City', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 36.31344, 'lon': -82.35347}}, {'zip': '37660', 'city': 'Kingsport', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 36.54843, 'lon': -82.56182}}, {'zip': '77530', 'city': 'Channelview', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.77606, 'lon': -95.11465}}, {'zip': '78233', 'city': 'Live Oak', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.56523, 'lon': -98.3364}}, {'zip': '78130', 'city': 'New Braunfels', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.703, 'lon': -98.12445}}, {'zip': '78212', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '77479', 'city': 'Sugar Land', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.61968, 'lon': -95.63495}}, {'zip': '05403', 'city': 'South Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 44.46699, 'lon': -73.17096}}, {'zip': '23606', 'city': 'Newport News', 'state': 'Virginia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 36.98038, 'lon': -76.42975}}, {'zip': '23294', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98004', 'city': 'Bellevue', 'state': 'Washington', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}, {'zip': '98007', 'city': 'Bellevue', 'state': 'Washington', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': 'T6L 5X8', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'R2K 3S8', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'B2N 1L2', 'city': 'Truro', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 45.36685, 'lon': -63.26538}}, {'zip': 'L1S 2J5', 'city': 'Ajax', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 43.85012, 'lon': -79.03288}}, {'zip': 'L7M 4Y1', 'city': 'Burlington', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 43.38621, 'lon': -79.83713}}, {'zip': 'P3A 1W8', 'city': 'Greater Sudbury', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 46.49, 'lon': -80.99001}}, {'zip': 'M3J 2C5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'N8X 1T3', 'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}, {'zip': 'N8X 5A6', 'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}, {'zip': 'J7J 2K8', 'city': 'Mirabel', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 45.65008, 'lon': -74.08251}}, {'zip': 'H1M 1B1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H9R 3J1', 'city': 'Pointe-Claire', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 45.44868, 'lon': -73.81669}}, {'zip': 'G1G 3Y8', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'G1V 4G5', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'G3K 2P8', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'J6E 2B4', 'city': 'Saint-Charles-Borromée', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 46.05007, 'lon': -73.46586}}, {'zip': 'G8T 7A1', 'city': 'Trois-Rivières', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 46.34515, 'lon': -72.5477}}, {'zip': 'G6P 6P6', 'city': 'Victoriaville', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 46.05007, 'lon': -71.96579}}, {'zip': 'S7N 0W8', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}, {'zip': 'G1W 4R4', 'city': 'Québec', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': '680 01', 'city': 'Boskovice', 'country': 'Czechia', 'facility': 'Research Site', 'geoPoint': {'lat': 49.48751, 'lon': 16.65997}}, {'zip': '250 01', 'city': 'Brandýs nad Labem', 'country': 'Czechia', 'facility': 'Research Site', 'geoPoint': {'lat': 50.18356, 'lon': 14.67244}}, {'zip': '37701', 'city': 'Jindřichův Hradec', 'country': 'Czechia', 'facility': 'Research Site', 'geoPoint': {'lat': 49.14404, 'lon': 15.00301}}, {'zip': '525947', 'city': 'Liberec', 'country': 'Czechia', 'facility': 'Research Site', 'geoPoint': {'lat': 50.76711, 'lon': 15.05619}}, {'zip': '410 02', 'city': 'Lovosice', 'country': 'Czechia', 'facility': 'Research Site', 'geoPoint': {'lat': 50.51504, 'lon': 14.05103}}, {'zip': '473 01', 'city': 'Nový Bor', 'country': 'Czechia', 'facility': 'Research Site', 'geoPoint': {'lat': 50.75761, 'lon': 14.55555}}, {'zip': '700 30', 'city': 'Ostrava-Hrabuvka', 'country': 'Czechia', 'facility': 'Research Site'}, {'zip': '708 68', 'city': 'Ostrava-Poruba', 'country': 'Czechia', 'facility': 'Research Site'}, {'zip': '140 00', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Research Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '140 59', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Research Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '15000', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Research Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '16900', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Research Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '190 00', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Research Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '337 22', 'city': 'Rokycany', 'country': 'Czechia', 'facility': 'Research Site', 'geoPoint': {'lat': 49.7427, 'lon': 13.59459}}, {'zip': '38601', 'city': 'Strakonice', 'country': 'Czechia', 'facility': 'Research Site', 'geoPoint': {'lat': 49.26141, 'lon': 13.90237}}, {'zip': '415 01', 'city': 'Teplice', 'country': 'Czechia', 'facility': 'Research Site', 'geoPoint': {'lat': 50.6404, 'lon': 13.82451}}, {'zip': '407 47', 'city': 'Varnsdorf', 'country': 'Czechia', 'facility': 'Research Site', 'geoPoint': {'lat': 50.91154, 'lon': 14.61824}}, {'zip': '43801', 'city': 'Žatec', 'country': 'Czechia', 'facility': 'Research Site', 'geoPoint': {'lat': 50.32717, 'lon': 13.54577}}, {'zip': '96049', 'city': 'Bamberg', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 49.89873, 'lon': 10.90067}}, {'zip': '10119', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '10629', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '10787', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12157', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13156', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '14059', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '51069', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '64283', 'city': 'Darmstadt', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 49.87167, 'lon': 8.65027}}, {'zip': '45355', 'city': 'Essen', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '60596', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '20253', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '20354', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '04109', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '04207', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '23552', 'city': 'Lübeck', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'zip': '63110', 'city': 'Rodgau-Dudenhofen', 'country': 'Germany', 'facility': 'Research Site'}, {'zip': '19055', 'city': 'Schwerin', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 53.62937, 'lon': 11.41316}}, {'zip': '2660', 'city': 'Balassagyarmat', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 48.07296, 'lon': 19.29614}}, {'zip': '1135', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '2700', 'city': 'Cegléd', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 47.17266, 'lon': 19.79952}}, {'zip': '9300', 'city': 'Csorna', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 47.61155, 'lon': 17.25012}}, {'zip': '2100', 'city': 'Gödöllő', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 47.59657, 'lon': 19.35515}}, {'zip': '4080', 'city': 'Hajdúnánás', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 47.85, 'lon': 21.43333}}, {'zip': '3000', 'city': 'Hatvan', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 47.66667, 'lon': 19.68333}}, {'zip': '2900', 'city': 'Komárom', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 47.74318, 'lon': 18.11913}}, {'zip': '6900', 'city': 'Makó', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 46.21667, 'lon': 20.48333}}, {'zip': '3529', 'city': 'Miskolc', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 48.10327, 'lon': 20.77806}}, {'zip': '4400', 'city': 'Nyíregyháza', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 47.95539, 'lon': 21.71671}}, {'zip': '7626', 'city': 'Pécs', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}, {'zip': '7635', 'city': 'Pécs', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}, {'zip': '8600', 'city': 'Siófok', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 46.90413, 'lon': 18.058}}, {'zip': '2440', 'city': 'Százhalombatta', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 47.32949, 'lon': 18.93878}}, {'zip': 'H-6722', 'city': 'Szeged', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}, {'zip': '5000', 'city': 'Szolnok', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 47.18066, 'lon': 20.19835}}, {'zip': '15-003', 'city': 'Bialystok', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '15-044', 'city': 'Bialystok', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '15-430', 'city': 'Bialystok', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '43-300', 'city': 'Bielsko-Biala', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 49.82245, 'lon': 19.04686}}, {'zip': '22-100', 'city': 'Chełm', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 51.14312, 'lon': 23.4716}}, {'zip': '82-300', 'city': 'Elblag', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 54.1522, 'lon': 19.40884}}, {'zip': '80-952', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '86-300', 'city': 'Grudziądz', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 53.48411, 'lon': 18.75366}}, {'zip': '40-648', 'city': 'Katowice', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'zip': '64-000', 'city': 'Kościan', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 52.08829, 'lon': 16.64866}}, {'zip': '30-901', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '31-159', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '59-220', 'city': 'Legnica', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 51.21006, 'lon': 16.1619}}, {'zip': '90-141', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '91-363', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '20-093', 'city': 'Lublin', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '09-505', 'city': 'Nowy Duninów', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 52.58271, 'lon': 19.47996}}, {'zip': '27-400', 'city': 'Ostrowiec Świętokrzyski', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 50.92936, 'lon': 21.38525}}, {'zip': '63-400', 'city': 'Ostrów Wielkopolski', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 51.65501, 'lon': 17.80686}}, {'zip': '41-94O', 'city': 'Piekary Śląskie', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 50.38017, 'lon': 18.92653}}, {'zip': '64-920', 'city': 'Piła', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 53.15145, 'lon': 16.73782}}, {'zip': '60-685', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '60-693', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '60-823', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '32-100', 'city': 'Proszowice', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 50.19275, 'lon': 20.28909}}, {'zip': '24-100', 'city': 'Puławy', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 51.41655, 'lon': 21.96939}}, {'zip': '41-709', 'city': 'Ruda Śląska', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 50.2584, 'lon': 18.85632}}, {'zip': '35-051', 'city': 'Rzeszów', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 50.04132, 'lon': 21.99901}}, {'zip': '35-205', 'city': 'Rzeszów', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 50.04132, 'lon': 21.99901}}, {'zip': '08-110', 'city': 'Siedlce', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 52.16772, 'lon': 22.29006}}, {'zip': '96-500', 'city': 'Sochaczew', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 52.22944, 'lon': 20.23838}}, {'zip': '16-400', 'city': 'Suwałki', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 54.11175, 'lon': 22.93087}}, {'zip': '70-111', 'city': 'Szczecin', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 53.42894, 'lon': 14.55302}}, {'zip': '33-100', 'city': 'Tarnów', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 50.01381, 'lon': 20.98698}}, {'zip': '55-100', 'city': 'Trzebnica', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 51.31076, 'lon': 17.06331}}, {'zip': '01-518', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '02-777', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '98-300', 'city': 'Wieluń', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 51.22097, 'lon': 18.56964}}, {'zip': '05-200', 'city': 'Wołomin', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 52.34006, 'lon': 21.24207}}, {'zip': '53-301', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '41-800', 'city': 'Zabrze', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 50.32492, 'lon': 18.78576}}, {'zip': '22-400', 'city': 'Zamość', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 50.72314, 'lon': 23.25196}}, {'zip': '656045', 'city': 'Barnaul', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 53.36199, 'lon': 83.72786}}, {'zip': '454106', 'city': 'Chelyabinsk', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.1611, 'lon': 61.42877}}, {'zip': '153005', 'city': 'Ivanovo', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 56.99988, 'lon': 40.97257}}, {'zip': '426035', 'city': 'Izhevsk', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 56.85225, 'lon': 53.19862}}, {'zip': '420008', 'city': "Kazan'", 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'zip': '420012', 'city': "Kazan'", 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'zip': '610027', 'city': 'Kirov', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 58.59809, 'lon': 49.65783}}, {'zip': '119991', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '123423', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '123995', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '125315', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '129090', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '603126', 'city': 'Nizhny Novgorod', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 56.32867, 'lon': 44.00205}}, {'zip': '630008', 'city': 'Novosibirsk', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}, {'zip': '630051', 'city': 'Novosibirsk', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}, {'zip': '630084', 'city': 'Novosibirsk', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}, {'zip': '630087', 'city': 'Novosibirsk', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}, {'zip': '644043', 'city': 'Omsk', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 54.99244, 'lon': 73.36859}}, {'zip': '644112', 'city': 'Omsk', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 54.99244, 'lon': 73.36859}}, {'zip': '440026', 'city': 'Penza', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 53.19568, 'lon': 45.01075}}, {'zip': '440067', 'city': 'Penza', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 53.19568, 'lon': 45.01075}}, {'zip': '614000', 'city': 'Perm', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 58.01046, 'lon': 56.25017}}, {'zip': '357538', 'city': 'Pytigorsk', 'country': 'Russia', 'facility': 'Research Site'}, {'zip': '344068', 'city': 'Rostov-on-Don', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 47.21997, 'lon': 39.70769}}, {'zip': '390026', 'city': 'Ryazan', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 54.62696, 'lon': 39.70415}}, {'zip': '193231', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '194044', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '194291', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '194354', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '196084', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '196143', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '196247', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '196601', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '197022', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '197089', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '197342', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '198260', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '410012', 'city': 'Saratov', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 51.54048, 'lon': 45.9901}}, {'zip': '214006', 'city': 'Smolensk', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 54.77826, 'lon': 32.05088}}, {'zip': '214019', 'city': 'Smolensk', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 54.77826, 'lon': 32.05088}}, {'zip': '432009', 'city': 'Ulyanovsk', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 54.32824, 'lon': 48.38657}}, {'zip': '600023', 'city': 'Vladimir', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 56.13854, 'lon': 40.39976}}, {'zip': '394066', 'city': 'Voronezh', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 51.66833, 'lon': 39.19204}}, {'zip': '150002', 'city': 'Yaroslavl', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 57.62987, 'lon': 39.87368}}, {'zip': '150062', 'city': 'Yaroslavl', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 57.62987, 'lon': 39.87368}}, {'zip': '620039', 'city': 'Yekaterinburg', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 56.85733, 'lon': 60.61529}}, {'zip': '620149', 'city': 'Yekaterinburg', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 56.85733, 'lon': 60.61529}}, {'zip': '14068', 'city': 'Anyang-si', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.3925, 'lon': 126.92694}}, {'zip': '49201', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '21431', 'city': 'Incheon', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '54907', 'city': 'Jeonju', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}, {'zip': '13620', 'city': 'Seongnam-si', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'zip': '02559', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '02841', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03181', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '04401', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '04551', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06591', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '08308', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pearl Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}