Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2025-12-26 @ 10:59 AM
Study NCT ID:
NCT00975195
Status:
COMPLETED
Last Update Posted:
2015-02-10
First Post:
2009-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Inhaled Corticosteroid Withdrawal in Patients With Chronic Obstructive Pulmonary Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Switzerland']}, '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': 'D000068299', 'term': 'Salmeterol Xinafoate'}, {'id': 'D000068298', 'term': 'Fluticasone'}], 'ancestors': [{'id': 'D000420', 'term': 'Albuterol'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000730', 'term': 'Androstadienes'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Additional secondary endpoints were listed in the original protocol. Those endpoints are of exploratory nature only and were not considered relevant for trial conclusions. For more information see tab "Full Text Review", section "More Information".'}}, 'adverseEventsModule': {'timeFrame': 'Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days', 'eventGroups': [{'id': 'EG000', 'title': 'Fluticasone Maintenance', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).', 'otherNumAtRisk': 1243, 'otherNumAffected': 464, 'seriousNumAtRisk': 1243, 'seriousNumAffected': 292}, {'id': 'EG001', 'title': 'Fluticasone Withdrawal', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).', 'otherNumAtRisk': 1242, 'otherNumAffected': 458, 'seriousNumAtRisk': 1242, 'seriousNumAffected': 300}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 93}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 80}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 410}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 413}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Anaemia macrocytic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Aortic valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Bundle branch block right', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Cardiac asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Cardiac disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Congestive cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Cor pulmonale', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Cor pulmonale chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Hypertensive heart disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Right ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Stress cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Tachyarrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Deafness unilateral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Angle closure glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Pterygium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Colonic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Gastric ulcer perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Gastroduodenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Oesophageal food impaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Salivary gland calculus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Impaired healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'General 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0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Malignant neoplasm of unknown primary site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Maxillofacial sinus neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 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1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Non-small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Oropharyngeal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Prostatic adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Renal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, 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and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Squamous cell carcinoma of lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, 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'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Embolic cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Hypoxic-ischaemic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Intercostal neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Ischaemic cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Meningorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Radiculitis cervical', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Bipolar I disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Panic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Focal segmental glomerulosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Mesangioproliferative glomerulonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Renal failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Urethral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Urinary 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'numAtRisk': 1242, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Asphyxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Bullous lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 154}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 180}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Chronic respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Hypercapnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Laryngeal leukoplakia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Nasal polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Alcohol detoxification', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Angioplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Hip arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Oxygen supplementation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Transurethral prostatectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Aortic arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Aortic thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Intermittent claudication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Subclavian artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1243, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1242, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to First Moderate or Severe On-treatment COPD Exacerbation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1243', 'groupId': 'OG000'}, {'value': '1242', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Maintenance', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).'}, {'id': 'OG001', 'title': 'Fluticasone Withdrawal', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).'}], 'classes': [{'categories': [{'measurements': [{'value': '107.0', 'groupId': 'OG000', 'lowerLimit': '94.0', 'upperLimit': '124.0'}, {'value': '110.0', 'groupId': 'OG001', 'lowerLimit': '99.0', 'upperLimit': '120.0'}]}]}], 'analyses': [{'pValue': '0.3497', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.058', 'ciLowerLimit': '0.941', 'ciUpperLimit': '1.189', 'pValueComment': 'Two-sided p-value to test superiority of fluticasone maintenance over fluticasone withdrawal if non-inferiority shown.', 'estimateComment': 'Ratio calculated as fluticasone withdrawal divided by fluticasone maintenance', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': "Wald's chi-square test", 'testedNonInferiority': True, 'nonInferiorityComment': 'Upper limit of 95% confidence interval (CI) \\<1.2 indicates non-inferiority of Fluticasone withdrawal compared with Fluticasone maintenance'}], 'paramType': 'NUMBER', 'timeFrame': 'During randomised treatment, up to 488 days', 'description': 'A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as an increase or new onset of ≥2 lower respiratory symptoms related to COPD, with ≥1 symptom lasting ≥3 days, requiring a change in treatment. Lower respiratory symptoms included shortness of breath, sputum production (volume), sputum purulence, cough, wheezing and chest tightness. A change in treatment included: hospitalisation/treatment in an urgent care unit, prescription of antibiotics and/or systemic steroids or a significant change of prescribed respiratory medication such as theophyllines, long-acting beta-agonists or inhaled corticosteroids. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for \\>6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.The "measure type" displays the 25th percentile and its 95% confidence interval.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Number of Moderate or Severe On-treatment COPD Exacerbations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1243', 'groupId': 'OG000'}, {'value': '1242', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Maintenance', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).'}, {'id': 'OG001', 'title': 'Fluticasone Withdrawal', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.91', 'groupId': 'OG000', 'lowerLimit': '0.83', 'upperLimit': '0.99'}, {'value': '0.95', 'groupId': 'OG001', 'lowerLimit': '0.87', 'upperLimit': '1.04'}]}]}], 'analyses': [{'pValue': '0.4441', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.18', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.06', 'estimateComment': 'Ratio calculated as fluticasone withdrawal divided by fluticasone maintenance', 'statisticalMethod': 'Regression, Negative Binomial', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for log time at risk using log link function', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'During randomised treatment, up to 488 days', 'description': 'Number of moderate or severe on-treatment COPD exacerbations, based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined and counted as moderate or severe if ≥1 of the contributing exacerbation events was moderate or severe. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for \\>6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. Exacerbations were considered moderate if they required prescription of antibiotics and/or systemic steroids.\n\nMeasured values show adjusted mean event rate.', 'unitOfMeasure': 'exacerbations per patient-year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients With ≥1 Moderate or Severe On-treatment COPD Exacerbation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1243', 'groupId': 'OG000'}, {'value': '1242', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Maintenance', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).'}, {'id': 'OG001', 'title': 'Fluticasone Withdrawal', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).'}], 'classes': [{'categories': [{'measurements': [{'value': '44.2', 'groupId': 'OG000'}, {'value': '46.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2269', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'During randomised treatment, up to 488 days', 'description': 'Presence (yes vs no) of at least one moderate or severe on-treatment COPD exacerbation, displayed as a percentage. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for \\>6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. Exacerbations were considered moderate if they required prescription of antibiotics and/or systemic steroids.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Time to First Severe On-treatment COPD Exacerbation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1243', 'groupId': 'OG000'}, {'value': '1242', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Maintenance', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).'}, {'id': 'OG001', 'title': 'Fluticasone Withdrawal', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable as not enough events during the timeframe.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '419.0', 'comment': 'Not estimable as not enough events during the timeframe.', 'groupId': 'OG001', 'lowerLimit': '379.0', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.0849', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.202', 'ciLowerLimit': '0.975', 'ciUpperLimit': '1.481', 'estimateComment': 'Ratio calculated as fluticasone withdrawal divided by fluticasone maintenance', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "Wald's chi-square test", 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'During randomised treatment, up to 488 days', 'description': 'Time to first severe on-treatment COPD exacerbation. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for \\>6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.\n\nThe "measure type" displays the 25th percentile and its 95% confidence interval.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Number of Severe On-treatment COPD Exacerbations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1243', 'groupId': 'OG000'}, {'value': '1242', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Maintenance', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).'}, {'id': 'OG001', 'title': 'Fluticasone Withdrawal', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.20', 'groupId': 'OG000', 'lowerLimit': '0.17', 'upperLimit': '0.23'}, {'value': '0.23', 'groupId': 'OG001', 'lowerLimit': '0.19', 'upperLimit': '0.27'}]}]}], 'analyses': [{'pValue': '0.2291', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.15', 'ciLowerLimit': '0.92', 'ciUpperLimit': '1.45', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.13', 'estimateComment': 'Ratio calculated as fluticasone withdrawal divided by fluticasone maintenance', 'statisticalMethod': 'Regression, Negative Binomial', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for log time at risk using log link function', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'During randomised treatment, up to 488 days', 'description': 'Number of severe on-treatment COPD exacerbations based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined and counted as severe if ≥1 of the contributing exacerbation events was severe. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for \\>6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.\n\nMeasured values show adjusted event rate.', 'unitOfMeasure': 'exacerbations per patient-year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients With at Least One Severe On-treatment COPD Exacerbation.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1243', 'groupId': 'OG000'}, {'value': '1242', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Maintenance', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).'}, {'id': 'OG001', 'title': 'Fluticasone Withdrawal', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).'}], 'classes': [{'categories': [{'measurements': [{'value': '13.4', 'groupId': 'OG000'}, {'value': '15.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2083', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'During randomised treatment, up to 488 days', 'description': 'Presence (yes vs no) of at least one severe on-treatment COPD exacerbation, displayed as a percentage. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for \\>6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Time to First On-treatment COPD Exacerbation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1243', 'groupId': 'OG000'}, {'value': '1242', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Maintenance', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).'}, {'id': 'OG001', 'title': 'Fluticasone Withdrawal', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).'}], 'classes': [{'categories': [{'measurements': [{'value': '365.0', 'comment': 'Not estimable as not enough events during the timeframe.', 'groupId': 'OG000', 'lowerLimit': '309.0', 'upperLimit': 'NA'}, {'value': '346.0', 'comment': 'Not estimable as not enough events during the timeframe.', 'groupId': 'OG001', 'lowerLimit': '302.0', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.5562', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.035', 'ciLowerLimit': '0.923', 'ciUpperLimit': '1.160', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'During randomised treatment, up to 488 days', 'description': 'Time to first on-treatment COPD exacerbation of any severity. The "measure type" displays the 25th percentile and its 95% confidence interval.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Number of On-treatment COPD Exacerbations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1243', 'groupId': 'OG000'}, {'value': '1242', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Maintenance', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).'}, {'id': 'OG001', 'title': 'Fluticasone Withdrawal', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.03', 'groupId': 'OG000', 'lowerLimit': '0.95', 'upperLimit': '1.12'}, {'value': '1.08', 'groupId': 'OG001', 'lowerLimit': '0.99', 'upperLimit': '1.17'}]}]}], 'analyses': [{'pValue': '0.4342', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.18', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.06', 'estimateComment': 'Ratio calculated as fluticasone withdrawal divided by fluticasone maintenance', 'statisticalMethod': 'Regression, Negative binomial', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for log time at risk using log link function', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'During randomised treatment, up to 488 days', 'description': 'Number of on-treatment COPD exacerbations of any severity, based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined.\n\nMeasured values show adjusted event rate.', 'unitOfMeasure': 'exacerbations per patient-year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients With at Least One On-treatment COPD Exacerbation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1243', 'groupId': 'OG000'}, {'value': '1242', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Maintenance', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).'}, {'id': 'OG001', 'title': 'Fluticasone Withdrawal', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).'}], 'classes': [{'categories': [{'measurements': [{'value': '46.9', 'groupId': 'OG000'}, {'value': '49.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3155', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'During randomised treatment, up to 488 days', 'description': 'Presence (yes vs no) of at least one on-treatment COPD exacerbation of any severity, displayed as a percentage.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Severity of On-treatment COPD Exacerbations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1243', 'groupId': 'OG000'}, {'value': '1242', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Maintenance', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).'}, {'id': 'OG001', 'title': 'Fluticasone Withdrawal', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).'}], 'classes': [{'title': 'None and patient completed randomised treatment', 'categories': [{'measurements': [{'value': '42.9', 'groupId': 'OG000'}, {'value': '41.2', 'groupId': 'OG001'}]}]}, {'title': 'None and patient discontinued randomised treatment', 'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000'}, {'value': '9.8', 'groupId': 'OG001'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '2.3', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '30.8', 'groupId': 'OG000'}, {'value': '31.5', 'groupId': 'OG001'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '13.4', 'groupId': 'OG000'}, {'value': '15.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During randomised treatment, up to 488 days', 'description': 'Severity of on-treatment COPD exacerbations: for each patient, the worst applicable category was taken (i.e. none, mild, moderate or severe)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Change in On-treatment Lung Function as Measured by Trough FEV1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1243', 'groupId': 'OG000'}, {'value': '1242', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Maintenance', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).'}, {'id': 'OG001', 'title': 'Fluticasone Withdrawal', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).'}], 'classes': [{'title': 'Week 6 visit (N=1135, 1135)', 'categories': [{'measurements': [{'value': '-0.009', 'spread': '0.0062', 'groupId': 'OG000'}, {'value': '-0.011', 'spread': '0.0062', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 visit (N=1114, 1092)', 'categories': [{'measurements': [{'value': '-0.011', 'spread': '0.0062', 'groupId': 'OG000'}, {'value': '-0.018', 'spread': '0.0063', 'groupId': 'OG001'}]}]}, {'title': 'Week 18 visit (N=1077, 1058)', 'categories': [{'measurements': [{'value': '-0.011', 'spread': '0.0064', 'groupId': 'OG000'}, {'value': '-0.050', 'spread': '0.0064', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 visit (N=970, 935)', 'categories': [{'measurements': [{'value': '-0.016', 'spread': '0.0094', 'groupId': 'OG000'}, {'value': '-0.059', 'spread': '0.0096', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0014', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.043', 'ciLowerLimit': '-0.069', 'ciUpperLimit': '-0.017', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0134', 'estimateComment': 'Difference calculated as fluticasone withdrawal minus fluticasone maintenance', 'groupDescription': 'Week 52 visit', 'statisticalMethod': 'Restricted maximum likelihood', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Repeated measures restricted maximum likelihood', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and week 6, 12, 18 and 52 visits', 'description': 'Change from baseline in on-treatment lung function as measured by trough forced expiratory volume in one second (FEV1); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.', 'unitOfMeasure': 'Litres', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Changes in On-treatment Dyspnoea as Measured by the Modified Medical Research Council (MMRC) Dyspnoea Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1243', 'groupId': 'OG000'}, {'value': '1242', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Maintenance', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).'}, {'id': 'OG001', 'title': 'Fluticasone Withdrawal', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).'}], 'classes': [{'title': 'Week 18 visit (N=1140, 1143)', 'categories': [{'measurements': [{'value': '-0.030', 'spread': '0.022', 'groupId': 'OG000'}, {'value': '-0.001', 'spread': '0.022', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 visit (N=1043, 1019)', 'categories': [{'measurements': [{'value': '-0.028', 'spread': '0.024', 'groupId': 'OG000'}, {'value': '0.035', 'spread': '0.024', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0632', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.064', 'ciLowerLimit': '-0.004', 'ciUpperLimit': '0.131', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.034', 'estimateComment': 'Difference calculated as fluticasone withdrawal minus fluticasone maintenance', 'groupDescription': 'Week 52 visit', 'statisticalMethod': 'Restricted maximum likelihood', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Repeated measures restricted maximum likelihood', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and week 18 and 52 visits', 'description': 'Change from baseline in on-treatment dyspnoea as measured by the Modified Medical Research Council (MMRC) dyspnoea scale; change was calculated as week score minus baseline score. Negative changes from baseline indicate an improvement in health.\n\nScale from 0 to 4:\n\n* 0 = not troubled by breathlessness, except during strenuous exercise\n* 1 = short of breath when hurrying or walking up a slight hill\n* 2 = walks slower than contemporaries on the same level because of breathlessness, or has to stop for breath when walking at own pace\n* 3 = stops for breath after approximately 100 yards, or after a few minutes on the level\n* 4 = too breathless to leave the house, or breathless when dressing or undressing\n\n"No breathlessness" was given a score of -1\n\nStatistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Change in On-treatment Physical Health Status as Determined by Body Mass Index (BMI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1243', 'groupId': 'OG000'}, {'value': '1242', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Maintenance', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).'}, {'id': 'OG001', 'title': 'Fluticasone Withdrawal', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).'}], 'classes': [{'title': 'Week 18 visit (N=1143, 1146)', 'categories': [{'measurements': [{'value': '0.030', 'spread': '0.028', 'groupId': 'OG000'}, {'value': '0.040', 'spread': '0.028', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 visit (N=1047, 1021)', 'categories': [{'measurements': [{'value': '0.004', 'spread': '0.039', 'groupId': 'OG000'}, {'value': '-0.009', 'spread': '0.039', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8137', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.013', 'ciLowerLimit': '-0.122', 'ciUpperLimit': '0.096', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.055', 'estimateComment': 'Difference calculated as fluticasone withdrawal minus fluticasone maintenance', 'groupDescription': 'Week 52 visit', 'statisticalMethod': 'Restricted maximum likelihood', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Repeated measures restricted maximum likelihood', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and week 18 and 52 visits', 'description': 'Change from baseline in on-treatment physical health status as determined by body mass index (BMI); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Change in On-treatment Exercise Capacity Measured by Six-minute Walk Test (6-MWT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1243', 'groupId': 'OG000'}, {'value': '1242', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Maintenance', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).'}, {'id': 'OG001', 'title': 'Fluticasone Withdrawal', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).'}], 'classes': [{'title': 'Week 18 visit (N=1111, 1110)', 'categories': [{'measurements': [{'value': '3.89', 'spread': '1.993', 'groupId': 'OG000'}, {'value': '1.94', 'spread': '1.993', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 visit (N=1013, 987)', 'categories': [{'measurements': [{'value': '3.94', 'spread': '2.231', 'groupId': 'OG000'}, {'value': '0.42', 'spread': '2.252', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2663', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.53', 'ciLowerLimit': '-9.74', 'ciUpperLimit': '2.69', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.170', 'estimateComment': 'Difference calculated as fluticasone withdrawal minus fluticasone maintenance', 'groupDescription': 'Week 52 visit', 'statisticalMethod': 'Restricted maximum likelihood', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Repeated measures restricted maximum likelihood', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and week 18 and 52 visits', 'description': 'Change from baseline in on-treatment exercise capacity measured by six-minute walk test (6-MWT); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Change in On-treatment BODE Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1243', 'groupId': 'OG000'}, {'value': '1242', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Maintenance', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).'}, {'id': 'OG001', 'title': 'Fluticasone Withdrawal', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).'}], 'classes': [{'title': 'Week 18 visit (N=1038, 1024)', 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.03', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 visit (N=931, 907)', 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '0.04', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0033', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.16', 'ciLowerLimit': '0.05', 'ciUpperLimit': '0.27', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.06', 'estimateComment': 'Difference calculated as fluticasone withdrawal minus fluticasone maintenance', 'groupDescription': 'Week 52 visit', 'statisticalMethod': 'Restricted maximum likelihood', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Repeated measures restricted maximum likelihood', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and week 18 and 52 visits', 'description': 'Change from baseline in on-treatment BODE index (Body mass index, airflow Obstruction, Dyspnea and Exercise capacity index), a composite score ranging from 0 (best) to 10 (worst); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Cough Impact Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '364', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Maintenance', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).'}, {'id': 'OG001', 'title': 'Fluticasone Withdrawal', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).'}], 'classes': [{'title': 'Week 12 visit (N=307, 319)', 'categories': [{'measurements': [{'value': '-1.65', 'spread': '0.986', 'groupId': 'OG000'}, {'value': '-1.24', 'spread': '0.968', 'groupId': 'OG001'}]}]}, {'title': 'Week 18 visit (N=302, 312)', 'categories': [{'measurements': [{'value': '-2.87', 'spread': '1.035', 'groupId': 'OG000'}, {'value': '-3.71', 'spread': '1.018', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 visit (N=268, 269)', 'categories': [{'measurements': [{'value': '-4.51', 'spread': '1.063', 'groupId': 'OG000'}, {'value': '-5.54', 'spread': '1.057', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4914', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.03', 'ciLowerLimit': '-3.98', 'ciUpperLimit': '1.91', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.499', 'estimateComment': 'Difference calculated as fluticasone withdrawal minus fluticasone maintenance', 'groupDescription': 'Week 52 visit', 'statisticalMethod': 'Restricted maximum likelihood', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Repeated measures restricted maximum likelihood', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and week 12, 18 and 52 visits', 'description': 'Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Cough impact domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from "not at all/never" to "extremely/always" on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less impact due to cough.\n\nStatistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set who completed CASA-Q'}, {'type': 'SECONDARY', 'title': 'Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Cough Symptoms Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '364', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Maintenance', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).'}, {'id': 'OG001', 'title': 'Fluticasone Withdrawal', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).'}], 'classes': [{'title': 'Week 12 visit (N=309, 318)', 'categories': [{'measurements': [{'value': '-0.32', 'spread': '1.062', 'groupId': 'OG000'}, {'value': '-0.85', 'spread': '1.048', 'groupId': 'OG001'}]}]}, {'title': 'Week 18 visit (N=305, 312)', 'categories': [{'measurements': [{'value': '-1.47', 'spread': '1.103', 'groupId': 'OG000'}, {'value': '-3.34', 'spread': '1.091', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 visit (N=270, 268)', 'categories': [{'measurements': [{'value': '-1.69', 'spread': '1.180', 'groupId': 'OG000'}, {'value': '-3.26', 'spread': '1.180', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3490', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.56', 'ciLowerLimit': '-4.84', 'ciUpperLimit': '1.71', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.669', 'estimateComment': 'Difference calculated as fluticasone withdrawal minus fluticasone maintenance', 'groupDescription': 'Week 52 visit', 'statisticalMethod': 'Restricted maximum likelihood', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Repeated measures restricted maximum likelihood', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and week 12, 18 and 52 visits', 'description': 'Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Cough symptoms domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from "not at all/never" to "a lot/always" on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less symptoms due to cough.\n\nStatistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set who completed CASA-Q'}, {'type': 'SECONDARY', 'title': 'Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Sputum Impact Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '364', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Maintenance', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).'}, {'id': 'OG001', 'title': 'Fluticasone Withdrawal', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).'}], 'classes': [{'title': 'Week 12 visit (N=308, 317)', 'categories': [{'measurements': [{'value': '-2.26', 'spread': '0.996', 'groupId': 'OG000'}, {'value': '-1.63', 'spread': '0.983', 'groupId': 'OG001'}]}]}, {'title': 'Week 18 visit (N=303, 310)', 'categories': [{'measurements': [{'value': '-2.38', 'spread': '0.977', 'groupId': 'OG000'}, {'value': '-3.31', 'spread': '0.967', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 visit (N=267, 267)', 'categories': [{'measurements': [{'value': '-4.29', 'spread': '1.047', 'groupId': 'OG000'}, {'value': '-4.15', 'spread': '1.045', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9262', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.14', 'ciLowerLimit': '-2.77', 'ciUpperLimit': '3.04', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.480', 'estimateComment': 'Difference calculated as fluticasone withdrawal minus fluticasone maintenance', 'groupDescription': 'Week 52 visit', 'statisticalMethod': 'Restricted maximum likelihood', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Repeated measures restricted maximum likelihood', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and week 12, 18 and 52 visits', 'description': 'Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Sputum impact domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from "not at all/never" to "a lot/always" on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less impact due to sputum.\n\nStatistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set who completed CASA-Q'}, {'type': 'SECONDARY', 'title': 'Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Sputum Symptoms Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '364', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Maintenance', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).'}, {'id': 'OG001', 'title': 'Fluticasone Withdrawal', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).'}], 'classes': [{'title': 'Week 12 visit (N=308, 317)', 'categories': [{'measurements': [{'value': '-1.36', 'spread': '1.154', 'groupId': 'OG000'}, {'value': '-1.24', 'spread': '1.139', 'groupId': 'OG001'}]}]}, {'title': 'Week 18 visit (N=302, 311)', 'categories': [{'measurements': [{'value': '-2.71', 'spread': '1.119', 'groupId': 'OG000'}, {'value': '-1.93', 'spread': '1.105', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 visit (N=269, 268)', 'categories': [{'measurements': [{'value': '-5.10', 'spread': '1.212', 'groupId': 'OG000'}, {'value': '-2.45', 'spread': '1.211', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1241', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.64', 'ciLowerLimit': '-0.73', 'ciUpperLimit': '6.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.716', 'estimateComment': 'Difference calculated as fluticasone withdrawal minus fluticasone maintenance', 'groupDescription': 'Week 52 visit', 'statisticalMethod': 'Restricted maximum likelihood', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Repeated measures restricted maximum likelihood', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and week 12, 18 and 52 visits', 'description': 'Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Sputum symptoms domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from "not at all/never" to "extremely/always" on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less symptoms due to sputum.\n\nStatistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set who completed CASA-Q'}, {'type': 'SECONDARY', 'title': 'Change in On-treatment FEV1 as Measured by Home Based Spirometry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1243', 'groupId': 'OG000'}, {'value': '1242', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Maintenance', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).'}, {'id': 'OG001', 'title': 'Fluticasone Withdrawal', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).'}], 'classes': [{'title': 'Week 6 visit (N=893, 939)', 'categories': [{'measurements': [{'value': '-0.049', 'spread': '0.0066', 'groupId': 'OG000'}, {'value': '-0.053', 'spread': '0.0065', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 visit (N=910, 930)', 'categories': [{'measurements': [{'value': '-0.050', 'spread': '0.0068', 'groupId': 'OG000'}, {'value': '-0.056', 'spread': '0.0067', 'groupId': 'OG001'}]}]}, {'title': 'Week 18 visit (N=913, 901)', 'categories': [{'measurements': [{'value': '-0.051', 'spread': '0.0068', 'groupId': 'OG000'}, {'value': '-0.093', 'spread': '0.0068', 'groupId': 'OG001'}]}]}, {'title': 'Week 27 visit (N=863, 843)', 'categories': [{'measurements': [{'value': '-0.056', 'spread': '0.0071', 'groupId': 'OG000'}, {'value': '-0.092', 'spread': '0.0072', 'groupId': 'OG001'}]}]}, {'title': 'Week 36 visit (N=854, 845)', 'categories': [{'measurements': [{'value': '-0.059', 'spread': '0.0074', 'groupId': 'OG000'}, {'value': '-0.099', 'spread': '0.0074', 'groupId': 'OG001'}]}]}, {'title': 'Week 45 visit (N=830, 815)', 'categories': [{'measurements': [{'value': '-0.061', 'spread': '0.0080', 'groupId': 'OG000'}, {'value': '-0.103', 'spread': '0.0080', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 visit (N=785, 788)', 'categories': [{'measurements': [{'value': '-0.067', 'spread': '0.0087', 'groupId': 'OG000'}, {'value': '-0.115', 'spread': '0.0087', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.048', 'ciLowerLimit': '-0.073', 'ciUpperLimit': '-0.024', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0123', 'estimateComment': 'Difference calculated as fluticasone withdrawal minus fluticasone maintenance', 'groupDescription': 'Week 52 visit', 'statisticalMethod': 'Restricted maximum likelihood', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Repeated measures restricted maximum likelihood', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits', 'description': 'Change from baseline in on-treatment Forced Expiratory Volume in One Second (FEV1) as measured by home based spirometry. Change was calculated as week score minus baseline score. The weekly mean was defined as the mean of the measurements taken during the last 7 days prior to the visit date, and was calculated if ≥4 of the 7 days had non-missing measurements. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.', 'unitOfMeasure': 'Litres', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Change in On-treatment FVC as Measured by Home Based Spirometry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1243', 'groupId': 'OG000'}, {'value': '1242', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Maintenance', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).'}, {'id': 'OG001', 'title': 'Fluticasone Withdrawal', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).'}], 'classes': [{'title': 'Week 6 visit (N=893, 939)', 'categories': [{'measurements': [{'value': '-0.116', 'spread': '0.0179', 'groupId': 'OG000'}, {'value': '-0.089', 'spread': '0.0177', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 visit (N=910, 930)', 'categories': [{'measurements': [{'value': '-0.113', 'spread': '0.0168', 'groupId': 'OG000'}, {'value': '-0.105', 'spread': '0.0167', 'groupId': 'OG001'}]}]}, {'title': 'Week 18 visit (N=913, 901)', 'categories': [{'measurements': [{'value': '-0.122', 'spread': '0.0177', 'groupId': 'OG000'}, {'value': '-0.124', 'spread': '0.0177', 'groupId': 'OG001'}]}]}, {'title': 'Week 27 visit (N=863, 843)', 'categories': [{'measurements': [{'value': '-0.123', 'spread': '0.0167', 'groupId': 'OG000'}, {'value': '-0.147', 'spread': '0.0167', 'groupId': 'OG001'}]}]}, {'title': 'Week 36 visit (N=854, 845)', 'categories': [{'measurements': [{'value': '-0.135', 'spread': '0.0170', 'groupId': 'OG000'}, {'value': '-0.158', 'spread': '0.0171', 'groupId': 'OG001'}]}]}, {'title': 'Week 45 visit (N=830, 815)', 'categories': [{'measurements': [{'value': '-0.141', 'spread': '0.0174', 'groupId': 'OG000'}, {'value': '-0.168', 'spread': '0.0175', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 visit (N=785, 788)', 'categories': [{'measurements': [{'value': '-0.157', 'spread': '0.0180', 'groupId': 'OG000'}, {'value': '-0.201', 'spread': '0.0180', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0855', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.044', 'ciLowerLimit': '-0.094', 'ciUpperLimit': '0.006', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0255', 'estimateComment': 'Difference calculated as fluticasone withdrawal minus fluticasone maintenance', 'groupDescription': 'Week 52 visit', 'statisticalMethod': 'Restricted maximum likelihood', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Repeated measures restricted maximum likelihood', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits', 'description': 'Change from baseline in on-treatment forced vital capacity (FVC) as measured by home based spirometry. Change was calculated as week score minus baseline score. The weekly mean was defined as the mean of the measurements taken during the last 7 days prior to the visit date, and was calculated if ≥4 of the 7 days had non-missing measurements. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.', 'unitOfMeasure': 'Litres', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Change in On-treatment PEFR as Measured by Home Based Spirometry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1243', 'groupId': 'OG000'}, {'value': '1242', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Maintenance', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).'}, {'id': 'OG001', 'title': 'Fluticasone Withdrawal', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).'}], 'classes': [{'title': 'Week 6 visit (N=893, 939)', 'categories': [{'measurements': [{'value': '-0.228', 'spread': '0.0249', 'groupId': 'OG000'}, {'value': '-0.230', 'spread': '0.0246', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 visit (N=910, 930)', 'categories': [{'measurements': [{'value': '-0.266', 'spread': '0.0253', 'groupId': 'OG000'}, {'value': '-0.290', 'spread': '0.0252', 'groupId': 'OG001'}]}]}, {'title': 'Week 18 visit (N=913, 901)', 'categories': [{'measurements': [{'value': '-0.295', 'spread': '0.0253', 'groupId': 'OG000'}, {'value': '-0.435', 'spread': '0.0254', 'groupId': 'OG001'}]}]}, {'title': 'Week 27 visit (N=863, 843)', 'categories': [{'measurements': [{'value': '-0.319', 'spread': '0.0273', 'groupId': 'OG000'}, {'value': '-0.430', 'spread': '0.0274', 'groupId': 'OG001'}]}]}, {'title': 'Week 36 visit (N=854, 845)', 'categories': [{'measurements': [{'value': '-0.352', 'spread': '0.0278', 'groupId': 'OG000'}, {'value': '-0.473', 'spread': '0.0278', 'groupId': 'OG001'}]}]}, {'title': 'Week 45 visit (N=830, 815)', 'categories': [{'measurements': [{'value': '-0.368', 'spread': '0.0297', 'groupId': 'OG000'}, {'value': '-0.490', 'spread': '0.0298', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 visit (N=785, 788)', 'categories': [{'measurements': [{'value': '-0.377', 'spread': '0.0318', 'groupId': 'OG000'}, {'value': '-0.538', 'spread': '0.0318', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.161', 'ciLowerLimit': '-0.249', 'ciUpperLimit': '-0.073', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0450', 'estimateComment': 'Difference calculated as fluticasone withdrawal minus fluticasone maintenance', 'groupDescription': 'Week 52 visit', 'statisticalMethod': 'Restricted maximum likelihood', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Repeated measures restricted maximum likelihood', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits', 'description': 'Change from baseline in on-treatment peak expiratory flow rate (PEFR) as measured by home based spirometry; change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.', 'unitOfMeasure': 'Litres/sec', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Activity Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1243', 'groupId': 'OG000'}, {'value': '1242', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Maintenance', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).'}, {'id': 'OG001', 'title': 'Fluticasone Withdrawal', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).'}], 'classes': [{'title': 'Week 27 visit (N=1002, 988)', 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.492', 'groupId': 'OG000'}, {'value': '0.85', 'spread': '0.496', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 visit (N=942, 916)', 'categories': [{'measurements': [{'value': '-0.19', 'spread': '0.512', 'groupId': 'OG000'}, {'value': '0.78', 'spread': '0.518', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1838', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '-0.46', 'ciUpperLimit': '2.40', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.728', 'estimateComment': 'Difference calculated as fluticasone withdrawal minus fluticasone maintenance', 'groupDescription': 'Week 52 visit', 'statisticalMethod': 'Restricted maximum likelihood', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Repeated measures restricted maximum likelihood', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and week 27 and 52 visits', 'description': 'Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Activity domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score.\n\nStatistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Impact Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1243', 'groupId': 'OG000'}, {'value': '1242', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Maintenance', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).'}, {'id': 'OG001', 'title': 'Fluticasone Withdrawal', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).'}], 'classes': [{'title': 'Week 27 visit (N=1004, 998)', 'categories': [{'measurements': [{'value': '-0.78', 'spread': '0.456', 'groupId': 'OG000'}, {'value': '0.35', 'spread': '0.457', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 visit (N=946, 921)', 'categories': [{'measurements': [{'value': '-0.08', 'spread': '0.494', 'groupId': 'OG000'}, {'value': '1.27', 'spread': '0.499', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0551', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.35', 'ciLowerLimit': '-0.03', 'ciUpperLimit': '2.72', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.702', 'estimateComment': 'Difference calculated as fluticasone withdrawal minus fluticasone maintenance', 'groupDescription': 'Week 52 visit', 'statisticalMethod': 'Restricted maximum likelihood', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Repeated measures restricted maximum likelihood', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and week 27 and 52 visits', 'description': 'Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Impact Domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score.\n\nStatistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Symptoms Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1243', 'groupId': 'OG000'}, {'value': '1242', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Maintenance', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).'}, {'id': 'OG001', 'title': 'Fluticasone Withdrawal', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).'}], 'classes': [{'title': 'Week 27 visit (N=1010, 998)', 'categories': [{'measurements': [{'value': '0.12', 'spread': '0.583', 'groupId': 'OG000'}, {'value': '0.62', 'spread': '0.586', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 visit (N=955, 921)', 'categories': [{'measurements': [{'value': '0.51', 'spread': '0.593', 'groupId': 'OG000'}, {'value': '1.11', 'spread': '0.602', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4804', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.60', 'ciLowerLimit': '-1.06', 'ciUpperLimit': '2.25', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.845', 'estimateComment': 'Difference calculated as fluticasone withdrawal minus fluticasone maintenance', 'groupDescription': 'Week 52 visit', 'statisticalMethod': 'Restricted maximum likelihood', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Repeated measures restricted maximum likelihood', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and week 27 and 52 visits', 'description': 'Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Symptoms domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score.\n\nStatistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1243', 'groupId': 'OG000'}, {'value': '1242', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Maintenance', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).'}, {'id': 'OG001', 'title': 'Fluticasone Withdrawal', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).'}], 'classes': [{'title': 'Week 27 visit (N=996, 986)', 'categories': [{'measurements': [{'value': '-0.42', 'spread': '0.398', 'groupId': 'OG000'}, {'value': '0.55', 'spread': '0.401', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 visit (N=939, 913)', 'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.432', 'groupId': 'OG000'}, {'value': '1.15', 'spread': '0.437', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0467', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.22', 'ciLowerLimit': '0.02', 'ciUpperLimit': '2.43', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.614', 'estimateComment': 'Difference calculated as fluticasone withdrawal minus fluticasone maintenance', 'groupDescription': 'Week 52 visit', 'statisticalMethod': 'Restricted maximum likelihood', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Repeated measures restricted maximum likelihood', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and week 27 and 52 visits', 'description': 'Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Total score. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score.\n\nStatistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Change in On-treatment Physician Global Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1243', 'groupId': 'OG000'}, {'value': '1242', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Maintenance', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).'}, {'id': 'OG001', 'title': 'Fluticasone Withdrawal', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).'}], 'classes': [{'title': 'Week 27 visit (N=1113, 1093)', 'categories': [{'measurements': [{'value': '0.10', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.03', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 visit (N=1041, 1014)', 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.03', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0223', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.21', 'ciUpperLimit': '-0.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.05', 'estimateComment': 'Difference calculated as fluticasone withdrawal minus fluticasone maintenance', 'groupDescription': 'Week 52 visit', 'statisticalMethod': 'Restricted maximum likelihood', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Repeated measures restricted maximum likelihood', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and week 27 and 52 visits', 'description': "Change from baseline in on-treatment physician global evaluation. The evaluation reflected the physician's opinion of the patient's overall condition and was based on the need for concomitant medication, the number and severity of exacerbations, the severity of cough, the ability to exercise, the amount of wheezing and any other relevant clinical observations. Patients were graded on a scale of 1 (poor) to 8 (excellent). Change was calculated as week score minus baseline score.\n\nStatistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fluticasone Maintenance', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).'}, {'id': 'FG001', 'title': 'Fluticasone Withdrawal', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1244'}, {'groupId': 'FG001', 'numSubjects': '1244'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Includes open-label treatment if appropriate', 'groupId': 'FG000', 'numSubjects': '1016'}, {'comment': 'Includes open-label treatment if appropriate', 'groupId': 'FG001', 'numSubjects': '1011'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '228'}, {'groupId': 'FG001', 'numSubjects': '233'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '108'}, {'groupId': 'FG001', 'numSubjects': '101'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'Other reason not defined above', 'reasons': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'Not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1243', 'groupId': 'BG000'}, {'value': '1242', 'groupId': 'BG001'}, {'value': '2485', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Fluticasone Maintenance', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).'}, {'id': 'BG001', 'title': 'Fluticasone Withdrawal', 'description': '18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.6', 'spread': '8.6', 'groupId': 'BG000'}, {'value': '64.0', 'spread': '8.4', 'groupId': 'BG001'}, {'value': '63.8', 'spread': '8.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '230', 'groupId': 'BG000'}, {'value': '206', 'groupId': 'BG001'}, {'value': '436', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1013', 'groupId': 'BG000'}, {'value': '1036', 'groupId': 'BG001'}, {'value': '2049', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Treated Set (TS) which included all patients who were dispensed study medication and were documented to have taken ≥1 dose of randomised treatment.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2488}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'dispFirstSubmitDate': '2014-04-30', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-09', 'studyFirstSubmitDate': '2009-09-10', 'dispFirstSubmitQcDate': '2014-04-30', 'resultsFirstSubmitDate': '2014-12-23', 'studyFirstSubmitQcDate': '2009-09-10', 'dispFirstPostDateStruct': {'date': '2014-05-16', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-02-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-02-09', 'studyFirstPostDateStruct': {'date': '2009-09-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to First Moderate or Severe On-treatment COPD Exacerbation', 'timeFrame': 'During randomised treatment, up to 488 days', 'description': 'A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as an increase or new onset of ≥2 lower respiratory symptoms related to COPD, with ≥1 symptom lasting ≥3 days, requiring a change in treatment. Lower respiratory symptoms included shortness of breath, sputum production (volume), sputum purulence, cough, wheezing and chest tightness. A change in treatment included: hospitalisation/treatment in an urgent care unit, prescription of antibiotics and/or systemic steroids or a significant change of prescribed respiratory medication such as theophyllines, long-acting beta-agonists or inhaled corticosteroids. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for \\>6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.The "measure type" displays the 25th percentile and its 95% confidence interval.'}], 'secondaryOutcomes': [{'measure': 'Number of Moderate or Severe On-treatment COPD Exacerbations', 'timeFrame': 'During randomised treatment, up to 488 days', 'description': 'Number of moderate or severe on-treatment COPD exacerbations, based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined and counted as moderate or severe if ≥1 of the contributing exacerbation events was moderate or severe. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for \\>6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. Exacerbations were considered moderate if they required prescription of antibiotics and/or systemic steroids.\n\nMeasured values show adjusted mean event rate.'}, {'measure': 'Proportion of Patients With ≥1 Moderate or Severe On-treatment COPD Exacerbation', 'timeFrame': 'During randomised treatment, up to 488 days', 'description': 'Presence (yes vs no) of at least one moderate or severe on-treatment COPD exacerbation, displayed as a percentage. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for \\>6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. Exacerbations were considered moderate if they required prescription of antibiotics and/or systemic steroids.'}, {'measure': 'Time to First Severe On-treatment COPD Exacerbation', 'timeFrame': 'During randomised treatment, up to 488 days', 'description': 'Time to first severe on-treatment COPD exacerbation. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for \\>6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.\n\nThe "measure type" displays the 25th percentile and its 95% confidence interval.'}, {'measure': 'Number of Severe On-treatment COPD Exacerbations', 'timeFrame': 'During randomised treatment, up to 488 days', 'description': 'Number of severe on-treatment COPD exacerbations based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined and counted as severe if ≥1 of the contributing exacerbation events was severe. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for \\>6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.\n\nMeasured values show adjusted event rate.'}, {'measure': 'Proportion of Patients With at Least One Severe On-treatment COPD Exacerbation.', 'timeFrame': 'During randomised treatment, up to 488 days', 'description': 'Presence (yes vs no) of at least one severe on-treatment COPD exacerbation, displayed as a percentage. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for \\>6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.'}, {'measure': 'Time to First On-treatment COPD Exacerbation', 'timeFrame': 'During randomised treatment, up to 488 days', 'description': 'Time to first on-treatment COPD exacerbation of any severity. The "measure type" displays the 25th percentile and its 95% confidence interval.'}, {'measure': 'Number of On-treatment COPD Exacerbations', 'timeFrame': 'During randomised treatment, up to 488 days', 'description': 'Number of on-treatment COPD exacerbations of any severity, based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined.\n\nMeasured values show adjusted event rate.'}, {'measure': 'Proportion of Patients With at Least One On-treatment COPD Exacerbation', 'timeFrame': 'During randomised treatment, up to 488 days', 'description': 'Presence (yes vs no) of at least one on-treatment COPD exacerbation of any severity, displayed as a percentage.'}, {'measure': 'Severity of On-treatment COPD Exacerbations', 'timeFrame': 'During randomised treatment, up to 488 days', 'description': 'Severity of on-treatment COPD exacerbations: for each patient, the worst applicable category was taken (i.e. none, mild, moderate or severe)'}, {'measure': 'Change in On-treatment Lung Function as Measured by Trough FEV1', 'timeFrame': 'Baseline and week 6, 12, 18 and 52 visits', 'description': 'Change from baseline in on-treatment lung function as measured by trough forced expiratory volume in one second (FEV1); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.'}, {'measure': 'Changes in On-treatment Dyspnoea as Measured by the Modified Medical Research Council (MMRC) Dyspnoea Scale', 'timeFrame': 'Baseline and week 18 and 52 visits', 'description': 'Change from baseline in on-treatment dyspnoea as measured by the Modified Medical Research Council (MMRC) dyspnoea scale; change was calculated as week score minus baseline score. Negative changes from baseline indicate an improvement in health.\n\nScale from 0 to 4:\n\n* 0 = not troubled by breathlessness, except during strenuous exercise\n* 1 = short of breath when hurrying or walking up a slight hill\n* 2 = walks slower than contemporaries on the same level because of breathlessness, or has to stop for breath when walking at own pace\n* 3 = stops for breath after approximately 100 yards, or after a few minutes on the level\n* 4 = too breathless to leave the house, or breathless when dressing or undressing\n\n"No breathlessness" was given a score of -1\n\nStatistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.'}, {'measure': 'Change in On-treatment Physical Health Status as Determined by Body Mass Index (BMI)', 'timeFrame': 'Baseline and week 18 and 52 visits', 'description': 'Change from baseline in on-treatment physical health status as determined by body mass index (BMI); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.'}, {'measure': 'Change in On-treatment Exercise Capacity Measured by Six-minute Walk Test (6-MWT)', 'timeFrame': 'Baseline and week 18 and 52 visits', 'description': 'Change from baseline in on-treatment exercise capacity measured by six-minute walk test (6-MWT); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.'}, {'measure': 'Change in On-treatment BODE Index', 'timeFrame': 'Baseline and week 18 and 52 visits', 'description': 'Change from baseline in on-treatment BODE index (Body mass index, airflow Obstruction, Dyspnea and Exercise capacity index), a composite score ranging from 0 (best) to 10 (worst); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.'}, {'measure': 'Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Cough Impact Domain', 'timeFrame': 'Baseline and week 12, 18 and 52 visits', 'description': 'Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Cough impact domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from "not at all/never" to "extremely/always" on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less impact due to cough.\n\nStatistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.'}, {'measure': 'Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Cough Symptoms Domain', 'timeFrame': 'Baseline and week 12, 18 and 52 visits', 'description': 'Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Cough symptoms domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from "not at all/never" to "a lot/always" on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less symptoms due to cough.\n\nStatistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.'}, {'measure': 'Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Sputum Impact Domain', 'timeFrame': 'Baseline and week 12, 18 and 52 visits', 'description': 'Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Sputum impact domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from "not at all/never" to "a lot/always" on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less impact due to sputum.\n\nStatistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.'}, {'measure': 'Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Sputum Symptoms Domain', 'timeFrame': 'Baseline and week 12, 18 and 52 visits', 'description': 'Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Sputum symptoms domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from "not at all/never" to "extremely/always" on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less symptoms due to sputum.\n\nStatistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.'}, {'measure': 'Change in On-treatment FEV1 as Measured by Home Based Spirometry', 'timeFrame': 'Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits', 'description': 'Change from baseline in on-treatment Forced Expiratory Volume in One Second (FEV1) as measured by home based spirometry. Change was calculated as week score minus baseline score. The weekly mean was defined as the mean of the measurements taken during the last 7 days prior to the visit date, and was calculated if ≥4 of the 7 days had non-missing measurements. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.'}, {'measure': 'Change in On-treatment FVC as Measured by Home Based Spirometry', 'timeFrame': 'Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits', 'description': 'Change from baseline in on-treatment forced vital capacity (FVC) as measured by home based spirometry. Change was calculated as week score minus baseline score. The weekly mean was defined as the mean of the measurements taken during the last 7 days prior to the visit date, and was calculated if ≥4 of the 7 days had non-missing measurements. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.'}, {'measure': 'Change in On-treatment PEFR as Measured by Home Based Spirometry', 'timeFrame': 'Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits', 'description': 'Change from baseline in on-treatment peak expiratory flow rate (PEFR) as measured by home based spirometry; change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.'}, {'measure': 'Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Activity Domain', 'timeFrame': 'Baseline and week 27 and 52 visits', 'description': 'Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Activity domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score.\n\nStatistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.'}, {'measure': 'Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Impact Domain', 'timeFrame': 'Baseline and week 27 and 52 visits', 'description': 'Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Impact Domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score.\n\nStatistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.'}, {'measure': 'Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Symptoms Domain', 'timeFrame': 'Baseline and week 27 and 52 visits', 'description': 'Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Symptoms domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score.\n\nStatistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.'}, {'measure': 'Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Total Score', 'timeFrame': 'Baseline and week 27 and 52 visits', 'description': 'Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Total score. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score.\n\nStatistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.'}, {'measure': 'Change in On-treatment Physician Global Evaluation', 'timeFrame': 'Baseline and week 27 and 52 visits', 'description': "Change from baseline in on-treatment physician global evaluation. The evaluation reflected the physician's opinion of the patient's overall condition and was based on the need for concomitant medication, the number and severity of exacerbations, the severity of cough, the ability to exercise, the amount of wheezing and any other relevant clinical observations. Patients were graded on a scale of 1 (poor) to 8 (excellent). Change was calculated as week score minus baseline score.\n\nStatistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest."}]}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'referencesModule': {'references': [{'pmid': '32943047', 'type': 'DERIVED', 'citation': 'Singh D, Wedzicha JA, Siddiqui S, de la Hoz A, Xue W, Magnussen H, Miravitlles M, Chalmers JD, Calverley PMA. Blood eosinophils as a biomarker of future COPD exacerbation risk: pooled data from 11 clinical trials. Respir Res. 2020 Sep 17;21(1):240. doi: 10.1186/s12931-020-01482-1.'}, {'pmid': '30545350', 'type': 'DERIVED', 'citation': 'Watz H, Tetzlaff K, Magnussen H, Mueller A, Rodriguez-Roisin R, Wouters EFM, Vogelmeier C, Calverley PMA. Spirometric changes during exacerbations of COPD: a post hoc analysis of the WISDOM trial. Respir Res. 2018 Dec 13;19(1):251. doi: 10.1186/s12931-018-0944-3.'}, {'pmid': '27066739', 'type': 'DERIVED', 'citation': 'Watz H, Tetzlaff K, Wouters EF, Kirsten A, Magnussen H, Rodriguez-Roisin R, Vogelmeier C, Fabbri LM, Chanez P, Dahl R, Disse B, Finnigan H, Calverley PM. Blood eosinophil count and exacerbations in severe chronic obstructive pulmonary disease after withdrawal of inhaled corticosteroids: a post-hoc analysis of the WISDOM trial. Lancet Respir Med. 2016 May;4(5):390-8. doi: 10.1016/S2213-2600(16)00100-4. Epub 2016 Apr 7.'}, {'pmid': '25196117', 'type': 'DERIVED', 'citation': 'Magnussen H, Disse B, Rodriguez-Roisin R, Kirsten A, Watz H, Tetzlaff K, Towse L, Finnigan H, Dahl R, Decramer M, Chanez P, Wouters EF, Calverley PM; WISDOM Investigators. Withdrawal of inhaled glucocorticoids and exacerbations of COPD. N Engl J Med. 2014 Oct 2;371(14):1285-94. doi: 10.1056/NEJMoa1407154. Epub 2014 Sep 8.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomised study to be conducted in patients with severe to very severe Chronic Obstructive Pulmonary Disease (COPD) to establish whether there is a need for these patients to be continuously treated with an inhaled corticosteroid on top of two potent long-acting bronchodilators. The study also aims to identify the type of patients who are likely to benefit from inhaled corticosteroid maintenance therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Male or female aged 40 years or more\n2. Severe to very severe chronic obstructive pulmonary disease (COPD)\n3. Current or ex-smoker with smoking history of at least 10 pack years\n4. At least one documented exacerbation of COPD in previous year\n\nExclusion criteria:\n\n1. Significant diseases other than COPD; significant alcohol or drug abuse\n2. Current clinical diagnosis of asthma requiring steroid treatment\n3. History of thoracotomy with pulmonary resection\n4. Regular use of daytime oxygen\n5. Recent history (within 3 months) of myocardial infarction\n6. Recent (within 6 weeks) respiratory infection or COPD exacerbation\n7. Recent (within 6 weeks) treatment with systemic corticosteroids at doses in excess of 5milligram / day\n8. Recent (within 3 months) unstable or life-threatening cardiac arrhythmia requiring intervention\n9. Recent (within 1 year) hospitalisation for cardiac failure\n10. Malignancy requiring chemotherapy or radiotherapy\n11. Clinical diagnosis of bronchiectasis\n12. Pregnant or nursing women\n13. Known hypersensitivity to study drugs\n14. Current or recent (within 30 days) participation in another clinical study\n15. Current participation in or recent completion (within 4 weeks) of a pulmonary rehabilitation program'}, 'identificationModule': {'nctId': 'NCT00975195', 'briefTitle': 'Inhaled Corticosteroid Withdrawal in Patients With Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Randomised, Double-blind, Active-controlled Study to Evaluate the Impact of Stepwise Withdrawal of Inhaled Corticosteroid Treatment in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease (COPD) on Optimized Bronchodilator Therapy', 'orgStudyIdInfo': {'id': '352.2046'}, 'secondaryIdInfos': [{'id': '2007-002522-29', 'type': 'EUDRACT_NUMBER', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'fluticasone high dose', 'description': 'fluticasone priopionate high dose and tiotropium inhalation and salmeterol xinafoate', 'interventionNames': ['Drug: tiotropium inhalation', 'Drug: salmeterol xinafoate', 'Drug: fluticasone propionate']}, {'type': 'EXPERIMENTAL', 'label': 'fluticasone medium & low doses', 'description': 'fluticasone priopionate medium and high doses; and tiotropium inhalation; and salmeterol xinafoate; and placebo matched to fluticasone priopionate', 'interventionNames': ['Drug: tiotropium inhalation', 'Drug: salmeterol xinafoate', 'Drug: fluticasone propionate', 'Drug: placebo matched for fluticasone propionate']}], 'interventions': [{'name': 'tiotropium inhalation', 'type': 'DRUG', 'armGroupLabels': ['fluticasone high dose', 'fluticasone medium & low doses']}, {'name': 'salmeterol xinafoate', 'type': 'DRUG', 'armGroupLabels': ['fluticasone high dose', 'fluticasone medium & low doses']}, {'name': 'fluticasone propionate', 'type': 'DRUG', 'armGroupLabels': ['fluticasone high dose', 'fluticasone medium & low doses']}, {'name': 'placebo matched for fluticasone propionate', 'type': 'DRUG', 'armGroupLabels': ['fluticasone medium & low 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