Ignite Creation Date:
2025-12-24 @ 4:24 PM
Ignite Modification Date:
2026-02-28 @ 12:12 PM
Study NCT ID:
NCT04058366
Status:
COMPLETED
Last Update Posted:
2024-01-16
First Post:
2019-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy
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': 'C000706587', 'term': 'elexacaftor, ivacaftor, tezacaftor drug combination'}, {'id': 'C545203', 'term': 'ivacaftor'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medicalinfo@vrtx.com', 'phone': '617-341-6777', 'title': 'Medical Monitor', 'organization': 'Vertex Pharmaceuticals Incorporated'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)', 'description': 'The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.', 'eventGroups': [{'id': 'EG000', 'title': 'Part A: ELX/TEZ/IVA', 'description': 'Participants received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 96 weeks.', 'otherNumAtRisk': 251, 'deathsNumAtRisk': 251, 'otherNumAffected': 223, 'seriousNumAtRisk': 251, 'deathsNumAffected': 1, 'seriousNumAffected': 38}, {'id': 'EG001', 'title': 'Part B: ELX/TEZ/IVA', 'description': 'Part B: Participants from certain countries participated in Part B and continued to receive ELX 200 mg qd /TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 48 weeks.', 'otherNumAtRisk': 84, 'deathsNumAtRisk': 84, 'otherNumAffected': 48, 'seriousNumAtRisk': 84, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Infective pulmonary exacerbation of cystic fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Vaccination complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Sputum increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Aspergilloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Infective exacerbation of bronchiectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Infective pulmonary exacerbation of cystic fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Intraductal proliferative breast lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Epididymal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Pneumothorax spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Rash erythematous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1,25.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: ELX/TEZ/IVA', 'description': 'Participants received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 96 weeks.'}], 'classes': [{'title': 'Participants with TEAEs', 'categories': [{'measurements': [{'value': '241', 'groupId': 'OG000'}]}]}, {'title': 'Participants with SAEs', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline up to Week 100', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The open label (OL) Safety Set for Part A was defined as all participants who received at least 1 dose of study drug in the OLS Part A (participants were assigned based on parent study actual treatment).'}, {'type': 'SECONDARY', 'title': 'Part A: Absolute Change From Parent Study Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ELX/TEZ/IVA', 'description': 'All participants who received Control (IVA or TEZ/IVA) or ELX/TEZ/IVA in parent study 104 were to receive ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 96 weeks in Part A of this study.'}], 'classes': [{'title': 'Control-IVA or TEZ/IVA: Change at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '5.7'}]}]}, {'title': 'ELX/TEZ/IVA: Change at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000', 'lowerLimit': '2.2', 'upperLimit': '5.2'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline at Week 96', 'description': 'FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.', 'unitOfMeasure': 'percentage points', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The OL Full Analysis Set (OL-FAS) for Part A is defined as all enrolled participants who have received at least 1 dose of study drug in the open-label study. This analysis set included study 104 parent study participants who received Control IVA or TEZ/IVA and ELX/TEZ/IVA. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome. Here "Number Analyzed" signifies participants who were evaluable for the specified category.'}, {'type': 'SECONDARY', 'title': 'Part A: Absolute Change From Parent Study Baseline in Sweat Chloride (SwCl)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ELX/TEZ/IVA', 'description': 'All participants who received Control (IVA or TEZ/IVA) or ELX/TEZ/IVA in parent study 104 were to receive ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 96 weeks in Part A of this study.'}], 'classes': [{'title': 'Control-IVA or TEZ/IVA: Change at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-23.0', 'groupId': 'OG000', 'lowerLimit': '-25.8', 'upperLimit': '-20.1'}]}]}, {'title': 'ELX/TEZ/IVA: Change at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-22.6', 'groupId': 'OG000', 'lowerLimit': '-25.4', 'upperLimit': '-19.9'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From 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': 'The OL Full Analysis Set (OL-FAS) for Part A is defined as all enrolled participants who have received at least 1 dose of study drug in the open-label study. This analysis set included study 104 parent study participants who received Control IVA or TEZ/IVA and ELX/TEZ/IVA. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome. Here, "Number Analyzed" signifies participants who were evaluable for the specified category.'}, {'type': 'SECONDARY', 'title': 'Part A: Absolute Change From Parent Study Baseline in Body Mass Index (BMI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ELX/TEZ/IVA', 'description': 'All participants who received Control (IVA or TEZ/IVA) or ELX/TEZ/IVA in parent study 104 were to receive ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 96 weeks in Part A of this study.'}], 'classes': [{'title': 'Control-IVA or TEZ/IVA: Change at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.15', 'groupId': 'OG000', 'lowerLimit': '0.84', 'upperLimit': '1.45'}]}]}, {'title': 'ELX/TEZ/IVA: Change at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.83', 'groupId': 'OG000', 'lowerLimit': '0.54', 'upperLimit': '1.11'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline at Week 96', 'description': 'BMI was defined as weight in kilogram (kg) divided by height in square meter (m\\^2).', 'unitOfMeasure': 'kg/m^2', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The OL Full Analysis Set (OL-FAS) for Part A is defined as all enrolled participants who have received at least 1 dose of study drug in the open-label study. This analysis set included study 104 parent study participants who received Control IVA or TEZ/IVA and ELX/TEZ/IVA. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome. Here, "Number Analyzed" signifies participants who were evaluable for the specified category.'}, {'type': 'SECONDARY', 'title': 'Part A: Absolute Change From Parent Study Baseline in BMI Z-score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ELX/TEZ/IVA', 'description': 'All participants who received Control (IVA or TEZ/IVA) or ELX/TEZ/IVA in parent study 104 were to receive ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 96 weeks in Part A of this study.'}], 'classes': [{'title': 'Control-IVA or TEZ/IVA: Change at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.11', 'groupId': 'OG000', 'lowerLimit': '-0.17', 'upperLimit': '0.40'}]}]}, {'title': 'ELX/TEZ/IVA: Change at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.40', 'groupId': 'OG000', 'lowerLimit': '0.17', 'upperLimit': '0.62'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline at Week 96', 'description': 'BMI was defined as weight in kilogram (kg) divided by squared height in meters (m\\^2). The z-score is a statistical measure to describe whether a value was above or below the standard. A z-score of 0 is equal to the standard. Lower numbers indicate values lower than the standard and higher numbers indicate values higher than the standard.', 'unitOfMeasure': 'z-score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The OL Full Analysis Set (OL-FAS) for Part A is defined as all enrolled participants who have received at least 1 dose of study drug in the open-label study. This analysis set included study 104 parent study participants who received Control IVA or TEZ/IVA and ELX/TEZ/IVA. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome. Here, "Number Analyzed" signifies participants who were evaluable for the specified category.'}, {'type': 'SECONDARY', 'title': 'Part A: Absolute Change From Parent Study Baseline in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ELX/TEZ/IVA', 'description': 'All participants who received Control (IVA or TEZ/IVA) or ELX/TEZ/IVA in parent study 104 were to receive ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 96 weeks in Part A of this study.'}], 'classes': [{'title': 'Control-IVA or TEZ/IVA: Change at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '4.6'}]}]}, {'title': 'ELX/TEZ/IVA: Change at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '3.8'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline at Week 96', 'unitOfMeasure': 'Kilogram (Kg)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The OL Full Analysis Set (OL-FAS) for Part A is defined as all enrolled subjects who have received at least 1 dose of study drug in the open-label study. This analysis set included study 104 parent study participants who received Control IVA or TEZ/IVA and ELX/TEZ/IVA. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome. Here, "Number Analyzed" signifies participants who were evaluable for the specified category.'}, {'type': 'SECONDARY', 'title': 'Part A: Absolute Change From Parent Study Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ELX/TEZ/IVA', 'description': 'All participants who received Control (IVA or TEZ/IVA) or ELX/TEZ/IVA in parent study 104 were to receive ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 96 weeks in Part A of this study.'}], 'classes': [{'title': 'Control-IVA or TEZ/IVA: Change at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '10.4'}]}]}, {'title': 'ELX/TEZ/IVA: Change at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000', 'lowerLimit': '5.1', 'upperLimit': '11.1'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From 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': 'The OL Full Analysis Set (OL-FAS) for Part A is defined as all enrolled participants who have received at least 1 dose of study drug in the open-label study. This analysis set included study 104 parent study participants who received Control IVA or TEZ/IVA and ELX/TEZ/IVA. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome. Here, "Number Analyzed" signifies participants who were evaluable for the specified category.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ELX/TEZ/IVA', 'description': 'Part A: Participants received ELX (elexacaftor) 200 milligram (mg) once daily (qd)/TEZ 100 mg qd/IVA 150 mg every 12 hours (q12h) in the treatment period for 96 weeks.\n\nPart B: Participants from certain countries participated in Part B and continued to receive ELX 200 mg qd /TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 48 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '251'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '215'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'Withdrawal of Consent (not due to AE)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Commercial drug is available for participants', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Other non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'The study was conducted as a single part study (Part A) in countries including United States (US), and the protocol for other countries was amended as a regional protocol so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B.', 'preAssignmentDetails': 'Participants from parent study VX18-445-104 (NCT04058353) were enrolled in this study. A total of 251 participants were enrolled in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'ELX/TEZ/IVA', 'description': 'Part A: Participants received ELX 200mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 96 weeks.\n\nPart B: Participants from certain countries participated in Part B and continued to receive ELX 200 mg qd /TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 48 weeks.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.9', 'spread': '14.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '124', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '127', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '224', 'groupId': 'BG000'}]}]}, {'title': 'Not collected per local regulations', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '225', 'groupId': 'BG000'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Not collected per local regulations', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}, {'title': 'More than one race', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The open label Full Analysis Set (OL-FAS) is defined as all enrolled participants who have received at least 1 dose of study drug in the open-label study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-07-29', 'size': 3262590, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-12-13T23:33', 'hasProtocol': True}, {'date': '2022-02-02', 'size': 883823, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-12-14T07:43', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 251}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT04058210', 'statusForNctId': 'APPROVED_FOR_MARKETING', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2022-12-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-15', 'studyFirstSubmitDate': '2019-08-14', 'resultsFirstSubmitDate': '2023-12-15', 'studyFirstSubmitQcDate': '2019-08-14', 'lastUpdatePostDateStruct': {'date': '2024-01-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-12-15', 'studyFirstPostDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'From Baseline up to Week 100'}], 'secondaryOutcomes': [{'measure': 'Part A: Absolute Change From Parent Study Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)', 'timeFrame': 'From Baseline at Week 96', 'description': 'FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.'}, {'measure': 'Part A: Absolute Change From Parent Study Baseline in Sweat Chloride (SwCl)', 'timeFrame': 'From Baseline at Week 96', 'description': 'Sweat samples were collected using an approved collection device.'}, {'measure': 'Part A: Absolute Change From Parent Study Baseline in Body Mass Index (BMI)', 'timeFrame': 'From Baseline at Week 96', 'description': 'BMI was defined as weight in kilogram (kg) divided by height in square meter (m\\^2).'}, {'measure': 'Part A: Absolute Change From Parent Study Baseline in BMI Z-score', 'timeFrame': 'From Baseline at Week 96', 'description': 'BMI was defined as weight in kilogram (kg) divided by squared height in meters (m\\^2). The z-score is a statistical measure to describe whether a value was above or below the standard. A z-score of 0 is equal to the standard. Lower numbers indicate values lower than the standard and higher numbers indicate values higher than the standard.'}, {'measure': 'Part A: Absolute Change From Parent Study Baseline in Body Weight', 'timeFrame': 'From Baseline at Week 96'}, {'measure': 'Part A: Absolute Change From Parent Study Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score', 'timeFrame': 'From 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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cystic Fibrosis']}, 'referencesModule': {'references': [{'pmid': '37983082', 'type': 'DERIVED', 'citation': 'Heneghan M, Southern KW, Murphy J, Sinha IP, Nevitt SJ. Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del). Cochrane Database Syst Rev. 2023 Nov 20;11(11):CD010966. doi: 10.1002/14651858.CD010966.pub4.'}, {'pmid': '33331662', 'type': 'DERIVED', 'citation': 'Southern KW, Murphy J, Sinha IP, Nevitt SJ. Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del). Cochrane Database Syst Rev. 2020 Dec 17;12(12):CD010966. doi: 10.1002/14651858.CD010966.pub3.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluated the long-term safety, efficacy, and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for the F508del mutation and a gating or residual function mutation (F/G and F/RF genotypes).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Completed study drug treatment in parent study (VX18-445-104); or had study drug interruption(s) in parent study but completed study visits up to the last scheduled visit of the Treatment Period in the parent study\n\nKey Exclusion Criteria:\n\n* History of study drug intolerance in parent study\n\nOther protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT04058366', 'briefTitle': 'Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vertex Pharmaceuticals Incorporated'}, 'officialTitle': 'A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)', 'orgStudyIdInfo': {'id': 'VX18-445-110'}, 'secondaryIdInfos': [{'id': '2019-000833-37', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ELX/TEZ/IVA', 'description': 'Part A: Participants received ELX (elexacaftor) 200 milligram (mg) once daily (qd)/TEZ 100 mg qd/IVA 150 mg every 12 hours (q12h) in the treatment period for 96 weeks.\n\nPart B: Participants from certain countries participated in Part B and continued to receive ELX 200 mg qd /TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 48 weeks.', 'interventionNames': ['Drug: ELX/TEZ/IVA', 'Drug: IVA']}], 'interventions': [{'name': 'ELX/TEZ/IVA', 'type': 'DRUG', 'otherNames': ['VX-445/VX-661/VX-770', 'elexacaftor/tezacaftor/ivacaftor'], 'description': 'Fixed-dose combination (FDC) tablet for oral administration.', 'armGroupLabels': ['ELX/TEZ/IVA']}, {'name': 'IVA', 'type': 'DRUG', 'otherNames': ['VX-770', 'ivacaftor'], 'description': 'Tablet for oral administration.', 'armGroupLabels': ['ELX/TEZ/IVA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner University of Arizona Medical Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': "Miller Children's Hospital / Long Beach Memorial", 'geoPoint': {'lat': 33.76696, 'lon': 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