Ignite Creation Date:
2025-12-26 @ 12:14 PM
Ignite Modification Date:
2025-12-26 @ 12:14 PM
Study NCT ID:
NCT00839800
Status:
COMPLETED
Last Update Posted:
2012-11-30
First Post:
2009-02-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Investigate the Efficacy of Symbicort® SMART.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Russia']}, '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', 'description': 'Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed', 'otherNumAtRisk': 1049, 'otherNumAffected': 279, 'seriousNumAtRisk': 1049, 'seriousNumAffected': 41}, {'id': 'EG001', 'title': 'Symbicort+Terbutaline As Needed', 'description': 'Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed', 'otherNumAtRisk': 1042, 'otherNumAffected': 293, 'seriousNumAtRisk': 1042, 'seriousNumAffected': 74}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 137}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 133}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 77}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Viral Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 72}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 58}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'seriousEvents': [{'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Angina Unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cleft Lip', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': "Meniere's Disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': "Basedow's Disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Retinal Detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Acute Abdomen', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Anal Fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Colonic Polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Gastric Polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hernia Obstructive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hepatotoxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Drug Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Tracheobronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Upper Respiratory Tract Infection Bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Acute Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Breast Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'H1n1 Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Lower Respiratory Tract Infection Bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Otitis Media Chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pneumonia Bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Septic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Tooth Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Varicella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Viral Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Traumatic Brain Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Foot Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Joint Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Lower Limb Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Muscle Strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Patella Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Sternal Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Type 2 Diabetes Mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Diabetes Mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Intervertebral Disc Protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Rheumatoid Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Uterine Leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Breast Cancer In Situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Intestinal Adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Metastatic Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Rectal Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abortion Spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abortion Threatened', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Premature Baby', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Major Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Breast Calcifications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dysfunctional Uterine Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Endometriosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Infertility Male', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 31}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nasal Septum Deviation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1049, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1042, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Percentage of Participants Who Had Experienced Asthma Exacerbation(s) at the End of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1049', 'groupId': 'OG000'}, {'value': '1042', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort SMART', 'description': 'Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed'}, {'id': 'OG001', 'title': 'Symbicort+Terbutaline As Needed', 'description': 'Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'week 52', 'description': 'Asthma exacerbation was defined as deterioration in asthma leading to oral glucocorticosteroid \\[GCS\\] treatment, hospitalization, or emergency room \\[ER\\] treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.'}, {'type': 'SECONDARY', 'title': 'Number of Asthma Exacerbations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1049', 'groupId': 'OG000'}, {'value': '1042', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort SMART', 'description': 'Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed'}, {'id': 'OG001', 'title': 'Symbicort+Terbutaline As Needed', 'description': 'Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed'}], 'classes': [{'categories': [{'measurements': [{'value': '259', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 52 weeks', 'description': 'Asthma exacerbation was defined as deterioration in asthma leading to oral GCS treatment, hospitalization, or ER treatment. Number of asthma exacerbations during 52 weeks treatment was presented here.', 'unitOfMeasure': 'Asthma exacerbations', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.'}, {'type': 'SECONDARY', 'title': 'Morning Peak Expiratory Flow (PEF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1034', 'groupId': 'OG000'}, {'value': '1026', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort SMART', 'description': 'Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed'}, {'id': 'OG001', 'title': 'Symbicort+Terbutaline As Needed', 'description': 'Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed'}], 'classes': [{'categories': [{'measurements': [{'value': '331.8', 'spread': '102.2', 'groupId': 'OG000'}, {'value': '324.7', 'spread': '101.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '52-week treatment period', 'description': 'The mean value from a 52-week treatment period.', 'unitOfMeasure': 'Liter/minute (L/min)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.'}, {'type': 'SECONDARY', 'title': 'Evening PEF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1034', 'groupId': 'OG000'}, {'value': '1026', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort SMART', 'description': 'Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed'}, {'id': 'OG001', 'title': 'Symbicort+Terbutaline As Needed', 'description': 'Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed'}], 'classes': [{'categories': [{'measurements': [{'value': '334.2', 'spread': '102.6', 'groupId': 'OG000'}, {'value': '327.8', 'spread': '103.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2-week run-in period (14 - 18 days before randomization - week 0) and a 52-week treatment period', 'description': 'The mean value from a 52-week treatment period.', 'unitOfMeasure': 'L/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.'}, {'type': 'SECONDARY', 'title': 'Forced Expiratory Volume in One Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1049', 'groupId': 'OG000'}, {'value': '1042', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort SMART', 'description': 'Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed'}, {'id': 'OG001', 'title': 'Symbicort+Terbutaline As Needed', 'description': 'Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed'}], 'classes': [{'categories': [{'measurements': [{'value': '2.258', 'spread': '0.76', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2.222', 'spread': '0.77', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '4, 12, 24, 36 and 52 weeks after randomization', 'description': 'The mean value for Weeks 4, 12, 24, 36 and 52 was analysed.', 'unitOfMeasure': 'Liter (L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.'}, {'type': 'SECONDARY', 'title': 'Use of As-needed Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1032', 'groupId': 'OG000'}, {'value': '1026', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort SMART', 'description': 'Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed'}, {'id': 'OG001', 'title': 'Symbicort+Terbutaline As Needed', 'description': 'Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed'}], 'classes': [{'categories': [{'measurements': [{'value': '1.21', 'spread': '1.39', 'groupId': 'OG000'}, {'value': '1.46', 'spread': '1.60', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '52-week treatment period', 'description': 'The mean value of total daily number of inhalations from the treatment period for use of as-needed medication (daytime, night-time).', 'unitOfMeasure': 'inhalations/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.'}, {'type': 'SECONDARY', 'title': 'Asthma Symptom Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1034', 'groupId': 'OG000'}, {'value': '1025', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort SMART', 'description': 'Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed'}, {'id': 'OG001', 'title': 'Symbicort+Terbutaline As Needed', 'description': 'Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed'}], 'classes': [{'categories': [{'measurements': [{'value': '1.12', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '1.22', 'spread': '1.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '52-week treatment period', 'description': 'The mean value from the treatment period for Total Asthma Symptom Score (total score: 0 is best - no asthma symptoms; 6 is worst).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.'}, {'type': 'SECONDARY', 'title': 'Nights With Awakening(s) Due to Asthma Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1024', 'groupId': 'OG000'}, {'value': '1025', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort SMART', 'description': 'Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed'}, {'id': 'OG001', 'title': 'Symbicort+Terbutaline As Needed', 'description': 'Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed'}], 'classes': [{'categories': [{'measurements': [{'value': '15.7', 'spread': '27.1', 'groupId': 'OG000'}, {'value': '17.5', 'spread': '27.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '52-week treatment period', 'description': 'The mean value from the treatment period was presented here.', 'unitOfMeasure': 'Nights With Awakening(s)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.'}, {'type': 'SECONDARY', 'title': 'The Percentage of Participants Who Had Experienced First Mild Asthma Exacerbations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1049', 'groupId': 'OG000'}, {'value': '1042', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort SMART', 'description': 'Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed'}, {'id': 'OG001', 'title': 'Symbicort+Terbutaline As Needed', 'description': 'Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed'}], 'classes': [{'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 52 weeks', 'description': 'Mild asthma exacerbation was defined as morning PEF ≥20% below baseline, daily as-needed medication use ≥2 inhalations above baseline, or a night with awakening due to asthma symptoms. The percentage of participants who had experienced mild asthma exacerbation(s) at the end of the study was presented here.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.'}, {'type': 'SECONDARY', 'title': 'Symptom-free Days (no Symptoms and no Awakenings)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1034', 'groupId': 'OG000'}, {'value': '1026', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort SMART', 'description': 'Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed'}, {'id': 'OG001', 'title': 'Symbicort+Terbutaline As Needed', 'description': 'Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed'}], 'classes': [{'categories': [{'measurements': [{'value': '45.5', 'spread': '37.8', 'groupId': 'OG000'}, {'value': '41.6', 'spread': '37.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '52-week treatment period', 'description': 'A symptom-free day was defined as a day without daytime or night-time symptoms and without night-time awakenings due to asthma symptoms. The mean value was presented here.', 'unitOfMeasure': 'symptom-free days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.'}, {'type': 'SECONDARY', 'title': 'Percentage of As-needed-free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1032', 'groupId': 'OG000'}, {'value': '1026', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort SMART', 'description': 'Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed'}, {'id': 'OG001', 'title': 'Symbicort+Terbutaline As Needed', 'description': 'Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed'}], 'classes': [{'categories': [{'measurements': [{'value': '51.4', 'spread': '36.7', 'groupId': 'OG000'}, {'value': '47.2', 'spread': '36.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '52-week treatment period', 'description': 'An as-needed-free day is defined as a night and day with no use of as-needed medication. The mean value from the treatment period was presented here.', 'unitOfMeasure': 'percentage of as-needed-free days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.'}, {'type': 'SECONDARY', 'title': 'Percentage of Asthma-control Days (no Asthma Symptoms, no Awakenings, and no As-needed Use)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1033', 'groupId': 'OG000'}, {'value': '1026', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort SMART', 'description': 'Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed'}, {'id': 'OG001', 'title': 'Symbicort+Terbutaline As Needed', 'description': 'Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed'}], 'classes': [{'categories': [{'measurements': [{'value': '41.7', 'spread': '37.3', 'groupId': 'OG000'}, {'value': '37.9', 'spread': '36.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '52-week treatment period', 'description': 'An asthma-control day was defined as a a night and day with no asthma symptoms, no awakenings due to asthma symptoms, and no as-needed medication use. The mean value from the treatment period was presented here.', 'unitOfMeasure': 'percentage of asthma-control days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.'}, {'type': 'SECONDARY', 'title': 'Asthma Control Questionnaire (ACQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1040', 'groupId': 'OG000'}, {'value': '1038', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort SMART', 'description': 'Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed'}, {'id': 'OG001', 'title': 'Symbicort+Terbutaline As Needed', 'description': 'Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed'}], 'classes': [{'categories': [{'measurements': [{'value': '1.162', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '1.289', 'spread': '0.75', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4, 12, 24, 36 and 52 weeks after randomization', 'description': 'The ACQ developed by Juniper and colleagues (Juniper et al 1999) was used without the FEV1 and Beta 2-agonist questions. The Asthma Control Questionnaire has 5 questions that are assessed on a 7-point scale from 0 to 6 where 0 represents good control and 6 represents poor control. The overall score is the mean of the five responses. At least 4 out of the 5 questions must have been answered to provide a value. The mean of the overall score for Weeks 4 to 52 was presented here.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Symbicort SMART', 'description': 'Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed'}, {'id': 'FG001', 'title': 'Symbicort+Terbutaline As Needed', 'description': 'Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1049'}, {'groupId': 'FG001', 'numSubjects': '1042'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '956'}, {'groupId': 'FG001', 'numSubjects': '932'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}, {'groupId': 'FG001', 'numSubjects': '110'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'Incorrect Enrolment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Study-Specific Discontinuation Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Safety Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Severe Non-Compliance to Protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'The first participant entered the study on 16 February 2009, and the last participant completed the study on 23 February 2011. A total of 3209 participants were enrolled at 148 centres in 13 countries in Asia, America and Europe, and 2091 participants who fulfilled the randomisation criteria were randomised.', 'preAssignmentDetails': 'The study started with an enrolment visit, Visit 1, 1-7 days prior to Visit 2 (run-in). At Visit 2 patients had to have a reversibility of ≥12% relative to baseline and their pre-bronchodilatory Forced expiratory volume in one second (FEV1) had to be ≥50% of the predicted normal value.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1049', 'groupId': 'BG000'}, {'value': '1042', 'groupId': 'BG001'}, {'value': '2091', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Symbicort SMART', 'description': 'Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed'}, {'id': 'BG001', 'title': 'Symbicort+Terbutaline As Needed', 'description': 'Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.7', 'groupId': 'BG000', 'lowerLimit': '16', 'upperLimit': '84'}, {'value': '45.6', 'groupId': 'BG001', 'lowerLimit': '16', 'upperLimit': '85'}, {'value': '45.7', 'groupId': 'BG002', 'lowerLimit': '16', 'upperLimit': '85'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '722', 'groupId': 'BG000'}, {'value': '692', 'groupId': 'BG001'}, {'value': '1414', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '327', 'groupId': 'BG000'}, {'value': '350', 'groupId': 'BG001'}, {'value': '677', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', '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': 2091}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-26', 'studyFirstSubmitDate': '2009-02-04', 'resultsFirstSubmitDate': '2012-02-21', 'studyFirstSubmitQcDate': '2009-02-09', 'lastUpdatePostDateStruct': {'date': '2012-11-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-11-26', 'studyFirstPostDateStruct': {'date': '2009-02-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Percentage of Participants Who Had Experienced Asthma Exacerbation(s) at the End of the Study', 'timeFrame': 'week 52', 'description': 'Asthma exacerbation was defined as deterioration in asthma leading to oral glucocorticosteroid \\[GCS\\] treatment, hospitalization, or emergency room \\[ER\\] treatment.'}], 'secondaryOutcomes': [{'measure': 'Number of Asthma Exacerbations', 'timeFrame': 'up to 52 weeks', 'description': 'Asthma exacerbation was defined as deterioration in asthma leading to oral GCS treatment, hospitalization, or ER treatment. Number of asthma exacerbations during 52 weeks treatment was presented here.'}, {'measure': 'Morning Peak Expiratory Flow (PEF)', 'timeFrame': '52-week treatment period', 'description': 'The mean value from a 52-week treatment period.'}, {'measure': 'Evening PEF', 'timeFrame': '2-week run-in period (14 - 18 days before randomization - week 0) and a 52-week treatment period', 'description': 'The mean value from a 52-week treatment period.'}, {'measure': 'Forced Expiratory Volume in One Second (FEV1)', 'timeFrame': '4, 12, 24, 36 and 52 weeks after randomization', 'description': 'The mean value for Weeks 4, 12, 24, 36 and 52 was analysed.'}, {'measure': 'Use of As-needed Medication', 'timeFrame': '52-week treatment period', 'description': 'The mean value of total daily number of inhalations from the treatment period for use of as-needed medication (daytime, night-time).'}, {'measure': 'Asthma Symptom Score', 'timeFrame': '52-week treatment period', 'description': 'The mean value from the treatment period for Total Asthma Symptom Score (total score: 0 is best - no asthma symptoms; 6 is worst).'}, {'measure': 'Nights With Awakening(s) Due to Asthma Symptoms', 'timeFrame': '52-week treatment period', 'description': 'The mean value from the treatment period was presented here.'}, {'measure': 'The Percentage of Participants Who Had Experienced First Mild Asthma Exacerbations', 'timeFrame': 'up to 52 weeks', 'description': 'Mild asthma exacerbation was defined as morning PEF ≥20% below baseline, daily as-needed medication use ≥2 inhalations above baseline, or a night with awakening due to asthma symptoms. The percentage of participants who had experienced mild asthma exacerbation(s) at the end of the study was presented here.'}, {'measure': 'Symptom-free Days (no Symptoms and no Awakenings)', 'timeFrame': '52-week treatment period', 'description': 'A symptom-free day was defined as a day without daytime or night-time symptoms and without night-time awakenings due to asthma symptoms. The mean value was presented here.'}, {'measure': 'Percentage of As-needed-free Days', 'timeFrame': '52-week treatment period', 'description': 'An as-needed-free day is defined as a night and day with no use of as-needed medication. The mean value from the treatment period was presented here.'}, {'measure': 'Percentage of Asthma-control Days (no Asthma Symptoms, no Awakenings, and no As-needed Use)', 'timeFrame': '52-week treatment period', 'description': 'An asthma-control day was defined as a a night and day with no asthma symptoms, no awakenings due to asthma symptoms, and no as-needed medication use. The mean value from the treatment period was presented here.'}, {'measure': 'Asthma Control Questionnaire (ACQ)', 'timeFrame': '4, 12, 24, 36 and 52 weeks after randomization', 'description': 'The ACQ developed by Juniper and colleagues (Juniper et al 1999) was used without the FEV1 and Beta 2-agonist questions. The Asthma Control Questionnaire has 5 questions that are assessed on a 7-point scale from 0 to 6 where 0 represents good control and 6 represents poor control. The overall score is the mean of the five responses. At least 4 out of the 5 questions must have been answered to provide a value. The mean of the overall score for Weeks 4 to 52 was presented here.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Asthma', 'Symbicort Turbuhaler'], 'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '32718193', 'type': 'DERIVED', 'citation': 'Zhang O, Minku LL, Gonem S. Detecting asthma exacerbations using daily home monitoring and machine learning. J Asthma. 2021 Nov;58(11):1518-1527. doi: 10.1080/02770903.2020.1802746. Epub 2020 Aug 14.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to compare the efficacy of Symbicort SMART (Symbicort Turbuhaler 160/4.5μg, one inhalation twice daily plus as needed) with Symbicort Turbuhaler 160/4.5μg, one inhalation twice daily plus terbutaline Turbuhaler 0.4 mg as needed, as asthma therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of asthma according to the Global Initiative for Asthma guidelines (GINA) 2007 with a documented history of at least 6 months duration.\n* Reversible airway obstruction, defined as an increase in FEV1 ≥12% relative to baseline for all patients 15-30 minutes after inhalation of in total 2 x 0.4 mg terbutaline Turbuhaler\n* Prescribed use of inhaled glucocorticoid steroid (GCS) (any brand) for at least 12 weeks.\n\nExclusion Criteria:\n\n* Respiratory infection affecting the asthma, as judged by the investigator, within 4 weeks.\n* Intake of oral, rectal or parenteral GCS within 4 weeks and/or depot parenteral GCS within 12 weeks.'}, 'identificationModule': {'nctId': 'NCT00839800', 'acronym': 'SAKURA', 'briefTitle': 'Study to Investigate the Efficacy of Symbicort® SMART.', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Comparison of Symbicort® SMART (160/4.5μg) and Symbicort® Turbuhaler 160/4.5 μg, Plus Terbutaline Turbuhaler 0.4 mg as Needed, for Treatment of Asthma - a 12-month, Randomized, Double-blind, Parallel Group, Active-controlled, Multinational Phase III Study in Asthmatic Patients From 16 Years', 'orgStudyIdInfo': {'id': 'D589LC00001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Symbicort Turbuhaler 160/4.5 µg one inhalation bid (twice daily) + Symbicort Turbuhaler 160/4.5 µg as needed', 'interventionNames': ['Drug: Symbicort Turbuhaler']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Symbicort Turbuhaler 160/4.5 µg one inhalation bid (twice daily) + terbutaline Turbuhaler 0.4 mg as needed', 'interventionNames': ['Drug: Symbicort Turbuhaler', 'Drug: Terbutaline Turbuhaler']}], 'interventions': [{'name': 'Symbicort Turbuhaler', 'type': 'DRUG', 'description': '160/4.5 µg', 'armGroupLabels': ['1', '2']}, {'name': 'Terbutaline Turbuhaler', 'type': 'DRUG', 'description': '0.4 mg', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Buenos Aires', 'state': 'Argentina', 'country': 'Argentina', 'facility': 'Research Site', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Capital Federal', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Research Site'}, {'city': 'Mar del Plata', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Research Site', 'geoPoint': {'lat': -38.00042, 'lon': -57.5562}}, {'city': 'Monte Grande', 'state': 'Buenos 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