Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-30 @ 8:02 PM
Study NCT ID:
NCT03874234
Status:
TERMINATED
Last Update Posted:
2023-02-27
First Post:
2019-03-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety, Tolerability and Pharmacokinetics (PKs) Investigation of GSK3186899 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007896', 'term': 'Leishmaniasis'}], 'ancestors': [{'id': 'D056986', 'term': 'Euglenozoa Infections'}, {'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012876', 'term': 'Skin Diseases, Parasitic'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000705476', 'term': 'GSK3186899'}]}}, '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': 'All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.', 'description': 'All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.', 'eventGroups': [{'id': 'EG000', 'title': 'Part A: Cohorts 1 and 2- Placebo', 'description': 'Participants in Part A Cohorts 1 and 2 received a single dose of placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 5, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Part A: Cohort 1- GSK3186899 30 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 30 mg on Day 1 in treatment Period 1.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Part A: Cohort 1- GSK3186899 60 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 60 mg on Day 1 in treatment Period 2.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Part A: Cohort 1- GSK3186899 120 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Part A: Cohorts 1 and 2- GSK3186899 300 mg', 'description': 'Participants in Part A received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4 of Cohort 1 and treatment Period 1 of Cohort 2.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 5, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Part A: Cohort 2- GSK3186899 600 mg', 'description': 'Participants in Part A Cohort 2 received a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Part A: Cohort 2- GSK3186899 800 mg', 'description': 'Participants in Part A Cohort 2 received a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Part A: Cohort 2- GSK3186899 Dose Level 7', 'description': 'Participants in Part A Cohort 2 were planned to receive dose level 7 on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Part A: Cohort 3- GSK3186899 (Fasted) + GSK3186899 (Fed)', 'description': 'Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'Part A: Cohort 3- GSK3186899 (Fed) + GSK3186899 (Fasted)', 'description': 'Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG010', 'title': 'Part B: Cohort 4- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 4 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG011', 'title': 'Part B: Cohort 5- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 5 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG012', 'title': 'Part B: Cohort 6- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 6 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Medical device site dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Medical device site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Taste disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abnormal dreams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part A- Cohorts 1 and 2: Number of Participants With Non-serious Adverse Events (Non-SAEs) and SAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohorts 1 and 2- Placebo', 'description': 'Participants in Part A Cohorts 1 and 2 received a single dose of placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.'}, {'id': 'OG001', 'title': 'Part A: Cohort 1- GSK3186899 30 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 30 mg on Day 1 in treatment Period 1.'}, {'id': 'OG002', 'title': 'Part A: Cohort 1- GSK3186899 60 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 60 mg on Day 1 in treatment Period 2.'}, {'id': 'OG003', 'title': 'Part A: Cohort 1- GSK3186899 120 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3.'}, {'id': 'OG004', 'title': 'Part A: Cohorts 1 and 2- GSK3186899 300 mg', 'description': 'Participants in Part A received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4 of Cohort 1 and treatment Period 1 of Cohort 2.'}, {'id': 'OG005', 'title': 'Part A: Cohort 2- GSK3186899 600 mg', 'description': 'Participants in Part A Cohort 2 received a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2.'}, {'id': 'OG006', 'title': 'Part A: Cohort 2- GSK3186899 800 mg', 'description': 'Participants in Part A Cohort 2 received a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3.'}, {'id': 'OG007', 'title': 'Part A: Cohort 2- GSK3186899 Dose Level 7', 'description': 'Participants in Part A Cohort 2 were planned to receive dose level 7 on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.'}], 'classes': [{'title': 'Non-SAEs', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 12', 'description': 'An adverse event (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. A 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, important medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the outcomes listed above. Safety Population consisted of all randomized participants who received at least one dose of study treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.'}, {'type': 'PRIMARY', 'title': 'Part A- Cohort 3: Number of Participants With Non-SAEs and SAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 3- GSK3186899 (Fasted) + GSK3186899 (Fed)', 'description': 'Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.'}, {'id': 'OG001', 'title': 'Part A: Cohort 3- GSK3186899 (Fed) + GSK3186899 (Fasted)', 'description': 'Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.'}], 'timeFrame': 'Up to Week 9', 'description': 'An adverse event (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. A 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, important medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the outcomes listed above.', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Data was not collected as no participants were enrolled in Part A Cohort 3.'}, {'type': 'PRIMARY', 'title': 'Part B: Number of Participants With Non-SAEs and SAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Cohort 4- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 4 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'OG001', 'title': 'Part B: Cohort 5- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 5 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'OG002', 'title': 'Part B: Cohort 6- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 6 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}], 'timeFrame': 'Up to Week 9', 'description': 'An adverse event (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. A 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, important medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the outcomes listed above.', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Data was not collected as no participants were enrolled in Part B.'}, {'type': 'PRIMARY', 'title': 'Part A- Cohorts 1 and 2: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohorts 1 and 2- Placebo', 'description': 'Participants in Part A Cohorts 1 and 2 received a single dose of placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.'}, {'id': 'OG001', 'title': 'Part A: Cohort 1- GSK3186899 30 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 30 mg on Day 1 in treatment Period 1.'}, {'id': 'OG002', 'title': 'Part A: Cohort 1- GSK3186899 60 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 60 mg on Day 1 in treatment Period 2.'}, {'id': 'OG003', 'title': 'Part A: Cohort 1- GSK3186899 120 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3.'}, {'id': 'OG004', 'title': 'Part A: Cohorts 1 and 2- GSK3186899 300 mg', 'description': 'Participants in Part A received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4 of Cohort 1 and treatment Period 1 of Cohort 2.'}, {'id': 'OG005', 'title': 'Part A: Cohort 2- GSK3186899 600 mg', 'description': 'Participants in Part A Cohort 2 received a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2.'}, {'id': 'OG006', 'title': 'Part A: Cohort 2- GSK3186899 800 mg', 'description': 'Participants in Part A Cohort 2 received a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3.'}, {'id': 'OG007', 'title': 'Part A: Cohort 2- GSK3186899 Dose Level 7', 'description': 'Participants in Part A Cohort 2 were planned to receive dose level 7 on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.'}], 'classes': [{'title': 'Basophils: To low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Basophils: To within range or no change', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}]}, {'title': 'Basophils: To high', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Hematocrit: To low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Hematocrit: To within range or no change', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}]}, {'title': 'Hematocrit: To high', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Hemoglobin: To low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Hemoglobin: To within range or no change', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}]}, {'title': 'Hemoglobin: To high', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Lymphocytes: To low', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Lymphocytes: To within range or no change', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}]}, {'title': 'Lymphocytes: To high', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Monocytes: To low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Monocytes: To within range or no change', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}]}, {'title': 'Monocytes: To high', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Neutrophils: To low', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Neutrophils: To within range or no change', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}]}, {'title': 'Neutrophils: To high', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Platelets: To low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'Platelets: To within range or no change', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}]}, {'title': 'Platelets: To high', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'RBC count: To low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'RBC count: To within range or no change', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}]}, {'title': 'RBC count: To high', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'WBC count: To low', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'WBC count: To within range or no change', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}]}, {'title': 'WBC count: To high', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'MC volume: To low', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'MC volume: To within range or no change', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}]}, {'title': 'MC volume: To high', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'MC Hb: To low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'MC Hb: To within range or no change', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}]}, {'title': 'MC Hb: To high', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Eosinophils: To low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Eosinophils: To within range or no change', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}]}, {'title': 'Eosinophils: To high', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 12', 'description': 'PCI ranges were \\<0.0 or \\>0.1\\*10\\^9 cells per(/)liter(L)(basophils), \\<37 or \\>50 proportion of red blood cells(RBC) in blood(hematocrit),\\<130 or \\>170 grams/L(hemoglobin\\[Hb\\]), \\<1.2 or \\>3.65\\*10\\^9cells(c)/L (lymphocytes),\\<0.2 or \\>1\\*10\\^9c/L(monocytes), \\<2 or \\>7.5\\*10\\^9c/L(neutrophils), \\<150 or \\>400\\*10\\^9 c/L(platelets), \\<3.0 or \\>10\\*10\\^9c/L(white blood cell\\[WBC\\]count), \\<4.4 or \\>5.8\\*10\\^12 c/L(RBC count), \\<80 or \\>99 femtoliter(mean corpuscular\\[MC\\] volume), \\<26.0 or \\>33.5 picogram(MC Hb), \\<0.0 or \\>0.4\\*10\\^9 c/L(eosinophils). Participants were counted in worst case category that their value changes to (low, within range or no change or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High) or whose value became within range, were recorded in To within Range or No Change category.Participants were counted twice if participant had values that changed To Low and To High, so the percentages may not add to 100 percentage(%).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.'}, {'type': 'PRIMARY', 'title': 'Part A- Cohort 3: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 3- GSK3186899 (Fasted) + GSK3186899 (Fed)', 'description': 'Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.'}, {'id': 'OG001', 'title': 'Part A: Cohort 3- GSK3186899 (Fed) + GSK3186899 (Fasted)', 'description': 'Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.'}], 'timeFrame': 'Up to Week 9', 'description': 'Blood samples were planned to be collected to analyze hematology parameters.', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Data was not collected as no participants were enrolled in Part A Cohort 3.'}, {'type': 'PRIMARY', 'title': 'Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Cohort 4- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 4 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'OG001', 'title': 'Part B: Cohort 5- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 5 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'OG002', 'title': 'Part B: Cohort 6- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 6 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}], 'timeFrame': 'Up to Week 9', 'description': 'Blood samples were planned to be collected to analyze hematology parameters.', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Data was not collected as no participants were enrolled in Part B.'}, {'type': 'PRIMARY', 'title': 'Part A- Cohorts 1 and 2: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohorts 1 and 2- Placebo', 'description': 'Participants in Part A Cohorts 1 and 2 received a single dose of placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.'}, {'id': 'OG001', 'title': 'Part A: Cohort 1- GSK3186899 30 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 30 mg on Day 1 in treatment Period 1.'}, {'id': 'OG002', 'title': 'Part A: Cohort 1- GSK3186899 60 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 60 mg on Day 1 in treatment Period 2.'}, {'id': 'OG003', 'title': 'Part A: Cohort 1- GSK3186899 120 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3.'}, {'id': 'OG004', 'title': 'Part A: Cohorts 1 and 2- GSK3186899 300 mg', 'description': 'Participants in Part A received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4 of Cohort 1 and treatment Period 1 of Cohort 2.'}, {'id': 'OG005', 'title': 'Part A: Cohort 2- GSK3186899 600 mg', 'description': 'Participants in Part A Cohort 2 received a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2.'}, {'id': 'OG006', 'title': 'Part A: Cohort 2- GSK3186899 800 mg', 'description': 'Participants in Part A Cohort 2 received a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3.'}, {'id': 'OG007', 'title': 'Part A: Cohort 2- GSK3186899 Dose Level 7', 'description': 'Participants in Part A Cohort 2 were planned to receive dose level 7 on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.'}], 'classes': [{'title': 'Albumin: To low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Albumin: To within range or NC', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}]}, {'title': 'Albumin: To high', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Alkaline phosphatase: To low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Alkaline phosphatase: To within range or NC', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}]}, {'title': 'Alkaline phosphatase: To high', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Alanine aminotransferase: To low', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Alanine aminotransferase: To within range or NC', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}]}, {'title': 'Alanine aminotransferase: To high', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'Aspartate aminotransferase: To low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Aspartate aminotransferase: To within range or NC', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}]}, {'title': 'Aspartate aminotransferase: To high', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'Direct bilirubin: To low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Direct bilirubin: To within range or NC', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}]}, {'title': 'Direct bilirubin: To high', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Bilirubin: To low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Bilirubin: To within range or NC', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}]}, {'title': 'Bilirubin: To high', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Calcium: To low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Calcium: To within range or NC', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}]}, {'title': 'Calcium: To high', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Creatinine: To low', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Creatinine: To within range or NC', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}]}, {'title': 'Creatinine: To high', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Potassium: To low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Potassium: To within range or NC', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}]}, {'title': 'Potassium: To high', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Magnesium: To low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Magnesium: To within range or NC', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}]}, {'title': 'Magnesium: To high', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Phosphate: To low', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'Phosphate: To within range or NC', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}]}, {'title': 'Phosphate: To high', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Protein: To low', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Protein: To within range or NC', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}]}, {'title': 'Protein: To high', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Sodium: To low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Sodium: To within range or NC', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}]}, {'title': 'Sodium: To high', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'C-reactive protein: To low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'C-reactive protein: To within range or NC', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}]}, {'title': 'C-reactive protein: To high', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 12', 'description': 'PCI ranges were \\<34 or \\>50 grams/L(albumin),\\<40 or \\>129 international units/L\\[IU/L\\](alkaline phosphatase),\\<10 or \\>50 IU/L(alanine aminotransferase),\\<0 or \\>37(aspartate aminotransferase), \\<0 or \\>20 micromoles(mcmol)/L (direct bilirubin),\\<0 or \\>20 mcmol/L(bilirubin), \\<2.2 or \\>2.6 millimoles/L(mmol/L)(calcium),\\<66 or \\>112 upper limit of normal mmol/L(creatinine), \\<3.5 or \\>5.1 mmol/L (potassium),\\<0.6 or \\>1 mmol/L (magnesium),\\<0.87 or \\>1.45mmol/L (phosphate),\\<63 or \\>83 g/L (protein),\\<135 or \\>145 mmol/L (sodium), \\<0.0 or \\>5.0 mg/L (C-reactive protein). Participants were counted in worst case category that their value changes to(low, within range \\[WR\\] or no change\\[NC\\] or high), unless there is NC in their category. Participants whose laboratory value category was unchanged (e.g. High to High) or whose value became WR, were recorded in To WR or NC category. Participants were counted twice if participant had values that changed To Low and To High, so percentages may not add to 100%.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.'}, {'type': 'PRIMARY', 'title': 'Part A- Cohort 3: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 3- GSK3186899 (Fasted) + GSK3186899 (Fed)', 'description': 'Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.'}, {'id': 'OG001', 'title': 'Part A: Cohort 3- GSK3186899 (Fed) + GSK3186899 (Fasted)', 'description': 'Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.'}], 'timeFrame': 'Up to Week 9', 'description': 'Blood samples were planned to be collected to analyze chemistry parameters.', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Data was not collected as no participants were enrolled in Part A Cohort 3.'}, {'type': 'PRIMARY', 'title': 'Part B: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Cohort 4- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 4 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'OG001', 'title': 'Part B: Cohort 5- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 5 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'OG002', 'title': 'Part B: Cohort 6- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 6 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}], 'timeFrame': 'Up to Week 9', 'description': 'Blood samples were planned to be collected to analyze chemistry parameters.', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Data was not collected as no participants were enrolled in Part B.'}, {'type': 'PRIMARY', 'title': 'Part A- Cohorts 1 and 2: Number of Participants With Worst-Case Any Increase in Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohorts 1 and 2- Placebo', 'description': 'Participants in Part A Cohorts 1 and 2 received a single dose of placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.'}, {'id': 'OG001', 'title': 'Part A: Cohort 1- GSK3186899 30 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 30 mg on Day 1 in treatment Period 1.'}, {'id': 'OG002', 'title': 'Part A: Cohort 1- GSK3186899 60 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 60 mg on Day 1 in treatment Period 2.'}, {'id': 'OG003', 'title': 'Part A: Cohort 1- GSK3186899 120 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3.'}, {'id': 'OG004', 'title': 'Part A: Cohorts 1 and 2- GSK3186899 300 mg', 'description': 'Participants in Part A received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4 of Cohort 1 and treatment Period 1 of Cohort 2.'}, {'id': 'OG005', 'title': 'Part A: Cohort 2- GSK3186899 600 mg', 'description': 'Participants in Part A Cohort 2 received a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2.'}, {'id': 'OG006', 'title': 'Part A: Cohort 2- GSK3186899 800 mg', 'description': 'Participants in Part A Cohort 2 received a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3.'}, {'id': 'OG007', 'title': 'Part A: Cohort 2- GSK3186899 Dose Level 7', 'description': 'Participants in Part A Cohort 2 were planned to receive dose level 7 on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.'}], 'classes': [{'title': 'Occult blood', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'Protein', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'Ketones', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 12', 'description': 'Urine samples were collected for analysis of occult blood, ketones and protein by a dipstick method. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine occult blood and protein can be read as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Any increase means any increase to trace, 1+, 2+ or 3+ post-Baseline relative to Baseline. Number of participants with worst case any increase in urinalysis results post-Baseline relative to Baseline has been presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.'}, {'type': 'PRIMARY', 'title': 'Part A- Cohort 3: Number of Participants With Worst-Case Any Increase in Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 3- GSK3186899 (Fasted) + GSK3186899 (Fed)', 'description': 'Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.'}, {'id': 'OG001', 'title': 'Part A: Cohort 3- GSK3186899 (Fed) + GSK3186899 (Fasted)', 'description': 'Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.'}], 'timeFrame': 'Up to Week 9', 'description': 'Urine samples were planned to be collected to analyze urine parameters.', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Data was not collected as no participants were enrolled in Part A Cohort 3.'}, {'type': 'PRIMARY', 'title': 'Part B: Number of Participants With Worst-Case Any Increase in Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Cohort 4- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 4 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'OG001', 'title': 'Part B: Cohort 5- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 5 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'OG002', 'title': 'Part B: Cohort 6- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 6 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}], 'timeFrame': 'Up to Week 9', 'description': 'Urine samples were planned to be collected to analyze urine parameters.', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Data was not collected as no participants were enrolled in Part B.'}, {'type': 'PRIMARY', 'title': 'Part A- Cohorts 1 and 2: Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohorts 1 and 2- Placebo', 'description': 'Participants in Part A Cohorts 1 and 2 received a single dose of placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.'}, {'id': 'OG001', 'title': 'Part A: Cohort 1- GSK3186899 30 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 30 mg on Day 1 in treatment Period 1.'}, {'id': 'OG002', 'title': 'Part A: Cohort 1- GSK3186899 60 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 60 mg on Day 1 in treatment Period 2.'}, {'id': 'OG003', 'title': 'Part A: Cohort 1- GSK3186899 120 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3.'}, {'id': 'OG004', 'title': 'Part A: Cohorts 1 and 2- GSK3186899 300 mg', 'description': 'Participants in Part A received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4 of Cohort 1 and treatment Period 1 of Cohort 2.'}, {'id': 'OG005', 'title': 'Part A: Cohort 2- GSK3186899 600 mg', 'description': 'Participants in Part A Cohort 2 received a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2.'}, {'id': 'OG006', 'title': 'Part A: Cohort 2- GSK3186899 800 mg', 'description': 'Participants in Part A Cohort 2 received a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3.'}, {'id': 'OG007', 'title': 'Part A: Cohort 2- GSK3186899 Dose Level 7', 'description': 'Participants in Part A Cohort 2 were planned to receive dose level 7 on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.'}], 'classes': [{'title': 'Abnormal - not clinically significant', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}]}, {'title': 'Abnormal - clinically significant', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 12', 'description': "Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT intervals. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with worst case post-Baseline abnormal ECG findings have been presented.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.'}, {'type': 'PRIMARY', 'title': 'Part A- Cohort 3: Number of Participants With Worst Case Post-Baseline Abnormal ECG Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 3- GSK3186899 (Fasted) + GSK3186899 (Fed)', 'description': 'Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.'}, {'id': 'OG001', 'title': 'Part A: Cohort 3- GSK3186899 (Fed) + GSK3186899 (Fasted)', 'description': 'Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.'}], 'timeFrame': 'Up to Week 9', 'description': 'Twelve lead ECGs were planned to be performed to measure PR interval, QRS duration, QT interval and corrected QT intervals.', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Data was not collected as no participants were enrolled in Part A Cohort 3.'}, {'type': 'PRIMARY', 'title': 'Part B: Number of Participants With Worst Case Post-Baseline Abnormal ECG Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Cohort 4- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 4 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'OG001', 'title': 'Part B: Cohort 5- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 5 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'OG002', 'title': 'Part B: Cohort 6- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 6 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}], 'timeFrame': 'Up to Week 9', 'description': 'Twelve lead ECGs were planned to be performed to measure PR interval, QRS duration, QT interval and corrected QT intervals.', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Data was not collected as no participants were enrolled in Part B.'}, {'type': 'PRIMARY', 'title': 'Part A- Cohorts 1 and 2: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohorts 1 and 2- Placebo', 'description': 'Participants in Part A Cohorts 1 and 2 received a single dose of placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.'}, {'id': 'OG001', 'title': 'Part A: Cohort 1- GSK3186899 30 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 30 mg on Day 1 in treatment Period 1.'}, {'id': 'OG002', 'title': 'Part A: Cohort 1- GSK3186899 60 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 60 mg on Day 1 in treatment Period 2.'}, {'id': 'OG003', 'title': 'Part A: Cohort 1- GSK3186899 120 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3.'}, {'id': 'OG004', 'title': 'Part A: Cohorts 1 and 2- GSK3186899 300 mg', 'description': 'Participants in Part A received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4 of Cohort 1 and treatment Period 1 of Cohort 2.'}, {'id': 'OG005', 'title': 'Part A: Cohort 2- GSK3186899 600 mg', 'description': 'Participants in Part A Cohort 2 received a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2.'}, {'id': 'OG006', 'title': 'Part A: Cohort 2- GSK3186899 800 mg', 'description': 'Participants in Part A Cohort 2 received a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3.'}, {'id': 'OG007', 'title': 'Part A: Cohort 2- GSK3186899 Dose Level 7', 'description': 'Participants in Part A Cohort 2 were planned to receive dose level 7 on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.'}], 'classes': [{'title': 'SBP: To Low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'SBP: To within Range or No Change', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}]}, {'title': 'SBP: To High', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'DBP: To Low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'DBP: To within Range or No Change', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}]}, {'title': 'DBP: To High', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Pulse rate: To Low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Pulse rate: To within Range or No Change', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}]}, {'title': 'Pulse rate: To High', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Respiratory rate: To Low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Respiratory rate: To within Range or No Change', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}]}, {'title': 'Respiratory rate: To High', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Body temperature: To Low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Body temperature: To within Range or No Change', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}]}, {'title': 'Body temperature: To High', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 12', 'description': 'Vital signs included systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse rate, respiratory rate and body temperature and were measured in a semi-supine position after 5 minutes rest. PCI ranges were, SBP (millimeters of mercury \\[mmHg\\]): \\<85 (low) or \\>160 (high), DBP (mmHg): \\<45 (low) or \\>100 (high), pulse rate (beats per minute): \\<40 (low) or \\>110 (high), respiration rate (breaths per minute): \\<10(low) or \\>25(high) and body temperature (degrees Celsius) \\<35 (low) or \\>38 (high). Participants were counted in the worst case category that their value changes to (low, within range or no change, or high), unless there is no change in their category. Participants whose vital signs value category was unchanged (e.g., High to High), or whose value became within range, were recorded in the "To within Range or No Change" category. Participants were counted twice if the participant had values that changed "To Low" and "To High", so the percentages may not add to 100%.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.'}, {'type': 'PRIMARY', 'title': 'Part A- Cohort 3: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 3- GSK3186899 (Fasted) + GSK3186899 (Fed)', 'description': 'Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.'}, {'id': 'OG001', 'title': 'Part A: Cohort 3- GSK3186899 (Fed) + GSK3186899 (Fasted)', 'description': 'Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.'}], 'timeFrame': 'Up to Week 9', 'description': 'Vital signs were planned to be measured in a semi-supine position after 5 minutes of rest.', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Data was not collected as no participants were enrolled in Part A Cohort 3.'}, {'type': 'PRIMARY', 'title': 'Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Cohort 4- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 4 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'OG001', 'title': 'Part B: Cohort 5- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 5 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'OG002', 'title': 'Part B: Cohort 6- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 6 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}], 'timeFrame': 'Up to Week 9', 'description': 'Vital signs were planned to be measured in a semi-supine position after 5 minutes of rest.', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Data was not collected as no participants were enrolled in Part B.'}, {'type': 'PRIMARY', 'title': 'Part A- Cohorts 1 and 2: Number of Participants With Abnormal Cardiac Telemetry Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohorts 1 and 2- Placebo', 'description': 'Participants in Part A Cohorts 1 and 2 received a single dose of placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.'}, {'id': 'OG001', 'title': 'Part A: Cohort 1- GSK3186899 30 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 30 mg on Day 1 in treatment Period 1.'}, {'id': 'OG002', 'title': 'Part A: Cohort 1- GSK3186899 60 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 60 mg on Day 1 in treatment Period 2.'}, {'id': 'OG003', 'title': 'Part A: Cohort 1- GSK3186899 120 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3.'}, {'id': 'OG004', 'title': 'Part A: Cohorts 1 and 2- GSK3186899 300 mg', 'description': 'Participants in Part A received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4 of Cohort 1 and treatment Period 1 of Cohort 2.'}, {'id': 'OG005', 'title': 'Part A: Cohort 2- GSK3186899 600 mg', 'description': 'Participants in Part A Cohort 2 received a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2.'}, {'id': 'OG006', 'title': 'Part A: Cohort 2- GSK3186899 800 mg', 'description': 'Participants in Part A Cohort 2 received a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3.'}, {'id': 'OG007', 'title': 'Part A: Cohort 2- GSK3186899 Dose Level 7', 'description': 'Participants in Part A Cohort 2 were planned to receive dose level 7 on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.'}], 'classes': [{'title': 'Abnormal - not clinically significant', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'Abnormal - clinically significant', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 24 hours post-dose', 'description': "Continuous cardiac telemetry was performed in a supine position after at least 5 minutes of rest. Abnormal findings were categorized as CS and not NCS. Clinically significant abnormal findings were those which were not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.'}, {'type': 'PRIMARY', 'title': 'Part A- Cohort 3: Number of Participants Abnormal Cardiac Telemetry Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 3- GSK3186899 (Fasted) + GSK3186899 (Fed)', 'description': 'Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.'}, {'id': 'OG001', 'title': 'Part A: Cohort 3- GSK3186899 (Fed) + GSK3186899 (Fasted)', 'description': 'Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.'}], 'timeFrame': 'Up to 24 hours post-dose', 'description': 'Continuous cardiac telemetry was planned to be performed in a supine position after at least 5 minutes of rest.', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Data was not collected as no participants were enrolled in Part A Cohort 3.'}, {'type': 'PRIMARY', 'title': 'Part B: Number of Participants Abnormal Cardiac Telemetry Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Cohort 4- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 4 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'OG001', 'title': 'Part B: Cohort 5- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 5 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'OG002', 'title': 'Part B: Cohort 6- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 6 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}], 'timeFrame': 'Up to 24 hours post-dose', 'description': 'Continuous cardiac telemetry was planned to be performed in a supine position after at least 5 minutes of rest.', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Data was not collected as no participants were enrolled in Part B.'}, {'type': 'SECONDARY', 'title': 'Part A- Cohorts 1 and 2: Plasma Concentration After Single Dose Administration of GSK3186899', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 1- GSK3186899 30 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 30 mg on Day 1 in treatment Period 1.'}, {'id': 'OG001', 'title': 'Part A: Cohort 1- GSK3186899 60 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 60 mg on Day 1 in treatment Period 2.'}, {'id': 'OG002', 'title': 'Part A: Cohort 1- GSK3186899 120 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3.'}, {'id': 'OG003', 'title': 'Part A: Cohorts 1 and 2- GSK3186899 300 mg', 'description': 'Participants in Part A received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4 of Cohort 1 and treatment Period 1 of Cohort 2.'}, {'id': 'OG004', 'title': 'Part A: Cohort 2- GSK3186899 600 mg', 'description': 'Participants in Part A Cohort 2 received a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2.'}, {'id': 'OG005', 'title': 'Part A: Cohort 2- GSK3186899 800 mg', 'description': 'Participants in Part A Cohort 2 received a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3.'}, {'id': 'OG006', 'title': 'Part A: Cohort 2- GSK3186899 Dose Level 7', 'description': 'Participants in Part A Cohort 2 were planned to receive dose level 7 on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.'}], 'classes': [{'title': 'Pre-dose', 'categories': [{'measurements': [{'value': '0.000', 'spread': '0.0000', 'groupId': 'OG000'}, {'value': '0.000', 'spread': '0.0000', 'groupId': 'OG001'}, {'value': '0.000', 'spread': '0.0000', 'groupId': 'OG002'}, {'value': '0.000', 'spread': '0.0000', 'groupId': 'OG003'}, {'value': '0.000', 'spread': '0.0000', 'groupId': 'OG004'}, {'value': '0.000', 'spread': '0.0000', 'groupId': 'OG005'}]}]}, {'title': '10 minutes', 'categories': [{'measurements': [{'value': '36.935', 'spread': '43.8179', 'groupId': 'OG000'}, {'value': '10.780', 'spread': '7.4009', 'groupId': 'OG001'}, {'value': '68.788', 'spread': '50.1741', 'groupId': 'OG002'}, {'value': '183.693', 'spread': '151.2143', 'groupId': 'OG003'}, {'value': '528.360', 'spread': '530.7085', 'groupId': 'OG004'}, {'value': '766.898', 'spread': '691.4467', 'groupId': 'OG005'}]}]}, {'title': '30 minutes', 'categories': [{'measurements': [{'value': '182.825', 'spread': '69.0839', 'groupId': 'OG000'}, {'value': '220.846', 'spread': '78.8200', 'groupId': 'OG001'}, {'value': '817.218', 'spread': '528.0808', 'groupId': 'OG002'}, {'value': '2112.646', 'spread': '943.7797', 'groupId': 'OG003'}, {'value': '5337.077', 'spread': '1679.9417', 'groupId': 'OG004'}, {'value': '7563.453', 'spread': '3748.7402', 'groupId': 'OG005'}]}]}, {'title': '1 hour', 'categories': [{'measurements': [{'value': '246.298', 'spread': '89.0970', 'groupId': 'OG000'}, {'value': '308.820', 'spread': '76.3337', 'groupId': 'OG001'}, {'value': '1217.430', 'spread': '414.4935', 'groupId': 'OG002'}, {'value': '2445.121', 'spread': '846.7178', 'groupId': 'OG003'}, {'value': '6213.155', 'spread': '2228.1232', 'groupId': 'OG004'}, {'value': '8148.812', 'spread': '3230.8260', 'groupId': 'OG005'}]}]}, {'title': '1.5 hours', 'categories': [{'measurements': [{'value': '193.372', 'spread': '75.7409', 'groupId': 'OG000'}, {'value': '292.106', 'spread': '70.6847', 'groupId': 'OG001'}, {'value': '1165.735', 'spread': '405.0558', 'groupId': 'OG002'}, {'value': '2809.873', 'spread': '731.2502', 'groupId': 'OG003'}, {'value': '6676.070', 'spread': '1731.9990', 'groupId': 'OG004'}, {'value': '7828.908', 'spread': '1936.6359', 'groupId': 'OG005'}]}]}, {'title': '2 hours', 'categories': [{'measurements': [{'value': '169.883', 'spread': '79.6579', 'groupId': 'OG000'}, {'value': '266.122', 'spread': '76.2478', 'groupId': 'OG001'}, {'value': '1019.690', 'spread': '317.4601', 'groupId': 'OG002'}, {'value': '2740.957', 'spread': '919.9618', 'groupId': 'OG003'}, {'value': '6388.922', 'spread': '1338.2507', 'groupId': 'OG004'}, {'value': '8139.085', 'spread': '1761.2188', 'groupId': 'OG005'}]}]}, {'title': '2.5 hours', 'categories': [{'measurements': [{'value': '143.448', 'spread': '69.7562', 'groupId': 'OG000'}, {'value': '296.102', 'spread': '44.6567', 'groupId': 'OG001'}, {'value': '981.000', 'spread': '287.9601', 'groupId': 'OG002'}, {'value': '2661.372', 'spread': '869.2819', 'groupId': 'OG003'}, {'value': '6930.995', 'spread': '1697.9608', 'groupId': 'OG004'}, {'value': '7714.882', 'spread': '2565.6688', 'groupId': 'OG005'}]}]}, {'title': '3 hours', 'categories': [{'measurements': [{'value': '124.742', 'spread': '67.6108', 'groupId': 'OG000'}, {'value': '297.366', 'spread': '98.0691', 'groupId': 'OG001'}, {'value': '841.170', 'spread': '203.0633', 'groupId': 'OG002'}, {'value': '2496.468', 'spread': '751.3136', 'groupId': 'OG003'}, {'value': '7377.713', 'spread': '1718.2385', 'groupId': 'OG004'}, {'value': '8306.098', 'spread': '2966.1881', 'groupId': 'OG005'}]}]}, {'title': '4 hours', 'categories': [{'measurements': [{'value': '71.845', 'spread': '41.2573', 'groupId': 'OG000'}, {'value': '211.540', 'spread': '98.3222', 'groupId': 'OG001'}, {'value': '586.375', 'spread': '187.1841', 'groupId': 'OG002'}, {'value': '2202.511', 'spread': '908.6908', 'groupId': 'OG003'}, {'value': '5230.308', 'spread': '1817.4993', 'groupId': 'OG004'}, {'value': '6492.033', 'spread': '2264.4485', 'groupId': 'OG005'}]}]}, {'title': '5 hours', 'categories': [{'measurements': [{'value': '48.675', 'spread': '29.1569', 'groupId': 'OG000'}, {'value': '149.386', 'spread': '77.3929', 'groupId': 'OG001'}, {'value': '407.900', 'spread': '132.1951', 'groupId': 'OG002'}, {'value': '1715.797', 'spread': '818.4628', 'groupId': 'OG003'}, {'value': '3910.825', 'spread': '1174.7813', 'groupId': 'OG004'}, {'value': '5828.517', 'spread': '1559.1849', 'groupId': 'OG005'}]}]}, {'title': '6 hours', 'categories': [{'measurements': [{'value': '33.648', 'spread': '18.7418', 'groupId': 'OG000'}, {'value': '109.636', 'spread': '61.8823', 'groupId': 'OG001'}, {'value': '318.288', 'spread': '101.9840', 'groupId': 'OG002'}, {'value': '1413.953', 'spread': '714.4323', 'groupId': 'OG003'}, {'value': '3752.580', 'spread': '662.1178', 'groupId': 'OG004'}, {'value': '5010.553', 'spread': '1424.1685', 'groupId': 'OG005'}]}]}, {'title': '8 hours', 'categories': [{'measurements': [{'value': '19.023', 'spread': '12.4100', 'groupId': 'OG000'}, {'value': '58.322', 'spread': '30.3314', 'groupId': 'OG001'}, {'value': '180.300', 'spread': '67.3578', 'groupId': 'OG002'}, {'value': '1008.525', 'spread': '554.8121', 'groupId': 'OG003'}, {'value': '3196.830', 'spread': '1133.3168', 'groupId': 'OG004'}, {'value': '4352.842', 'spread': '1510.7803', 'groupId': 'OG005'}]}]}, {'title': '10 hours', 'categories': [{'measurements': [{'value': '9.447', 'spread': '6.7790', 'groupId': 'OG000'}, {'value': '30.156', 'spread': '14.0233', 'groupId': 'OG001'}, {'value': '111.350', 'spread': '40.8868', 'groupId': 'OG002'}, {'value': '673.839', 'spread': '419.1869', 'groupId': 'OG003'}, {'value': '2571.757', 'spread': '1287.9872', 'groupId': 'OG004'}, {'value': '3519.375', 'spread': '1243.8441', 'groupId': 'OG005'}]}]}, {'title': '12 hours', 'categories': [{'measurements': [{'value': '4.975', 'spread': '3.8146', 'groupId': 'OG000'}, {'value': '14.662', 'spread': '9.4905', 'groupId': 'OG001'}, {'value': '53.978', 'spread': '33.6205', 'groupId': 'OG002'}, {'value': '394.246', 'spread': '259.4013', 'groupId': 'OG003'}, {'value': '1818.825', 'spread': '952.8830', 'groupId': 'OG004'}, {'value': '2676.418', 'spread': '1366.8170', 'groupId': 'OG005'}]}]}, {'title': '24 hours', 'categories': [{'measurements': [{'value': '0.000', 'spread': '0.0000', 'groupId': 'OG000'}, {'value': '1.526', 'spread': '1.0015', 'groupId': 'OG001'}, {'value': '4.078', 'spread': '1.2666', 'groupId': 'OG002'}, {'value': '39.462', 'spread': '31.0353', 'groupId': 'OG003'}, {'value': '457.593', 'spread': '549.4177', 'groupId': 'OG004'}, {'value': '787.852', 'spread': '862.1917', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment period', 'description': 'Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK3186899. PK Population consisted of all participants in the Safety Population who received at least 1 non-missing PK assessment.', 'unitOfMeasure': 'Nanogram per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population. Only those participants with data available at the specified time points were analyzed. Data for Part A: Cohorts 1 and 2- GSK3186899 300 mg arm was presented in a single arm because of similar dosing strategies as pre-defined in the protocol.Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.'}, {'type': 'SECONDARY', 'title': 'Part A- Cohort 3: Plasma Concentration After Single Dose Administration of GSK3186899', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 3- GSK3186899 (Fasted) + GSK3186899 (Fed)', 'description': 'Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.'}, {'id': 'OG001', 'title': 'Part A: Cohort 3- GSK3186899 (Fed) + GSK3186899 (Fasted)', 'description': 'Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.'}], 'timeFrame': 'Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment period', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population. Data was not collected as no participants were enrolled in Part A Cohort 3.'}, {'type': 'SECONDARY', 'title': 'Part A- Cohorts 1 and 2: Area Under the Plasma Concentration-time Curve From Time 0 to Last Time of Quantifiable Concentration (AUC[0-t]) After Single Dose Administration of GSK3186899', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 1- GSK3186899 30 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 30 mg on Day 1 in treatment Period 1.'}, {'id': 'OG001', 'title': 'Part A: Cohort 1- GSK3186899 60 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 60 mg on Day 1 in treatment Period 2.'}, {'id': 'OG002', 'title': 'Part A: Cohort 1- GSK3186899 120 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3.'}, {'id': 'OG003', 'title': 'Part A: Cohorts 1 and 2- GSK3186899 300 mg', 'description': 'Participants in Part A received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4 of Cohort 1 and treatment Period 1 of Cohort 2.'}, {'id': 'OG004', 'title': 'Part A: Cohort 2- GSK3186899 600 mg', 'description': 'Participants in Part A Cohort 2 received a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2.'}, {'id': 'OG005', 'title': 'Part A: Cohort 2- GSK3186899 800 mg', 'description': 'Participants in Part A Cohort 2 received a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3.'}, {'id': 'OG006', 'title': 'Part A: Cohort 2- GSK3186899 Dose Level 7', 'description': 'Participants in Part A Cohort 2 were planned to receive dose level 7 on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.'}], 'classes': [{'categories': [{'measurements': [{'value': '725.40', 'spread': '41.62', 'groupId': 'OG000'}, {'value': '1597.85', 'spread': '32.30', 'groupId': 'OG001'}, {'value': '5268.31', 'spread': '31.32', 'groupId': 'OG002'}, {'value': '18105.45', 'spread': '47.08', 'groupId': 'OG003'}, {'value': '58201.67', 'spread': '29.14', 'groupId': 'OG004'}, {'value': '77531.24', 'spread': '34.57', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment period', 'description': 'Blood samples were collected at indicated time points for PK analysis of GSK3186899.', 'unitOfMeasure': 'Hours*nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population. Only those participants with data available at the specified time points were analyzed. Data for Part A: Cohorts 1 and 2- GSK3186899 300 mg arm was presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.'}, {'type': 'SECONDARY', 'title': 'Part A- Cohort 3: AUC(0-t) After Single Dose Administration of GSK3186899', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 3- GSK3186899 (Fasted) + GSK3186899 (Fed)', 'description': 'Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.'}, {'id': 'OG001', 'title': 'Part A: Cohort 3- GSK3186899 (Fed) + GSK3186899 (Fasted)', 'description': 'Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.'}], 'timeFrame': 'Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment period', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population. Data was not collected as no participants were enrolled in Part A Cohort 3.'}, {'type': 'SECONDARY', 'title': 'Part A- Cohorts 1 and 2: Area Under the Plasma Concentration-time Curve From Time 0 to Extrapolated to Infinity (AUC[0-infinity]) After Single Dose Administration of GSK3186899', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 1- GSK3186899 30 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 30 mg on Day 1 in treatment Period 1.'}, {'id': 'OG001', 'title': 'Part A: Cohort 1- GSK3186899 60 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 60 mg on Day 1 in treatment Period 2.'}, {'id': 'OG002', 'title': 'Part A: Cohort 1- GSK3186899 120 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3.'}, {'id': 'OG003', 'title': 'Part A: Cohorts 1 and 2- GSK3186899 300 mg', 'description': 'Participants in Part A received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4 of Cohort 1 and treatment Period 1 of Cohort 2.'}, {'id': 'OG004', 'title': 'Part A: Cohort 2- GSK3186899 600 mg', 'description': 'Participants in Part A Cohort 2 received a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2.'}, {'id': 'OG005', 'title': 'Part A: Cohort 2- GSK3186899 800 mg', 'description': 'Participants in Part A Cohort 2 received a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3.'}, {'id': 'OG006', 'title': 'Part A: Cohort 2- GSK3186899 Dose Level 7', 'description': 'Participants in Part A Cohort 2 were planned to receive dose level 7 on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.'}], 'classes': [{'categories': [{'measurements': [{'value': '739.13', 'spread': '42.31', 'groupId': 'OG000'}, {'value': '1607.27', 'spread': '32.10', 'groupId': 'OG001'}, {'value': '5287.60', 'spread': '31.20', 'groupId': 'OG002'}, {'value': '18265.32', 'spread': '47.50', 'groupId': 'OG003'}, {'value': '61539.43', 'spread': '35.59', 'groupId': 'OG004'}, {'value': '83867.58', 'spread': '42.98', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment period', 'description': 'Blood samples were collected at indicated time points for PK analysis of GSK3186899.', 'unitOfMeasure': 'Hours*nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population. Only those participants with data available at the specified time points were analyzed. Data for Part A: Cohorts 1 and 2- GSK3186899 300 mg arm was presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.'}, {'type': 'SECONDARY', 'title': 'Part A- Cohort 3: AUC(0-infinity) After Single Dose Administration of GSK3186899', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 3- GSK3186899 (Fasted) + GSK3186899 (Fed)', 'description': 'Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.'}, {'id': 'OG001', 'title': 'Part A: Cohort 3- GSK3186899 (Fed) + GSK3186899 (Fasted)', 'description': 'Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.'}], 'timeFrame': 'Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment period', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population. Data was not collected as no participants were enrolled in Part A Cohort 3.'}, {'type': 'SECONDARY', 'title': 'Part A- Cohorts 1 and 2: Maximum Observed Plasma Drug Concentration (Cmax) After Single Dose Administration of GSK3186899', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 1- GSK3186899 30 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 30 mg on Day 1 in treatment Period 1.'}, {'id': 'OG001', 'title': 'Part A: Cohort 1- GSK3186899 60 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 60 mg on Day 1 in treatment Period 2.'}, {'id': 'OG002', 'title': 'Part A: Cohort 1- GSK3186899 120 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3.'}, {'id': 'OG003', 'title': 'Part A: Cohorts 1 and 2- GSK3186899 300 mg', 'description': 'Participants in Part A received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4 of Cohort 1 and treatment Period 1 of Cohort 2.'}, {'id': 'OG004', 'title': 'Part A: Cohort 2- GSK3186899 600 mg', 'description': 'Participants in Part A Cohort 2 received a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2.'}, {'id': 'OG005', 'title': 'Part A: Cohort 2- GSK3186899 800 mg', 'description': 'Participants in Part A Cohort 2 received a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3.'}, {'id': 'OG006', 'title': 'Part A: Cohort 2- GSK3186899 Dose Level 7', 'description': 'Participants in Part A Cohort 2 were planned to receive dose level 7 on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.'}], 'classes': [{'categories': [{'measurements': [{'value': '239.206', 'spread': '34.38', 'groupId': 'OG000'}, {'value': '356.232', 'spread': '19.32', 'groupId': 'OG001'}, {'value': '1214.000', 'spread': '29.72', 'groupId': 'OG002'}, {'value': '3011.334', 'spread': '37.57', 'groupId': 'OG003'}, {'value': '8219.997', 'spread': '15.50', 'groupId': 'OG004'}, {'value': '9445.301', 'spread': '28.78', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment period', 'description': 'Blood samples were collected at indicated time points for PK analysis of GSK3186899.', 'unitOfMeasure': 'Nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population. Only those participants with data available at the specified time points were analyzed. Data for Part A: Cohorts 1 and 2- GSK3186899 300 mg arm was presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.'}, {'type': 'SECONDARY', 'title': 'Part A- Cohort 3: Cmax After Single Dose Administration of GSK3186899', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 3- GSK3186899 (Fasted) + GSK3186899 (Fed)', 'description': 'Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.'}, {'id': 'OG001', 'title': 'Part A: Cohort 3- GSK3186899 (Fed) + GSK3186899 (Fasted)', 'description': 'Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.'}], 'timeFrame': 'Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment period', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population. Data was not collected as no participants were enrolled in Part A Cohort 3.'}, {'type': 'SECONDARY', 'title': 'Part A- Cohorts 1 and 2: Time to Maximum Observed Plasma Drug Concentration (Tmax) After Single Dose Administration of GSK3186899', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 1- GSK3186899 30 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 30 mg on Day 1 in treatment Period 1.'}, {'id': 'OG001', 'title': 'Part A: Cohort 1- GSK3186899 60 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 60 mg on Day 1 in treatment Period 2.'}, {'id': 'OG002', 'title': 'Part A: Cohort 1- GSK3186899 120 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3.'}, {'id': 'OG003', 'title': 'Part A: Cohorts 1 and 2- GSK3186899 300 mg', 'description': 'Participants in Part A received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4 of Cohort 1 and treatment Period 1 of Cohort 2.'}, {'id': 'OG004', 'title': 'Part A: Cohort 2- GSK3186899 600 mg', 'description': 'Participants in Part A Cohort 2 received a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2.'}, {'id': 'OG005', 'title': 'Part A: Cohort 2- GSK3186899 800 mg', 'description': 'Participants in Part A Cohort 2 received a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3.'}, {'id': 'OG006', 'title': 'Part A: Cohort 2- GSK3186899 Dose Level 7', 'description': 'Participants in Part A Cohort 2 were planned to receive dose level 7 on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '1.5'}, {'value': '3.00', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '3.0'}, {'value': '1.00', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '1.5'}, {'value': '2.00', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '4.0'}, {'value': '2.75', 'groupId': 'OG004', 'lowerLimit': '1.0', 'upperLimit': '3.0'}, {'value': '2.50', 'groupId': 'OG005', 'lowerLimit': '1.0', 'upperLimit': '4.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment period', 'description': 'Blood samples were collected at indicated time points for PK analysis of GSK3186899.', 'unitOfMeasure': 'Hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population. Only those participants with data available at the specified time points were analyzed. Data for Part A: Cohorts 1 and 2- GSK3186899 300 mg arm was presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.'}, {'type': 'SECONDARY', 'title': 'Part A- Cohort 3: Tmax After Single Dose Administration of GSK3186899', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 3- GSK3186899 (Fasted) + GSK3186899 (Fed)', 'description': 'Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.'}, {'id': 'OG001', 'title': 'Part A: Cohort 3- GSK3186899 (Fed) + GSK3186899 (Fasted)', 'description': 'Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.'}], 'timeFrame': 'Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment period', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population. Data was not collected as no participants were enrolled in Part A Cohort 3.'}, {'type': 'SECONDARY', 'title': 'Part A- Cohorts 1 and 2: Trough Plasma Concentration (Ctau) After Single Dose Administration of GSK3186899', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 1- GSK3186899 30 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 30 mg on Day 1 in treatment Period 1.'}, {'id': 'OG001', 'title': 'Part A: Cohort 1- GSK3186899 60 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 60 mg on Day 1 in treatment Period 2.'}, {'id': 'OG002', 'title': 'Part A: Cohort 1- GSK3186899 120 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3.'}, {'id': 'OG003', 'title': 'Part A: Cohorts 1 and 2- GSK3186899 300 mg', 'description': 'Participants in Part A received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4 of Cohort 1 and treatment Period 1 of Cohort 2.'}, {'id': 'OG004', 'title': 'Part A: Cohort 2- GSK3186899 600 mg', 'description': 'Participants in Part A Cohort 2 received a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2.'}, {'id': 'OG005', 'title': 'Part A: Cohort 2- GSK3186899 800 mg', 'description': 'Participants in Part A Cohort 2 received a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3.'}, {'id': 'OG006', 'title': 'Part A: Cohort 2- GSK3186899 Dose Level 7', 'description': 'Participants in Part A Cohort 2 were planned to receive dose level 7 on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.'}], 'timeFrame': 'Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment period', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population. Data was not collected for this endpoint as it was incorrectly stated as one of the Secondary Endpoint in Objectives and Endpoints section of the Protocol, where the reference to Ctau for single ascending dose part was an error. Data for Part A: Cohorts 1 and 2- GSK3186899 300 mg arm was planned to be presented in a single arm because of similar dosing strategies as pre-defined in the protocol.'}, {'type': 'SECONDARY', 'title': 'Part A- Cohort 3: Ctau After Single Dose Administration of GSK3186899', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 3- GSK3186899 (Fasted) + GSK3186899 (Fed)', 'description': 'Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.'}, {'id': 'OG001', 'title': 'Part A: Cohort 3- GSK3186899 (Fed) + GSK3186899 (Fasted)', 'description': 'Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.'}], 'timeFrame': 'Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment period', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population. Data was not collected as no participants were enrolled in Part A Cohort 3.'}, {'type': 'SECONDARY', 'title': 'Part A- Cohorts 1 and 2: Apparent Terminal Half-life (T1/2) After Single Dose Administration of GSK3186899', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 1- GSK3186899 30 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 30 mg on Day 1 in treatment Period 1.'}, {'id': 'OG001', 'title': 'Part A: Cohort 1- GSK3186899 60 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 60 mg on Day 1 in treatment Period 2.'}, {'id': 'OG002', 'title': 'Part A: Cohort 1- GSK3186899 120 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3.'}, {'id': 'OG003', 'title': 'Part A: Cohorts 1 and 2- GSK3186899 300 mg', 'description': 'Participants in Part A received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4 of Cohort 1 and treatment Period 1 of Cohort 2.'}, {'id': 'OG004', 'title': 'Part A: Cohort 2- GSK3186899 600 mg', 'description': 'Participants in Part A Cohort 2 received a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2.'}, {'id': 'OG005', 'title': 'Part A: Cohort 2- GSK3186899 800 mg', 'description': 'Participants in Part A Cohort 2 received a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3.'}, {'id': 'OG006', 'title': 'Part A: Cohort 2- GSK3186899 Dose Level 7', 'description': 'Participants in Part A Cohort 2 were planned to receive dose level 7 on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.982', 'groupId': 'OG000', 'lowerLimit': '1.44', 'upperLimit': '2.44'}, {'value': '2.955', 'groupId': 'OG001', 'lowerLimit': '1.66', 'upperLimit': '3.50'}, {'value': '2.758', 'groupId': 'OG002', 'lowerLimit': '2.58', 'upperLimit': '3.93'}, {'value': '3.302', 'groupId': 'OG003', 'lowerLimit': '2.65', 'upperLimit': '3.98'}, {'value': '4.655', 'groupId': 'OG004', 'lowerLimit': '3.22', 'upperLimit': '8.93'}, {'value': '5.135', 'groupId': 'OG005', 'lowerLimit': '4.32', 'upperLimit': '10.78'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment period', 'description': 'Blood samples were collected at indicated time points for PK analysis of GSK3186899.', 'unitOfMeasure': 'Hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population. Only those participants with data available at the specified time points were analyzed. Data for Part A: Cohorts 1 and 2- GSK3186899 300 mg arm was presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.'}, {'type': 'SECONDARY', 'title': 'Part A- Cohort 3: T1/2 After Single Dose Administration of GSK3186899', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 3- GSK3186899 (Fasted) + GSK3186899 (Fed)', 'description': 'Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.'}, {'id': 'OG001', 'title': 'Part A: Cohort 3- GSK3186899 (Fed) + GSK3186899 (Fasted)', 'description': 'Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.'}], 'timeFrame': 'Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment period', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population. Data was not collected as no participants were enrolled in Part A Cohort 3.'}, {'type': 'SECONDARY', 'title': 'Part A- Cohorts 1 and 2: Predicted Accumulation Ratio After Single Dose Administration of GSK3186899', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 1- GSK3186899 30 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 30 mg on Day 1 in treatment Period 1.'}, {'id': 'OG001', 'title': 'Part A: Cohort 1- GSK3186899 60 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 60 mg on Day 1 in treatment Period 2.'}, {'id': 'OG002', 'title': 'Part A: Cohort 1- GSK3186899 120 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3.'}, {'id': 'OG003', 'title': 'Part A: Cohorts 1 and 2- GSK3186899 300 mg', 'description': 'Participants in Part A received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4 of Cohort 1 and treatment Period 1 of Cohort 2.'}, {'id': 'OG004', 'title': 'Part A: Cohort 2- GSK3186899 600 mg', 'description': 'Participants in Part A Cohort 2 received a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2.'}, {'id': 'OG005', 'title': 'Part A: Cohort 2- GSK3186899 800 mg', 'description': 'Participants in Part A Cohort 2 received a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3.'}, {'id': 'OG006', 'title': 'Part A: Cohort 2- GSK3186899 Dose Level 7', 'description': 'Participants in Part A Cohort 2 were planned to receive dose level 7 on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0183', 'spread': '0.01324', 'groupId': 'OG000'}, {'value': '1.0631', 'spread': '0.03952', 'groupId': 'OG001'}, {'value': '1.0704', 'spread': '0.04505', 'groupId': 'OG002'}, {'value': '1.0889', 'spread': '0.03246', 'groupId': 'OG003'}, {'value': '1.2603', 'spread': '0.19948', 'groupId': 'OG004'}, {'value': '1.3429', 'spread': '0.26138', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment period', 'description': 'Blood samples were collected at indicated time points for PK analysis of GSK3186899. Predicted accumulation ratio is calculated as 1/(1-e\\^\\[k\\*tau\\]) where k is elimination rate constant following the single dose and tau is the dosing interval for the intended repeat dosing.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population. Only those participants with data available at the specified time points were analyzed. Data for Part A: Cohorts 1 and 2- GSK3186899 300 mg arm was presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.'}, {'type': 'SECONDARY', 'title': 'Part A- Cohort 3: Predicted Accumulation Ratio After Single Dose Administration of GSK3186899', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 3- GSK3186899 (Fasted) + GSK3186899 (Fed)', 'description': 'Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.'}, {'id': 'OG001', 'title': 'Part A: Cohort 3- GSK3186899 (Fed) + GSK3186899 (Fasted)', 'description': 'Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.'}], 'timeFrame': 'Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment period', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population. Data was not collected as no participants were enrolled in Part A Cohort 3.'}, {'type': 'SECONDARY', 'title': 'Part B: Plasma Concentration After Repeat Dose Administration of GSK3186899', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Cohort 4- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 4 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'OG001', 'title': 'Part B: Cohort 5- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 5 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'OG002', 'title': 'Part B: Cohort 6- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 6 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}], 'timeFrame': 'Days 1 and 10: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Days 2 to 9: Pre-dose', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population. Data was not collected as no participants were enrolled in Part B.'}, {'type': 'SECONDARY', 'title': 'Part B: AUC(0-t) After Repeat Dose Administration of GSK3186899', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Cohort 4- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 4 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'OG001', 'title': 'Part B: Cohort 5- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 5 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'OG002', 'title': 'Part B: Cohort 6- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 6 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}], 'timeFrame': 'Days 1 and 10: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Days 2 to 9: Pre-dose', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population. Data was not collected as no participants were enrolled in Part B.'}, {'type': 'SECONDARY', 'title': 'Part B: AUC(0-infinity) After Repeat Dose Administration of GSK3186899', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Cohort 4- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 4 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'OG001', 'title': 'Part B: Cohort 5- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 5 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'OG002', 'title': 'Part B: Cohort 6- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 6 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}], 'timeFrame': 'Days 1 and 10: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Days 2 to 9: Pre-dose', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population. Data was not collected as no participants were enrolled in Part B.'}, {'type': 'SECONDARY', 'title': 'Part B: Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval (AUC[0-tau]) After Repeat Dose Administration of GSK3186899', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Cohort 4- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 4 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'OG001', 'title': 'Part B: Cohort 5- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 5 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'OG002', 'title': 'Part B: Cohort 6- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 6 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}], 'timeFrame': 'Days 1 and 10: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Days 2 to 9: Pre-dose', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population. Data was not collected as no participants were enrolled in Part B.'}, {'type': 'SECONDARY', 'title': 'Part B: Cmax After Repeat Dose Administration of GSK3186899', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Cohort 4- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 4 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'OG001', 'title': 'Part B: Cohort 5- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 5 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'OG002', 'title': 'Part B: Cohort 6- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 6 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}], 'timeFrame': 'Days 1 and 10: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Days 2 to 9: Pre-dose', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population. Data was not collected as no participants were enrolled in Part B.'}, {'type': 'SECONDARY', 'title': 'Part B: Tmax After Repeat Dose Administration of GSK3186899', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Cohort 4- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 4 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'OG001', 'title': 'Part B: Cohort 5- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 5 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'OG002', 'title': 'Part B: Cohort 6- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 6 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}], 'timeFrame': 'Days 1 and 10: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Days 2 to 9: Pre-dose', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population. Data was not collected as no participants were enrolled in Part B.'}, {'type': 'SECONDARY', 'title': 'Part B: T1/2 After Repeat Dose Administration of GSK3186899', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Cohort 4- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 4 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'OG001', 'title': 'Part B: Cohort 5- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 5 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'OG002', 'title': 'Part B: Cohort 6- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 6 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}], 'timeFrame': 'Days 1 and 10: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Days 2 to 9: Pre-dose', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population. Data was not collected as no participants were enrolled in Part B.'}, {'type': 'SECONDARY', 'title': 'Part A- Cohorts 1 and 2: Dose-proportionality of GSK3186899 Administered as Single Dose Based on AUC(0-infinity)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohorts 1 and 2- GSK3186899 30 to 800 mg', 'description': 'Participants in Part A received a single dose of GSK3186899 30, 60, 120, 300, 600 and 800 mg in any of the treatment Periods of Cohorts 1 or 2 according to randomization schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.47', 'groupId': 'OG000', 'lowerLimit': '1.34', 'upperLimit': '1.61'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment period', 'description': 'Blood samples were collected at indicated time points for PK analysis. Dose proportionality was assessed using Power model with fixed effects of logarithm of treatment and participant as random effect. Slope and 90% confidence interval for the slope are presented.', 'unitOfMeasure': 'Slope of log dose', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population. Only those participants with data available at the specified time points were analyzed. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.'}, {'type': 'SECONDARY', 'title': 'Part A- Cohort 3: Dose-proportionality of GSK3186899 Administered as Single Dose Based on AUC(0-infinity)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 3- GSK3186899 (Fasted) + GSK3186899 (Fed)', 'description': 'Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.'}, {'id': 'OG001', 'title': 'Part A: Cohort 3- GSK3186899 (Fed) + GSK3186899 (Fasted)', 'description': 'Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.'}], 'timeFrame': 'Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment period', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis.', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population. Data was not collected as no participants were enrolled in Part A Cohort 3.'}, {'type': 'SECONDARY', 'title': 'Part A- Cohorts 1 and 2: Dose-proportionality of GSK3186899 Administered as Single Dose Based on Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohorts 1 and 2- GSK3186899 30 to 800 mg', 'description': 'Participants in Part A received a single dose of GSK3186899 30, 60, 120, 300, 600 and 800 mg in any of the treatment Periods of Cohorts 1 or 2 according to randomization schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.19', 'groupId': 'OG000', 'lowerLimit': '1.09', 'upperLimit': '1.30'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment period', 'description': 'Blood samples were collected at indicated time points for PK analysis. Dose proportionality was assessed using Power model with fixed effects of logarithm of treatment and participant as random effect. Slope and 90% confidence interval for the slope are presented.', 'unitOfMeasure': 'Slope of log dose', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population. Only those participants with data available at the specified time points were analyzed. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.'}, {'type': 'SECONDARY', 'title': 'Part A- Cohort 3: Dose-proportionality of GSK3186899 Administered as Single Dose Based on Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 3- GSK3186899 (Fasted) + GSK3186899 (Fed)', 'description': 'Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.'}, {'id': 'OG001', 'title': 'Part A: Cohort 3- GSK3186899 (Fed) + GSK3186899 (Fasted)', 'description': 'Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.'}], 'timeFrame': 'Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment period', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis.', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population. Data was not collected as no participants were enrolled in Part A Cohort 3.'}, {'type': 'SECONDARY', 'title': 'Part B: Dose-proportionality of GSK3186899 Administered as Repeat Dose Based on AUC(0-tau)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Cohort 4- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 4 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'OG001', 'title': 'Part B: Cohort 5- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 5 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'OG002', 'title': 'Part B: Cohort 6- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 6 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}], 'timeFrame': 'Days 1 and 10: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Days 2 to 9: Pre-dose', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis.', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population. Data was not collected as no participants were enrolled in Part B.'}, {'type': 'SECONDARY', 'title': 'Part B: Dose-proportionality of GSK3186899 Administered as Repeat Dose Based on Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Cohort 4- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 4 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'OG001', 'title': 'Part B: Cohort 5- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 5 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'OG002', 'title': 'Part B: Cohort 6- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 6 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}], 'timeFrame': 'Days 1 and 10: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Days 2 to 9: Pre-dose', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis.', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population. Data was not collected as no participants were enrolled in Part B.'}, {'type': 'SECONDARY', 'title': 'Part B: Dose-proportionality of GSK3186899 Administered as Repeat Dose Based on Ctau', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Cohort 4- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 4 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'OG001', 'title': 'Part B: Cohort 5- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 5 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'OG002', 'title': 'Part B: Cohort 6- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 6 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}], 'timeFrame': 'Days 1 and 10: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Days 2 to 9: Pre-dose', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis.', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population. Data was not collected as no participants were enrolled in Part B.'}, {'type': 'SECONDARY', 'title': 'Part B: Relative Accumulation Ratio of GSK3186899 After Repeat Dose Administration by AUC(0-tau)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Cohort 4- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 4 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'OG001', 'title': 'Part B: Cohort 5- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 5 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'OG002', 'title': 'Part B: Cohort 6- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 6 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}], 'timeFrame': 'Days 1 and 10: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis. Accumulation ratio was planned to be calculated as ratio of AUC(0-tau) at Day 10 to AUC(0-tau) at Day 1.', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population. Data was not collected as no participants were enrolled in Part B.'}, {'type': 'SECONDARY', 'title': 'Part B: Relative Accumulation Ratio of GSK3186899 After Repeat Dose Administration by Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Cohort 4- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 4 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'OG001', 'title': 'Part B: Cohort 5- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 5 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'OG002', 'title': 'Part B: Cohort 6- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 6 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}], 'timeFrame': 'Days 1 and 10: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis. Accumulation ratio was planned to be calculated as ratio of Cmax at Day 10 to Cmax at Day 1.', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population. Data was not collected as no participants were enrolled in Part B.'}, {'type': 'SECONDARY', 'title': 'Part B: Relative Accumulation Ratio of GSK3186899 After Repeat Dose Administration by Ctau', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Cohort 4- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 4 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'OG001', 'title': 'Part B: Cohort 5- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 5 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'OG002', 'title': 'Part B: Cohort 6- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 6 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}], 'timeFrame': 'Days 1 and 10: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis. Accumulation ratio was planned to be calculated as ratio of Ctau at Day 10 to Ctau at Day 1.', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population. Data was not collected as no participants were enrolled in Part B.'}, {'type': 'SECONDARY', 'title': 'Part B: Time Invariance Ratio of GSK3186899 After Repeat Dose Administration Using AUC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Cohort 4- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 4 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'OG001', 'title': 'Part B: Cohort 5- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 5 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'OG002', 'title': 'Part B: Cohort 6- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 6 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}], 'timeFrame': 'Days 1 and 10: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis. Time-invariance ratio was planned to be calculated as AUC(0-12) on Day 10 to AUC(0-infinity) on Day 1.', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population. Data was not collected as no participants were enrolled in Part B.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part A: Cohort 1-GSK3186899 30 mg/60 mg/120 mg/Placebo', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 30 milligram (mg) on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 60 mg on Day 1 in treatment Period 2; followed by a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3; further followed by a single dose of Placebo on Day 1 in treatment Period 4. There was a washout period of 10 days between each treatment period.'}, {'id': 'FG001', 'title': 'Part A:Cohort 1-GSK3186899 30 mg/60 mg/Placebo/300 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 30 mg on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 60 mg on Day 1 in treatment Period 2; followed by a single dose of Placebo on Day 1 in treatment Period 3; further followed by a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4. There was a washout period of 10 days between each treatment period.'}, {'id': 'FG002', 'title': 'Part A:Cohort 1-GSK3186899 30 mg/Placebo/120 mg/300 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 30 mg on Day 1 in treatment Period 1; followed by a single dose of Placebo on Day 1 in treatment Period 2; followed by a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3; further followed by a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4. There was a washout period of 10 days between each treatment period.'}, {'id': 'FG003', 'title': 'Part A:Cohort 1-Placebo/GSK3186899 60 mg/120 mg/300 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of Placebo on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 60 mg on Day 1 in treatment Period 2; followed by a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3; further followed by a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4. There was a washout period of 10 days between each treatment period.'}, {'id': 'FG004', 'title': 'Part A:Cohort 2-GSK3186899 300 mg/600 mg/800 mg/Placebo', 'description': 'Participants in Part A Cohort 2 received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2; followed by a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3; further followed by a single dose of Placebo on Day 1 in treatment Period 4. There was a washout period of 10 days between each treatment period.'}, {'id': 'FG005', 'title': 'Part A:Cohort 2-GSK3186899 300 mg/600 mg/Placebo/Dose Level 7', 'description': 'Participants in Part A Cohort 2 received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2; followed by a single dose of Placebo on Day 1 in treatment Period 3; further followed by dose level 7 was planned to receive on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended. There was a washout period of 10 days between each treatment period.'}, {'id': 'FG006', 'title': 'Part A:Cohort 2-GSK3186899 300 mg/Placebo/800 mg/Dose Level 7', 'description': 'Participants in Part A Cohort 2 received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 1; followed by a single dose of Placebo on Day 1 in treatment Period 2; followed by a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3; further followed by dose level 7 was planned to receive on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended. There was a washout period of 10 days between each treatment period.'}, {'id': 'FG007', 'title': 'Part A:Cohort 2-Placebo/GSK3186899 600 mg/800 mg/Dose Level 7', 'description': 'Participants in Part A Cohort 2 received a single dose of Placebo on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2; followed by a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3; further followed by dose level 7 was planned to receive on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended. There was a washout period of 10 days between each treatment period.'}, {'id': 'FG008', 'title': 'Part A: Cohort 3- GSK3186899 (Fasted) + GSK3186899 (Fed)', 'description': 'Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.'}, {'id': 'FG009', 'title': 'Part A: Cohort 3- GSK3186899 (Fed) + GSK3186899 (Fasted)', 'description': 'Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.'}, {'id': 'FG010', 'title': 'Part B: Cohort 4- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 4 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'FG011', 'title': 'Part B: Cohort 5- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 5 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'FG012', 'title': 'Part B: Cohort 6- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 6 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}], 'periods': [{'title': 'Part A: Cohort 1-Period 1 (Day1)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Safety Population Consisted of All Randomized Participants Who Received at Least 1 Dose of Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}]}, {'title': 'PartA:Cohort1-WashoutPeriod1(Upto Day10)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}]}, {'title': 'Part A: Cohort 1-Period 2 (Day1)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'comment': 'New participant enrolled and dosed', 'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Safety Population Consisted of All Randomized Participants Who Received at Least 1 Dose of Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}]}, {'title': 'PartA:Cohort1-WashoutPeriod2(Upto Day10)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}]}, {'title': 'Part A: Cohort 1-Period 3 (Day1)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'New participant enrolled and dosed.', 'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Safety Population Consisted of All Randomized Participants Who Received at Least 1 Dose of Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 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'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}]}, {'title': 'PartA:Cohort1-WashoutPeriod3(Upto Day10)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}]}, {'title': 'Part A: Cohort 1-Period 4 (Day1)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'comment': 'New participant enrolled and dosed.', 'groupId': 'FG003', 'numSubjects': '2'}, 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Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, 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{'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}]}, {'title': 'PartA:Cohort2-WashoutPeriod1(Upto Day10)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}]}, {'title': 'Part A: Cohort 2-Period 2 (Day1)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'comment': 'New participant enrolled and dosed.', 'groupId': 'FG004', 'numSubjects': '2'}, {'comment': 'New participant enrolled and dosed.', 'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'comment': 'New participant enrolled and dosed.', 'groupId': 'FG007', 'numSubjects': '2'}, 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'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}]}, {'title': 'PartA:Cohort2-WashoutPeriod2(Upto Day10)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}]}, {'title': 'Part A: Cohort 2-Period 3 (Day1)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'comment': 'New participant enrolled and dosed.', 'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'comment': 'New participant enrolled and dosed.', 'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Safety Population Consisted of All Randomized Participants Who Received at Least 1 Dose of Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}]}, {'title': 'PartA:Cohort2-WashoutPeriod3(Upto Day10)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}]}, {'title': 'Part A: Cohort 2-Period 4 (Day1)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}]}, {'title': 'Part A: Cohort 3- Period 1 (Day 1)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}]}, {'title': 'PartA:Cohort3-WashoutPeriod (Upto Day10)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}]}, {'title': 'Part A: Cohort 3- Period 2 (Day 1)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}]}, {'title': 'Part B: Cohorts 4 to 6 (Days 1 to 10)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This was 2-part study. Part A comprised of 3 Cohorts (Cohorts 1, 2 and 3); Part B comprised 3 cohorts (Cohorts 4, 5 and 6). Study was terminated after completion of Cohort 2, Period 3 of Part A following strategic review after emergence of nonclinical data with non-GlaxoSmithKline asset. Hence, no participants were enrolled in Cohort 2 Period 4 and Cohort 3 of Part A and in all Cohorts of Part B.', 'preAssignmentDetails': 'A total 25 participants were enrolled (Enrolled Population consisted of all participants who passed screening and entered the study) in this study (Part A: Cohort 1- 11 participants, Cohort 2- 14 participants). Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '24', 'groupId': 'BG013'}]}], 'groups': [{'id': 'BG000', 'title': 'Part A: Cohort 1-GSK3186899 30 mg/60 mg/120 mg/Placebo', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 30 milligram (mg) on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 60 mg on Day 1 in treatment Period 2; followed by a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3; further followed by a single dose of Placebo on Day 1 in treatment Period 4. There was a washout period of 10 days between each treatment period.'}, {'id': 'BG001', 'title': 'Part A:Cohort 1-GSK3186899 30 mg/60 mg/Placebo/300 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 30 mg on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 60 mg on Day 1 in treatment Period 2; followed by a single dose of Placebo on Day 1 in treatment Period 3; further followed by a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4. There was a washout period of 10 days between each treatment period.'}, {'id': 'BG002', 'title': 'Part A:Cohort 1-GSK3186899 30 mg/Placebo/120 mg/300 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of GSK3186899 30 mg on Day 1 in treatment Period 1; followed by a single dose of Placebo on Day 1 in treatment Period 2; followed by a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3; further followed by a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4. There was a washout period of 10 days between each treatment period.'}, {'id': 'BG003', 'title': 'Part A:Cohort 1-Placebo/GSK3186899 60 mg/120 mg/300 mg', 'description': 'Participants in Part A Cohort 1 received a single dose of Placebo on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 60 mg on Day 1 in treatment Period 2; followed by a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3; further followed by a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4. There was a washout period of 10 days between each treatment period.'}, {'id': 'BG004', 'title': 'Part A:Cohort 2-GSK3186899 300 mg/600 mg/800 mg/Placebo', 'description': 'Participants in Part A Cohort 2 received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2; followed by a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3; further followed by a single dose of Placebo on Day 1 in treatment Period 4. There was a washout period of 10 days between each treatment period.'}, {'id': 'BG005', 'title': 'Part A:Cohort 2-GSK3186899 300 mg/600 mg/Placebo/Dose Level 7', 'description': 'Participants in Part A Cohort 2 received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2; followed by a single dose of Placebo on Day 1 in treatment Period 3; further followed by dose level 7 was planned to receive on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended. There was a washout period of 10 days between each treatment period.'}, {'id': 'BG006', 'title': 'Part A:Cohort 2-GSK3186899 300 mg/Placebo/800 mg/Dose Level 7', 'description': 'Participants in Part A Cohort 2 received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 1; followed by a single dose of Placebo on Day 1 in treatment Period 2; followed by a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3; further followed by dose level 7 was planned to receive on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended. There was a washout period of 10 days between each treatment period.'}, {'id': 'BG007', 'title': 'Part A:Cohort 2-Placebo/GSK3186899 600 mg/800 mg/Dose Level 7', 'description': 'Participants in Part A Cohort 2 received a single dose of Placebo on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2; followed by a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3; further followed by dose level 7 was planned to receive on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended. There was a washout period of 10 days between each treatment period.'}, {'id': 'BG008', 'title': 'Part A: Cohort 3- GSK3186899 (Fasted) + GSK3186899 (Fed)', 'description': 'Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.'}, {'id': 'BG009', 'title': 'Part A: Cohort 3- GSK3186899 (Fed) + GSK3186899 (Fasted)', 'description': 'Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.'}, {'id': 'BG010', 'title': 'Part B: Cohort 4- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 4 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'BG011', 'title': 'Part B: Cohort 5- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 5 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'BG012', 'title': 'Part B: Cohort 6- GSK3186899 or Placebo', 'description': 'Participants in Part B Cohort 6 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.'}, {'id': 'BG013', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.7', 'spread': '6.51', 'groupId': 'BG000'}, {'value': '34.0', 'spread': '1.41', 'groupId': 'BG001'}, {'value': '33.0', 'spread': '8.49', 'groupId': 'BG002'}, {'value': '31.3', 'spread': '8.77', 'groupId': 'BG003'}, {'value': '34.5', 'spread': '13.20', 'groupId': 'BG004'}, {'value': '37.3', 'spread': '4.04', 'groupId': 'BG005'}, {'value': '39.7', 'spread': '8.50', 'groupId': 'BG006'}, {'value': '41.0', 'spread': '10.54', 'groupId': 'BG007'}, {'value': '36.9', 'spread': '8.76', 'groupId': 'BG013'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline characteristics were reported for Safety Population which consisted of all randomized participants who received at least one dose of study treatment.', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '24', 'groupId': 'BG013'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Baseline characteristics were reported for Safety Population which consisted of all randomized participants who received at least one dose of study treatment.', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Asian - Central/South Asian Heritage', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '1', 'groupId': 'BG013'}]}, {'title': 'Asian - South East Asian Heritage', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '1', 'groupId': 'BG013'}]}, {'title': 'White - White/Caucasian/European Heritage', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '19', 'groupId': 'BG013'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '2', 'groupId': 'BG013'}]}, {'title': 'Mixed Race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '1', 'groupId': 'BG013'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Baseline characteristics were reported for Safety Population which consisted of all randomized participants who received at least one dose of study treatment.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'This study was terminated after completion of Cohort 2, Period 3 of Part A following strategic review after emergence of nonclinical data with non-GlaxoSmithKline asset. Hence, no participants were enrolled in Cohort 2 Period 4 and Cohort 3 of Part A and in all Cohorts of Part B. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-19', 'size': 1220236, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-03-04T06:20', 'hasProtocol': True}, {'date': '2019-11-21', 'size': 1157967, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-03-04T06:25', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'This will be a double-blind study. Subjects and Investigator will be blinded to the study treatment.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Subjects will receive escalating doses of GSK3186899 and placebo in Part A of the study. Subjects will receive repeat doses either of GSK3186899 or placebo in Part B of the study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'whyStopped': 'The trial was terminated early following strategic review after emergence of nonclinical data with a non-GlaxoSmithKline asset.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2019-10-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-24', 'studyFirstSubmitDate': '2019-03-12', 'resultsFirstSubmitDate': '2022-05-24', 'studyFirstSubmitQcDate': '2019-03-12', 'lastUpdatePostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-05-24', 'studyFirstPostDateStruct': {'date': '2019-03-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part A- Cohorts 1 and 2: Number of Participants With Non-serious Adverse Events (Non-SAEs) and SAEs', 'timeFrame': 'Up to Week 12', 'description': 'An adverse event (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. A 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, important medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the outcomes listed above. Safety Population consisted of all randomized participants who received at least one dose of study treatment.'}, {'measure': 'Part A- Cohort 3: Number of Participants With Non-SAEs and SAEs', 'timeFrame': 'Up to Week 9', 'description': 'An adverse event (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. A 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, important medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the outcomes listed above.'}, {'measure': 'Part B: Number of Participants With Non-SAEs and SAEs', 'timeFrame': 'Up to Week 9', 'description': 'An adverse event (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. A 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, important medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the outcomes listed above.'}, {'measure': 'Part A- Cohorts 1 and 2: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline', 'timeFrame': 'Up to Week 12', 'description': 'PCI ranges were \\<0.0 or \\>0.1\\*10\\^9 cells per(/)liter(L)(basophils), \\<37 or \\>50 proportion of red blood cells(RBC) in blood(hematocrit),\\<130 or \\>170 grams/L(hemoglobin\\[Hb\\]), \\<1.2 or \\>3.65\\*10\\^9cells(c)/L (lymphocytes),\\<0.2 or \\>1\\*10\\^9c/L(monocytes), \\<2 or \\>7.5\\*10\\^9c/L(neutrophils), \\<150 or \\>400\\*10\\^9 c/L(platelets), \\<3.0 or \\>10\\*10\\^9c/L(white blood cell\\[WBC\\]count), \\<4.4 or \\>5.8\\*10\\^12 c/L(RBC count), \\<80 or \\>99 femtoliter(mean corpuscular\\[MC\\] volume), \\<26.0 or \\>33.5 picogram(MC Hb), \\<0.0 or \\>0.4\\*10\\^9 c/L(eosinophils). Participants were counted in worst case category that their value changes to (low, within range or no change or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High) or whose value became within range, were recorded in To within Range or No Change category.Participants were counted twice if participant had values that changed To Low and To High, so the percentages may not add to 100 percentage(%).'}, {'measure': 'Part A- Cohort 3: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline', 'timeFrame': 'Up to Week 9', 'description': 'Blood samples were planned to be collected to analyze hematology parameters.'}, {'measure': 'Part B: Number of Participants With Worst Case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline', 'timeFrame': 'Up to Week 9', 'description': 'Blood samples were planned to be collected to analyze hematology parameters.'}, {'measure': 'Part A- Cohorts 1 and 2: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline', 'timeFrame': 'Up to Week 12', 'description': 'PCI ranges were \\<34 or \\>50 grams/L(albumin),\\<40 or \\>129 international units/L\\[IU/L\\](alkaline phosphatase),\\<10 or \\>50 IU/L(alanine aminotransferase),\\<0 or \\>37(aspartate aminotransferase), \\<0 or \\>20 micromoles(mcmol)/L (direct bilirubin),\\<0 or \\>20 mcmol/L(bilirubin), \\<2.2 or \\>2.6 millimoles/L(mmol/L)(calcium),\\<66 or \\>112 upper limit of normal mmol/L(creatinine), \\<3.5 or \\>5.1 mmol/L (potassium),\\<0.6 or \\>1 mmol/L (magnesium),\\<0.87 or \\>1.45mmol/L (phosphate),\\<63 or \\>83 g/L (protein),\\<135 or \\>145 mmol/L (sodium), \\<0.0 or \\>5.0 mg/L (C-reactive protein). Participants were counted in worst case category that their value changes to(low, within range \\[WR\\] or no change\\[NC\\] or high), unless there is NC in their category. Participants whose laboratory value category was unchanged (e.g. High to High) or whose value became WR, were recorded in To WR or NC category. Participants were counted twice if participant had values that changed To Low and To High, so percentages may not add to 100%.'}, {'measure': 'Part A- Cohort 3: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline', 'timeFrame': 'Up to Week 9', 'description': 'Blood samples were planned to be collected to analyze chemistry parameters.'}, {'measure': 'Part B: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline', 'timeFrame': 'Up to Week 9', 'description': 'Blood samples were planned to be collected to analyze chemistry parameters.'}, {'measure': 'Part A- Cohorts 1 and 2: Number of Participants With Worst-Case Any Increase in Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method', 'timeFrame': 'Up to Week 12', 'description': 'Urine samples were collected for analysis of occult blood, ketones and protein by a dipstick method. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine occult blood and protein can be read as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Any increase means any increase to trace, 1+, 2+ or 3+ post-Baseline relative to Baseline. Number of participants with worst case any increase in urinalysis results post-Baseline relative to Baseline has been presented.'}, {'measure': 'Part A- Cohort 3: Number of Participants With Worst-Case Any Increase in Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method', 'timeFrame': 'Up to Week 9', 'description': 'Urine samples were planned to be collected to analyze urine parameters.'}, {'measure': 'Part B: Number of Participants With Worst-Case Any Increase in Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method', 'timeFrame': 'Up to Week 9', 'description': 'Urine samples were planned to be collected to analyze urine parameters.'}, {'measure': 'Part A- Cohorts 1 and 2: Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings', 'timeFrame': 'Up to Week 12', 'description': "Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT intervals. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with worst case post-Baseline abnormal ECG findings have been presented."}, {'measure': 'Part A- Cohort 3: Number of Participants With Worst Case Post-Baseline Abnormal ECG Findings', 'timeFrame': 'Up to Week 9', 'description': 'Twelve lead ECGs were planned to be performed to measure PR interval, QRS duration, QT interval and corrected QT intervals.'}, {'measure': 'Part B: Number of Participants With Worst Case Post-Baseline Abnormal ECG Findings', 'timeFrame': 'Up to Week 9', 'description': 'Twelve lead ECGs were planned to be performed to measure PR interval, QRS duration, QT interval and corrected QT intervals.'}, {'measure': 'Part A- Cohorts 1 and 2: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline', 'timeFrame': 'Up to Week 12', 'description': 'Vital signs included systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse rate, respiratory rate and body temperature and were measured in a semi-supine position after 5 minutes rest. PCI ranges were, SBP (millimeters of mercury \\[mmHg\\]): \\<85 (low) or \\>160 (high), DBP (mmHg): \\<45 (low) or \\>100 (high), pulse rate (beats per minute): \\<40 (low) or \\>110 (high), respiration rate (breaths per minute): \\<10(low) or \\>25(high) and body temperature (degrees Celsius) \\<35 (low) or \\>38 (high). Participants were counted in the worst case category that their value changes to (low, within range or no change, or high), unless there is no change in their category. Participants whose vital signs value category was unchanged (e.g., High to High), or whose value became within range, were recorded in the "To within Range or No Change" category. Participants were counted twice if the participant had values that changed "To Low" and "To High", so the percentages may not add to 100%.'}, {'measure': 'Part A- Cohort 3: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline', 'timeFrame': 'Up to Week 9', 'description': 'Vital signs were planned to be measured in a semi-supine position after 5 minutes of rest.'}, {'measure': 'Part B: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline', 'timeFrame': 'Up to Week 9', 'description': 'Vital signs were planned to be measured in a semi-supine position after 5 minutes of rest.'}, {'measure': 'Part A- Cohorts 1 and 2: Number of Participants With Abnormal Cardiac Telemetry Findings', 'timeFrame': 'Up to 24 hours post-dose', 'description': "Continuous cardiac telemetry was performed in a supine position after at least 5 minutes of rest. Abnormal findings were categorized as CS and not NCS. Clinically significant abnormal findings were those which were not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition."}, {'measure': 'Part A- Cohort 3: Number of Participants Abnormal Cardiac Telemetry Findings', 'timeFrame': 'Up to 24 hours post-dose', 'description': 'Continuous cardiac telemetry was planned to be performed in a supine position after at least 5 minutes of rest.'}, {'measure': 'Part B: Number of Participants Abnormal Cardiac Telemetry Findings', 'timeFrame': 'Up to 24 hours post-dose', 'description': 'Continuous cardiac telemetry was planned to be performed in a supine position after at least 5 minutes of rest.'}], 'secondaryOutcomes': [{'measure': 'Part A- Cohorts 1 and 2: Plasma Concentration After Single Dose Administration of GSK3186899', 'timeFrame': 'Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment period', 'description': 'Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK3186899. PK Population consisted of all participants in the Safety Population who received at least 1 non-missing PK assessment.'}, {'measure': 'Part A- Cohort 3: Plasma Concentration After Single Dose Administration of GSK3186899', 'timeFrame': 'Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment period', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.'}, {'measure': 'Part A- Cohorts 1 and 2: Area Under the Plasma Concentration-time Curve From Time 0 to Last Time of Quantifiable Concentration (AUC[0-t]) After Single Dose Administration of GSK3186899', 'timeFrame': 'Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment period', 'description': 'Blood samples were collected at indicated time points for PK analysis of GSK3186899.'}, {'measure': 'Part A- Cohort 3: AUC(0-t) After Single Dose Administration of GSK3186899', 'timeFrame': 'Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment period', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.'}, {'measure': 'Part A- Cohorts 1 and 2: Area Under the Plasma Concentration-time Curve From Time 0 to Extrapolated to Infinity (AUC[0-infinity]) After Single Dose Administration of GSK3186899', 'timeFrame': 'Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment period', 'description': 'Blood samples were collected at indicated time points for PK analysis of GSK3186899.'}, {'measure': 'Part A- Cohort 3: AUC(0-infinity) After Single Dose Administration of GSK3186899', 'timeFrame': 'Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment period', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.'}, {'measure': 'Part A- Cohorts 1 and 2: Maximum Observed Plasma Drug Concentration (Cmax) After Single Dose Administration of GSK3186899', 'timeFrame': 'Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment period', 'description': 'Blood samples were collected at indicated time points for PK analysis of GSK3186899.'}, {'measure': 'Part A- Cohort 3: Cmax After Single Dose Administration of GSK3186899', 'timeFrame': 'Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment period', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.'}, {'measure': 'Part A- Cohorts 1 and 2: Time to Maximum Observed Plasma Drug Concentration (Tmax) After Single Dose Administration of GSK3186899', 'timeFrame': 'Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment period', 'description': 'Blood samples were collected at indicated time points for PK analysis of GSK3186899.'}, {'measure': 'Part A- Cohort 3: Tmax After Single Dose Administration of GSK3186899', 'timeFrame': 'Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment period', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.'}, {'measure': 'Part A- Cohorts 1 and 2: Trough Plasma Concentration (Ctau) After Single Dose Administration of GSK3186899', 'timeFrame': 'Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment period', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.'}, {'measure': 'Part A- Cohort 3: Ctau After Single Dose Administration of GSK3186899', 'timeFrame': 'Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment period', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.'}, {'measure': 'Part A- Cohorts 1 and 2: Apparent Terminal Half-life (T1/2) After Single Dose Administration of GSK3186899', 'timeFrame': 'Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment period', 'description': 'Blood samples were collected at indicated time points for PK analysis of GSK3186899.'}, {'measure': 'Part A- Cohort 3: T1/2 After Single Dose Administration of GSK3186899', 'timeFrame': 'Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment period', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.'}, {'measure': 'Part A- Cohorts 1 and 2: Predicted Accumulation Ratio After Single Dose Administration of GSK3186899', 'timeFrame': 'Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment period', 'description': 'Blood samples were collected at indicated time points for PK analysis of GSK3186899. Predicted accumulation ratio is calculated as 1/(1-e\\^\\[k\\*tau\\]) where k is elimination rate constant following the single dose and tau is the dosing interval for the intended repeat dosing.'}, {'measure': 'Part A- Cohort 3: Predicted Accumulation Ratio After Single Dose Administration of GSK3186899', 'timeFrame': 'Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment period', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.'}, {'measure': 'Part B: Plasma Concentration After Repeat Dose Administration of GSK3186899', 'timeFrame': 'Days 1 and 10: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Days 2 to 9: Pre-dose', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.'}, {'measure': 'Part B: AUC(0-t) After Repeat Dose Administration of GSK3186899', 'timeFrame': 'Days 1 and 10: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Days 2 to 9: Pre-dose', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.'}, {'measure': 'Part B: AUC(0-infinity) After Repeat Dose Administration of GSK3186899', 'timeFrame': 'Days 1 and 10: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Days 2 to 9: Pre-dose', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.'}, {'measure': 'Part B: Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval (AUC[0-tau]) After Repeat Dose Administration of GSK3186899', 'timeFrame': 'Days 1 and 10: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Days 2 to 9: Pre-dose', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.'}, {'measure': 'Part B: Cmax After Repeat Dose Administration of GSK3186899', 'timeFrame': 'Days 1 and 10: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Days 2 to 9: Pre-dose', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.'}, {'measure': 'Part B: Tmax After Repeat Dose Administration of GSK3186899', 'timeFrame': 'Days 1 and 10: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Days 2 to 9: Pre-dose', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.'}, {'measure': 'Part B: T1/2 After Repeat Dose Administration of GSK3186899', 'timeFrame': 'Days 1 and 10: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Days 2 to 9: Pre-dose', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.'}, {'measure': 'Part A- Cohorts 1 and 2: Dose-proportionality of GSK3186899 Administered as Single Dose Based on AUC(0-infinity)', 'timeFrame': 'Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment period', 'description': 'Blood samples were collected at indicated time points for PK analysis. Dose proportionality was assessed using Power model with fixed effects of logarithm of treatment and participant as random effect. Slope and 90% confidence interval for the slope are presented.'}, {'measure': 'Part A- Cohort 3: Dose-proportionality of GSK3186899 Administered as Single Dose Based on AUC(0-infinity)', 'timeFrame': 'Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment period', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis.'}, {'measure': 'Part A- Cohorts 1 and 2: Dose-proportionality of GSK3186899 Administered as Single Dose Based on Cmax', 'timeFrame': 'Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment period', 'description': 'Blood samples were collected at indicated time points for PK analysis. Dose proportionality was assessed using Power model with fixed effects of logarithm of treatment and participant as random effect. Slope and 90% confidence interval for the slope are presented.'}, {'measure': 'Part A- Cohort 3: Dose-proportionality of GSK3186899 Administered as Single Dose Based on Cmax', 'timeFrame': 'Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment period', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis.'}, {'measure': 'Part B: Dose-proportionality of GSK3186899 Administered as Repeat Dose Based on AUC(0-tau)', 'timeFrame': 'Days 1 and 10: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Days 2 to 9: Pre-dose', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis.'}, {'measure': 'Part B: Dose-proportionality of GSK3186899 Administered as Repeat Dose Based on Cmax', 'timeFrame': 'Days 1 and 10: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Days 2 to 9: Pre-dose', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis.'}, {'measure': 'Part B: Dose-proportionality of GSK3186899 Administered as Repeat Dose Based on Ctau', 'timeFrame': 'Days 1 and 10: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Days 2 to 9: Pre-dose', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis.'}, {'measure': 'Part B: Relative Accumulation Ratio of GSK3186899 After Repeat Dose Administration by AUC(0-tau)', 'timeFrame': 'Days 1 and 10: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis. Accumulation ratio was planned to be calculated as ratio of AUC(0-tau) at Day 10 to AUC(0-tau) at Day 1.'}, {'measure': 'Part B: Relative Accumulation Ratio of GSK3186899 After Repeat Dose Administration by Cmax', 'timeFrame': 'Days 1 and 10: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis. Accumulation ratio was planned to be calculated as ratio of Cmax at Day 10 to Cmax at Day 1.'}, {'measure': 'Part B: Relative Accumulation Ratio of GSK3186899 After Repeat Dose Administration by Ctau', 'timeFrame': 'Days 1 and 10: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis. Accumulation ratio was planned to be calculated as ratio of Ctau at Day 10 to Ctau at Day 1.'}, {'measure': 'Part B: Time Invariance Ratio of GSK3186899 After Repeat Dose Administration Using AUC', 'timeFrame': 'Days 1 and 10: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose', 'description': 'Blood samples were planned to be collected at indicated time points for PK analysis. Time-invariance ratio was planned to be calculated as AUC(0-12) on Day 10 to AUC(0-infinity) on Day 1.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dose escalation phase', 'First time in human', 'Single ascending dose', 'Multiple ascending dose', 'GSK3186899'], 'conditions': ['Leishmaniasis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety, tolerability and PK profile of single and repeat ascending doses of GSK3186899 in healthy subjects. This is a Phase 1 first time in human study, to investigate the effect of food on PK of GSK3186899. This study will consists of two parts. Part A (dose escalation phase) will be a single ascending, sequential cross-over design in cohorts 1, 2 and 3 of subjects. Cohort 1 and 2 will be 4-way cross-over which includes 4 dosing regimens of GSK3186899 and placebo (3:1 ratio) under fasted conditions. Cohort 3 will be 2-way cross-over which includes 2 treatment periods, 2 dosing regimens in fasted and fed conditions. In Part B (repeat dose escalation phase) subjects will be randomized to receive repeat doses of either GSK3186899 or placebo (3:1 ratio) in either fed or fasted conditions. Part B will be conducted based on the review of all safety, tolerability and PK data from Part A. The study duration includes screening, treatment periods and follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria\n\n* Subject must be 18 to 55 years of age inclusive, at the time of signing the informed consent.\n* Healthy as determined by the Investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the normal reference range for the population being studied may be included only if the Investigator in consultation with the Medical Monitor (if required) agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.\n* Body weight \\>=50 kilogram (kg) and body mass index (BMI) within the range 18.5 to 28 kilogram per square meter (kg/m\\^2) (inclusive).\n* Male and/or female subjects: A male subject with a female partner of reproductive potential must agree to use contraception during the treatment period and for at least 90 days after the last dose of study treatment and refrain from donating sperm during this period. A female subject is eligible to participate if she is not a woman of childbearing potential (WONCBP).\n* Capable of giving signed informed consent.\n\nExclusion Criteria\n\n* History or presence of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study treatment; or interfering with the interpretation of data.\n* Previous history of leishmaniasis.\n* ALT \\>1.5\\* upper limit of normal (ULN).\n* Bilirubin \\>1.5\\*ULN (isolated bilirubin \\>1.5\\*ULN is acceptable if bilirubin is fractionated and direct bilirubin \\<35 percent).\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* Current or past history of clinically significant gastritis or gastroduodenal ulcers or regular use of non-steroidal anti-inflammatory drugs (NSAID).\n* ECG QT interval corrected for heart rate (QTc) \\>450 milliseconds (msec).\n* Past or intended use of over-the-counter or prescription medication, including herbal medications, NSAIDs, proton-pump inhibitors (PPIs) or anti-H2 antagonists within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is the longest) prior to dosing. Other concomitant medication may be considered on a case by case basis by the Investigator in consultation with the medical monitor.\n* Participation in the study would result in loss of blood or blood products in excess of 500 milliliter (mL) within a 56-day period.\n* Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.\n* The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).\n* Sensitivity to any of the study treatments, or components thereof, or drug or other allergy that, in the opinion of the Investigator or GlaxoSmithKline (GSK) Medical Monitor, contraindicates participation in the study.\n* Regular use of known drugs of abuse.\n* Subjects with renal function defined as Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) with an age appropriate glomerular filtration rate (GFR) \\<=80 (mL/minute/1.73m\\^2).\n* Presence of Hepatitis B surface antigen (HBsAg) or Positive Hepatitis C antibody test result at screening.\n* Positive human immunodeficiency virus (HIV) antibody test.\n* Positive pre-study drug/alcohol screen.\n* Presence of clinically significant hematuria and/or proteinuria.\n* Carbon monoxide levels indicative of smoking or history or regular use of tobacco or nicotine-containing products within 3 months prior to screening.\n* Part A (Food effect) Cohort 3 only: Subject must have no dietary restrictions (example, lactose intolerance) or inability to eat an adapted standard meal (includes 35-40 percent fat content).\n* Part A (Food effect) Cohort 3 only: History of gall bladder surgery or gall bladder removal, or history of an acute disease state (example, cholelithiasis) within 14 days prior to receiving the study treatment.\n* Part B only: Early morning cortisol \\<420 nanomoles per liter (nmol/L) and inadequate response (rise of \\<250 millimoles per liter (mmol/L) from Baseline) to adrenocorticotropic hormone (ACTH) stimulation test at Day -1."}, 'identificationModule': {'nctId': 'NCT03874234', 'briefTitle': 'Safety, Tolerability and Pharmacokinetics (PKs) Investigation of GSK3186899 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Randomized, Double-blind (Sponsor Unblinded), Placebo-controlled, First Time in Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single (in Both Fed and Fasted States) and Repeat Doses of GSK3186899 in Healthy Participants', 'orgStudyIdInfo': {'id': '208436'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A: Subjects receiving GSK3186899 + placebo in Cohort 1', 'description': 'Subjects will receive 3 single ascending oral doses (SAD) of GSK3186899 and 1 dose of placebo as spray dried powder, under fasted conditions on Day 1 of cohort 1 in each of the four treatment periods. In each treatment period GSK3186899 and placebo will be administered in a 3:1 ratio. A wash out period of at least 10 days will be maintained between each treatment period.', 'interventionNames': ['Drug: GSK3186899', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: Subjects receiving GSK3186899 + placebo in Cohort 2', 'description': 'Subjects will receive 3 SAD of GSK3186899 and 1 dose of placebo as spray dried powder, under fasted conditions on Day 1 of cohort 2 in each of the four treatment periods. In each treatment period GSK3186899 and placebo will be administered in a 3:1 ratio. A wash out period of at least 10 days will be maintained between each treatment period.', 'interventionNames': ['Drug: GSK3186899', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: Subjects receiving GSK3186899 in Cohort 3', 'description': 'Subjects will receive GSK3186899 orally, under fasted condition and fed conditions on Day 1 of cohort 3 in each of the two treatment periods. There will be a wash out period of at least 10 days between each treatment period. A dose level will be determined based on the effect of food on the safety, tolerability and PK of a single dose of GSK3186899, with dose level selected from Cohorts 1 and 2.', 'interventionNames': ['Drug: GSK3186899']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: Subjects receiving GSK3186899', 'description': 'Subjects will receive GSK3186899, orally, twice daily (BID) on Days 1 to 10. Subjects will receive each dose after either fed or fasted conditions. Part B will be initiated based on the review of all safety, tolerability and PK data from Part A.', 'interventionNames': ['Drug: GSK3186899']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part B: Subjects receiving placebo', 'description': 'Subjects will receive placebo, orally, BID on Days 1 to 10. Subjects will receive each dose after either fed or fasted conditions. Part B will be initiated based on the review of all safety, tolerability and PK data from Part A.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'GSK3186899', 'type': 'DRUG', 'description': 'GSK3186899 will be available as white to slightly colored, spray dried powder in a bottle to be administered orally along with mixture of propylene glycol and water.', 'armGroupLabels': ['Part A: Subjects receiving GSK3186899 + placebo in Cohort 1', 'Part A: Subjects receiving GSK3186899 + placebo in Cohort 2', 'Part A: Subjects receiving GSK3186899 in Cohort 3', 'Part B: Subjects receiving GSK3186899']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo will be available as white to slightly colored, blend powder in a bottle to be administered orally along with mixture of propylene glycol and water.', 'armGroupLabels': ['Part A: Subjects receiving GSK3186899 + placebo in Cohort 1', 'Part A: Subjects receiving GSK3186899 + placebo in Cohort 2', 'Part B: Subjects receiving placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CB2 2GG', 'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, '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'}, 'responsibleParty': {'type': 'SPONSOR'}}}}