Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2026-01-05 @ 12:06 AM
Study NCT ID:
NCT02951195
Status:
COMPLETED
Last Update Posted:
2021-01-28
First Post:
2016-10-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Evaluating the Safety of VX-152 Combination Therapy in Adults With Cystic Fibrosis
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': 'C000654124', 'term': 'tezacaftor, ivacaftor 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': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 Through Safety Follow-up Visit (Up to Day 43 for Part 1 and Day 71 for Part 2)', 'eventGroups': [{'id': 'EG000', 'title': 'Part 1: Placebo', 'description': 'Participants received placebo matched to VX-152/TEZ/IVA TC for 2 weeks.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Part 1 Cohort 1A: TC', 'description': 'Participants received VX-152 100 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Part 1 Cohort 1B: TC', 'description': 'Participants received VX-152 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 7, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Part 1 Cohort 1C: TC', 'description': 'Participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 9, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Part 2 Cohort 2A: TEZ/IVA', 'description': 'Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 3, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Part 2 Cohort 2A: TC', 'description': 'Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 6, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Part 2 Cohort 2B: TEZ/IVA', 'description': 'Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 5, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Part 2 Cohort 2B: TC', 'description': 'Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 18, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ear discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Eye swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Faeces soft', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Post-tussive vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vessel puncture site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Chronic sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Infective pulmonary exacerbation of cystic fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 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'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pleuritic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pulmonary pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Respiration abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Respiratory tract congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Sputum discoloured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Sputum increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Upper respiratory tract congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'seriousEvents': [{'term': 'Infective pulmonary exacerbation of cystic fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], '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': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '21', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Placebo', 'description': 'Participants received placebo matched to VX-152/TEZ/IVA TC for 2 weeks.'}, {'id': 'OG001', 'title': 'Part 1 Cohort 1A: TC', 'description': 'Participants received VX-152 100 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.'}, {'id': 'OG002', 'title': 'Part 1 Cohort 1B: TC', 'description': 'Participants received VX-152 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.'}, {'id': 'OG003', 'title': 'Part 1 Cohort 1C: TC', 'description': 'Participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.'}, {'id': 'OG004', 'title': 'Part 2 Cohort 2A: TEZ/IVA', 'description': 'Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.'}, {'id': 'OG005', 'title': 'Part 2 Cohort 2A: TC', 'description': 'Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.'}, {'id': 'OG006', 'title': 'Part 2 Cohort 2B: TEZ/IVA', 'description': 'Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.'}, {'id': 'OG007', 'title': 'Part 2 Cohort 2B: TC', 'description': 'Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.'}], 'classes': [{'title': 'Participants with TEAEs', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}]}, {'title': 'Participants with SAEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 Through Safety Follow-up Visit (Up to Day 43 for Part 1 and Day 71 for Part 2)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set included all participants who received at least 1 dose of study drug in the treatment period.'}, {'type': 'PRIMARY', 'title': 'Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Day 15 for Part 1 and Part 2 Cohort 2A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Placebo', 'description': 'Participants received placebo matched to VX-152/TEZ/IVA TC for 2 weeks.'}, {'id': 'OG001', 'title': 'Part 1 Cohort 1A: TC', 'description': 'Participants received VX-152 100 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.'}, {'id': 'OG002', 'title': 'Part 1 Cohort 1B: TC', 'description': 'Participants received VX-152 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.'}, {'id': 'OG003', 'title': 'Part 1 Cohort 1C: TC', 'description': 'Participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.'}, {'id': 'OG004', 'title': 'Part 2 Cohort 2A: TEZ/IVA', 'description': 'Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.'}, {'id': 'OG005', 'title': 'Part 2 Cohort 2A: TC', 'description': 'Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'groupId': 'OG000', 'lowerLimit': '-4.8', 'upperLimit': '3.3'}, {'value': '5.7', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '10.3'}, {'value': '9.7', 'groupId': 'OG002', 'lowerLimit': '6.1', 'upperLimit': '13.3'}, {'value': '8.0', 'groupId': 'OG003', 'lowerLimit': '4.0', 'upperLimit': '12.0'}, {'value': '-1.0', 'groupId': 'OG004', 'lowerLimit': '-9.9', 'upperLimit': '7.8'}, {'value': '7.3', 'groupId': 'OG005', 'lowerLimit': '1.9', 'upperLimit': '12.6'}]}]}], 'analyses': [{'pValue': '0.0207', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.4', 'ciLowerLimit': '0.3', 'ciUpperLimit': '12.6', 'statisticalMethod': 'Mixed-effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.5', 'ciLowerLimit': '5.0', 'ciUpperLimit': '15.9', 'statisticalMethod': 'Mixed-effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0019', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.8', 'ciLowerLimit': '3.0', 'ciUpperLimit': '14.5', 'statisticalMethod': 'Mixed-effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0540', 'groupIds': ['OG004', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.3', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '18.7', 'statisticalMethod': 'Mixed-effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline at Day 15', '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 the intended cystic fibrosis transmembrane conductance regulator protein (CFTR) allele mutation who received at least 1 dose of study drug in the treatment period. As pre-specified in analysis plan, only Part 1 and Part 2 Cohort 2A arms were assessed for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Absolute Change in ppFEV1 Through Day 29 for Part 2 Cohort 2B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 Cohort 2B: TEZ/IVA', 'description': 'Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.'}, {'id': 'OG001', 'title': 'Part 2 Cohort 2B: TC', 'description': 'Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.2', 'groupId': 'OG000', 'lowerLimit': '-6.6', 'upperLimit': '2.1'}, {'value': '6.5', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '9.0'}]}]}], 'analyses': [{'pValue': '0.0007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.7', 'ciLowerLimit': '3.7', 'ciUpperLimit': '13.8', 'statisticalMethod': 'Mixed-effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY'}], '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': 'FAS. As pre-specified in analysis plan, only Part 2 Cohort 2B arms were assessed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Absolute Change in Sweat Chloride Concentrations at Day 15 for Part 1 and Part 2 Cohort 2A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Placebo', 'description': 'Participants received placebo matched to VX-152/TEZ/IVA TC for 2 weeks.'}, {'id': 'OG001', 'title': 'Part 1 Cohort 1A: TC', 'description': 'Participants received VX-152 100 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.'}, {'id': 'OG002', 'title': 'Part 1 Cohort 1B: TC', 'description': 'Participants received VX-152 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.'}, {'id': 'OG003', 'title': 'Part 1 Cohort 1C: TC', 'description': 'Participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.'}, {'id': 'OG004', 'title': 'Part 2 Cohort 2A: TEZ/IVA', 'description': 'Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.'}, {'id': 'OG005', 'title': 'Part 2 Cohort 2A: TC', 'description': 'Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-8.4', 'upperLimit': '8.3'}, {'value': '-19.5', 'groupId': 'OG001', 'lowerLimit': '-29.1', 'upperLimit': '-10.0'}, {'value': '-13.6', 'groupId': 'OG002', 'lowerLimit': '-21.4', 'upperLimit': '-5.8'}, {'value': '-27.5', 'groupId': 'OG003', 'lowerLimit': '-35.0', 'upperLimit': '-20.1'}, {'value': '3.5', 'groupId': 'OG004', 'lowerLimit': '-9.2', 'upperLimit': '16.2'}, {'value': '-21.3', 'groupId': 'OG005', 'lowerLimit': '-29.5', 'upperLimit': '-13.1'}]}]}], 'analyses': [{'pValue': '0.0018', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19.5', 'ciLowerLimit': '-32.2', 'ciUpperLimit': '-6.8', 'statisticalMethod': 'Mixed-effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0106', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.6', 'ciLowerLimit': '-25.0', 'ciUpperLimit': '-2.1', 'statisticalMethod': 'Mixed-effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-27.5', 'ciLowerLimit': '-38.6', 'ciUpperLimit': '-16.3', 'statisticalMethod': 'Mixed-effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0017', 'groupIds': ['OG004', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-24.8', 'ciLowerLimit': '-40.0', 'ciUpperLimit': '-9.7', 'statisticalMethod': 'Mixed-effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline at Day 15', 'description': 'Sweat samples were collected using an approved collection device.', 'unitOfMeasure': 'millimole per liter (mmol/L)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. As pre-specified in analysis plan, only Part 1 and Part 2 Cohort 2A arms were assessed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Absolute Change in Sweat Chloride Concentrations Through Day 29 for Part 2 Cohort 2B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 Cohort 2B: TEZ/IVA', 'description': 'Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.'}, {'id': 'OG001', 'title': 'Part 2 Cohort 2B: TC', 'description': 'Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '-6.8', 'upperLimit': '10.0'}, {'value': '-22.3', 'groupId': 'OG001', 'lowerLimit': '-27.3', 'upperLimit': '-17.3'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-23.9', 'ciLowerLimit': '-33.7', 'ciUpperLimit': '-14.1', 'statisticalMethod': 'Mixed-effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline Through Day 29', 'description': 'Sweat samples were collected using an approved collection device.', 'unitOfMeasure': 'mmol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. As pre-specified in analysis plan, only Part 2 Cohort 2B arms were assessed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Relative Change in ppFEV1 at Day 15 for Part 1 and Part 2 Cohort 2A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Placebo', 'description': 'Participants received placebo matched to VX-152/TEZ/IVA for 2 weeks.'}, {'id': 'OG001', 'title': 'Part 1 Cohort 1A: TC', 'description': 'Participants received VX-152 100 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.'}, {'id': 'OG002', 'title': 'Part 1 Cohort 1B: TC', 'description': 'Participants received VX-152 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.'}, {'id': 'OG003', 'title': 'Part 1 Cohort 1C: TC', 'description': 'Participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.'}, {'id': 'OG004', 'title': 'Part 2 Cohort 2A: TEZ/IVA', 'description': 'Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.'}, {'id': 'OG005', 'title': 'Part 2 Cohort 2A: TC', 'description': 'Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.3', 'groupId': 'OG000', 'lowerLimit': '-9.8', 'upperLimit': '5.3'}, {'value': '10.3', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '19.0'}, {'value': '19.0', 'groupId': 'OG002', 'lowerLimit': '12.3', 'upperLimit': '25.8'}, {'value': '14.8', 'groupId': 'OG003', 'lowerLimit': '7.3', 'upperLimit': '22.4'}, {'value': '-1.4', 'groupId': 'OG004', 'lowerLimit': '-17.1', 'upperLimit': '14.4'}, {'value': '13.2', 'groupId': 'OG005', 'lowerLimit': '3.7', 'upperLimit': '22.7'}]}]}], 'analyses': [{'pValue': '0.0166', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.5', 'ciLowerLimit': '1.1', 'ciUpperLimit': '24.0', 'statisticalMethod': 'Mixed-effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.3', 'ciLowerLimit': '11.2', 'ciUpperLimit': '31.4', 'statisticalMethod': 'Mixed-effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0013', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.1', 'ciLowerLimit': '6.3', 'ciUpperLimit': '27.8', 'statisticalMethod': 'Mixed-effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0563', 'groupIds': ['OG004', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.5', 'ciLowerLimit': '-3.8', 'ciUpperLimit': '32.9', 'statisticalMethod': 'Mixed-effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline at Day 15', '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. As pre-specified in analysis plan, only Part 1 and Part 2 Cohort 2A arms were assessed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Relative Change in ppFEV1 Through Day 29 for Part 2 Cohort 2B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 Cohort 2B: TEZ/IVA', 'description': 'Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.'}, {'id': 'OG001', 'title': 'Part 2 Cohort 2B: TC', 'description': 'Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.0', 'groupId': 'OG000', 'lowerLimit': '-9.2', 'upperLimit': '5.1'}, {'value': '11.5', 'groupId': 'OG001', 'lowerLimit': '7.4', 'upperLimit': '15.7'}]}]}], 'analyses': [{'pValue': '0.0012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.6', 'ciLowerLimit': '5.3', 'ciUpperLimit': '21.9', 'statisticalMethod': 'Mixed-effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY'}], '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. As pre-specified in analysis plan, only Part 2 Cohort 2B arms were assessed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score at Day 15 for Part 1 and Part 2 Cohort 2A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Placebo', 'description': 'Participants received placebo matched to VX-152/TEZ/IVA for 2 weeks.'}, {'id': 'OG001', 'title': 'Part 1 Cohort 1A: TC', 'description': 'Participants received VX-152 100 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.'}, {'id': 'OG002', 'title': 'Part 1 Cohort 1B: TC', 'description': 'Participants received VX-152 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.'}, {'id': 'OG003', 'title': 'Part 1 Cohort 1C: TC', 'description': 'Participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.'}, {'id': 'OG004', 'title': 'Part 2 Cohort 2A: TEZ/IVA', 'description': 'Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.'}, {'id': 'OG005', 'title': 'Part 2 Cohort 2A: TC', 'description': 'Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.6', 'groupId': 'OG000', 'lowerLimit': '-18.6', 'upperLimit': '3.4'}, {'value': '6.6', 'groupId': 'OG001', 'lowerLimit': '-6.0', 'upperLimit': '19.1'}, {'value': '21.8', 'groupId': 'OG002', 'lowerLimit': '12.1', 'upperLimit': '31.6'}, {'value': '18.6', 'groupId': 'OG003', 'lowerLimit': '8.8', 'upperLimit': '28.5'}, {'value': '5.8', 'groupId': 'OG004', 'lowerLimit': '-8.0', 'upperLimit': '19.6'}, {'value': '10.6', 'groupId': 'OG005', 'lowerLimit': '1.9', 'upperLimit': '19.2'}]}]}], 'analyses': [{'pValue': '0.0476', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.1', 'ciLowerLimit': '-2.6', 'ciUpperLimit': '30.9', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '29.4', 'ciLowerLimit': '14.8', 'ciUpperLimit': '44.0', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0006', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.2', 'ciLowerLimit': '11.3', 'ciUpperLimit': '41.1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2714', 'groupIds': ['OG004', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.8', 'ciLowerLimit': '-11.6', 'ciUpperLimit': '21.2', 'statisticalMethod': 'Mixed-effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline at Day 15', '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. As pre-specified in analysis plan, only Part 1 and Part 2 Cohort 2A arms were assessed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in CFQ-R Respiratory Domain Score at Day 29 for Part 2 Cohort 2B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 Cohort 2B: TEZ/IVA', 'description': 'Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.'}, {'id': 'OG001', 'title': 'Part 2 Cohort 2B: TC', 'description': 'Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000', 'lowerLimit': '-3.7', 'upperLimit': '13.3'}, {'value': '16.1', 'groupId': 'OG001', 'lowerLimit': '11.2', 'upperLimit': '21.0'}]}]}], 'analyses': [{'pValue': '0.0138', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.3', 'ciLowerLimit': '1.3', 'ciUpperLimit': '21.2', 'statisticalMethod': 'Mixed-effects Model for Repeated Measure', 'nonInferiorityType': 'SUPERIORITY'}], '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. As pre-specified in analysis plan, only Part 2 Cohort 2B arms were assessed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Pre-dose Plasma Concentration (Ctrough) of VX-152, TEZ, M1-TEZ, IVA, and M1-IVA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '21', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Cohort 1A: TC', 'description': 'Participants received VX-152 100 mg q12h/TEZ 100 qd/IVA 150 mg q12h TC for 2 weeks.'}, {'id': 'OG001', 'title': 'Part 1 Cohort 1B: TC', 'description': 'Participants received VX-152 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.'}, {'id': 'OG002', 'title': 'Part 1 Cohort 1C: TC', 'description': 'Participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.'}, {'id': 'OG003', 'title': 'Part 2 Cohort 2A: TEZ/IVA', 'description': 'Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.'}, {'id': 'OG004', 'title': 'Part 2 Cohort 2A: TC', 'description': 'Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.'}, {'id': 'OG005', 'title': 'Part 2 Cohort 2B: TEZ/IVA', 'description': 'Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.'}, {'id': 'OG006', 'title': 'Part 2 Cohort 2B: TC', 'description': 'Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.'}], 'classes': [{'title': 'Day 8: VX-152', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '21', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '167', 'spread': '65.4', 'groupId': 'OG000'}, {'value': '240', 'spread': '370', 'groupId': 'OG001'}, {'value': '538', 'spread': '576', 'groupId': 'OG002'}, {'value': '355', 'spread': '287', 'groupId': 'OG004'}, {'value': '463', 'spread': '730', 'groupId': 'OG006'}]}]}, {'title': 'Day 15: VX-152', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '173', 'spread': '72.1', 'groupId': 'OG000'}, {'value': '278', 'spread': '212', 'groupId': 'OG001'}, {'value': '804', 'spread': '812', 'groupId': 'OG002'}, {'value': '554', 'spread': '429', 'groupId': 'OG004'}, {'value': '560', 'spread': '657', 'groupId': 'OG006'}]}]}, {'title': 'Day 29: VX-152', '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': '0', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '698', 'spread': '1040', 'groupId': 'OG006'}]}]}, {'title': 'Day 8: TEZ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '21', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '2610', 'spread': '1400', 'groupId': 'OG000'}, {'value': '1500', 'spread': '1140', 'groupId': 'OG001'}, {'value': '1680', 'spread': '996', 'groupId': 'OG002'}, {'value': '1900', 'spread': '1730', 'groupId': 'OG003'}, {'value': '1830', 'spread': '693', 'groupId': 'OG004'}, {'value': '2010', 'spread': '669', 'groupId': 'OG005'}, {'value': '1460', 'spread': '1470', 'groupId': 'OG006'}]}]}, {'title': 'Day 15: TEZ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '2450', 'spread': '2000', 'groupId': 'OG000'}, {'value': '1220', 'spread': '545', 'groupId': 'OG001'}, {'value': '1180', 'spread': '495', 'groupId': 'OG002'}, {'value': '1120', 'spread': '135', 'groupId': 'OG003'}, {'value': '1620', 'spread': '1030', 'groupId': 'OG004'}, {'value': '1970', 'spread': '1040', 'groupId': 'OG005'}, {'value': '1050', 'spread': '543', 'groupId': 'OG006'}]}]}, {'title': 'Day 29: TEZ', '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': '6', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '2470', 'spread': '1060', 'groupId': 'OG005'}, {'value': '1190', 'spread': '422', 'groupId': 'OG006'}]}]}, {'title': 'Day 8: M1-TEZ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '21', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '4520', 'spread': '1090', 'groupId': 'OG000'}, {'value': '3060', 'spread': '1480', 'groupId': 'OG001'}, {'value': '3490', 'spread': '1640', 'groupId': 'OG002'}, {'value': '3760', 'spread': '1100', 'groupId': 'OG003'}, {'value': '4900', 'spread': '1050', 'groupId': 'OG004'}, {'value': '4980', 'spread': '1450', 'groupId': 'OG005'}, {'value': '4150', 'spread': '1280', 'groupId': 'OG006'}]}]}, {'title': 'Day 15: M1-TEZ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '4680', 'spread': '1020', 'groupId': 'OG000'}, {'value': '2890', 'spread': '898', 'groupId': 'OG001'}, {'value': '3310', 'spread': '1220', 'groupId': 'OG002'}, {'value': '3430', 'spread': '824', 'groupId': 'OG003'}, {'value': '4270', 'spread': '1280', 'groupId': 'OG004'}, {'value': '4420', 'spread': '1810', 'groupId': 'OG005'}, {'value': '3650', 'spread': '1320', 'groupId': 'OG006'}]}]}, {'title': 'Day 29: M1-TEZ', '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': '6', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '4280', 'spread': '1650', 'groupId': 'OG005'}, {'value': '3680', 'spread': '742', 'groupId': 'OG006'}]}]}, {'title': 'Day 8: IVA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '21', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '779', 'spread': '442', 'groupId': 'OG000'}, {'value': '522', 'spread': '401', 'groupId': 'OG001'}, {'value': '545', 'spread': '234', 'groupId': 'OG002'}, {'value': '702', 'spread': '425', 'groupId': 'OG003'}, {'value': '610', 'spread': '262', 'groupId': 'OG004'}, {'value': '953', 'spread': '360', 'groupId': 'OG005'}, {'value': '434', 'spread': '251', 'groupId': 'OG006'}]}]}, {'title': 'Day 15: IVA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '841', 'spread': '588', 'groupId': 'OG000'}, {'value': '535', 'spread': '310', 'groupId': 'OG001'}, {'value': '467', 'spread': '236', 'groupId': 'OG002'}, {'value': '441', 'spread': '300', 'groupId': 'OG003'}, {'value': '645', 'spread': '373', 'groupId': 'OG004'}, {'value': '863', 'spread': '488', 'groupId': 'OG005'}, {'value': '389', 'spread': '222', 'groupId': 'OG006'}]}]}, {'title': 'Day 29: IVA', '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': '6', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '1010', 'spread': '446', 'groupId': 'OG005'}, {'value': '468', 'spread': '279', 'groupId': 'OG006'}]}]}, {'title': 'Day 8: M1-IVA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '21', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '1590', 'spread': '1050', 'groupId': 'OG000'}, {'value': '1040', 'spread': '947', 'groupId': 'OG001'}, {'value': '1330', 'spread': '747', 'groupId': 'OG002'}, {'value': '1660', 'spread': '1200', 'groupId': 'OG003'}, {'value': '1470', 'spread': '671', 'groupId': 'OG004'}, {'value': '1810', 'spread': '665', 'groupId': 'OG005'}, {'value': '1170', 'spread': '551', 'groupId': 'OG006'}]}]}, {'title': 'Day 15: M1-IVA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '1230', 'spread': '326', 'groupId': 'OG000'}, {'value': '1200', 'spread': '848', 'groupId': 'OG001'}, {'value': '1140', 'spread': '550', 'groupId': 'OG002'}, {'value': '1030', 'spread': '762', 'groupId': 'OG003'}, {'value': '1510', 'spread': '891', 'groupId': 'OG004'}, {'value': '1620', 'spread': '760', 'groupId': 'OG005'}, {'value': '1100', 'spread': '598', 'groupId': 'OG006'}]}]}, {'title': 'Day 29: M1-IVA', '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': '6', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '1890', 'spread': '659', 'groupId': 'OG005'}, {'value': '1240', 'spread': '705', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose at Day 8, Day 15 and Day 29', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Set (PK) included all participants who received at least 1 dose of study drug in treatment period. Here "Number Analyzed" signifies those participants who were evaluable at specified time points. Day 29 assessments were planned for Part 2: Cohort 2B groups only. VX-152 Ctrough category was not applicable to Part 2: TEZ/IVA groups.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 1: Placebo', 'description': 'Participants received placebo matched to VX-152/TEZ/IVA triple combination (TC) for 2 weeks.'}, {'id': 'FG001', 'title': 'Part 1 Cohort 1A: TC', 'description': 'Participants received VX-152 100 milligram (mg) every 12 hours (q12h)/TEZ 100 mg once daily (qd)/IVA 150 mg q12h TC for 2 weeks.'}, {'id': 'FG002', 'title': 'Part 1 Cohort 1B: TC', 'description': 'Participants received VX-152 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.'}, {'id': 'FG003', 'title': 'Part 1 Cohort 1C: TC', 'description': 'Participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.'}, {'id': 'FG004', 'title': 'Part 2 Cohort 2A: TEZ/IVA', 'description': 'Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.'}, {'id': 'FG005', 'title': 'Part 2 Cohort 2A: TC', 'description': 'Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.'}, {'id': 'FG006', 'title': 'Part 2 Cohort 2B: TEZ/IVA', 'description': 'Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.'}, {'id': 'FG007', 'title': 'Part 2 Cohort 2B: TC', 'description': 'Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '7'}, {'groupId': 'FG007', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '7'}, {'groupId': 'FG007', 'numSubjects': '21'}]}, {'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'}]}]}], 'preAssignmentDetails': 'A total of 80 participants were enrolled in the study (34 participants in Part 1 and 46 participants in Part 2). Out of 46 participants enrolled in Part 2, 4 participants discontinued during the run-in period and were not randomized in the treatment period. Therefore, results are presented for 76 participants in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '21', 'groupId': 'BG007'}, {'value': '76', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1: Placebo', 'description': 'Participants received placebo matched to VX-152/TEZ/IVA TC for 2 weeks.'}, {'id': 'BG001', 'title': 'Part 1 Cohort 1A: TC', 'description': 'Participants received VX-152 100 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.'}, {'id': 'BG002', 'title': 'Part 1 Cohort 1B: TC', 'description': 'Participants received VX-152 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.'}, {'id': 'BG003', 'title': 'Part 1 Cohort 1C: TC', 'description': 'Participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks.'}, {'id': 'BG004', 'title': 'Part 2 Cohort 2A: TEZ/IVA', 'description': 'Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.'}, {'id': 'BG005', 'title': 'Part 2 Cohort 2A: TC', 'description': 'Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 200 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 2 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.'}, {'id': 'BG006', 'title': 'Part 2 Cohort 2B: TEZ/IVA', 'description': 'Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received placebo matched to VX-152 and TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.'}, {'id': 'BG007', 'title': 'Part 2 Cohort 2B: TC', 'description': 'Following run-in period on TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-152 300 mg q12h/TEZ 100 mg qd/IVA 150 mg q12h TC for 4 weeks in treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 2 weeks in washout period.'}, {'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': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '21', 'groupId': 'BG007'}, {'value': '76', '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': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '14', 'groupId': 'BG007'}, {'value': '39', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}, {'value': '37', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '21', 'groupId': 'BG007'}, {'value': '73', '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': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', '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': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '21', 'groupId': 'BG007'}, {'value': '74', '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': '1', 'groupId': 'BG000'}, {'value': '1', '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': '2', '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': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}]}, {'title': '≥40 to <70 percent', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '18', 'groupId': 'BG007'}, {'value': '58', 'groupId': 'BG008'}]}, {'title': '≥70 to ≤90 percent', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '14', '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': '2017-04-14', 'size': 1172096, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-01-07T08:10', 'hasProtocol': True}, {'date': '2017-07-27', 'size': 1007281, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-01-07T08:11', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'dispFirstSubmitDate': '2019-01-09', 'completionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-07', 'studyFirstSubmitDate': '2016-10-26', 'dispFirstSubmitQcDate': '2019-01-09', 'resultsFirstSubmitDate': '2021-01-07', 'studyFirstSubmitQcDate': '2016-10-28', 'dispFirstPostDateStruct': {'date': '2019-01-14', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-07', 'studyFirstPostDateStruct': {'date': '2016-11-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01', '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 Visit (Up to Day 43 for Part 1 and Day 71 for Part 2)'}, {'measure': 'Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Day 15 for Part 1 and Part 2 Cohort 2A', 'timeFrame': 'From Baseline at Day 15', 'description': 'FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.'}, {'measure': 'Absolute Change in ppFEV1 Through Day 29 for Part 2 Cohort 2B', '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 at Day 15 for Part 1 and Part 2 Cohort 2A', 'timeFrame': 'From Baseline at Day 15', 'description': 'Sweat samples were collected using an approved collection device.'}, {'measure': 'Absolute Change in Sweat Chloride Concentrations Through Day 29 for Part 2 Cohort 2B', 'timeFrame': 'From Baseline Through Day 29', 'description': 'Sweat samples were collected using an approved collection device.'}, {'measure': 'Relative Change in ppFEV1 at Day 15 for Part 1 and Part 2 Cohort 2A', 'timeFrame': 'From Baseline at Day 15', 'description': 'FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.'}, {'measure': 'Relative Change in ppFEV1 Through Day 29 for Part 2 Cohort 2B', '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 at Day 15 for Part 1 and Part 2 Cohort 2A', 'timeFrame': 'From Baseline at Day 15', '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': 'Absolute Change From Baseline in CFQ-R Respiratory Domain Score at Day 29 for Part 2 Cohort 2B', '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': 'Pre-dose Plasma Concentration (Ctrough) of VX-152, TEZ, M1-TEZ, IVA, and M1-IVA', 'timeFrame': 'Pre-dose at Day 8, Day 15 and Day 29'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': 'This is a Phase 2, randomized, double blind, placebo and active-controlled, parallel group, multicenter study designed to evaluate the safety and tolerability of VX-152 in Triple Combination (TC) with tezacaftor (TEZ; VX-661) and ivacaftor (IVA; VX-770) in subjects with cystic fibrosis (CF) who are heterozygous for the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ and/or IVA therapy (F508del/MF), or who are homozygous for the F508del mutation of the CF transmembrane conductance regulator (CFTR) gene (F508del/F508del).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing and able to comply with scheduled visits, treatment pan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures.\n* Body weight ≥35 kg.\n* Sweat chloride value ≥ 60 mmol/L from test results obtained during screening.\n* Subjects must have an eligible CFTR genotype:\n\n * Cohorts 1A, 1B, 1C: Heterozygous for F508del and a minimal function mutation known or predicted not to respond to TEZ and/or IVA.\n * Cohorts 2A, 2B: Homozygous for F508del.\n* Subjects must have an FEV1 ≥40% and ≤90% of predicted normal for age, sex, and height at the Screening Visit.\n* Stable CF disease as judged by the investigator.\n* Willing to remain on a stable CF medication regimen through the planned end of treatment or if applicable the Safety Follow-up Visit.\n\nExclusion Criteria:\n\n* History of any comorbidity that in the opinion of the investigator might confound the results of the study or pose an additional risk in administering study drug to the subject.\n* History of cirrhosis with portal hypertension.\n* Risk factors for Torsade de Pointes.\n* History of hemolysis.\n* Glucose-6-phosphate dehydrogenase (G6PD) deficiency assessed at Screening.\n* Clinically significant abnormal laboratory values at screening.\n* An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy for pulmonary disease within 28 days before the first dose of study drug.\n* Lung infection with organisms associated with a more rapid decline in pulmonary status.\n* An acute illness not related to CF within 14 days before the first dose of study drug.\n* A standard digital ECG demonstrating QTc \\>450 msec at screening.\n* History of solid organ or hematological transplantation.\n* History or evidence of cataract or lens opacity determined to be clinically significant by the ophthalmologist or optometrist, based on the ophthalmologic examination during the Screening Period.\n* History of alcohol or drug abuse in the past year, including but not limited to, cannabis, cocaine, and opiates, as deemed by the investigator.\n* Ongoing or prior participation in an investigational drug study with certain exceptions.\n* Use of commercially available CFTR modulator within 14 days before screening (applies only to Cohorts 1A, 1B, and 1C).\n* Pregnant or nursing females: Females of childbearing potential must have a negative pregnancy test at screening and Day 1.'}, 'identificationModule': {'nctId': 'NCT02951195', 'briefTitle': 'A Study Evaluating the Safety of VX-152 Combination Therapy in Adults With Cystic Fibrosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vertex Pharmaceuticals Incorporated'}, 'officialTitle': 'A Phase 2, Randomized, Double Blind, Controlled Study to Evaluate the Safety of VX-152 Combination Therapy in Adults With Cystic Fibrosis', 'orgStudyIdInfo': {'id': 'VX16-152-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Part 1: Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 Cohort 1A: TC', 'interventionNames': ['Drug: VX-152', 'Drug: TEZ/IVA', 'Drug: IVA']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 Cohort 1B: TC', 'interventionNames': ['Drug: VX-152', 'Drug: TEZ/IVA', 'Drug: IVA']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 Cohort 1C: TC', 'interventionNames': ['Drug: VX-152', 'Drug: TEZ/IVA', 'Drug: IVA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part 2 Cohort 2A: TEZ/IVA', 'interventionNames': ['Drug: TEZ/IVA', 'Drug: IVA', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 Cohort 2A: TC', 'interventionNames': ['Drug: VX-152', 'Drug: TEZ/IVA', 'Drug: IVA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part 2 Cohort 2B: TEZ/IVA', 'interventionNames': ['Drug: TEZ/IVA', 'Drug: IVA', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 Cohort 2B: TC', 'interventionNames': ['Drug: VX-152', 'Drug: TEZ/IVA', 'Drug: IVA']}], 'interventions': [{'name': 'VX-152', 'type': 'DRUG', 'description': 'Tablet for oral administration.', 'armGroupLabels': ['Part 1 Cohort 1A: TC', 'Part 1 Cohort 1B: TC', 'Part 1 Cohort 1C: TC', 'Part 2 Cohort 2A: TC', 'Part 2 Cohort 2B: TC']}, {'name': 'TEZ/IVA', 'type': 'DRUG', 'otherNames': ['VX-661/VX-770', 'Tezacaftor/Ivacaftor'], 'description': 'Fixed-dose combination tablet for oral administration.', 'armGroupLabels': ['Part 1 Cohort 1A: TC', 'Part 1 Cohort 1B: TC', 'Part 1 Cohort 1C: TC', 'Part 2 Cohort 2A: TC', 'Part 2 Cohort 2A: TEZ/IVA', 'Part 2 Cohort 2B: TC', 'Part 2 Cohort 2B: TEZ/IVA']}, {'name': 'IVA', 'type': 'DRUG', 'otherNames': ['VX-770', 'Ivacaftor'], 'description': 'Tablet for oral administration.', 'armGroupLabels': ['Part 1 Cohort 1A: TC', 'Part 1 Cohort 1B: TC', 'Part 1 Cohort 1C: TC', 'Part 2 Cohort 2A: TC', 'Part 2 Cohort 2A: TEZ/IVA', 'Part 2 Cohort 2B: TC', 'Part 2 Cohort 2B: TEZ/IVA']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo matched to VX-152.', 'armGroupLabels': ['Part 2 Cohort 2A: TEZ/IVA', 'Part 2 Cohort 2B: TEZ/IVA']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo matched to VX-152/TEZ/IVA triple combination (TC).', 'armGroupLabels': ['Part 1: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vertex Pharmaceuticals Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}