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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-25 @ 2:06 AM

Ignite Modification Date: 2026-01-07 @ 7:59 PM

Study NCT ID: NCT02727660

Status: COMPLETED

Last Update Posted: 2019-09-26

First Post: 2016-03-30

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: A Study to Assess the Efficacy and Safety of PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week Period in Subjects With Moderate to Very Severe COPD (Sophos)

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

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'}], '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 52 weeks, which includes screening and follow up (14 days after last dose of study drug).', 'eventGroups': [{'id': 'EG000', 'title': 'BFF MDI 320/9.6 ug', 'description': 'Budesonide Formoterol Fumarate Metered dose inhalation 320/9.6 ug', 'otherNumAtRisk': 619, 'deathsNumAtRisk': 619, 'otherNumAffected': 266, 'seriousNumAtRisk': 619, 'deathsNumAffected': 3, 'seriousNumAffected': 60}, {'id': 'EG001', 'title': 'BFF MDI 160/9.6 ug', 'description': 'Budesonide Formoterol Fumarate Metered dose inhalation 160/9.6 ug', 'otherNumAtRisk': 617, 'deathsNumAtRisk': 617, 'otherNumAffected': 279, 'seriousNumAtRisk': 617, 'deathsNumAffected': 4, 'seriousNumAffected': 78}, {'id': 'EG002', 'title': 'FF MDI 9.6 ug', 'description': 'Formoterol Fumarate Metered dose inhalation 9.6 ug', 'otherNumAtRisk': 607, 'deathsNumAtRisk': 607, 'otherNumAffected': 268, 'seriousNumAtRisk': 607, 'deathsNumAffected': 8, 'seriousNumAffected': 83}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 53, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 61, 'numAffected': 53}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 43, 'numAffected': 36}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 29, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 18, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 28, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 20, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 20, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 14, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 17, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 32, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 33, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 65, 'numAffected': 50}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 19, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 18, 'numAffected': 16}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 24, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 24, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 20, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 21, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 32, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 33, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 65, 'numAffected': 50}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 4, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypercapnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary alveolar haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abscess intestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Appendicitis perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Clostridial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Clostridium difficile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hydrocele male infected', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pnuemonia mycoplasmal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Post procedural infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrial fibrilation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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{'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Peripheral artery aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Brain injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cervical radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diabetic neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vascular encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal tubular acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ureteric obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cachexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypovalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Type II diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Mental status change', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Alcohol withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 607, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Morning Pre-dose Trough FEV1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '542', 'groupId': 'OG000'}, {'value': '540', 'groupId': 'OG001'}, {'value': '501', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BFF MDI 320/9.6 ug', 'description': 'Budesonide Formoterol Fumarate Metered dose inhalation 320/9.6 ug'}, {'id': 'OG001', 'title': 'BFF MDI 160/9.6 ug', 'description': 'Budesonide Formoterol Fumarate Metered dose inhalation 160/9.6 ug'}, {'id': 'OG002', 'title': 'FF MDI 9.6 ug', 'description': 'Formoterol Fumarate Metered dose inhalation 9.6 ug'}], 'classes': [{'categories': [{'measurements': [{'value': '0.072', 'groupId': 'OG000', 'lowerLimit': '0.053', 'upperLimit': '0.090'}, {'value': '0.069', 'groupId': 'OG001', 'lowerLimit': '0.051', 'upperLimit': '0.087'}, {'value': '0.037', 'groupId': 'OG002', 'lowerLimit': '0.018', 'upperLimit': '0.056'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'at Week 12', 'description': 'Morning pre-dose trough FEV1 (Forced Expiratory Volume in one second) at week 12', 'unitOfMeasure': 'Liter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population Only subjects who had morning pre-dose trough FEV1 measured at the week 12 visit are included in the "at Week 12" timepoint'}, {'type': 'SECONDARY', 'title': 'Time to First Moderate or Severe COPD Exacerbation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '619', 'groupId': 'OG000'}, {'value': '617', 'groupId': 'OG001'}, {'value': '607', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BFF MDI 320/9.6 ug', 'description': 'Budesonide Formoterol Fumarate Metered dose inhalation 320/9.6 ug'}, {'id': 'OG001', 'title': 'BFF MDI 160/9.6 ug', 'description': 'Budesonide Formoterol Fumarate Metered dose inhalation 160/9.6 ug'}, {'id': 'OG002', 'title': 'FF MDI 9.6 ug', 'description': 'Formoterol Fumarate Metered dose inhalation 9.6 ug'}], 'classes': [{'title': 'Percent of Subjects Exacerbated within 12 Weeks', 'categories': [{'measurements': [{'value': '19.2', 'groupId': 'OG000', 'lowerLimit': '16.2', 'upperLimit': '22.6'}, {'value': '19.3', 'groupId': 'OG001', 'lowerLimit': '16.3', 'upperLimit': '22.7'}, {'value': '24.8', 'groupId': 'OG002', 'lowerLimit': '21.5', 'upperLimit': '28.6'}]}]}, {'title': 'Percent of Subjects Exacerbated within 24 Weeks', 'categories': [{'measurements': [{'value': '31.2', 'groupId': 'OG000', 'lowerLimit': '27.5', 'upperLimit': '35.4'}, {'value': '32.9', 'groupId': 'OG001', 'lowerLimit': '29.1', 'upperLimit': '37.1'}, {'value': '35.1', 'groupId': 'OG002', 'lowerLimit': '31.3', 'upperLimit': '39.4'}]}]}, {'title': 'Percent of Subjects Exacerbated within 36 Weeks', 'categories': [{'measurements': [{'value': '41.0', 'groupId': 'OG000', 'lowerLimit': '36.5', 'upperLimit': '45.9'}, {'value': '41.3', 'groupId': 'OG001', 'lowerLimit': '36.9', 'upperLimit': '46.0'}, {'value': '46.2', 'groupId': 'OG002', 'lowerLimit': '41.5', 'upperLimit': '51.2'}]}]}, {'title': 'Percent of Subjects Exacerbated within 52 Weeks', 'categories': [{'measurements': [{'value': '50.1', 'groupId': 'OG000', 'lowerLimit': '44.4', 'upperLimit': '56.0'}, {'value': '48.6', 'groupId': 'OG001', 'lowerLimit': '43.1', 'upperLimit': '54.4'}, {'value': '54.8', 'groupId': 'OG002', 'lowerLimit': '49.0', 'upperLimit': '60.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'over 52 weeks', 'description': 'Time to first moderate or severe COPD (Chronic Obstructive Pulmonary Disease) exacerbation over 52 weeks', 'unitOfMeasure': 'Percentage of Subjects with Exacerbation', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Average Daily Rescue Ventolin HFA Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '612', 'groupId': 'OG000'}, {'value': '610', 'groupId': 'OG001'}, {'value': '599', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BFF MDI 320/9.6 ug', 'description': 'Budesonide Formoterol Fumarate Metered dose inhalation 320/9.6 ug'}, {'id': 'OG001', 'title': 'BFF MDI 160/9.6 ug', 'description': 'Budesonide Formoterol Fumarate Metered dose inhalation 160/9.6 ug'}, {'id': 'OG002', 'title': 'FF MDI 9.6 ug', 'description': 'Formoterol Fumarate Metered dose inhalation 9.6 ug'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.9', 'groupId': 'OG000', 'lowerLimit': '-1.1', 'upperLimit': '-0.7'}, {'value': '-0.9', 'groupId': 'OG001', 'lowerLimit': '-1.1', 'upperLimit': '-0.7'}, {'value': '-0.6', 'groupId': 'OG002', 'lowerLimit': '-0.8', 'upperLimit': '-0.4'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'over 12 weeks', 'description': 'Change from baseline in average daily rescue Ventolin HFA use over 12 weeks', 'unitOfMeasure': 'Puffs per day', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population Only subjects who had rescue Ventolin HFA doses recorded over the 12 week period are included in the "over 12 Weeks" timepoint'}, {'type': 'SECONDARY', 'title': "Percentage of Subjects Achieving an MCID (Minimal Clinically Important Difference) of 4 Units or More in Saint George's Respiratory Questionnaire (SGRQ) Total Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '619', 'groupId': 'OG000'}, {'value': '617', 'groupId': 'OG001'}, {'value': '607', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BFF MDI 320/9.6 ug', 'description': 'Budesonide Formoterol Fumarate Metered dose inhalation 320/9.6 ug'}, {'id': 'OG001', 'title': 'BFF MDI 160/9.6 ug', 'description': 'Budesonide Formoterol Fumarate Metered dose inhalation 160/9.6 ug'}, {'id': 'OG002', 'title': 'FF MDI 9.6 ug', 'description': 'Formoterol Fumarate Metered dose inhalation 9.6 ug'}], 'classes': [{'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at Week 12', '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 on health-related quality of life as compared to FF MDI 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. A decrease from baseline in SGRQ total score of 4 units or more is considered a clinically meaningful improvement in quality of life.", 'unitOfMeasure': 'Percentage of Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BFF MDI 320/9.6 ug', 'description': 'Budesonide Formoterol Fumarate Metered dose inhalation 320/9.6 ug'}, {'id': 'FG001', 'title': 'BFF MDI 160/9.6 ug', 'description': 'Budesonide Formoterol Fumarate Metered dose inhalation 160/9.6 ug'}, {'id': 'FG002', 'title': 'FF MDI 9.6 ug', 'description': 'Formoterol Fumarate Metered dose inhalation 9.6 ug'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'mITT Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '619'}, {'groupId': 'FG001', 'numSubjects': '617'}, {'groupId': 'FG002', 'numSubjects': '607'}]}, {'type': 'COMPLETED', 'comment': 'Completed Study Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '503'}, {'groupId': 'FG001', 'numSubjects': '501'}, {'groupId': 'FG002', 'numSubjects': '442'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '116'}, {'groupId': 'FG001', 'numSubjects': '116'}, {'groupId': 'FG002', 'numSubjects': '165'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '70'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '32'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '30'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Protocol Specified Disc. Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Administrative Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'This study screened subjects at 292 study centers in 18 countries and randomized subjects at 259 study centers, from April 2016 to April 2018.', 'preAssignmentDetails': 'Subjects were randomized in a 1:1:1 ratio to BFF MDI 320/9.6 μg, BFF MDI 160/9.6 μg, and FF MDI 9.6 μg treatment groups'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '629', 'groupId': 'BG000'}, {'value': '630', 'groupId': 'BG001'}, {'value': '617', 'groupId': 'BG002'}, {'value': '1876', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'BFF MDI 320/9.6 ug', 'description': 'Budesonide Formoterol Fumarate Metered dose inhalation 320/9.6 ug'}, {'id': 'BG001', 'title': 'BFF MDI 160/9.6 ug', 'description': 'Budesonide Formoterol Fumarate Metered dose inhalation 160/9.6 ug'}, {'id': 'BG002', 'title': 'FF MDI 9.6 ug', 'description': 'Formoterol Fumarate Metered dose inhalation 9.6 ug'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '619', 'groupId': 'BG000'}, {'value': '617', 'groupId': 'BG001'}, {'value': '607', 'groupId': 'BG002'}, {'value': '1843', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '65.3', 'spread': '8.1', 'groupId': 'BG000'}, {'value': '64.5', 'spread': '8.4', 'groupId': 'BG001'}, {'value': '64.8', 'spread': '8.5', 'groupId': 'BG002'}, {'value': '64.9', 'spread': '8.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'mITT Population'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '619', 'groupId': 'BG000'}, {'value': '617', 'groupId': 'BG001'}, {'value': '607', 'groupId': 'BG002'}, {'value': '1843', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '252', 'groupId': 'BG000'}, {'value': '272', 'groupId': 'BG001'}, {'value': '268', 'groupId': 'BG002'}, {'value': '792', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '367', 'groupId': 'BG000'}, {'value': '345', 'groupId': 'BG001'}, {'value': '339', 'groupId': 'BG002'}, {'value': '1051', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'mITT Population'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '619', 'groupId': 'BG000'}, {'value': '617', 'groupId': 'BG001'}, {'value': '607', 'groupId': 'BG002'}, {'value': '1843', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '190', 'groupId': 'BG000'}, {'value': '200', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}, {'value': '580', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '423', 'groupId': 'BG000'}, {'value': '414', 'groupId': 'BG001'}, {'value': '412', 'groupId': 'BG002'}, {'value': '1249', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'mITT Population'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '619', 'groupId': 'BG000'}, {'value': '617', 'groupId': 'BG001'}, {'value': '607', 'groupId': 'BG002'}, {'value': '1843', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '81', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '514', 'groupId': 'BG000'}, {'value': '516', 'groupId': 'BG001'}, {'value': '504', 'groupId': 'BG002'}, {'value': '1534', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '147', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'mITT Population'}], 'populationDescription': 'The Intent-To-Treat (ITT) Population is defined as all subjects who were randomized to treatment (presented here). The Modified Intent-To-Treat (mITT) Population, a subset of the ITT Population, is defined as all subjects with post-randomization data obtained prior to d/c from treatment. The mITT Population was used for all efficacy analyses.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-01-08', 'size': 6812900, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-03-26T18:28', 'hasProtocol': True}, {'date': '2018-02-09', 'size': 2227202, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-03-26T18:28', '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': 1876}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-04-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-03', 'studyFirstSubmitDate': '2016-03-30', 'resultsFirstSubmitDate': '2019-05-22', 'studyFirstSubmitQcDate': '2016-03-30', 'lastUpdatePostDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-03', 'studyFirstPostDateStruct': {'date': '2016-04-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morning Pre-dose Trough FEV1', 'timeFrame': 'at Week 12', 'description': 'Morning pre-dose trough FEV1 (Forced Expiratory Volume in one second) at week 12'}], 'secondaryOutcomes': [{'measure': 'Time to First Moderate or Severe COPD Exacerbation', 'timeFrame': 'over 52 weeks', 'description': 'Time to first moderate or severe COPD (Chronic Obstructive Pulmonary Disease) exacerbation over 52 weeks'}, {'measure': 'Change From Baseline in Average Daily Rescue Ventolin HFA Use', 'timeFrame': 'over 12 weeks', 'description': 'Change from baseline in average daily rescue Ventolin HFA use over 12 weeks'}, {'measure': "Percentage of Subjects Achieving an MCID (Minimal Clinically Important Difference) of 4 Units or More in Saint George's Respiratory Questionnaire (SGRQ) Total Score", 'timeFrame': 'at Week 12', '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 on health-related quality of life as compared to FF MDI 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. A decrease from baseline in SGRQ total score of 4 units or more is considered a clinically meaningful improvement in quality of life."}]}, '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.'}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4138&filename=PT009003_Protocol_Redacted_PDFA.pdf', 'label': 'Related Info'}, {'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4138&filename=PT009003_SAP_Redacted_PDFA.pdf', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD exacerbation and lung function study with PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6 μg, all administered BID.', 'detailedDescription': 'This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD exacerbation and lung function study. Subjects will undergo a 1- to 4-week Screening Period. Subjects who successfully complete the Screening Period will be randomized to one of the following three treatment groups: PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6 μg, all administered BID. Following randomization, subjects will enter the Treatment Period and undergo additional treatment visits over 52 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. At least 40 years of age and no older than 80 years of age\n3. COPD patients who are symptomatic\n4. Must be receiving one or more inhaled bronchodilators as maintenance therapy\n5. Must have a documented history of COPD exacerbations\n\nExclusion Criteria:\n\n1. Current diagnosis of asthma\n2. COPD due to α1-Antitrypsin Deficiency\n3. Known active tuberculosis, lung cancer, cystic fibrosis, and significant bronchiectasis, Pulmonary resection or Lung Volume Reduction Surgery during the past 6 months.\n4. Long-term-oxygen therapy (≥ 15 hours a day).'}, 'identificationModule': {'nctId': 'NCT02727660', 'briefTitle': 'A Study to Assess the Efficacy and Safety of PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week Period in Subjects With Moderate to Very Severe COPD (Sophos)', '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 on COPD Exacerbations Over a 52-Week Treatment Period in Subjects With Moderate to Very Severe COPD', 'orgStudyIdInfo': {'id': 'PT009003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BFF MDI (PT009) 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 (PT009) 320/9.6 μg']}, {'type': 'EXPERIMENTAL', 'label': 'BFF MDI (PT009) 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 (PT009) 160/9.6 μg']}, {'type': 'EXPERIMENTAL', 'label': 'FF MDI (PT005) 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 (PT005) 9.6 μg']}], 'interventions': [{'name': 'BFF MDI (PT009) 320/9.6 μg', 'type': 'DRUG', 'otherNames': ['Budesonide and Formoterol Fumarate Inhalation Aerosol'], 'description': 'Blinded Treatment', 'armGroupLabels': ['BFF MDI (PT009) 320/9.6 μg']}, {'name': 'BFF MDI (PT009) 160/9.6 μg', 'type': 'DRUG', 'otherNames': ['Budesonide and Formoterol Fumarate Inhalation Aerosol'], 'description': 'Blinded Treatment', 'armGroupLabels': ['BFF MDI (PT009) 160/9.6 μg']}, {'name': 'FF MDI (PT005) 9.6 μg', 'type': 'DRUG', 'otherNames': ['Formoterol Fumarate Inhalation'], 'description': 'Blinded Treatment', 'armGroupLabels': ['FF MDI (PT005) 9.6 μg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36305', 'city': 'Dothan', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 31.22323, 'lon': -85.39049}}, {'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '35660', 'city': 'Sheffield', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.76509, 'lon': -87.69864}}, {'zip': '86001', 'city': 'Flagstaff', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.19807, 'lon': -111.65127}}, {'zip': '92627', 'city': 'Costa Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.64113, 'lon': -117.91867}}, {'zip': '95670', 'city': 'Gold River', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.62629, 'lon': -121.24662}}, {'zip': '95648', 'city': 'Lincoln', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.89156, 'lon': -121.29301}}, {'zip': '90822', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92117', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92120', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '91786', 'city': 'Upland', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.09751, 'lon': -117.64839}}, {'zip': '92886', 'city': 'Yorba Linda', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.88863, 'lon': -117.81311}}, {'zip': '80301', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}, {'zip': '80246', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06716', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33472', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '32626', 'city': 'Chiefland', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.47496, 'lon': -82.85984}}, {'zip': '33765', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '32117', 'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}, {'zip': '33012', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '34741', 'city': 'Kissimmee', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 28.30468, 'lon': -81.41667}}, {'zip': '34748', 'city': 'Leesburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 28.81082, 'lon': -81.87786}}, {'zip': '33971', 'city': 'Lehigh Acres', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 26.62535, 'lon': -81.6248}}, {'zip': '32952', 'city': 'Merritt Island', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 28.359, 'lon': -80.69}}, {'zip': '33126', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33145', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': 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