Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-26 @ 1:18 AM
Study NCT ID:
NCT03449134
Status:
COMPLETED
Last Update Posted:
2021-06-16
First Post:
2018-02-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-027)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-06-02', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000096822', 'term': 'Chronic Cough'}], 'ancestors': [{'id': 'D003371', 'term': 'Cough'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000597312', 'term': 'Gefapixant'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'In accordance with standard editorial and ethical practice, the Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. In this case, a coordinating investigator will be designated by mutual agreement. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission to allow the Sponsor to protect proprietary information and comment.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'On-Treatment Period (plus 2-week telephone follow-up): Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)', 'description': 'All-Cause Mortality reported for all randomized participants by applicable treatment period. Serious and Other AEs include all randomized participants who received ≥1 dose of study drug during the Treatment Period. AEs were reported for a participant separately during the Treatment Period (MedDRA 23.0) and optional Off-Tx Period (MedDRA 23.1). Per protocol, only All-Cause Mortality, drug-related serious and nonserious AEs, and pregnancies were monitored during the Off-Tx Period.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received dose-matched placebo tablets twice daily (BID) during the 12-week main study period and 40-week extension period.', 'otherNumAtRisk': 243, 'deathsNumAtRisk': 244, 'otherNumAffected': 129, 'seriousNumAtRisk': 243, 'deathsNumAffected': 2, 'seriousNumAffected': 14}, {'id': 'EG001', 'title': 'Gefapixant 15 mg BID', 'description': 'Participants received a gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg BID during the 12-week main study period and 40-week extension period.', 'otherNumAtRisk': 244, 'deathsNumAtRisk': 244, 'otherNumAffected': 140, 'seriousNumAtRisk': 244, 'deathsNumAffected': 1, 'seriousNumAffected': 17}, {'id': 'EG002', 'title': 'Gefapixant 45 mg BID', 'description': 'Participants received a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 12-week main study period and 40-week extension period.', 'otherNumAtRisk': 243, 'deathsNumAtRisk': 244, 'otherNumAffected': 179, 'seriousNumAtRisk': 243, 'deathsNumAffected': 0, 'seriousNumAffected': 13}, {'id': 'EG003', 'title': 'Placebo: Off-Tx', 'description': 'Participants previously treated with dose-matched placebo BID for 52 weeks during the main study and extension study periods were observed for up to 3 months during an optional Off-Treatment Durability study period (participants received no treatment).', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Gefapixant 15 mg BID: Off-Tx', 'description': 'Participants previously treated with gefapixant 15 mg BID for 52 weeks during the main study and extension study periods were observed for up to 3 months during an optional Off-Treatment Durability study period (participants received no treatment).', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 1, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Gefapixant 45 mg BID: Off-Tx', 'description': 'Participants previously treated with gefapixant 45 mg BID for 52 weeks during the main study and extension study periods were observed for up to 3 months during an optional Off-Treatment Durability study period (participants received no treatment).', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 1, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 19, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 19, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 23, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 22, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 20, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 25, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 17, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 75, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 60, 'numAffected': 47}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 63, 'numAffected': 50}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 19, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 18, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 21, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 17, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 27, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Ageusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 37, 'numAffected': 33}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 25, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 101, 'numAffected': 88}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 55, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 57, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 51, 'numAffected': 29}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypogeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Taste disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 24, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 21, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 18, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 14, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 18, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'seriousEvents': [{'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cardiac amyloidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal adhesions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal wall cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Duodenal ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 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{'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Temporal arteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Model-Based Geometric Mean Ratio (GMR) of 24-hour Objective Coughs Per Hour (Week 12/Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}, {'value': '217', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received dose-matched placebo tablets twice daily (BID) during the 12-week main study period and 40-week extension period.'}, {'id': 'OG001', 'title': 'Gefapixant 15 mg BID', 'description': 'Participants received a gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg BID during the 12-week main study period and 40-week extension period.'}, {'id': 'OG002', 'title': 'Gefapixant 45 mg BID', 'description': 'Participants received a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 12-week main study period and 40-week extension period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.47', 'groupId': 'OG000', 'lowerLimit': '0.41', 'upperLimit': '0.54'}, {'value': '0.48', 'groupId': 'OG001', 'lowerLimit': '0.41', 'upperLimit': '0.55'}, {'value': '0.38', 'groupId': 'OG002', 'lowerLimit': '0.33', 'upperLimit': '0.44'}]}]}], 'analyses': [{'pValue': '0.041', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Estimated Percent Change Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-18.45', 'ciLowerLimit': '-32.92', 'ciUpperLimit': '-0.86', 'pValueComment': 'Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.', 'groupDescription': 'Estimated relative reduction (ERR) relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e\\*\\*DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 12 based on log transformed data.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.874', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated Percent Change Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.56', 'ciLowerLimit': '-16.13', 'ciUpperLimit': '22.99', 'pValueComment': 'Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.', 'groupDescription': 'Estimated relative reduction (ERR) relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e\\*\\*DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 12 based on log transformed data.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': '24-hour objective coughs per hour was defined as the total number of cough events during the monitoring period (24-hour interval) divided by 24 hours (denominator could be different if the recording period was actually \\<24 hours but ≥20 hours). Assessment was based on 24-hour sound recordings using a digital recording device which recorded sounds from the lungs and trachea through a chest contact sensor, as well as ambient sounds through a lapel microphone. A longitudinal analysis of covariance (ANCOVA) model was applied to log-transformed cough counts to determine geometric mean (GM) 24-hour objective coughs per hour at baseline and Week 12 on the original scale. The GMR corresponding to the Week 12 GM 24-hour objective coughs per hour divided by the Baseline GM 24-hour objective coughs per hour was reported for all treatment study arms.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in the analysis model who had taken at least 1 dose of study intervention and provided at least 1 baseline and at least 1 Week 12 24-hour cough observation during the treatment period were analyzed.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Experiencing At Least One Adverse Event (AE) During Treatment and Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '244', 'groupId': 'OG001'}, {'value': '243', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received dose-matched placebo tablets twice daily (BID) during the 12-week main study period and 40-week extension period.'}, {'id': 'OG001', 'title': 'Gefapixant 15 mg BID', 'description': 'Participants received a gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg BID during the 12-week main study period and 40-week extension period.'}, {'id': 'OG002', 'title': 'Gefapixant 45 mg BID', 'description': 'Participants received a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 12-week main study period and 40-week extension period.'}], 'classes': [{'categories': [{'measurements': [{'value': '184', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '208', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to approximately 54 weeks', 'description': 'An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with at least one AE during either the 52-week treatment period or 2-week telephone follow-up was reported for all treatment study arms.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study intervention during the 52-week treatment period were analyzed. Per protocol, participants who continued in the optional Off-Treatment observational period were not included in the primary safety analysis.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Discontinued Treatment Due to AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '244', 'groupId': 'OG001'}, {'value': '243', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received dose-matched placebo tablets twice daily (BID) during the 12-week main study period and 40-week extension period.'}, {'id': 'OG001', 'title': 'Gefapixant 15 mg BID', 'description': 'Participants received a gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg BID during the 12-week main study period and 40-week extension period.'}, {'id': 'OG002', 'title': 'Gefapixant 45 mg BID', 'description': 'Participants received a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 12-week main study period and 40-week extension period.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to approximately 52 weeks', 'description': "An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinued study intervention during the 52-week treatment period due to an AE for which the action taken was listed as 'drug withdrawn' was reported for all treatment study arms.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study intervention during the 52-week treatment period were analyzed. Per protocol, participants who continued in the optional Off-Treatment observational period were not included in the primary safety analysis'}, {'type': 'SECONDARY', 'title': 'Model-Based Geometric Mean Ratio (GMR) of Awake Objective Coughs Per Hour (Week 12/Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}, {'value': '217', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received dose-matched placebo tablets twice daily (BID) during the 12-week main study period and 40-week extension period.'}, {'id': 'OG001', 'title': 'Gefapixant 15 mg BID', 'description': 'Participants received a gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg BID during the 12-week main study period and 40-week extension period.'}, {'id': 'OG002', 'title': 'Gefapixant 45 mg BID', 'description': 'Participants received a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 12-week main study period and 40-week extension period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.46', 'groupId': 'OG000', 'lowerLimit': '0.40', 'upperLimit': '0.53'}, {'value': '0.47', 'groupId': 'OG001', 'lowerLimit': '0.41', 'upperLimit': '0.55'}, {'value': '0.38', 'groupId': 'OG002', 'lowerLimit': '0.33', 'upperLimit': '0.44'}]}]}], 'analyses': [{'pValue': '0.056', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Estimated Percent Change Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-17.68', 'ciLowerLimit': '-32.57', 'ciUpperLimit': '0.50', 'pValueComment': 'Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.', 'groupDescription': 'Estimated relative reduction (ERR) relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e\\*\\*DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 12 based on log transformed data.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.770', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated Percent Change Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.95', 'ciLowerLimit': '-15.33', 'ciUpperLimit': '25.19', 'pValueComment': 'Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.', 'groupDescription': 'Estimated relative reduction (ERR) relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e\\*\\*DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 12 based on log transformed data.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Awake objective coughs per hour was defined as the total number of cough events during the monitoring period (24-hour interval) while the participant is awake divided by the total duration (in hours) for the monitoring period that the participant was awake. Assessment was based on 24-hour sound recordings using a digital recording device which recorded sounds from the lungs and trachea through a chest contact sensor, as well as ambient sounds through a lapel microphone. A longitudinal ANCOVA model was applied to log-transformed cough counts to determine GM awake objective coughs per hour at baseline and Week 12 on the original scale. The GMR corresponding to the Week 12 GM awake objective coughs per hour divided by the Baseline GM awake objective coughs per hour was reported for all treatment study arms.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in the analysis model who had taken at least 1 dose of study intervention and provided at least 1 baseline and at least 1 Week 12 awake cough observation during the treatment period were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants (Model-Based) With a ≤ -30% Change From Baseline in 24-hour Objective Coughs Per Hour at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}, {'value': '217', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received dose-matched placebo tablets twice daily (BID) during the 12-week main study period and 40-week extension period.'}, {'id': 'OG001', 'title': 'Gefapixant 15 mg BID', 'description': 'Participants received a gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg BID during the 12-week main study period and 40-week extension period.'}, {'id': 'OG002', 'title': 'Gefapixant 45 mg BID', 'description': 'Participants received a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 12-week main study period and 40-week extension period.'}], 'classes': [{'categories': [{'measurements': [{'value': '65.9', 'groupId': 'OG000'}, {'value': '66.2', 'groupId': 'OG001'}, {'value': '69.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.416', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.20', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.86', 'groupDescription': 'Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline, and the interaction of baseline (underlying continuous response) by visit as covariates.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.948', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.66', 'ciUpperLimit': '1.55', 'groupDescription': 'Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline, and the interaction of baseline (underlying continuous response) by visit as covariates.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 12', 'description': '24-hour coughs per hour was defined as the total number of cough events during the monitoring period (24-hour interval) divided by 24 hours (denominator could be different if the recording period was actually \\<24 hours but ≥20 hours). Assessment based on 24-hour sound recordings using a digital recording device. Percent change in 24-hour coughs per hour = (change from baseline in 24-hour coughs per hour / baseline 24-hour coughs per hour) ×100%. Negative values indicate a decrease in cough rate, while positive values indicate an increase in cough rate. A participant was considered a responder if the percent change from baseline in 24-hour coughs per hour was ≤ -30% (or a ≥30% reduction from baseline); a participant was considered a non-responder otherwise. The percentage of participants (logistic regression model-based) with a ≤ -30% change from baseline in 24-hour coughs per hour at Week 12 (≥30% reduction from baseline) was reported for all treatment study arms.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in the analysis model who had taken at least 1 dose of study intervention and had available 24-hour cough data at baseline and at least one available post-baseline measurement were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants (Model-Based) With a ≤ -1.3-point Change From Baseline in Mean Weekly Cough Severity Diary (CSD) Total Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '241', 'groupId': 'OG001'}, {'value': '234', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received dose-matched placebo tablets twice daily (BID) during the 12-week main study period and 40-week extension period.'}, {'id': 'OG001', 'title': 'Gefapixant 15 mg BID', 'description': 'Participants received a gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg BID during the 12-week main study period and 40-week extension period.'}, {'id': 'OG002', 'title': 'Gefapixant 45 mg BID', 'description': 'Participants received a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 12-week main study period and 40-week extension period.'}], 'classes': [{'categories': [{'measurements': [{'value': '52.4', 'groupId': 'OG000'}, {'value': '62.1', 'groupId': 'OG001'}, {'value': '60.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.39', 'ciLowerLimit': '0.94', 'ciUpperLimit': '2.05', 'groupDescription': 'Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline CSD score, and the interaction of baseline (underlying continuous response) by visit as covariates.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.48', 'ciLowerLimit': '1.01', 'ciUpperLimit': '2.18', 'groupDescription': 'Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline CSD score, and the interaction of baseline (underlying continuous response) by visit as covariates.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 12', 'description': 'The CSD evaluates frequency of cough, intensity of cough and disruption and has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD score was the sum of these seven item scores (Min=0, Max=70). Mean weekly total score was defined as the average of the mean total daily scores collected during the week prior to each visit. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Day -6 to Day 0). Participants were considered responders if the change from baseline in mean weekly CSD total score was ≤ -1.3 points (or a ≥1.3 point reduction from baseline); and considered a non-responder otherwise. Negative values indicate a decrease in cough severity, while positive values indicate an increase in cough severity. The percentage of participants (logistic regression model-based) with a ≤ -1.3 point change from baseline in CSD at Week 12 (or ≥1.3 point reduction from baseline) was reported for all treatment study arms.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in the analysis model who had taken at least 1 dose of study intervention and had available CSD data at baseline and at least one available post-baseline measurement were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants (Model-Based) With a ≤ -2.7-point Change From Baseline in Mean Weekly CSD Total Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '241', 'groupId': 'OG001'}, {'value': '234', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received dose-matched placebo tablets twice daily (BID) during the 12-week main study period and 40-week extension period.'}, {'id': 'OG001', 'title': 'Gefapixant 15 mg BID', 'description': 'Participants received a gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg BID during the 12-week main study period and 40-week extension period.'}, {'id': 'OG002', 'title': 'Gefapixant 45 mg BID', 'description': 'Participants received a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 12-week main study period and 40-week extension period.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000'}, {'value': '37.9', 'groupId': 'OG001'}, {'value': '40.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.68', 'ciLowerLimit': '1.11', 'ciUpperLimit': '2.54', 'groupDescription': 'Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline CSD score, and the interaction of baseline (underlying continuous response) by visit as covariates.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.53', 'ciLowerLimit': '1.01', 'ciUpperLimit': '2.30', 'groupDescription': 'Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline CSD score, and the interaction of baseline (underlying continuous response) by visit as covariates.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 12', 'description': 'The CSD evaluates frequency of cough, intensity of cough and disruption and has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD score was the sum of these seven item scores (Min=0, Max=70). Mean weekly total score was defined as the average of the mean total daily scores collected during the week prior to each visit. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Day -6 to Day 0). Participants were considered responders if the change from baseline in mean weekly CSD total score was ≤ -2.7 points (or a ≥2.7 point reduction from baseline); and considered a non-responder otherwise. Negative values indicate a decrease in cough severity, while positive values indicate an increase in cough severity. The percentage of participants (logistic regression model-based) with a ≤ -2.7 point change from baseline in CSD at Week 12 (or ≥2.7 point reduction from baseline) was reported for all treatment study arms.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in the analysis model who had taken at least 1 dose of study intervention and had available CSD data at baseline and at least one available post-baseline measurement were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants (Model-Based) With a ≤ -30 Millimeter (mm) Change From Baseline in Cough Severity Visual Analog Scale (VAS) Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '241', 'groupId': 'OG001'}, {'value': '234', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received dose-matched placebo tablets twice daily (BID) during the 12-week main study period and 40-week extension period.'}, {'id': 'OG001', 'title': 'Gefapixant 15 mg BID', 'description': 'Participants received a gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg BID during the 12-week main study period and 40-week extension period.'}, {'id': 'OG002', 'title': 'Gefapixant 45 mg BID', 'description': 'Participants received a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 12-week main study period and 40-week extension period.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.3', 'groupId': 'OG000'}, {'value': '36.7', 'groupId': 'OG001'}, {'value': '41.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.54', 'ciLowerLimit': '1.03', 'ciUpperLimit': '2.30', 'groupDescription': 'Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline VAS score, and the interaction of baseline (underlying continuous response) by visit as covariates.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.27', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.89', 'groupDescription': 'Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline VAS score, and the interaction of baseline (underlying continuous response) by visit as covariates.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 12', 'description': 'Cough severity was scored using the Cough Severity VAS, a single-item question asking the participant to rate the severity of their cough "today" using a 100 mm VAS (100-point scale) ranging from 0 ("No Cough") to 100 ("Extremely Severe Cough"). Mean weekly VAS score was derived as the average of VAS scores collected during the week prior to each visit. Baseline was defined as the average VAS scores collected during the week prior to Day 1 (Day -6 to Day 0). A participant was considered a responder if the change from baseline in mean weekly Cough Severity VAS score was ≤-30 mm (or a ≥30 mm reduction from baseline); participants considered non-responders otherwise. Negative values indicate a decrease in cough severity, while positive values indicate an increase in cough severity. The percentage of participants (logistic regression model-based) with ≤ -30 mm change from baseline in Cough Severity VAS at Week 12 (≥30 mm reduction from baseline) was reported for all treatment study arms.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in the analysis model who had taken at least 1 dose of study intervention and had available Cough Severity VAS data at baseline and at least one available post-baseline measurement were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants (Model-Based) With a ≥1.3-point Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}, {'value': '214', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received dose-matched placebo tablets twice daily (BID) during the 12-week main study period and 40-week extension period.'}, {'id': 'OG001', 'title': 'Gefapixant 15 mg BID', 'description': 'Participants received a gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg BID during the 12-week main study period and 40-week extension period.'}, {'id': 'OG002', 'title': 'Gefapixant 45 mg BID', 'description': 'Participants received a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 12-week main study period and 40-week extension period.'}], 'classes': [{'categories': [{'measurements': [{'value': '61.3', 'groupId': 'OG000'}, {'value': '68.8', 'groupId': 'OG001'}, {'value': '67.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.30', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.98', 'groupDescription': 'Comparison based on a logistic regression model that included visit, treatment-by-visit interaction, gender, region, baseline LCQ score, and the interaction of baseline (underlying continuous response) by visit as covariates.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.39', 'ciLowerLimit': '0.92', 'ciUpperLimit': '2.12', 'groupDescription': 'Comparison based on a logistic regression model that included visit, treatment-by-visit interaction, gender, region, baseline LCQ score, and the interaction of baseline (underlying continuous response) by visit as covariates.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 12', 'description': 'The LCQ assesses the impact of chronic cough on health-related quality of life. It consists of 19 items which are divided over 3 domains: Physical (items 1, 2, 3, 9, 10, 11, 14 and 15), Psychological (4, 5, 6, 12, 13, 16, and 17), and Social (7, 8, 18, 19). A 7-point Likert scale is used to rate each item. For each domain, the domain score (range 1-7) is the sum of individual item score within the domain divided by the number of items in the domain. LCQ total score is the sum of the three domain scores and ranges from 3-21; with a higher score corresponding to a better health status. A participant was considered a responder if the change from baseline in LCQ total score was ≥1.3-points (increase from baseline); a participant was considered a non-responder otherwise. The percentage of participants (logistic regression model-based) with a ≥1.3-point change from baseline in LCQ total score at Week 12 was reported for all treatment study arms.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in the analysis model who had taken at least 1 dose of study intervention and had available LCQ data at baseline and at least one available post-baseline measurement were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received dose-matched placebo tablets twice daily (BID) during the 12-week main study period and 40-week extension period.'}, {'id': 'FG001', 'title': 'Gefapixant 15 mg BID', 'description': 'Participants received a gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg BID during the 12-week main study period and 40-week extension period.'}, {'id': 'FG002', 'title': 'Gefapixant 45 mg BID', 'description': 'Participants received a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 12-week main study period and 40-week extension period.'}], 'periods': [{'title': '52-Week Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '244'}, {'groupId': 'FG001', 'numSubjects': '244'}, {'groupId': 'FG002', 'numSubjects': '244'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '243'}, {'groupId': 'FG001', 'numSubjects': '244'}, {'groupId': 'FG002', 'numSubjects': '243'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '199'}, {'groupId': 'FG001', 'numSubjects': '200'}, {'groupId': 'FG002', 'numSubjects': '184'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '60'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Screen Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '39'}, {'groupId': 'FG002', 'numSubjects': '55'}]}, {'type': 'Site Closure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': '12-Week Off-Treatment Durability Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Not all participants continued in the optional Off-Treatment Period.', 'groupId': 'FG000', 'numSubjects': '10'}, {'comment': 'Not all participants continued in the optional Off-Treatment Period.', 'groupId': 'FG001', 'numSubjects': '18'}, {'comment': 'Not all participants continued in the optional Off-Treatment Period.', 'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Of 732 participants randomized to the 52-week treatment period, 730 participants received at least 1 dose of study intervention. After the main study, 41 participants continued in an optional Off-Treatment observational study period (no treatment).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'BG000'}, {'value': '244', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}, {'value': '732', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received dose-matched placebo tablets twice daily (BID) during the 12-week main study period and 40-week extension period.'}, {'id': 'BG001', 'title': 'Gefapixant 15 mg BID', 'description': 'Participants received a gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg BID during the 12-week main study period and 40-week extension period.'}, {'id': 'BG002', 'title': 'Gefapixant 45 mg BID', 'description': 'Participants received a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 12-week main study period and 40-week extension period.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'BG000'}, {'value': '244', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}, {'value': '732', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '57.9', 'spread': '13.1', 'groupId': 'BG000'}, {'value': '59.6', 'spread': '11.7', 'groupId': 'BG001'}, {'value': '59.5', 'spread': '13.1', 'groupId': 'BG002'}, {'value': '59.0', 'spread': '12.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'BG000'}, {'value': '244', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}, {'value': '732', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '182', 'groupId': 'BG000'}, {'value': '181', 'groupId': 'BG001'}, {'value': '181', 'groupId': 'BG002'}, {'value': '544', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '188', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'BG000'}, {'value': '244', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}, {'value': '732', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '101', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '204', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}, {'value': '617', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'BG000'}, {'value': '244', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}, {'value': '732', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '104', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '190', 'groupId': 'BG000'}, {'value': '195', 'groupId': 'BG001'}, {'value': '187', 'groupId': 'BG002'}, {'value': '572', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Geographic Region', 'classes': [{'title': 'Asia Pacific', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'BG000'}, {'value': '244', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}, {'value': '732', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '103', 'groupId': 'BG003'}]}]}, {'title': 'Europe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'BG000'}, {'value': '244', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}, {'value': '732', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}, {'value': '366', 'groupId': 'BG003'}]}]}, {'title': 'North America', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'BG000'}, {'value': '244', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}, {'value': '732', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '167', 'groupId': 'BG003'}]}]}, {'title': 'Others', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'BG000'}, {'value': '244', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}, {'value': '732', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '95', 'groupId': 'BG003'}]}]}, {'title': 'Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'BG000'}, {'value': '244', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}, {'value': '732', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Geographic region of enrollment with 5 categories: Asia-Pacific, Europe, North America, Others, and Missing.', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline 24-hour Coughs per Hour', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'BG000'}, {'value': '235', 'groupId': 'BG001'}, {'value': '237', 'groupId': 'BG002'}, {'value': '704', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '38.07', 'spread': '79.42', 'groupId': 'BG000'}, {'value': '26.79', 'spread': '21.13', 'groupId': 'BG001'}, {'value': '28.53', 'spread': '37.14', 'groupId': 'BG002'}, {'value': '31.10', 'spread': '52.04', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': '24-hour objective coughs per hour was defined as the total number of cough events during the monitoring period (24-hour interval) divided by 24 hours (denominator could be different if the recording period was actually \\<24 hours but ≥20 hours). Baseline assessment was based on 24-hour sound recordings using a digital recording device which recorded sounds from the lungs and trachea through a chest contact sensor, as well as ambient sounds through a lapel microphone.', 'unitOfMeasure': 'coughs/hour', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All participants with 24-hour Coughs per Hour data available at baseline.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-04-26', 'size': 1365554, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-05-07T15:04', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants with refractory or unexplained chronic cough will be randomized to 1 of 3 treatment groups during the Treatment Period: Placebo, gefapixant 15 mg twice daily (BID), or gefapixant 45 mg BID. Participants will remain on their assigned treatment throughout the study. A safety follow-up phone call will be conducted at a minimum of 14 days after last dose of study treatment.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 732}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-14', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-08-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-15', 'studyFirstSubmitDate': '2018-02-22', 'resultsFirstSubmitDate': '2021-05-07', 'studyFirstSubmitQcDate': '2018-02-22', 'lastUpdatePostDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-15', 'studyFirstPostDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Model-Based Geometric Mean Ratio (GMR) of 24-hour Objective Coughs Per Hour (Week 12/Baseline)', 'timeFrame': 'Baseline, Week 12', 'description': '24-hour objective coughs per hour was defined as the total number of cough events during the monitoring period (24-hour interval) divided by 24 hours (denominator could be different if the recording period was actually \\<24 hours but ≥20 hours). Assessment was based on 24-hour sound recordings using a digital recording device which recorded sounds from the lungs and trachea through a chest contact sensor, as well as ambient sounds through a lapel microphone. A longitudinal analysis of covariance (ANCOVA) model was applied to log-transformed cough counts to determine geometric mean (GM) 24-hour objective coughs per hour at baseline and Week 12 on the original scale. The GMR corresponding to the Week 12 GM 24-hour objective coughs per hour divided by the Baseline GM 24-hour objective coughs per hour was reported for all treatment study arms.'}, {'measure': 'Number of Participants Experiencing At Least One Adverse Event (AE) During Treatment and Follow-up', 'timeFrame': 'Up to approximately 54 weeks', 'description': 'An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with at least one AE during either the 52-week treatment period or 2-week telephone follow-up was reported for all treatment study arms.'}, {'measure': 'Number of Participants Who Discontinued Treatment Due to AEs', 'timeFrame': 'Up to approximately 52 weeks', 'description': "An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinued study intervention during the 52-week treatment period due to an AE for which the action taken was listed as 'drug withdrawn' was reported for all treatment study arms."}], 'secondaryOutcomes': [{'measure': 'Model-Based Geometric Mean Ratio (GMR) of Awake Objective Coughs Per Hour (Week 12/Baseline)', 'timeFrame': 'Baseline, Week 12', 'description': 'Awake objective coughs per hour was defined as the total number of cough events during the monitoring period (24-hour interval) while the participant is awake divided by the total duration (in hours) for the monitoring period that the participant was awake. Assessment was based on 24-hour sound recordings using a digital recording device which recorded sounds from the lungs and trachea through a chest contact sensor, as well as ambient sounds through a lapel microphone. A longitudinal ANCOVA model was applied to log-transformed cough counts to determine GM awake objective coughs per hour at baseline and Week 12 on the original scale. The GMR corresponding to the Week 12 GM awake objective coughs per hour divided by the Baseline GM awake objective coughs per hour was reported for all treatment study arms.'}, {'measure': 'Percentage of Participants (Model-Based) With a ≤ -30% Change From Baseline in 24-hour Objective Coughs Per Hour at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': '24-hour coughs per hour was defined as the total number of cough events during the monitoring period (24-hour interval) divided by 24 hours (denominator could be different if the recording period was actually \\<24 hours but ≥20 hours). Assessment based on 24-hour sound recordings using a digital recording device. Percent change in 24-hour coughs per hour = (change from baseline in 24-hour coughs per hour / baseline 24-hour coughs per hour) ×100%. Negative values indicate a decrease in cough rate, while positive values indicate an increase in cough rate. A participant was considered a responder if the percent change from baseline in 24-hour coughs per hour was ≤ -30% (or a ≥30% reduction from baseline); a participant was considered a non-responder otherwise. The percentage of participants (logistic regression model-based) with a ≤ -30% change from baseline in 24-hour coughs per hour at Week 12 (≥30% reduction from baseline) was reported for all treatment study arms.'}, {'measure': 'Percentage of Participants (Model-Based) With a ≤ -1.3-point Change From Baseline in Mean Weekly Cough Severity Diary (CSD) Total Score at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'The CSD evaluates frequency of cough, intensity of cough and disruption and has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD score was the sum of these seven item scores (Min=0, Max=70). Mean weekly total score was defined as the average of the mean total daily scores collected during the week prior to each visit. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Day -6 to Day 0). Participants were considered responders if the change from baseline in mean weekly CSD total score was ≤ -1.3 points (or a ≥1.3 point reduction from baseline); and considered a non-responder otherwise. Negative values indicate a decrease in cough severity, while positive values indicate an increase in cough severity. The percentage of participants (logistic regression model-based) with a ≤ -1.3 point change from baseline in CSD at Week 12 (or ≥1.3 point reduction from baseline) was reported for all treatment study arms.'}, {'measure': 'Percentage of Participants (Model-Based) With a ≤ -2.7-point Change From Baseline in Mean Weekly CSD Total Score at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'The CSD evaluates frequency of cough, intensity of cough and disruption and has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD score was the sum of these seven item scores (Min=0, Max=70). Mean weekly total score was defined as the average of the mean total daily scores collected during the week prior to each visit. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Day -6 to Day 0). Participants were considered responders if the change from baseline in mean weekly CSD total score was ≤ -2.7 points (or a ≥2.7 point reduction from baseline); and considered a non-responder otherwise. Negative values indicate a decrease in cough severity, while positive values indicate an increase in cough severity. The percentage of participants (logistic regression model-based) with a ≤ -2.7 point change from baseline in CSD at Week 12 (or ≥2.7 point reduction from baseline) was reported for all treatment study arms.'}, {'measure': 'Percentage of Participants (Model-Based) With a ≤ -30 Millimeter (mm) Change From Baseline in Cough Severity Visual Analog Scale (VAS) Score at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'Cough severity was scored using the Cough Severity VAS, a single-item question asking the participant to rate the severity of their cough "today" using a 100 mm VAS (100-point scale) ranging from 0 ("No Cough") to 100 ("Extremely Severe Cough"). Mean weekly VAS score was derived as the average of VAS scores collected during the week prior to each visit. Baseline was defined as the average VAS scores collected during the week prior to Day 1 (Day -6 to Day 0). A participant was considered a responder if the change from baseline in mean weekly Cough Severity VAS score was ≤-30 mm (or a ≥30 mm reduction from baseline); participants considered non-responders otherwise. Negative values indicate a decrease in cough severity, while positive values indicate an increase in cough severity. The percentage of participants (logistic regression model-based) with ≤ -30 mm change from baseline in Cough Severity VAS at Week 12 (≥30 mm reduction from baseline) was reported for all treatment study arms.'}, {'measure': 'Percentage of Participants (Model-Based) With a ≥1.3-point Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'The LCQ assesses the impact of chronic cough on health-related quality of life. It consists of 19 items which are divided over 3 domains: Physical (items 1, 2, 3, 9, 10, 11, 14 and 15), Psychological (4, 5, 6, 12, 13, 16, and 17), and Social (7, 8, 18, 19). A 7-point Likert scale is used to rate each item. For each domain, the domain score (range 1-7) is the sum of individual item score within the domain divided by the number of items in the domain. LCQ total score is the sum of the three domain scores and ranges from 3-21; with a higher score corresponding to a better health status. A participant was considered a responder if the change from baseline in LCQ total score was ≥1.3-points (increase from baseline); a participant was considered a non-responder otherwise. The percentage of participants (logistic regression model-based) with a ≥1.3-point change from baseline in LCQ total score at Week 12 was reported for all treatment study arms.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Cough']}, 'referencesModule': {'references': [{'pmid': '35569802', 'type': 'DERIVED', 'citation': 'Dicpinigaitis PV, Birring SS, Blaiss M, McGarvey LP, Morice AH, Pavord ID, Satia I, Smith JA, La Rosa C, Li Q, Nguyen AM, Schelfhout J, Tzontcheva A, Muccino D. Demographic, clinical, and patient-reported outcome data from 2 global, phase 3 trials of chronic cough. Ann Allergy Asthma Immunol. 2023 Jan;130(1):60-66. doi: 10.1016/j.anai.2022.05.003. Epub 2022 May 13.'}, {'pmid': '35248186', 'type': 'DERIVED', 'citation': 'McGarvey LP, Birring SS, Morice AH, Dicpinigaitis PV, Pavord ID, Schelfhout J, Nguyen AM, Li Q, Tzontcheva A, Iskold B, Green SA, Rosa C, Muccino DR, Smith JA; COUGH-1 and COUGH-2 Investigators. Efficacy and safety of gefapixant, a P2X3 receptor antagonist, in refractory chronic cough and unexplained chronic cough (COUGH-1 and COUGH-2): results from two double-blind, randomised, parallel-group, placebo-controlled, phase 3 trials. Lancet. 2022 Mar 5;399(10328):909-923. doi: 10.1016/S0140-6736(21)02348-5.'}]}, 'descriptionModule': {'briefSummary': 'The main objectives of this study will be to evaluate the efficacy of gefapixant in reducing cough frequency as measured over a 24-hour period at Week 12, and to evaluate the safety and tolerability of gefapixant. The primary hypothesis is that at least one gefapixant dose is superior to placebo in reducing coughs per hour (over 24 hours) at Week 12.', 'detailedDescription': 'The study will include a screening period to determine participant inclusion, and the Baseline visit will include 24 hours of objective measurement of cough. The study will consist of two treatment periods, a main 12-week treatment period and a 40-week extension period (52 weeks total treatment), followed by a 14-day telephone follow-up period.\n\nParticipants at selected sites and countries who complete the main and extension study periods may consent to participate in an observational, 3-month, Off-treatment Durability Study Period, which extends the Estimated Study Completion Date. The Off-treatment Durability Study Period will explore the impact of withdrawing gefapixant in refractory or unexplained chronic cough participants who have been treated for 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chest radiograph or computed tomography scan of the thorax (within 5 years of Screening/Visit 1 and after the onset of chronic cough) not demonstrating any abnormality considered to be significantly contributing to the chronic cough or any other clinically significant lung disease in the opinion of the principal investigator or the sub-investigator\n* Has had chronic cough for at least 1 year with a diagnosis of refractory chronic cough or unexplained chronic cough\n* Female participants are eligible if not pregnant, not breastfeeding, and either not of childbearing potential, or agree to follow contraceptive guidance\n* Provides written informed consent and is willing and able to comply with the study protocol (including use of the digital cough recording device and completion of study questionnaires)\n\nExclusion Criteria:\n\n* Is a current smoker or has given up smoking within 12 months of Screening\n* Has forced expiratory volume in 1 second (FEV1)/ forced vital capacity (FVC) ratio \\<60%\n* Has a history of respiratory tract infection or recent clinically significant change in pulmonary status\n* Has a history of chronic bronchitis\n* Is currently taking an angiotensin converting enzyme inhibitor (ACEI), or has used an ACEI within 3 months of Screening\n* Has an estimated glomerular filtration rate (eGFR) \\<30mL/min/1.73 m\\^2 at Screening OR eGFR ≥30 mL/min/1.73 m\\^2 and \\<50 mL/min/1.73 m\\^2 at Screening with unstable renal function\n* Has a history of malignancy \\<=5 years\n* Is a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence\n* Has a history of anaphylaxis or cutaneous adverse drug reaction (with or without systemic symptoms) to sulfonamide antibiotics or other sulfonamide-containing drugs\n* Has systolic blood pressure \\>160 mm Hg or diastolic blood pressure \\>90 mm Hg at Screening\n* Has a known allergy/sensitivity or contraindication to gefapixant\n* Has donated or lost \\>=1 unit of blood within 8 weeks prior to the first dose of gefapixant\n* Has previously received gefapixant or is currently participating in or has participated in an interventional clinical study\n* Had significantly abnormal laboratory tests at Screening'}, 'identificationModule': {'nctId': 'NCT03449134', 'briefTitle': 'A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-027)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Month Study to Evaluate the Efficacy and Safety of MK-7264 in Adult Participants With Chronic Cough (PN027)', 'orgStudyIdInfo': {'id': '7264-027'}, 'secondaryIdInfos': [{'id': 'MK-7264-027', 'type': 'OTHER', 'domain': 'Merck Protocol Number'}, {'id': '2017-000537-31', 'type': 'EUDRACT_NUMBER'}, {'id': '184098', 'type': 'REGISTRY', 'domain': 'JAPAN-CTI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants receive dose-matched placebo tablets twice daily (BID) during the 12-week main study period and 40-week extension period.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Gefapixant 15 mg BID', 'description': 'Participants receive a gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg BID during the 12-week main study period and 40-week extension period.', 'interventionNames': ['Drug: Placebo', 'Drug: Gefapixant']}, {'type': 'EXPERIMENTAL', 'label': 'Gefapixant 45 mg BID', 'description': 'Participants receive a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 12-week main study period and 40-week extension period.', 'interventionNames': ['Drug: Placebo', 'Drug: Gefapixant']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants receive dose-matched placebo tablets orally BID during the 12-week main study period and during the 40-week extension period.', 'armGroupLabels': ['Gefapixant 15 mg BID', 'Gefapixant 45 mg BID', 'Placebo']}, {'name': 'Gefapixant', 'type': 'DRUG', 'otherNames': ['MK-7264'], 'description': 'Gefapixant 15 mg or 45 mg tablet administered orally BID during the 12-week main study period and during the 40-week extension period, according to randomization.', 'armGroupLabels': ['Gefapixant 15 mg BID', 'Gefapixant 45 mg BID']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85340', 'city': 'Litchfield Park', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Solutions of Arizona PC ( Site 0036)', 'geoPoint': {'lat': 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