Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-03-04 @ 10:25 PM
Study NCT ID:
NCT02392234
Status:
COMPLETED
Last Update Posted:
2018-06-12
First Post:
2015-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase 3 Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Mutation
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': 'C545203', 'term': 'ivacaftor'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medicalinfo@vrtx.com', 'phone': '617-341-6777', 'title': 'Medical Monitor', 'organization': 'Vertex Pharmaceuticals Incorporated'}, 'certainAgreement': {'otherDetails': 'PI is free to publish results of the study after (1) the first multi-center publication, (2) if the sponsor elects not to publish the results, or (3) 18 months after close of the study, whichever occurs first. Proposed publications are to be submitted to the sponsor for review and comment for a period of at least 45 days (which may be extended under certain circumstances related to protection of intellectual property); the sponsor cannot require changes to the proposed publications.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 up to Week 28', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo matched to VX-661/Ivacaftor (IVA) fixed dose combination (FDC) tablet and placebo matched to IVA tablet in the morning, placebo matched to IVA tablet in the evening for 8 weeks in treatment period 1 and 2.', 'otherNumAtRisk': 162, 'deathsNumAtRisk': 162, 'otherNumAffected': 87, 'seriousNumAtRisk': 162, 'deathsNumAffected': 0, 'seriousNumAffected': 14}, {'id': 'EG001', 'title': 'Ivacaftor', 'description': 'IVA 150 milligram (mg) tablet and placebo matched to VX-661/IVA FDC tablet in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 1 and 2.', 'otherNumAtRisk': 157, 'deathsNumAtRisk': 157, 'otherNumAffected': 54, 'seriousNumAtRisk': 157, 'deathsNumAffected': 0, 'seriousNumAffected': 10}, {'id': 'EG002', 'title': 'VX-661/IVA', 'description': 'VX-661 100 mg/IVA 150 mg FDC tablet and placebo matched to IVA in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 1 and 2.', 'otherNumAtRisk': 162, 'deathsNumAtRisk': 162, 'otherNumAffected': 80, 'seriousNumAtRisk': 162, 'deathsNumAffected': 0, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 23}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Sputum increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Infective pulmonary exacerbation of cystic fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}], 'seriousEvents': [{'term': 'Infective pulmonary exacerbation of cystic fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Distal intestinal obstruction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pulmonary function test decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Urethral stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Acute febrile neutrophilic dermatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Absolute Change From Study Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Average of Week 4 and Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}, {'value': '159', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to VX-661/Ivacaftor (IVA) fixed dose combination (FDC) tablet and placebo matched to IVA tablet in the morning, placebo matched to IVA tablet in the evening for 8 weeks in treatment period 1 and 2.'}, {'id': 'OG001', 'title': 'Ivacaftor', 'description': 'IVA 150 milligram (mg) tablet and placebo matched to VX-661/IVA FDC tablet in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 1 and 2.'}, {'id': 'OG002', 'title': 'VX-661/IVA', 'description': 'VX-661 100 mg/IVA 150 mg FDC tablet and placebo matched to IVA in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 1 and 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3', 'groupId': 'OG000', 'lowerLimit': '-1.2', 'upperLimit': '0.6'}, {'value': '4.4', 'groupId': 'OG001', 'lowerLimit': '3.5', 'upperLimit': '5.3'}, {'value': '6.5', 'groupId': 'OG002', 'lowerLimit': '5.6', 'upperLimit': '7.3'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.7', 'ciLowerLimit': '3.7', 'ciUpperLimit': '5.8', 'statisticalMethod': 'Linear Mixed Effects Model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.8', 'ciLowerLimit': '5.7', 'ciUpperLimit': '7.8', 'statisticalMethod': 'Linear Mixed Effects Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 4 and Week 8 of each treatment period', 'description': 'FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.', 'unitOfMeasure': 'percentage of predicted FEV1', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Full Analysis Set (FAS) included all randomized participants who carry the protocol specified cystic fibrosis transmembrane conductance regulator gene (CFTR) mutations and had received at least 1 dose of study drug. Here 'Overall Number of participants analyzed' signifies those participants who had evaluable data for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Absolute Change From Study Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score at Average of Week 4 and Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}, {'value': '161', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to VX-661/Ivacaftor (IVA) fixed dose combination (FDC) tablet and placebo matched to IVA tablet in the morning, placebo matched to IVA tablet in the evening for 8 weeks in treatment period 1 and 2.'}, {'id': 'OG001', 'title': 'Ivacaftor', 'description': 'IVA 150 milligram (mg) tablet and placebo matched to VX-661/IVA FDC tablet in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 1 and 2.'}, {'id': 'OG002', 'title': 'VX-661/IVA', 'description': 'IVA 150 milligram (mg) tablet and placebo matched to VX-661/IVA FDC tablet in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 1 and 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.0', 'groupId': 'OG000', 'lowerLimit': '-2.9', 'upperLimit': '1.0'}, {'value': '8.7', 'groupId': 'OG001', 'lowerLimit': '6.8', 'upperLimit': '10.7'}, {'value': '10.1', 'groupId': 'OG002', 'lowerLimit': '8.2', 'upperLimit': '12.1'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.7', 'ciLowerLimit': '7.2', 'ciUpperLimit': '12.2', 'statisticalMethod': 'Linear Mixed Effects Model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.1', 'ciLowerLimit': '8.7', 'ciUpperLimit': '13.6', 'statisticalMethod': 'Linear Mixed Effects Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 4 and Week 8 of each treatment period', 'description': 'The CFQ-R assessed respiratory symptoms on a scale with scores ranging from 0 to 100; where higher scores indicated fewer symptoms and better health-related quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS was used. Here 'Overall Number of participants analyzed' signifies those participants who had evaluable data for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}, {'value': '162', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to VX-661/Ivacaftor (IVA) fixed dose combination (FDC) tablet and placebo matched to IVA tablet in the morning, placebo matched to IVA tablet in the evening for 8 weeks in treatment period 1 and 2.'}, {'id': 'OG001', 'title': 'Ivacaftor', 'description': 'IVA 150 milligram (mg) tablet and placebo matched to VX-661/IVA FDC tablet in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 1 and 2.'}, {'id': 'OG002', 'title': 'VX-661/IVA', 'description': 'VX-661 100 mg/IVA 150 mg FDC tablet and placebo matched to IVA in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 1 and 2.'}], 'classes': [{'title': 'Participants with any AEs', 'categories': [{'measurements': [{'value': '126', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}]}, {'title': 'Participants with SAEs', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to Week 28', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set included all participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Relative Change From Study Baseline in ppFEV1 at Average of Week 4 and Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}, {'value': '159', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to VX-661/Ivacaftor (IVA) fixed dose combination (FDC) tablet and placebo matched to IVA tablet in the morning, placebo matched to IVA tablet in the evening for 8 weeks in treatment period 1 and 2.'}, {'id': 'OG001', 'title': 'Ivacaftor', 'description': 'IVA 150 milligram (mg) tablet and placebo matched to VX-661/IVA FDC tablet in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 1 and 2.'}, {'id': 'OG002', 'title': 'VX-661/IVA', 'description': 'VX-661 100 mg/IVA 150 mg FDC tablet and placebo matched to IVA in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 1 and 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000', 'lowerLimit': '-1.7', 'upperLimit': '1.4'}, {'value': '7.9', 'groupId': 'OG001', 'lowerLimit': '6.4', 'upperLimit': '9.4'}, {'value': '11.2', 'groupId': 'OG002', 'lowerLimit': '9.7', 'upperLimit': '12.7'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.1', 'ciLowerLimit': '6.3', 'ciUpperLimit': '9.9', 'statisticalMethod': 'Linear Mixed Effects Model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.4', 'ciLowerLimit': '9.6', 'ciUpperLimit': '13.2', 'statisticalMethod': 'Linear Mixed Effects Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 4 and Week 8 of each treatment period', '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 was used. Here 'Overall Number of participants analyzed' signifies those participants who had evaluable data for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Absolute Change From Study Baseline in Sweat Chloride at Average of Week 4 and Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '151', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to VX-661/Ivacaftor (IVA) fixed dose combination (FDC) tablet and placebo matched to IVA tablet in the morning, placebo matched to IVA tablet in the evening for 8 weeks in treatment period 1 and 2.'}, {'id': 'OG001', 'title': 'Ivacaftor', 'description': 'IVA 150 milligram (mg) tablet and placebo matched to VX-661/IVA FDC tablet in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 1 and 2.'}, {'id': 'OG002', 'title': 'VX-661/IVA', 'description': 'VX-661 100 mg/IVA 150 mg FDC tablet and placebo matched to IVA in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 1 and 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.4', 'groupId': 'OG000', 'lowerLimit': '-2.3', 'upperLimit': '1.5'}, {'value': '-4.9', 'groupId': 'OG001', 'lowerLimit': '-6.7', 'upperLimit': '-3.0'}, {'value': '-9.9', 'groupId': 'OG002', 'lowerLimit': '-11.8', 'upperLimit': '-8.0'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.5', 'ciLowerLimit': '-6.7', 'ciUpperLimit': '-2.3', 'statisticalMethod': 'Linear Mixed Effects Model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.5', 'ciLowerLimit': '-11.7', 'ciUpperLimit': '-7.3', 'statisticalMethod': 'Linear Mixed Effects Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 4 and Week 8 of each treatment period', 'unitOfMeasure': 'millimoles per liter (mmol/L)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS was used. Here 'Overall Number of participants analyzed' signifies those participants who had evaluable data for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Trough Plasma Concentrations (Ctrough) of VX-661, VX-661 Metabolites (M1 VX-661), IVA and IVA Metabolite (M1 IVA) After Administration of VX-661/IVA Combination Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'VX-661/IVA', 'description': 'VX-661 100 mg/IVA 150 mg FDC tablet and placebo matched to IVA in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 1 and 2.'}], 'classes': [{'title': 'VX-661', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2370', 'spread': '1330', 'groupId': 'OG000'}]}]}, {'title': 'M1 VX-661', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5230', 'spread': '1940', 'groupId': 'OG000'}]}]}, {'title': 'IVA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '909', 'spread': '530', 'groupId': 'OG000'}]}]}, {'title': 'M1 IVA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2010', 'spread': '1050', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-morning dose on Week 8 of each treatment period', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) set included all randomized participants who received any amount of study drug and had a PK assessment.'}, {'type': 'SECONDARY', 'title': 'Ctrough of IVA and IVA Metabolite (M1 IVA) After Administration of IVA Monotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ivacaftor', 'description': 'IVA 150 milligram (mg) tablet and placebo matched to VX-661/IVA FDC tablet in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 1 and 2.'}], 'classes': [{'title': 'IVA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '696', 'spread': '435', 'groupId': 'OG000'}]}]}, {'title': 'M1 IVA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1550', 'spread': '808', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-morning dose on Week 8 of each treatment period', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK set was used. Here 'Overall Number of participants analyzed' signifies those participants who had evaluable data for this outcome measure."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'First VX-661/IVA, Then IVA', 'description': 'VX-661 100 milligram (mg) plus IVA 150 mg fixed dose combination (FDC) tablet and placebo matched to IVA in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 1 followed by IVA 150 mg tablet and placebo matched to VX-661 plus IVA FDC tablet in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 2. Each treatment period was separated by a minimum 8 weeks of washout period.'}, {'id': 'FG001', 'title': 'First VX-661/IVA, Then Placebo', 'description': 'VX-661 100 mg plus IVA 150 mg FDC tablet and placebo matched to IVA in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 1 followed by placebo matched to VX-661 plus IVA FDC tablet and placebo matched to IVA tablet in the morning, placebo matched to IVA tablet in the evening for 8 weeks in treatment period 2. Each treatment period was separated by a minimum 8 weeks of washout period.'}, {'id': 'FG002', 'title': 'First IVA, Then Placebo', 'description': 'IVA 150 mg tablet and placebo matched to VX-661 plus IVA FDC tablet in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 1 followed by placebo matched to VX-661 plus IVA FDC tablet and placebo matched to IVA tablet in the morning, placebo matched to IVA tablet in the evening for 8 weeks in treatment period 2. Each treatment period was separated by a minimum 8 weeks of washout period.'}, {'id': 'FG003', 'title': 'First IVA, Then VX- 661/IVA', 'description': 'IVA 150 mg tablet and placebo matched to VX-661 plus IVA FDC tablet in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 1 followed by VX-661 100 mg plus IVA 150 mg FDC tablet and placebo matched to IVA tablet in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 2. Each treatment period was separated by a minimum 8 weeks of washout period.'}, {'id': 'FG004', 'title': 'First Placebo, Then VX- 661/IVA', 'description': 'Placebo matched to VX-661 plus IVA FDC tablet and placebo matched to IVA tablet in the morning, placebo matched to IVA tablet in the evening for 8 weeks in treatment period 1 followed by VX-661 100 mg plus IVA 150 mg FDC tablet and placebo matched to IVA tablet in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 2. Each treatment period was separated by a minimum 8 weeks of washout period.'}, {'id': 'FG005', 'title': 'First Placebo, Then IVA', 'description': 'Placebo matched to VX-661 plus IVA FDC tablet and placebo matched to IVA tablet in the morning, placebo matched to IVA tablet in the evening for 8 weeks in treatment period 1 followed by IVA 150 mg tablet and placebo matched to VX-661 plus IVA FDC tablet in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 2. Each treatment period was separated by a minimum 8 weeks of washout period.'}], 'periods': [{'title': 'Treatment Period 1 (8 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '40'}, {'groupId': 'FG003', 'numSubjects': '42'}, {'groupId': 'FG004', 'numSubjects': '41'}, {'groupId': 'FG005', 'numSubjects': '41'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '39'}, {'groupId': 'FG003', 'numSubjects': '42'}, {'groupId': 'FG004', 'numSubjects': '40'}, {'groupId': 'FG005', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '38'}, {'groupId': 'FG003', 'numSubjects': '41'}, {'groupId': 'FG004', 'numSubjects': '37'}, {'groupId': 'FG005', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 2 (8 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '38'}, {'groupId': 'FG003', 'numSubjects': '41'}, {'groupId': 'FG004', 'numSubjects': '37'}, {'groupId': 'FG005', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '38'}, {'groupId': 'FG003', 'numSubjects': '41'}, {'groupId': 'FG004', 'numSubjects': '37'}, {'groupId': 'FG005', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 248 participants were enrolled. Out of which, 246 received at least 1 dose of study drug were included in safety set and 244 participants who carried intended cystic fibrosis transmembrane conductance regulator (CFTR) mutations were included in Full analysis set.', 'preAssignmentDetails': 'Participants were randomized to 1 of 6 treatment sequences, each of which included 2 treatment periods and 2 of 3 potential treatments (placebo, VX-661/ivacaftor \\[IVA\\], IVA). Treatment periods were separated by an 8 week wash-out period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '41', 'groupId': 'BG004'}, {'value': '41', 'groupId': 'BG005'}, {'value': '248', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'First VX- 661/IVA, Then IVA', 'description': 'VX-661 100 mg plus IVA 150 mg FDC tablet and placebo matched to IVA in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 1 followed by IVA 150 mg tablet and placebo matched to VX-661 plus IVA FDC tablet in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 2. Each treatment period was separated by a minimum 8 weeks of washout period.'}, {'id': 'BG001', 'title': 'First VX-661/IVA, Then Placebo', 'description': 'VX-661 100 mg plus IVA 150 mg FDC tablet and placebo matched to IVA in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 1 followed by placebo matched to VX-661 plus IVA FDC tablet and placebo matched to IVA tablet in the morning, placebo matched to IVA tablet in the evening for 8 weeks in treatment period 2. Each treatment period was separated by a minimum 8 weeks of washout period.'}, {'id': 'BG002', 'title': 'First IVA, Then Placebo', 'description': 'IVA 150 mg tablet and placebo matched to VX-661 plus IVA FDC tablet in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 1 followed by placebo matched to VX-661 plus IVA FDC tablet and placebo matched to IVA tablet in the morning, placebo matched to IVA tablet in the evening for 8 weeks in treatment period 2. Each treatment period was separated by a minimum 8 weeks of washout period.'}, {'id': 'BG003', 'title': 'First IVA, Then VX- 661/IVA', 'description': 'IVA 150 mg tablet and placebo matched to VX-661 plus IVA FDC tablet in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 1 followed by VX-661 100 mg plus IVA 150 mg FDC tablet and placebo matched to IVA tablet in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 2. Each treatment period was separated by a minimum 8 weeks of washout period.'}, {'id': 'BG004', 'title': 'First Placebo, Then VX- 661/IVA', 'description': 'Placebo matched to VX-661 plus IVA FDC tablet and placebo matched to IVA tablet in the morning, placebo matched to IVA tablet in the evening for 8 weeks in treatment period 1 followed by VX-661 100 mg plus IVA 150 mg FDC tablet and placebo matched to IVA tablet in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 2. Each treatment period was separated by a minimum 8 weeks of washout period.'}, {'id': 'BG005', 'title': 'First Placebo, Then IVA', 'description': 'Placebo matched to VX-661 plus IVA FDC tablet and placebo matched to IVA tablet in the morning, placebo matched to IVA tablet in the evening for 8 weeks in treatment period 1 followed by IVA 150 mg tablet and placebo matched to VX-661 plus IVA FDC tablet in the morning, IVA 150 mg tablet in the evening for 8 weeks in treatment period 2. Each treatment period was separated by a minimum 8 weeks of washout period.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '34', 'groupId': 'BG006'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '34', 'groupId': 'BG004'}, {'value': '35', 'groupId': 'BG005'}, {'value': '212', 'groupId': 'BG006'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '23', 'groupId': 'BG005'}, {'value': '134', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}, {'value': '114', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}, {'value': '39', 'groupId': 'BG005'}, {'value': '237', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}], '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': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'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'}]}, {'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'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}, {'value': '39', 'groupId': 'BG005'}, {'value': '241', 'groupId': 'BG006'}]}, {'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'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Full Analysis Set (FAS) was defined as all randomized subjects who carry the intended cystic fibrosis transmembrane conductance regulator (CFTR) mutations and had received at least 1 dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-06-10', 'size': 4171706, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-03-14T18:04', 'hasProtocol': True}, {'date': '2017-02-24', 'size': 12812759, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-03-14T18:05', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 248}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'dispFirstSubmitDate': '2018-02-12', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-08', 'studyFirstSubmitDate': '2015-03-12', 'dispFirstSubmitQcDate': '2018-02-12', 'resultsFirstSubmitDate': '2018-03-14', 'studyFirstSubmitQcDate': '2015-03-12', 'dispFirstPostDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-05-08', 'studyFirstPostDateStruct': {'date': '2015-03-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute Change From Study Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Average of Week 4 and Week 8', 'timeFrame': 'Baseline, Week 4 and Week 8 of each treatment period', 'description': 'FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.'}], 'secondaryOutcomes': [{'measure': 'Absolute Change From Study Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score at Average of Week 4 and Week 8', 'timeFrame': 'Baseline, Week 4 and Week 8 of each treatment period', 'description': 'The CFQ-R assessed respiratory symptoms on a scale with scores ranging from 0 to 100; where higher scores indicated fewer symptoms and better health-related quality of life.'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Day 1 up to Week 28'}, {'measure': 'Relative Change From Study Baseline in ppFEV1 at Average of Week 4 and Week 8', 'timeFrame': 'Baseline, Week 4 and Week 8 of each treatment period', 'description': 'FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.'}, {'measure': 'Absolute Change From Study Baseline in Sweat Chloride at Average of Week 4 and Week 8', 'timeFrame': 'Baseline, Week 4 and Week 8 of each treatment period'}, {'measure': 'Trough Plasma Concentrations (Ctrough) of VX-661, VX-661 Metabolites (M1 VX-661), IVA and IVA Metabolite (M1 IVA) After Administration of VX-661/IVA Combination Therapy', 'timeFrame': 'Pre-morning dose on Week 8 of each treatment period'}, {'measure': 'Ctrough of IVA and IVA Metabolite (M1 IVA) After Administration of IVA Monotherapy', 'timeFrame': 'Pre-morning dose on Week 8 of each treatment period'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cystic Fibrosis']}, 'referencesModule': {'references': [{'pmid': '37983082', 'type': 'DERIVED', 'citation': 'Heneghan M, Southern KW, Murphy J, Sinha IP, Nevitt SJ. Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del). Cochrane Database Syst Rev. 2023 Nov 20;11(11):CD010966. doi: 10.1002/14651858.CD010966.pub4.'}, {'pmid': '36509366', 'type': 'DERIVED', 'citation': 'Acaster S, Mukuria C, Rowen D, Brazier JE, Wainwright CE, Quon BS, Duckers J, Quittner AL, Lou Y, Sosnay PR, McGarry LJ. Development of the Cystic Fibrosis Questionnaire-Revised-8 Dimensions: Estimating Utilities From the Cystic Fibrosis Questionnaire-Revised. Value Health. 2023 Apr;26(4):567-578. doi: 10.1016/j.jval.2022.12.002. Epub 2022 Dec 9.'}, {'pmid': '33331662', 'type': 'DERIVED', 'citation': 'Southern KW, Murphy J, Sinha IP, Nevitt SJ. Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del). Cochrane Database Syst Rev. 2020 Dec 17;12(12):CD010966. doi: 10.1002/14651858.CD010966.pub3.'}, {'pmid': '29099333', 'type': 'DERIVED', 'citation': 'Rowe SM, Daines C, Ringshausen FC, Kerem E, Wilson J, Tullis E, Nair N, Simard C, Han L, Ingenito EP, McKee C, Lekstrom-Himes J, Davies JC. Tezacaftor-Ivacaftor in Residual-Function Heterozygotes with Cystic Fibrosis. N Engl J Med. 2017 Nov 23;377(21):2024-2035. doi: 10.1056/NEJMoa1709847. Epub 2017 Nov 3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of VX-661 in combination with ivacaftor (IVA, VX-770) and IVA monotherapy in participants with Cystic Fibrosis (CF) who are heterozygous for F508del-CFTR allele and a second allele with a CFTR mutation predicted to have residual function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Heterozygous for F508del-CFTR and a second allele with a CFTR mutation predicted to have residual function\n* Forced Expiratory Volume in 1 Second (FEV1) greater than or equal to (≥) 40 percent (%) and less than or equal to (≤) 90% of predicted normal for age, sex, and height during screening\n* Sweat chloride value ≥60 millimole per liter (mmol/L) during screening OR as documented in the participant's medical record\n* Stable CF disease as judged by the investigator\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 participant\n* An acute upper or lower respiratory infection, pulmonary exacerbation\n* History of solid organ or hematological transplantation\n* Ongoing or prior participation in an investigational drug study (including studies investigating VX-661, lumacaftor \\[VX-809\\], and/or ivacaftor) within 30 days of screening\n* Pregnant and nursing females\n* Sexually active participants of reproductive potential who are not willing to follow the contraception requirements"}, 'identificationModule': {'nctId': 'NCT02392234', 'briefTitle': 'A Phase 3 Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Mutation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vertex Pharmaceuticals Incorporated'}, 'officialTitle': 'A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function', 'orgStudyIdInfo': {'id': 'VX14-661-108'}, 'secondaryIdInfos': [{'id': '2014-004788-18', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VX-661/Ivacaftor combination', 'interventionNames': ['Drug: VX-661/Ivacaftor', 'Drug: Ivacaftor', 'Drug: Placebo matched to Ivacaftor']}, {'type': 'EXPERIMENTAL', 'label': 'Ivacaftor monotherapy', 'interventionNames': ['Drug: Ivacaftor', 'Drug: Placebo matched to VX-661/ ivacaftor']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo matched to VX-661/ ivacaftor', 'Drug: Placebo matched to Ivacaftor']}], 'interventions': [{'name': 'VX-661/Ivacaftor', 'type': 'DRUG', 'otherNames': ['VX-661+VX-770'], 'description': 'Fixed dose combination tablet, oral use', 'armGroupLabels': ['VX-661/Ivacaftor combination']}, {'name': 'Ivacaftor', 'type': 'DRUG', 'otherNames': ['IVA, VX-770'], 'description': 'Tablet, oral use', 'armGroupLabels': ['Ivacaftor monotherapy', 'VX-661/Ivacaftor combination']}, {'name': 'Placebo matched to VX-661/ ivacaftor', 'type': 'DRUG', 'description': 'Fixed dose combination tablet, oral use', 'armGroupLabels': ['Ivacaftor monotherapy', 'Placebo']}, {'name': 'Placebo matched to Ivacaftor', 'type': 'DRUG', 'description': 'Tablet, oral use', 'armGroupLabels': ['Placebo', 'VX-661/Ivacaftor combination']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'city': 'Oakland', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'city': 'Pensacola', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Park Ridge', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 42.01114, 'lon': -87.84062}}, {'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'city': 'Valhalla', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 41.07482, 'lon': -73.77513}}, {'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': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'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': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}, {'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}, {'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'city': 'Adelaide', 'country': 'Australia', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'city': 'Melbourne', 'country': 'Australia', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'city': 'South Brisbane', 'country': 'Australia', 'geoPoint': {'lat': -27.48034, 'lon': 153.02049}}, {'city': 'Westmead', 'country': 'Australia', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'city': 'Ghent', 'country': 'Belgium', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Montreal', 'country': 'Canada', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Québec', 'country': 'Canada', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'city': 'Toronto', 'country': 'Canada', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Vancouver', 'country': 'Canada', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'city': 'Marseille', 'state': 'Bouches-du-Rhone', 'country': 'France', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Montpellier', 'state': 'Herault', 'country': 'France', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Rennes', 'state': 'Ille Et Vilaine', 'country': 'France', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Lille', 'state': 'Nord', 'country': 'France', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Paris', 'state': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Bron', 'state': 'Rhone', 'country': 'France', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'city': 'Bordeaux', 'country': 'France', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'city': 'München', 'state': 'Bavaria', 'country': 'Germany', 'geoPoint': {'lat': 48.69668, 'lon': 13.46314}}, {'city': 'Hanover', 'state': 'Lower Saxony', 'country': 'Germany', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Essen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'Jena', 'state': 'Thuringia', 'country': 'Germany', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'city': 'Berlin', 'country': 'Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Haifa', 'country': 'Israel', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'city': 'Jerusalem', 'country': 'Israel', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'city': 'Petah Tikva', 'country': 'Israel', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'city': 'Ramat Gan', 'country': 'Israel', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}, {'city': 'Ancona', 'country': 'Italy', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'city': 'Milan', 'country': 'Italy', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Orbassano', 'country': 'Italy', 'geoPoint': {'lat': 45.00547, 'lon': 7.53813}}, {'city': 'Potenza', 'country': 'Italy', 'geoPoint': {'lat': 40.64175, 'lon': 15.80794}}, {'city': 'Roma', 'country': 'Italy', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Verona', 'country': 'Italy', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'The Hague', 'country': 'Netherlands', 'geoPoint': {'lat': 52.07667, 'lon': 4.29861}}, {'city': 'Utrecht', 'country': 'Netherlands', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'city': 'Bern', 'country': 'Switzerland', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'city': 'Sankt Gallen', 'country': 'Switzerland', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}, {'city': 'Zurich', 'country': 'Switzerland', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'city': 'Exeter', 'state': 'Devon', 'country': 'United Kingdom', 'geoPoint': {'lat': 50.7236, 'lon': -3.52751}}, {'city': 'London', 'state': 'Greater London', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Manchester', 'state': 'Greater Manchester', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'city': 'Southampton', 'state': 'Hampshire', 'country': 'United Kingdom', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'city': 'Liverpool', 'state': 'Lancashire', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'city': 'Glasgow', 'state': 'Strathclyde', 'country': 'United Kingdom', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'city': 'Leeds', 'state': 'West Yorkshire', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vertex Pharmaceuticals Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}