Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2026-02-20 @ 1:46 PM
Study NCT ID:
NCT02563067
Status:
COMPLETED
Last Update Posted:
2021-05-03
First Post:
2015-09-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Efficacy and Safety of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment.
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': 'C000604875', 'term': 'fevipiprant'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Novartis.email@novartis.com', 'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 56 weeks.', 'description': 'Any sign or symptom that occurs during the study treatment plus 7 days post treatment for adverse events and 30 days post treatment for serious adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'QAW039 150 mg', 'description': 'QAW039 150 mg', 'otherNumAtRisk': 296, 'deathsNumAtRisk': 296, 'otherNumAffected': 181, 'seriousNumAtRisk': 296, 'deathsNumAffected': 0, 'seriousNumAffected': 20}, {'id': 'EG001', 'title': 'QAW039 450 mg', 'description': 'QAW039 450 mg', 'otherNumAtRisk': 293, 'deathsNumAtRisk': 293, 'otherNumAffected': 183, 'seriousNumAtRisk': 293, 'deathsNumAffected': 1, 'seriousNumAffected': 20}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo', 'otherNumAtRisk': 287, 'deathsNumAtRisk': 287, 'otherNumAffected': 180, 'seriousNumAtRisk': 287, 'deathsNumAffected': 1, 'seriousNumAffected': 18}], 'otherEvents': [{'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 32}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 42}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 26}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Upper respiratory tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 129}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 119}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 145}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Ulcerative keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Liver disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Escherichia sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Gastrointestinal viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Fracture displacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Lumbar vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Seroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Ulna fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Gouty arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Ovarian neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Parathyroid tumour benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Renal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Brain hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Uterine enlargement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Uterine prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Nasal polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Arterial thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Lymphoedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 287, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rate of Moderate-to-severe Asthma Exacerbations During the 52-week Treatment Period in High Eosinophils Subpopulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '193', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'QAW039 150 mg', 'description': 'QAW039 150 mg once daily'}, {'id': 'OG001', 'title': 'QAW039 450 mg', 'description': 'QAW039 450 mg once daily'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.73', 'groupId': 'OG000', 'lowerLimit': '0.57', 'upperLimit': '0.94'}, {'value': '0.76', 'groupId': 'OG001', 'lowerLimit': '0.59', 'upperLimit': '0.99'}, {'value': '1.06', 'groupId': 'OG002', 'lowerLimit': '0.84', 'upperLimit': '1.33'}]}]}], 'analyses': [{'pValue': '0.059', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.50', 'ciUpperLimit': '0.96', 'statisticalMethod': 'negative binomial regression model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. 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The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/ limitation) scale. The ACQ-5 score is the average of the individual item scores and ranges from 0 to 6. Higher scores indicates worsening of condition. The high eosinophils subpopulation consists of all patients with blood eosinophil count ≥ 250 cells/μL at baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) in high eosinophils subpopulation (count ≥ 250 cells/μL)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 52 in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) in High Eosinophils Subpopulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '193', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'QAW039 150 mg', 'description': 'QAW039 150 mg once daily'}, {'id': 'OG001', 'title': 'QAW039 450 mg', 'description': 'QAW039 450 mg once daily'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.192', 'spread': '0.0306', 'groupId': 'OG000'}, {'value': '0.162', 'spread': '0.0311', 'groupId': 'OG001'}, {'value': '0.124', 'spread': '0.0313', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.369', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.068', 'ciLowerLimit': '-0.018', 'ciUpperLimit': '0.154', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.'}, {'pValue': '0.824', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.038', 'ciLowerLimit': '-0.048', 'ciUpperLimit': '0.124', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the last available FEV1 measurement taken prior to the first dose of randomized study drug. 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Overall type I error rate controlled at two-sided 5%.'}, {'pValue': '0.348', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.76', 'ciLowerLimit': '0.58', 'ciUpperLimit': '1.00', 'statisticalMethod': 'negative binomial regression model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. 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Overall type I error rate controlled at two-sided 5%.'}, {'pValue': '0.824', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '-0.02', 'ciUpperLimit': '0.26', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'AQLQ is a 32-item instrument administered as a self-assessment. AQLQ+12 is a modified version of AQLQ developed to measure functional impairments of participants aged 12-70 years. It is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Participants were asked to recall their experiences during the last 2 weeks and respond to each question on a 7-point scale (1=severe impairment, 7=no impairment), where higher scores indicated "better quality of life." Overall AQLQ+12 score is the mean of all 32 responses.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS), including all randomized patients who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 52 in Asthma Control Questionnaire-5 (ACQ-5) Score in Overall Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}, {'value': '287', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'QAW039 150 mg', 'description': 'QAW039 150 mg once daily'}, {'id': 'OG001', 'title': 'QAW039 450 mg', 'description': 'QAW039 450 mg once daily'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.83', 'spread': '0.055', 'groupId': 'OG000'}, {'value': '-0.77', 'spread': '0.055', 'groupId': 'OG001'}, {'value': '-0.70', 'spread': '0.055', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.824', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '0.03', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.'}, {'pValue': '0.824', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.07', 'ciLowerLimit': '-0.23', 'ciUpperLimit': '0.08', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'The ACQ-5 is a five-item, self-completed questionnaire, which is used as a measure of asthma control of a participant. The five questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze) enquire about the frequency and/or severity of symptoms over the previous week. The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/ limitation) scale. The ACQ-5 score is the average of the individual item scores and ranges from 0 to 6. 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Overall type I error rate controlled at two-sided 5%.'}, {'pValue': '0.595', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.061', 'ciLowerLimit': '-0.008', 'ciUpperLimit': '0.130', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. 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All patients who received study drug and had high eosinophils count', 'achievements': [{'groupId': 'FG000', 'numSubjects': '198'}, {'groupId': 'FG001', 'numSubjects': '196'}, {'groupId': 'FG002', 'numSubjects': '193'}]}, {'type': 'FAS/SAF: Overall Population', 'comment': 'Full analysis set/safety set. All patients who received study drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '296'}, {'groupId': 'FG001', 'numSubjects': '293'}, {'groupId': 'FG002', 'numSubjects': '287'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '277'}, {'groupId': 'FG001', 'numSubjects': '268'}, {'groupId': 'FG002', 'numSubjects': '267'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '20'}]}], 'dropWithdraws': [{'type': 'Subject/guardian decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '16'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Technical problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Death post Treatment/safety period', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited from centers in Argentina (18), Canada (5), Czech Republic (7), Greece (6), India (12), Israel (5), Italy (22), Japan (16), Lebanon (3), Malaysia (4), Mexico (3), Netherlands (4), Russian Federation (11), Serbia (4), Slovakia (11), South Africa (3), Spain (13), Taiwan (3) and the United States (19).', 'preAssignmentDetails': 'The study included a Screening period of up to 2 weeks and a Placebo Run-in period of 2 to 6 weeks, during which eligibility for randomization was determined'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'BG000'}, {'value': '294', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}, {'value': '877', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'QAW039 150 mg', 'description': 'QAW039 150 mg once daily'}, {'id': 'BG001', 'title': 'QAW039 450 mg', 'description': 'QAW039 450 mg once daily'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo once daily'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.8', 'spread': '14.60', 'groupId': 'BG000'}, {'value': '49.6', 'spread': '15.25', 'groupId': 'BG001'}, {'value': '50.9', 'spread': '14.16', 'groupId': 'BG002'}, {'value': '50.1', 'spread': '14.68', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '165', 'groupId': 'BG000'}, {'value': '178', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}, {'value': '520', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '131', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}, {'value': '357', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Caucasian', 'measurements': [{'value': '234', 'groupId': 'BG000'}, {'value': '235', 'groupId': 'BG001'}, {'value': '227', 'groupId': 'BG002'}, {'value': '696', 'groupId': 'BG003'}]}, {'title': 'Black', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '126', 'groupId': 'BG003'}]}, {'title': 'Native American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'Unknown', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Other', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-02-10', 'size': 1356145, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-01-31T04:30', 'hasProtocol': True}, {'date': '2019-08-26', 'size': 815565, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-01-31T04:30', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 877}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'dispFirstSubmitDate': '2019-07-17', 'completionDateStruct': {'date': '2019-08-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-05', 'studyFirstSubmitDate': '2015-09-28', 'dispFirstSubmitQcDate': '2019-07-29', 'resultsFirstSubmitDate': '2020-01-31', 'studyFirstSubmitQcDate': '2015-09-28', 'dispFirstPostDateStruct': {'date': '2019-08-06', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-05', 'studyFirstPostDateStruct': {'date': '2015-09-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Moderate-to-severe Asthma Exacerbations During the 52-week Treatment Period in High Eosinophils Subpopulation', 'timeFrame': '52 weeks', 'description': "A severe asthma exacerbation is defined as treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days and hospitalization; or treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days and emergency department visit (greater than 24 hours\\*); or death due to asthma.\n\nA moderate asthma exacerbation is defined as treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days either as an outpatient or in emergency department visits (Emergency department visit less than or equal to 24 hours). The high eosinophils subpopulation consists of all patients with blood eosinophil count ≥ 250 cells/μL at baseline."}, {'measure': 'Rate of Moderate-to-severe Asthma Exacerbations During the 52-week Treatment Period in Overall Population', 'timeFrame': '52 weeks', 'description': "A severe asthma exacerbation is defined as treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days and hospitalization; or treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days and emergency department visit (greater than 24 hours\\*); or death due to asthma.\n\nA moderate asthma exacerbation is defined as treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days either as an outpatient or in emergency department visits (Emergency department visit less than or equal to 24 hours)."}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score in High Eosinophils Subpopulation', 'timeFrame': 'Baseline, Week 52', 'description': 'AQLQ is a 32-item instrument administered as a self-assessment. AQLQ+12 is a modified version of AQLQ developed to measure functional impairments of participants aged 12-70 years. It is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Participants were asked to recall their experiences during the last 2 weeks and respond to each question on a 7-point scale (1=severe impairment, 7=no impairment), where higher scores indicated "better quality of life." Overall AQLQ+12 score is the mean of all 32 responses. The high eosinophils subpopulation consists of all patients with blood eosinophil count ≥ 250 cells/μL at baseline.'}, {'measure': 'Change From Baseline to Week 52 in Asthma Control Questionnaire-5 (ACQ-5) Score in High Eosinophils Subpopulation', 'timeFrame': 'Baseline, Week 52', 'description': 'The ACQ-5 is a five-item, self-completed questionnaire, which is used as a measure of asthma control of a participant. The five questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze) enquire about the frequency and/or severity of symptoms over the previous week. The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/ limitation) scale. The ACQ-5 score is the average of the individual item scores and ranges from 0 to 6. Higher scores indicates worsening of condition. The high eosinophils subpopulation consists of all patients with blood eosinophil count ≥ 250 cells/μL at baseline.'}, {'measure': 'Change From Baseline to Week 52 in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) in High Eosinophils Subpopulation', 'timeFrame': 'Baseline, Week 52', 'description': 'Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the last available FEV1 measurement taken prior to the first dose of randomized study drug. The high eosinophils subpopulation consists of all patients with blood eosinophil count ≥ 250 cells/μL at baseline.'}, {'measure': 'Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score in Overall Population', 'timeFrame': 'Baseline, Week 52', 'description': 'AQLQ is a 32-item instrument administered as a self-assessment. AQLQ+12 is a modified version of AQLQ developed to measure functional impairments of participants aged 12-70 years. It is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Participants were asked to recall their experiences during the last 2 weeks and respond to each question on a 7-point scale (1=severe impairment, 7=no impairment), where higher scores indicated "better quality of life." Overall AQLQ+12 score is the mean of all 32 responses.'}, {'measure': 'Change From Baseline to Week 52 in Asthma Control Questionnaire-5 (ACQ-5) Score in Overall Population', 'timeFrame': 'Baseline, Week 52', 'description': 'The ACQ-5 is a five-item, self-completed questionnaire, which is used as a measure of asthma control of a participant. The five questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze) enquire about the frequency and/or severity of symptoms over the previous week. The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/ limitation) scale. The ACQ-5 score is the average of the individual item scores and ranges from 0 to 6. Higher scores indicates worsening of condition.'}, {'measure': 'Change From Baseline to Week 52 in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) in Overall Population', 'timeFrame': 'Baseline, Week 52', 'description': 'Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the last available FEV1 measurement taken prior to the first dose of randomized study drug.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Asthma', 'QAW039'], 'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '32979986', 'type': 'DERIVED', 'citation': 'Brightling CE, Gaga M, Inoue H, Li J, Maspero J, Wenzel S, Maitra S, Lawrence D, Brockhaus F, Lehmann T, Brindicci C, Knorr B, Bleecker ER. Effectiveness of fevipiprant in reducing exacerbations in patients with severe asthma (LUSTER-1 and LUSTER-2): two phase 3 randomised controlled trials. Lancet Respir Med. 2021 Jan;9(1):43-56. doi: 10.1016/S2213-2600(20)30412-4. Epub 2020 Sep 24.'}]}, 'descriptionModule': {'briefSummary': 'This study aimed to determine the efficacy and safety of QAW039 and QAW039 450 mg compared to placebo, when added to GINA (Global Initiative for Asthma) steps 4 and 5 standard-of- care (SoC) asthma therapy (GINA 2016) in the following two populations:\n\n* patient with inadequately controlled severe asthma and high eosinophil counts (eosinophil count at Visit 1 ≥250 cells/ µl) (sub-population)\n* patients with inadequately controlled severe asthma (overall study population) Inadequate control is defined as partly controlled or uncontrolled asthma (GINA 2016)', 'detailedDescription': 'This study used a randomized, multicenter, double-blind, placebo-controlled parallel-group design in which QAW039 (150 mg and 450 mg) or placebo was added to GINA steps 4 and 5 asthma therapy.\n\nThe study included:\n\n* Screening period of up to 2 weeks to assess eligibility;\n* Run-in period of approximately 2 weeks and a maximum of 6 weeks on placebo to collect baseline data for efficacy variables and compliance with the Electronic Peak Flow/ eDiary device. Upon completion of the run-in period, all patients who met the eligibility criteria were randomized to one of three treatments: QAW039 150 mg or QAW039 450 mg or placebo once daily in a ratio of 1:1:1.\n* Treatment period of 52 weeks (assessment period for all Primary and Secondary Outcome Measures). Clinic visits were scheduled approximately 4 weeks after randomization and then at approximately 8-week intervals during the active-treatment period. Phone calls occurred at specified time points between visits occurring at 8-week intervals. Patients who had successfully completed 52 weeks of treatment in this study were offered an optional participation in a safety study (CQAW039A2315).\n* Follow-up period of 4 weeks, investigational and drug-free, following the last dose of study drug. A follow-up visit occurred approximately 4 weeks (i.e., approximately 30 days) following the last dose of study therapy to complete safety assessments and pregnancy testing (if applicable).\n\nThe follow-up period applied to all patients except those patients who had entered the optional safety study (CQAW039A2315) directly after the Week 52 study visit'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent.\n* Male and female patients aged ≥12 years.\n* A diagnosis of severe asthma, uncontrolled on GINA 4/5 asthma medication.\n* Evidence of airway reversibility or airway hyper- reactivity.\n* FEV1 ≤80% of the predicted normal value for patients aged ≥18 years; FEV1 of ≤90% for patients aged 12 to \\<18 years\n* An ACQ score ≥1.5\n* A history of 2 or more asthma exacerbations within the 12 months prior to entering the study.\n\nExclusion Criteria:\n\n* Use of other investigational drugs within 5 half-lives of study entry, or within 30 days, whichever is longer.\n* Subjects who have participated in another trial of QAW039.\n* A QTcF (Fridericia) ≥450 msec (male) or ≥460 msec (female).\n* History of malignancy with the exception of local basal cell carcinoma of the skin.\n* Pregnant or nursing (lactating) women.\n* Serious co-morbidities.\n* Patients on \\>20 mg of simvastatin, \\> 40 mg of atorvastatin, \\>40 mg of pravastatin, or \\>2 mg of pitavastatin.'}, 'identificationModule': {'nctId': 'NCT02563067', 'briefTitle': 'Study of Efficacy and Safety of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of QAW039 When Added to Existing Asthma Therapy in Patients With Uncontrolled Severe Asthma.', 'orgStudyIdInfo': {'id': 'CQAW039A2314'}, 'secondaryIdInfos': [{'id': '2015-003172-67', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'QAW039 150 mg', 'description': 'QAW039 150 mg once daily', 'interventionNames': ['Drug: QAW039']}, {'type': 'EXPERIMENTAL', 'label': 'QAW039 450 mg', 'description': 'QAW039 450 mg once daily', 'interventionNames': ['Drug: QAW039']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo once daily', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'QAW039', 'type': 'DRUG', 'description': 'QAW039 150 mg once daily', 'armGroupLabels': ['QAW039 150 mg']}, {'name': 'QAW039', 'type': 'DRUG', 'description': 'QAW039 450 mg once daily', 'armGroupLabels': ['QAW039 450 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo once daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 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