Viewing Study NCT00970268

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Ignite Creation Date: 2025-12-24 @ 5:43 PM
Ignite Modification Date: 2025-12-29 @ 8:54 AM
Study NCT ID: NCT00970268
Status: COMPLETED
Last Update Posted: 2017-01-06
First Post: 2009-09-01
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Long-term Extension Study of the Safety, Tolerability, and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-36)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D029481', 'term': 'Bronchitis, Chronic'}, {'id': 'D004646', 'term': 'Emphysema'}], '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'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C542859', 'term': 'aclidinium bromide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '1-877-240-9479', 'title': 'AstraZeneca Clinical', 'organization': 'Study Information Center'}, 'certainAgreement': {'otherDetails': 'All data generated in this study will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be prepared at the completion of the study.\n\nPublication of the results by the Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute, Inc.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Event Reporting occurred from August 2009 to November 2010 at 77 study sites (71 in the United States and 6 additional sites in Canada).', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo to Aclidinium Bromide 200 μg', 'description': 'Patients were given 12 weeks of placebo, then switched to Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment', 'otherNumAtRisk': 44, 'otherNumAffected': 36, 'seriousNumAtRisk': 44, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Aclidinium Bromide 200 μg to Aclidinium Bromide 200 μg', 'description': 'Patients were given 12 weeks of Aclidinium bromide, 200 microgram dose, then continued with the 200 microgram dose, oral inhalation twice per day for an additional 52 weeks of treatment.', 'otherNumAtRisk': 93, 'otherNumAffected': 63, 'seriousNumAtRisk': 93, 'seriousNumAffected': 13}, {'id': 'EG002', 'title': 'Placebo to Aclidinium Bromide 400μg', 'description': 'Patients were given 12 weeks of placebo, then switched to Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment', 'otherNumAtRisk': 46, 'otherNumAffected': 28, 'seriousNumAtRisk': 46, 'seriousNumAffected': 7}, {'id': 'EG003', 'title': 'Aclidinium Bromide 400μg to Aclidinium Bromide 400μg', 'description': 'Patients were given 12 weeks of Aclidinium bromide, 400 microgram dose, then continued with the 400 microgram dose twice per day, oral inhalation, for an additional 52 weeks of treatment.', 'otherNumAtRisk': 106, 'otherNumAffected': 64, 'seriousNumAtRisk': 106, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'Chronic obstructive pulmonary disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 24}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Bundle branch block left', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}], 'seriousEvents': [{'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Breast cancer stage II', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Haemorrhagic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Hypovolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Haemorrhoidal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Lobar pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Lung squamous cell carcinoma stage unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Multiple drug overdose accidental', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Small cell lung cancer stage unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Aclidinium Bromide 200 μg', 'description': 'Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment for patients who received 12 weeks of placebo in the lead-in study.'}, {'id': 'OG001', 'title': 'Aclidinium Bromide 200 μg - Aclidinium Bromide 200 μg', 'description': 'Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment in patients who also received 200 micrograms of Aclidinium bromide for 12 weeks in the lead-in study.'}, {'id': 'OG002', 'title': 'Placebo - Aclidinium Bromide 400 μg', 'description': 'Aclidinium bromide, 400 microgram dose, oral inhalation, twice per day for 52 weeks of treatment for patients who received 12 weeks of placebo in the lead-in study.'}, {'id': 'OG003', 'title': 'Aclidinium Bromide 400 μg - Aclidinium Bromide 400 μg', 'description': 'Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment in patients who also received 400 microgram of Aclidinium bromide for 12 weeks in the lead-in study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.035', 'spread': '0.040', 'groupId': 'OG000'}, {'value': '0.069', 'spread': '0.028', 'groupId': 'OG001'}, {'value': '0.069', 'spread': '0.037', 'groupId': 'OG002'}, {'value': '0.056', 'spread': '0.025', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from baseline (visit 2 of lead-in study LAS-MD-33) to 52 weeks', 'description': 'Change From Baseline (Visit 2 of lead-in Study NCT00891462, \\[LAS-MD-33\\]) to Week 52 (Week 64 From Start of NCT00891462, \\[LAS-MD-33\\]) in Morning Predose (Trough) FEV1', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'From the total of 291 patients enrolled, 289 patients (99.3%) received at least 1 dose of double-blind treatment and therefore were included in the Safety Population. Of these patients, 246 (84.5%) had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the ITT Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Peak FEV1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Aclidinium Bromide 200 μg', 'description': 'Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment for patients who received 12 weeks of placebo in the lead-in study.'}, {'id': 'OG001', 'title': 'Aclidinium Bromide 200 μg - Aclidinium Bromide 200 μg', 'description': 'Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment in patients who also received 200 micrograms of Aclidinium bromide for 12 weeks in the lead-in study.'}, {'id': 'OG002', 'title': 'Placebo - Aclidinium Bromide 400 μg', 'description': 'Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment for patients who received 12 weeks of placebo in the lead-in study.'}, {'id': 'OG003', 'title': 'Aclidinium Bromide 400 μg - Aclidinium Bromide 400 μg', 'description': 'Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment in patients who also received 400 micrograms of Aclidinium bromide for 12 weeks in the lead-in study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.111', 'spread': '0.040', 'groupId': 'OG000'}, {'value': '0.213', 'spread': '0.028', 'groupId': 'OG001'}, {'value': '0.222', 'spread': '0.038', 'groupId': 'OG002'}, {'value': '0.219', 'spread': '0.025', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '52 weeks', 'description': 'Change From Baseline (Visit 2 of study NCT00891462, \\[LAS-MD-33\\])in Peak FEV1 in liters at Week 52 (Week 64 from the start of NCT00891462, \\[LAS-MD-33\\]).', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aclidinium Bromide 200 μg', 'description': 'Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment.'}, {'id': 'FG001', 'title': 'Aclidinium Bromide 400 μg', 'description': 'Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '139'}, {'groupId': 'FG001', 'numSubjects': '152'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '96'}, {'groupId': 'FG001', 'numSubjects': '103'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '49'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Other Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COPD Exacerbation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Inclusion/Exclusion Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patient recruitment occurred from August of 2009 to March of 2010 and was by invitation only to patients who had completed study NCT00891462 (LAS-MD-33). In total, there were 77 individual study sites, 71 in the United States and 6 additional sites in Canada.', 'preAssignmentDetails': 'From the total of 291 patients enrolled, 289 patients (99.3%) received at least 1 dose of double-blind treatment and therefore were included in the Safety Population. Of these patients, 246 (84.5%) had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the Intent To Treat (ITT) Population.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '289', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Aclidinium Bromide 200 μg', 'description': 'Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment.'}, {'id': 'BG001', 'title': 'Aclidinium Bromide 400 μg', 'description': 'Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.3', 'spread': '10.1', 'groupId': 'BG000'}, {'value': '64.4', 'spread': '10.0', 'groupId': 'BG001'}, {'value': '63.9', 'spread': '9.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '≥ 40 to < 60 years', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}]}, {'title': '≥ 60 to < 70 years', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}]}, {'title': '≥ 70 years', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '128', 'groupId': 'BG000'}, {'value': '138', 'groupId': 'BG001'}, {'value': '266', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 291}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'dispFirstSubmitDate': '2011-10-04', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-16', 'studyFirstSubmitDate': '2009-09-01', 'dispFirstSubmitQcDate': '2011-10-04', 'resultsFirstSubmitDate': '2012-08-14', 'studyFirstSubmitQcDate': '2009-09-01', 'dispFirstPostDateStruct': {'date': '2011-10-06', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-01-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-08-14', 'studyFirstPostDateStruct': {'date': '2009-09-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)', 'timeFrame': 'Change from baseline (visit 2 of lead-in study LAS-MD-33) to 52 weeks', 'description': 'Change From Baseline (Visit 2 of lead-in Study NCT00891462, \\[LAS-MD-33\\]) to Week 52 (Week 64 From Start of NCT00891462, \\[LAS-MD-33\\]) in Morning Predose (Trough) FEV1'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Peak FEV1', 'timeFrame': '52 weeks', 'description': 'Change From Baseline (Visit 2 of study NCT00891462, \\[LAS-MD-33\\])in Peak FEV1 in liters at Week 52 (Week 64 from the start of NCT00891462, \\[LAS-MD-33\\]).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD', 'Chronic Obstructive Pulmonary Disease', 'Chronic Bronchitis', 'Emphysema', 'Airflow Obstruction, Chronic', 'Chronic Airflow Obstruction', 'Chronic Obstructive Airway Disease', 'Chronic Obstructive Lung Disease'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '23679347', 'type': 'DERIVED', 'citation': "D'Urzo A, Kerwin E, Rennard S, He T, Gil EG, Caracta C. One-year extension study of ACCORD COPD I: safety and efficacy of two doses of twice-daily aclidinium bromide in patients with COPD. COPD. 2013 Aug;10(4):500-10. doi: 10.3109/15412555.2013.791809. Epub 2013 May 16."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this extension study is to evaluate the long-term safety, tolerability, and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe chronic obstructive pulmonary disease (COPD). This study will be 54 weeks in duration; a 52-week double-blind treatment period and 2 week follow-up phone call, following a 12 week lead-in study. All patients will be randomized from the lead-in study at one of two doses of aclidinium.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Completion of a lead-in study (NCT00891462)\n\nExclusion Criteria:\n\n* Use or anticipated use of any medication prohibited in this study\n* Evidence of abnormal clinical laboratory values, vital signs, or electrocardiographic (ECG) results or the presence of abnormities in physical examination findings\n* The presence of anti-cholinergic effects (eg, dry mouth, urinary retention, narrow angle glaucoma)\n* QTcB of \\>500 msec on both the pre-dose and post-dose ECG\n* Women who are pregnant, intend to become pregnant, or are breast-feeding\n* A life expectancy of less than 1 year\n* Noncompliance with IP dosing and/or attending clinic visits during the lead-in study\n* Significant interruption of double-blind therapy during the transition from the lead-in study into the extension study.'}, 'identificationModule': {'nctId': 'NCT00970268', 'briefTitle': 'Long-term Extension Study of the Safety, Tolerability, and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-36)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Long-term, Randomized, Double-blind Extension Study of the Safety, Tolerability, and Efficacy of Aclidinium Bromide at Two Dose Levels When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': 'LAS-MD-36'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Aclidinium bromide dose, inhaled, for 52 weeks of treatment', 'interventionNames': ['Drug: Aclidinium bromide']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Aclidinium bromide dose, inhaled, for 52 weeks of treatment', 'interventionNames': ['Drug: Aclidinium bromide']}], 'interventions': [{'name': 'Aclidinium bromide', 'type': 'DRUG', 'description': 'Aclidinium bromide 200 μg, oral inhalation twice per day for 52 weeks of treatment', 'armGroupLabels': ['1']}, {'name': 'Aclidinium bromide', 'type': 'DRUG', 'description': 'Aclidinium bromide 400 μg, oral inhalation twice per day for 52 weeks of treatment', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Forest Investigative Site 1162', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Forest Investigative Site 1127', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85306', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Forest Investigative Site 0909', 'geoPoint': {'lat': 33.53865, 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States', 'facility': 'Forest Investigative Site 1119', 'geoPoint': {'lat': 42.0898, 'lon': -76.80773}}, {'zip': '11040', 'city': 'New Hyde Park', 'state': 'New York', 'country': 'United States', 'facility': 'Forest Investigative Site 1151', 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Forest Investigative Site 1141', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Forest Investigative Site 1163', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28801', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Forest Investigative Site 1130', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '44718', 'city': 'Canton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Forest Investigative Site 1134', 'geoPoint': {'lat': 40.79895, 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