Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2026-01-05 @ 5:22 PM
Study NCT ID:
NCT00463866
Status:
COMPLETED
Last Update Posted:
2010-03-22
First Post:
2007-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Local Phase 4 Pan-European SMART Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069502', 'term': 'Budesonide, Formoterol Fumarate Drug Combination'}], 'ancestors': [{'id': 'D000068759', 'term': 'Formoterol Fumarate'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D019819', 'term': 'Budesonide'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aztrial_results_posting@astrazeneca.com', 'title': 'Gerard Lynch', 'organization': 'AstraZeneca'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Symbicort® SMART®) 1*2', 'description': '1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.', 'otherNumAtRisk': 4008, 'otherNumAffected': 0, 'seriousNumAtRisk': 4008, 'seriousNumAffected': 77}, {'id': 'EG001', 'title': 'Symbicort® SMART®) 2*2', 'description': '2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.', 'otherNumAtRisk': 4045, 'otherNumAffected': 0, 'seriousNumAtRisk': 4045, 'seriousNumAffected': 88}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Atrioventricular Block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Tachyarrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Exomphalos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Abdominal Pain Lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': "Crohn's Disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Diverticulum Intestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Gastrointestinal Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Inguinal Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pancreatitis Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Reflux Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Salivary Gland Enlargement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Umbilical Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Non-Cardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cholecystitis Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 4}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Food Allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Sarcoidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Bronchiectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Campylobacter Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Chronic Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Epstein-Barr Virus Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Lower Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Lung Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Meningitis Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pilonidal Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Tracheobronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Animal Bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Ankle Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Femur Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Fibula Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Joint Dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Joint Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Ligament Rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Lower Limb Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Meniscus Lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Multiple Drug Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Rib Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Tibia Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Traumatic Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Upper Limb Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Type 2 Diabetes Mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Fibromyalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Intervertebral Disc Protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Muscle Mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Muscle Spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Muscular Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Spinal Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Basal Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Bladder Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Breast Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Metastases To Liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Parathyroid Tumour Benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Prostate Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Uterine Leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Vocal Cord Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Carotid Sinus Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Haemorrhage Intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Haemorrhagic Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Ischaemic Cerebral Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Loss Of Consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Abortion Spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Endometriosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Vaginal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Asthmatic Crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Chronic Obstructive Pulmonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pharyngeal Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Sleep Apnoea Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4008, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4045, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Severe Asthma Exacerbations Per Participant.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4008', 'groupId': 'OG000'}, {'value': '4045', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort® SMART®) 1*2', 'description': '1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.'}, {'id': 'OG001', 'title': 'Symbicort® SMART®) 2*2', 'description': '2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.097', 'spread': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '0.080', 'spread': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '5'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Time to first severe asthma exacerbation, translated to mean number of severe asthma exacerbations per participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.', 'unitOfMeasure': 'Severe exacerbations per participant', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fraction of Participants With Severe Asthma Exacerbation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4008', 'groupId': 'OG000'}, {'value': '4045', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort® SMART®) 1*2', 'description': '1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.'}, {'id': 'OG001', 'title': 'Symbicort® SMART®) 2*2', 'description': '2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.09686', 'spread': '0.08528', 'groupId': 'OG000', 'lowerLimit': '0.08528', 'upperLimit': '0.11'}, {'value': '0.07955', 'spread': '0.06927', 'groupId': 'OG001', 'lowerLimit': '0.06927', 'upperLimit': '0.09135'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months.', 'description': 'The total number of severe asthma exacerbations was calculated for each participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.', 'unitOfMeasure': 'Fraction of participants with event', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Number of Severe Asthma Exacerbations That Led to Hospitalisation and/or Emergency Room Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4008', 'groupId': 'OG000'}, {'value': '4045', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort® SMART®) 1*2', 'description': '1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.'}, {'id': 'OG001', 'title': 'Symbicort® SMART®) 2*2', 'description': '2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0120', 'spread': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '0.0091', 'spread': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months.', 'description': 'A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment. Number of events per participant', 'unitOfMeasure': 'Number of events per participant', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Number of Days Per Participant With Oral/Systemic Glucocorticosteroids During Severe Asthma Exacerbation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4008', 'groupId': 'OG000'}, {'value': '4045', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort® SMART®) 1*2', 'description': '1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.'}, {'id': 'OG001', 'title': 'Symbicort® SMART®) 2*2', 'description': '2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.6', 'spread': '8.1', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '5.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months.', 'description': 'Total number of days with oral/systemic glucocorticosteroids during severe exacerbation calculated for each participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.', 'unitOfMeasure': 'Days per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Daily Number of Inhalations of As-needed Medication.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3880', 'groupId': 'OG000'}, {'value': '3881', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort® SMART®) 1*2', 'description': '1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.'}, {'id': 'OG001', 'title': 'Symbicort® SMART®) 2*2', 'description': '2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.897', 'spread': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9.14'}, {'value': '0.625', 'spread': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '9.07'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'The number of as-needed inhalations was measured 2 times during 2 weeks before 13 weeks and 26 weeks of treatment.', 'unitOfMeasure': 'Inhalations per day per participant', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Inhalations of as-needed medication recorded by 3880 participants in the Symbicort SMART 1\\*2 Reporting Group and recorded by 3881 participants in the Symbicort SMART 2\\*2 Reporting Group'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With a Well Controlled Asthma Week.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3714', 'groupId': 'OG000'}, {'value': '3718', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort® SMART®) 1*2', 'description': '1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.'}, {'id': 'OG001', 'title': 'Symbicort® SMART®) 2*2', 'description': '2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '43.69', 'spread': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '54.26', 'spread': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '100'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months.', 'description': 'The mean percent of participants fulfilling the criteria for a well controlled asthma week in each treatment. A well controlled asthma week is defined as a week with no exacerbations and no night-time awakenings due to asthma and a maximum of 2 days with symptoms and as-needed inhalation use.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this measure recorded by 3714 participants in the Symbicort SMART 1\\*2 Reporting Group and recorded by 3718 participants in the Symbicort SMART 2\\*2 Reporting Group.'}, {'type': 'SECONDARY', 'title': 'Mean Overall Asthma Control Questionnaire (ACQ) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3709', 'groupId': 'OG000'}, {'value': '3735', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort® SMART®) 1*2', 'description': '1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.'}, {'id': 'OG001', 'title': 'Symbicort® SMART®) 2*2', 'description': '2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.18', 'spread': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5.7'}, {'value': '1.089', 'spread': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '5.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months.', 'description': 'The ACQ5 was used. The lower value the better with a full range from 0=no impairment, 6= maximum impairment. Awakenings, morning symptoms, limitations, shortness of breath and wheeze.', 'unitOfMeasure': 'Scores in a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this measure recorded by 3709 participants in the Symbicort SMART 1\\*2 Reporting Group and recorded by 3735 participants in the Symbicort SMART 2\\*2 Reporting Group.'}, {'type': 'SECONDARY', 'title': 'The Mean Total Daily Dose of Steroids From Symbicort.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3874', 'groupId': 'OG000'}, {'value': '3873', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort® SMART®) 1*2', 'description': '1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.'}, {'id': 'OG001', 'title': 'Symbicort® SMART®) 2*2', 'description': '2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '462.96', 'spread': '179.10', 'groupId': 'OG000'}, {'value': '736.58', 'spread': '152.70', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'The mean total daily dose of steroids from Symbicort was calculated as the sum of the maintenance dose and the as-needed dose.', 'unitOfMeasure': 'μg budesonide per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': ': Data for this measure recorded by 3874 participants in the Symbicort SMART 1\\*2 Reporting Group and recorded by 3873 participants in the Symbicort SMART 2\\*2 Reporting Group.'}, {'type': 'SECONDARY', 'title': 'Mean Cost Per Participant Per Country', 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Mean cost is calculated for each country using participants from the whole study and country specific costs. Mean value for the whole study can not be calculated.', 'unitOfMeasure': 'Euro', 'dispersionType': 'Full Range', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Symbicort® SMART®) 1*2', 'description': '1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.'}, {'id': 'FG001', 'title': 'Symbicort® SMART®) 2*2', 'description': '2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '4203 participants randomised. Out of these, 195 had no efficacy data after randomisation.', 'groupId': 'FG000', 'numSubjects': '4008'}, {'comment': '4221 participants randomised. Out of these, 176 had no efficacy data after randomisation.', 'groupId': 'FG001', 'numSubjects': '4045'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3699'}, {'groupId': 'FG001', 'numSubjects': '3705'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '309'}, {'groupId': 'FG001', 'numSubjects': '340'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '93'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '79'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'Incorrect Enrolment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '66'}]}, {'type': 'Severe Non-Compliance to Protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'Safety Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Mis-Randomization of subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '22'}]}]}], 'recruitmentDetails': 'This was a 6-month, randomised, open label, parallel-group, active controlled, multinational study, in participants with uncontrolled/partly controlled asthma, who were symptomatic despite daily use of inhaled glucocorticosteroid (IGCS) with or without Long-Acting β2 agonist (LABA).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4008', 'groupId': 'BG000'}, {'value': '4045', 'groupId': 'BG001'}, {'value': '8053', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Symbicort® SMART®) 1*2', 'description': '1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.'}, {'id': 'BG001', 'title': 'Symbicort® SMART®) 2*2', 'description': '2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.8', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '96'}, {'value': '47.9', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '90'}, {'value': '47.8', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '96'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2483', 'groupId': 'BG000'}, {'value': '2512', 'groupId': 'BG001'}, {'value': '4995', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1525', 'groupId': 'BG000'}, {'value': '1533', 'groupId': 'BG001'}, {'value': '3058', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Treatment with Long-Acting β2 agonist (LABA) at baseline.', 'classes': [{'title': 'Number of participants using LABA at baseline.', 'categories': [{'measurements': [{'value': '3108', 'groupId': 'BG000'}, {'value': '3118', 'groupId': 'BG001'}, {'value': '6226', 'groupId': 'BG002'}]}]}, {'title': 'Number of participants without LABA at baseline.', 'categories': [{'measurements': [{'value': '900', 'groupId': 'BG000'}, {'value': '927', 'groupId': 'BG001'}, {'value': '1827', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Asthma control questionnaire (ACQ5) score at study entry', 'classes': [{'title': 'ACQ5 score at study entry', 'categories': [{'measurements': [{'value': '1.85', 'spread': '0.98', 'groupId': 'BG000'}, {'value': '1.86', 'spread': '1.01', 'groupId': 'BG001'}, {'value': '1.85', 'spread': '0.99', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'ACQ5 was used. The lower value the better with a full range from 0=no impairment, 6= maximum impairment. Awakenings, morning symptoms, limitations, shortness of breath and wheeze.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Exacerbations past 12 months before study start.', 'classes': [{'categories': [{'measurements': [{'value': '1.47', 'spread': '2.42', 'groupId': 'BG000'}, {'value': '1.42', 'spread': '2.42', 'groupId': 'BG001'}, {'value': '1.45', 'spread': '2.42', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Number of exacerbations per participant', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Inhaled glucocorticosteroids (IGCS) dose at study entry.', 'classes': [{'title': 'IGCS dose at study entry', 'categories': [{'measurements': [{'value': '1046', 'spread': '595', 'groupId': 'BG000'}, {'value': '1037', 'spread': '575', 'groupId': 'BG001'}, {'value': '1042', 'spread': '585', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'μg/day', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Participants with a well controlled asthma week at study entry.', 'classes': [{'categories': [{'measurements': [{'value': '11.97', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '11.77', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '11.87', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '100'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': 'FULL_RANGE'}, {'title': 'Pulmonary function test at baseline.', 'classes': [{'title': 'Percent Included', 'categories': [{'measurements': [{'value': '90.8', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '90.1', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '90.4', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '100'}]}]}], 'paramType': 'MEAN', 'description': 'Peak Expiratory Flow (PEF) was recorded at baseline, the assessment was performed at least 15 minutes after 2 inhalations of Symbicort 160/4.5µg. pn=predicted normal. Symbicort SMART 1\\*2 arm: n=4001 and Symbicort SMART 2\\*2 arm: n=4003.', 'unitOfMeasure': 'Percent of predicted normal value of PEF', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8424}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-03-08', 'studyFirstSubmitDate': '2007-04-19', 'resultsFirstSubmitDate': '2009-12-22', 'studyFirstSubmitQcDate': '2007-04-19', 'lastUpdatePostDateStruct': {'date': '2010-03-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-03-08', 'studyFirstPostDateStruct': {'date': '2007-04-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-03-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Severe Asthma Exacerbations Per Participant.', 'timeFrame': '6 months', 'description': 'Time to first severe asthma exacerbation, translated to mean number of severe asthma exacerbations per participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.'}], 'secondaryOutcomes': [{'measure': 'Fraction of Participants With Severe Asthma Exacerbation', 'timeFrame': '6 months.', 'description': 'The total number of severe asthma exacerbations was calculated for each participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.'}, {'measure': 'Total Number of Severe Asthma Exacerbations That Led to Hospitalisation and/or Emergency Room Treatment.', 'timeFrame': '6 months.', 'description': 'A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment. Number of events per participant'}, {'measure': 'Total Number of Days Per Participant With Oral/Systemic Glucocorticosteroids During Severe Asthma Exacerbation', 'timeFrame': '6 months.', 'description': 'Total number of days with oral/systemic glucocorticosteroids during severe exacerbation calculated for each participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.'}, {'measure': 'Mean Daily Number of Inhalations of As-needed Medication.', 'timeFrame': '4 weeks', 'description': 'The number of as-needed inhalations was measured 2 times during 2 weeks before 13 weeks and 26 weeks of treatment.'}, {'measure': 'Percent of Participants With a Well Controlled Asthma Week.', 'timeFrame': '6 months.', 'description': 'The mean percent of participants fulfilling the criteria for a well controlled asthma week in each treatment. A well controlled asthma week is defined as a week with no exacerbations and no night-time awakenings due to asthma and a maximum of 2 days with symptoms and as-needed inhalation use.'}, {'measure': 'Mean Overall Asthma Control Questionnaire (ACQ) Score', 'timeFrame': '6 months.', 'description': 'The ACQ5 was used. The lower value the better with a full range from 0=no impairment, 6= maximum impairment. Awakenings, morning symptoms, limitations, shortness of breath and wheeze.'}, {'measure': 'The Mean Total Daily Dose of Steroids From Symbicort.', 'timeFrame': '4 weeks', 'description': 'The mean total daily dose of steroids from Symbicort was calculated as the sum of the maintenance dose and the as-needed dose.'}, {'measure': 'Mean Cost Per Participant Per Country', 'timeFrame': '6 months', 'description': 'Mean cost is calculated for each country using participants from the whole study and country specific costs. Mean value for the whole study can not be calculated.'}]}, 'conditionsModule': {'keywords': ['Asthma'], 'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '21586508', 'type': 'DERIVED', 'citation': "Aubier M, Haughney J, Selroos O, van Schayck OC, Ekstrom T, Ostinelli J, Buhl R. Is the patient's baseline inhaled steroid dose a factor for choosing the budesonide/formoterol maintenance and reliever therapy regimen? Ther Adv Respir Dis. 2011 Oct;5(5):289-98. doi: 10.1177/1753465811407236. Epub 2011 May 17."}, {'pmid': '21435854', 'type': 'DERIVED', 'citation': 'Haughney J, Aubier M, Jorgensen L, Ostinelli J, Selroos O, van Schayck CP, Buhl R. Comparing asthma treatment in elderly versus younger patients. Respir Med. 2011 Jun;105(6):838-45. doi: 10.1016/j.rmed.2011.02.011. Epub 2011 Mar 23.'}, {'pmid': '20595145', 'type': 'DERIVED', 'citation': 'Aubier M, Buhl R, Ekstrom T, Ostinelli J, van Schayck CP, Selroos O, Haughney J. Comparison of two twice-daily doses of budesonide/formoterol maintenance and reliever therapy. Eur Respir J. 2010 Sep;36(3):524-30. doi: 10.1183/09031936.00022010. Epub 2010 Jul 1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of two different maintenance doses of Symbicort Maintenance And Reliever Therapy (SMART) in adult asthmatic patients. A 6 month treatment period'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients at out-patient clinics\n* \\>18 years with a minimum of 6 months documented history of persistent asthma who have used inhaled glucocorticosteroids for at least one month and have a history of use in rapid-acting B2 agonists for symptom relief\n\nExclusion Criteria:\n\n* Asthma exacerbation within the last 14 days prior to study start\n* subject aged \\>40 years with a smoking history of \\>10pack-years\n* subjects with chronic obstructive lung disease or other significant respiratory disease'}, 'identificationModule': {'nctId': 'NCT00463866', 'briefTitle': 'Local Phase 4 Pan-European SMART Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'orgStudyIdInfo': {'id': 'D5890L00022'}, 'secondaryIdInfos': [{'id': 'EUROSMART'}, {'id': 'EudraCTNo. 2006-006512-30'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Budesonide/formoterol', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aalst', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'city': 'Aarschot', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.98715, 'lon': 4.83695}}, {'city': 'Aatrijken', 'country': 'Belgium', 'facility': 'Research Site'}, {'city': 'Asse', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.91011, 'lon': 4.19836}}, {'city': 'Balen', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 51.16837, 'lon': 5.17027}}, {'city': 'Bastogne', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.00347, 'lon': 5.71844}}, {'city': 'Bellaire', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.64453, 'lon': 5.66585}}, {'city': 'Betrix', 'country': 'Belgium', 'facility': 'Research Site'}, {'city': 'Binche', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.41155, 'lon': 4.16469}}, {'city': 'Blankenberge', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 51.31306, 'lon': 3.13227}}, {'city': 'Boortmeerbeek', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.97929, 'lon': 4.57443}}, {'city': 'Bornem', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 51.09716, 'lon': 4.24364}}, {'city': 'Boussu', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.43417, 'lon': 3.7944}}, {'city': 'Bruges', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'city': 'Brussels', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Buizingen', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.74227, 'lon': 4.25278}}, {'city': 'Burdinne', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.58454, 'lon': 5.07663}}, {'city': 'Champion', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.4953, 'lon': 4.90385}}, {'city': 'Charleroi', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.41136, 'lon': 4.44448}}, {'city': 'Châtelet', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.40338, 'lon': 4.52826}}, {'city': 'Chênée', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.612, 'lon': 5.6141}}, {'city': 'Dendermonde', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 51.02869, 'lon': 4.10106}}, {'city': 'Diksmuide', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 51.03248, 'lon': 2.86384}}, {'city': 'Drongen', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 51.05067, 'lon': 3.65649}}, {'city': 'Duffel', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 51.09554, 'lon': 4.50903}}, {'city': 'Edegem', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'city': 'Eeklo', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 51.18703, 'lon': 3.55654}}, {'city': 'Ekeren', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 51.28087, 'lon': 4.41813}}, {'city': 'Erembodegem', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.91905, 'lon': 4.05041}}, {'city': 'Evergem', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 51.11306, 'lon': 3.70976}}, {'city': 'Fleurus', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.48351, 'lon': 4.55006}}, {'city': 'Gembloux', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.56149, 'lon': 4.69889}}, {'city': 'Genk', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}, {'city': 'Ghent', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Gilly', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.42449, 'lon': 4.4789}}, {'city': 'Graty', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.63172, 'lon': 3.99624}}, {'city': 'Grivegnée', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.62148, 'lon': 5.61101}}, {'city': 'Halle', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.73385, 'lon': 4.23454}}, {'city': 'Ham', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.94066, 'lon': 3.45852}}, {'city': 'Ham-sur-Heure', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.323, 'lon': 4.38844}}, {'city': 'Hasselt', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}, {'city': 'Havinnes', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.61658, 'lon': 3.46341}}, {'city': 'Heist-op-den-Berg', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 51.07537, 'lon': 4.72827}}, {'city': 'Herentals', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 51.17655, 'lon': 4.83248}}, {'city': 'Herstal', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.66415, 'lon': 5.62346}}, {'city': 'Hoboken', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 51.17611, 'lon': 4.34844}}, {'city': 'Hoeselt', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.84714, 'lon': 5.48767}}, {'city': 'Hooglede', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.98333, 'lon': 3.08333}}, {'city': 'Hornu', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.4328, 'lon': 3.82736}}, {'city': 'Houthalen-Helchteren', 'country': 'Belgium', 'facility': 'Research 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