Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-02-25 @ 7:03 PM
Study NCT ID:
NCT02544451
Status:
COMPLETED
Last Update Posted:
2021-05-24
First Post:
2015-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000599212', 'term': 'lumacaftor, ivacaftor drug combination'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medicalinfo@vrtx.com', 'phone': '617-341-6777', 'title': 'Medical Monitor', 'organization': 'Vertex Pharmaceuticals Incorporated'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168', 'description': 'Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment Period 1: LUM/IVA to LUM/IVA', 'description': 'Participants received LUM/IVA in parent studies (109, 011B) and continued to receive LUM/IVA for 96 weeks in the current study.', 'otherNumAtRisk': 143, 'deathsNumAtRisk': 143, 'otherNumAffected': 141, 'seriousNumAtRisk': 143, 'deathsNumAffected': 0, 'seriousNumAffected': 43}, {'id': 'EG001', 'title': 'Treatment Period 1: PBO to LUM/IVA', 'description': 'Participants received PBO in parent study (109) and then received LUM/IVA for 96 weeks in the current study.', 'otherNumAtRisk': 96, 'deathsNumAtRisk': 96, 'otherNumAffected': 93, 'seriousNumAtRisk': 96, 'deathsNumAffected': 0, 'seriousNumAffected': 29}, {'id': 'EG002', 'title': 'Treatment Period 1: Observational Cohort', 'description': 'Participants completed a parent study (109, 011B) but were not eligible or elected to not receive LUM/IVA for 96 weeks in the current study.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Treatment Period 2: LUM/IVA', 'description': 'Eligible subjects from Treatment Period 1 received LUM/IVA for up to approximately 168 weeks.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 9, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Infective pulmonary exacerbation of cystic fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Pharyngitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Bacterial disease carrier', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Upper respiratory tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 91}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 64}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Sputum increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Nasal polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Respiration abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Bacterial test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Pseudomonas test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Pulmonary function test decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Activated partial thromboplastin time prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Forced expiratory volume decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'International normalised ratio increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Prothrombin time prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Seasonal allergy', 'stats': 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'sourceVocabulary': '21.0, 22.1'}, {'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Autoimmune hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 22.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.0, 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'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to Week 100', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who received at least 1 dose of study drug in Treatment Period 1.'}, {'type': 'SECONDARY', 'title': 'Absolute Change in Lung Clearance Index (LCI) 2.5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LUM/IVA to LUM/IVA', 'description': 'All participants in the LCI set who received LUM/IVA in the parent study.'}, {'id': 'OG001', 'title': 'PBO to LUM/IVA', 'description': 'All participants in the LCI set who received PBO in the parent study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.85', 'groupId': 'OG000', 'lowerLimit': '-1.25', 'upperLimit': '-0.45'}, {'value': '-0.86', 'groupId': 'OG001', 'lowerLimit': '-1.33', 'upperLimit': '-0.38'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Parent Study Baseline at Week 96', 'description': 'LCI 2.5 represents the number of lung turnovers required to reduce the end tidal inert gas concentration to 1/40th of its starting value.', 'unitOfMeasure': 'lung clearance index', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'LCI set includes all participants enrolled and dosed in either parent study 109 or 011B LCI sub-study. Analysis period includes both parent study and current study.'}, {'type': 'SECONDARY', 'title': 'Absolute Change in Sweat Chloride', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LUM/IVA to LUM/IVA', 'description': 'All participants in the FAS who received LUM/IVA in the parent study.'}, {'id': 'OG001', 'title': 'PBO to LUM/IVA', 'description': 'All participants in the FAS who received PBO in the parent study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-22.9', 'groupId': 'OG000', 'lowerLimit': '-25.5', 'upperLimit': '-20.3'}, {'value': '-22.8', 'groupId': 'OG001', 'lowerLimit': '-26.3', 'upperLimit': '-19.3'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Parent Study Baseline at Week 96', 'description': 'Sweat samples were collected using an approved collection device.', 'unitOfMeasure': 'millimole per liter (mmol/L)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) includes all participants enrolled and dosed in either parent study. Analysis period includes both parent study and current study.'}, {'type': 'SECONDARY', 'title': 'Absolute Change in Body Mass Index (BMI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LUM/IVA to LUM/IVA', 'description': 'All participants in the FAS who received LUM/IVA in the parent study.'}, {'id': 'OG001', 'title': 'PBO to LUM/IVA', 'description': 'All participants in the FAS who received PBO in the parent study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.78', 'groupId': 'OG000', 'lowerLimit': '1.56', 'upperLimit': '1.99'}, {'value': '2.04', 'groupId': 'OG001', 'lowerLimit': '1.77', 'upperLimit': '2.31'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Parent Study Baseline at Week 96', 'description': 'BMI was defined as weight in kilograms divided by height in square meter (m\\^2).', 'unitOfMeasure': 'kg/m^2', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS.'}, {'type': 'SECONDARY', 'title': 'Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LUM/IVA to LUM/IVA', 'description': 'All participants in the FAS who received LUM/IVA in the parent study.'}, {'id': 'OG001', 'title': 'PBO to LUM/IVA', 'description': 'All participants in the FAS who received PBO in the parent study.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000', 'lowerLimit': '4.8', 'upperLimit': '10.0'}, {'value': '6.6', 'groupId': 'OG001', 'lowerLimit': '3.1', 'upperLimit': '10.0'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Parent Study Baseline at Week 96', 'description': 'The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS.'}, {'type': 'SECONDARY', 'title': 'Observational Cohort: Safety as Assessed by Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Observational Cohort', 'description': 'Participants completed a parent study (109, 011B) but were not eligible or elected to not receive LUM/IVA for 96 weeks in the current study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to Week 100', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants included in the observational cohort.'}, {'type': 'SECONDARY', 'title': 'Absolute Change in LCI 5.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LUM/IVA to LUM/IVA', 'description': 'All participants in the LCI set who received LUM/IVA in the parent study.'}, {'id': 'OG001', 'title': 'PBO to LUM/IVA', 'description': 'All participants in the LCI set who received PBO in the parent study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.21', 'groupId': 'OG000', 'lowerLimit': '-0.36', 'upperLimit': '-0.06'}, {'value': '-0.31', 'groupId': 'OG001', 'lowerLimit': '-0.49', 'upperLimit': '-0.13'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Parent Study Baseline at Week 96', 'description': 'LCI 5.0 represents the number of lung turnovers required to reduce the end tidal inert gas concentration to 1/20th of its starting value.', 'unitOfMeasure': 'lung clearance index', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'LCI set.'}, {'type': 'SECONDARY', 'title': 'Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LUM/IVA to LUM/IVA', 'description': 'All participants in the FAS who received LUM/IVA in the parent study.'}, {'id': 'OG001', 'title': 'PBO to LUM/IVA', 'description': 'All participants in the FAS who received PBO in the parent study.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '5.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-2.7', 'upperLimit': '2.7'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Parent Study Baseline at Week 96', 'description': 'FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.', 'unitOfMeasure': 'percent predicted of FEV1', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS.'}, {'type': 'SECONDARY', 'title': 'Relative Change in ppFEV1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LUM/IVA to LUM/IVA', 'description': 'All participants in the FAS who received LUM/IVA in the parent study.'}, {'id': 'OG001', 'title': 'PBO to LUM/IVA', 'description': 'All participants in the FAS who received PBO in the parent study.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000', 'lowerLimit': '2.2', 'upperLimit': '7.5'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '-2.9', 'upperLimit': '4.0'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Parent Study Baseline at Week 96', 'description': 'FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS.'}, {'type': 'SECONDARY', 'title': 'Absolute Change in BMI-for-age Z-score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LUM/IVA to LUM/IVA', 'description': 'All participants in the FAS who received LUM/IVA in the parent study.'}, {'id': 'OG001', 'title': 'PBO to LUM/IVA', 'description': 'All participants in the FAS who received PBO in the parent study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.17', 'groupId': 'OG000', 'lowerLimit': '0.08', 'upperLimit': '0.26'}, {'value': '0.31', 'groupId': 'OG001', 'lowerLimit': '0.19', 'upperLimit': '0.42'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Parent Study Baseline at Week 96', 'description': 'BMI was defined as weight in kilograms divided by height in m\\^2. z-score is a statistical measure to describe whether a mean was above or below the standard. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean.', 'unitOfMeasure': 'z-score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS.'}, {'type': 'SECONDARY', 'title': 'Absolute Change in Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LUM/IVA to LUM/IVA', 'description': 'All participants in the FAS who received LUM/IVA in the parent study.'}, {'id': 'OG001', 'title': 'PBO to LUM/IVA', 'description': 'All participants in the FAS who received PBO in the parent study.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000', 'lowerLimit': '9.6', 'upperLimit': '11.0'}, {'value': '11.0', 'groupId': 'OG001', 'lowerLimit': '10.1', 'upperLimit': '11.8'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Parent Study Baseline at Week 96', 'unitOfMeasure': 'kg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS.'}, {'type': 'SECONDARY', 'title': 'Absolute Change in Weight-for-age Z-score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LUM/IVA to LUM/IVA', 'description': 'All participants in the FAS who received LUM/IVA in the parent study.'}, {'id': 'OG001', 'title': 'PBO to LUM/IVA', 'description': 'All participants in the FAS who received PBO in the parent study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.12', 'groupId': 'OG000', 'lowerLimit': '0.04', 'upperLimit': '0.20'}, {'value': '0.24', 'groupId': 'OG001', 'lowerLimit': '0.14', 'upperLimit': '0.34'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Parent Study Baseline at Week 96', 'description': 'z-score is a statistical measure to describe whether a mean was above or below the standard. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean.', 'unitOfMeasure': 'z-score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS.'}, {'type': 'SECONDARY', 'title': 'Absolute Change in Height', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LUM/IVA to LUM/IVA', 'description': 'All participants in the FAS who received LUM/IVA in the parent study.'}, {'id': 'OG001', 'title': 'PBO to LUM/IVA', 'description': 'All participants in the FAS who received PBO in the parent study.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.4', 'groupId': 'OG000', 'lowerLimit': '12.9', 'upperLimit': '14.0'}, {'value': '13.5', 'groupId': 'OG001', 'lowerLimit': '12.8', 'upperLimit': '14.1'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Parent Study Baseline at Week 96', 'unitOfMeasure': 'centimeter (cm)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS.'}, {'type': 'SECONDARY', 'title': 'Absolute Change in Height-for-age Z-score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LUM/IVA to LUM/IVA', 'description': 'All participants in the FAS who received LUM/IVA in the parent study.'}, {'id': 'OG001', 'title': 'PBO to LUM/IVA', 'description': 'All participants in the FAS who received PBO in the parent study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.01', 'groupId': 'OG000', 'lowerLimit': '-0.08', 'upperLimit': '0.07'}, {'value': '0.02', 'groupId': 'OG001', 'lowerLimit': '-0.07', 'upperLimit': '0.11'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Parent Study Baseline at Week 96', 'description': 'z-score is a statistical measure to describe whether a mean was above or below the standard. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean.', 'unitOfMeasure': 'z-score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS.'}, {'type': 'SECONDARY', 'title': 'Absolute Change in Treatment Satisfaction Questionnaire for Medication (TSQM) Total Domain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LUM/IVA to LUM/IVA', 'description': 'All participants in the FAS who received LUM/IVA in the parent study.'}, {'id': 'OG001', 'title': 'PBO to LUM/IVA', 'description': 'All participants in the FAS who received PBO in the parent study.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '8.4'}, {'value': '3.9', 'groupId': 'OG001', 'lowerLimit': '-0.6', 'upperLimit': '8.5'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Parent Study Baseline at Week 96', 'description': "The TSQM measures participants' experiences with their medication on four dimensions: effectiveness, side effects, convenience and global satisfaction. For each dimension, responses are added and transformed in the total domain score, which ranges from 0 to 100, where higher scores indicate greater satisfaction.", 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS.'}, {'type': 'SECONDARY', 'title': 'Time-to-first Pulmonary Exacerbation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LUM/IVA to LUM/IVA', 'description': 'All participants who received LUM/IVA in parent study 109.'}, {'id': 'OG001', 'title': 'PBO to LUM/IVA', 'description': 'All participants who received PBO in parent study 109.'}], 'classes': [{'categories': [{'measurements': [{'value': '720.00', 'comment': 'Upper limit of inter-quartile range could not be estimated because less than 75% of participants had events.', 'groupId': 'OG000', 'lowerLimit': '278.00', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and upper limit of inter-quartile range could not be estimated because less than 50% of participants had events.', 'groupId': 'OG001', 'lowerLimit': '513.00', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Parent Study Baseline through Week 96', 'description': 'Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis included all participants dosed in parent study 109. LUM/IVA to LUM/IVA analysis period includes both parent study and current study. PBO to LUM/IVA analysis period includes the current study only.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Having At Least 1 Pulmonary Exacerbation Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LUM/IVA to LUM/IVA', 'description': 'All participants who received LUM/IVA in parent study 109.'}, {'id': 'OG001', 'title': 'PBO to LUM/IVA', 'description': 'All participants who received PBO in parent study 109.'}], 'classes': [{'categories': [{'measurements': [{'value': '49.5', 'groupId': 'OG000'}, {'value': '32.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Parent Study Baseline through Week 96', 'description': 'Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis included all participants dosed in parent study 109. LUM/IVA to LUM/IVA analysis period includes both parent study and current study. PBO to LUM/IVA analysis period includes the current study only.'}, {'type': 'SECONDARY', 'title': 'Number of Pulmonary Exacerbation Events Per Patient-year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LUM/IVA to LUM/IVA', 'description': 'All participants who received LUM/IVA in parent study 109.'}, {'id': 'OG001', 'title': 'PBO to LUM/IVA', 'description': 'All participants who received PBO in parent study 109.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.45', 'groupId': 'OG000', 'lowerLimit': '0.33', 'upperLimit': '0.61'}, {'value': '0.30', 'groupId': 'OG001', 'lowerLimit': '0.21', 'upperLimit': '0.43'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Parent Study Baseline through Week 96', 'description': 'Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms.', 'unitOfMeasure': 'events per patient-year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis included all participants dosed in parent study 109. LUM/IVA to LUM/IVA analysis period includes both parent study and current study. PBO to LUM/IVA analysis period includes the current study only.'}, {'type': 'SECONDARY', 'title': 'Rate of Change in LCI 2.5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LUM/IVA Overall', 'description': 'All participants who received LUM/IVA in parent study 109, 011B LCI sub-study, or current study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.01', 'groupId': 'OG000', 'lowerLimit': '-0.12', 'upperLimit': '0.09'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 15 after first dose of LUM/IVA through Week 96', 'description': 'Rate of change analysis evaluates the change in LCI 2.5 after long term treatment with LUM/IVA. A rate of change equal to zero would indicate that treatment effects were stable.', 'unitOfMeasure': 'slope', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'As pre-specified in the SAP, this analysis was conducted in the LUM/IVA Overall group because of sample size. Analysis period is 15 days after first dose of LUM/IVA in parent study or current study (if assigned to placebo in study 109) through the end of current study.'}, {'type': 'SECONDARY', 'title': 'Rate of Change in LCI 5.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LUM/IVA Overall', 'description': 'All participants who received LUM/IVA in parent study 109, 011B LCI sub-study, or current study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.04', 'upperLimit': '0.04'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 15 after first dose of LUM/IVA through Week 96', 'description': 'Rate of change analysis evaluates the change in LCI 5.0 after long term treatment with LUM/IVA. A rate of change equal to zero would indicate that treatment effects were stable.', 'unitOfMeasure': 'slope', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'As pre-specified in the SAP, this analysis was conducted in the LUM/IVA Overall group because of sample size. Analysis period is 15 days after first dose of LUM/IVA in parent study or current study (if assigned to placebo in study 109) through the end of current study.'}, {'type': 'SECONDARY', 'title': 'Rate of Change in ppFEV1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LUM/IVA Overall', 'description': 'All participants who received LUM/IVA in either parent study or current study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.58', 'groupId': 'OG000', 'lowerLimit': '0.02', 'upperLimit': '1.14'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 15 after first dose of LUM/IVA through Week 96', 'description': 'Rate of change analysis evaluates the change in ppFEV1 after long term treatment with LUM/IVA. A rate of change equal to zero would indicate that treatment effects were stable.', 'unitOfMeasure': 'slope', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'As pre-specified in the SAP, this analysis was conducted in the LUM/IVA Overall group because of sample size. Analysis period is 15 days after first dose of LUM/IVA in parent study or current study (if assigned to placebo in study 109) through the end of current study.'}, {'type': 'SECONDARY', 'title': 'Treatment Period 2: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Period 2: LUM/IVA', 'description': 'Eligible subjects from Treatment Period 1 received LUM/IVA for up to approximately 168 weeks.'}], 'classes': [{'title': 'Participants with any AEs', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Participants with SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to Week 168', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who received at least 1 dose of study drug in Treatment Period 2.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Period 1: LUM/IVA to LUM/IVA', 'description': 'Participants received LUM/IVA in parent studies (109, 011B) and continued to receive LUM/IVA for 96 weeks in the current study.'}, {'id': 'FG001', 'title': 'Treatment Period 1: PBO to LUM/IVA', 'description': 'Participants received placebo (PBO) in parent study (109) and then received LUM/IVA for 96 weeks in the current study.'}, {'id': 'FG002', 'title': 'Treatment Period 1: Observational Cohort', 'description': 'Participants completed a parent study (109, 011B) but were not eligible or elected to not receive LUM/IVA for 96 weeks in the current study.'}, {'id': 'FG003', 'title': 'Treatment Period 2: LUM/IVA', 'description': 'Eligible subjects from Treatment Period 1 received LUM/IVA for up to approximately 168 weeks.'}], 'periods': [{'title': 'Treatment Period 1 (96 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '143'}, {'groupId': 'FG001', 'numSubjects': '96'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '129'}, {'groupId': 'FG001', 'numSubjects': '84'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal of consent (not due to AE)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 2 (168 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Commercial drug is available for subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '10'}]}]}], 'recruitmentDetails': 'This study consists of 2 Treatment Periods: Treatment Period 1 and Treatment Period 2. Treatment Period 1 had Treatment Cohorts and an Observational Cohort.', 'preAssignmentDetails': 'Participants from Parent Studies 109 (NCT02514473) and 011B (NCT01897233) were enrolled in this study. A total of 240 participants were enrolled in Treatment Period 1 Treatment Cohorts, out of which 1 participant was enrolled but never dosed. Participants enrolled in the Observational and Treatment Period 2 Cohorts were followed for safety endpoint only, no efficacy data were collected.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '245', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'LUM/IVA to LUM/IVA', 'description': 'Participants received LUM/IVA in parent studies (109, 011B) and continued to receive LUM/IVA for 96 weeks in the current study.'}, {'id': 'BG001', 'title': 'PBO to LUM/IVA', 'description': 'Participants received PBO in parent study (109) and then received LUM/IVA for 96 weeks in the current study.'}, {'id': 'BG002', 'title': 'Observational Cohort', 'description': 'Participants completed a parent study (109, 011B) but were not eligible or elected to not receive LUM/IVA for 96 weeks in the current study.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'title': 'Less than 9 Years', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '101', 'groupId': 'BG003'}]}, {'title': 'Greater than or equal to 9 years', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '104', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '139', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '238', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '140', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '238', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Treatment Cohort: All participants dosed in the parent studies and dosed in the current study.\n\nObservational Cohort: All participants enrolled in the observational cohort of the current study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-09-15', 'size': 13701105, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-08-23T13:39', 'hasProtocol': True}, {'date': '2018-07-20', 'size': 10725928, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-08-23T13:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 246}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-27', 'studyFirstSubmitDate': '2015-09-01', 'resultsFirstSubmitDate': '2019-08-29', 'studyFirstSubmitQcDate': '2015-09-04', 'lastUpdatePostDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-11', 'studyFirstPostDateStruct': {'date': '2015-09-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment Period 1 (Treatment Cohorts): Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Day 1 up to Week 100'}], 'secondaryOutcomes': [{'measure': 'Absolute Change in Lung Clearance Index (LCI) 2.5', 'timeFrame': 'From Parent Study Baseline at Week 96', 'description': 'LCI 2.5 represents the number of lung turnovers required to reduce the end tidal inert gas concentration to 1/40th of its starting value.'}, {'measure': 'Absolute Change in Sweat Chloride', 'timeFrame': 'From Parent Study Baseline at Week 96', 'description': 'Sweat samples were collected using an approved collection device.'}, {'measure': 'Absolute Change in Body Mass Index (BMI)', 'timeFrame': 'From Parent Study Baseline at Week 96', 'description': 'BMI was defined as weight in kilograms divided by height in square meter (m\\^2).'}, {'measure': 'Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score', 'timeFrame': 'From Parent Study Baseline at Week 96', 'description': 'The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.'}, {'measure': 'Observational Cohort: Safety as Assessed by Serious Adverse Events (SAEs)', 'timeFrame': 'Day 1 up to Week 100'}, {'measure': 'Absolute Change in LCI 5.0', 'timeFrame': 'From Parent Study Baseline at Week 96', 'description': 'LCI 5.0 represents the number of lung turnovers required to reduce the end tidal inert gas concentration to 1/20th of its starting value.'}, {'measure': 'Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)', 'timeFrame': 'From Parent Study Baseline at Week 96', 'description': 'FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.'}, {'measure': 'Relative Change in ppFEV1', 'timeFrame': 'From Parent Study Baseline at Week 96', 'description': 'FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.'}, {'measure': 'Absolute Change in BMI-for-age Z-score', 'timeFrame': 'From Parent Study Baseline at Week 96', 'description': 'BMI was defined as weight in kilograms divided by height in m\\^2. z-score is a statistical measure to describe whether a mean was above or below the standard. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean.'}, {'measure': 'Absolute Change in Weight', 'timeFrame': 'From Parent Study Baseline at Week 96'}, {'measure': 'Absolute Change in Weight-for-age Z-score', 'timeFrame': 'From Parent Study Baseline at Week 96', 'description': 'z-score is a statistical measure to describe whether a mean was above or below the standard. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean.'}, {'measure': 'Absolute Change in Height', 'timeFrame': 'From Parent Study Baseline at Week 96'}, {'measure': 'Absolute Change in Height-for-age Z-score', 'timeFrame': 'From Parent Study Baseline at Week 96', 'description': 'z-score is a statistical measure to describe whether a mean was above or below the standard. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean.'}, {'measure': 'Absolute Change in Treatment Satisfaction Questionnaire for Medication (TSQM) Total Domain Score', 'timeFrame': 'From Parent Study Baseline at Week 96', 'description': "The TSQM measures participants' experiences with their medication on four dimensions: effectiveness, side effects, convenience and global satisfaction. For each dimension, responses are added and transformed in the total domain score, which ranges from 0 to 100, where higher scores indicate greater satisfaction."}, {'measure': 'Time-to-first Pulmonary Exacerbation', 'timeFrame': 'From Parent Study Baseline through Week 96', 'description': 'Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms.'}, {'measure': 'Percentage of Participants Having At Least 1 Pulmonary Exacerbation Event', 'timeFrame': 'From Parent Study Baseline through Week 96', 'description': 'Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms.'}, {'measure': 'Number of Pulmonary Exacerbation Events Per Patient-year', 'timeFrame': 'From Parent Study Baseline through Week 96', 'description': 'Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms.'}, {'measure': 'Rate of Change in LCI 2.5', 'timeFrame': 'Day 15 after first dose of LUM/IVA through Week 96', 'description': 'Rate of change analysis evaluates the change in LCI 2.5 after long term treatment with LUM/IVA. A rate of change equal to zero would indicate that treatment effects were stable.'}, {'measure': 'Rate of Change in LCI 5.0', 'timeFrame': 'Day 15 after first dose of LUM/IVA through Week 96', 'description': 'Rate of change analysis evaluates the change in LCI 5.0 after long term treatment with LUM/IVA. A rate of change equal to zero would indicate that treatment effects were stable.'}, {'measure': 'Rate of Change in ppFEV1', 'timeFrame': 'Day 15 after first dose of LUM/IVA through Week 96', 'description': 'Rate of change analysis evaluates the change in ppFEV1 after long term treatment with LUM/IVA. A rate of change equal to zero would indicate that treatment effects were stable.'}, {'measure': 'Treatment Period 2: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Day 1 up to Week 168'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cystic Fibrosis']}, 'referencesModule': {'references': [{'pmid': '33516285', 'type': 'DERIVED', 'citation': 'Chilvers MA, Davies JC, Milla C, Tian S, Han Z, Cornell AG, Owen CA, Ratjen F. Long-term safety and efficacy of lumacaftor-ivacaftor therapy in children aged 6-11 years with cystic fibrosis homozygous for the F508del-CFTR mutation: a phase 3, open-label, extension study. Lancet Respir Med. 2021 Jul;9(7):721-732. doi: 10.1016/S2213-2600(20)30517-8. Epub 2021 Jan 28.'}]}, 'descriptionModule': {'briefSummary': 'Study 110 is a Phase 3, multicenter study in subjects aged 6 years and older with cystic fibrosis (CF) who are homozygous for the F508del-CF transmembrane conductance regulator (CFTR) mutation and who participated in Study 109 (NCT02514473) or Study 011B (NCT01897233). Study 110 is designed to evaluate the safety and efficacy of long term treatment of lumacaftor in combination with ivacaftor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects entering the Treatment Cohort must meet both of the following criteria:\n\n* Completed study visits up to Week 24 of Study 109 or Week 26 of Study 011B and did not permanently discontinue treatment\n* Willing to remain on a stable CF medication through the Safety Follow-up Visit.\n\nSubjects entering the Observational Cohort must meet 1 of the following criteria:\n\n* Completed 24 weeks of study drug treatment in Study 109 or completed 24 weeks of study drug treatment and the Week 26 Safety Follow up in Study 011B.\n* Received at least 4 weeks of study drug and completed visits up to Week 24 of Study 109 or Week 26 of Study 011B.\n\nExclusion Criteria (Treatment Cohort Only):\n\n* History of any comorbidity or laboratory abnormality that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject (e.g., cirrhosis with portal hypertension).\n* Pregnant and nursing females.\n* Sexually active subjects of reproductive potential who are not willing to follow the contraception requirements.\n* History of drug intolerance in the prior study that would pose an additional risk to the subject in the opinion of investigator\n* History of poor compliance with study drug and/or procedure in the previous study as deemed by the investigator.\n* Participation in an investigational drug trial (including studies investigating lumacaftor and/or ivacaftor).'}, 'identificationModule': {'nctId': 'NCT02544451', 'briefTitle': 'Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vertex Pharmaceuticals Incorporated'}, 'officialTitle': 'A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation', 'orgStudyIdInfo': {'id': 'VX15-809-110'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Period 1: LUM/IVA to LUM/IVA', 'interventionNames': ['Drug: LUM/IVA']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Period 1: Placebo (PBO) to LUM/IVA', 'interventionNames': ['Drug: LUM/IVA']}, {'type': 'NO_INTERVENTION', 'label': 'Treatment Period 1: Observational Cohort'}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Period 2: LUM/IVA', 'interventionNames': ['Drug: LUM/IVA']}], 'interventions': [{'name': 'LUM/IVA', 'type': 'DRUG', 'otherNames': ['VX-809/VX-770', 'lumacaftor/ivacaftor'], 'description': 'Lumacaftor (LUM) 200 mg every 12 hours (q12h)/ivacaftor (IVA) 250 mg q12h (for 6 through 11 years of age).\n\nLUM 400 mg q12h/IVA 250 mg q12h (for 12 years and older).', 'armGroupLabels': ['Treatment Period 1: LUM/IVA to LUM/IVA', 'Treatment Period 1: Placebo (PBO) to LUM/IVA']}, {'name': 'LUM/IVA', 'type': 'DRUG', 'otherNames': ['VX-809/VX-770', 'lumacaftor/ivacaftor'], 'description': 'LUM 200 mg q12h/IVA 250 mg q12h (for 6 through 11 years of age).', 'armGroupLabels': ['Treatment Period 2: LUM/IVA']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'city': 'Boston', 'state': 'Massachusetts', 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