Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2026-02-25 @ 7:27 PM
Study NCT ID:
NCT03372603
Status:
TERMINATED
Last Update Posted:
2019-10-02
First Post:
2017-12-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Assess the Effectiveness and Side Effects of GSK2798745 in Participants With Chronic Cough
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003371', 'term': 'Cough'}, {'id': 'D000096822', 'term': 'Chronic Cough'}], 'ancestors': [{'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': 'C000656065', 'term': 'GSK2798745'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AEs and SAEs were collected from the start of the treatment up to 45 days', 'description': 'AEs and SAEs were collected for All Subjects population', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 9, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'GSK2798745', 'description': 'Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 11, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Irritable bowel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Ear pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypoacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Feeling cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Suprapubic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nasal pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Cough Counts During Day Time Hours Following 7-days of Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.'}, {'id': 'OG001', 'title': 'GSK2798745', 'description': 'Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '180.570', 'groupId': 'OG000', 'lowerLimit': '137.852', 'upperLimit': '235.446'}, {'value': '241.105', 'groupId': 'OG001', 'lowerLimit': '181.383', 'upperLimit': '320.600'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.336', 'ciLowerLimit': '0.965', 'ciUpperLimit': '1.847', 'estimateComment': 'Treatment comparison ratio of GSK2798745 and placebo using posterior median ratio and 90% credible interval is presented.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 10 hours post-dose on Day 7 of each treatment period', 'description': 'Coughs were monitored using the VitaloJAK cough monitor. The total cough counts during day-time (10 hours) was calculated from the time of the monitor being attached i.e. immediately after dosing on Day 7 to 10 hours past the time of monitoring. Total cough counts were log-transformed prior to analysis. A non-informative prior was used. Analysis was performed using a Bayesian mixed model adjusting for subject-level and period-adjusted baselines, treatment and period. Subject-level baseline is defined as the mean of the two period-specific baselines. Period-adjusted baseline is defined as the difference between the period-specific baseline and subject-level baseline for each period. Posterior median and 95% credible interval is reported. All Subjects Population included all randomized participants who took at least 1 dose of study treatment. Participants were analyzed according to the treatment they actually received.', 'unitOfMeasure': 'Cough counts', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Subjects Population. Only those participants with data available at the specified data points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.'}, {'id': 'OG001', 'title': 'GSK2798745', 'description': 'Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.'}], 'classes': [{'title': 'Any AE', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Any SAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 45 days', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Subjects Population.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Values for Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Amino Transferase (AST) and Creatinine Kinase (CK)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.'}, {'id': 'OG001', 'title': 'GSK2798745', 'description': 'Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.'}], 'classes': [{'title': 'ALP', 'categories': [{'measurements': [{'value': '1.8', 'spread': '9.28', 'groupId': 'OG000'}, {'value': '-3.1', 'spread': '6.75', 'groupId': 'OG001'}]}]}, {'title': 'ALT', 'categories': [{'measurements': [{'value': '0.2', 'spread': '2.31', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '5.32', 'groupId': 'OG001'}]}]}, {'title': 'AST', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '3.69', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '2.65', 'groupId': 'OG001'}]}]}, {'title': 'CK', 'categories': [{'measurements': [{'value': '-3.0', 'spread': '21.71', 'groupId': 'OG000'}, {'value': '-12.1', 'spread': '52.12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 8 of each treatment period', 'description': 'Blood samples were collected for the analysis of clinical chemistry parameters including ALP, ALT, AST and CK. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.', 'unitOfMeasure': 'International units per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All Subjects Population. Only those participants with data available at the specified data points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Values for Clinical Chemistry Parameter: Direct Bilirubin, Total Bilirubin and Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.'}, {'id': 'OG001', 'title': 'GSK2798745', 'description': 'Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.'}], 'classes': [{'title': 'Direct bilirubin', 'categories': [{'measurements': [{'value': '0.1', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': 'Total bilirubin', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '3.41', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '3.25', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine', 'categories': [{'measurements': [{'value': '0.31', 'spread': '6.458', 'groupId': 'OG000'}, {'value': '1.70', 'spread': '4.031', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 8 for each treatment period', 'description': 'Blood samples were collected for the analysis of clinical chemistry parameters including direct bilirubin, total bilirubin and creatinine. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.', 'unitOfMeasure': 'Micromoles per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All Subjects Population. Only those participants with data available at the specified data points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Values for Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Urea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.'}, {'id': 'OG001', 'title': 'GSK2798745', 'description': 'Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.'}], 'classes': [{'title': 'Calcium', 'categories': [{'measurements': [{'value': '0.011', 'spread': '0.0588', 'groupId': 'OG000'}, {'value': '0.019', 'spread': '0.0782', 'groupId': 'OG001'}]}]}, {'title': 'Glucose', 'categories': [{'measurements': [{'value': '-0.22', 'spread': '1.234', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.956', 'groupId': 'OG001'}]}]}, {'title': 'Potassium', 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.299', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.270', 'groupId': 'OG001'}]}]}, {'title': 'Sodium', 'categories': [{'measurements': [{'value': '0.2', 'spread': '1.44', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '1.46', 'groupId': 'OG001'}]}]}, {'title': 'Urea', 'categories': [{'measurements': [{'value': '0.18', 'spread': '0.683', 'groupId': 'OG000'}, {'value': '-0.36', 'spread': '0.908', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 8 of each treatment period', 'description': 'Blood samples were collected for the analysis of clinical chemistry parameters including calcium, glucose, potassium, sodium and urea/blood urea nitrogen (BUN). Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.', 'unitOfMeasure': 'Millimoles per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All Subjects Population. Only those participants with data available at the specified data points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Values for Clinical Chemistry Parameter: Total Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.'}, {'id': 'OG001', 'title': 'GSK2798745', 'description': 'Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'spread': '2.65', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '2.53', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 8 of each treatment period', 'description': 'Blood samples were collected for the analysis of clinical chemistry parameter total protein. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.', 'unitOfMeasure': 'Grams per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All Subjects Population. Only those participants with data available at the specified data points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormal Values of Cardiac Troponin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.'}, {'id': 'OG001', 'title': 'GSK2798745', 'description': 'Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not applicable (NA) indicates Troponin I values were recorded as less than lower limit of quantification (\\<0.02) at all time points.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'NA indicates Troponin I values were recorded as less than lower limit of quantification (\\<0.02) at all time points.', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 45 days', 'description': 'Cardiac troponin values was measured in participants.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Subjects Population.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell (WBC) Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.'}, {'id': 'OG001', 'title': 'GSK2798745', 'description': 'Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.'}], 'classes': [{'title': 'Basophils', 'categories': [{'measurements': [{'value': '0.005', 'spread': '0.0250', 'groupId': 'OG000'}, {'value': '-0.005', 'spread': '0.0316', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils', 'categories': [{'measurements': [{'value': '-0.005', 'spread': '0.0400', 'groupId': 'OG000'}, {'value': '-0.007', 'spread': '0.0758', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes', 'categories': [{'measurements': [{'value': '0.019', 'spread': '0.3065', 'groupId': 'OG000'}, {'value': '-0.002', 'spread': '0.2608', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes', 'categories': [{'measurements': [{'value': '-0.012', 'spread': '0.1110', 'groupId': 'OG000'}, {'value': '0.027', 'spread': '0.1012', 'groupId': 'OG001'}]}]}, {'title': 'Total neutrophils', 'categories': [{'measurements': [{'value': '0.186', 'spread': '0.5817', 'groupId': 'OG000'}, {'value': '0.064', 'spread': '1.0102', 'groupId': 'OG001'}]}]}, {'title': 'Platelet count', 'categories': [{'measurements': [{'value': '6.8', 'spread': '13.57', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '19.76', 'groupId': 'OG001'}]}]}, {'title': 'WBC count', 'categories': [{'measurements': [{'value': '0.20', 'spread': '0.614', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '1.276', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 8 of each treatment period', 'description': 'Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and WBC count. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.', 'unitOfMeasure': 'Giga units per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All Subjects Population. Only those participants with data available at the specified data points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Values for Hematology Parameter: Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.'}, {'id': 'OG001', 'title': 'GSK2798745', 'description': 'Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'spread': '2.29', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '3.52', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 8 for each treatment period', 'description': 'Blood samples were collected for the analysis of hematology parameter: hemoglobin. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.', 'unitOfMeasure': 'Grams per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All Subjects Population. Only those participants with data available at the specified data points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Values for Hematology Parameter: Hematocrit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.'}, {'id': 'OG001', 'title': 'GSK2798745', 'description': 'Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0020', 'spread': '0.01009', 'groupId': 'OG000'}, {'value': '0.0029', 'spread': '0.00979', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 8 of each treatment period', 'description': 'Blood samples were collected for the analysis of hematology parameter: hematocrit. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.', 'unitOfMeasure': 'Percentage of red blood cells in blood', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All Subjects Population. Only those participants with data available at the specified data points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Values for Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.'}, {'id': 'OG001', 'title': 'GSK2798745', 'description': 'Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.377', 'groupId': 'OG000'}, {'value': '-0.09', 'spread': '0.442', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 8 for each treatment period', 'description': 'Blood samples were collected for the analysis of hematology parameter: MCH. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.', 'unitOfMeasure': 'Picograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All Subjects Population. Only those participants with data available at the specified data points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Values for Hematology Parameter: Mean Corpuscular Volume (MCV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.'}, {'id': 'OG001', 'title': 'GSK2798745', 'description': 'Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'spread': '2.01', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '1.53', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 8 of each treatment period', 'description': 'Blood samples were collected for the analysis of hematology parameter: MCV. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.', 'unitOfMeasure': 'Femtoliters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All Subjects Population. Only those participants with data available at the specified data points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Values for Hematology Parameter: Red Blood Cell (RBC) Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.'}, {'id': 'OG001', 'title': 'GSK2798745', 'description': 'Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.04', 'spread': '0.112', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.103', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 8 for each treatment period', 'description': 'Blood samples were collected for the analysis of hematology parameter: RBC count. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.', 'unitOfMeasure': 'Tera units per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All Subjects Population. Only those participants with data available at the specified data points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Values for Hematology Parameter: Reticulocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.'}, {'id': 'OG001', 'title': 'GSK2798745', 'description': 'Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.0002', 'spread': '0.00300', 'groupId': 'OG000'}, {'value': '-0.0002', 'spread': '0.00260', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -1) and Day 8 for each treatment period', 'description': 'Blood samples were collected for the analysis of hematology parameter: reticulocytes. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.', 'unitOfMeasure': 'Percentage of reticulocytes in blood', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All Subjects Population. Only those participants with data available at the specified data points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormal Urinalysis Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.'}, {'id': 'OG001', 'title': 'GSK2798745', 'description': 'Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 8', 'description': 'Urine samples were collected for analysis of urinalysis data by dipstick method. Number of participants with abnormal urinalysis data has been presented. Abnormality was defined as value of potential clinical importance (PCI). PCI was flagged when a result changed from negative on Day 1 (pre-dose) to positive on Day 8.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Subjects Population. Only those participants with data available at the specified data points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.'}, {'id': 'OG001', 'title': 'GSK2798745', 'description': 'Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.'}], 'classes': [{'title': 'DBP', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '8.59', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '13.07', 'groupId': 'OG001'}]}]}, {'title': 'SBP', 'categories': [{'measurements': [{'value': '1.6', 'spread': '12.65', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '20.10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-dose on Day 1) and Day 8 of each treatment period', 'description': 'Blood pressure was measured at indicated time points in supine position after 5 minutes rest for the participant. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.', 'unitOfMeasure': 'Millimeters of mercury', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All Subjects Population. Only those participants with data available at the specified data points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Temperature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.'}, {'id': 'OG001', 'title': 'GSK2798745', 'description': 'Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.02', 'spread': '0.635', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '0.331', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-dose on Day 1) and Day 8 of each treatment period', 'description': 'Temperature was measured at indicated time points in supine position after 5 minutes rest for the participant. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.', 'unitOfMeasure': 'Degrees Celsius', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All Subjects Population. Only those participants with data available at the specified data points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.'}, {'id': 'OG001', 'title': 'GSK2798745', 'description': 'Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'spread': '8.65', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '12.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-dose on Day 1) and Day 8 of each treatment period', 'description': 'Heart rate was measured at indicated time points in supine position after 5 minutes rest for the participant. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.', 'unitOfMeasure': 'Beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All Subjects Population. Only those participants with data available at the specified data points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormal Electrocardiogram (ECG) Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.'}, {'id': 'OG001', 'title': 'GSK2798745', 'description': 'Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 in either treatment period 1 or 2. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.'}], 'classes': [{'title': 'Day 1 pre-dose, not clinically significant,n=17,16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 1 pre-dose, clinically significant, n=17,16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 8, not clinically significant, n=17,15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 8, clinically significant, n=17,15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (pre-dose on Day 1) and Day 8 of each treatment period', 'description': 'Twelve-lead ECG was obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT (QTc) intervals. Number of participants with abnormal-clinically significant and abnormal-not clinically significant values has been presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category title).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo/GSK2798745', 'description': 'Participants were administered two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7 of treatment period 1. In treatment period 2, participants received two tablets of 2.4 milligrams (mg) GSK2798745 each on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.'}, {'id': 'FG001', 'title': 'GSK2798745/Placebo', 'description': 'Participants were administered two tablets of 2.4 mg GSK2798745 on Day 1 followed by one tablet of 2.4 mg GSK2798745 on Days 2 to 7 of treatment period 1. In treatment period 2, participants received two tablets of placebo on Day 1 followed by one tablet of placebo on Days 2 to 7. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.'}], 'periods': [{'title': 'Treatment Period 1 (Up to 7 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Wash-out Period (14-21 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Sponsor terminated study treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 2 (Up to 7 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Study closed/Terminated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Study was conducted at 4 centers in the United Kingdom. Participants who met eligibility criteria entered a 2-period crossover study. Participants were randomized to either placebo or GSK2798745 in each Treatment Period (each 7 days, with a 14-21 day washout). Total duration of participation was 10.5 weeks. Study terminated on grounds of futility', 'preAssignmentDetails': 'A total of 34 participants were screened of which 17 failed screening and 17 participants were included in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'All participants who were randomized to either of the two treatment sequences Placebo/GSK2798745 and GSK2798745/Placebo and received GSK2798745 and placebo in either Treatment period 1 or 2 were included. All doses were administered once daily via the oral route with a glass of water. The treatment periods were separated by a wash-out period of 14 to 21 days.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.0', 'spread': '9.85', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian-Japanese/East Asian (EA)/South EA Heritage', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-25', 'size': 2616521, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-08-20T01:37', 'hasProtocol': True}, {'date': '2018-09-07', 'size': 921743, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-08-20T01:40', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'All study staff involved in clinical assessments (which includes the investigator, sub-investigators, other site staff), and the subject will be blinded to the treatment allocated to individual subjects.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This is a multi-center, randomized, placebo-controlled, double-blind, two-period crossover study. Each subject will be screened (screening may be conducted across more than 1 visit); each subject will have 2 treatment periods (each 7 days) with a washout period of 14 to 21 days between the treatment periods; and each subject will have a follow-up visit (within 7 to 10 days after their last dose). Each subject will be involved in the study for a maximum of 10 and a half weeks.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'whyStopped': 'Study terminated due to lack of efficacy of GSK2798745 in chronic cough.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-10-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-06', 'studyFirstSubmitDate': '2017-12-08', 'resultsFirstSubmitDate': '2019-09-06', 'studyFirstSubmitQcDate': '2017-12-08', 'lastUpdatePostDateStruct': {'date': '2019-10-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-06', 'studyFirstPostDateStruct': {'date': '2017-12-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Cough Counts During Day Time Hours Following 7-days of Dosing', 'timeFrame': 'Up to 10 hours post-dose on Day 7 of each treatment period', 'description': 'Coughs were monitored using the VitaloJAK cough monitor. The total cough counts during day-time (10 hours) was calculated from the time of the monitor being attached i.e. immediately after dosing on Day 7 to 10 hours past the time of monitoring. Total cough counts were log-transformed prior to analysis. A non-informative prior was used. Analysis was performed using a Bayesian mixed model adjusting for subject-level and period-adjusted baselines, treatment and period. Subject-level baseline is defined as the mean of the two period-specific baselines. Period-adjusted baseline is defined as the difference between the period-specific baseline and subject-level baseline for each period. Posterior median and 95% credible interval is reported. All Subjects Population included all randomized participants who took at least 1 dose of study treatment. Participants were analyzed according to the treatment they actually received.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Up to 45 days', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgment.'}, {'measure': 'Change From Baseline Values for Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Amino Transferase (AST) and Creatinine Kinase (CK)', 'timeFrame': 'Baseline (Day -1) and Day 8 of each treatment period', 'description': 'Blood samples were collected for the analysis of clinical chemistry parameters including ALP, ALT, AST and CK. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.'}, {'measure': 'Change From Baseline Values for Clinical Chemistry Parameter: Direct Bilirubin, Total Bilirubin and Creatinine', 'timeFrame': 'Baseline (Day -1) and Day 8 for each treatment period', 'description': 'Blood samples were collected for the analysis of clinical chemistry parameters including direct bilirubin, total bilirubin and creatinine. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.'}, {'measure': 'Change From Baseline Values for Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Urea', 'timeFrame': 'Baseline (Day -1) and Day 8 of each treatment period', 'description': 'Blood samples were collected for the analysis of clinical chemistry parameters including calcium, glucose, potassium, sodium and urea/blood urea nitrogen (BUN). Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.'}, {'measure': 'Change From Baseline Values for Clinical Chemistry Parameter: Total Protein', 'timeFrame': 'Baseline (Day -1) and Day 8 of each treatment period', 'description': 'Blood samples were collected for the analysis of clinical chemistry parameter total protein. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.'}, {'measure': 'Number of Participants With Abnormal Values of Cardiac Troponin', 'timeFrame': 'Up to 45 days', 'description': 'Cardiac troponin values was measured in participants.'}, {'measure': 'Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell (WBC) Count', 'timeFrame': 'Baseline (Day -1) and Day 8 of each treatment period', 'description': 'Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and WBC count. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.'}, {'measure': 'Change From Baseline Values for Hematology Parameter: Hemoglobin', 'timeFrame': 'Baseline (Day -1) and Day 8 for each treatment period', 'description': 'Blood samples were collected for the analysis of hematology parameter: hemoglobin. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.'}, {'measure': 'Change From Baseline Values for Hematology Parameter: Hematocrit', 'timeFrame': 'Baseline (Day -1) and Day 8 of each treatment period', 'description': 'Blood samples were collected for the analysis of hematology parameter: hematocrit. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.'}, {'measure': 'Change From Baseline Values for Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)', 'timeFrame': 'Baseline (Day -1) and Day 8 for each treatment period', 'description': 'Blood samples were collected for the analysis of hematology parameter: MCH. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.'}, {'measure': 'Change From Baseline Values for Hematology Parameter: Mean Corpuscular Volume (MCV)', 'timeFrame': 'Baseline (Day -1) and Day 8 of each treatment period', 'description': 'Blood samples were collected for the analysis of hematology parameter: MCV. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.'}, {'measure': 'Change From Baseline Values for Hematology Parameter: Red Blood Cell (RBC) Count', 'timeFrame': 'Baseline (Day -1) and Day 8 for each treatment period', 'description': 'Blood samples were collected for the analysis of hematology parameter: RBC count. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.'}, {'measure': 'Change From Baseline Values for Hematology Parameter: Reticulocytes', 'timeFrame': 'Baseline (Day -1) and Day 8 for each treatment period', 'description': 'Blood samples were collected for the analysis of hematology parameter: reticulocytes. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.'}, {'measure': 'Number of Participants With Abnormal Urinalysis Data', 'timeFrame': 'Up to Day 8', 'description': 'Urine samples were collected for analysis of urinalysis data by dipstick method. Number of participants with abnormal urinalysis data has been presented. Abnormality was defined as value of potential clinical importance (PCI). PCI was flagged when a result changed from negative on Day 1 (pre-dose) to positive on Day 8.'}, {'measure': 'Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)', 'timeFrame': 'Baseline (pre-dose on Day 1) and Day 8 of each treatment period', 'description': 'Blood pressure was measured at indicated time points in supine position after 5 minutes rest for the participant. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.'}, {'measure': 'Change From Baseline in Temperature', 'timeFrame': 'Baseline (pre-dose on Day 1) and Day 8 of each treatment period', 'description': 'Temperature was measured at indicated time points in supine position after 5 minutes rest for the participant. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.'}, {'measure': 'Change From Baseline in Heart Rate', 'timeFrame': 'Baseline (pre-dose on Day 1) and Day 8 of each treatment period', 'description': 'Heart rate was measured at indicated time points in supine position after 5 minutes rest for the participant. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.'}, {'measure': 'Number of Participants With Abnormal Electrocardiogram (ECG) Findings', 'timeFrame': 'Baseline (pre-dose on Day 1) and Day 8 of each treatment period', 'description': 'Twelve-lead ECG was obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT (QTc) intervals. Number of participants with abnormal-clinically significant and abnormal-not clinically significant values has been presented.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['GSK2798745, efficacy, safety, chronic cough, crossover study'], 'conditions': ['Cough']}, 'descriptionModule': {'briefSummary': 'GSK2798745 is a potent and selective transient receptor potential vanilloid 4 (TRPV4) channel blocker being investigated for the treatment of chronic cough. This is a multi-center, randomized, placebo-controlled, double-blind, two-period crossover study with a purpose to evaluate efficacy and safety of GSK2798745. Each subject will have 2 treatment periods, and will be randomized to one of the following treatments in each period: A) Placebo matching to GSK2798745 once daily for 7 days. B) 4.8 milligrams (mg) GSK2798745 on Day 1, followed by 2.4 mg GSK2798745 once daily for 6 days. There will be a washout period of 14 to 21 days between the treatment periods. A maximum of 48 subjects will be enrolled in the study and the total duration of participation in the study will be maximum of 10 and a half weeks including follow-up visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age between 18 and 75 years of age inclusive, at the time of signing the informed consent.\n* Chronic idiopathic cough for \\>=1 year (before screening), defined as: a cough that is unresponsive to at least 8 weeks of targeted treatment, or a cough for which no objective evidence of an underlying trigger has been determined, despite medical investigations.\n* No significant findings on chest imaging (chest X-ray \\[CXR\\] or Computed tomography scan) within 12 months before screening (subjects with an abnormal CXR within 12 months, from a temporary process, will be allowed to participate if a repeat CXR is normal).\n* Forced expiratory volume in one second (FEV1) \\>=80% of the predicted normal value (at screening), or documented evidence of FEV1 \\>=80% within the 6 months before screening.\n* Score of \\>=40 millimeters (mm) on the Cough Severity Visual Analogue Scale (VAS) at Screening.\n* Body weight \\>=50 kilogram (kg) and body mass index (BMI) within the range 18 to 40 kilogram per meter square (kg/m\\^2) (inclusive) at screening.\n* A male participant must agree to follow the contraception requirements stated in the protocol from the time of first dose of study treatment until 2 weeks after last dose of study treatment, and refrain from donating sperm during this period.\n* A female participant is eligible to participate if she is not of childbearing potential.\n* Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n\nExclusion Criteria:\n\n* History or current evidence of any serious or clinically significant gastrointestinal, renal, endocrine, neurologic, hematologic or other condition that is uncontrolled on permitted therapies or that would, in the opinion of the investigator or the medical monitor, make the subject unsuitable for inclusion in this study.\n* History or current evidence of chronic productive cough.\n* History of acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting within the 6 months before screening.\n* Active ulcer disease or gastrointestinal bleeding at the time of screening (positive fecal occult blood test \\[FOBT\\] at screening).\n* History of stroke or seizure disorder within 5 years of screening.\n* Respiratory tract infection within 6 weeks of screening.\n* Subject who, in the investigator's opinion, poses a significant suicide risk. Evidence of serious suicide risk may include any history of suicidal behavior and/or any evidence of suicidal ideation on any questionnaires e.g. Type 4 or 5 on the Columbia Suicidality Severity Rating Scale (C-SSRS) in the last 6 months (assessed at screening).\n* Alanine transferase (ALT) \\> twice the upper limit of normal (ULN) at screening.\n* Bilirubin \\>1.5 times ULN (isolated bilirubin \\>1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin \\<35%) at screening.\n* Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).\n* QT interval corrected (QTc) \\>450 milliseconds (msec) or QTc \\>480 msec in subjects with bundle branch block at screening.\n* Use of a listed prohibited medication within the restricted timeframe relative to the first dose of study treatment.\n* Use of a strong inhibitors or inducers of cytochrome P450 (CYP) 3A or pglycoprotein.\n* Participation in the study would result in loss of blood or blood products in excess of 500 milliliters (mL) within 3 months of screening.\n* Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.\n* Current enrollment or past participation within the 3 months before screening in any clinical study involving an investigational study treatment or any other type of medical research.\n* Positive human immunodeficiency virus (HIV) antibody test at screening.\n* Presence of Hepatitis B surface antigen (HBsAg) at screening.\n* Positive Hepatitis C antibody test result at screening or within 3 months prior to starting study treatment.\n* Positive Hepatitis C ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study treatment.\n* Cardiac troponin at screening \\> ULN for the assay.\n* History of alcohol abuse within 6 months of screening, in the opinion of the investigator.\n* Current smoker or history of smoking within the 6 months before screening, or a cumulative history of \\>= 20 pack years. Pack years = (Number of cigarettes smoked/day/20) x (Number of years smoked)\n* Sensitivity to any of the study treatments, or components thereof, or drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates participation in the study."}, 'identificationModule': {'nctId': 'NCT03372603', 'briefTitle': 'A Study to Assess the Effectiveness and Side Effects of GSK2798745 in Participants With Chronic Cough', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Placebo-controlled, Double-blind (Sponsor Open), Randomized, Crossover Study to Assess the Efficacy, Safety, and Tolerability of GSK2798745 in Participants With Chronic Cough', 'orgStudyIdInfo': {'id': '207702'}, 'secondaryIdInfos': [{'id': '2017-002265-21', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Sequence AB', 'description': 'Subjects will receive GSK2798745 matching placebo tablets (two tablets on Day 1 followed by one tablet once daily for 6 days), via oral route (treatment period of total 7 days). After a washout period of 14 to 21 days, subjects will then receive 4.8 mg (two tablets of 2.4 mg) GSK2798745 on Day 1, followed by 2.4 mg GSK2798745 tablets once daily for 6 days via oral route (treatment period of total 7 days).', 'interventionNames': ['Drug: GSK2798745', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Sequence BA', 'description': 'Subjects will receive 4.8 mg (two tablets of 2.4 mg) GSK2798745 on Day 1, followed by 2.4 mg GSK2798745 tablets once daily for 6 days via oral route (treatment period of total 7 days). After a washout period of 14 to 21 days, subjects will then receive GSK2798745 matching placebo tablets (two tablets on Day 1 followed by one tablet once daily for 6 days), via oral route (treatment period of total 7 days).', 'interventionNames': ['Drug: GSK2798745', 'Drug: Placebo']}], 'interventions': [{'name': 'GSK2798745', 'type': 'DRUG', 'description': 'GSK2798745 tablets will be available as white to almost white, round, film-coated tablets (micronized active pharmaceutical ingredient \\[API\\]) to be taken with a glass of water (approximately 240 mL).', 'armGroupLabels': ['Treatment Sequence AB', 'Treatment Sequence BA']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo tablets will be available as white to almost white, round, film-coated tablets to be taken with a glass of water (approximately 240 mL).', 'armGroupLabels': ['Treatment Sequence AB', 'Treatment Sequence BA']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M23 9LT', 'city': 'Manchester', 'state': 'Lancashire', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'M23 9L', 'city': 'Manchester', 'state': 'Lancashire', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'BT9 7BL', 'city': 'Belfast', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}, {'zip': 'BT9 7B', 'city': 'Belfast', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}, {'zip': 'HU16 5JQ', 'city': 'Cottingham', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.50243, 'lon': -0.7554}}, {'zip': 'HU16 5', 'city': 'Cottingham', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.50243, 'lon': -0.7554}}, {'zip': 'NE29 8NH', 'city': 'North Shields', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 55.01646, 'lon': -1.44925}}, {'zip': 'NE29 8', 'city': 'North Shields', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 55.01646, 'lon': -1.44925}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}, {'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)'}]}, 'ipdSharingStatementModule': {'url': 'http://clinicalstudydatarequest.com', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.', 'ipdSharing': 'YES', 'description': 'IPD for this study will be made available via the Clinical Study Data Request site.', 'accessCriteria': 'Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Biomedical Advanced Research and Development Authority', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}