Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-28 @ 2:37 PM
Study NCT ID:
NCT04853368
Status:
TERMINATED
Last Update Posted:
2024-07-16
First Post:
2021-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate Adverse Events and Change in Disease Activity With Oral Capsules of Galicaftor/Navocaftor/ABBV-119 or Galicaftor/Navocaftor/ABBV-576 Combination Therapies in Adult Participants With Cystic Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Czechia', 'Germany', 'United Kingdom'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000708865', 'term': 'GLPG2222'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'AbbVie'}, 'certainAgreement': {'otherDetails': 'AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality is reported from enrollment to the end of study, median time on follow up in Part 1 was 28 days (d) for Cohort 1 (C1). In Part 2, was 28d for C1; 28 and 28d for C2; and 14, 20.5, and 14d for C3. Treatment-emergent AEs and serious AEs were collected from first dose of study drug until 30d after the last dose of study drug; mean duration on study drug in Part 1 was 28.2d for C1. In Part 2, was 25.8d for C1; 28 and 28.3d for C2; and 16.8, 20.5, and 17.5d for C3.', 'description': 'For Cohort 1 - Triple Combination Treatment arm, a TEAE was collected through day 56 and within 30 days after the last dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1 (Day -29 to -1) Dual Combination Galicaftor + Navocaftor for F508del Homozygous', 'description': 'F508del Homozygous cystic fibrosis (CF) participants received Galicaftor/Navocaftor dual combination (Day\n\n-29 to -1).\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 4, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort 1(Day 1 - 29) Triple Combination Galicaftor + Navocaftor + ABBV-119 for F508del Homozygous', 'description': 'F508del homozygous CF participants from Cohort 1(Day -29 to -1) who received Galicaftor/ Navocaftor dual combination therapy.\n\nfollowed by\n\nGalicaftor/Navocaftor/ABBV-119 triple combination therapy (Day 1- 29).\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules\n\nABBV-119: 210 mg BID, Oral capsules', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 10, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Cohort 2(Day 1 - 29) Triple Combination Galicaftor+ Navocaftor + ABBV-119 for F508del Heterozygous', 'description': 'F508del Heterozygous CF participants received Galicaftor/Navocaftor/ABBV-119 triple combination therapy (Day 1 - 29).\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules\n\nABBV-119: 210 mg BID, Oral capsules', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 4, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Cohort 2 (Day 1 - 29) Placebo F508del Heterozygous', 'description': 'F508del Heterozygous CF participants received placebo (Day 1 - 29).\n\nPlacebo: Oral capsules', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 2, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Cohort 3 (Day 1 - 29) Triple Combination Galicaftor + Navocaftor + ABBV-576 for F508del Homozygous', 'description': 'F508del Homozygous CF participants received Galicaftor/Navocaftor/ABBV-576 triple combination therapy (Day 1 - 29).\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules\n\nABBV-576: 5 mg QD, Oral capsules', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 7, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Cohort 3(Day 1 - 29)Triple Combination Galicaftor + Navocaftor + ABBV-576 for F508del Heterozygous', 'description': 'F508del Heterozygous CF participants received Galicaftor/Navocaftor/ABBV-576 triple combination therapy (Day 1 - 29).\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules\n\nABBV-576: 5 mg QD, Oral capsules', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'ABDOMINAL PAIN LOWER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'DISTAL INTESTINAL OBSTRUCTION SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'DYSPEPSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'FLATULENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'GASTROOESOPHAGEAL REFLUX DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'STEATORRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'CHEST DISCOMFORT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'INFLUENZA LIKE ILLNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'NON-CARDIAC CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'INFECTIVE PULMONARY EXACERBATION OF CYSTIC FIBROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'NASAL INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'FORCED EXPIRATORY VOLUME DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'FORCED VITAL CAPACITY DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'SPIROMETRY ABNORMAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'DECREASED APPETITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'LETHARGY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'POST-TRAUMATIC HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'CATARRH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'DYSPNOEA EXERTIONAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'EPISTAXIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'HAEMOPTYSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'RESPIRATORY TRACT CONGESTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'RHINORRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'SPUTUM INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'UPPER-AIRWAY COUGH SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'NIGHT SWEATS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'seriousEvents': [{'term': 'CYSTIC FIBROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'GENERAL PHYSICAL HEALTH DETERIORATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'INFECTIVE EXACERBATION OF BRONCHIECTASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cohorts 1 and 2: Absolute Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1(Day 1 - 29) Triple Combination Galicaftor + Navocaftor + ABBV-119 for F508del Homozygous', 'description': 'F508del homozygous CF participants from Cohort 1(Day -29 to -1) who received Galicaftor/Navocaftor dual combination therapy\n\nfollowed by\n\nGalicaftor/Navocaftor/ABBV-119 triple combination therapy (Day 1- 29).\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules\n\nABBV-119: 210 mg BID, Oral capsules'}, {'id': 'OG001', 'title': 'Cohort 2(Day 1 - 29) Triple Combination Galicaftor+ Navocaftor + ABBV-119 for F508del Heterozygous', 'description': 'F508del Heterozygous CF participants received Galicaftor/Navocaftor/ABBV-119 triple combination therapy (Day 1 - 29).\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules\n\nABBV-119: 210 mg BID, Oral capsules'}, {'id': 'OG002', 'title': 'Cohort 2 (Day 1 - 29) Placebo for F508del Heterozygous', 'description': 'F508del Heterozygous CF participants received placebo (Day 1 - 29).\n\nPlacebo: Oral capsules'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'spread': '3.68', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '5.62', 'groupId': 'OG001'}, {'value': '-2.0', 'spread': '6.63', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000'], 'paramType': 'LS Mean of Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.6', 'ciLowerLimit': '1.22', 'ciUpperLimit': '4.04', 'pValueComment': 'One-sided p-value; p-value \\<=0.05 indicates significance.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.84', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Primary analysis of ppFEV1 using MMRM excludes data inconsistent with baseline in terms of the timing of bronchodilator or airway clearance regimen.'}, {'pValue': '0.254', 'groupIds': ['OG001'], 'paramType': 'LS Mean of Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.3', 'ciLowerLimit': '-2.07', 'ciUpperLimit': '4.67', 'pValueComment': 'One-sided p-value; p-value \\<=0.05 indicates significance.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.92', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Primary analysis of ppFEV1 using MMRM excludes data inconsistent with baseline in terms of the timing of bronchodilator or airway clearance regimen.'}, {'pValue': '0.402', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean of Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.9', 'ciLowerLimit': '-5.07', 'ciUpperLimit': '6.77', 'pValueComment': 'One-sided p-value; p-value \\<=0.05 indicates significance.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Primary analysis of ppFEV1 using MMRM excludes data inconsistent with baseline in terms of the timing of bronchodilator or airway clearance regimen.'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (Baseline) through Day 29', 'description': 'FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration and is used as a measure of lung function. Mixed-effect model with repeated measures (MMRM) was used for the analyses.', 'unitOfMeasure': 'percent predicted FEV1 (%ppFEV1)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per-Protocol (PP) Population includes all enrolled subjects (randomized subjects for Cohort 2) who carry the intended CFTR mutation based on central lab report and received at least one dose of the Triple Therapy or placebo.'}, {'type': 'PRIMARY', 'title': 'Cohort 3: Absolute Change From Baseline Through Day 29 in Sweat Chloride (SwCl) in mmol/L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 3 (Day 1 - 29) Triple Combination Galicaftor + Navocaftor + ABBV-576 for F508del Homozygous', 'description': 'F508del Homozygous CF participants received Galicaftor/Navocaftor/ABBV-576 triple combination therapy (Day 1 - 29).\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules\n\nABBV-576: 5 mg QD, Oral capsules'}, {'id': 'OG001', 'title': 'Cohort 3 (Day 1 - 29)Triple Combination Galicaftor + Navocaftor + ABBV-576 for F508del Heterozygous', 'description': 'F508del Heterozygous CF participants received Galicaftor/Navocaftor/ABBV-576 triple combination therapy (Day 1 - 29).\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules\n\nABBV-576: 5 mg QD, Oral capsules'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000', 'lowerLimit': '24', 'upperLimit': '24'}, {'value': '40', 'groupId': 'OG001', 'lowerLimit': '40', 'upperLimit': '40'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (Baseline) through Day 29', 'description': 'Sweat collection was performed to evaluate sweat chloride concentration. SwCl is a biomarker of cystic fibrosis transmembrane conductance regulator (CFTR) activity. Persons with CF have higher levels of chloride in their sweat. MMRM was used for the analysis.', 'unitOfMeasure': 'Milli-mole/Liter (mmol/L)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per-Protocol (PP) Population includes all enrolled subjects (randomized subjects for Cohort 2) who carry the intended CFTR mutation based on central lab report and received at least one dose of the Triple Therapy or placebo.'}, {'type': 'SECONDARY', 'title': 'Cohorts 1 and 2: Absolute Change From Baseline Through Day 29 in Sweat Chloride (SwCl) in mmol/L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1(Day 1 - 29) Triple Combination Galicaftor + Navocaftor + ABBV-119 for F508del Homozygous', 'description': 'F508del Homozygous CF participants from Cohort 1(Day -29 to -1) who received Galicaftor/Navocaftor dual combination therapy\n\nfollowed by\n\nGalicaftor/Navocaftor/ABBV-119 triple combination therapy (Day 1- 29).\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules\n\nABBV-119: 210 mg BID, Oral capsules'}, {'id': 'OG001', 'title': 'Cohort 2(Day 1 - 29) Triple Combination Galicaftor+ Navocaftor + ABBV-119 for F508del Heterozygous', 'description': 'F508del Heterozygous CF participants received Galicaftor/Navocaftor/ABBV-119 triple combination therapy (Day 1 - 29).\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules\n\nABBV-119: 210 mg BID, Oral capsules'}, {'id': 'OG002', 'title': 'Cohort 2 (Day 1 - 29) Placebo for F508del Heterozygous', 'description': 'F508del Heterozygous CF participants received placebo (Day 1 - 29).\n\nPlacebo: Oral capsules'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'spread': '10.78', 'groupId': 'OG000'}, {'value': '-11.5', 'spread': '16.61', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '4.56', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.022', 'groupIds': ['OG000'], 'paramType': 'LS Mean of Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '5.5', 'ciLowerLimit': '1.07', 'ciUpperLimit': '9.92', 'pValueComment': 'One-sided p-value; p-value \\<=0.05 indicates significance.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.63', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The LS mean is estimated using the mixed-Effect model repeat measurement method.'}, {'pValue': '0.043', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean of Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-14.1', 'ciLowerLimit': '-27.59', 'ciUpperLimit': '-0.62', 'pValueComment': 'One-sided p-value; p-value \\<=0.05 indicates significance.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The LS mean is estimated using the mixed-Effect model repeat measurement method.'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (Baseline) through Day 29', 'description': 'Sweat collection was performed to evaluate sweat chloride concentration. SwCl is a biomarker of CFTR activity. Persons with CF have higher levels of chloride in their sweat. MMRM was used for the analysis.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per-Protocol (PP) Population includes all enrolled subjects (randomized subjects for Cohort 2) who carry the intended CFTR mutation based on central lab report and received at least one dose of the Triple Therapy or placebo.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline Through Day 29 in Forced Vital Capacity (FVC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1(Day 1 - 29) Triple Combination Galicaftor + Navocaftor + ABBV-119 for F508del Homozygous', 'description': 'F508del Homozygous CF participants from Cohort 1(Day -29 to -1) who received Galicaftor/Navocaftor dual combination therapy\n\nfollowed by\n\nGalicaftor/Navocaftor/ABBV-119 triple combination therapy (Day 1- 29).\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules\n\nABBV-119: 210 mg BID, Oral capsules'}, {'id': 'OG001', 'title': 'Cohort 2(Day 1 - 29) Triple Combination Galicaftor+ Navocaftor + ABBV-119 for F508del Heterozygous', 'description': 'F508del Heterozygous CF participants received Galicaftor/Navocaftor/ABBV-119 triple combination therapy (Day 1 - 29).\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules\n\nABBV-119: 210 mg BID, Oral capsules'}, {'id': 'OG002', 'title': 'Cohort 2 (Day 1 - 29) Placebo for F508del Heterozygous', 'description': 'F508del Heterozygous CF participants received placebo (Day 1 - 29).\n\nPlacebo: Oral capsules'}, {'id': 'OG003', 'title': 'Cohort 3 (Day 1 - 29) Triple Combination Galicaftor + Navocaftor + ABBV-576 for F508del Homozygous', 'description': 'F508del Homozygous CF participants received Galicaftor/Navocaftor/ABBV-576 triple combination therapy (Day\n\n1 - 29).\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules\n\nABBV-576: 5 mg QD, Oral capsules'}, {'id': 'OG004', 'title': 'Cohort 3(Day 1 - 29)Triple Combination Galicaftor + Navocaftor + ABBV-576 for F508del Heterozygous', 'description': 'F508del Heterozygous CF participants received Galicaftor/nNavocaftor/ABBV-576 triple combination therapy (Day 1 - 29).\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules\n\nABBV-576: 5 mg QD, Oral capsules'}], 'classes': [{'categories': [{'measurements': [{'value': '0.10', 'spread': '0.256', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.269', 'groupId': 'OG001'}, {'value': '-0.07', 'spread': '0.297', 'groupId': 'OG002'}, {'value': '-0.22', 'spread': '0.318', 'groupId': 'OG003'}, {'value': '-0.28', 'spread': 'NA', 'comment': 'Not applicable; value could not be estimated due to n=1', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000'], 'paramType': 'LS Mean of Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.14', 'ciLowerLimit': '0.059', 'ciUpperLimit': '0.219', 'pValueComment': 'One-sided p-value; p-value \\<=0.05 indicates significance.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.047', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The LS mean is estimated using the mixed-Effect model repeat measurement method.'}, {'pValue': '0.475', 'groupIds': ['OG001'], 'paramType': 'LS Mean of Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.01', 'ciLowerLimit': '-0.162', 'ciUpperLimit': '0.150', 'pValueComment': 'One-sided p-value; p-value \\<=0.05 indicates significance.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.089', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The LS mean is estimated using the mixed-Effect model repeat measurement method.'}, {'pValue': '0.352', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean of Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.06', 'ciLowerLimit': '-0.332', 'ciUpperLimit': '0.212', 'pValueComment': 'One-sided p-value; p-value \\<=0.05 indicates significance.', 'groupDescription': 'Cohort 2: Difference between Triple Therapy and Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The LS mean is estimated using the mixed-Effect model repeat measurement method.'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (Baseline) through Day 29', 'description': 'FVC is the total amount of air exhaled during forced expiratory volume (FEV) test and is a lung function test that is measured during spirometry. MMRM was used for the analyses.', 'unitOfMeasure': 'Liters (L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per-Protocol (PP) Population includes all enrolled subjects (randomized subjects for Cohort 2) who carry the intended CFTR mutation based on central lab report and received at least one dose of the Triple Therapy or placebo.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-Lung Capacity (FEF25-75)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1(Day 1 - 29) Triple Combination Galicaftor + Navocaftor + ABBV-119 for F508del Homozygous', 'description': 'F508del homozygous CF participants from Cohort 1(Day -29 to -1) who received Galicaftor/Navocaftor dual combination therapy\n\nfollowed by\n\nGalicaftor/Navocaftor/ABBV-119 triple combination therapy (Day 1- 29).\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules\n\nABBV-119: 210 mg BID, Oral capsules'}, {'id': 'OG001', 'title': 'Cohort 2(Day 1 - 29) Triple Combination Galicaftor+ Navocaftor + ABBV-119 for F508del Heterozygous', 'description': 'F508del Heterozygous CF participants received Galicaftor/Navocaftor/ABBV-119 triple combination therapy (Day 1 - 29).\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules\n\nABBV-119: 210 mg BID, Oral capsules'}, {'id': 'OG002', 'title': 'Cohort 2 (Day 1 - 29) Placebo F508del Heterozygous', 'description': 'F508del Heterozygous CF participants received placebo (Day 1 - 29).\n\nPlacebo: Oral capsules'}, {'id': 'OG003', 'title': 'Cohort 3 (Day 1 - 29) Triple Combination Galicaftor + Navocaftor + ABBV-576 for F508del Homozygous', 'description': 'F508del Homozygous CF participants receive Galicaftor/Navocaftor/ABBV-576 triple combination therapy (Day 1 - 29).\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules\n\nABBV-576: 5 mg QD, Oral capsules'}, {'id': 'OG004', 'title': 'Cohort 3(Day 1 - 29)Triple Combination Galicaftor + Navocaftor + ABBV-576 for F508del Heterozygous', 'description': 'F508del Heterozygous CF participants received Galicaftor/nNavocaftor/ABBV-576 triple combination therapy (Day 1 - 29).\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules\n\nABBV-576: 5 mg QD, Oral capsules'}], 'classes': [{'categories': [{'measurements': [{'value': '0.067', 'spread': '0.2038', 'groupId': 'OG000'}, {'value': '0.134', 'spread': '0.2506', 'groupId': 'OG001'}, {'value': '-0.082', 'spread': '0.1947', 'groupId': 'OG002'}, {'value': '-0.329', 'spread': '0.378', 'groupId': 'OG003'}, {'value': '-0.263', 'spread': 'NA', 'comment': 'Not applicable; value could not be estimated due to n=1', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.017', 'groupIds': ['OG000'], 'paramType': 'LS Mean of Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.089', 'ciLowerLimit': '0.0209', 'ciUpperLimit': '0.1568', 'pValueComment': 'One-sided p-value; p-value \\<=0.05 indicates significance.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0403', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The LS mean is estimated using the mixed-Effect model repeat measurement method.'}, {'pValue': '0.169', 'groupIds': ['OG001'], 'paramType': 'LS Mean of Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.103', 'ciLowerLimit': '-0.1814', 'ciUpperLimit': '0.2880', 'pValueComment': 'One-sided p-value; p-value \\<=0.05 indicates significance.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1033', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The LS mean is estimated using the mixed-Effect model repeat measurement method.'}, {'pValue': '0.230', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.136', 'ciLowerLimit': '-0.1809', 'ciUpperLimit': '0.4527', 'pValueComment': 'One-sided p-value; p-value \\<=0.05 indicates significance.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The LS mean is estimated using the mixed-Effect model repeat measurement method.'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (Baseline) through Day 29', 'description': 'FEF25-75 is a lung function test that is measured during spirometry, and is defined as the forced expiratory flow between 25% and 75% of vital capacity (mid-lung capacity). MMRM was used for analyses.', 'unitOfMeasure': 'Liters/second (L/sec)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per-Protocol (PP) Population includes all enrolled subjects (randomized subjects for Cohort 2) who carry the intended CFTR mutation based on central lab report and received at least one dose of the Triple Therapy or placebo.'}, {'type': 'SECONDARY', 'title': 'Relative Changes From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1(Day 1 - 29) Triple Combination Galicaftor + Navocaftor + ABBV-119 for F508del Homozygous', 'description': 'F508del homozygous CF participants from Cohort 1(Day -29 to -1) who received Galicaftor/Navocaftor dual combination therapy\n\nfollowed by\n\nGalicaftor/Navocaftor/ABBV-119 triple combination therapy (Day 1- 29).\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules\n\nABBV-119: 210 mg BID, Oral capsules'}, {'id': 'OG001', 'title': 'Cohort 2(Day 1 - 29) Triple Combination Galicaftor+ Navocaftor + ABBV-119 for F508del Heterozygous', 'description': 'F508del Heterozygous CF participants received Galicaftor/Navocaftor/ABBV-119 triple combination therapy (Day 1 - 29).\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules\n\nABBV-119: 210 mg BID, Oral capsules'}, {'id': 'OG002', 'title': 'Cohort 2 (Day 1 - 29) Placebo F508del Heterozygous', 'description': 'F508del Heterozygous CF participants received placebo (Day 1 - 29).\n\nPlacebo: Oral capsules'}, {'id': 'OG003', 'title': 'Cohort 3 (Day 1 - 29) Triple Combination Galicaftor + Navocaftor + ABBV-576 for F508del Homozygous', 'description': 'F508del Homozygous CF participants receive Galicaftor/Navocaftor/ABBV-576 triple combination therapy (Day 1 - 29).\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules\n\nABBV-576: 5 mg QD, Oral capsules'}, {'id': 'OG004', 'title': 'Cohort 3(Day 1 - 29)Triple Combination Galicaftor + Navocaftor + ABBV-576 for F508del Heterozygous', 'description': 'F508del Heterozygous CF participants received Galicaftor/nNavocaftor/ABBV-576 triple combination therapy (Day 1 - 29).\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules\n\nABBV-576: 5 mg QD, Oral capsules'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'spread': '6.07', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '8.15', 'groupId': 'OG001'}, {'value': '-4.9', 'spread': '12.25', 'groupId': 'OG002'}, {'value': '-9.1', 'spread': '5.12', 'groupId': 'OG003'}, {'value': '-19.1', 'spread': 'NA', 'comment': 'value could not be estimated due to n=1', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000'], 'paramType': 'LS Mean of Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '4.4', 'ciLowerLimit': '2.04', 'ciUpperLimit': '6.78', 'pValueComment': 'One-sided p-value; p-value \\<=0.05 indicates significance.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.350', 'groupIds': ['OG001'], 'paramType': 'LS Mean of Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.3', 'ciLowerLimit': '-4.42', 'ciUpperLimit': '6.97', 'pValueComment': 'One-sided p-value; p-value \\<=0.05 indicates significance.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.412', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean of Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.3', 'ciLowerLimit': '-8.75', 'ciUpperLimit': '11.34', 'pValueComment': 'One-sided p-value; p-value \\<=0.05 indicates significance.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (Baseline) through Day 29', 'description': 'FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration and is used as a measure of lung function. MMRM was used for the analyses. Note: The primary analysis of ppFEV1 using MMRM excludes data that are inconsistent with baseline in terms of the timing of bronchodilator or airway clearance regimen.', 'unitOfMeasure': '% ppFEV1', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per-Protocol (PP) Population includes all enrolled subjects (randomized subjects for Cohort 2) who carry the intended CFTR mutation based on central lab report and received at least one dose of the Triple Therapy or placebo.'}, {'type': 'SECONDARY', 'title': 'Relative Changes From Baseline Through Day 29 in Forced Vital Capacity (FVC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1(Day 1 - 29) Triple Combination Galicaftor + Navocaftor + ABBV-119 for F508del Homozygous', 'description': 'F508del homozygous CF participants from Cohort 1(Day -29 to -1) who received Galicaftor/Navocaftor dual combination therapy\n\nfollowed by\n\nGalicaftor/Navocaftor/ABBV-119 triple combination therapy (Day 1- 29).\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules\n\nABBV-119: 210 mg BID, Oral capsules'}, {'id': 'OG001', 'title': 'Cohort 2(Day 1 - 29) Triple Combination Galicaftor+ Navocaftor + ABBV-119 for F508del Heterozygous', 'description': 'F508del Heterozygous CF participants received Galicaftor/Navocaftor/ABBV-119 triple combination therapy (Day 1 - 29).\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules\n\nABBV-119: 210 mg BID, Oral capsules'}, {'id': 'OG002', 'title': 'Cohort 2 (Day 1 - 29) Placebo for F508del Heterozygous', 'description': 'F508del Heterozygous CF participants received placebo (Day 1 - 29).\n\nPlacebo: Oral capsules'}, {'id': 'OG003', 'title': 'Cohort 3 (Day 1 - 29)Triple Combination Galicaftor + Navocaftor + ABBV-576 for F508del Homozygous', 'description': 'F508del Homozygous CF participants receive Galicaftor/Navocaftor/ABBV-576 triple combination therapy (Day 1 - 29).\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules\n\nABBV-576: 5 mg QD, Oral capsules'}, {'id': 'OG004', 'title': 'Cohort 3(Day 1 - 29)Triple Combination Galicaftor + Navocaftor + ABBV-576 for F508del Heterozygous', 'description': 'F508del Heterozygous CF participants received Galicaftor/Navocaftor/ABBV-576 triple combination therapy (Day 1 - 29).\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules\n\nABBV-576: 5 mg QD, Oral capsules'}], 'classes': [{'categories': [{'measurements': [{'value': '3.75', 'spread': '7.006', 'groupId': 'OG000'}, {'value': '1.07', 'spread': '6.524', 'groupId': 'OG001'}, {'value': '-2.06', 'spread': '8.004', 'groupId': 'OG002'}, {'value': '-6.01', 'spread': '8.782', 'groupId': 'OG003'}, {'value': '-16.91', 'spread': 'NA', 'comment': 'value could not be estimated due to n=1', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'LS Mean of Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '4.36', 'ciLowerLimit': '2.190', 'ciUpperLimit': '6.524', 'pValueComment': 'One-sided p-value; p-value \\<=0.05 indicates significance.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.396', 'groupIds': ['OG001'], 'paramType': 'LS Mean of Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.59', 'ciLowerLimit': '-4.449', 'ciUpperLimit': '3.268', 'pValueComment': 'One-sided p-value; p-value \\<=0.05 indicates significance.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.305', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean of Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-2.00', 'ciLowerLimit': '-8.724', 'ciUpperLimit': '4.732', 'pValueComment': 'One-sided p-value; p-value \\<=0.05 indicates significance.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (Baseline) through Day 29', 'description': 'FVC is the total amount of air exhaled during FEV test and is a lung function test that is measured during spirometry. MMRM was used for the analyses.', 'unitOfMeasure': 'Liters (L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per-Protocol (PP) Population includes all enrolled subjects (randomized subjects for Cohort 2) who carry the intended CFTR mutation based on central lab report and received at least one dose of the Triple Therapy or placebo.'}, {'type': 'SECONDARY', 'title': 'Relative Changes From Baseline Through Day 29 in Forced Expiratory Flow at Mid-Lung Capacity (FEF25-75)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1(Day 1 - 29) Triple Combination Galicaftor + Navocaftor + ABBV-119 for F508del Homozygous', 'description': 'F508del homozygous CF participants from Cohort 1(Day -29 to -1) who received Galicaftor/Navocaftor dual combination therapy\n\nfollowed by\n\nGalicaftor/Navocaftor/ABBV-119 triple combination therapy (Day 1- 29).\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules\n\nABBV-119: 210 mg BID, Oral capsules'}, {'id': 'OG001', 'title': 'Cohort 2(Day 1 - 29) Triple Combination Galicaftor+ Navocaftor + ABBV-119 for F508del Heterozygous', 'description': 'F508del Heterozygous CF participants received Galicaftor/Navocaftor/ABBV-119 triple combination therapy (Day 1 - 29).\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules\n\nABBV-119: 210 mg BID, Oral capsules'}, {'id': 'OG002', 'title': 'Cohort 2 (Day 1 - 29) Placebo for F508del Heterozygous', 'description': 'F508del Heterozygous CF participants received placebo (Day 1 - 29).\n\nPlacebo: Oral capsules'}, {'id': 'OG003', 'title': 'Cohort 3 (Day 1 - 29) Triple Combination Galicaftor + Navocaftor + ABBV-576 for F508del Homozygous', 'description': 'F508del Homozygous CF participants received Galicaftor/Navocaftor/ABBV-576 triple combination therapy (Day 1 - 29).\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules\n\nABBV-576: 5 mg QD, Oral capsules'}, {'id': 'OG004', 'title': 'Cohort 3(Day 1 - 29)Triple Combination Galicaftor + Navocaftor + ABBV-576 for F508del Heterozygous', 'description': 'F508del Heterozygous CF participants received Galicaftor/nNavocaftor/ABBV-576 triple combination therapy (Day 1 - 29).\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules\n\nABBV-576: 5 mg QD, Oral capsules'}], 'classes': [{'categories': [{'measurements': [{'value': '4.553', 'spread': '13.2453', 'groupId': 'OG000'}, {'value': '8.701', 'spread': '12.9781', 'groupId': 'OG001'}, {'value': '-6.449', 'spread': '25.1954', 'groupId': 'OG002'}, {'value': '-8.288', 'spread': '24.409', 'groupId': 'OG003'}, {'value': '-25.784', 'spread': 'NA', 'comment': 'value could not be estimated due to n=1', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.018', 'groupIds': ['OG000'], 'paramType': 'LS Mean of Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '6.475', 'ciLowerLimit': '1.4443', 'ciUpperLimit': '11.5056', 'pValueComment': 'One-sided p-value; p-value \\<=0.05 indicates significance.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.214', 'groupIds': ['OG001'], 'paramType': 'LS Mean of Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '6.019', 'ciLowerLimit': '-7.1464', 'ciUpperLimit': '19.1844', 'pValueComment': 'One-sided p-value; p-value \\<=0.05 indicates significance.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.286', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean of Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '7.290', 'ciLowerLimit': '-15.1860', 'ciUpperLimit': '29.7660', 'pValueComment': 'One-sided p-value; p-value \\<=0.05 indicates significance.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (Baseline) through Day 29', 'description': 'FEF25-75 is a lung function test that is measured during spirometry, and is defined as the forced expiratory flow between 25% and 75% of vital capacity (mid-lung capacity). MMRM was used for analyses.', 'unitOfMeasure': 'Liters/second (L/sec)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per-Protocol (PP) Population includes all enrolled subjects (randomized subjects for Cohort 2) who carry the intended CFTR mutation based on central lab report and received at least one dose of the Triple Therapy or placebo.'}, {'type': 'SECONDARY', 'title': 'Absolute Change in CF Questionnaire-Revised (CFQ-R) Respiratory Domain Score From Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1(Day 1 - 29) Triple Combination Galicaftor + Navocaftor + ABBV-119 for F508del Homozygous', 'description': 'F508del homozygous CF participants from Cohort 1(Day -29 to -1) who received Galicaftor/Navocaftor dual combination therapy\n\nfollowed by\n\nGalicaftor/Navocaftor/ABBV-119 triple combination therapy (Day 1- 29).\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules\n\nABBV-119: 210 mg BID, Oral capsules'}, {'id': 'OG001', 'title': 'Cohort 2(Day 1 - 29) Triple Combination Galicaftor+ Navocaftor + ABBV-119 for F508del Heterozygous', 'description': 'F508del Heterozygous CF participants received Galicaftor/Navocaftor/ABBV-119 triple combination therapy (Day 1 - 29).\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules\n\nABBV-119: 210 mg BID, Oral capsules'}, {'id': 'OG002', 'title': 'Cohort 2 (Day 1 - 29) Placebo for F508del Heterozygous', 'description': 'F508del Heterozygous CF participants received placebo (Day 1 - 29).\n\nPlacebo: Oral capsules'}, {'id': 'OG003', 'title': 'Cohort 3 (Day 1 - 29) Triple Combination Galicaftor + Navocaftor + ABBV-576 for F508del Homozygous', 'description': 'F508del Homozygous CF participants receive Galicaftor/Navocaftor/ABBV-576 triple combination therapy (Day\n\n1 - 29).\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules\n\nABBV-576: 5 mg QD, Oral capsules'}, {'id': 'OG004', 'title': 'Cohort 3(Day 1 - 29)Triple Combination Galicaftor + Navocaftor + ABBV-576 for F508del Heterozygous', 'description': 'F508del Heterozygous CF participants received Galicaftor/Navocaftor/ABBV-576 triple combination therapy (Day 1 - 29).\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules\n\nABBV-576: 5 mg QD, Oral capsules'}], 'classes': [{'categories': [{'measurements': [{'value': '5.56', 'spread': '15.930', 'groupId': 'OG000'}, {'value': '10.32', 'spread': '19.092', 'groupId': 'OG001'}, {'value': '-5.56', 'spread': '21.754', 'groupId': 'OG002'}, {'value': '-9.26', 'spread': '22.453', 'groupId': 'OG003'}, {'value': '-22.22', 'spread': 'NA', 'comment': 'value could not be estimated due to n=1', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.057', 'groupIds': ['OG000'], 'paramType': 'LS Mean of Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '5.6', 'ciLowerLimit': '-0.26', 'ciUpperLimit': '11.37', 'pValueComment': 'One-sided p-value; p-value \\<=0.05 indicates significance.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.088', 'groupIds': ['OG001'], 'paramType': 'LS Mean of Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '8.6', 'ciLowerLimit': '-2.18', 'ciUpperLimit': '19.40', 'pValueComment': 'One-sided p-value; p-value \\<=0.05 indicates significance.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.142', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean of Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '11.2', 'ciLowerLimit': '-6.90', 'ciUpperLimit': '29.25', 'pValueComment': 'One-sided p-value; p-value \\<=0.05 indicates significance.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Note: The LS mean is estimated using the linear regression on the change in CFQ-R from baseline to day 29.'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (Baseline) through Day 29', 'description': 'The CF Questionnaire-Revised (CFQ-R) Respiratory Domain Score is designed for use in participants with a diagnosis of cystic fibrosis and is designed to measure impact on overall health, daily life, perceived well-being, and symptoms. CFQ-R has a total of 50 questions. Questions 40, 41, 42, 44, 45, 46, scored 1, 2, 3, or 4, from worst to best, were used to calculate the respiratory domain score. The scaled score for the domain is calculated as 100 × (mean scores of all non-missing questions - 1) / 3, ranging from 0 to 100. If more than 3 questions in the domain have missing scores, the scaled score was set as missing. Note: The LS mean is estimated using the linear regression on the change in CFQ-R from baseline to day 29. The higher CFQ-R respiratory score indicates better health. A positive change in CFQ-R respiratory score since baseline indicates improved health quality, while a negative change indicates a decreased health quality.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per-Protocol (PP) Population includes all enrolled subjects (randomized subjects for Cohort 2) who carry the intended CFTR mutation based on central lab report and received at least one dose of the Triple Therapy or placebo.'}, {'type': 'SECONDARY', 'title': 'Cohort 3: Absolute Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 3 (Day 1 - 29) Triple Combination Galicaftor + Navocaftor + ABBV-576 for F508del Homozygous', 'description': 'F508del Homozygous CF participants receive Galicaftor/Navocaftor/ABBV-576 triple combination therapy (Day 1 - 29).\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules\n\nABBV-576: 5 mg QD, Oral capsules'}, {'id': 'OG001', 'title': 'Cohort 3 (Day 1 - 29) Triple Combination Galicaftor + Navocaftor + ABBV-576 for F508del Heterozygous', 'description': 'F508del Heterozygous CF participants received Galicaftor/nNavocaftor/ABBV-576 triple combination therapy (Day 1 - 29).\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules\n\nABBV-576: 5 mg QD, Oral capsules'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.7', 'groupId': 'OG000', 'lowerLimit': '-9.0', 'upperLimit': '-3.0'}, {'value': '-9.0', 'groupId': 'OG001', 'lowerLimit': '-9.0', 'upperLimit': '-9.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (Baseline) through Day 29', 'description': 'FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration and is used as a measure of lung function. MMRM was used for the analyses. Note: The primary analysis of ppFEV1 using MMRM excludes data that are inconsistent with baseline in terms of the timing of bronchodilator or airway clearance regimen.', 'unitOfMeasure': '% ppFEV1', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per-Protocol (PP) Population includes all enrolled subjects (randomized subjects for Cohort 2) who carry the intended CFTR mutation based on central lab report and received at least one dose of the Triple Therapy or placebo.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'C1(d-29 to -1) Dual Combo G + N', 'description': 'F508del Homozygous cystic fibrosis (CF) participants received Galicaftor/ Navocaftor dual combination (Day -29 to -1).\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules'}, {'id': 'FG001', 'title': 'C1(d1 - 29) Triple Combo G + N + ABBV-119', 'description': 'F508del homozygous CF participants from Cohort 1(Day -29 to -1) who received G + N dual combination therapy\n\nfollowed by\n\nGalicaftor/Navocaftor/ABBV-119 triple combination therapy (Day 1- 29).\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules\n\nABBV-119: 210 mg BID, Oral capsules'}, {'id': 'FG002', 'title': 'C2(d1 - 29) Triple Combo G + N + ABBV-119', 'description': 'F508del Heterozygous CF participants received Galicaftor/Navocaftor/ABBV-119 triple combination therapy (Day 1 - 29).\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules\n\nABBV-119: 210 mg BID, Oral capsules'}, {'id': 'FG003', 'title': 'C2(d1 - 29) Placebo', 'description': 'F508del Heterozygous CF participants received placebo (Day 1 - 29).\n\nPlacebo: Oral capsules'}, {'id': 'FG004', 'title': 'C3 (d1 - 29) Triple Combo G + N + ABBV-576 for F508del Homo', 'description': 'F508del Homozygous CF participants received Galicaftor/Navocaftor/ABBV-576 triple combination therapy (Day 1 - 29).\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules\n\nABBV-576: 5 mg QD, Oral capsules'}, {'id': 'FG005', 'title': 'C3 (d1 - 29) Triple Combo G + N + ABBV-576 for F508del Hetero', 'description': 'F508del Heterozygous CF participants received Galicaftor/Navocaftor/ABBV-576 triple combination therapy (Day 1 - 29).\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules\n\nABBV-576: 5 mg QD, Oral capsules'}], 'periods': [{'title': 'Part 1 (Day -29 to -1)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Part 2 (Day 1-29)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'In this 2-part study, Cystic Fibrosis (CF) participants either homozygous or heterozygous for F508del mutation were placed in cohorts based on genotype and treatment status of ETI therapy. In Part 1, Cohort 1(Day -29 to -1) (C1) completed Galicaftor + Navocaftor (G+N) dual combination therapy for 28 days (d) and automatically started Part 2. In Part 2, C1(d1 - 29) and C2(d1 - 29) received G+N+ABBV-119 triple combination, and C3(d1 -29) received G+N+ABBV-576 triple combination for 28d'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '48', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'C1 (d -29 to -1) Dual Combo: G + N, and C1 (d1 - 29) Triple Combo: G + N + ABBV-119 for F508del Homo', 'description': 'Cohort 1 (Day -29 to -1):\n\nF508del Homozygous cystic fibrosis (CF) participants received Galicaftor/Navocaftor dual combination therapy:\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules\n\nCohort 1 (Day 1 to 29):\n\nF508del Homozygous cystic fibrosis CF participants from Cohort 1 (Day -29 to -2) dual combination who received Galicaftor/Navocaftor dual combination followed by Galicaftor/Navocaftor/ABBV-119 triple combination therapy:\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules\n\nABBV-119: 210 mg BID, Oral capsules'}, {'id': 'BG001', 'title': 'Cohort 2 (d1 - 29) Triple Combo: G + N + ABBV-119 for F508del Heterozygous', 'description': 'F508del Heterozygous CF participants received Galicaftor/Navocaftor/ABBV-119 triple combination therapy(Day 1 - 29).\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules\n\nABBV-119: 210 mg BID, Oral capsules'}, {'id': 'BG002', 'title': 'Cohort 2 (d1 - 29) Placebo for F508del Heterozygous', 'description': 'F508del Heterozygous CF participants received placebo (Day 1 - 29).\n\nPlacebo: Oral capsules'}, {'id': 'BG003', 'title': 'Cohort 3 (d1 - 29) Triple Combo: G + N + ABBV-576 for F508del Homozygous', 'description': 'F508del Homozygous CF participants receive Galicaftor/Navocaftor/ABBV-576 triple combination therapy (Day 1 - 29).\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules\n\nABBV-576: 5 mg QD, Oral capsules'}, {'id': 'BG004', 'title': 'Cohort 3 (d1 - 29) Triple Combo: G + N + ABBV-576 for F508del Heterozygous', 'description': 'F508del Heterozygous CF participants received Galicaftor/nNavocaftor/ABBV-576 triple combination therapy (Day 1 - 29).\n\nGalicaftor: 300 mg QD, Oral capsules\n\nNavocaftor: 50 mg QD, Oral capsules\n\nABBV-576: 5 mg QD, Oral capsules'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '48', 'groupId': 'BG005'}]}], 'categories': [{'title': '<=18 years', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '48', 'groupId': 'BG005'}]}, {'title': '>=65 years', '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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '48', 'groupId': 'BG005'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '31', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '48', 'groupId': 'BG005'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '47', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '48', 'groupId': 'BG005'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'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'}]}, {'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'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '47', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Australia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '48', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}]}]}, {'title': 'Hungary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '48', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}]}]}, {'title': 'Netherlands', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '48', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}]}, {'title': 'New Zealand', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '48', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}]}]}, {'title': 'Slovakia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '48', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '48', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (%) at Baseline (Day 1)', 'classes': [{'title': 'Cohort 1 (Day 1 - 29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '57.0', 'spread': '14.63', 'groupId': 'BG000'}, {'value': '57.0', 'spread': '14.63', 'groupId': 'BG005'}]}]}, {'title': 'Cohort 2 (Day 1 - 29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '62.9', 'spread': '18.27', 'groupId': 'BG001'}, {'value': '67.3', 'spread': '19.97', 'groupId': 'BG002'}, {'value': '64.2', 'spread': '18.07', 'groupId': 'BG005'}]}]}, {'title': 'Cohort 3 (Day 1 - 29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '57.0', 'spread': '19.77', 'groupId': 'BG003'}, {'value': '51.0', 'spread': '5.66', 'groupId': 'BG004'}, {'value': '55.9', 'spread': '17.94', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'description': 'Note: Percentages calculated on non-missing/non-unknown values. @ Baseline refers to (1) the last value before the first dose of the Dual Therapy for the Cohort 1 dual run-in summary, (2) the last value before the first dose of the Triple Therapy or matching placebo for the other summaries.\n\n\\& Subjects may have more than one microbiology history in the past year. Percentages were calculated based on N.', 'unitOfMeasure': 'percent predicted FEV1 (%)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The number of participants analyzed for each Cohort varied from Overall analyzed as follows: Cohort 1 (N=24); Cohort 2 (N=13); Cohort 3 (N=11).'}, {'title': 'Sweat Chloride (SwCl) in mmol/L at Baseline (Day 1) Cohort 3', 'classes': [{'title': 'Cohort 3 (Day 1 - 29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '42.94', 'spread': '10.333', 'groupId': 'BG003'}, {'value': '26.50', 'spread': '4.950', 'groupId': 'BG004'}, {'value': '39.95', 'spread': '11.494', 'groupId': 'BG005'}]}]}, {'title': 'Cohort 1 (Day 1 - 29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '76.71', 'spread': '13.127', 'groupId': 'BG000'}, {'value': '76.71', 'spread': '13.127', 'groupId': 'BG005'}]}]}, {'title': 'Cohort 2 (Day1 - 29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '93.61', 'spread': '12.437', 'groupId': 'BG001'}, {'value': '98.38', 'spread': '9.978', 'groupId': 'BG002'}, {'value': '95.08', 'spread': '11.543', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'description': 'Note: @ Baseline refers to the last value before the first dose of the triple combination therapy.\n\n\\* The genotype information is based on the central lab test result. When this information is not available, the CFTR genotype documented at the screening visit is used.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The number of participants analyzed for each Cohort varied from Overall analyzed as follows: Cohort 1 (N=24); Cohort 2 (N=13); Cohort 3 (N=11).'}], 'populationDescription': 'The Full Analysis Set (FAS) includes all enrolled subjects (randomized subjects for Cohort 2) who received at least 1 dose of study drug as dual or triple combination (or corresponding placebo). The FAS was used for demographics and baseline characteristics analyses.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-08-26', 'size': 2839312, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-06-03T17:02', 'hasProtocol': True}, {'date': '2023-05-31', 'size': 502524, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-06-03T17:04', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'whyStopped': 'Strategic considerations', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-15', 'studyFirstSubmitDate': '2021-04-19', 'resultsFirstSubmitDate': '2024-06-03', 'studyFirstSubmitQcDate': '2021-04-19', 'lastUpdatePostDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-15', 'studyFirstPostDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cohorts 1 and 2: Absolute Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)', 'timeFrame': 'Day 1 (Baseline) through Day 29', 'description': 'FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration and is used as a measure of lung function. Mixed-effect model with repeated measures (MMRM) was used for the analyses.'}, {'measure': 'Cohort 3: Absolute Change From Baseline Through Day 29 in Sweat Chloride (SwCl) in mmol/L', 'timeFrame': 'Day 1 (Baseline) through Day 29', 'description': 'Sweat collection was performed to evaluate sweat chloride concentration. SwCl is a biomarker of cystic fibrosis transmembrane conductance regulator (CFTR) activity. Persons with CF have higher levels of chloride in their sweat. MMRM was used for the analysis.'}], 'secondaryOutcomes': [{'measure': 'Cohorts 1 and 2: Absolute Change From Baseline Through Day 29 in Sweat Chloride (SwCl) in mmol/L', 'timeFrame': 'Day 1 (Baseline) through Day 29', 'description': 'Sweat collection was performed to evaluate sweat chloride concentration. SwCl is a biomarker of CFTR activity. Persons with CF have higher levels of chloride in their sweat. MMRM was used for the analysis.'}, {'measure': 'Absolute Change From Baseline Through Day 29 in Forced Vital Capacity (FVC)', 'timeFrame': 'Day 1 (Baseline) through Day 29', 'description': 'FVC is the total amount of air exhaled during forced expiratory volume (FEV) test and is a lung function test that is measured during spirometry. MMRM was used for the analyses.'}, {'measure': 'Absolute Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-Lung Capacity (FEF25-75)', 'timeFrame': 'Day 1 (Baseline) through Day 29', 'description': 'FEF25-75 is a lung function test that is measured during spirometry, and is defined as the forced expiratory flow between 25% and 75% of vital capacity (mid-lung capacity). MMRM was used for analyses.'}, {'measure': 'Relative Changes From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)', 'timeFrame': 'Day 1 (Baseline) through Day 29', 'description': 'FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration and is used as a measure of lung function. MMRM was used for the analyses. Note: The primary analysis of ppFEV1 using MMRM excludes data that are inconsistent with baseline in terms of the timing of bronchodilator or airway clearance regimen.'}, {'measure': 'Relative Changes From Baseline Through Day 29 in Forced Vital Capacity (FVC)', 'timeFrame': 'Day 1 (Baseline) through Day 29', 'description': 'FVC is the total amount of air exhaled during FEV test and is a lung function test that is measured during spirometry. MMRM was used for the analyses.'}, {'measure': 'Relative Changes From Baseline Through Day 29 in Forced Expiratory Flow at Mid-Lung Capacity (FEF25-75)', 'timeFrame': 'Day 1 (Baseline) through Day 29', 'description': 'FEF25-75 is a lung function test that is measured during spirometry, and is defined as the forced expiratory flow between 25% and 75% of vital capacity (mid-lung capacity). MMRM was used for analyses.'}, {'measure': 'Absolute Change in CF Questionnaire-Revised (CFQ-R) Respiratory Domain Score From Baseline.', 'timeFrame': 'Day 1 (Baseline) through Day 29', 'description': 'The CF Questionnaire-Revised (CFQ-R) Respiratory Domain Score is designed for use in participants with a diagnosis of cystic fibrosis and is designed to measure impact on overall health, daily life, perceived well-being, and symptoms. CFQ-R has a total of 50 questions. Questions 40, 41, 42, 44, 45, 46, scored 1, 2, 3, or 4, from worst to best, were used to calculate the respiratory domain score. The scaled score for the domain is calculated as 100 × (mean scores of all non-missing questions - 1) / 3, ranging from 0 to 100. If more than 3 questions in the domain have missing scores, the scaled score was set as missing. Note: The LS mean is estimated using the linear regression on the change in CFQ-R from baseline to day 29. The higher CFQ-R respiratory score indicates better health. A positive change in CFQ-R respiratory score since baseline indicates improved health quality, while a negative change indicates a decreased health quality.'}, {'measure': 'Cohort 3: Absolute Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)', 'timeFrame': 'Day 1 (Baseline) through Day 29', 'description': 'FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration and is used as a measure of lung function. MMRM was used for the analyses. Note: The primary analysis of ppFEV1 using MMRM excludes data that are inconsistent with baseline in terms of the timing of bronchodilator or airway clearance regimen.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cystic Fibrosis (CF)', 'Galicaftor', 'Navocaftor', 'ABBV-119', 'ABBV-576'], 'conditions': ['Cystic Fibrosis (CF)']}, 'descriptionModule': {'briefSummary': 'Cystic Fibrosis (CF) is a rare, life-threatening, genetic disease that affects the lungs and digestive system, significantly impairing the quality of life, with those affected having a median age of death at 40. The main objective of this study is to assess how safe and effective is the combination therapy of galicaftor/navocaftor/ABBV-119 or Galicaftor/Navocaftor/ABBV-576 in adult participants with CF who are homozygous or heterozygous for the F508del mutation in each arm.\n\nGalicaftor/Navocaftor/ABBV-119 combination therapy and Galicaftor/Navocaftor/ABBV-576 is being developed as an investigational drug for the treatment of CF. Study doctors place participants in 1 of the 4 groups, called treatment arms. Each group receives a different treatment. Around 90 adult participants with a diagnosis of CF will be enrolled in the study around approximately 35 sites worldwide.\n\nParticipants in arm 1 will receive oral capsules of galicaftor/navocaftor dual combination for 28 days followed by galicaftor/navocaftor/ABBV-119 triple combination for 28 days. Participants in arms 2 and 3 will receive the galicaftor/navocaftor/ABBV-119 triple combination or placebo for 28 days. Participants in arm 4 will receive galicaftor/navocaftor/ABBV-576 triple combination therapy for 28 days. For all study arms, ABBV-576, galicaftor, navocaftor, will be given once daily and ABBV-119 twice a day.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.', 'detailedDescription': 'Participants in Cohorts 1 and 3 will receive Open-label therapy. Participants in Cohorts 2 will receive Double-blinded therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed clinical diagnosis of cystic fibrosis (CF).\n* Arm 1 participants with genotype homozygous for the F508del CF transmembrane conductance regulator (CFTR) mutation and not receiving elexacaftor/tezacaftor/ivacaftor (ETI) treatment .\n* Arm 2 and 3 participants with genotype heterozygous for the F508del CFTR mutation and a minimal function mutation and not receiving ETI treatment.\n* Arm 4 participants with genotype either homozygous or heterozygous for the F508del mutation. Participants must be receiving stable ETI treatment.\n* Percent predicted forced expiratory volume in 1 second (ppFEV1) \\>= 40% and \\<=90% of predicted normal for age, gender and height at screening.\n* For arms 1 and 2: sweat chloride (SwCl) \\>= 60 mmol/L at screening. For participants who participated in Study M19-530, it is acceptable to use a SwCl value that the central lab provided in Study M19-530 to establish eligibility.\n* Weight \\>= 35 kg at screening and Day -28 for arm 1 or day 1 for arms 2 to 4.\n\nExclusion Criteria:\n\n\\- Clinically significant laboratory values at screening that would pose undue risk for the participant or interfere with safety assessments (per the investigator).'}, 'identificationModule': {'nctId': 'NCT04853368', 'briefTitle': 'Study to Evaluate Adverse Events and Change in Disease Activity With Oral Capsules of Galicaftor/Navocaftor/ABBV-119 or Galicaftor/Navocaftor/ABBV-576 Combination Therapies in Adult Participants With Cystic Fibrosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Phase 2 Study of Galicaftor/Navocaftor/ABBV-119 or Galicaftor/Navocaftor/ABBV-576 Combination Therapies in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation', 'orgStudyIdInfo': {'id': 'M19-771'}, 'secondaryIdInfos': [{'id': '2020-005805-25', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'F508del Homozygous Cystic Fibrosis (CF) Participants', 'description': 'F508del homozygous cystic fibrosis (CF) participants receive galicaftor/navocaftor dual combination (28 days) followed by galicaftor/navocaftor/ABBV-119 triple combination therapy (28 days).', 'interventionNames': ['Drug: Galicaftor', 'Drug: Navocaftor', 'Drug: ABBV-119']}, {'type': 'EXPERIMENTAL', 'label': 'F508del Heterozygous CF Participants (Active Drug Group)', 'description': 'F508del heterozygous CF participants receive galicaftor/navocaftor/ABBV-119 combination therapy (28 days).', 'interventionNames': ['Drug: Galicaftor', 'Drug: Navocaftor', 'Drug: ABBV-119']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'F508del Heterozygous CF Participants (Placebo Group)', 'description': 'F508del heterozygous CF participants receive placebo (28 days).', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'F508del Homozygous and Heterozygous CF Participants', 'description': 'F508del homozygous and heterozygous CF participants receive galicaftor/navocaftor/ABBV-576 triple combination therapy for 28 days.', 'interventionNames': ['Drug: ABBV-576', 'Drug: Galicaftor', 'Drug: Navocaftor']}], 'interventions': [{'name': 'ABBV-576', 'type': 'DRUG', 'description': 'Oral capsules', 'armGroupLabels': ['F508del Homozygous and Heterozygous CF Participants']}, {'name': 'Galicaftor', 'type': 'DRUG', 'otherNames': ['ABBV-2222'], 'description': 'Oral capsules', 'armGroupLabels': ['F508del Heterozygous CF Participants (Active Drug Group)', 'F508del Homozygous Cystic Fibrosis (CF) Participants', 'F508del Homozygous and Heterozygous CF Participants']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral capsules', 'armGroupLabels': ['F508del Heterozygous CF Participants (Placebo Group)']}, {'name': 'Navocaftor', 'type': 'DRUG', 'otherNames': ['ABBV-3067'], 'description': 'Oral capsules', 'armGroupLabels': ['F508del Heterozygous CF Participants (Active Drug Group)', 'F508del Homozygous Cystic Fibrosis (CF) Participants', 'F508del Homozygous and Heterozygous CF Participants']}, {'name': 'ABBV-119', 'type': 'DRUG', 'description': 'Oral capsules', 'armGroupLabels': ['F508del Heterozygous CF Participants (Active Drug Group)', 'F508del Homozygous Cystic Fibrosis (CF) Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608-1771', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Velocity Clinical Research /ID# 248675', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '90030', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California /ID# 249147', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '93003-1651', 'city': 'Ventura', 'state': 'California', 'country': 'United States', 'facility': 'Ventura County Medical Center /ID# 248586', 'geoPoint': {'lat': 34.27834, 'lon': -119.29317}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Central FL Pulmonary Orlando /ID# 245432', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '66160-8500', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Health Sy /ID# 249056', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Boston Children's Hospital /ID# 248646", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Harper University Hospital /ID# 248917', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University-School of Medicine /ID# 245393', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth-Hitchcock Medical Center /ID# 245706', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '03104-4125', 'city': 'Manchester', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth Hitchcock Manchester /ID# 248795', 'geoPoint': {'lat': 42.99564, 'lon': -71.45479}}, {'zip': '12208-3504', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Albany Medical College-Pulmonary /ID# 248838', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '11042', 'city': 'New Hyde Park', 'state': 'New York', 'country': 'United States', 'facility': 'Northwell Health/Long Island Jewish Hospital /ID# 248916', 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}, {'zip': '10595', 'city': 'Valhalla', 'state': 'New York', 'country': 'United States', 'facility': 'New York Medical College /ID# 248640', 'geoPoint': {'lat': 41.07482, 'lon': -73.77513}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'UH Cleveland Medical Center /ID# 245433', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43606-3845', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'ProMedica Toledo Harris McIntosh /ID# 248627', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '73104-5410', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma HSC /ID# 249190', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Health /ID# 248585', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina /ID# 245403', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center /ID# 245400', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75708', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'The Univ Texas HSC at Tyler /ID# 248498', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': "Children's Hospital of Richmond at VCU /ID# 248561", 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '53226-3548', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin - Plank Rd /ID# 249079', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '2050', 'city': 'Camperdown', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Royal Prince Alfred Hospital /ID# 228781', 'geoPoint': {'lat': -33.88965, 'lon': 151.17642}}, {'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Westmead Hospital /ID# 227281', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '4101', 'city': 'South Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Mater Misericordiae Limited /ID# 227279', 'geoPoint': {'lat': -27.48034, 'lon': 153.02049}}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Royal Adelaide Hospital /ID# 228486', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Alfred Health /ID# 227283', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '3052', 'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'facility': "Royal Children's Hospital /ID# 227280", 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'zip': '6009', 'city': 'Nedlands', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Institute for Respiratory Health /ID# 227624', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'zip': '2650', 'city': 'Edegem', 'state': 'Antwerpen', 'country': 'Belgium', 'facility': 'Uza /Id# 228533', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '1090', 'city': 'Jette', 'state': 'Brussels Capital', 'country': 'Belgium', 'facility': 'UZ Brussel /ID# 226607', 'geoPoint': {'lat': 50.87309, 'lon': 4.33419}}, {'zip': '9000', 'city': 'Ghent', 'state': 'Oost-Vlaanderen', 'country': 'Belgium', 'facility': 'UZ Gent /ID# 226605', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '3000', 'city': 'Leuven', 'state': 'Vlaams-Brabant', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Leuven /ID# 226608', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '1121', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Orszagos Koranyi Pulmonologiai Intezet /ID# 228810', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '3015 GD', 'city': 'Rotterdam', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Erasmus Medisch Centrum /ID# 234254', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '1105 AZ', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academisch Medisch Centrum /ID# 234253', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '2545 AA', 'city': 'The Hague', 'country': 'Netherlands', 'facility': 'HagaZiekenhuis /ID# 234138', 'geoPoint': {'lat': 52.07667, 'lon': 4.29861}}, {'zip': '1051', 'city': 'Epsom', 'state': 'Auckland', 'country': 'New Zealand', 'facility': 'Greenlane Clinical Centre /ID# 227282', 'geoPoint': {'lat': -36.88745, 'lon': 174.77059}}, {'zip': '8011', 'city': 'Christchurch', 'state': 'Canterbury', 'country': 'New Zealand', 'facility': 'Christchurch Hospital /ID# 227335', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}, {'zip': '975 17', 'city': 'Banská Bystrica', 'country': 'Slovakia', 'facility': 'Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 228044', 'geoPoint': {'lat': 48.73947, 'lon': 19.14932}}, {'zip': '821 06', 'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'Univerzitna nemocnica Bratislava Nemocnica Ruzinov /ID# 228042', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/abbvie/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/', 'ipdSharing': 'YES', 'description': 'AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.', 'accessCriteria': 'Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}