Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-02-21 @ 9:25 PM
Study NCT ID:
NCT04594369
Status:
COMPLETED
Last Update Posted:
2025-12-16
First Post:
2020-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Estonia', 'Lithuania'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-11-06', 'type': 'ESTIMATED'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'C000619932', 'term': 'brensocatib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medicalinformation@Insmed.com', 'phone': '1-844-446-7633', 'title': 'Insmed Medical Information', 'organization': 'Insmed Incorporated'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to Week 56', 'description': 'The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.', 'eventGroups': [{'id': 'EG000', 'title': 'Brensocatib 10 mg', 'description': 'Participants received brensocatib 10 mg tablets, orally, once daily, for 52 weeks.', 'otherNumAtRisk': 582, 'deathsNumAtRisk': 582, 'otherNumAffected': 197, 'seriousNumAtRisk': 582, 'deathsNumAffected': 2, 'seriousNumAffected': 101}, {'id': 'EG001', 'title': 'Brensocatib 25 mg', 'description': 'Participants received brensocatib 25 mg tablets, orally, once daily, for 52 weeks.', 'otherNumAtRisk': 574, 'deathsNumAtRisk': 574, 'otherNumAffected': 213, 'seriousNumAtRisk': 574, 'deathsNumAffected': 4, 'seriousNumAffected': 97}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Participants received a brensocatib matching placebo tablets orally, once daily, for 52 weeks.', 'otherNumAtRisk': 563, 'deathsNumAtRisk': 563, 'otherNumAffected': 203, 'seriousNumAtRisk': 563, 'deathsNumAffected': 8, 'seriousNumAffected': 108}], 'otherEvents': [{'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 89}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 113}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 83}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 43}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 33}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 35}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 49}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 39}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 36}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Diastolic dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Ischaemic cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Blindness transient', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Cataract nuclear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Macular hole', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Vitreoretinal traction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Vitreous haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Femoral hernia incarcerated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Malabsorption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Mechanical ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Generalised oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Biliary cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Hepatic steatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Abscess neck', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Aspergillus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Bacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Bronchitis fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Burkholderia gladioli infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Coronavirus infection', 'stats': 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'sourceVocabulary': '27.0'}, {'term': 'Anal squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Benign salivary gland neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Brain neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Colorectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Malignant melanoma in situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Mantle cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Papillary thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 562, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Device malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Pelvic organ prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Uterovaginal prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Bronchiectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 48}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 67}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Eosinophilic pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Lung opacity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Nasal polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Pneumothorax spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Pulmonary arterial hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Actinic keratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 582, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 574, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Annualized Rate of Pulmonary Exacerbations (PEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '583', 'groupId': 'OG000'}, {'value': '575', 'groupId': 'OG001'}, {'value': '563', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brensocatib 10 mg', 'description': 'Participants received brensocatib 10 mg, tablets orally, once daily, for 52 weeks.'}, {'id': 'OG001', 'title': 'Brensocatib 25 mg', 'description': 'Participants received brensocatib 25 mg, tablets orally, once daily, for 52 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received a brensocatib matching placebo, tablets orally, once daily, for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.015', 'groupId': 'OG000', 'lowerLimit': '0.910', 'upperLimit': '1.132'}, {'value': '1.036', 'groupId': 'OG001', 'lowerLimit': '0.927', 'upperLimit': '1.157'}, {'value': '1.286', 'groupId': 'OG002', 'lowerLimit': '1.158', 'upperLimit': '1.428'}]}]}], 'analyses': [{'pValue': '=0.0019', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.789', 'ciLowerLimit': '0.680', 'ciUpperLimit': '0.916', 'pValueComment': 'Adjusted p-value = 0.0038. The enhanced mixture-based gatekeeping procedure was used to control the overall type I error rate. Multiplicity adjusted p-value for the primary endpoint was tested at two-sided alpha = 0.01.', 'groupDescription': 'Model treatment \\& randomization stratification factor=geographic region, sputum sample (Pseudomonas aeruginosa) at start \\& PE last 12 months, age group (fixed effects) \\& time at risk (log scale) as offset variable. Robust sandwich covariance estimator used.', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.0046', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.806', 'ciLowerLimit': '0.694', 'ciUpperLimit': '0.936', 'pValueComment': 'Adjusted p-value = 0.0048. The enhanced mixture-based gatekeeping procedure was used to control the overall type I error rate. Multiplicity adjusted p-value for the primary endpoint was tested at two-sided alpha = 0.01.', 'groupDescription': 'Model treatment \\& randomization stratification factor=geographic region, sputum sample (Pseudomonas aeruginosa) at start \\& PE last 12 months, age group (fixed effects) \\& time at risk (log scale) as offset variable. Robust sandwich covariance estimator used.', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 52', 'description': "PE was defined as having 3 or more of these symptoms for at least 48 hours resulting in a physician's decision to prescribe antibiotics: 1. Increased cough 2. Increased sputum volume or change in sputum consistency 3. Increased sputum purulence 4. Increased breathlessness and/or decreased exercise tolerance 5. Fatigue and/or malaise 6. Hemoptysis. A severe pulmonary exacerbation was that required intravenous (IV) antibacterial drug treatment and/or hospitalization. A minimum of 14 days must have occurred between one exacerbation onset and the next. Any exacerbation that occurred less than 14 days from the prior exacerbation was not considered a new exacerbation. Independent adjudication committee with pulmonary physicians adjudicated reported PE events to see if they fulfil the protocol definition. The rate of PE was analyzed using the negative binomial model.", 'unitOfMeasure': 'exacerbation per participant-year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Time to First PE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '583', 'groupId': 'OG000'}, {'value': '575', 'groupId': 'OG001'}, {'value': '563', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brensocatib 10 mg', 'description': 'Participants received brensocatib 10 mg, tablets orally, once daily, for 52 weeks.'}, {'id': 'OG001', 'title': 'Brensocatib 25 mg', 'description': 'Participants received brensocatib 25 mg, tablets orally, once daily, for 52 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received a brensocatib matching placebo, tablets orally, once daily, for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '49.000', 'comment': 'NA indicates that upper limit of confidence interval (CI) was not estimable due to insufficient number of participants with events during the 52 weeks treatment period.', 'groupId': 'OG000', 'lowerLimit': '40.000', 'upperLimit': 'NA'}, {'value': '50.714', 'comment': 'NA indicates that upper limit of confidence interval (CI) was not estimable due to insufficient number of participants with events during the 52 weeks treatment period.', 'groupId': 'OG001', 'lowerLimit': '37.571', 'upperLimit': 'NA'}, {'value': '36.714', 'groupId': 'OG002', 'lowerLimit': '31.143', 'upperLimit': '41.429'}]}]}], 'analyses': [{'pValue': '=0.01', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.813', 'ciLowerLimit': '0.695', 'ciUpperLimit': '0.952', 'pValueComment': 'Adjusted p-value = 0.0200. The enhanced mixture-based gatekeeping procedure was used to control the overall type I error rate. Multiplicity adjusted p-value for the secondary endpoints were tested at two-sided alpha = 0.05.', 'groupDescription': 'Estimate of Cox proportional hazard model=effect for treatment, sputum sample for Pseudomonas aeruginosa at screening and PE \\[\\<3 or ≥3\\] in last 12 months, stratification region and age group. Robust sandwich covariance estimator used.', 'statisticalMethod': 'Cox proportional hazard', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.0182', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.825', 'ciLowerLimit': '0.703', 'ciUpperLimit': '0.968', 'pValueComment': 'Adjusted p-value = 0.0364. The enhanced mixture-based gatekeeping procedure was used to control the overall type I error rate. Multiplicity adjusted p-value for the secondary endpoints were tested at two-sided alpha = 0.05.', 'groupDescription': 'Estimate of Cox proportional hazard model=effect for treatment, sputum sample for Pseudomonas aeruginosa at screening and PE \\[\\<3 or ≥3\\] in last 12 months, stratification region and age group. Robust sandwich covariance estimator used.', 'statisticalMethod': 'Cox proportional hazard', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Week 52', 'description': "PE was defined as having 3 or more of following symptoms for at least 48 hours resulting in physician's decision to prescribe antibiotics:1.Increased cough2.Increased sputum volume or change in sputum consistency3.Increased sputum purulence4.Increased breathlessness \\&/or decreased exercise tolerance5.Fatigue \\&/or malaise6.Hemoptysis.Severe PE were those requiring IV antibacterial drug treatment \\&/or hospitalization. Minimum of 14 days must have occurred between one exacerbation onset and next. Any exacerbation that occurred within 14 days of prior exacerbation was not considered a new exacerbation. Time to first PE was calculated from randomization date to onset date of the first exacerbation. Participants who did not have exacerbation at end of 52-week treatment period were considered as censored at date of Week 52 in Cox proportional hazard model. Independent adjudication committee with pulmonary physicians adjudicated reported PE events to see if they fulfil protocol definition.", 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Responder Status for Exacerbation-Free Over the 52-Week Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '583', 'groupId': 'OG000'}, {'value': '575', 'groupId': 'OG001'}, {'value': '563', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brensocatib 10 mg', 'description': 'Participants received brensocatib 10 mg, tablets orally, once daily, for 52 weeks.'}, {'id': 'OG001', 'title': 'Brensocatib 25 mg', 'description': 'Participants received brensocatib 25 mg, tablets orally, once daily, for 52 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received a brensocatib matching placebo, tablets orally, once daily, for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '48.5', 'groupId': 'OG000'}, {'value': '48.5', 'groupId': 'OG001'}, {'value': '40.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '=0.0059', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.412', 'ciLowerLimit': '1.105', 'ciUpperLimit': '1.806', 'pValueComment': 'Adjusted p-value = 0.0200. The enhanced mixture-based gatekeeping procedure was used to control the overall type I error rate. Multiplicity adjusted p-value for the secondary endpoints were tested at two-sided alpha = 0.05.', 'groupDescription': "Missing responder status was imputed 100 times. Dataset was analyzed via logistic regression with treatment group, sputum P. aeruginosa status, prior PEs (\\<3/≥3), region, and age group as fixed effects. Results were then combined using Rubin's rules.", 'statisticalMethod': 'Logistic Regression', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.0074', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '1.095', 'ciUpperLimit': '1.792', 'pValueComment': 'Adjusted p-value = 0.0364. The enhanced mixture-based gatekeeping procedure was used to control the overall type I error rate. Multiplicity adjusted p-value for the secondary endpoints were tested at two-sided alpha = 0.05.', 'groupDescription': "Missing responder status was imputed 100 times. Dataset was analyzed via logistic regression with treatment group, sputum P. aeruginosa status, prior PEs (\\<3/≥3), region, and age group as fixed effects. Results were then combined using Rubin's rules.", 'statisticalMethod': 'Logistic Regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 52', 'description': "Responder status was based on percentage of participants who were exacerbation free over 52-weeks of treatment period. Pulmonary exacerbation was defined as having 3 or more of the following symptoms for at least 48 hours resulting in a physician's decision to prescribe antibiotics: 1. Increased cough 2. Increased sputum volume or change in sputum consistency 3. Increased sputum purulence 4. Increased breathlessness and/or decreased exercise tolerance 5. Fatigue and/or malaise 6. Hemoptysis. A minimum of 14 days must have occurred between one exacerbation onset and the next. Any exacerbation that occurred less than 14 days from the prior exacerbation was not considered a new exacerbation. Independent adjudication committee of pulmonary physicians adjudicated reported PE events to see if they fulfill protocol definition. For discontinuation prior to Week 52 without having experienced a confirmed PE, responder status was imputed by multiple imputation.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at Week 52 in Postbronchodilator Forced Expiratory Volume in 1 Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '564', 'groupId': 'OG000'}, {'value': '551', 'groupId': 'OG001'}, {'value': '539', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brensocatib 10 mg', 'description': 'Participants received brensocatib 10 mg, tablets orally, once daily, for 52 weeks.'}, {'id': 'OG001', 'title': 'Brensocatib 25 mg', 'description': 'Participants received brensocatib 25 mg, tablets orally, once daily, for 52 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received a brensocatib matching placebo, tablets orally, once daily, for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.050', 'spread': '0.0093', 'groupId': 'OG000'}, {'value': '-0.024', 'spread': '0.0099', 'groupId': 'OG001'}, {'value': '-0.062', 'spread': '0.0094', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '=0.3841', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Least square (LS) Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.011', 'ciLowerLimit': '-0.014', 'ciUpperLimit': '0.037', 'pValueComment': 'Adjusted p-value = 0.3841. The enhanced mixture-based gatekeeping procedure was used to control the overall type I error rate. Multiplicity adjusted p-value was tested at two-sided alpha = 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0132', 'groupDescription': 'Analysis on linear repeated measure model=treatment visit, sputum sample for Pseudomonas aeruginosa at start, PE \\[\\<3 or ≥3\\] last 12 months, stratification region, age group (fixed effect) \\& baseline (covariate). Robust sandwich covariance estimator used.', 'statisticalMethod': 'Linear repeated measures model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.0054', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.038', 'ciLowerLimit': '0.011', 'ciUpperLimit': '0.065', 'pValueComment': 'Adjusted p-value = 0.0364. The enhanced mixture-based gatekeeping procedure was used to control the overall type I error rate. Multiplicity adjusted p-value was tested at two-sided alpha = 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0136', 'groupDescription': 'Analysis on linear repeated measure model=treatment visit, sputum sample for Pseudomonas aeruginosa at start, PE \\[\\<3 or ≥3\\] last 12 months, stratification region, age group (fixed effect) \\& baseline (covariate). Robust sandwich covariance estimator used.', 'statisticalMethod': 'Linear repeated measures model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'FEV1 was used to assess lung function and is the maximum amount of air that can be forced out in one second after first second after taking a forced expiration as measured by spirometer. Postbronchodilator FEV1 tests included spirometry tests performed referred to the spirometry performed within 30 minutes after administration of bronchodilator (4 puffs of salbutamol/albuterol, terbutaline or ipratropium). A positive change from baseline indicates an improvement in lung function. Baseline was the most recent non-missing assessment determined as best effort prior to the first dose of the investigational product.', 'unitOfMeasure': 'liter (L)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT analysis set included all participants who were randomized. 'Overall number of participants analyzed' indicates the number of participants with data available for analyses."}, {'type': 'SECONDARY', 'title': 'Annualized Rate of Severe PEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '583', 'groupId': 'OG000'}, {'value': '575', 'groupId': 'OG001'}, {'value': '563', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brensocatib 10 mg', 'description': 'Participants received brensocatib 10 mg, tablets orally, once daily, for 52 weeks.'}, {'id': 'OG001', 'title': 'Brensocatib 25 mg', 'description': 'Participants received brensocatib 25 mg, tablets orally, once daily, for 52 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received a brensocatib matching placebo, tablets orally, once daily, for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.137', 'groupId': 'OG000', 'lowerLimit': '0.103', 'upperLimit': '0.182'}, {'value': '0.137', 'groupId': 'OG001', 'lowerLimit': '0.105', 'upperLimit': '0.179'}, {'value': '0.185', 'groupId': 'OG002', 'lowerLimit': '0.142', 'upperLimit': '0.242'}]}]}], 'analyses': [{'pValue': '=0.1277', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.742', 'ciLowerLimit': '0.505', 'ciUpperLimit': '1.089', 'pValueComment': 'Adjusted p-value = 0.3841. The enhanced mixture-based gatekeeping procedure was used to control the overall type I error rate. Multiplicity adjusted p-value was tested at two-sided alpha = 0.05.', 'groupDescription': 'Analysis based on a negative binomial model including treatment, sputum sample for Pseudomonas aeruginosa at screening, PE \\[\\<3 or ≥3\\] in previous 12 months, stratification region and age group. Robust sandwich covariance estimator used.', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.1025', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.74', 'ciLowerLimit': '0.515', 'ciUpperLimit': '1.062', 'pValueComment': 'Adjusted p-value = 0.2050. The enhanced mixture-based gatekeeping procedure was used to control the overall type I error rate. Multiplicity adjusted p-value was tested at two-sided alpha = 0.05.', 'groupDescription': 'Analysis based on a negative binomial model including treatment, sputum sample for Pseudomonas aeruginosa at screening, PE \\[\\<3 or ≥3\\] in previous 12 months, stratification region and age group. Robust sandwich covariance estimator used.', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 52', 'description': "Pulmonary exacerbation was defined as having 3 or more of the following symptoms for at least 48 hours resulting in a physician's decision to prescribe antibiotics: 1. Increased cough 2. Increased sputum volume or change in sputum consistency 3. Increased sputum purulence 4. Increased breathlessness and/or decreased exercise tolerance 5. Fatigue and/or malaise 6. Hemoptysis. A severe PE was defined as those requiring IV antibacterial drug treatment and/or hospitalization. A minimum of 14 days must have occurred between one exacerbation onset and the next. Any exacerbation that occurred less than 14 days from the prior exacerbation was not considered a new exacerbation. Independent adjudication committee with pulmonary physicians adjucated reported PE events to see if they fulfil the protocol definition. The rate of PE was analyzed using the negative binomial model.", 'unitOfMeasure': 'exacerbation per participant-year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set included all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at Week 52 in Quality of Life Questionnaire - Bronchiectasis (QOL-B) Respiratory Symptoms Domain Score in Adult Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '487', 'groupId': 'OG000'}, {'value': '495', 'groupId': 'OG001'}, {'value': '486', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brensocatib 10 mg', 'description': 'Participants received brensocatib 10 mg, tablets orally, once daily, for 52 weeks.'}, {'id': 'OG001', 'title': 'Brensocatib 25 mg', 'description': 'Participants received brensocatib 25 mg, tablets orally, once daily, for 52 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received a brensocatib matching placebo, tablets orally, once daily, for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.841', 'spread': '0.7706', 'groupId': 'OG000'}, {'value': '8.575', 'spread': '0.7556', 'groupId': 'OG001'}, {'value': '4.809', 'spread': '0.7500', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '=0.0594', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.031', 'ciLowerLimit': '-0.081', 'ciUpperLimit': '4.143', 'pValueComment': 'Adjusted p-value = 0.3841. The enhanced mixture-based gatekeeping procedure was used to control the overall type I error rate. Multiplicity adjusted p-value was tested at two-sided alpha = 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.0775', 'groupDescription': 'Analysis based on a linear repeated measures model with treatment group, visit, sputum sample for Pseudomonas aeruginosa at screening, pulmonary exacerbations \\[\\<3 or ≥3\\] in previous 12 months, stratification region fixed effect, baseline as covariate.', 'statisticalMethod': 'linear repeated measures model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.0004', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.766', 'ciLowerLimit': '1.680', 'ciUpperLimit': '5.852', 'pValueComment': 'Adjusted p-value = 0.2050. The enhanced mixture-based gatekeeping procedure was used to control the overall type I error rate. Multiplicity adjusted p-value was tested at two-sided alpha = 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.0642', 'groupDescription': 'Analysis based on a linear repeated measures model with treatment group, visit, sputum sample for Pseudomonas aeruginosa at screening, pulmonary exacerbations \\[\\<3 or ≥3\\] in previous 12 months, stratification region fixed effect, baseline as covariate.', 'statisticalMethod': 'linear repeated measures model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'The QOL-B is a validated, self-administered patient-reported outcome (PRO) that assesses symptoms, functioning, and health-related quality of life for participants with non-cystic fibrosis bronchiectasis (NCFBE). It contains 37 items in 8 domains (Respiratory Symptoms, Physical Functioning, Role Functioning, Emotional Functioning, Social Functioning, Vitality, Health Perceptions and Treatment Burden). Each of the 37 items is scored from 1 to 4, and each of the 8 domains scale scores is standardized on a 0-100 point scale, with higher scores representing fewer symptoms or better functioning. A positive change from Baseline indicates improvement in symptoms. For this outcome measure, change in the respiratory symptoms domain score from Baseline was reported. Baseline refers to most recent assessment on or before study Day 1.', 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set included all participants who were randomised. Overall number of participants analyzed indicates the number of participants with data available for analyses.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '582', 'groupId': 'OG000'}, {'value': '574', 'groupId': 'OG001'}, {'value': '563', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brensocatib 10 mg', 'description': 'Participants received brensocatib 10 mg, tablets orally, once daily, for 52 weeks.'}, {'id': 'OG001', 'title': 'Brensocatib 25 mg', 'description': 'Participants received brensocatib 25 mg, tablets orally, once daily, for 52 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received a brensocatib matching placebo, tablets orally, once daily, for 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '452', 'groupId': 'OG000'}, {'value': '440', 'groupId': 'OG001'}, {'value': '448', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 56', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs are AEs that occurred on or after the date of first dose of study drugs and within 28 days after the end of treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.'}, {'type': 'SECONDARY', 'title': 'Plasma Concentration of Brensocatib in Adults (Main Study)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brensocatib 10 mg', 'description': 'Participants received brensocatib 10 mg tablets, orally, once daily, for 52 weeks.'}, {'id': 'OG001', 'title': 'Brensocatib 25 mg', 'description': 'Participants received brensocatib 25 mg tablets, orally, once daily, for 52 weeks.'}], 'classes': [{'title': 'Day 1: 2 h post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40.52', 'spread': '69.1', 'groupId': 'OG000'}, {'value': '134.9', 'spread': '51.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 4: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.60', 'spread': '68.7', 'groupId': 'OG000'}, {'value': '157.4', 'spread': '70.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 4: 2 h post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.5', 'spread': '32.8', 'groupId': 'OG000'}, {'value': '293.6', 'spread': '35.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 16: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.19', 'spread': '55.0', 'groupId': 'OG000'}, {'value': '131.6', 'spread': '69.0', 'groupId': 'OG001'}]}]}, {'title': 'Pre-dose at Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49.30', 'spread': '63.9', 'groupId': 'OG000'}, {'value': '143.0', 'spread': '64.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 28: 2 h post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91.79', 'spread': '45.3', 'groupId': 'OG000'}, {'value': '323.7', 'spread': '40.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 40: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.71', 'spread': '54.2', 'groupId': 'OG000'}, {'value': '136.8', 'spread': '63.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 40: 2 h post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '107.3', 'spread': '45.0', 'groupId': 'OG000'}, {'value': '302.6', 'spread': '40.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 52: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.78', 'spread': '61.7', 'groupId': 'OG000'}, {'value': '135.4', 'spread': '60.3', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '2 hours (h) post-dose on Day 1; Pre-dose and 2 h post-dose at Weeks 4, 28 and 40; Pre-dose at Weeks 16 and 52', 'unitOfMeasure': 'nanograms per milliliter (ng/ml)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "The Pharmacokinetics (PK) concentration analysis set included adult participants who consented to participate in the main study in adult's cohort, received at least 1 dose of brensocatib, and had at least 1 postdose plasma concentration of brensocatib. 'Overall number of participants analyzed' indicates the number of participants with data available for analysis. 'Number analyzed' signifies number of adult participants with data available for analysis at specified time point."}, {'type': 'SECONDARY', 'title': 'Plasma Concentration of Brensocatib in Adults (PK Substudy)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brensocatib 10 mg', 'description': 'Participants received brensocatib 10 mg tablets, orally, once daily, for 52 weeks.'}, {'id': 'OG001', 'title': 'Brensocatib 25 mg', 'description': 'Participants received brensocatib 25 mg tablets, orally, once daily, for 52 weeks.'}], 'classes': [{'title': 'Day 1: 0.5 h post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.51', 'spread': '97.9', 'groupId': 'OG000'}, {'value': '85.13', 'spread': '103.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 1: 2 h post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.52', 'spread': '55.0', 'groupId': 'OG000'}, {'value': '120.0', 'spread': '56.2', 'groupId': 'OG001'}]}]}, {'title': 'Day 1: 4-8 h post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.13', 'spread': '52.9', 'groupId': 'OG000'}, {'value': '108.5', 'spread': '46.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 4: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57.53', 'spread': '53.4', 'groupId': 'OG000'}, {'value': '131.3', 'spread': '60.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 4: 2 h post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.3', 'spread': '44.1', 'groupId': 'OG000'}, {'value': '286.7', 'spread': '38.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 16: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.24', 'spread': '58.1', 'groupId': 'OG000'}, {'value': '138.0', 'spread': '64.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 28: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.33', 'spread': '54.7', 'groupId': 'OG000'}, {'value': '124.6', 'spread': '59.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 28: 0.5 h post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '89.75', 'spread': '46.0', 'groupId': 'OG000'}, {'value': '235.5', 'spread': '53.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 28: 2 h post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '95.33', 'spread': '35.3', 'groupId': 'OG000'}, {'value': '271.9', 'spread': '46.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 28: 4-8 h post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '86.27', 'spread': '40.7', 'groupId': 'OG000'}, {'value': '246.4', 'spread': '43.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 40: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.80', 'spread': '54.4', 'groupId': 'OG000'}, {'value': '119.3', 'spread': '51.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 40: 2 h post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '93.74', 'spread': '32.1', 'groupId': 'OG000'}, {'value': '271.2', 'spread': '45.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 52: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49.93', 'spread': '72.2', 'groupId': 'OG000'}, {'value': '131.6', 'spread': '56.5', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0.5 h, 2 h, and 4 to 8 h post-dose on Day 1and at Week 28; Pre-dose and 2 h post-dose at Weeks 4 and 48; Pre-dose at Weeks 16 and 52', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "The PK concentration analysis set included adult participants who consented to participate in the PK substudy and received at least 1 dose of brensocatib, and had at least 1 postdose plasma concentration of brensocatib. 'Overall number of participants analyzed' indicates the number of participants with data available for analysis. 'Number analyzed' signifies number of adult participants with data available for analysis at specified time point."}, {'type': 'SECONDARY', 'title': 'Plasma Concentration of Brensocatib in Adolescents (Main Study)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brensocatib 10 mg', 'description': 'Participants received brensocatib 10 mg tablets, orally, once daily, for 52 weeks.'}, {'id': 'OG001', 'title': 'Brensocatib 25 mg', 'description': 'Participants received brensocatib 25 mg tablets, orally, once daily, for 52 weeks.'}], 'classes': [{'title': 'Day 1: 0.5 h post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '63.20', 'spread': '51.7', 'groupId': 'OG000'}, {'value': '109.3', 'spread': '139.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 1: 2 h post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68.33', 'spread': '32.5', 'groupId': 'OG000'}, {'value': '202.5', 'spread': '50.7', 'groupId': 'OG001'}]}]}, {'title': 'Day 1: 4-8 h post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '56.07', 'spread': '24.1', 'groupId': 'OG000'}, {'value': '196.1', 'spread': '52.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 4: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.10', 'spread': '64.2', 'groupId': 'OG000'}, {'value': '126.6', 'spread': '90.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 4: 2 h post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '134.9', 'spread': '52.8', 'groupId': 'OG000'}, {'value': '432.9', 'spread': '44.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 16: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40.62', 'spread': '51.6', 'groupId': 'OG000'}, {'value': '158.1', 'spread': '95.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 28: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.74', 'spread': '57.2', 'groupId': 'OG000'}, {'value': '132.9', 'spread': '96.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 28: 0.5 h post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '123.4', 'spread': '49.1', 'groupId': 'OG000'}, {'value': '321.6', 'spread': '93.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 28: 2 h post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '118.5', 'spread': '30.5', 'groupId': 'OG000'}, {'value': '336.9', 'spread': '77.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 28: 4-8 h post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '115.4', 'spread': '27.7', 'groupId': 'OG000'}, {'value': '309.9', 'spread': '48.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 40: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.30', 'spread': '52.5', 'groupId': 'OG000'}, {'value': '84.39', 'spread': '102.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 40: 2 h post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '110.4', 'spread': '43.9', 'groupId': 'OG000'}, {'value': '262.8', 'spread': '77.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 52: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.02', 'spread': '64.8', 'groupId': 'OG000'}, {'value': '104.0', 'spread': '57.8', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0.5 h, 2 h, and 4 to 8 h post-dose on Day 1 and at Week 28; Pre-dose and 2 h post-dose at Weeks 4 and 48; Pre-dose at Weeks 16 and 52', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "The PK concentration analysis set included adolescent participants who consented to participate in the main study and received at least 1 dose of brensocatib, and had at least 1 postdose plasma concentration of brensocatib. 'Overall number of participants analyzed' indicates the number of participants with data available for analysis. 'Number analyzed' signifies number of adolescent participants with data available for analysis at specified time point."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Brensocatib 10 Milligrams (mg)', 'description': 'Participants received brensocatib 10 mg tablets, orally, once daily, for 52 weeks.'}, {'id': 'FG001', 'title': 'Brensocatib 25 mg', 'description': 'Participants received brensocatib 25 mg tablets, orally, once daily, for 52 weeks.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Participants received a brensocatib matching placebo, tablets orally, once daily, for 52 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '583'}, {'groupId': 'FG001', 'numSubjects': '575'}, {'groupId': 'FG002', 'numSubjects': '563'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '458'}, {'groupId': 'FG001', 'numSubjects': '466'}, {'groupId': 'FG002', 'numSubjects': '457'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '125'}, {'groupId': 'FG001', 'numSubjects': '109'}, {'groupId': 'FG002', 'numSubjects': '106'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '37'}]}, {'type': 'Reason not specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '56'}, {'groupId': 'FG002', 'numSubjects': '43'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 373 sites in 36 countries from 01 Dec 2020 to 28 Oct 2024.', 'preAssignmentDetails': 'A total of 2296 participants were screened, 1767 participants with non-cystic fibrosis bronchiectasis were enrolled in the study. Due to the war in Ukraine, 44 participants from Ukraine were discontinued and excluded from all analyses. There were 2 additional participants who were excluded from all analyses due to serious Good Clinical Practice (GCP) non-compliance. A total of 1721 participants were randomized and analyzed.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '583', 'groupId': 'BG000'}, {'value': '575', 'groupId': 'BG001'}, {'value': '563', 'groupId': 'BG002'}, {'value': '1721', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Brensocatib 10 mg', 'description': 'Participants received brensocatib 10 mg tablets, orally, once daily, for 52 weeks.'}, {'id': 'BG001', 'title': 'Brensocatib 25 mg', 'description': 'Participants received brensocatib 25 mg tablets orally, once daily, for 52 weeks.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Participants received a brensocatib matching placebo tablets orally, once daily, for 52 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.8', 'spread': '15.92', 'groupId': 'BG000'}, {'value': '60.6', 'spread': '15.78', 'groupId': 'BG001'}, {'value': '60.0', 'spread': '15.44', 'groupId': 'BG002'}, {'value': '60.2', 'spread': '15.72', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '385', 'groupId': 'BG000'}, {'value': '360', 'groupId': 'BG001'}, {'value': '362', 'groupId': 'BG002'}, {'value': '1107', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '198', 'groupId': 'BG000'}, {'value': '215', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}, {'value': '614', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '177', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '170', 'groupId': 'BG002'}, {'value': '511', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '391', 'groupId': 'BG000'}, {'value': '397', 'groupId': 'BG001'}, {'value': '373', 'groupId': 'BG002'}, {'value': '1161', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '191', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '431', 'groupId': 'BG000'}, {'value': '430', 'groupId': 'BG001'}, {'value': '405', 'groupId': 'BG002'}, {'value': '1266', 'groupId': 'BG003'}]}, {'title': 'Other', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '153', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Intent-to-treat (ITT) analysis set included all participants who were randomized.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-02-14', 'size': 5616928, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-11-28T00:54', 'hasProtocol': True}, {'date': '2024-04-19', 'size': 2452713, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-10-27T12:54', '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': 1767}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT05344508', 'statusForNctId': 'APPROVED_FOR_MARKETING', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-28', 'studyFirstSubmitDate': '2020-10-14', 'resultsFirstSubmitDate': '2025-10-27', 'studyFirstSubmitQcDate': '2020-10-14', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-28', 'studyFirstPostDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Annualized Rate of Pulmonary Exacerbations (PEs)', 'timeFrame': 'Up to Week 52', 'description': "PE was defined as having 3 or more of these symptoms for at least 48 hours resulting in a physician's decision to prescribe antibiotics: 1. Increased cough 2. Increased sputum volume or change in sputum consistency 3. Increased sputum purulence 4. Increased breathlessness and/or decreased exercise tolerance 5. Fatigue and/or malaise 6. Hemoptysis. A severe pulmonary exacerbation was that required intravenous (IV) antibacterial drug treatment and/or hospitalization. A minimum of 14 days must have occurred between one exacerbation onset and the next. Any exacerbation that occurred less than 14 days from the prior exacerbation was not considered a new exacerbation. Independent adjudication committee with pulmonary physicians adjudicated reported PE events to see if they fulfil the protocol definition. The rate of PE was analyzed using the negative binomial model."}], 'secondaryOutcomes': [{'measure': 'Time to First PE', 'timeFrame': 'Up to Week 52', 'description': "PE was defined as having 3 or more of following symptoms for at least 48 hours resulting in physician's decision to prescribe antibiotics:1.Increased cough2.Increased sputum volume or change in sputum consistency3.Increased sputum purulence4.Increased breathlessness \\&/or decreased exercise tolerance5.Fatigue \\&/or malaise6.Hemoptysis.Severe PE were those requiring IV antibacterial drug treatment \\&/or hospitalization. Minimum of 14 days must have occurred between one exacerbation onset and next. Any exacerbation that occurred within 14 days of prior exacerbation was not considered a new exacerbation. Time to first PE was calculated from randomization date to onset date of the first exacerbation. Participants who did not have exacerbation at end of 52-week treatment period were considered as censored at date of Week 52 in Cox proportional hazard model. Independent adjudication committee with pulmonary physicians adjudicated reported PE events to see if they fulfil protocol definition."}, {'measure': 'Responder Status for Exacerbation-Free Over the 52-Week Treatment Period', 'timeFrame': 'Up to Week 52', 'description': "Responder status was based on percentage of participants who were exacerbation free over 52-weeks of treatment period. Pulmonary exacerbation was defined as having 3 or more of the following symptoms for at least 48 hours resulting in a physician's decision to prescribe antibiotics: 1. Increased cough 2. Increased sputum volume or change in sputum consistency 3. Increased sputum purulence 4. Increased breathlessness and/or decreased exercise tolerance 5. Fatigue and/or malaise 6. Hemoptysis. A minimum of 14 days must have occurred between one exacerbation onset and the next. Any exacerbation that occurred less than 14 days from the prior exacerbation was not considered a new exacerbation. Independent adjudication committee of pulmonary physicians adjudicated reported PE events to see if they fulfill protocol definition. For discontinuation prior to Week 52 without having experienced a confirmed PE, responder status was imputed by multiple imputation."}, {'measure': 'Change From Baseline at Week 52 in Postbronchodilator Forced Expiratory Volume in 1 Second (FEV1)', 'timeFrame': 'Baseline, Week 52', 'description': 'FEV1 was used to assess lung function and is the maximum amount of air that can be forced out in one second after first second after taking a forced expiration as measured by spirometer. Postbronchodilator FEV1 tests included spirometry tests performed referred to the spirometry performed within 30 minutes after administration of bronchodilator (4 puffs of salbutamol/albuterol, terbutaline or ipratropium). A positive change from baseline indicates an improvement in lung function. Baseline was the most recent non-missing assessment determined as best effort prior to the first dose of the investigational product.'}, {'measure': 'Annualized Rate of Severe PEs', 'timeFrame': 'Up to Week 52', 'description': "Pulmonary exacerbation was defined as having 3 or more of the following symptoms for at least 48 hours resulting in a physician's decision to prescribe antibiotics: 1. Increased cough 2. Increased sputum volume or change in sputum consistency 3. Increased sputum purulence 4. Increased breathlessness and/or decreased exercise tolerance 5. Fatigue and/or malaise 6. Hemoptysis. A severe PE was defined as those requiring IV antibacterial drug treatment and/or hospitalization. A minimum of 14 days must have occurred between one exacerbation onset and the next. Any exacerbation that occurred less than 14 days from the prior exacerbation was not considered a new exacerbation. Independent adjudication committee with pulmonary physicians adjucated reported PE events to see if they fulfil the protocol definition. The rate of PE was analyzed using the negative binomial model."}, {'measure': 'Change From Baseline at Week 52 in Quality of Life Questionnaire - Bronchiectasis (QOL-B) Respiratory Symptoms Domain Score in Adult Participants', 'timeFrame': 'Baseline, Week 52', 'description': 'The QOL-B is a validated, self-administered patient-reported outcome (PRO) that assesses symptoms, functioning, and health-related quality of life for participants with non-cystic fibrosis bronchiectasis (NCFBE). It contains 37 items in 8 domains (Respiratory Symptoms, Physical Functioning, Role Functioning, Emotional Functioning, Social Functioning, Vitality, Health Perceptions and Treatment Burden). Each of the 37 items is scored from 1 to 4, and each of the 8 domains scale scores is standardized on a 0-100 point scale, with higher scores representing fewer symptoms or better functioning. A positive change from Baseline indicates improvement in symptoms. For this outcome measure, change in the respiratory symptoms domain score from Baseline was reported. Baseline refers to most recent assessment on or before study Day 1.'}, {'measure': 'Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to Week 56', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs are AEs that occurred on or after the date of first dose of study drugs and within 28 days after the end of treatment.'}, {'measure': 'Plasma Concentration of Brensocatib in Adults (Main Study)', 'timeFrame': '2 hours (h) post-dose on Day 1; Pre-dose and 2 h post-dose at Weeks 4, 28 and 40; Pre-dose at Weeks 16 and 52'}, {'measure': 'Plasma Concentration of Brensocatib in Adults (PK Substudy)', 'timeFrame': '0.5 h, 2 h, and 4 to 8 h post-dose on Day 1and at Week 28; Pre-dose and 2 h post-dose at Weeks 4 and 48; Pre-dose at Weeks 16 and 52'}, {'measure': 'Plasma Concentration of Brensocatib in Adolescents (Main Study)', 'timeFrame': '0.5 h, 2 h, and 4 to 8 h post-dose on Day 1 and at Week 28; Pre-dose and 2 h post-dose at Weeks 4 and 48; Pre-dose at Weeks 16 and 52'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ASPEN', 'Brensocatib', 'INS1007'], 'conditions': ['Non-Cystic Fibrosis Bronchiectasis']}, 'referencesModule': {'references': [{'pmid': '40267423', 'type': 'DERIVED', 'citation': 'Chalmers JD, Burgel PR, Daley CL, De Soyza A, Haworth CS, Mauger D, Loebinger MR, McShane PJ, Ringshausen FC, Blasi F, Shteinberg M, Mange K, Teper A, Fernandez C, Zambrano M, Fan C, Zhang X, Metersky ML; ASPEN Investigators. Phase 3 Trial of the DPP-1 Inhibitor Brensocatib in Bronchiectasis. N Engl J Med. 2025 Apr 24;392(16):1569-1581. doi: 10.1056/NEJMoa2411664.'}, {'pmid': '39040578', 'type': 'DERIVED', 'citation': 'Chalmers JD, Burgel PR, Daley CL, De Soyza A, Haworth CS, Mauger D, Mange K, Teper A, Fernandez C, Conroy D, Metersky M. Brensocatib in non-cystic fibrosis bronchiectasis: ASPEN protocol and baseline characteristics. ERJ Open Res. 2024 Jul 22;10(4):00151-2024. doi: 10.1183/23120541.00151-2024. eCollection 2024 Jul.'}, {'pmid': '35976570', 'type': 'DERIVED', 'citation': 'Chalmers JD, Usansky H, Rubino CM, Teper A, Fernandez C, Zou J, Mange KC. Pharmacokinetic/Pharmacodynamic Evaluation of the Dipeptidyl Peptidase 1 Inhibitor Brensocatib for Non-cystic Fibrosis Bronchiectasis. Clin Pharmacokinet. 2022 Oct;61(10):1457-1469. doi: 10.1007/s40262-022-01147-w. Epub 2022 Jul 25.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the effect of brensocatib at 10 mg and 25 mg compared with placebo on the rate of pulmonary exacerbations (PEs) over the 52-week treatment period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Provide their signed study informed consent to participate.\n\n a. Adolescent participants must have signed study assent form to participate, and the adolescent's parent or legal guardian must have provided signed informed consent for the adolescent to participate.\n2. Clinical history consistent with non-cystic fibrosis bronchiectasis (NCFBE) (cough, chronic sputum production and/or recurrent respiratory infections) that is confirmed by chest computerized tomography (CT) scan.\n3. At least 2 PEs defined by need for antibiotic prescription by a physician for the signs and symptoms of respiratory infections in the past 12 months before the Screening Visit.\n\n a. Adolescent participants are required to have at least 1 pulmonary exacerbation in the prior 12 months.\n4. Women must be postmenopausal (defined as no menses for 12 months without an alternative medical cause), surgically sterile, or using highly effective contraception (ie, methods that can achieve a failure rate \\<1% per year when used consistently and correctly) from Day 1 to at least 90 days after the last dose.\n5. Male participants with female partners of childbearing potential must be using effective contraception from Day 1 to at least 90 days after the last dose.\n6. Male participants with pregnant or non-pregnant women of child-bearing potential partners must use condoms to avoid potential exposure to the embryo/fetus.\n\nExclusion Criteria:\n\n1. A primary diagnosis of chronic obstructive pulmonary disease (COPD) or asthma as judged by the Investigator.\n2. Bronchiectasis due to cystic fibrosis.\n3. Current smokers as defined per Centers for Disease Control (CDC).\n4. Known or suspected immunodeficiency disorder, including history of invasive opportunistic infections.\n5. Known history of human immunodeficiency virus (HIV) infection.\n6. Currently being treated for nontuberculous mycobacteria (NTM) lung infection, allergic bronchopulmonary aspergillosis, or tuberculosis (TB).\n7. Active and current symptomatic infection by 2019 corona virus disease (COVID-19).\n8. Inability to follow the procedures of the study (eg, due to language problems or psychological disorders).\n9. Receiving medications or therapy that are prohibited as concomitant medications.\n10. Previously participated in a clinical trial for brensocatib.\n11. Received any live attenuated vaccine within 4 weeks prior to the first administration of brensocatib.\n12. Suffering an exacerbation 4 weeks before Screening or during the Screening period.\n13. Adult participants only: Have compliance issues with completion of electronic diary entries during the Screening Period and in the opinion of the Investigator, compliance is unlikely to improve during the study.\n14. Participated in any other interventional clinical studies within 3 months before Screening Visit.\n15. History of alcohol or drug abuse within 6 months prior to the Screening Visit.\n16. Is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study.\n17. Known history of hypersensitivity to brensocatib or any of its excipients."}, 'identificationModule': {'nctId': 'NCT04594369', 'acronym': 'ASPEN', 'briefTitle': 'A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Insmed Incorporated'}, 'officialTitle': 'A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects With Non-Cystic Fibrosis Bronchiectasis - The ASPEN Study', 'orgStudyIdInfo': {'id': 'INS1007-301'}, 'secondaryIdInfos': [{'id': '2020-003688-25', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brensocatib 10 milligrams (mg)', 'description': 'Participants will receive brensocatib 10 mg, tablets orally, once daily, for 52 weeks.', 'interventionNames': ['Drug: Brensocatib 10 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Brensocatib 25 mg', 'description': 'Participants will receive brensocatib 25 mg, tablets orally, once daily, for 52 weeks.', 'interventionNames': ['Drug: Brensocatib 25 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive a brensocatib-matching placebo, tablets orally, once daily, for 52 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Brensocatib 10 mg', 'type': 'DRUG', 'otherNames': ['INS1007'], 'description': 'Oral tablet.', 'armGroupLabels': ['Brensocatib 10 milligrams (mg)']}, {'name': 'Brensocatib 25 mg', 'type': 'DRUG', 'otherNames': ['INS1007'], 'description': 'Oral tablet.', 'armGroupLabels': ['Brensocatib 25 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Brensocatib-matching oral tablet.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 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{'lat': 34.22834, 'lon': -118.53675}}, {'zip': '92262', 'city': 'Palm Springs', 'state': 'California', 'country': 'United States', 'facility': 'USA022', 'geoPoint': {'lat': 33.8303, 'lon': -116.54529}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'USA024', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92120', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'USA035', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '93105', 'city': 'Santa Barbara', 'state': 'California', 'country': 'United States', 'facility': 'USA078', 'geoPoint': {'lat': 34.42083, 'lon': -119.69819}}, {'zip': '93003', 'city': 'Ventura', 'state': 'California', 'country': 'United States', 'facility': 'USA027', 'geoPoint': {'lat': 34.27834, 'lon': -119.29317}}, {'zip': '80206', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'USA075', 'geoPoint': {'lat': 39.73915, 'lon': 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