Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2026-03-01 @ 6:28 AM
Study NCT ID:
NCT02875366
Status:
COMPLETED
Last Update Posted:
2019-06-17
First Post:
2016-08-15
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of the Effects of Lumacaftor/Ivacaftor (LUM/IVA) on Exercise Tolerance in Subjects With Cystic Fibrosis (CF), Homozygous for the F508del-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': 'C000599212', 'term': 'lumacaftor, ivacaftor drug combination'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medicalinfo@vrtx.com', 'phone': '617-341-6777', 'title': 'Medical Monitor', 'organization': 'Vertex Pharmaceuticals Incorporated'}, 'certainAgreement': {'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': 'Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks.', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 34, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'LUM/IVA', 'description': 'Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks.', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 28, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Infective pulmonary exacerbation of cystic fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Vulvovaginal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Respiration abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Increased viscosity of bronchial secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Sputum increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bacterial test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Blood iron decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Fungal test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'seriousEvents': [{'term': 'Infective pulmonary exacerbation of cystic fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lower respiratory tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cytomegalovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Distal intestinal obstruction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Testicular torsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Relative (Percent) Change From Baseline in Maximal Oxygen Consumption (VO2max) During Cardiopulmonary Exercise Testing (CPET) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks.'}, {'id': 'OG001', 'title': 'LUM/IVA', 'description': 'Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.5', 'groupId': 'OG000', 'lowerLimit': '-7.7', 'upperLimit': '0.8'}, {'value': '-6.6', 'groupId': 'OG001', 'lowerLimit': '-11.3', 'upperLimit': '-2.0'}]}]}], 'analyses': [{'pValue': '0.3021', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.2', 'ciLowerLimit': '-9.2', 'ciUpperLimit': '2.9', 'statisticalMethod': 'Mixed effects model for repeated measure', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'CPET was used to assess change in exercise tolerance, as measured by VO2max.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) included all randomized participants who received any amount of study drug. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome.'}, {'type': 'SECONDARY', 'title': 'Relative (Percent) Change From Baseline in Exercise Duration During CPET at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks.'}, {'id': 'OG001', 'title': 'LUM/IVA', 'description': 'Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '-3.0', 'upperLimit': '3.8'}, {'value': '-2.8', 'groupId': 'OG001', 'lowerLimit': '-6.5', 'upperLimit': '1.0'}]}]}], 'analyses': [{'pValue': '0.1894', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.2', 'ciLowerLimit': '-8.0', 'ciUpperLimit': '1.6', 'statisticalMethod': 'Mixed effects model for repeated measure', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Exercise duration is defined as the time at the termination of CPET exercise minus the corresponding time when CPET starts for each CPET exercise.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Exercise Duration During CPET at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks.'}, {'id': 'OG001', 'title': 'LUM/IVA', 'description': 'Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.1', 'groupId': 'OG000', 'lowerLimit': '-20.0', 'upperLimit': '15.9'}, {'value': '-17.4', 'groupId': 'OG001', 'lowerLimit': '-37.2', 'upperLimit': '2.4'}]}]}], 'analyses': [{'pValue': '0.2328', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.3', 'ciLowerLimit': '-40.8', 'ciUpperLimit': '10.1', 'statisticalMethod': 'Mixed effects model for repeated measure', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Exercise duration is defined as the time at the termination of CPET exercise minus the corresponding time when CPET starts for each CPET exercise.', 'unitOfMeasure': 'seconds', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in VO2max During CPET at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks.'}, {'id': 'OG001', 'title': 'LUM/IVA', 'description': 'Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.3', 'groupId': 'OG000', 'lowerLimit': '-2.5', 'upperLimit': '-0.1'}, {'value': '-2.7', 'groupId': 'OG001', 'lowerLimit': '-4.0', 'upperLimit': '-1.3'}]}]}], 'analyses': [{'pValue': '0.1203', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-3.1', 'ciUpperLimit': '0.4', 'statisticalMethod': 'Mixed effects model for repeated measure', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'CPET was used to assess change in exercise tolerance, as measured by VO2max.', 'unitOfMeasure': 'milliliter per kilogram per minute', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Oxygen Consumption (VO2) at Anaerobic Threshold at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks.'}, {'id': 'OG001', 'title': 'LUM/IVA', 'description': 'Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.6', 'groupId': 'OG000', 'lowerLimit': '-5.8', 'upperLimit': '195.0'}, {'value': '-55.1', 'groupId': 'OG001', 'lowerLimit': '-168.0', 'upperLimit': '57.9'}]}]}], 'analyses': [{'pValue': '0.0439', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-149.6', 'ciLowerLimit': '-295.0', 'ciUpperLimit': '-4.2', 'statisticalMethod': 'Mixed effects model for repeated measure', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Anaerobic threshold was defined as the exercise intensity at which lactate starts to accumulate.', 'unitOfMeasure': 'milliliter per minute', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome.'}, {'type': 'SECONDARY', 'title': 'Relative (Percent) Change From Baseline in VO2 at Anaerobic Threshold at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks.'}, {'id': 'OG001', 'title': 'LUM/IVA', 'description': 'Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '17.8'}, {'value': '1.8', 'groupId': 'OG001', 'lowerLimit': '-7.7', 'upperLimit': '11.3'}]}]}], 'analyses': [{'pValue': '0.2237', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.5', 'ciLowerLimit': '-19.8', 'ciUpperLimit': '4.7', 'statisticalMethod': 'Mixed effects model for repeated measure', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Anaerobic threshold was defined as the exercise intensity at which lactate starts to accumulate.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Functional VO2 Gain at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks.'}, {'id': 'OG001', 'title': 'LUM/IVA', 'description': 'Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.07', 'groupId': 'OG000', 'lowerLimit': '-0.29', 'upperLimit': '0.43'}, {'value': '-0.53', 'groupId': 'OG001', 'lowerLimit': '-0.93', 'upperLimit': '-0.14'}]}]}], 'analyses': [{'pValue': '0.0226', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.60', 'ciLowerLimit': '-1.12', 'ciUpperLimit': '-0.09', 'statisticalMethod': 'Mixed effects model for repeated measure', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'unitOfMeasure': 'milliliter per minute per watt', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome.'}, {'type': 'SECONDARY', 'title': 'Relative (Percent) Change From Baseline in Functional VO2 Gain at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks.'}, {'id': 'OG001', 'title': 'LUM/IVA', 'description': 'Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.46', 'groupId': 'OG000', 'lowerLimit': '-3.10', 'upperLimit': '6.03'}, {'value': '-4.85', 'groupId': 'OG001', 'lowerLimit': '-9.93', 'upperLimit': '0.22'}]}]}], 'analyses': [{'pValue': '0.0613', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.32', 'ciLowerLimit': '-12.94', 'ciUpperLimit': '0.31', 'statisticalMethod': 'Mixed effects model for repeated measure', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Pulmonary Ventilation (VE) Versus Carbon Dioxide Production (VCO2) Slope at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks.'}, {'id': 'OG001', 'title': 'LUM/IVA', 'description': 'Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '-0.3', 'upperLimit': '1.4'}, {'value': '0.8', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '1.7'}]}]}], 'analyses': [{'pValue': '0.6409', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '1.5', 'statisticalMethod': 'Mixed effects model for repeated measure', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome.'}, {'type': 'SECONDARY', 'title': 'Relative (Percent) Change From Baseline in Pulmonary Ventilation (VE) Versus Carbon Dioxide Production (VCO2) Slope at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks.'}, {'id': 'OG001', 'title': 'LUM/IVA', 'description': 'Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '-0.7', 'upperLimit': '4.6'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '5.8'}]}]}], 'analyses': [{'pValue': '0.5889', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '-2.7', 'ciUpperLimit': '4.7', 'statisticalMethod': 'Mixed effects model for repeated measure', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks.'}, {'id': 'OG001', 'title': 'LUM/IVA', 'description': 'Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.0', 'groupId': 'OG000', 'lowerLimit': '-7.3', 'upperLimit': '-0.7'}, {'value': '-0.6', 'groupId': 'OG001', 'lowerLimit': '-4.0', 'upperLimit': '2.9'}]}]}], 'analyses': [{'pValue': '0.1460', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.4', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '8.1', 'statisticalMethod': 'Mixed effects model for repeated measure', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', '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': 'FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome.'}, {'type': 'SECONDARY', 'title': 'Relative (Percent) Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks.'}, {'id': 'OG001', 'title': 'LUM/IVA', 'description': 'Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.4', 'groupId': 'OG000', 'lowerLimit': '-10.3', 'upperLimit': '-0.5'}, {'value': '-1.8', 'groupId': 'OG001', 'lowerLimit': '-6.9', 'upperLimit': '3.2'}]}]}], 'analyses': [{'pValue': '0.3091', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.5', 'ciLowerLimit': '-3.4', 'ciUpperLimit': '10.4', 'statisticalMethod': 'Mixed effects model for repeated measure', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', '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. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Body Mass Index (BMI) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks.'}, {'id': 'OG001', 'title': 'LUM/IVA', 'description': 'Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.6'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '0.8'}]}]}], 'analyses': [{'pValue': '0.3961', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.6', 'statisticalMethod': 'Mixed effects model for repeated measure', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'BMI was defined as weight in kilograms (kg) divided by height in square meter (m\\^2).', 'unitOfMeasure': 'kg/m^2', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome.'}, {'type': 'SECONDARY', 'title': 'Relative (Percent) Change From Baseline in BMI at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks.'}, {'id': 'OG001', 'title': 'LUM/IVA', 'description': 'Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.1'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '4.1'}]}]}], 'analyses': [{'pValue': '0.3905', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '3.1', 'statisticalMethod': 'Mixed effects model for repeated measure', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'BMI was defined as weight in kg divided by height in m\\^2.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks.'}, {'id': 'OG001', 'title': 'LUM/IVA', 'description': 'Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.1', 'groupId': 'OG000', 'lowerLimit': '-11.7', 'upperLimit': '-0.5'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-5.9', 'upperLimit': '6.1'}]}]}], 'analyses': [{'pValue': '0.1257', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.2', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '14.1', 'statisticalMethod': 'Mixed effects model for repeated measure', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', '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. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome.'}, {'type': 'SECONDARY', 'title': 'Number of Participants in Each Severity Category of Patient Health Questionnaire (PHQ-8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks.'}, {'id': 'OG001', 'title': 'LUM/IVA', 'description': 'Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks.'}], 'classes': [{'title': 'Baseline: None to minimal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Moderately severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: None to minimal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: Moderately severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 24', 'description': 'The PHQ-8 is an eight item self-reported measure of depression. Each item is rated on a scale ranging from 0 (not at all) to 3 (nearly every day). Total score is the sum of individual eight items and ranges from 0 to 24, with higher scores indicating more severe depression symptoms. Total score of 0 to 5 indicates none to minimal depression, 6 to 10 indicates mild depression, 11 to 15 indicates moderate depression, 16 to 20 indicates moderately severe depression and 21 to 24 indicates severe depression.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Here "Number Analyzed" signifies those participants who were evaluated for this outcome at the specified time point.'}, {'type': 'SECONDARY', 'title': 'Number of Participants in Each Severity Category of Generalized Anxiety Disorder (GAD-7) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks.'}, {'id': 'OG001', 'title': 'LUM/IVA', 'description': 'Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks.'}], 'classes': [{'title': 'Baseline: None to minimal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: None to minimal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 24', 'description': 'The GAD-7 is a seven item, self-reported measurement of GAD severity. Each item is rated on a scale ranging from 0 (not at all) to 3 (nearly every day). Total score is the sum of individual seven items and ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms. Total score of 0 to 5 indicates none to minimal anxiety, 6 to 10 indicates mild anxiety, 11 to 15 indicates moderate anxiety, 16 to 21 indicates severe anxiety.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Here "Number Analyzed" signifies those participants who were evaluated for this outcome at the specified time point.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Daily Physical Activity Counts as Determined by Actigraphy at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks.'}, {'id': 'OG001', 'title': 'LUM/IVA', 'description': 'Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-23239', 'spread': '73936.4', 'groupId': 'OG000'}, {'value': '-22409', 'spread': '52450.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Participants were provided with a wrist-worn actigraphy device which continuously collected data about daily physical activity counts.', 'unitOfMeasure': 'physical activity counts per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. 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Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Duration of Sleep Time at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks.'}, {'id': 'OG001', 'title': 'LUM/IVA', 'description': 'Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.74', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Participants were provided with a wrist-worn actigraphy device which continuously collected data about sleep duration and quality.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome.'}, {'type': 'SECONDARY', 'title': 'Relative (Percent) Change From Baseline in Duration of Sleep Time at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks.'}, {'id': 'OG001', 'title': 'LUM/IVA', 'description': 'Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.7', 'spread': '12.30', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '9.79', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Participants were provided with a wrist-worn actigraphy device which continuously collected data about sleep duration and quality.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Time Above Sedentary Duration at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks.'}, {'id': 'OG001', 'title': 'LUM/IVA', 'description': 'Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'spread': '1.48', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '2.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Participants were provided with a wrist-worn actigraphy device which continuously collected data about daily activities and sleep duration and quality.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome.'}, {'type': 'SECONDARY', 'title': 'Relative (Percent) Change From Baseline in Time Above Sedentary Duration at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks.'}, {'id': 'OG001', 'title': 'LUM/IVA', 'description': 'Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'spread': '64.76', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '77.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Participants were provided with a wrist-worn actigraphy device which continuously collected data about daily activities and sleep duration and quality.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks.'}, {'id': 'OG001', 'title': 'LUM/IVA', 'description': 'Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks.'}], 'classes': [{'title': 'Participants With AEs', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Participants With SAEs', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to Week 28', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set was defined as all participants who received at least 1 dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to lumacaftor (LUM)/ivacaftor (IVA) fixed-dose combination tablet orally every 12 hours (q12h) for 24 weeks.'}, {'id': 'FG001', 'title': 'LUM/IVA', 'description': 'Participants received LUM 400 milligram (mg)/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to LUM/IVA fixed-dose combination tablet orally q12h for 24 weeks.'}, {'id': 'BG001', 'title': 'LUM/IVA', 'description': 'Participants received LUM 400 mg/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26.1', 'spread': '10.58', 'groupId': 'BG000'}, {'value': '24.9', 'spread': '10.17', 'groupId': 'BG001'}, {'value': '25.5', 'spread': '10.33', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-01-15', 'size': 11155117, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-09-28T10:41', 'hasProtocol': True}, {'date': '2017-05-17', 'size': 1652716, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-09-28T10:42', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-18', 'studyFirstSubmitDate': '2016-08-15', 'resultsFirstSubmitDate': '2018-09-30', 'studyFirstSubmitQcDate': '2016-08-22', 'lastUpdatePostDateStruct': {'date': '2019-06-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-18', 'studyFirstPostDateStruct': {'date': '2016-08-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relative (Percent) Change From Baseline in Maximal Oxygen Consumption (VO2max) During Cardiopulmonary Exercise Testing (CPET) at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'CPET was used to assess change in exercise tolerance, as measured by VO2max.'}], 'secondaryOutcomes': [{'measure': 'Relative (Percent) Change From Baseline in Exercise Duration During CPET at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'Exercise duration is defined as the time at the termination of CPET exercise minus the corresponding time when CPET starts for each CPET exercise.'}, {'measure': 'Absolute Change From Baseline in Exercise Duration During CPET at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'Exercise duration is defined as the time at the termination of CPET exercise minus the corresponding time when CPET starts for each CPET exercise.'}, {'measure': 'Absolute Change From Baseline in VO2max During CPET at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'CPET was used to assess change in exercise tolerance, as measured by VO2max.'}, {'measure': 'Absolute Change From Baseline in Oxygen Consumption (VO2) at Anaerobic Threshold at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'Anaerobic threshold was defined as the exercise intensity at which lactate starts to accumulate.'}, {'measure': 'Relative (Percent) Change From Baseline in VO2 at Anaerobic Threshold at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'Anaerobic threshold was defined as the exercise intensity at which lactate starts to accumulate.'}, {'measure': 'Absolute Change From Baseline in Functional VO2 Gain at Week 24', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Relative (Percent) Change From Baseline in Functional VO2 Gain at Week 24', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Absolute Change From Baseline in Pulmonary Ventilation (VE) Versus Carbon Dioxide Production (VCO2) Slope at Week 24', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Relative (Percent) Change From Baseline in Pulmonary Ventilation (VE) Versus Carbon Dioxide Production (VCO2) Slope at Week 24', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.'}, {'measure': 'Relative (Percent) Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.'}, {'measure': 'Absolute Change From Baseline in Body Mass Index (BMI) at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'BMI was defined as weight in kilograms (kg) divided by height in square meter (m\\^2).'}, {'measure': 'Relative (Percent) Change From Baseline in BMI at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'BMI was defined as weight in kg divided by height in m\\^2.'}, {'measure': 'Absolute Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score at Week 24', 'timeFrame': 'Baseline, Week 24', '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 in Each Severity Category of Patient Health Questionnaire (PHQ-8)', 'timeFrame': 'Baseline, Week 24', 'description': 'The PHQ-8 is an eight item self-reported measure of depression. Each item is rated on a scale ranging from 0 (not at all) to 3 (nearly every day). Total score is the sum of individual eight items and ranges from 0 to 24, with higher scores indicating more severe depression symptoms. Total score of 0 to 5 indicates none to minimal depression, 6 to 10 indicates mild depression, 11 to 15 indicates moderate depression, 16 to 20 indicates moderately severe depression and 21 to 24 indicates severe depression.'}, {'measure': 'Number of Participants in Each Severity Category of Generalized Anxiety Disorder (GAD-7) Scores', 'timeFrame': 'Baseline, Week 24', 'description': 'The GAD-7 is a seven item, self-reported measurement of GAD severity. Each item is rated on a scale ranging from 0 (not at all) to 3 (nearly every day). Total score is the sum of individual seven items and ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms. Total score of 0 to 5 indicates none to minimal anxiety, 6 to 10 indicates mild anxiety, 11 to 15 indicates moderate anxiety, 16 to 21 indicates severe anxiety.'}, {'measure': 'Absolute Change From Baseline in Daily Physical Activity Counts as Determined by Actigraphy at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'Participants were provided with a wrist-worn actigraphy device which continuously collected data about daily physical activity counts.'}, {'measure': 'Relative (Percent) Change From Baseline in Physical Activity as Determined by Actigraphy at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'Participants were provided with a wrist-worn actigraphy device which continuously collected data about daily physical activities.'}, {'measure': 'Absolute Change From Baseline in Duration of Sleep Time at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'Participants were provided with a wrist-worn actigraphy device which continuously collected data about sleep duration and quality.'}, {'measure': 'Relative (Percent) Change From Baseline in Duration of Sleep Time at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'Participants were provided with a wrist-worn actigraphy device which continuously collected data about sleep duration and quality.'}, {'measure': 'Absolute Change From Baseline in Time Above Sedentary Duration at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'Participants were provided with a wrist-worn actigraphy device which continuously collected data about daily activities and sleep duration and quality.'}, {'measure': 'Relative (Percent) Change From Baseline in Time Above Sedentary Duration at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'Participants were provided with a wrist-worn actigraphy device which continuously collected data about daily activities and sleep duration and quality.'}, {'measure': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Day 1 up to Week 28'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cystic Fibrosis']}, 'referencesModule': {'references': [{'pmid': '33358691', 'type': 'DERIVED', 'citation': 'Wilson J, You X, Ellis M, Urquhart DS, Jha L, Duncan M, Tian S, Harris RA, Kotsimbos T, Keating D. VO2max as an exercise tolerance endpoint in people with cystic fibrosis: Lessons from a lumacaftor/ivacaftor trial. J Cyst Fibros. 2021 May;20(3):499-505. doi: 10.1016/j.jcf.2020.12.006. Epub 2020 Dec 24.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase 4, randomized, double-blind, placebo-controlled, parallel-group study in subjects aged 12 years and older with CF who are homozygous for the F508del-CFTR mutation. This study is designed to evaluate the effect of LUM/IVA on exercise tolerance in subjects with CF, homozygous for the F508del-CFTR mutation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Homozygous for the F508del-CFTR mutation\n* Confirmed diagnosis of CF defined as a sweat chloride value ≥60 mmol/L by quantitative pilocarpine iontophoresis\n* Stable CF disease as judged by the investigator\n* Forced expiratory volume in 1 second (FEV1) at least 40% and not greater than 90% of predicted\n\nExclusion Criteria:\n\n* History of any comorbidity that might confound the results of the study, interfere with the use of cardiopulmonary exercise tests (CPETs) as an assessment, or pose an additional risk in administering study drug to the subject\n* Any previous exposure to LUM or IVA\n* History of cardiac arrhythmia, ischemic heart disease, congestive heart failure, or other clinically significant cardiac condition, or medical condition requiring chronic use of a beta blocker, non-dihydropyridine calcium channel blocker, or other cardiac medication known to affect exercise tolerance\n* History of solid organ or hematological transplantation\n* For subjects under 18 years of age at Screening, except those who have had bilateral lens removal, selected findings on a screening ophthalmologic examination will be exclusionary\n* Using or expected to require any concomitant medication that is prohibited in this study\n* History of alcohol or drug abuse, as deemed by the investigator, in the past year, including but not limited to cannabis, cocaine, and opiates\n* Participation in an investigational drug study within 30 days before the Screening Visit\n* Pregnant or nursing females; males with a female partner who is pregnant or nursing\n* Colonization with organisms associated with a more rapid decline in pulmonary status'}, 'identificationModule': {'nctId': 'NCT02875366', 'briefTitle': 'A Study of the Effects of Lumacaftor/Ivacaftor (LUM/IVA) on Exercise Tolerance in Subjects With Cystic Fibrosis (CF), Homozygous for the F508del-CFTR Mutation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vertex Pharmaceuticals Incorporated'}, 'officialTitle': 'A Phase 4, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Study of the Effect of Lumacaftor/Ivacaftor Combination Therapy on Exercise Tolerance in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation', 'orgStudyIdInfo': {'id': 'VX15-809-112'}, 'secondaryIdInfos': [{'id': '2016-000066-34', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo matched to LUM/IVA fixed-dose combination tablet orally every 12 hours (q12h) for 24 weeks.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'LUM/IVA', 'description': 'LUM 400 milligram (mg)/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks.', 'interventionNames': ['Drug: LUM/IVA']}], 'interventions': [{'name': 'LUM/IVA', 'type': 'DRUG', 'otherNames': ['Lumacaftor/Ivacaftor'], 'armGroupLabels': ['LUM/IVA']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'city': 'Adelaide', 'country': 'Australia', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'city': 'Camperdown', 'country': 'Australia', 'geoPoint': {'lat': -33.88965, 'lon': 151.17642}}, {'city': 'Clayton', 'country': 'Australia', 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}, {'city': 'Nedlands', 'country': 'Australia', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'city': 'New Lambton Heights', 'country': 'Australia', 'geoPoint': {'lat': -32.92466, 'lon': 151.69364}}, {'city': 'Randwick', 'country': 'Australia', 'geoPoint': {'lat': -33.91439, 'lon': 151.24895}}, {'city': 'South Brisbane', 'country': 'Australia', 'geoPoint': {'lat': -27.48034, 'lon': 153.02049}}, {'city': 'Subiaco', 'country': 'Australia', 'geoPoint': {'lat': -31.9485, 'lon': 115.8268}}, {'city': 'Westmead', 'country': 'Australia', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'city': 'Edinburgh', 'country': 'United Kingdom', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vertex Pharmaceuticals Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}