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Ignite Creation Date: 2025-12-24 @ 11:54 PM

Ignite Modification Date: 2026-02-07 @ 2:21 PM

Study NCT ID: NCT03224351

Status: COMPLETED

Last Update Posted: 2021-04-22

First Post: 2017-07-18

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: A Study Evaluating the Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}}}}, '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': 'C000629057', 'term': 'VX-659'}, {'id': 'C000654124', 'term': 'tezacaftor, ivacaftor drug combination'}, {'id': 'C545203', 'term': 'ivacaftor'}, {'id': 'C000625213', 'term': 'tezacaftor'}]}}, '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': 'Day 1 Through Safety Follow-up (up to Day 61 for Part 1, Day 85 for Part 2 and Day 57 for Part 3)', 'eventGroups': [{'id': 'EG000', 'title': 'Part 1: Placebo', 'description': 'Participants received placebo matched to VX-659/TEZ/IVA in TC treatment period for 4 weeks and placebo matched to TEZ/IVA in washout period for 4 days.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 8, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Part 1: VX-659/TEZ/IVA TC - Low Dose', 'description': 'Participants received VX-659 80 mg qd/TEZ 100 mg qd/IVA 150 mg every 12 q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 days.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 10, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Part 1: VX-659/TEZ/IVA TC - Medium Dose', 'description': 'Participants received VX-659 240 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 days.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 15, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Part 1: VX-659/TEZ/IVA TC - High Dose', 'description': 'Participants received VX-659 400 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 days.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 17, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Part 2: TEZ/IVA', 'description': 'Following run-in period with TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 weeks.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 8, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': 'Part 2: VX-659/TEZ/IVA TC', 'description': 'Following run-in period with TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-659 400 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 weeks.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 15, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'Part 3: Placebo', 'description': 'Participants received placebo matched to VX-659/TEZ/VX-561 in TC treatment period for 4 weeks.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG007', 'title': 'Part 3: VX-659/TEZ/VX-561 TC', 'description': 'Participants received VX-659 400 mg qd/TEZ 100 mg qd/VX-561 200 mg qd in TC treatment period for 4 weeks.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 18, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Fibroadenoma of breast', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Application site rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Exercise tolerance decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Testicular pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vaginal discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Neutrophil count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Bacterial test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'International normalised ratio increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Prothrombin time prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Activated partial thromboplastin time prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Blood glucose decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Blood triglycerides increased', 'stats': 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{'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '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': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Placebo', 'description': 'Participants received placebo matched to VX-659/TEZ/IVA in TC treatment period for 4 weeks and placebo matched to TEZ/IVA in washout period for 4 days.'}, {'id': 'OG001', 'title': 'Part 1: VX-659/TEZ/IVA TC - Low Dose', 'description': 'Participants received VX-659 80 mg qd/TEZ 100 mg qd/IVA 150 mg every 12 q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 days.'}, {'id': 'OG002', 'title': 'Part 1: VX-659/TEZ/IVA TC - Medium Dose', 'description': 'Participants received VX-659 240 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 days.'}, {'id': 'OG003', 'title': 'Part 1: VX-659/TEZ/IVA TC - High Dose', 'description': 'Participants received VX-659 400 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 days.'}, {'id': 'OG004', 'title': 'Part 2: TEZ/IVA', 'description': 'Following run-in period with TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 weeks.'}, {'id': 'OG005', 'title': 'Part 2: VX-659/TEZ/IVA TC', 'description': 'Following run-in period with TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-659 400 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 weeks.'}, {'id': 'OG006', 'title': 'Part 3: Placebo', 'description': 'Participants received placebo matched to VX-659/TEZ/VX-561 in TC treatment period for 4 weeks.'}, {'id': 'OG007', 'title': 'Part 3: VX-659/TEZ/VX-561 TC', 'description': 'Participants received VX-659 400 mg qd/TEZ 100 mg qd/VX-561 200 mg qd in TC treatment period for 4 weeks.'}], 'classes': [{'title': 'Participants with TEAEs', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '18', 'groupId': 'OG007'}]}]}, {'title': 'Participants with SAEs', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 Through Safety Follow-up (up to Day 61 for Part 1, Day 85 for Part 2 and Day 57 for Part 3)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set included all participants who received at least 1 dose of study drug in TC treatment period.'}, {'type': 'PRIMARY', 'title': 'Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Placebo', 'description': 'Participants received placebo matched to VX-659/TEZ/IVA in TC treatment period for 4 weeks and placebo matched to TEZ/IVA in washout period for 4 days.'}, {'id': 'OG001', 'title': 'Part 1: VX-659/TEZ/IVA TC - Low Dose', 'description': 'Participants received VX-659 80 mg qd/TEZ 100 mg qd/IVA 150 mg every 12 q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 days.'}, {'id': 'OG002', 'title': 'Part 1: VX-659/TEZ/IVA TC - Medium Dose', 'description': 'Participants received VX-659 240 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 days.'}, {'id': 'OG003', 'title': 'Part 1: VX-659/TEZ/IVA TC - High Dose', 'description': 'Participants received VX-659 400 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 days.'}, {'id': 'OG004', 'title': 'Part 2: TEZ/IVA', 'description': 'Following run-in period with TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 weeks.'}, {'id': 'OG005', 'title': 'Part 2: VX-659/TEZ/IVA TC', 'description': 'Following run-in period with TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-659 400 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 weeks.'}, {'id': 'OG006', 'title': 'Part 3: Placebo', 'description': 'Participants received placebo matched to VX-659/TEZ/VX-561 in TC treatment period for 4 weeks.'}, {'id': 'OG007', 'title': 'Part 3: VX-659/TEZ/VX-561 TC', 'description': 'Participants received VX-659 400 mg qd/TEZ 100 mg qd/VX-561 200 mg qd in TC treatment period for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '-5.3', 'upperLimit': '6.1'}, {'value': '10.2', 'groupId': 'OG001', 'lowerLimit': '4.8', 'upperLimit': '15.5'}, {'value': '12.0', 'groupId': 'OG002', 'lowerLimit': '8.0', 'upperLimit': '16.0'}, {'value': '13.3', 'groupId': 'OG003', 'lowerLimit': '9.5', 'upperLimit': '17.1'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '-3.9', 'upperLimit': '3.9'}, {'value': '9.7', 'groupId': 'OG005', 'lowerLimit': '6.6', 'upperLimit': '12.7'}, {'value': '-5.0', 'groupId': 'OG006', 'lowerLimit': '-12.2', 'upperLimit': '2.1'}, {'value': '12.2', 'groupId': 'OG007', 'lowerLimit': '8.3', 'upperLimit': '16.2'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline Through Day 29', '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': 'Full Analysis Set (FAS) included all randomized participants with an eligible cystic fibrosis transmembrane conductance regulator protein (CFTR) genotype and received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Absolute Change in Sweat Chloride Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Placebo', 'description': 'Participants received placebo matched to VX-659/TEZ/IVA in TC treatment period for 4 weeks and placebo matched to TEZ/IVA in washout period for 4 days.'}, {'id': 'OG001', 'title': 'Part 1: VX-659/TEZ/IVA TC - Low Dose', 'description': 'Participants received VX-659 80 mg qd/TEZ 100 mg qd/IVA 150 mg every 12 q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 days.'}, {'id': 'OG002', 'title': 'Part 1: VX-659/TEZ/IVA TC - Medium Dose', 'description': 'Participants received VX-659 240 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 days.'}, {'id': 'OG003', 'title': 'Part 1: VX-659/TEZ/IVA TC - High Dose', 'description': 'Participants received VX-659 400 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 days.'}, {'id': 'OG004', 'title': 'Part 2: TEZ/IVA', 'description': 'Following run-in period with TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 weeks.'}, {'id': 'OG005', 'title': 'Part 2: VX-659/TEZ/IVA TC', 'description': 'Following run-in period with TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-659 400 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 weeks.'}, {'id': 'OG006', 'title': 'Part 3: Placebo', 'description': 'Participants received placebo matched to VX-659/TEZ/VX-561 in TC treatment period for 4 weeks.'}, {'id': 'OG007', 'title': 'Part 3: VX-659/TEZ/VX-561 TC', 'description': 'Participants received VX-659 400 mg qd/TEZ 100 mg qd/VX-561 200 mg qd in TC treatment period for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '-6.3', 'upperLimit': '12.2'}, {'value': '-45.7', 'groupId': 'OG001', 'lowerLimit': '-54.4', 'upperLimit': '-37.0'}, {'value': '-43.8', 'groupId': 'OG002', 'lowerLimit': '-50.7', 'upperLimit': '-37.0'}, {'value': '-51.4', 'groupId': 'OG003', 'lowerLimit': '-57.8', 'upperLimit': '-44.9'}, {'value': '3.0', 'groupId': 'OG004', 'lowerLimit': '-2.8', 'upperLimit': '8.9'}, {'value': '-42.2', 'groupId': 'OG005', 'lowerLimit': '-46.8', 'upperLimit': '-37.7'}, {'value': '-1.3', 'groupId': 'OG006', 'lowerLimit': '-12.4', 'upperLimit': '9.8'}, {'value': '-38.1', 'groupId': 'OG007', 'lowerLimit': '-44.4', 'upperLimit': '-31.8'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline Through Day 29', 'description': 'Sweat samples were collected using an approved collection device.', 'unitOfMeasure': 'millimole per liter (mmol/L)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS.'}, {'type': 'SECONDARY', 'title': 'Relative Change in ppFEV1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Placebo', 'description': 'Participants received placebo matched to VX-659/TEZ/IVA in TC treatment period for 4 weeks and placebo matched to TEZ/IVA in washout period for 4 days.'}, {'id': 'OG001', 'title': 'Part 1: VX-659/TEZ/IVA TC - Low Dose', 'description': 'Participants received VX-659 80 mg qd/TEZ 100 mg qd/IVA 150 mg every 12 q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 days.'}, {'id': 'OG002', 'title': 'Part 1: VX-659/TEZ/IVA TC - Medium Dose', 'description': 'Participants received VX-659 240 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 days.'}, {'id': 'OG003', 'title': 'Part 1: VX-659/TEZ/IVA TC - High Dose', 'description': 'Participants received VX-659 400 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 days.'}, {'id': 'OG004', 'title': 'Part 2: TEZ/IVA', 'description': 'Following run-in period with TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 weeks.'}, {'id': 'OG005', 'title': 'Part 2: VX-659/TEZ/IVA TC', 'description': 'Following run-in period with TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-659 400 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 weeks.'}, {'id': 'OG006', 'title': 'Part 3: Placebo', 'description': 'Participants received placebo matched to VX-659/TEZ/VX-561 in TC treatment period for 4 weeks.'}, {'id': 'OG007', 'title': 'Part 3: VX-659/TEZ/VX-561 TC', 'description': 'Participants received VX-659 400 mg qd/TEZ 100 mg qd/VX-561 200 mg qd in TC treatment period for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-10.5', 'upperLimit': '10.4'}, {'value': '18.8', 'groupId': 'OG001', 'lowerLimit': '8.9', 'upperLimit': '28.7'}, {'value': '21.1', 'groupId': 'OG002', 'lowerLimit': '13.8', 'upperLimit': '28.5'}, {'value': '24.6', 'groupId': 'OG003', 'lowerLimit': '17.6', 'upperLimit': '31.6'}, {'value': '0.1', 'groupId': 'OG004', 'lowerLimit': '-7.1', 'upperLimit': '7.3'}, {'value': '17.3', 'groupId': 'OG005', 'lowerLimit': '11.7', 'upperLimit': '23.0'}, {'value': '-11.3', 'groupId': 'OG006', 'lowerLimit': '-23.7', 'upperLimit': '1.1'}, {'value': '21.5', 'groupId': 'OG007', 'lowerLimit': '14.6', 'upperLimit': '28.4'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline Through Day 29', '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 Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Placebo', 'description': 'Participants received placebo matched to VX-659/TEZ/IVA in TC treatment period for 4 weeks and placebo matched to TEZ/IVA in washout period for 4 days.'}, {'id': 'OG001', 'title': 'Part 1: VX-659/TEZ/IVA TC - Low Dose', 'description': 'Participants received VX-659 80 mg qd/TEZ 100 mg qd/IVA 150 mg every 12 q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 days.'}, {'id': 'OG002', 'title': 'Part 1: VX-659/TEZ/IVA TC - Medium Dose', 'description': 'Participants received VX-659 240 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 days.'}, {'id': 'OG003', 'title': 'Part 1: VX-659/TEZ/IVA TC - High Dose', 'description': 'Participants received VX-659 400 mg qd/TEZ 100 mg/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 days.'}, {'id': 'OG004', 'title': 'Part 2: TEZ/IVA', 'description': 'Following run-in period with TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 weeks.'}, {'id': 'OG005', 'title': 'Part 2: VX-659/TEZ/IVA TC', 'description': 'Following run-in period with TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-659 400 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 weeks.'}, {'id': 'OG006', 'title': 'Part 3: Placebo', 'description': 'Participants received placebo matched to VX-659/TEZ/VX-561 in TC treatment period for 4 weeks.'}, {'id': 'OG007', 'title': 'Part 3: VX-659/TEZ/VX-561 TC', 'description': 'Participants received VX-659 400 mg qd/TEZ 100 mg qd/VX-561 200 mg qd in TC treatment period for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000', 'lowerLimit': '-7.5', 'upperLimit': '16.8'}, {'value': '24.6', 'groupId': 'OG001', 'lowerLimit': '13.0', 'upperLimit': '36.2'}, {'value': '19.8', 'groupId': 'OG002', 'lowerLimit': '11.0', 'upperLimit': '28.6'}, {'value': '21.8', 'groupId': 'OG003', 'lowerLimit': '13.6', 'upperLimit': '30.0'}, {'value': '2.9', 'groupId': 'OG004', 'lowerLimit': '-5.2', 'upperLimit': '11.1'}, {'value': '19.5', 'groupId': 'OG005', 'lowerLimit': '13.1', 'upperLimit': '25.9'}, {'value': '-4.1', 'groupId': 'OG006', 'lowerLimit': '-17.8', 'upperLimit': '9.6'}, {'value': '14.7', 'groupId': 'OG007', 'lowerLimit': '7.1', 'upperLimit': '22.4'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline at Day 29', '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': 'Observed Pre-dose Concentration (Ctrough) of VX-659, TEZ, M1-TEZ, IVA, M1-IVA, and VX-561', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: VX-659/TEZ/IVA TC - Low Dose', 'description': 'Participants received VX-659 80 mg qd/TEZ 100 mg qd/IVA 150 mg every 12 q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 days.'}, {'id': 'OG001', 'title': 'Part 1: VX-659/TEZ/IVA TC - Medium Dose', 'description': 'Participants received VX-659 240 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 days.'}, {'id': 'OG002', 'title': 'Part 1: VX-659/TEZ/IVA TC - High Dose', 'description': 'Participants received VX-659 400 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 days.'}, {'id': 'OG003', 'title': 'Part 2: TEZ/IVA', 'description': 'Following run-in period with TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 weeks.'}, {'id': 'OG004', 'title': 'Part 2: VX-659/TEZ/IVA TC', 'description': 'Following run-in period with TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-659 400 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 weeks.'}, {'id': 'OG005', 'title': 'Part 3: VX-659/TEZ/VX-561 TC', 'description': 'Participants received VX-659 400 mg qd/TEZ 100 mg qd/VX-561 200 mg qd in TC treatment period for 4 weeks.'}], 'classes': [{'title': 'VX-659: Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '393', 'spread': '604', 'groupId': 'OG000'}, {'value': '622', 'spread': '429', 'groupId': 'OG001'}, {'value': '1100', 'spread': '731', 'groupId': 'OG002'}, {'value': '835', 'spread': '474', 'groupId': 'OG004'}, {'value': '1140', 'spread': '646', 'groupId': 'OG005'}]}]}, {'title': 'VX-659: Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '566', 'spread': '861', 'groupId': 'OG000'}, {'value': '699', 'spread': '489', 'groupId': 'OG001'}, {'value': '1080', 'spread': '582', 'groupId': 'OG002'}, {'value': '1070', 'spread': '914', 'groupId': 'OG004'}, {'value': '923', 'spread': '582', 'groupId': 'OG005'}]}]}, {'title': 'TEZ: Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1910', 'spread': '1360', 'groupId': 'OG000'}, {'value': '1250', 'spread': '907', 'groupId': 'OG001'}, {'value': '1110', 'spread': '455', 'groupId': 'OG002'}, {'value': '1050', 'spread': '473', 'groupId': 'OG003'}, {'value': '1350', 'spread': '1440', 'groupId': 'OG004'}, {'value': '1000', 'spread': '305', 'groupId': 'OG005'}]}]}, {'title': 'TEZ: Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1910', 'spread': '1230', 'groupId': 'OG000'}, {'value': '1050', 'spread': '553', 'groupId': 'OG001'}, {'value': '1010', 'spread': '479', 'groupId': 'OG002'}, {'value': '1150', 'spread': '480', 'groupId': 'OG003'}, {'value': '955', 'spread': '422', 'groupId': 'OG004'}, {'value': '776', 'spread': '321', 'groupId': 'OG005'}]}]}, {'title': 'M1-TEZ: Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '4390', 'spread': '949', 'groupId': 'OG000'}, {'value': '3710', 'spread': '1230', 'groupId': 'OG001'}, {'value': '4280', 'spread': '1190', 'groupId': 'OG002'}, {'value': '4160', 'spread': '1260', 'groupId': 'OG003'}, {'value': '4010', 'spread': '1210', 'groupId': 'OG004'}, {'value': '4060', 'spread': '660', 'groupId': 'OG005'}]}]}, {'title': 'M1-TEZ: Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '4300', 'spread': '774', 'groupId': 'OG000'}, {'value': '3650', 'spread': '1280', 'groupId': 'OG001'}, {'value': '3870', 'spread': '1020', 'groupId': 'OG002'}, {'value': '3790', 'spread': '1080', 'groupId': 'OG003'}, {'value': '3810', 'spread': '1120', 'groupId': 'OG004'}, {'value': '3660', 'spread': '1190', 'groupId': 'OG005'}]}]}, {'title': 'IVA: Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '824', 'spread': '781', 'groupId': 'OG000'}, {'value': '522', 'spread': '567', 'groupId': 'OG001'}, {'value': '423', 'spread': '261', 'groupId': 'OG002'}, {'value': '458', 'spread': '239', 'groupId': 'OG003'}, {'value': '313', 'spread': '158', 'groupId': 'OG004'}]}]}, {'title': 'IVA: Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '719', 'spread': '604', 'groupId': 'OG000'}, {'value': '443', 'spread': '398', 'groupId': 'OG001'}, {'value': '371', 'spread': '220', 'groupId': 'OG002'}, {'value': '490', 'spread': '179', 'groupId': 'OG003'}, {'value': '296', 'spread': '175', 'groupId': 'OG004'}]}]}, {'title': 'M1-IVA: Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1200', 'spread': '711', 'groupId': 'OG000'}, {'value': '1050', 'spread': '852', 'groupId': 'OG001'}, {'value': '1170', 'spread': '674', 'groupId': 'OG002'}, {'value': '1310', 'spread': '684', 'groupId': 'OG003'}, {'value': '844', 'spread': '622', 'groupId': 'OG004'}]}]}, {'title': 'M1-IVA Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1130', 'spread': '682', 'groupId': 'OG000'}, {'value': '1140', 'spread': '950', 'groupId': 'OG001'}, {'value': '1030', 'spread': '460', 'groupId': 'OG002'}, {'value': '1240', 'spread': '321', 'groupId': 'OG003'}, {'value': '866', 'spread': '691', 'groupId': 'OG004'}]}]}, {'title': 'VX-561: Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '380', 'spread': '240', 'groupId': 'OG005'}]}]}, {'title': 'VX-561: Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '288', 'spread': '165', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose at Day 15 and Day 29', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Set (PK) included all participants who have received at least 1 dose of study drug in TC treatment period. Here "Number Analyzed" signifies those participants who were evaluable at specified time points. VX-659 category was not applicable for Part 2: TEZ/IVA group. VX-561 category was applicable for Part 3: TC group only. IVA and M1-IVA categories were not applicable for Part 3: TC group.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 1: Placebo', 'description': 'Participants received placebo matched to VX-659/TEZ/IVA in TC treatment period for 4 weeks and placebo matched to TEZ/IVA in washout period for 4 days.'}, {'id': 'FG001', 'title': 'Part 1: VX-659/TEZ/IVA TC - Low Dose', 'description': 'Participants received VX-659 80 milligram (mg) once daily (qd)/TEZ 100 mg qd/IVA 150 mg every 12 hours (q12h) in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 days.'}, {'id': 'FG002', 'title': 'Part 1: VX-659/TEZ/IVA TC - Medium Dose', 'description': 'Participants received VX-659 240 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 days.'}, {'id': 'FG003', 'title': 'Part 1: VX-659/TEZ/IVA TC - High Dose', 'description': 'Participants received VX-659 400 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 days.'}, {'id': 'FG004', 'title': 'Part 2: TEZ/IVA', 'description': 'Following run-in period with TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 weeks.'}, {'id': 'FG005', 'title': 'Part 2: VX-659/TEZ/IVA TC', 'description': 'Following run-in period with TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-659 400 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 weeks.'}, {'id': 'FG006', 'title': 'Part 3: Placebo', 'description': 'Participants received placebo matched to VX-659/TEZ/VX-561 in TC treatment period for 4 weeks.'}, {'id': 'FG007', 'title': 'Part 3: VX-659/TEZ/VX-561 TC', 'description': 'Participants received VX-659 400 mg qd/TEZ 100 mg qd/VX-561 200 mg qd in TC treatment period for 4 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '22'}, {'groupId': 'FG004', 'numSubjects': '11'}, {'groupId': 'FG005', 'numSubjects': '18'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '22'}, {'groupId': 'FG004', 'numSubjects': '11'}, {'groupId': 'FG005', 'numSubjects': '18'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Total of 124 participants were enrolled in this study (63 in Part 1, 36 in Part 2 and 25 in Part C). Out of 36 participants enrolled in Part 2, 7 participants discontinued treatment in run-in period and were not randomized in triple combination (TC) treatment period. Therefore, below results are presented for 117 participants.', 'preAssignmentDetails': 'This study included 3 parts and was conducted in adult participants with cystic fibrosis (CF).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '19', 'groupId': 'BG007'}, {'value': '117', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1: Placebo', 'description': 'Participants received placebo matched to VX-659/TEZ/IVA in TC treatment period for 4 weeks and placebo matched to TEZ/IVA in washout period for 4 days.'}, {'id': 'BG001', 'title': 'Part 1: VX-659/TEZ/IVA TC - Low Dose', 'description': 'Participants received VX-659 80 mg qd/TEZ 100 mg qd/IVA 150 mg every 12 q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 days.'}, {'id': 'BG002', 'title': 'Part 1: VX-659/TEZ/IVA TC - Medium Dose', 'description': 'Participants received VX-659 240 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 days.'}, {'id': 'BG003', 'title': 'Part 1: VX-659/TEZ/IVA TC - High Dose', 'description': 'Participants received VX-659 400 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 days.'}, {'id': 'BG004', 'title': 'Part 2: TEZ/IVA', 'description': 'Following run-in period with TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 weeks.'}, {'id': 'BG005', 'title': 'Part 2: VX-659/TEZ/IVA TC', 'description': 'Following run-in period with TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-659 400 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 weeks.'}, {'id': 'BG006', 'title': 'Part 3: Placebo', 'description': 'Participants received placebo matched to VX-659/TEZ/VX-561 in TC treatment period for 4 weeks.'}, {'id': 'BG007', 'title': 'Part 3: VX-659/TEZ/VX-561 TC', 'description': 'Participants received VX-659 400 mg qd/TEZ 100 mg qd/VX-561 200 mg qd in TC treatment period for 4 weeks.'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<18 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}]}, {'title': '>=18 and <65 years', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '19', 'groupId': 'BG007'}, {'value': '117', 'groupId': 'BG008'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '11', 'groupId': 'BG007'}, {'value': '54', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}, {'value': '63', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '18', 'groupId': 'BG007'}, {'value': '111', 'groupId': 'BG008'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}]}], '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'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '17', 'groupId': 'BG007'}, {'value': '113', 'groupId': 'BG008'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)', 'classes': [{'categories': [{'title': '<40 percent', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}]}, {'title': '≥40 to <70 percent', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '13', 'groupId': 'BG007'}, {'value': '79', 'groupId': 'BG008'}]}, {'title': '≥70 to ≤90 percent', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '30', 'groupId': 'BG008'}]}, {'title': '>90 percent', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-09-01', 'size': 2039462, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-02-08T01:40', 'hasProtocol': True}, {'date': '2017-09-19', 'size': 1209144, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-02-08T01:40', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'dispFirstSubmitDate': '2019-02-28', 'completionDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-29', 'studyFirstSubmitDate': '2017-07-18', 'dispFirstSubmitQcDate': '2021-03-29', 'resultsFirstSubmitDate': '2021-02-25', 'studyFirstSubmitQcDate': '2017-07-18', 'dispFirstPostDateStruct': {'date': '2021-04-22', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-04-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-29', 'studyFirstPostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Day 1 Through Safety Follow-up (up to Day 61 for Part 1, Day 85 for Part 2 and Day 57 for Part 3)'}, {'measure': 'Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)', 'timeFrame': 'From Baseline Through Day 29', 'description': 'FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.'}], 'secondaryOutcomes': [{'measure': 'Absolute Change in Sweat Chloride Concentrations', 'timeFrame': 'From Baseline Through Day 29', 'description': 'Sweat samples were collected using an approved collection device.'}, {'measure': 'Relative Change in ppFEV1', 'timeFrame': 'From Baseline Through Day 29', 'description': 'FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.'}, {'measure': 'Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score', 'timeFrame': 'From Baseline at Day 29', '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': 'Observed Pre-dose Concentration (Ctrough) of VX-659, TEZ, M1-TEZ, IVA, M1-IVA, and VX-561', 'timeFrame': 'Pre-dose at Day 15 and Day 29'}]}, 'oversightModule': {'oversightHasDmc': True, '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.'}, {'pmid': '30334693', 'type': 'DERIVED', 'citation': 'Davies JC, Moskowitz SM, Brown C, Horsley A, Mall MA, McKone EF, Plant BJ, Prais D, Ramsey BW, Taylor-Cousar JL, Tullis E, Uluer A, McKee CM, Robertson S, Shilling RA, Simard C, Van Goor F, Waltz D, Xuan F, Young T, Rowe SM; VX16-659-101 Study Group. VX-659-Tezacaftor-Ivacaftor in Patients with Cystic Fibrosis and One or Two Phe508del Alleles. N Engl J Med. 2018 Oct 25;379(17):1599-1611. doi: 10.1056/NEJMoa1807119. Epub 2018 Oct 18.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase 2, randomized, double-blind, placebo- and tezacaftor/ivacaftor (TEZ/IVA)-controlled, parallel-group, 3-part, multicenter study designed to evaluate the safety and efficacy of VX-659 in triple combination (TC) with TEZ and IVA in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation of the CF transmembrane conductance regulator (CFTR) gene (F/F genotype), or who are heterozygous for the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ, IVA, or TEZ/IVA (F/MF genotypes).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Body weight ≥35 kg.\n* Subjects must have an eligibleCFTR genotype.\n\n * Part 1 and Part 3: Heterozygous for F508del and an MF mutation (F/MF)\n * Part 2: Homozygous for F508del (F/F)\n* FEV1 value ≥40% and ≤90% of predicted mean for age, sex, and height\n\nKey Exclusion Criteria:\n\n* History of clinically significant cirrhosis with or without portal hypertension.\n* Glucose-6-phosphate dehydrogenase (G6PD) deficiency\n* Lung infection with organisms associated with a more rapid decline in pulmonary status.\n* History of solid organ or hematological transplantation.\n\nOther protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT03224351', 'briefTitle': 'A Study Evaluating the Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vertex Pharmaceuticals Incorporated'}, 'officialTitle': 'A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-659 Combination Therapy in Subjects Aged 18 Years and Older With Cystic Fibrosis', 'orgStudyIdInfo': {'id': 'VX16-659-101'}, 'secondaryIdInfos': [{'id': '2016-003585-11', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Part 1: Placebo', 'description': 'Participants received placebo matched to VX-659/TEZ/IVA in TC treatment period for 4 weeks and placebo matched TEZ/IVA in washout period for 4 days.', 'interventionNames': ['Drug: Placebo (matched to VX-659/TEZ/IVA)']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: VX-659/TEZ/IVA TC - Low Dose', 'description': 'Participants received VX-659 80 milligram (mg) once daily (qd)/TEZ 100 mg qd/IVA 150 mg every 12 hours (q12h) in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 days.', 'interventionNames': ['Drug: VX-659', 'Drug: TEZ/IVA', 'Drug: IVA']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: VX-659/TEZ/IVA TC - Medium Dose', 'description': 'Participants received VX-659 240 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in TC treatment period for 4 weeks and TEZ 100 mg qd/IVA 150 mg q12h in washout period for 4 days.', 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