Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-03-03 @ 3:06 PM
Study NCT ID:
NCT01574651
Status:
COMPLETED
Last Update Posted:
2014-05-22
First Post:
2012-04-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of QVA149 on Health Related Quality of Life in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C554862', 'term': 'indacaterol-glycopyrronium combination'}, {'id': 'D000069447', 'term': 'Tiotropium Bromide'}, {'id': 'D000068759', 'term': 'Formoterol Fumarate'}], 'ancestors': [{'id': 'D012602', 'term': 'Scopolamine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialandresults.registries@novartis.com', 'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharnaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol', 'description': 'QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.', 'otherNumAtRisk': 476, 'otherNumAffected': 72, 'seriousNumAtRisk': 476, 'seriousNumAffected': 30}, {'id': 'EG001', 'title': 'Tiotropium Plus Formoterol and Placebo to QVA149', 'description': 'Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.', 'otherNumAtRisk': 458, 'otherNumAffected': 79, 'seriousNumAtRisk': 458, 'seriousNumAffected': 24}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 53}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 20}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 15}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Congestive cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Cor pulmonale', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Myocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Stress cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Amblyopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Cataract cortical', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Cataract nuclear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Intestinal polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Cardiac death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Cervical vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Chest injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Joint injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Spinal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Cervical spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Osteochondrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Spinal column stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Synovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Oesophageal carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Oropharyngeal cancer stage unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Brain injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Cerebral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Myoclonus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Nystagmus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Inguinal hernia repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Laryngeal fistula repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Mastectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Umbilical hernia repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 476, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 458, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '16.0'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "St. George's Respiratory Questionnaire (SGRQ-C) Total Score After 26 Weeks of Treatment (Non-inferiority Analysis).", 'denoms': [{'units': 'Participants', 'counts': [{'value': '476', 'groupId': 'OG000'}, {'value': '458', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol', 'description': 'QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.'}, {'id': 'OG001', 'title': 'Tiotropium Plus Formoterol and Placebo to QVA149', 'description': 'Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.'}], 'classes': [{'title': 'Baseline (n=452,441)', 'categories': [{'measurements': [{'value': '44.70', 'spread': '17.718', 'groupId': 'OG000'}, {'value': '45.68', 'spread': '17.720', 'groupId': 'OG001'}]}]}, {'title': 'Week 26 (n=475,456)', 'categories': [{'measurements': [{'value': '41.30', 'spread': '19.923', 'groupId': 'OG000'}, {'value': '43.19', 'spread': '19.284', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 26', 'description': 'SGRQ is a health related quality of life questionnaire consisting of 40 items in three areas: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). The total score is 0 to 100 with a higher score indicating poorer health status. For patients who completed the study but with missing SGRQ-C during treatment, the missing SGRQ-C were replaced by the last observation carried forward (LOCF). Symptom scores were expected to improve over treatment, therefore the replacement of missing values with earlier measurements did not result in overoptimistic imputation and this procedure could be regarded as conservative.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated.'}, {'type': 'SECONDARY', 'title': "St. George's Respiratory Questionnaire (SGRQ-C) Total Score After 26 Weeks of Treatment (Superiority Analysis).", 'denoms': [{'units': 'Participants', 'counts': [{'value': '476', 'groupId': 'OG000'}, {'value': '458', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol', 'description': 'QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.'}, {'id': 'OG001', 'title': 'Tiotropium Plus Formoterol and Placebo to QVA149', 'description': 'Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.'}], 'classes': [{'title': 'Baseline (n=452,441)', 'categories': [{'measurements': [{'value': '44.70', 'spread': '17.718', 'groupId': 'OG000'}, {'value': '45.68', 'spread': '17.720', 'groupId': 'OG001'}]}]}, {'title': 'Week 26 (n=475,456)', 'categories': [{'measurements': [{'value': '41.30', 'spread': '19.923', 'groupId': 'OG000'}, {'value': '43.19', 'spread': '19.284', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 26', 'description': "SGRQ is a health related quality of life questionnaire consisting of 40 items in three areas: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). The total score is 0 to 100 with a higher score indicating poorer health status. For patients who completed the study but with missing SGRQ-C during treatment, the missing SGRQ-C were replaced by the last observation carried forward (LOCF). Symptom scores were expected to improve over treatment, therefore the replacement of missing values with earlier measurements did not result in overoptimistic imputation and this procedure could be regarded as conservative. Superiority of QVA 110/50 μg to tiotropium 18 μg q.d. plus formoterol 12 μg b.i.d. in terms of health related quality of life as assessed by St George's Respiratory Questionnaire (SGRQ-C) after 26 weeks of treatment", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated'}, {'type': 'SECONDARY', 'title': 'Transition Dyspnea Index (TDI) Focal Score After 26 Weeks of Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '462', 'groupId': 'OG000'}, {'value': '443', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol', 'description': 'QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.'}, {'id': 'OG001', 'title': 'Tiotropium Plus Formoterol and Placebo to QVA149', 'description': 'Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.34', 'spread': '3.440', 'groupId': 'OG000'}, {'value': '0.87', 'spread': '3.439', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 26', 'description': 'Baseline Dyspnea Index (BDI)/Transition Dyspnea Index (TDI) focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort and captures changes from baseline. BDI was measured at day 1 prior to the first dose with domain scores ranging from 0=very severe to 4=no impairment and a total score ranging from 0 to 12(best). TDI captures changes from baseline. Each domain is scored from -3=major deterioration to 3=major improvement to give an overall TDI focal score of -9 to 9. Higher numbers indicate a better score. missing values were replaced by the latest observed value (LOCF)', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With at Least One Exacerbation Requiring Systemic Corticosteroids and/or Antibiotics Over 26 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '476', 'groupId': 'OG000'}, {'value': '458', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol', 'description': 'QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.'}, {'id': 'OG001', 'title': 'Tiotropium Plus Formoterol and Placebo to QVA149', 'description': 'Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.9', 'groupId': 'OG000'}, {'value': '13.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26', 'description': 'The percent of participants with at least one moderate exacerbation within the 26 weeks that required systemic corticosteroids and/or antibiotics during the treatment', 'unitOfMeasure': 'Percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With at Least One Exacerbation Requiring Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '476', 'groupId': 'OG000'}, {'value': '458', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol', 'description': 'QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.'}, {'id': 'OG001', 'title': 'Tiotropium Plus Formoterol and Placebo to QVA149', 'description': 'Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}, {'value': '2.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26', 'description': 'The percent of patients with at least one severe exacerbation within the 26 weeks that required hospitalization. COPD exacerbations were considered to be severe if hospitalization were required.', 'unitOfMeasure': 'Percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated'}, {'type': 'SECONDARY', 'title': 'Time- Event Analysis, Number of Participants With at Least One COPD Exacerbation (Moderate or Severe) During the Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '476', 'groupId': 'OG000'}, {'value': '458', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol', 'description': 'QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.'}, {'id': 'OG001', 'title': 'Tiotropium Plus Formoterol and Placebo to QVA149', 'description': 'Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.'}], 'classes': [{'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26', 'description': 'The number of participants with at least one moderate or severe COPD exacerbation. COPD exacerbations are considered to be moderate if treatment with systemic corticosteroids and/or antibiotics was required. COPD exacerbations are considered to be severe if hospitalizations were required.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated'}, {'type': 'SECONDARY', 'title': 'Trough FEV1 at Baseline and Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '476', 'groupId': 'OG000'}, {'value': '458', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol', 'description': 'QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.'}, {'id': 'OG001', 'title': 'Tiotropium Plus Formoterol and Placebo to QVA149', 'description': 'Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.329', 'spread': '0.4806', 'groupId': 'OG000'}, {'value': '1.313', 'spread': '0.4525', 'groupId': 'OG001'}]}]}, {'title': 'Week 26', 'categories': [{'measurements': [{'value': '1.495', 'spread': '0.5060', 'groupId': 'OG000'}, {'value': '1.409', 'spread': '0.4878', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'Trough FEV1 is the mean value of FEV1 (forced expiratory volume in one second) measured at 23:15h and 23:45h after the morning doses. The baseline value was measured at day 1 prior to the first dose.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated'}, {'type': 'SECONDARY', 'title': 'FEV1 30 Min After the Morning Dose at Baseline and Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '476', 'groupId': 'OG000'}, {'value': '458', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol', 'description': 'QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.'}, {'id': 'OG001', 'title': 'Tiotropium Plus Formoterol and Placebo to QVA149', 'description': 'Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.'}], 'classes': [{'title': 'Baseline (n=475,458)', 'categories': [{'measurements': [{'value': '1.517', 'spread': '0.5025', 'groupId': 'OG000'}, {'value': '1.495', 'spread': '0.4860', 'groupId': 'OG001'}]}]}, {'title': 'Week 26 (n=476,458)', 'categories': [{'measurements': [{'value': '1.605', 'spread': '0.5356', 'groupId': 'OG000'}, {'value': '1.565', 'spread': '0.5124', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'FEV1 30min is the forced expiratory volume in one second measured 30 min after the morning dose.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated'}, {'type': 'SECONDARY', 'title': 'Symptoms Score Reported by the Patients Using Part I "Symptoms" of SGRO-C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '476', 'groupId': 'OG000'}, {'value': '458', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol', 'description': 'QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.'}, {'id': 'OG001', 'title': 'Tiotropium Plus Formoterol and Placebo to QVA149', 'description': 'Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.'}], 'classes': [{'title': 'Baseline (n=473,457)', 'categories': [{'measurements': [{'value': '64.10', 'spread': '19.884', 'groupId': 'OG000'}, {'value': '64.29', 'spread': '19.768', 'groupId': 'OG001'}]}]}, {'title': 'Week 26 (n=476,458)', 'categories': [{'measurements': [{'value': '58.31', 'spread': '21.764', 'groupId': 'OG000'}, {'value': '60.16', 'spread': '20.678', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'Part I of the SGRQ-C covers "symptoms" and is concerned with respiratory symptoms, their frequency and severity. Each questionnaire response has a unique empirically derived "weight". A score was calculated from these weights. The lowest possible value is zero and the highest 100. A higher value corresponds to greater impairment of health status.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol', 'description': 'QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.'}, {'id': 'FG001', 'title': 'Tiotropium Plus Formoterol and Placebo to QVA149', 'description': 'Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '476'}, {'groupId': 'FG001', 'numSubjects': '458'}]}, {'type': 'Full Analysis Set (FAS)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '476'}, {'groupId': 'FG001', 'numSubjects': '458'}]}, {'type': 'Per Protocol Set (PPS)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '373'}, {'groupId': 'FG001', 'numSubjects': '374'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '415'}, {'groupId': 'FG001', 'numSubjects': '406'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '52'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Administrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': "Patient's inability to use the device", 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'Abnormal laboratory value(s)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Abnormal test procedure result(s)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Unsatisfactory therapeutic effect', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '476', 'groupId': 'BG000'}, {'value': '458', 'groupId': 'BG001'}, {'value': '934', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol', 'description': 'QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.'}, {'id': 'BG001', 'title': 'Tiotropium Plus Formoterol and Placebo to QVA149', 'description': 'Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.6', 'spread': '8.43', 'groupId': 'BG000'}, {'value': '63.1', 'spread': '8.15', 'groupId': 'BG001'}, {'value': '62.9', 'spread': '8.29', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '159', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '319', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '317', 'groupId': 'BG000'}, {'value': '298', 'groupId': 'BG001'}, {'value': '615', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 934}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-19', 'studyFirstSubmitDate': '2012-04-06', 'resultsFirstSubmitDate': '2014-03-27', 'studyFirstSubmitQcDate': '2012-04-06', 'lastUpdatePostDateStruct': {'date': '2014-05-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-03-27', 'studyFirstPostDateStruct': {'date': '2012-04-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "St. George's Respiratory Questionnaire (SGRQ-C) Total Score After 26 Weeks of Treatment (Non-inferiority Analysis).", 'timeFrame': 'Baseline, week 26', 'description': 'SGRQ is a health related quality of life questionnaire consisting of 40 items in three areas: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). The total score is 0 to 100 with a higher score indicating poorer health status. For patients who completed the study but with missing SGRQ-C during treatment, the missing SGRQ-C were replaced by the last observation carried forward (LOCF). Symptom scores were expected to improve over treatment, therefore the replacement of missing values with earlier measurements did not result in overoptimistic imputation and this procedure could be regarded as conservative.'}], 'secondaryOutcomes': [{'measure': "St. George's Respiratory Questionnaire (SGRQ-C) Total Score After 26 Weeks of Treatment (Superiority Analysis).", 'timeFrame': 'Baseline, week 26', 'description': "SGRQ is a health related quality of life questionnaire consisting of 40 items in three areas: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). The total score is 0 to 100 with a higher score indicating poorer health status. For patients who completed the study but with missing SGRQ-C during treatment, the missing SGRQ-C were replaced by the last observation carried forward (LOCF). Symptom scores were expected to improve over treatment, therefore the replacement of missing values with earlier measurements did not result in overoptimistic imputation and this procedure could be regarded as conservative. Superiority of QVA 110/50 μg to tiotropium 18 μg q.d. plus formoterol 12 μg b.i.d. in terms of health related quality of life as assessed by St George's Respiratory Questionnaire (SGRQ-C) after 26 weeks of treatment"}, {'measure': 'Transition Dyspnea Index (TDI) Focal Score After 26 Weeks of Treatment.', 'timeFrame': 'Week 26', 'description': 'Baseline Dyspnea Index (BDI)/Transition Dyspnea Index (TDI) focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort and captures changes from baseline. BDI was measured at day 1 prior to the first dose with domain scores ranging from 0=very severe to 4=no impairment and a total score ranging from 0 to 12(best). TDI captures changes from baseline. Each domain is scored from -3=major deterioration to 3=major improvement to give an overall TDI focal score of -9 to 9. Higher numbers indicate a better score. missing values were replaced by the latest observed value (LOCF)'}, {'measure': 'Percent of Participants With at Least One Exacerbation Requiring Systemic Corticosteroids and/or Antibiotics Over 26 Weeks', 'timeFrame': 'Week 26', 'description': 'The percent of participants with at least one moderate exacerbation within the 26 weeks that required systemic corticosteroids and/or antibiotics during the treatment'}, {'measure': 'Percent of Participants With at Least One Exacerbation Requiring Hospitalization', 'timeFrame': 'Week 26', 'description': 'The percent of patients with at least one severe exacerbation within the 26 weeks that required hospitalization. COPD exacerbations were considered to be severe if hospitalization were required.'}, {'measure': 'Time- Event Analysis, Number of Participants With at Least One COPD Exacerbation (Moderate or Severe) During the Treatment Period', 'timeFrame': 'Week 26', 'description': 'The number of participants with at least one moderate or severe COPD exacerbation. COPD exacerbations are considered to be moderate if treatment with systemic corticosteroids and/or antibiotics was required. COPD exacerbations are considered to be severe if hospitalizations were required.'}, {'measure': 'Trough FEV1 at Baseline and Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'Trough FEV1 is the mean value of FEV1 (forced expiratory volume in one second) measured at 23:15h and 23:45h after the morning doses. The baseline value was measured at day 1 prior to the first dose.'}, {'measure': 'FEV1 30 Min After the Morning Dose at Baseline and Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'FEV1 30min is the forced expiratory volume in one second measured 30 min after the morning dose.'}, {'measure': 'Symptoms Score Reported by the Patients Using Part I "Symptoms" of SGRO-C', 'timeFrame': 'Baseline, Week 26', 'description': 'Part I of the SGRQ-C covers "symptoms" and is concerned with respiratory symptoms, their frequency and severity. Each questionnaire response has a unique empirically derived "weight". A score was calculated from these weights. The lowest possible value is zero and the highest 100. A higher value corresponds to greater impairment of health status.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['QVA149', 'Health related quality of life', 'Formoterol', 'Tiotropium', 'COPD'], 'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)']}, 'descriptionModule': {'briefSummary': 'This study will assess the efficacy and safety of QVA149 compared to tiotropium plus formoterol in patients with moderate to severe COPD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female adults aged ≥ 40 yrs\n* Patients with moderate to severe chronic obstructive pulmonary disease (GOLD 2010 guidelines)\n* Smoking history of at least 10 pack years\n* Post-bronchodilator FEV1 \\< 80% and ≥30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) \\<70%\n\nExclusion Criteria:\n\n* Pregnant women or nursing mothers or women of child-bearing potential not using adequate contraception\n* Patients with a history of long QT syndrome\n* Patients with Type I or uncontrolled Type II diabetes\n* Patients who have had a COPD exacerbation or respiratory tract infection within 6 weeks prior to screening\n* Patients with any history of asthma\n* Patients with pulmonary lobectomy, lung volume reduction surgery, or lung transplantation\n* Patients with concomitant pulmonary disease\n* Patients requiring long term oxygen therapy (\\>15 h a day)\n\nOther protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01574651', 'acronym': 'QUANTIFY', 'briefTitle': 'The Effect of QVA149 on Health Related Quality of Life in Patients With Chronic Obstructive Pulmonary Disease (COPD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 26-week Treatment, Multicenter, Randomized, Parallel Group, Blinded Study to Assess the Efficacy and Safety of QVA149 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease Using Tiotropium Plus Formoterol as Control', 'orgStudyIdInfo': {'id': 'CQVA149ADE01'}, 'secondaryIdInfos': [{'id': '2011-004870-26', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'QVA149 plus placebo to tiotropium and placebo to formoterol', 'description': 'QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.', 'interventionNames': ['Drug: QVA149', 'Drug: Placebo to tiotropium', 'Drug: Placebo to formoterol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tiotropium plus Formoterol and placebo to QVA149', 'description': 'Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.', 'interventionNames': ['Drug: Tiotropium', 'Drug: Formoterol', 'Drug: Placebo to QVA149']}], 'interventions': [{'name': 'QVA149', 'type': 'DRUG', 'description': 'QVA149 110/50µg, once daily (q.d.) is administered via a single-dose dry powder inhaler', 'armGroupLabels': ['QVA149 plus placebo to tiotropium and placebo to formoterol']}, {'name': 'Placebo to tiotropium', 'type': 'DRUG', 'description': 'Placebo to tiotropium capsules daily (q.d.) for inhalation, delivered via proprietary inhaler (Handihaler®). Placebo tiotropium inhalation capsules were matched in size and color to tiotropium 18 μg q.d. inhalation capsules', 'armGroupLabels': ['QVA149 plus placebo to tiotropium and placebo to formoterol']}, {'name': 'Placebo to formoterol', 'type': 'DRUG', 'description': 'Placebo to formoterol capsules twice daily (b.i.d) delivered via Aerolizer® device. Placebo formoterol inhalation capsules were equally matched in size, shape and color to formoterol 12 μg b.i.d. inhalation capsules.', 'armGroupLabels': ['QVA149 plus placebo to tiotropium and placebo to formoterol']}, {'name': 'Tiotropium', 'type': 'DRUG', 'description': "Tiotropium 18µg, once daily is administered via the manufacturer's proprietary inhalation device.", 'armGroupLabels': ['Tiotropium plus Formoterol and placebo to QVA149']}, {'name': 'Formoterol', 'type': 'DRUG', 'description': "Formoterol 12µg, twice daily is administered via the manufacturer's proprietary inhalation device.", 'armGroupLabels': ['Tiotropium plus Formoterol and placebo to QVA149']}, {'name': 'Placebo to QVA149', 'type': 'DRUG', 'description': 'Placebo to QVA149 is administered via a single-dose dry powder inhaler. Placebo QVA149 inhalation capsules were equally matched in size, shape and color to QVA149 110/50 μg q.d. inhalation capsules', 'armGroupLabels': ['Tiotropium plus Formoterol and placebo to QVA149']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10969', 'city': 'Berlin', 'state': 'Germany', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12099', 'city': 'Berlin', 'state': 'Germany', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '14050', 'city': 'Berlin', 'state': 'Germany', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '01307', 'city': 'Dresden', 'state': 'Germany', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '69117', 'city': 'Heidelberg', 'state': 'Germany', 'country': 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