Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2025-12-25 @ 4:49 PM
Study NCT ID:
NCT01313650
Status:
COMPLETED
Last Update Posted:
2018-08-06
First Post:
2011-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A 24-week Evaluation of GSK573719/Vilanterol (62.5/25mcg) and Components in 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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of treatment (up to 24 weeks).', 'description': 'SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all participants who had received at least one dose of randomized study medication during treatment period.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received matching placebo QD via a DPI in the morning for 24 weeks.', 'otherNumAtRisk': 280, 'otherNumAffected': 62, 'seriousNumAtRisk': 280, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'UMEC 62.5 µg QD', 'description': 'Participants received UMEC 62.5 µg QD via a DPI in the morning for 24 weeks.', 'otherNumAtRisk': 418, 'otherNumAffected': 96, 'seriousNumAtRisk': 418, 'seriousNumAffected': 27}, {'id': 'EG002', 'title': 'VI 25 µg QD', 'description': 'Participants received VI 25 µg QD via a DPI for 24 weeks.', 'otherNumAtRisk': 421, 'otherNumAffected': 87, 'seriousNumAtRisk': 421, 'seriousNumAffected': 24}, {'id': 'EG003', 'title': 'UMEC/VI 62.5/25 µg QD', 'description': 'Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 24 weeks.', 'otherNumAtRisk': 413, 'otherNumAffected': 93, 'seriousNumAtRisk': 413, 'seriousNumAffected': 21}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 39}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 35}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypoventilation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Infective exacerbation of chronic obstructive airway disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lung infection pseudomonal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Appendix disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastric haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastric ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Irritable bowel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lower gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Alcohol poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Forearm fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Encephalitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Colon adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Endometrial cancer stage III', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 413, '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': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cholecystitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Biliary colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lymph node pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Menometrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Troponin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fracture nonunion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Alcohol abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 418, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 421, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 413, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '317', 'groupId': 'OG002'}, {'value': '330', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo QD via a DPI in the morning for 24 weeks.'}, {'id': 'OG001', 'title': 'UMEC 62.5 µg QD', 'description': 'Participants received UMEC 62.5 µg QD via a DPI in the morning for 24 weeks.'}, {'id': 'OG002', 'title': 'VI 25 µg QD', 'description': 'Participants received VI 25 µg QD via a DPI for 24 weeks.'}, {'id': 'OG003', 'title': 'UMEC/VI 62.5/25 µg QD', 'description': 'Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.004', 'spread': '0.0158', 'groupId': 'OG000'}, {'value': '0.119', 'spread': '0.0126', 'groupId': 'OG001'}, {'value': '0.076', 'spread': '0.0127', 'groupId': 'OG002'}, {'value': '0.171', 'spread': '0.0126', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.115', 'ciLowerLimit': '0.076', 'ciUpperLimit': '0.155', 'estimateComment': 'Least squares mean difference=UMEC 62.5 µg minus Placebo.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.072', 'ciLowerLimit': '0.032', 'ciUpperLimit': '0.112', 'estimateComment': 'Least squares mean difference=VI 25 µg minus Placebo.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.167', 'ciLowerLimit': '0.128', 'ciUpperLimit': '0.207', 'estimateComment': 'Least squares mean difference=UMEC/VI 62.5/25 µg minus Placebo.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).'}, {'pValue': '0.004', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.052', 'ciLowerLimit': '0.017', 'ciUpperLimit': '0.087', 'estimateComment': 'Least squares mean difference=UMEC/VI 62.5/25 minus UMEC 62.5 µg.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.095', 'ciLowerLimit': '0.060', 'ciUpperLimit': '0.130', 'estimateComment': 'Least squares mean difference=UMEC/VI 62.5/25 minus VI 25 µg.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 169', 'description': "FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84, 112, 168, and 169. Baseline is defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after the previous morning's dosing (ie., trough FEV1 on Day 169 is the mean of the FEV1 values obtained 23 and 24 hours after the morning dosing on Day 168). Change from Baseline at a particular visit was calculated as the trough FEV1 at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline , smoking status, center group, day, and day by Baseline and day by treatment interactions. ITT=Intent-to-Treat; par.=participants.", 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Mean Transition Dyspnea Index (TDI) Focal Score at Day 168 (Week 24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}, {'value': '317', 'groupId': 'OG002'}, {'value': '336', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo QD via a DPI in the morning for 24 weeks.'}, {'id': 'OG001', 'title': 'UMEC 62.5 µg QD', 'description': 'Participants received UMEC 62.5 µg QD via a DPI in the morning for 24 weeks.'}, {'id': 'OG002', 'title': 'VI 25 µg QD', 'description': 'Participants received VI 25 µg QD via a DPI for 24 weeks.'}, {'id': 'OG003', 'title': 'UMEC/VI 62.5/25 µg QD', 'description': 'Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '0.16', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '0.16', 'groupId': 'OG002'}, {'value': '2.4', 'spread': '0.16', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 168 (Week 24)', 'description': "Considered an 'other' endpoint by the FDA. The TDI is an interviewer-administered instrument which measures the changes in the participant's dyspnea from Baseline. This questionnaire was collected on Days 28, 84 and 168. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9. Analysis was performed using a repeated measures model with covariates of treatment, Baseline dyspnea index (BDI) focal score,smoking status, center group, day, day by BDI focal score and day by treatment interactions.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Weighted Mean (WM) 0-6 Hour FEV1 Obtained Post-dose at Day 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '319', 'groupId': 'OG001'}, {'value': '311', 'groupId': 'OG002'}, {'value': '333', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo QD via a DPI in the morning for 24 weeks.'}, {'id': 'OG001', 'title': 'UMEC 62.5 µg QD', 'description': 'Participants received UMEC 62.5 µg QD via a DPI in the morning for 24 weeks.'}, {'id': 'OG002', 'title': 'VI 25 µg QD', 'description': 'Participants received VI 25 µg QD via a DPI for 24 weeks.'}, {'id': 'OG003', 'title': 'UMEC/VI 62.5/25 µg QD', 'description': 'Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.001', 'spread': '0.0158', 'groupId': 'OG000'}, {'value': '0.151', 'spread': '0.0128', 'groupId': 'OG001'}, {'value': '0.123', 'spread': '0.0128', 'groupId': 'OG002'}, {'value': '0.243', 'spread': '0.0127', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 168', 'description': 'FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM was calculated at Days 1, 28, 84, and 168 using the 0-6-hour post-dose FEV1 measurements collected on that day, which included pre-dose (Day 1: 30 minutes \\[min\\] and 5 min prior to dosing; other serial visits: 23 and 24 hours after the previous morning dose) and post-dose at 15 min, 30 min, 1 hour, 3 hours, and 6 hours. Change from Baseline at a particular visit was calculated as the WM at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessments made 30 min and 5 min pre-dose on Day 1), smoking status, center group, day, and day by Baseline and day by treatment interactions.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in the Mean Shortness of Breath With Daily Activities (SOBDA) Score for Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}, {'value': '230', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo QD via a DPI in the morning for 24 weeks.'}, {'id': 'OG001', 'title': 'UMEC 62.5 µg QD', 'description': 'Participants received UMEC 62.5 µg QD via a DPI in the morning for 24 weeks.'}, {'id': 'OG002', 'title': 'VI 25 µg QD', 'description': 'Participants received VI 25 µg QD via a DPI for 24 weeks.'}, {'id': 'OG003', 'title': 'UMEC/VI 62.5/25 µg QD', 'description': 'Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.037', 'groupId': 'OG000'}, {'value': '-0.16', 'spread': '0.029', 'groupId': 'OG001'}, {'value': '-0.21', 'spread': '0.030', 'groupId': 'OG002'}, {'value': '-0.23', 'spread': '0.029', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': "The newly developed SOBDA questionnaire assesses dyspnea or shortness of breath (SOB) with daily activities. The SOBDA questionnaire is made up of 13 items completed by the participant (par.) each evening prior to bedtime, when the par. is instructed to reflect on the current day's activities. The daily score is computed as the mean of the scores on the 13 items (\\>=7 items must have non-missing responses for this to be calculated). The par. is assigned a weekly mean SOBDA score ranging from 1 to 4 (greater scores indicate more severe breathlessness with daily activities) based on the mean of 7 days of data (\\>=4 of 7 days must be completed for a weekly mean to be calculated). Change from BL is the mean weekly SOBDA score minus BL. Analysis was performed using MMRM with covariates of treatment, BL (mean score in the week prior to treatment), smoking status, center group, week, week by BL and week by treatment interactions. This MMRM analysis only included Weeks 4, 8, 12, and 24.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.'}, {'id': 'FG001', 'title': 'UMEC 62.5 µg QD', 'description': 'Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg) QD via a DPI in the morning for 24 weeks.'}, {'id': 'FG002', 'title': 'VI 25 µg QD', 'description': 'Participants received vilanterol (VI) 25 µg QD via a DPI for 24 weeks.'}, {'id': 'FG003', 'title': 'UMEC/VI 62.5/25 µg QD', 'description': 'Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 24 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '280'}, {'groupId': 'FG001', 'numSubjects': '418'}, {'groupId': 'FG002', 'numSubjects': '421'}, {'groupId': 'FG003', 'numSubjects': '413'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '204'}, {'groupId': 'FG001', 'numSubjects': '324'}, {'groupId': 'FG002', 'numSubjects': '318'}, {'groupId': 'FG003', 'numSubjects': '332'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '94'}, {'groupId': 'FG002', 'numSubjects': '103'}, {'groupId': 'FG003', 'numSubjects': '81'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '23'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '32'}, {'groupId': 'FG003', 'numSubjects': '20'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '15'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Met Protocol-defined Stopping Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '15'}]}]}], 'preAssignmentDetails': 'Participants (par.) who met eligibility criteria at Screening (Visit 1) completed a 7 to 10-day run-in period and were then randomized to a 24-week treatment (trt.) period. A total of 2210 participants were screened; 1536 participants were randomized and 1532 participants took at least one dose of randomized medication.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'BG000'}, {'value': '418', 'groupId': 'BG001'}, {'value': '421', 'groupId': 'BG002'}, {'value': '413', 'groupId': 'BG003'}, {'value': '1532', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received matching placebo QD via a DPI in the morning for 24 weeks.'}, {'id': 'BG001', 'title': 'UMEC 62.5 µg QD', 'description': 'Participants received UMEC 62.5 µg QD via a DPI in the morning for 24 weeks.'}, {'id': 'BG002', 'title': 'VI 25 µg QD', 'description': 'Participants received VI 25 µg QD via a DPI for 24 weeks.'}, {'id': 'BG003', 'title': 'UMEC/VI 62.5/25 µg QD', 'description': 'Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 24 weeks.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.2', 'spread': '9.04', 'groupId': 'BG000'}, {'value': '64.0', 'spread': '9.16', 'groupId': 'BG001'}, {'value': '62.7', 'spread': '8.52', 'groupId': 'BG002'}, {'value': '63.1', 'spread': '8.71', 'groupId': 'BG003'}, {'value': '63.1', 'spread': '8.86', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}, {'value': '108', 'groupId': 'BG003'}, {'value': '449', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '195', 'groupId': 'BG000'}, {'value': '298', 'groupId': 'BG001'}, {'value': '285', 'groupId': 'BG002'}, {'value': '305', 'groupId': 'BG003'}, {'value': '1083', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African American/African Heritage', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '47', 'groupId': 'BG004'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}]}, {'title': 'Asian - Central/South Asian Heritage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}, {'title': 'Asian - East Asian Heritage', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}, {'title': 'Asian - Japanese Heritage', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}]}, {'title': 'Asian - South East Asian Heritage', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '50', 'groupId': 'BG004'}]}]}, {'title': 'Native Hawaiian or other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'White - White/Caucasian/European Heritage', 'categories': [{'measurements': [{'value': '237', 'groupId': 'BG000'}, {'value': '354', 'groupId': 'BG001'}, {'value': '363', 'groupId': 'BG002'}, {'value': '348', 'groupId': 'BG003'}, {'value': '1302', 'groupId': 'BG004'}]}]}, {'title': 'White - Mixed Race', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'Mixed Race', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, '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': 1538}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2012-04-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-02', 'studyFirstSubmitDate': '2011-03-10', 'resultsFirstSubmitDate': '2014-01-16', 'studyFirstSubmitQcDate': '2011-03-10', 'lastUpdatePostDateStruct': {'date': '2018-08-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-01-16', 'studyFirstPostDateStruct': {'date': '2011-03-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change From Baseline in the Mean Shortness of Breath With Daily Activities (SOBDA) Score for Week 24', 'timeFrame': 'Baseline and Week 24', 'description': "The newly developed SOBDA questionnaire assesses dyspnea or shortness of breath (SOB) with daily activities. The SOBDA questionnaire is made up of 13 items completed by the participant (par.) each evening prior to bedtime, when the par. is instructed to reflect on the current day's activities. The daily score is computed as the mean of the scores on the 13 items (\\>=7 items must have non-missing responses for this to be calculated). The par. is assigned a weekly mean SOBDA score ranging from 1 to 4 (greater scores indicate more severe breathlessness with daily activities) based on the mean of 7 days of data (\\>=4 of 7 days must be completed for a weekly mean to be calculated). Change from BL is the mean weekly SOBDA score minus BL. Analysis was performed using MMRM with covariates of treatment, BL (mean score in the week prior to treatment), smoking status, center group, week, week by BL and week by treatment interactions. This MMRM analysis only included Weeks 4, 8, 12, and 24."}], 'primaryOutcomes': [{'measure': 'Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24)', 'timeFrame': 'Baseline and Day 169', 'description': "FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84, 112, 168, and 169. Baseline is defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after the previous morning's dosing (ie., trough FEV1 on Day 169 is the mean of the FEV1 values obtained 23 and 24 hours after the morning dosing on Day 168). Change from Baseline at a particular visit was calculated as the trough FEV1 at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline , smoking status, center group, day, and day by Baseline and day by treatment interactions. ITT=Intent-to-Treat; par.=participants."}], 'secondaryOutcomes': [{'measure': 'Mean Transition Dyspnea Index (TDI) Focal Score at Day 168 (Week 24)', 'timeFrame': 'Day 168 (Week 24)', 'description': "Considered an 'other' endpoint by the FDA. The TDI is an interviewer-administered instrument which measures the changes in the participant's dyspnea from Baseline. This questionnaire was collected on Days 28, 84 and 168. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9. Analysis was performed using a repeated measures model with covariates of treatment, Baseline dyspnea index (BDI) focal score,smoking status, center group, day, day by BDI focal score and day by treatment interactions."}, {'measure': 'Change From Baseline in Weighted Mean (WM) 0-6 Hour FEV1 Obtained Post-dose at Day 168', 'timeFrame': 'Baseline and Day 168', 'description': 'FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM was calculated at Days 1, 28, 84, and 168 using the 0-6-hour post-dose FEV1 measurements collected on that day, which included pre-dose (Day 1: 30 minutes \\[min\\] and 5 min prior to dosing; other serial visits: 23 and 24 hours after the previous morning dose) and post-dose at 15 min, 30 min, 1 hour, 3 hours, and 6 hours. Change from Baseline at a particular visit was calculated as the WM at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessments made 30 min and 5 min pre-dose on Day 1), smoking status, center group, day, and day by Baseline and day by treatment interactions.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['long-acting beta agonist', 'anticholinergic'], 'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'referencesModule': {'availIpds': [{'id': '113373', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '113373', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '113373', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '113373', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Annotated Case Report Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '113373', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '113373', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '113373', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'references': [{'pmid': '23830094', 'type': 'DERIVED', 'citation': 'Donohue JF, Maleki-Yazdi MR, Kilbride S, Mehta R, Kalberg C, Church A. Efficacy and safety of once-daily umeclidinium/vilanterol 62.5/25 mcg in COPD. Respir Med. 2013 Oct;107(10):1538-46. doi: 10.1016/j.rmed.2013.06.001. Epub 2013 Jul 2.'}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': 'This is a phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of GSK573719/GW642444 Inhalation Powder, GSK573719 Inhalation Powder, GW642444 Inhalation Powder and Placebo when administered once-daily via a Novel Dry Powder Inhaler over a 24-week treatment period in subjects with COPD. Subjects who meet eligibility criteria at Screening (Visit 1) will complete a 7 to14 day run-in period followed by a randomization visit (Visit 2) then a 24-week treatment period. There will be a total of 9 clinic study visits. A follow-up phone contact for adverse event assessment will be conducted approximately one week after the last study visit (Visit 9 or Early Withdrawal). The total duration of subject participation in the study will be approximately 27 weeks. A subset of subjects at selected sites will also perform 24-hour serial spirometry and Holter monitoring during the study and provide serial blood samples for pharmacokinetic analysis. Sparse pharmacokinetic sampling for population pharmacokinetic analyses will be obtained from non-subset subjects. The primary measure of efficacy is clinic visit trough (pre-bronchodilator and pre-dose) FEV1 on Treatment Day 169. Safety will be assessed by adverse events, 12-lead ECGs, vital signs, clinical laboratory tests, and 24 hour Holter monitoring (subset only).', 'detailedDescription': 'This is a 24-week, phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group study.\n\nEligible subjects will be randomized to GSK573719/GW642444 125/25mcg, GSK573719 125mcg, GW642444 25mcg, and placebo treatment groups in a 3:3:3:2 ratio such that of the planned 1463 total number of randomized subjects approximately 399 subjects will be randomized to each active treatment group and 266 subjects will be randomized to placebo. All treatments will be administered once-daily in the morning by inhalation using a Novel Dry Powder Inhaler (Novel DPI).\n\nThere will be a total of 9 study clinic visits conducted on an outpatient basis. Subjects who meet the eligibility criteria at Screening (Visit 1) will complete a 7 to 14 day run-in period followed by a 24-week treatment period. Clinic visits will be at Screening, Randomization (Day 1), Day 2, after 4, 8, 12, 16, and 24-weeks of treatment, and 1 day after the Week 24 Visit (also referred as Treatment Day 169). A follow-up contact for adverse assessment will be conducted by telephone approximately 7 days after Visit 9 or the Early Withdrawal Visit. The total duration of subject participation, including follow-up will be approximately 27 weeks. All subjects will be provided with albuterol/salbutamol for use on an "as-needed" basis throughout the run-in and study treatment periods.\n\nAt screening, pre-bronchodilator spirometry testing will be followed by post-albuterol/salbutamol spirometry testing. Post-albuterol/salbutamol FEV1 and FEV1/FVC values will be used to determine subject eligibility. To further characterize bronchodilator responsiveness, post-ipratropium testing will be conducted following completion of post-albuterol/salbutamol spirometry.\n\nSpirometry will be conducted at each post-randomization clinic visit. Six hour post-dose serial spirometry will be conducted at Visits 2, 4, 6, and 8. Trough spirometry will be obtained 23 and 24 hours after the previous day\'s dose of blinded study medication at Visits 3 to 9. All subjects will be provided with an electronic diary (eDiary) for completion daily in the evening throughout the run-in and treatment periods. Subjects will use the eDiary to record dyspnea scores using the Shortness of Breath with Daily Activities instrument (SOBDA), daily use of supplemental albuterol/salbutamol as either puffs/day from a metered-dose inhaler (MDI) and/or nebules used per day, and any healthcare contacts related to COPD.\n\nAdditional assessments of dyspnea will be obtained using the Baseline and Transition Dyspnea Index (BDI/TDI) which is an interviewer based instrument. At Visit 2, the severity of dyspnea at baseline will be assessed using the BDI. At subsequent visits (Visits 4, 6, and 8) change from baseline will be assessed using the TDI. Disease specific health status will be evaluated using the subject-completed St. George\'s Respiratory Questionnaire (SGRQ). The SGRQ will be completed at Visits 2, 4, 6, and 8. Administration of the SGRQ and BDI/TDI should be done prior to spirometry testing.\n\nThe occurrence of adverse events will be evaluated throughout the study beginning at Visit 2. SAEs will be collected over the same time period as for AEs. However, any SAEs assessed as related to study participation (e.g., study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy) or related to a GSK concomitant medication, will be recorded from the time a subject consents to participate in the study up to and including any follow up contact.\n\nAdditional safety assessments of vital signs (blood pressure and pulse rate), 12-lead ECGs and standard clinical laboratory tests (hematology and chemistry) will be obtained at selected clinic visits. Blood samples for population pharmacokinetic analyses will be obtained.\n\nAt selected study sites, a subset of approximately 198 subjects will perform 24-hour serial spirometry during the study for evaluation of lung function over the dosing period. In conjunction with the serial spirometry, this subset of subjects will also perform 24 hour Holter monitoring and provide blood samples for PK analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of COPD\n* 10 pack-year or greater history of cigarette smoking\n* Post-bronchodilator FEV1/FVC of \\<0.7\n* Predicted FEV1 of 70% of normal or less\n* Modified Medical Research Council (mMRC) dyspnea score of 2 or greater\n\nExclusion Criteria:\n\n* Women who are pregnant, lactating, or planning to become pregnant\n* Respiratory disorders other than COPD, including a current diagnosis of asthma\n* Clinically significant non-respiratory diseases or abnormalities that are not adequate controlled\n* Significant allergy or hypersensitivity to anticholinergics, beta-agonist, or the excipients of magnesium stereate or lactose used in the inhaler delivery device\n* Hospitalization for COPD or pneumonia within 12 weeks prior to screening\n* Lung volume reduction surgery within 12 weeks prior to screening\n* Abnormal and clinically significant ECG findings at screening\n* Clinically significant laboratory findings at screening\n* Use of systemic corticosteroids, antibiotics for respiratory tract infections, strong cytochrome P450 3A4 inhibitors, high dose inhaled steroids (\\>1000mcg fluticasone propionate or equivalent), PDE4 inhibitors, tiotropium, oral beta2-agoinists, short- and long-acting inhaled beta2-agonists, ipratropium, inhaled sodium cromoglycate or nedocromil sodium, or investigational medicines for defined time periods prior to the screening visit\n* Use of long-term oxygen therapy (12 hours or greater per day)\n* Regular use of nebulized treatment with short-acting bronchodilators\n* Participation in the acute phase of a pulmonary rehabilitation program\n* A know or suspected history of alcohol or drug abuse\n* Affiliation with the investigational site\n* Previous use of GSK573719 or GW642444 alone or in combination, including the combination of fluticasone furoate and GW64244'}, 'identificationModule': {'nctId': 'NCT01313650', 'acronym': 'DB2113373', 'briefTitle': 'A 24-week Evaluation of GSK573719/Vilanterol (62.5/25mcg) and Components in COPD', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A 24-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GSK573719/GW642444 Inhalation Powder and the Individual Components Delivered Once-Daily Via a Novel Dry Powder Inhaler in Subjects With Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': '113373'}, 'secondaryIdInfos': [{'id': '2010-023349-32', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GSK573719/GW642444', 'description': '62.5/25mcg', 'interventionNames': ['Drug: 62.5/25mcg']}, {'type': 'EXPERIMENTAL', 'label': 'GSK573719', 'description': '62.5mcg', 'interventionNames': ['Drug: 62.5mcg']}, {'type': 'EXPERIMENTAL', 'label': 'GW642444', 'description': '25mcg', 'interventionNames': ['Drug: 25mcg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': '62.5/25mcg', 'type': 'DRUG', 'description': 'GSK573719/GW64244', 'armGroupLabels': ['GSK573719/GW642444']}, {'name': '62.5mcg', 'type': 'DRUG', 'description': 'GSK573719', 'armGroupLabels': ['GSK573719']}, {'name': '25mcg', 'type': 'DRUG', 'description': 'GW642444', 'armGroupLabels': ['GW642444']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85723', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90048', 'city': 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