Viewing Study NCT01957150

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Ignite Creation Date: 2025-12-24 @ 5:07 PM
Ignite Modification Date: 2026-02-20 @ 6:21 PM
Study NCT ID: NCT01957150
Status: COMPLETED
Last Update Posted: 2019-04-10
First Post: 2013-10-04
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Study Evaluating the Effect of Fluticasone Furoate/ Vilanterol (FF/VI) Inhalation Powder Compared With Vilanterol (VI) Inhalation Powder on Bone Mineral Density (BMD) in Subjects With Chronic Obstructive Pulmonary Disease (COPD).
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C523187', 'term': 'fluticasone furoate'}, {'id': 'C550468', 'term': 'vilanterol'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GSKClinicalSupportHD@gsk.com', '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': 'Serious adverse events and non-serious adverse events were collected from randomization of the study until 159 weeks.', 'description': 'Safety Population. The non-serious AEs are reported using a frequency threshold of \\>3%.', 'eventGroups': [{'id': 'EG000', 'title': 'Participants Administered VI', 'description': 'Following run-in period of 14 to 21 days, eligible participants were administered VI 25 microgram (mcg) once daily via ELLIPTA inhaler for 156 weeks.', 'otherNumAtRisk': 142, 'deathsNumAtRisk': 142, 'otherNumAffected': 102, 'seriousNumAtRisk': 142, 'deathsNumAffected': 6, 'seriousNumAffected': 42}, {'id': 'EG001', 'title': 'Participants Administered FF/VI', 'description': 'Following run-in period of 14 to 21 days, eligible participants were administered FF 100 mcg along with VI 25 mcg once daily via ELLIPTA inhaler for 156 weeks.', 'otherNumAtRisk': 141, 'deathsNumAtRisk': 141, 'otherNumAffected': 116, 'seriousNumAtRisk': 141, 'deathsNumAffected': 4, 'seriousNumAffected': 41}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 57, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 75, 'numAffected': 40}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 23, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 30, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 18, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 20, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 18, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 24, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 17, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 13, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 27, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 28, 'numAffected': 20}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 14, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Osteoporosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 19, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 17, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 24, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 44, 'numAffected': 26}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 10, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'seriousEvents': [{'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 10, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Chronic respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pneumothorax spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 15, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Abdominal wall abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cardiac asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Ischaemic cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Substance abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Calculus bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Urinary tract obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Vesical fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Vestibular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Contrast media reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Rectocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hepatitis cholestatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage Change From Baseline in Bone Mineral Density (BMD) Measured at Total Hip', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Administered VI', 'description': 'Following run-in period of 14 to 21 days, eligible participants were administered VI 25 microgram (mcg) once daily via ELLIPTA inhaler for 156 weeks.'}, {'id': 'OG001', 'title': 'Participants Administered FF/VI', 'description': 'Following run-in period of 14 to 21 days, eligible participants were administered FF 100 mcg along with VI 25 mcg once daily via ELLIPTA inhaler for 156 weeks.'}], 'classes': [{'title': 'Overall % change per year, n = 132, 130', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.18', 'groupId': 'OG000', 'lowerLimit': '-0.18', 'upperLimit': '0.55'}, {'value': '-0.27', 'groupId': 'OG001', 'lowerLimit': '-0.63', 'upperLimit': '0.09'}]}]}, {'title': '% change by Week 26, n= 130, 130', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.37', 'groupId': 'OG000', 'lowerLimit': '-0.07', 'upperLimit': '0.82'}, {'value': '0.31', 'groupId': 'OG001', 'lowerLimit': '-0.13', 'upperLimit': '0.76'}]}]}, {'title': '% change by Week 52, n = 104, 121', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.35', 'groupId': 'OG000', 'lowerLimit': '-0.21', 'upperLimit': '0.91'}, {'value': '-0.43', 'groupId': 'OG001', 'lowerLimit': '-0.96', 'upperLimit': '0.10'}]}]}, {'title': '% change by Week 78, n = 97, 102', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.22', 'groupId': 'OG000', 'lowerLimit': '-0.41', 'upperLimit': '0.85'}, {'value': '-0.68', 'groupId': 'OG001', 'lowerLimit': '-1.29', 'upperLimit': '-0.07'}]}]}, {'title': '% change by Week 104, n = 94, 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.16', 'groupId': 'OG000', 'lowerLimit': '-0.84', 'upperLimit': '0.52'}, {'value': '-1.02', 'groupId': 'OG001', 'lowerLimit': '-1.68', 'upperLimit': '-0.36'}]}]}, {'title': '% change by Week 130, n = 88, 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.73', 'upperLimit': '0.75'}, {'value': '-1.02', 'groupId': 'OG001', 'lowerLimit': '-1.75', 'upperLimit': '-0.29'}]}]}, {'title': '% change by Week 156, n = 76, 75', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.16', 'groupId': 'OG000', 'lowerLimit': '-1.02', 'upperLimit': '0.71'}, {'value': '-1.29', 'groupId': 'OG001', 'lowerLimit': '-2.13', 'upperLimit': '-0.45'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage Change from Baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.46', 'ciLowerLimit': '-0.97', 'ciUpperLimit': '0.06', 'estimateComment': 'Treatment comparison for overall weeks', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority was demonstrated if the lower limit of 95 % confidence interval (CI) for the overall treatment difference change from Baseline between FF/VI and VI was greater than -1 % year'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Visit 1) and 26, 52, 78, 104, 130 and 156 Weeks', 'description': 'BMD analysis performed on log (BMD ratio to baseline) using a repeated measures model with covariates of treatment group, age, gender, baseline BMI, visit, log baseline BMD, log baseline BMD by visit and treatment group by visit interactions. These estimates were then converted into annual changes and averaged to calculate the overall treatment estimates and difference which were used for testing non-inferiority. The analysis shown is for the "While on Treatment" estimand of the difference in percentage change from baseline per annum between FF/VI ± BMD medication/SCS (systemic corticosteroids) and VI ± BMD medication/SCS. Baseline is defined as the measurement performed at Visit 1. Percentage change is calculated as (BMD value post-Baseline divided by Baseline value) -1 multiplied by 100.', 'unitOfMeasure': 'Percentage change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).All randomized participants who received at least one dose of study treatment were included in Safety Population.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in BMD Measurements at Total Hip by Gender (Male Participants)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Administered VI', 'description': 'Following run-in period of 14 to 21 days, eligible participants were administered VI 25 microgram (mcg) once daily via ELLIPTA inhaler for 156 weeks.'}, {'id': 'OG001', 'title': 'Participants Administered FF/VI', 'description': 'Following run-in period of 14 to 21 days, eligible participants were administered FF 100 mcg along with VI 25 mcg once daily via ELLIPTA inhaler for 156 weeks.'}], 'classes': [{'title': 'Overall Week % change per year, n = 67, 63', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.27', 'groupId': 'OG000', 'lowerLimit': '-0.23', 'upperLimit': '0.77'}, {'value': '-0.20', 'groupId': 'OG001', 'lowerLimit': '-0.70', 'upperLimit': '0.31'}]}]}, {'title': '% change by Week 26, n = 66, 63', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.45', 'groupId': 'OG000', 'lowerLimit': '-0.06', 'upperLimit': '0.97'}, {'value': '0.44', 'groupId': 'OG001', 'lowerLimit': '-0.09', 'upperLimit': '0.97'}]}]}, {'title': '% change by Week 52, n = 52, 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.48', 'groupId': 'OG000', 'lowerLimit': '-0.31', 'upperLimit': '1.27'}, {'value': '-0.43', 'groupId': 'OG001', 'lowerLimit': '-1.19', 'upperLimit': '0.33'}]}]}, {'title': '% change by Week 78, n = 51, 46', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000', 'lowerLimit': '-0.81', 'upperLimit': '0.95'}, {'value': '-0.68', 'groupId': 'OG001', 'lowerLimit': '-1.56', 'upperLimit': '0.21'}]}]}, {'title': '% change by Week 104, n = 50, 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.07', 'groupId': 'OG000', 'lowerLimit': '-0.86', 'upperLimit': '1.00'}, {'value': '-0.68', 'groupId': 'OG001', 'lowerLimit': '-1.62', 'upperLimit': '0.27'}]}]}, {'title': '% change by Week 130, n = 44, 39', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.37', 'groupId': 'OG000', 'lowerLimit': '-0.75', 'upperLimit': '1.50'}, {'value': '-0.89', 'groupId': 'OG001', 'lowerLimit': '-2.02', 'upperLimit': '0.26'}]}]}, {'title': '% change by Week 156, n = 40, 35', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.05', 'groupId': 'OG000', 'lowerLimit': '-1.26', 'upperLimit': '1.37'}, {'value': '-1.39', 'groupId': 'OG001', 'lowerLimit': '-2.71', 'upperLimit': '-0.05'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage Change from Baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.47', 'ciLowerLimit': '-1.17', 'ciUpperLimit': '0.24', 'estimateComment': 'Overall Weeks for Male', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority was demonstrated if the lower limit of 95% CI for the overall treatment difference change from Baseline between FF/VI and VI was greater than -1 % year'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Visit 1) and 26, 52, 78, 104, 130 and 156 Weeks', 'description': 'BMD analysis performed on log (BMD ratio to baseline) using separate repeated measures models for each gender with covariates of treatment group, age, baseline BMI, visit, log baseline BMD, log baseline BMD by visit and treatment group by visit interactions. These estimates were then converted into annual changes and averaged to calculate the overall treatment estimates and difference which were used for testing non-inferiority. The analysis shown is for the "While on Treatment" estimand of the difference in percentage change from baseline per annum between FF/VI ± BMD medication/SCS (systemic corticosteroids) and VI ± BMD medication/SCS. Baseline is defined as the measurement performed at Visit 1. Percentage change is calculated as (BMD value post-Baseline divided by Baseline value) -1 multiplied by 100.', 'unitOfMeasure': 'Percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in BMD Measurements at Total Hip by Gender (Female Participants)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Administered VI', 'description': 'Following run-in period of 14 to 21 days, eligible participants were administered VI 25 microgram (mcg) once daily via ELLIPTA inhaler for 156 weeks.'}, {'id': 'OG001', 'title': 'Participants Administered FF/VI', 'description': 'Following run-in period of 14 to 21 days, eligible participants were administered FF 100 mcg along with VI 25 mcg once daily via ELLIPTA inhaler for 156 weeks.'}], 'classes': [{'title': 'OverallWeek % change per year, n = 65, 67', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.09', 'groupId': 'OG000', 'lowerLimit': '-0.46', 'upperLimit': '0.64'}, {'value': '-0.31', 'groupId': 'OG001', 'lowerLimit': '-0.84', 'upperLimit': '0.22'}]}]}, {'title': '% change by Week 26, n = 64, 67', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.28', 'groupId': 'OG000', 'lowerLimit': '-0.45', 'upperLimit': '1.02'}, {'value': '0.20', 'groupId': 'OG001', 'lowerLimit': '-0.51', 'upperLimit': '0.92'}]}]}, {'title': '% change by Week 52, n = 52, 65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.13', 'groupId': 'OG000', 'lowerLimit': '-0.67', 'upperLimit': '0.94'}, {'value': '-0.42', 'groupId': 'OG001', 'lowerLimit': '-1.16', 'upperLimit': '0.33'}]}]}, {'title': '% change by Week 78, n = 46, 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.37', 'groupId': 'OG000', 'lowerLimit': '-0.54', 'upperLimit': '1.28'}, {'value': '-0.63', 'groupId': 'OG001', 'lowerLimit': '-1.48', 'upperLimit': '0.23'}]}]}, {'title': '% change by Week 104, n = 44, 53', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.40', 'groupId': 'OG000', 'lowerLimit': '-1.40', 'upperLimit': '0.61'}, {'value': '-1.26', 'groupId': 'OG001', 'lowerLimit': '-2.19', 'upperLimit': '-0.32'}]}]}, {'title': '% change by Week 130, n = 44, 45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.18', 'groupId': 'OG000', 'lowerLimit': '-1.12', 'upperLimit': '0.77'}, {'value': '-0.99', 'groupId': 'OG001', 'lowerLimit': '-1.90', 'upperLimit': '-0.08'}]}]}, {'title': '% change by Week 156, n = 36, 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.42', 'groupId': 'OG000', 'lowerLimit': '-1.56', 'upperLimit': '0.73'}, {'value': '-1.19', 'groupId': 'OG001', 'lowerLimit': '-2.27', 'upperLimit': '-0.11'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage Change from Baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.40', 'ciLowerLimit': '-1.16', 'ciUpperLimit': '0.36', 'estimateComment': 'Overall Weeks for female', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority was demonstrated if the lower limit of 95% CI for the overall treatment difference change from Baseline between FF/VI and VI was greater than -1 % year'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Visit 1) and 26, 52, 78, 104, 130 and 156 Weeks', 'description': 'BMD analysis performed on log (BMD ratio to baseline) using separate repeated measures models for each gender with covariates of treatment group, age, baseline BMI, visit, log baseline BMD, log baseline BMD by visit and treatment group by visit interactions. These estimates were then converted into annual changes and averaged to calculate the overall treatment estimates and difference which were used for testing non-inferiority. The analysis shown is for the "While on Treatment" estimand of the difference in percentage change from baseline per annum between FF/VI ± BMD medication/SCS (systemic corticosteroids) and VI ± BMD medication/SCS. Baseline is defined as the measurement performed at Visit 1. Percentage change is calculated as (BMD value post-Baseline divided by Baseline value) -1 multiplied by 100.', 'unitOfMeasure': 'Percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in BMD Measurements at Lumbar Spine (L1 to L4) by Gender (Male Participants)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Administered VI', 'description': 'Following run-in period of 14 to 21 days, eligible participants were administered VI 25 microgram (mcg) once daily via ELLIPTA inhaler for 156 weeks.'}, {'id': 'OG001', 'title': 'Participants Administered FF/VI', 'description': 'Following run-in period of 14 to 21 days, eligible participants were administered FF 100 mcg along with VI 25 mcg once daily via ELLIPTA inhaler for 156 weeks.'}], 'classes': [{'title': 'Overall, male % change per year, n = 69, 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.41', 'groupId': 'OG000', 'lowerLimit': '0.79', 'upperLimit': '2.04'}, {'value': '0.38', 'groupId': 'OG001', 'lowerLimit': '-0.26', 'upperLimit': '1.02'}]}]}, {'title': '% change by Week 26, n = 67, 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.03', 'groupId': 'OG000', 'lowerLimit': '0.26', 'upperLimit': '1.80'}, {'value': '0.42', 'groupId': 'OG001', 'lowerLimit': '-0.36', 'upperLimit': '1.21'}]}]}, {'title': '% change by Week 52, n = 53, 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.91', 'groupId': 'OG000', 'lowerLimit': '0.89', 'upperLimit': '2.94'}, {'value': '0.11', 'groupId': 'OG001', 'lowerLimit': '-0.88', 'upperLimit': '1.11'}]}]}, {'title': '% change by Week 78, n = 52, 45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.09', 'groupId': 'OG000', 'lowerLimit': '0.84', 'upperLimit': '3.35'}, {'value': '0.64', 'groupId': 'OG001', 'lowerLimit': '-0.67', 'upperLimit': '1.97'}]}]}, {'title': '% change by Week 104, n = 52, 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.72', 'groupId': 'OG000', 'lowerLimit': '1.48', 'upperLimit': '3.98'}, {'value': '0.42', 'groupId': 'OG001', 'lowerLimit': '-0.88', 'upperLimit': '1.75'}]}]}, {'title': '% change by Week 130, n = 47, 38', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.95', 'groupId': 'OG000', 'lowerLimit': '0.76', 'upperLimit': '3.16'}, {'value': '0.47', 'groupId': 'OG001', 'lowerLimit': '-0.82', 'upperLimit': '1.78'}]}]}, {'title': '% change by Week 156, n = 43, 35', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.96', 'groupId': 'OG000', 'lowerLimit': '1.68', 'upperLimit': '4.25'}, {'value': '1.49', 'groupId': 'OG001', 'lowerLimit': '0.13', 'upperLimit': '2.86'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage Change from Baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.02', 'ciLowerLimit': '-1.90', 'ciUpperLimit': '-0.13', 'estimateComment': 'Overall Weeks for Male', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Visit 1) and 26, 52, 78, 104, 130 and 156 Weeks', 'description': 'BMD analysis performed on log (BMD ratio to baseline) using separate repeated measures models for each gender with covariates of treatment group, age, baseline BMI, visit, log baseline BMD, log baseline BMD by visit and treatment group by visit interactions. These estimates were then converted into annual changes and averaged to calculate the overall treatment estimates and difference which were used for testing non-inferiority. The analysis shown is for the "While on Treatment" estimand of the difference in percentage change from baseline per annum between FF/VI ± BMD medication/SCS (systemic corticosteroids) and VI ± BMD medication/SCS. Baseline is defined as the measurement performed at Visit 1. Percentage change is calculated as (BMD value post-Baseline divided by Baseline value) -1 multiplied by 100.', 'unitOfMeasure': 'Percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in BMD Measurements at Lumbar Spine (L1 to L4) by Gender (Female Participants)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Administered VI', 'description': 'Following run-in period of 14 to 21 days, eligible participants were administered VI 25 microgram (mcg) once daily via ELLIPTA inhaler for 156 weeks.'}, {'id': 'OG001', 'title': 'Participants Administered FF/VI', 'description': 'Following run-in period of 14 to 21 days, eligible participants were administered FF 100 mcg along with VI 25 mcg once daily via ELLIPTA inhaler for 156 weeks.'}], 'classes': [{'title': 'Overall Week % change per year, n = 66, 68', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.17', 'groupId': 'OG000', 'lowerLimit': '-0.42', 'upperLimit': '0.77'}, {'value': '0.12', 'groupId': 'OG001', 'lowerLimit': '-0.45', 'upperLimit': '0.70'}]}]}, {'title': '% change by Week 26, n = 66, 68', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.10', 'groupId': 'OG000', 'lowerLimit': '-0.67', 'upperLimit': '0.88'}, {'value': '-0.19', 'groupId': 'OG001', 'lowerLimit': '-0.95', 'upperLimit': '0.58'}]}]}, {'title': '% change by Week 52, n = 51, 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.48', 'groupId': 'OG000', 'lowerLimit': '-1.44', 'upperLimit': '0.48'}, {'value': '0.57', 'groupId': 'OG001', 'lowerLimit': '-0.31', 'upperLimit': '1.46'}]}]}, {'title': '% change by Week 78, n = 46, 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.33', 'groupId': 'OG000', 'lowerLimit': '-0.60', 'upperLimit': '1.26'}, {'value': '0.25', 'groupId': 'OG001', 'lowerLimit': '-0.61', 'upperLimit': '1.11'}]}]}, {'title': '% change by Week 104, n = 43, 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.65', 'groupId': 'OG000', 'lowerLimit': '-0.50', 'upperLimit': '1.80'}, {'value': '0.64', 'groupId': 'OG001', 'lowerLimit': '-0.41', 'upperLimit': '1.70'}]}]}, {'title': '% change by Week 130, n = 44, 49', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.33', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '2.67'}, {'value': '0.10', 'groupId': 'OG001', 'lowerLimit': '-1.12', 'upperLimit': '1.33'}]}]}, {'title': '% change by Week 156, n = 36, 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.80', 'groupId': 'OG000', 'lowerLimit': '-0.74', 'upperLimit': '2.36'}, {'value': '0.10', 'groupId': 'OG001', 'lowerLimit': '-1.32', 'upperLimit': '1.53'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage Change from Baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.87', 'ciUpperLimit': '0.78', 'estimateComment': 'Overall Weeks for female', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Visit 1) and 26, 52, 78, 104, 130 and 156 Weeks', 'description': 'BMD analysis performed on log (BMD ratio to baseline) using separate repeated measures models for each gender with covariates of treatment group, age, baseline BMI, visit, log baseline BMD, log baseline BMD by visit and treatment group by visit interactions. These estimates were then converted into annual changes and averaged to calculate the overall treatment estimates and difference which were used for testing non-inferiority. The analysis shown is for the "While on Treatment" estimand of the difference in percentage change from baseline per annum between FF/VI ± BMD medication/SCS (systemic corticosteroids) and VI ± BMD medication/SCS. Baseline is defined as the measurement performed at Visit 1. Percentage change is calculated as (BMD value post-Baseline divided by Baseline value) -1 multiplied by 100.', 'unitOfMeasure': 'Percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in BMD Measurements at Lumbar Spine (L1 to L4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Administered VI', 'description': 'Following run-in period of 14 to 21 days, eligible participants were administered VI 25 microgram (mcg) once daily via ELLIPTA inhaler for 156 weeks.'}, {'id': 'OG001', 'title': 'Participants Administered FF/VI', 'description': 'Following run-in period of 14 to 21 days, eligible participants were administered FF 100 mcg along with VI 25 mcg once daily via ELLIPTA inhaler for 156 weeks.'}], 'classes': [{'title': 'Overall week % change per year, n=135, 132', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.79', 'groupId': 'OG000', 'lowerLimit': '0.36', 'upperLimit': '1.22'}, {'value': '0.28', 'groupId': 'OG001', 'lowerLimit': '-0.15', 'upperLimit': '0.71'}]}]}, {'title': '% change by Week 26, n = 133, 132', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.55', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '1.10'}, {'value': '0.13', 'groupId': 'OG001', 'lowerLimit': '-0.41', 'upperLimit': '0.68'}]}]}, {'title': '% change by Week 52, n = 104, 122', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.71', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '1.42'}, {'value': '0.40', 'groupId': 'OG001', 'lowerLimit': '-0.26', 'upperLimit': '1.07'}]}]}, {'title': '% change by Week 78, n= 98, 102', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.20', 'groupId': 'OG000', 'lowerLimit': '0.43', 'upperLimit': '1.99'}, {'value': '0.45', 'groupId': 'OG001', 'lowerLimit': '-0.31', 'upperLimit': '1.21'}]}]}, {'title': '% change by Week 104, n = 95, 97', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.66', 'groupId': 'OG000', 'lowerLimit': '0.82', 'upperLimit': '2.51'}, {'value': '0.61', 'groupId': 'OG001', 'lowerLimit': '-0.22', 'upperLimit': '1.44'}]}]}, {'title': '% change by Week 130, n = 91, 87', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.70', 'groupId': 'OG000', 'lowerLimit': '0.80', 'upperLimit': '2.61'}, {'value': '0.30', 'groupId': 'OG001', 'lowerLimit': '-0.60', 'upperLimit': '1.20'}]}]}, {'title': '% change by Week 156, n = 79, 77', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.84', 'groupId': 'OG000', 'lowerLimit': '0.86', 'upperLimit': '2.84'}, {'value': '0.83', 'groupId': 'OG001', 'lowerLimit': '-0.14', 'upperLimit': '1.81'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage Change from Baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.51', 'ciLowerLimit': '-1.11', 'ciUpperLimit': '0.10', 'estimateComment': 'Overall week', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Visit 1) and 26, 52, 78, 104, 130 and 156 Weeks', 'description': 'BMD analysis performed on log (BMD ratio to baseline) using a repeated measures model with covariates of treatment group, age, gender, baseline BMI, visit, log baseline BMD, log baseline BMD by visit and treatment group by visit interactions. These estimates were then converted into annual changes and averaged to calculate the overall treatment estimates and difference which were used for testing non-inferiority. The analysis shown is for the "While on Treatment" estimand of the difference in percentage change from baseline per annum between FF/VI ± BMD medication/SCS (systemic corticosteroids) and VI ± BMD medication/SCS. Baseline is defined as the measurement performed at Visit 1. Percentage change is calculated as (BMD value post-Baseline divided by Baseline value) -1 multiplied by 100.', 'unitOfMeasure': 'Percentage Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Participants Administered VI', 'description': 'Following run-in period of 14 to 21 days, eligible participants were administered VI 25 microgram (mcg) once daily via ELLIPTA inhaler for 156 weeks.'}, {'id': 'FG001', 'title': 'Participants Administered FF/VI', 'description': 'Following run-in period of 14 to 21 days, eligible participants were administered FF 100 mcg along with VI 25 mcg once daily via ELLIPTA inhaler for 156 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '142'}, {'groupId': 'FG001', 'numSubjects': '141'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '87'}, {'groupId': 'FG001', 'numSubjects': '83'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '58'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}]}], 'recruitmentDetails': 'The study was conducted on participants with chronic obstructive pulmonary disease (COPD) in five countries to assess the long-term safety effects of Fluticasone Furoate (FF) component of the FF/Vilanterol (VI) inhalation powder.', 'preAssignmentDetails': 'A total of 482 participants were screened of which 199 were screen failures. A total of 283 participants were randomized in a 1:1 ratio to receive either VI or FF/VI.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '283', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Participants Administered VI', 'description': 'Following run-in period of 14 to 21 days, eligible participants were administered VI 25 microgram (mcg) once daily via ELLIPTA inhaler for 156 weeks.'}, {'id': 'BG001', 'title': 'Participants Administered FF/VI', 'description': 'Following run-in period of 14 to 21 days, eligible participants were administered FF 100 mcg along with VI 25 mcg once daily via ELLIPTA inhaler for 156 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.0', 'spread': '8.19', 'groupId': 'BG000'}, {'value': '64.4', 'spread': '9.04', 'groupId': 'BG001'}, {'value': '65.2', 'spread': '8.65', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Safety population', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Safety population', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Central/South Asian Heritage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '141', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '280', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Safety population', 'unitOfMeasure': 'Count of participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-08-14', 'size': 1073088, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-01-15T03:15', 'hasProtocol': True}, {'date': '2018-05-17', 'size': 657925, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-01-15T03:17', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 283}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-03-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-21', 'studyFirstSubmitDate': '2013-10-04', 'resultsFirstSubmitDate': '2019-03-21', 'studyFirstSubmitQcDate': '2013-10-04', 'lastUpdatePostDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-21', 'studyFirstPostDateStruct': {'date': '2013-10-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage Change From Baseline in Bone Mineral Density (BMD) Measured at Total Hip', 'timeFrame': 'Baseline (Visit 1) and 26, 52, 78, 104, 130 and 156 Weeks', 'description': 'BMD analysis performed on log (BMD ratio to baseline) using a repeated measures model with covariates of treatment group, age, gender, baseline BMI, visit, log baseline BMD, log baseline BMD by visit and treatment group by visit interactions. These estimates were then converted into annual changes and averaged to calculate the overall treatment estimates and difference which were used for testing non-inferiority. The analysis shown is for the "While on Treatment" estimand of the difference in percentage change from baseline per annum between FF/VI ± BMD medication/SCS (systemic corticosteroids) and VI ± BMD medication/SCS. Baseline is defined as the measurement performed at Visit 1. Percentage change is calculated as (BMD value post-Baseline divided by Baseline value) -1 multiplied by 100.'}], 'secondaryOutcomes': [{'measure': 'Percentage Change From Baseline in BMD Measurements at Total Hip by Gender (Male Participants)', 'timeFrame': 'Baseline (Visit 1) and 26, 52, 78, 104, 130 and 156 Weeks', 'description': 'BMD analysis performed on log (BMD ratio to baseline) using separate repeated measures models for each gender with covariates of treatment group, age, baseline BMI, visit, log baseline BMD, log baseline BMD by visit and treatment group by visit interactions. These estimates were then converted into annual changes and averaged to calculate the overall treatment estimates and difference which were used for testing non-inferiority. The analysis shown is for the "While on Treatment" estimand of the difference in percentage change from baseline per annum between FF/VI ± BMD medication/SCS (systemic corticosteroids) and VI ± BMD medication/SCS. Baseline is defined as the measurement performed at Visit 1. Percentage change is calculated as (BMD value post-Baseline divided by Baseline value) -1 multiplied by 100.'}, {'measure': 'Percentage Change From Baseline in BMD Measurements at Total Hip by Gender (Female Participants)', 'timeFrame': 'Baseline (Visit 1) and 26, 52, 78, 104, 130 and 156 Weeks', 'description': 'BMD analysis performed on log (BMD ratio to baseline) using separate repeated measures models for each gender with covariates of treatment group, age, baseline BMI, visit, log baseline BMD, log baseline BMD by visit and treatment group by visit interactions. These estimates were then converted into annual changes and averaged to calculate the overall treatment estimates and difference which were used for testing non-inferiority. The analysis shown is for the "While on Treatment" estimand of the difference in percentage change from baseline per annum between FF/VI ± BMD medication/SCS (systemic corticosteroids) and VI ± BMD medication/SCS. Baseline is defined as the measurement performed at Visit 1. Percentage change is calculated as (BMD value post-Baseline divided by Baseline value) -1 multiplied by 100.'}, {'measure': 'Percentage Change From Baseline in BMD Measurements at Lumbar Spine (L1 to L4) by Gender (Male Participants)', 'timeFrame': 'Baseline (Visit 1) and 26, 52, 78, 104, 130 and 156 Weeks', 'description': 'BMD analysis performed on log (BMD ratio to baseline) using separate repeated measures models for each gender with covariates of treatment group, age, baseline BMI, visit, log baseline BMD, log baseline BMD by visit and treatment group by visit interactions. These estimates were then converted into annual changes and averaged to calculate the overall treatment estimates and difference which were used for testing non-inferiority. The analysis shown is for the "While on Treatment" estimand of the difference in percentage change from baseline per annum between FF/VI ± BMD medication/SCS (systemic corticosteroids) and VI ± BMD medication/SCS. Baseline is defined as the measurement performed at Visit 1. Percentage change is calculated as (BMD value post-Baseline divided by Baseline value) -1 multiplied by 100.'}, {'measure': 'Percentage Change From Baseline in BMD Measurements at Lumbar Spine (L1 to L4) by Gender (Female Participants)', 'timeFrame': 'Baseline (Visit 1) and 26, 52, 78, 104, 130 and 156 Weeks', 'description': 'BMD analysis performed on log (BMD ratio to baseline) using separate repeated measures models for each gender with covariates of treatment group, age, baseline BMI, visit, log baseline BMD, log baseline BMD by visit and treatment group by visit interactions. These estimates were then converted into annual changes and averaged to calculate the overall treatment estimates and difference which were used for testing non-inferiority. The analysis shown is for the "While on Treatment" estimand of the difference in percentage change from baseline per annum between FF/VI ± BMD medication/SCS (systemic corticosteroids) and VI ± BMD medication/SCS. Baseline is defined as the measurement performed at Visit 1. Percentage change is calculated as (BMD value post-Baseline divided by Baseline value) -1 multiplied by 100.'}, {'measure': 'Percentage Change From Baseline in BMD Measurements at Lumbar Spine (L1 to L4)', 'timeFrame': 'Baseline (Visit 1) and 26, 52, 78, 104, 130 and 156 Weeks', 'description': 'BMD analysis performed on log (BMD ratio to baseline) using a repeated measures model with covariates of treatment group, age, gender, baseline BMI, visit, log baseline BMD, log baseline BMD by visit and treatment group by visit interactions. These estimates were then converted into annual changes and averaged to calculate the overall treatment estimates and difference which were used for testing non-inferiority. The analysis shown is for the "While on Treatment" estimand of the difference in percentage change from baseline per annum between FF/VI ± BMD medication/SCS (systemic corticosteroids) and VI ± BMD medication/SCS. Baseline is defined as the measurement performed at Visit 1. Percentage change is calculated as (BMD value post-Baseline divided by Baseline value) -1 multiplied by 100.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'descriptionModule': {'briefSummary': 'This is a multi-center, randomized, double-blind, parallel-group study. The FF/VI inhalation powder once daily and VI inhalation powder once daily will be evaluated in subjects with COPD over 156 weeks. The primary objective of this study is to evaluate the effect of the inhaled corticosteroid FF on bone mineral density assessed at the total hip by comparing FF/VI treatment with VI treatment in subjects with moderate COPD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Informed consent: Subjects must give their signed and dated written informed consent to participate.\n* Gender: Male or female subjects. Female subjects must be post-menopausal or using a highly effective method for avoidance of pregnancy. The decision to include or exclude women of childbearing potential may be made at the discretion of the investigator in accordance with local practice in relation to adequate contraception.\n* Age: \\>= 40 years of age at Screening (Visit 1)\n* COPD diagnosis: Subjects with a clinical history of COPD in accordance with the following definition by the American Thoracic Society/European Respiratory Society: COPD is a preventable and treatable disease characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and is associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking. Although COPD affects the lungs, it also produces significant systemic consequences.\n* Tobacco use: Subjects with a current or prior history of \\>=10 pack-years of cigarette smoking at screening (Visit 1). Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Number of pack years = (number of cigarettes per day/20) x number of years smoked Note: Pipe and/or cigar use cannot be used to calculate pack year history.\n* Severity of Disease: Subject with a measured post-albuterol/salbutamol Forced expiratory volume (FEV1)/forced vital capacity (FVC) ratio of \\<0.70 at Screening (Visit 1). Subjects with a measured post-albuterol/salbutamol 50% \\<=FEV1 \\<=70% of predicted normal values calculated using National Health and Nutrition Examination Survey (NHANES III) reference equations at Screening (Visit 1).\n* Native Hip: Have at least one evaluable native hip.\n\nExclusion Criteria:\n\n* Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study.\n* Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD).\n* Alpha1-antitrypsin deficiency: Subjects with alpha-1 antitrypsin deficiency as the underlying cause of COPD.\n* Other respiratory disorders: Subjects with tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases.\n* Lung resection or transplantation: Subjects with lung volume reduction surgery within the 12 months prior to Screening Visit 1 or having had a lung transplant.\n* Chest X-ray: Subjects with a chest X-ray (or Computer Axial Tomography (CT) scan) that revealed evidence of clinically significant abnormalities not believed to be due to the presence of COPD. A chest X-ray should be taken at Screening Visit 1 if a chest X-ray or CT scan is not available within 12 months prior to Visit 1.\n* Poorly controlled COPD: Subjects with poorly controlled COPD, defined as the occurrence of the following in the 12 weeks prior to Screening Visit 1: Acute worsening of COPD that is managed by the subject with corticosteroids or antibiotics or that requires treatment prescribed by a physician or requires hospitalization.\n* Moderate or severe COPD exacerbation or lower respiratory tract infection: Subjects with 2 or more moderate or severe COPD exacerbations and/or a lower respiratory tract infection (including pneumonia) within the 12 months prior to Screening Visit 1 or experience a moderate or severe COPD exacerbation and/or a lower respiratory infection (including pneumonia) during the Run-In period. NOTE: A moderate COPD exacerbation is defined as requiring systemic corticosteroids and/or antibiotics. A severe COPD exacerbation is defined as requiring hospitalization.\n* Abnormal clinically significant laboratory finding: Subjects who have an abnormal, clinically significant finding in any liver chemistry, biochemical, or haematology tests at Screening Visit 1 or upon repeat prior to randomization.\n* Abnormal and clinically significant 12-lead Electrocardiogram (ECG): Subjects who have an abnormal, clinically significant ECG finding at Screening Visit 1.\n* Non-Compliance during Run-In Period: Failure to demonstrate adequate compliance with run-in medication (\\< 80% compliant), the ability to withhold COPD medications, and to keep clinic visit appointments.\n* Bone disorders/conditions: Subjects with historical or current evidence of bone cancer, severe scoliosis, rheumatoid arthritis, metabolic bone diseases (other than osteoporosis) including hyper-or hypo-parathyroidism, Paget's disease of bone, osteomalacia, or osteogenesis imperfecta. Removal of vertebrae between L1 and L4 of the lumbar spine and/or presence of metal implants or devices, such as plates, rods, or screws in the lumbar spine and/or hip.\n* Immobility: Wheel chair bound or paraplegic.\n* Low vitamin D: Previously known low-serum 25-hydroxy vitamin D concentration (less than 10ng \\[25nmoles\\] per liter).\n* Other diseases/abnormalities: Serious, uncontrolled disease (including serious psychological disorders) likely to interfere with the study within the 3-year study.\n* Cancer: Subjects with carcinoma that has not been in complete remission for at least 5 years. Carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded if the subject has been considered cured within 5 years since diagnosis.\n* Drug/food allergy: Subjects with a history of hypersensitivity to any of the study medications (e.g. beta-agonists, corticosteroid) or components of the inhalation powder (e.g. lactose, magnesium stearate). In addition, patients with a history of severe milk protein allergy that, in the opinion of the study physician, contraindicates the subject's participation will also be excluded.\n* Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years.\n* Prohibited medications prior to spirometry at Visit 1: Subjects who are medically unable to withhold the following medications prior to spirometry testing at Visit 1\n* No use within 48 hours (hrs) prior to Visit 1 Spirometry Testing: Inhaled corticosteroids, Inhaled Inhaled Corticosteroids (ICS)/ long acting beta2-agonist (LABA) combination products, Long-acting anticholinergics (e.g., tiotropium), Theophylline preparations, Oral leukotriene inhibitors (zafirlukast, montelukast, zileuton), Oral PDE-4 inhibitors (e.g. roflumilast), Oral beta-agonists (Long-acting), Inhaled long acting beta2-agonist (LABA)-Indacaterol.\n* No use within 24 hrs prior to Visit 1 Spirometry Testing: Other inhaled LABAs (e.g., salmeterol), Inhaled sodium cromoglycate or nedocromil sodium.\n* No use within 12 hrs prior to Visit 1 Spirometry Testing: Oral beta-agonists (Short-acting).\n* No use within 4 hrs prior to Visit 1 Spirometry Testing: Ipratropium/ albuterol (salbutamol) combination product, Inhaled short-acting beta2-agonists, Short-acting anti-cholinergics (e.g., ipratropium bromide).\n* Additional medication: Use of the following medications within the following time intervals prior to Visit 1 or during the study (unless otherwise specified):\n* No use within 12 weeks prior to Screening Visit 1 or thereafter at any time during the study (unless otherwise specified): Depot corticosteroids.\n* No use within 30 days prior to Screening Visit 1 or thereafter at any time during the study (unless otherwise specified): Systemic, Oral, parenteral, intra-articular corticosteroids (Subjects may take courses of systemic corticosteroids, where necessary, for treatment of an exacerbation during the double-blind treatment period).\n* No use within 30 days or 5 half lives whichever is longer prior to Screening Visit 1 or thereafter at any time during the study (unless otherwise specified): Any other investigational drug.\n* COPD medications: Use of ICS, long-acting beta2-agonists (LABA), or ICS/LABA combination products (other than the study-provided double-blind study medication) at Visit 2 (Randomization) or during the double-blind treatment period.\n* Oxygen therapy: Subjects receiving treatment with long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day. Oxygen prn use (i.e., \\<=12 hours per day) is not exclusionary.\n* Non-compliance: Subjects at risk of non-compliance, or unable to comply with the study procedures. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.\n* Questionable validity of consent: Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study.\n* Affiliation with investigator site: Study investigators, sub-investigators, study coordinators, employees of a participating investigator or immediate family members of the aforementioned are excluded from participating in this study."}, 'identificationModule': {'nctId': 'NCT01957150', 'briefTitle': 'Study Evaluating the Effect of Fluticasone Furoate/ Vilanterol (FF/VI) Inhalation Powder Compared With Vilanterol (VI) Inhalation Powder on Bone Mineral Density (BMD) in Subjects With Chronic Obstructive Pulmonary Disease (COPD).', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Multi-centre, Randomized, Double-blind, Parallel-group Study Evaluating the Effect of Fluticasone Furoate/ Vilanterol (FF/VI) Inhalation Powder Once Daily Compared With Vilanterol (VI) Inhalation Powder Once Daily on Bone Mineral Density (BMD) in Subjects With Chronic Obstructive Pulmonary Disease (COPD).', 'orgStudyIdInfo': {'id': '102972'}, 'secondaryIdInfos': [{'id': '2012-004801-28', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fluticasone Furoate/Vilanterol 100/25 micrograms (mcg) QD', 'description': 'Subjects will self administer FF/VI 100/25 mcg inhalation powder once daily for 156 weeks via the NDPI.', 'interventionNames': ['Drug: Fluticasone Furoate/Vilanterol']}, {'type': 'EXPERIMENTAL', 'label': 'Vilanterol 25 mcg QD', 'description': 'Subjects will self administer VI 25 mcg inhalation powder once daily for 156 weeks via the NDPI.', 'interventionNames': ['Drug: Vilanterol']}], 'interventions': [{'name': 'Fluticasone Furoate/Vilanterol', 'type': 'DRUG', 'description': "Dry white powder containing 100 mcg of Fluticasone Furoate blended with lactose per blister was administered by NDPI. Dry white powder containing 25 mcg of Vilanterol micronised drug (as the 'M' salt triphenylacetate) blended with lactose and magnesium stearate per blister was administered by NDPI.", 'armGroupLabels': ['Fluticasone Furoate/Vilanterol 100/25 micrograms (mcg) QD']}, {'name': 'Vilanterol', 'type': 'DRUG', 'description': "Dry white powder containing 25 mcg of Vilanterol micronised drug (as the 'M' salt triphenylacetate) blended with lactose and magnesium stearate per blister was administered by NDPI.", 'armGroupLabels': ['Vilanterol 25 mcg QD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35501', 'city': 'Jasper', 'state': 'Alabama', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.83122, 'lon': -87.27751}}, {'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '33316', 'city': 'Fort Lauderdale', 'state': 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