Viewing Study NCT01597635

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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-24 @ 10:44 PM

Ignite Modification Date: 2025-12-30 @ 5:59 PM

Study NCT ID: NCT01597635

Status: COMPLETED

Last Update Posted: 2017-09-28

First Post: 2012-01-26

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: The Safety, Tolerability, PK and PD of GSK2586881 in Patients With Acute Lung Injury

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055371', 'term': 'Acute Lung Injury'}, {'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'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': 'Upto follow-up Day 7.', 'description': 'The All subjects population was used for analysis.', 'eventGroups': [{'id': 'EG000', 'title': 'Part A', 'description': 'Eligible participants received multiple single intravenous escalating doses of GSK2586881 (0.1 mg/kg, 0.2 mg/kg, 0.4 mg/kg, 0.8 mg/kg) as a slow infusion over 3-5 minutes over 2 days.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 3, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Part B (Placebo BID)', 'description': 'Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 14, 'seriousNumAtRisk': 20, 'deathsNumAffected': 2, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Part B (GSK2586881 BID)', 'description': 'Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 15, 'seriousNumAtRisk': 19, 'deathsNumAffected': 1, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Generalised oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood calcium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood magnesium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood phosphorus decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood sodium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Body temperature increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oxygen saturation decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypernatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Food intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypochloraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Metabolic alkalosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Catheter site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Drug withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Local swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thrombocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 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{'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Scrotal erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Scrotal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eye haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Endotracheal intubation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Multi-organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Graft versus host disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Empyema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchial anastomosis complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Heart Rate Assessments Upto Day 7 (Part B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B (Placebo BID)', 'description': 'Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.'}, {'id': 'OG001', 'title': 'Part B (GSK2586881 BID)', 'description': 'Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.'}], 'classes': [{'title': 'Heart rate on Day 1 at Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '87.4', 'spread': '16.32', 'groupId': 'OG000'}, {'value': '97.7', 'spread': '16.25', 'groupId': 'OG001'}]}]}, {'title': 'Heart rate on Day 1 at 0.5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '87.9', 'spread': '17.08', 'groupId': 'OG000'}, {'value': '95.3', 'spread': '15.10', 'groupId': 'OG001'}]}]}, {'title': 'Heart rate on Day 1 at 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '88.8', 'spread': '18.22', 'groupId': 'OG000'}, {'value': '94.7', 'spread': '17.59', 'groupId': 'OG001'}]}]}, {'title': 'Heart rate on Day 1 at 6 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '90.0', 'spread': '18.03', 'groupId': 'OG000'}, {'value': '96.5', 'spread': '18.58', 'groupId': 'OG001'}]}]}, {'title': 'Heart rate on Day 1 at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '87.6', 'spread': '20.60', 'groupId': 'OG000'}, {'value': '97.1', 'spread': '18.46', 'groupId': 'OG001'}]}]}, {'title': 'Heart rate on Day 2 at 0 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '92.2', 'spread': '19.02', 'groupId': 'OG000'}, {'value': '93.4', 'spread': '16.98', 'groupId': 'OG001'}]}]}, {'title': 'Heart rate on Day 3 at 0 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '93.3', 'spread': '19.20', 'groupId': 'OG000'}, {'value': '97.7', 'spread': '14.11', 'groupId': 'OG001'}]}]}, {'title': 'Heart rate on Day 3 at 0.5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91.7', 'spread': '16.29', 'groupId': 'OG000'}, {'value': '97.2', 'spread': '12.81', 'groupId': 'OG001'}]}]}, {'title': 'Heart rate on Day 3 at 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '93.2', 'spread': '16.51', 'groupId': 'OG000'}, {'value': '95.2', 'spread': '13.31', 'groupId': 'OG001'}]}]}, {'title': 'Heart rate on Day 3 at 6 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '93.2', 'spread': '16.63', 'groupId': 'OG000'}, {'value': '97.5', 'spread': '14.44', 'groupId': 'OG001'}]}]}, {'title': 'Heart rate on Day 3 at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '93.8', 'spread': '20.12', 'groupId': 'OG000'}, {'value': '93.6', 'spread': '16.08', 'groupId': 'OG001'}]}]}, {'title': 'Heart rate on Day 3 at 18 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.1', 'spread': '19.34', 'groupId': 'OG000'}, {'value': '88.9', 'spread': '15.69', 'groupId': 'OG001'}]}]}, {'title': 'Heart rate on Day 3 at 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '90.8', 'spread': '15.46', 'groupId': 'OG000'}, {'value': '95.1', 'spread': '13.25', 'groupId': 'OG001'}]}]}, {'title': 'Heart rate at follow-up Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91.6', 'spread': '19.06', 'groupId': 'OG000'}, {'value': '94.2', 'spread': '15.17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Day 7', 'description': 'Vital sign included heart rate. Assessments were performed at Pre-dose, 0.5 hours, 2 hours, 6 hours and 12 hours on Day 1, 0 hours on Day 2 at 0 hours, 0.5 hours, 2 hours, 6 hours, 12 hours, 18 hours and 24 hours on Day 3 and at follow-up on Day 7.', 'unitOfMeasure': 'Beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The All Subjects - Part B Population was defined as all participants in Part B who received at least one dose of study medication. Only those participants available at the specified time points were analyzed.'}, {'type': 'PRIMARY', 'title': 'Diastolic and Systolic Blood Pressure Assessments Upto Day 7 (Part B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B (Placebo BID)', 'description': 'Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.'}, {'id': 'OG001', 'title': 'Part B (GSK2586881 BID)', 'description': 'Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.'}], 'classes': [{'title': 'Diastolic blood pressure on Day 1 at Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '64.7', 'spread': '12.86', 'groupId': 'OG000'}, {'value': '53.9', 'spread': '10.36', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic blood pressure on Day 1 at 0.5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '64.4', 'spread': '13.75', 'groupId': 'OG000'}, {'value': '54.3', 'spread': '11.39', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic blood pressure on Day 1 at 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '64.4', 'spread': '12.59', 'groupId': 'OG000'}, {'value': '54.8', 'spread': '9.60', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic blood pressure on Day 1 at 6 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '63.4', 'spread': '12.08', 'groupId': 'OG000'}, {'value': '57.1', 'spread': '9.21', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic blood pressure on Day 1 at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '64.3', 'spread': '12.78', 'groupId': 'OG000'}, {'value': '57.6', 'spread': '10.05', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic blood pressure on Day 2 at 0 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '67.0', 'spread': '15.17', 'groupId': 'OG000'}, {'value': '57.0', 'spread': '10.22', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic blood pressure on Day 3 at 0 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '63.9', 'spread': '14.50', 'groupId': 'OG000'}, {'value': '62.7', 'spread': '14.03', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic blood pressure on Day 3 at 0.5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.6', 'spread': '13.21', 'groupId': 'OG000'}, {'value': '61.1', 'spread': '12.83', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic blood pressure on Day 3 at 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.2', 'spread': '10.34', 'groupId': 'OG000'}, {'value': '58.1', 'spread': '11.20', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic blood pressure on Day 3 at 6 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.2', 'spread': '13.83', 'groupId': 'OG000'}, {'value': '62.2', 'spread': '16.59', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic blood pressure on Day 3 at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.0', 'spread': '16.40', 'groupId': 'OG000'}, {'value': '60.6', 'spread': '13.20', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic blood pressure on Day 3 at 18 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.2', 'spread': '16.31', 'groupId': 'OG000'}, {'value': '61.8', 'spread': '10.50', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic blood pressure on Day 3 at 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.4', 'spread': '15.19', 'groupId': 'OG000'}, {'value': '61.1', 'spread': '13.06', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic blood pressure on follow-up Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.4', 'spread': '11.58', 'groupId': 'OG000'}, {'value': '62.7', 'spread': '8.52', 'groupId': 'OG001'}]}]}, {'title': 'Systolic blood pressure on Day 1 at Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '122.0', 'spread': '18.97', 'groupId': 'OG000'}, {'value': '106.1', 'spread': '12.68', 'groupId': 'OG001'}]}]}, {'title': 'Systolic blood pressure on Day 1 at 0.5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '118.8', 'spread': '20.01', 'groupId': 'OG000'}, {'value': '105.7', 'spread': '12.66', 'groupId': 'OG001'}]}]}, {'title': 'Systolic blood pressure on Day 1 at 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '122.9', 'spread': '14.85', 'groupId': 'OG000'}, {'value': '107.5', 'spread': '20.49', 'groupId': 'OG001'}]}]}, {'title': 'Systolic blood pressure on Day 1 at 6 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '121.6', 'spread': '17.80', 'groupId': 'OG000'}, {'value': '118.7', 'spread': '16.41', 'groupId': 'OG001'}]}]}, {'title': 'Systolic blood pressure on Day 1 at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '122.9', 'spread': '21.88', 'groupId': 'OG000'}, {'value': '116.9', 'spread': '24.33', 'groupId': 'OG001'}]}]}, {'title': 'Systolic blood pressure on Day 2 at 0 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '131.6', 'spread': '23.68', 'groupId': 'OG000'}, {'value': '114.8', 'spread': '18.94', 'groupId': 'OG001'}]}]}, {'title': 'Systolic blood pressure on Day 3 at 0 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '124.4', 'spread': '16.32', 'groupId': 'OG000'}, {'value': '125.2', 'spread': '23.70', 'groupId': 'OG001'}]}]}, {'title': 'Systolic blood pressure on Day 3 at 0.5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '127.1', 'spread': '15.76', 'groupId': 'OG000'}, {'value': '121.9', 'spread': '23.60', 'groupId': 'OG001'}]}]}, {'title': 'Systolic blood pressure on Day 3 at 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '125.2', 'spread': '14.77', 'groupId': 'OG000'}, {'value': '118.5', 'spread': '20.87', 'groupId': 'OG001'}]}]}, {'title': 'Systolic blood pressure on Day 3 at 6 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '127.8', 'spread': '19.01', 'groupId': 'OG000'}, {'value': '118.5', 'spread': '19.60', 'groupId': 'OG001'}]}]}, {'title': 'Systolic blood pressure on Day 3 at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '130.2', 'spread': '21.95', 'groupId': 'OG000'}, {'value': '123.2', 'spread': '24.61', 'groupId': 'OG001'}]}]}, {'title': 'Systolic blood pressure on Day 3 at 18 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '137.5', 'spread': '23.92', 'groupId': 'OG000'}, {'value': '129.0', 'spread': '17.45', 'groupId': 'OG001'}]}]}, {'title': 'Systolic blood pressure on Day 3 at 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '128.8', 'spread': '20.43', 'groupId': 'OG000'}, {'value': '130.3', 'spread': '24.97', 'groupId': 'OG001'}]}]}, {'title': 'Systolic blood pressure on follow-up Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '129.1', 'spread': '22.22', 'groupId': 'OG000'}, {'value': '129.9', 'spread': '17.92', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Day 7', 'description': 'Vital sign included systolic blood pressure and diastolic blood pressure. Assessments were performed at Pre-dose, 0.5 hours, 2 hours, 6 hours and 12 hours on Day 1, 0 hours on Day 2 at 0 hours, 0.5 hours, 2 hours, 6 hours, 12 hours, 18 hours and 24 hours on Day 3 and at follow-up on Day 7.', 'unitOfMeasure': 'Millimeters of merucry', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The All Subjects - Part B Population. Only those participants available at the specified time points were analyzed.'}, {'type': 'PRIMARY', 'title': 'Electrocardiogram (ECG) Parameters, Including PR, QRS, QT, and QTCU and RR Intervals Upto Day 7 (Part B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B (Placebo BID)', 'description': 'Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.'}, {'id': 'OG001', 'title': 'Part B (GSK2586881 BID)', 'description': 'Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.'}], 'classes': [{'title': 'PR interval on Day 1,Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '136.8', 'spread': '24.19', 'groupId': 'OG000'}, {'value': '139.0', 'spread': '25.09', 'groupId': 'OG001'}]}]}, {'title': 'PR interval on Day 3,12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '128.5', 'spread': '42.09', 'groupId': 'OG000'}, {'value': '149.3', 'spread': '19.76', 'groupId': 'OG001'}]}]}, {'title': 'PR interval at follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '140.4', 'spread': '17.81', 'groupId': 'OG000'}, {'value': '144.8', 'spread': '20.73', 'groupId': 'OG001'}]}]}, {'title': 'QRS duration on Day 1,Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.0', 'spread': '9.27', 'groupId': 'OG000'}, {'value': '95.5', 'spread': '16.62', 'groupId': 'OG001'}]}]}, {'title': 'QRS duration on Day 3,12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '82.8', 'spread': '8.66', 'groupId': 'OG000'}, {'value': '98.8', 'spread': '15.86', 'groupId': 'OG001'}]}]}, {'title': 'QRS duration at follow-up Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '84.4', 'spread': '9.01', 'groupId': 'OG000'}, {'value': '88.6', 'spread': '16.86', 'groupId': 'OG001'}]}]}, {'title': 'Uncorrected QT interval on Day 1,Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '350.0', 'spread': '27.96', 'groupId': 'OG000'}, {'value': '357.5', 'spread': '44.13', 'groupId': 'OG001'}]}]}, {'title': 'Uncorrected QT interval on Day 3,12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '357.8', 'spread': '48.90', 'groupId': 'OG000'}, {'value': '369.8', 'spread': '33.92', 'groupId': 'OG001'}]}]}, {'title': 'Uncorrected QT interval at follow-up Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '354.3', 'spread': '37.12', 'groupId': 'OG000'}, {'value': '377.5', 'spread': '49.46', 'groupId': 'OG001'}]}]}, {'title': 'Corrected QT interval(Basett) on Day 1,Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '463.0', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated as a single participant was analyzed.', 'groupId': 'OG000'}, {'value': '469.4', 'spread': '66.08', 'groupId': 'OG001'}]}]}, {'title': 'Corrected QT interval(Basett) on Day 3,12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '438.9', 'spread': '13.02', 'groupId': 'OG000'}, {'value': '468.9', 'spread': '41.59', 'groupId': 'OG001'}]}]}, {'title': 'Corrected QT interval(Basett) at follow-up Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '453.5', 'spread': '31.57', 'groupId': 'OG000'}, {'value': '483.5', 'spread': '46.51', 'groupId': 'OG001'}]}]}, {'title': 'Corrected QT interval(Fridericia), Day 1,Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '423.4', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated as a single participant was analyzed.', 'groupId': 'OG000'}, {'value': '418.1', 'spread': '49.03', 'groupId': 'OG001'}]}]}, {'title': 'Corrected QT interval(Fridericia), Day 3,12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '406.3', 'spread': '20.18', 'groupId': 'OG000'}, {'value': '432.7', 'spread': '35.92', 'groupId': 'OG001'}]}]}, {'title': 'Corrected QT interval(Fridericia),follow-up Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '419.5', 'spread': '12.66', 'groupId': 'OG000'}, {'value': '439.6', 'spread': '36.29', 'groupId': 'OG001'}]}]}, {'title': 'QTCU on Day 1,Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '458.3', 'spread': '8.81', 'groupId': 'OG000'}, {'value': '447.3', 'spread': '27.65', 'groupId': 'OG001'}]}]}, {'title': 'QTCU on Day 3,12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '440.3', 'spread': '40.07', 'groupId': 'OG000'}, {'value': '445.4', 'spread': '28.11', 'groupId': 'OG001'}]}]}, {'title': 'QTCU at follow-up Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '441.6', 'spread': '17.72', 'groupId': 'OG000'}, {'value': '457.3', 'spread': '26.12', 'groupId': 'OG001'}]}]}, {'title': 'RR interval on Day 1,Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '584.6', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated as a single participant was analyzed.', 'groupId': 'OG000'}, {'value': '513.6', 'spread': '97.25', 'groupId': 'OG001'}]}]}, {'title': 'RR interval on Day 3,12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '638.8', 'spread': '135.85', 'groupId': 'OG000'}, {'value': '623.2', 'spread': '76.02', 'groupId': 'OG001'}]}]}, {'title': 'RR interval at follow-up Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '661.7', 'spread': '203.97', 'groupId': 'OG000'}, {'value': '582.9', 'spread': '128.96', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Day 7', 'description': 'Single 12-lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QTCU and RR intervals. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.', 'unitOfMeasure': 'millisecond', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The All Subjects - Part B Population. Only those participants available at the specified time points were analyzed.'}, {'type': 'PRIMARY', 'title': 'Hematology Parameters Basophils, Eosinophil, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count Upto Day 7 (Part B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B (Placebo BID)', 'description': 'Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.'}, {'id': 'OG001', 'title': 'Part B (GSK2586881 BID)', 'description': 'Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.'}], 'classes': [{'title': 'Basophils on Day 1 at Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.020', 'spread': 'NA', 'comment': 'Standard deviation was not calculated as a single participant was analyzed.', 'groupId': 'OG000'}, {'value': '0.000', 'spread': '0.0000', 'groupId': 'OG001'}]}]}, {'title': 'Basophils on Day 3 at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.015', 'spread': '0.0296', 'groupId': 'OG000'}, {'value': '0.011', 'spread': '0.0277', 'groupId': 'OG001'}]}]}, {'title': 'Basophils on Follow-up Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.025', 'spread': '0.0431', 'groupId': 'OG000'}, {'value': '0.113', 'spread': '0.1848', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils on Day 1 at Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.110', 'spread': 'NA', 'comment': 'Standard deviation was not calculated as a single participant was analyzed.', 'groupId': 'OG000'}, {'value': '0.233', 'spread': '0.4041', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils on Day 3 at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.096', 'spread': '0.1624', 'groupId': 'OG000'}, {'value': '0.163', 'spread': '0.2280', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils on Follow-up Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.137', 'spread': '0.1074', 'groupId': 'OG000'}, {'value': '0.324', 'spread': '0.4957', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes on Day 1 at Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.81', 'spread': '4.603', 'groupId': 'OG000'}, {'value': '0.52', 'spread': '0.266', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes on Day 3 at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.08', 'spread': '0.948', 'groupId': 'OG000'}, {'value': '0.60', 'spread': '0.380', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes on Follow-up Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.61', 'spread': '1.244', 'groupId': 'OG000'}, {'value': '1.04', 'spread': '0.663', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes on Day 1 at Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.760', 'spread': '1.7112', 'groupId': 'OG000'}, {'value': '0.377', 'spread': '0.3356', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes on Day 3 at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.503', 'spread': '0.4046', 'groupId': 'OG000'}, {'value': '0.571', 'spread': '0.6336', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes on Follow-up Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.669', 'spread': '0.3986', 'groupId': 'OG000'}, {'value': '0.727', 'spread': '0.5812', 'groupId': 'OG001'}]}]}, {'title': 'Total neutrophils on Day 1 at Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.990', 'spread': '4.5113', 'groupId': 'OG000'}, {'value': '7.807', 'spread': '9.3471', 'groupId': 'OG001'}]}]}, {'title': 'Total neutrophils on Day 3 at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.563', 'spread': '6.0785', 'groupId': 'OG000'}, {'value': '9.931', 'spread': '6.8583', 'groupId': 'OG001'}]}]}, {'title': 'Total neutrophils on Follow-up Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.775', 'spread': '21.6419', 'groupId': 'OG000'}, {'value': '11.761', 'spread': '5.5496', 'groupId': 'OG001'}]}]}, {'title': 'Platelet count on Day 1 at Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '170.3', 'spread': '67.26', 'groupId': 'OG000'}, {'value': '236.0', 'spread': '158.73', 'groupId': 'OG001'}]}]}, {'title': 'Platelet count on Day 3 at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '218.9', 'spread': '120.68', 'groupId': 'OG000'}, {'value': '235.9', 'spread': '134.43', 'groupId': 'OG001'}]}]}, {'title': 'Platelet count on Follow-up Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '334.1', 'spread': '169.06', 'groupId': 'OG000'}, {'value': '369.8', 'spread': '169.70', 'groupId': 'OG001'}]}]}, {'title': 'White blood cell count on Day 1 at Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.15', 'spread': '14.289', 'groupId': 'OG000'}, {'value': '10.72', 'spread': '8.829', 'groupId': 'OG001'}]}]}, {'title': 'White blood cell count on Day 3 at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.82', 'spread': '5.927', 'groupId': 'OG000'}, {'value': '11.82', 'spread': '6.618', 'groupId': 'OG001'}]}]}, {'title': 'White blood cell count on Follow-up Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.09', 'spread': '5.197', 'groupId': 'OG000'}, {'value': '36.56', 'spread': '84.293', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Day 7', 'description': 'Hematology parameters included basophils, eosinophil, lymphocytes, monocytes, total neutrophils, platelet count and white blood cell count. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.', 'unitOfMeasure': 'giga per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The All Subjects - Part B Population. Only those participants available at the specified time points were analyzed.'}, {'type': 'PRIMARY', 'title': 'Hematology Parameters Red Blood Cell Count and Reticulocyte Count Assessment Upto Day 7 (Part B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B (Placebo BID)', 'description': 'Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.'}, {'id': 'OG001', 'title': 'Part B (GSK2586881 BID)', 'description': 'Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.'}], 'classes': [{'title': 'Red blood cell count on Day 1 at Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.207', 'spread': '0.7733', 'groupId': 'OG000'}, {'value': '2.678', 'spread': '0.5117', 'groupId': 'OG001'}]}]}, {'title': 'Red blood cell count on Day 3 at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.271', 'spread': '0.5725', 'groupId': 'OG000'}, {'value': '3.076', 'spread': '0.5001', 'groupId': 'OG001'}]}]}, {'title': 'Red blood cell count on Follow-up Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.352', 'spread': '0.6374', 'groupId': 'OG000'}, {'value': '3.314', 'spread': '0.7700', 'groupId': 'OG001'}]}]}, {'title': 'Reticulocyte count on Day 1 at Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.025', 'spread': '0.0195', 'groupId': 'OG000'}, {'value': '0.044', 'spread': 'NA', 'comment': 'Standard deviation was not calculated as a single participant was analyzed.', 'groupId': 'OG001'}]}]}, {'title': 'Reticulocyte count on Day 3 at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.832', 'spread': '2.5186', 'groupId': 'OG000'}, {'value': '3.697', 'spread': '12.6920', 'groupId': 'OG001'}]}]}, {'title': 'Reticulocyte count on Follow-up Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.607', 'spread': '5.1055', 'groupId': 'OG000'}, {'value': '8.629', 'spread': '25.6392', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Day 7', 'description': 'Hematology parameters included red blood cell count and reticulocyte count. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.', 'unitOfMeasure': 'trillion cells per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The All Subjects - Part B Population. Only those participants available at the specified time points were analyzed.'}, {'type': 'PRIMARY', 'title': 'Hematology Parameter Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Assessment Upto Day 7 (Part B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B (Placebo BID)', 'description': 'Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.'}, {'id': 'OG001', 'title': 'Part B (GSK2586881 BID)', 'description': 'Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.'}], 'classes': [{'title': 'Hemoglobin on Day 1 at Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.5', 'spread': '24.83', 'groupId': 'OG000'}, {'value': '84.0', 'spread': '13.09', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin on Day 3 at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '195.8', 'spread': '286.77', 'groupId': 'OG000'}, {'value': '180.8', 'spread': '266.16', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin on Follow-up Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '244.7', 'spread': '401.03', 'groupId': 'OG000'}, {'value': '213.6', 'spread': '301.50', 'groupId': 'OG001'}]}]}, {'title': 'MCHC on Day 1 at Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '331.8', 'spread': '10.68', 'groupId': 'OG000'}, {'value': '339.5', 'spread': '19.12', 'groupId': 'OG001'}]}]}, {'title': 'MCHC on Day 3 at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '328.4', 'spread': '14.73', 'groupId': 'OG000'}, {'value': '330.8', 'spread': '16.82', 'groupId': 'OG001'}]}]}, {'title': 'MCHC on Follow-up Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '327.8', 'spread': '12.35', 'groupId': 'OG000'}, {'value': '325.4', 'spread': '6.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Day 7', 'description': 'Hematology parameters included hemoglobin and MCHC. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.', 'unitOfMeasure': 'grams per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The All Subjects - Part B Population. Only those participants available at the specified time points were analyzed.'}, {'type': 'PRIMARY', 'title': 'Hematology Parameter Mean Corpuscle Volume (MCV) Assessment Upto Day 7 (Part B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B (Placebo BID)', 'description': 'Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.'}, {'id': 'OG001', 'title': 'Part B (GSK2586881 BID)', 'description': 'Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.'}], 'classes': [{'title': 'MCV on Day 1 at Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77.37', 'spread': '33.654', 'groupId': 'OG000'}, {'value': '93.87', 'spread': '0.971', 'groupId': 'OG001'}]}]}, {'title': 'MCV on Day 3 at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91.28', 'spread': '5.611', 'groupId': 'OG000'}, {'value': '90.69', 'spread': '5.976', 'groupId': 'OG001'}]}]}, {'title': 'MCV on Follow-up Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '92.53', 'spread': '7.234', 'groupId': 'OG000'}, {'value': '90.46', 'spread': '7.063', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Day 7', 'description': 'Hematology parameter included MCV. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.', 'unitOfMeasure': 'femtoliters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The All Subjects - Part B Population. Only those participants available at the specified time points were analyzed.'}, {'type': 'PRIMARY', 'title': 'Hematology Parameter Mean Corpuscle Hemoglobin (MCH) Assessment Upto Day 7 (Part B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B (Placebo BID)', 'description': 'Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.'}, {'id': 'OG001', 'title': 'Part B (GSK2586881 BID)', 'description': 'Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.'}], 'classes': [{'title': 'MCH on Day 1 at Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.30', 'spread': '4.493', 'groupId': 'OG000'}, {'value': '30.40', 'spread': '0.361', 'groupId': 'OG001'}]}]}, {'title': 'MCH on Day 3 at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.02', 'spread': '2.695', 'groupId': 'OG000'}, {'value': '30.32', 'spread': '1.955', 'groupId': 'OG001'}]}]}, {'title': 'MCH on Follow-up Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.49', 'spread': '2.545', 'groupId': 'OG000'}, {'value': '30.25', 'spread': '2.071', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Day 7', 'description': 'Hematology parameter included MCH. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.', 'unitOfMeasure': 'picograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The All Subjects - Part B Population. Only those participants available at the specified time points were analyzed.'}, {'type': 'PRIMARY', 'title': 'Hematology Parameter Hematocrit Assessment Upto Day 7 (Part B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B (Placebo BID)', 'description': 'Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.'}, {'id': 'OG001', 'title': 'Part B (GSK2586881 BID)', 'description': 'Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.'}], 'classes': [{'title': 'Hematocrit on Day 1 at Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.201', 'spread': '0.1666', 'groupId': 'OG000'}, {'value': '0.196', 'spread': '0.1333', 'groupId': 'OG001'}]}]}, {'title': 'Hematocrit on Day 3 at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.271', 'spread': '0.1071', 'groupId': 'OG000'}, {'value': '1.519', 'spread': '5.3867', 'groupId': 'OG001'}]}]}, {'title': 'Hematocrit on Follow-up Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.254', 'spread': '0.1298', 'groupId': 'OG000'}, {'value': '2.270', 'spread': '7.5504', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Day 7', 'description': 'Hematology parameter included hematocrit. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.', 'unitOfMeasure': 'Fraction', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The All Subjects - Part B Population. Only those participants available at the specified time points were analyzed.'}, {'type': 'PRIMARY', 'title': 'Clinical Chemistry Parameters Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen Assessment Upto Day 7 (Part B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B (Placebo BID)', 'description': 'Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.'}, {'id': 'OG001', 'title': 'Part B (GSK2586881 BID)', 'description': 'Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.'}], 'classes': [{'title': 'Calcium on Day 1 at Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.927', 'spread': '0.0736', 'groupId': 'OG000'}, {'value': '1.894', 'spread': '0.1070', 'groupId': 'OG001'}]}]}, {'title': 'Calcium on Day 3 at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.983', 'spread': '0.1220', 'groupId': 'OG000'}, {'value': '1.982', 'spread': '0.1296', 'groupId': 'OG001'}]}]}, {'title': 'Calcium on Follow-up Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.155', 'spread': '0.1016', 'groupId': 'OG000'}, {'value': '2.104', 'spread': '0.1448', 'groupId': 'OG001'}]}]}, {'title': 'Chloride on Day 1 at Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '108.8', 'spread': '5.93', 'groupId': 'OG000'}, {'value': '104.0', 'spread': '7.18', 'groupId': 'OG001'}]}]}, {'title': 'Chloride on Day 3 at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '107.7', 'spread': '5.12', 'groupId': 'OG000'}, {'value': '106.0', 'spread': '6.05', 'groupId': 'OG001'}]}]}, {'title': 'Chloride on Follow-up Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '104.4', 'spread': '3.76', 'groupId': 'OG000'}, {'value': '103.7', 'spread': '5.01', 'groupId': 'OG001'}]}]}, {'title': 'Carbon dioxide on Day 1 at Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.40', 'spread': '5.273', 'groupId': 'OG000'}, {'value': '23.28', 'spread': '6.685', 'groupId': 'OG001'}]}]}, {'title': 'Carbon dioxide on Day 3 at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.35', 'spread': '3.176', 'groupId': 'OG000'}, {'value': '27.83', 'spread': '6.071', 'groupId': 'OG001'}]}]}, {'title': 'Carbon dioxide on Follow-up Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.69', 'spread': '3.728', 'groupId': 'OG000'}, {'value': '27.39', 'spread': '3.412', 'groupId': 'OG001'}]}]}, {'title': 'Glucose on Day 1 at Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.015', 'spread': '0.7499', 'groupId': 'OG000'}, {'value': '6.159', 'spread': '1.1230', 'groupId': 'OG001'}]}]}, {'title': 'Glucose on Day 3 at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.095', 'spread': '2.1569', 'groupId': 'OG000'}, {'value': '7.411', 'spread': '1.6158', 'groupId': 'OG001'}]}]}, {'title': 'Glucose on Follow-up Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.701', 'spread': '1.6354', 'groupId': 'OG000'}, {'value': '7.285', 'spread': '1.5159', 'groupId': 'OG001'}]}]}, {'title': 'Potassium on Day 1 at Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.88', 'spread': '0.444', 'groupId': 'OG000'}, {'value': '3.72', 'spread': '0.164', 'groupId': 'OG001'}]}]}, {'title': 'Potassium on Day 3 at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.20', 'spread': '0.511', 'groupId': 'OG000'}, {'value': '3.96', 'spread': '0.578', 'groupId': 'OG001'}]}]}, {'title': 'Potassium on Follow-up Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.83', 'spread': '0.505', 'groupId': 'OG000'}, {'value': '3.92', 'spread': '0.435', 'groupId': 'OG001'}]}]}, {'title': 'Sodium on Day 1 at Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '141.8', 'spread': '3.11', 'groupId': 'OG000'}, {'value': '137.6', 'spread': '3.71', 'groupId': 'OG001'}]}]}, {'title': 'Sodium on Day 3 at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '143.1', 'spread': '4.46', 'groupId': 'OG000'}, {'value': '141.6', 'spread': '4.03', 'groupId': 'OG001'}]}]}, {'title': 'Sodium on Follow-up Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '141.9', 'spread': '4.59', 'groupId': 'OG000'}, {'value': '139.7', 'spread': '4.58', 'groupId': 'OG001'}]}]}, {'title': 'Urea/Blood urea nitrogen on Day 1 at Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.433', 'spread': '3.0512', 'groupId': 'OG000'}, {'value': '11.399', 'spread': '7.4163', 'groupId': 'OG001'}]}]}, {'title': 'Urea/Blood urea nitrogen on Day 3 at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.410', 'spread': '6.5542', 'groupId': 'OG000'}, {'value': '9.485', 'spread': '6.5777', 'groupId': 'OG001'}]}]}, {'title': 'Urea/Blood urea nitrogen on Follow-up Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.787', 'spread': '9.3546', 'groupId': 'OG000'}, {'value': '9.207', 'spread': '6.5375', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Day 7', 'description': 'Clinical chemistry parameters included calcium, chloride, carbon dioxide, glucose, potassium, sodium, Urea/Blood urea nitrogen. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.', 'unitOfMeasure': 'millimoles per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The All Subjects - Part B Population. Only those participants available at the specified time points were analyzed.'}, {'type': 'PRIMARY', 'title': 'Clinical Chemistry Parameters Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Assessment Upto Day 7 (Part B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B (Placebo BID)', 'description': 'Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.'}, {'id': 'OG001', 'title': 'Part B (GSK2586881 BID)', 'description': 'Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.'}], 'classes': [{'title': 'Direct bilirubin on Day 1 at Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.663', 'spread': '7.8146', 'groupId': 'OG000'}, {'value': '13.792', 'spread': '17.7932', 'groupId': 'OG001'}]}]}, {'title': 'Direct bilirubin on Day 3 at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.446', 'spread': '14.2406', 'groupId': 'OG000'}, {'value': '10.428', 'spread': '22.4573', 'groupId': 'OG001'}]}]}, {'title': 'Direct bilirubin on Follow-up Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.140', 'spread': '3.5564', 'groupId': 'OG000'}, {'value': '2.576', 'spread': '1.6103', 'groupId': 'OG001'}]}]}, {'title': 'Total bilirubin on Day 1 at Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.672', 'spread': '11.1375', 'groupId': 'OG000'}, {'value': '21.926', 'spread': '20.4768', 'groupId': 'OG001'}]}]}, {'title': 'Total bilirubin on Day 3 at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.803', 'spread': '15.8462', 'groupId': 'OG000'}, {'value': '14.119', 'spread': '24.8465', 'groupId': 'OG001'}]}]}, {'title': 'Total bilirubin on Follow-up Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.547', 'spread': '10.7837', 'groupId': 'OG000'}, {'value': '5.818', 'spread': '3.0149', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine on Day 1 at Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '85.194', 'spread': '19.9261', 'groupId': 'OG000'}, {'value': '126.228', 'spread': '71.9085', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine on Day 3 at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '108.189', 'spread': '102.4388', 'groupId': 'OG000'}, {'value': '103.066', 'spread': '90.6252', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine on Follow-up Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91.726', 'spread': '45.2713', 'groupId': 'OG000'}, {'value': '90.516', 'spread': '71.8052', 'groupId': 'OG001'}]}]}, {'title': 'Uric acid on Day 1 at Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '233.432', 'spread': '67.9909', 'groupId': 'OG000'}, {'value': '181.453', 'spread': '203.5924', 'groupId': 'OG001'}]}]}, {'title': 'Uric acid on Day 3 at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '192.925', 'spread': '143.7971', 'groupId': 'OG000'}, {'value': '228.144', 'spread': '134.9558', 'groupId': 'OG001'}]}]}, {'title': 'Uric acid on Follow-up Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '241.766', 'spread': '72.0137', 'groupId': 'OG000'}, {'value': '225.326', 'spread': '144.4626', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Day 7', 'description': 'Clinical chemistry parameters included direct bilirubin, total bilirubin, creatinine and uric acid. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.', 'unitOfMeasure': 'micromoles per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The All Subjects - Part B Population. Only those participants available at the specified time points were analyzed.'}, {'type': 'PRIMARY', 'title': 'Clinical Chemistry Parameters Alkaline Phosphatase, Asparatate Amino Transferase, Alanine Amino Transferase, Gamma Glutamyl Transferase Assessment Upto Day 7 (Part B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B (Placebo BID)', 'description': 'Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.'}, {'id': 'OG001', 'title': 'Part B (GSK2586881 BID)', 'description': 'Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.'}], 'classes': [{'title': 'Alkaline phosphatase on Day 1 at Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.6', 'spread': '18.57', 'groupId': 'OG000'}, {'value': '94.0', 'spread': '50.86', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline phosphatase on Day 3 at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '130.9', 'spread': '68.16', 'groupId': 'OG000'}, {'value': '109.2', 'spread': '63.02', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline phosphatase on Follow-up Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '101.1', 'spread': '40.15', 'groupId': 'OG000'}, {'value': '117.0', 'spread': '56.07', 'groupId': 'OG001'}]}]}, {'title': 'Alanine amino transferase on Day 1 at Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '101.8', 'spread': '105.98', 'groupId': 'OG000'}, {'value': '56.8', 'spread': '42.20', 'groupId': 'OG001'}]}]}, {'title': 'Alanine amino transferase on Day 3 at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.4', 'spread': '71.27', 'groupId': 'OG000'}, {'value': '43.6', 'spread': '50.72', 'groupId': 'OG001'}]}]}, {'title': 'Alanine amino transferase on Follow-up Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.9', 'spread': '42.74', 'groupId': 'OG000'}, {'value': '117.9', 'spread': '224.94', 'groupId': 'OG001'}]}]}, {'title': 'Asparatate amino transferase on Day 1 at Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '96.8', 'spread': '46.09', 'groupId': 'OG000'}, {'value': '64.6', 'spread': '37.14', 'groupId': 'OG001'}]}]}, {'title': 'Asparatate amino transferase on Day 3 at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '56.2', 'spread': '34.60', 'groupId': 'OG000'}, {'value': '62.0', 'spread': '71.54', 'groupId': 'OG001'}]}]}, {'title': 'Asparatate amino transferase on Follow-up Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.6', 'spread': '20.25', 'groupId': 'OG000'}, {'value': '76.5', 'spread': '106.39', 'groupId': 'OG001'}]}]}, {'title': 'Gamma glutamyl transferase on Day 1 at Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '96.0', 'spread': '22.63', 'groupId': 'OG000'}, {'value': '40.7', 'spread': '25.89', 'groupId': 'OG001'}]}]}, {'title': 'Gamma glutamyl transferase on Day 3 at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '156.5', 'spread': '149.89', 'groupId': 'OG000'}, {'value': '98.4', 'spread': '71.85', 'groupId': 'OG001'}]}]}, {'title': 'Gamma glutamyl transferase on Follow-up Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '116.4', 'spread': '105.36', 'groupId': 'OG000'}, {'value': '143.0', 'spread': '138.22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Day 7', 'description': 'Clinical chemistry parameters included alkaline phosphatase, asparatate amino transferase, alanine amino transferase, gamma glutamyl transferase. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.', 'unitOfMeasure': 'International units per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The All Subjects - Part B Population. Only those participants available at the specified time points were analyzed.'}, {'type': 'PRIMARY', 'title': 'Clinical Chemistry Parameters Albumin and Total Protein Assessment Upto Day 7 (Part B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B (Placebo BID)', 'description': 'Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.'}, {'id': 'OG001', 'title': 'Part B (GSK2586881 BID)', 'description': 'Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.'}], 'classes': [{'title': 'Albumin on Day 1 at Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.6', 'spread': '2.19', 'groupId': 'OG000'}, {'value': '18.6', 'spread': '3.21', 'groupId': 'OG001'}]}]}, {'title': 'Albumin on Day 3 at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.5', 'spread': '5.05', 'groupId': 'OG000'}, {'value': '22.3', 'spread': '4.88', 'groupId': 'OG001'}]}]}, {'title': 'Albumin on Follow-up Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.9', 'spread': '6.62', 'groupId': 'OG000'}, {'value': '25.5', 'spread': '6.27', 'groupId': 'OG001'}]}]}, {'title': 'Total protein on Day 1 at Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.60', 'spread': '5.983', 'groupId': 'OG000'}, {'value': '50.20', 'spread': '2.775', 'groupId': 'OG001'}]}]}, {'title': 'Total protein on Day 3 at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55.06', 'spread': '7.122', 'groupId': 'OG000'}, {'value': '52.12', 'spread': '7.457', 'groupId': 'OG001'}]}]}, {'title': 'Total protein on Follow-up Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60.86', 'spread': '8.646', 'groupId': 'OG000'}, {'value': '58.18', 'spread': '10.323', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Day 7', 'description': 'Clinical chemistry parameters included albumin and total protein. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.', 'unitOfMeasure': 'grams per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The All Subjects - Part B Population. Only those participants available at the specified time points were analyzed.'}, {'type': 'PRIMARY', 'title': 'Number of Participant With Adverse Event (AE) and Serious Adverse Event (SAE) Assessment Upto Day 7 (Part A)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A', 'description': 'Eligible participants received multiple single intravenous escalating doses of GSK2586881 (0.1 milligrams per kg \\[mg/kg\\], 0.2 mg/kg, 0.4 mg/kg, 0.8 mg/kg) as a slow infusion over 3-5 minutes over 2 days.'}], 'classes': [{'title': 'Any AE', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Anys SAE', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 7', 'description': 'An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The All Subjects - Part A Population was defined as all participants in Part A who received at least one dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Par With AE and Serious Adverse Event (SAE) Assessment Upto Day 7 (Part B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B (Placebo BID)', 'description': 'Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.'}, {'id': 'OG001', 'title': 'Part B (GSK2586881 BID)', 'description': 'Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.'}], 'classes': [{'title': 'Any AE', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Any SAE', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 7', 'description': 'An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury.', 'unitOfMeasure': 'Participant', 'reportingStatus': 'POSTED', 'populationDescription': 'All Subjects - Part B Population.'}, {'type': 'SECONDARY', 'title': 'Analysis of GSK2586881 Plasma Pharmacokinetic Concentration (Part A)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A', 'description': 'Eligible participants received multiple single intravenous escalating doses of GSK2586881 (0.1 milligrams per kg \\[mg/kg\\], 0.2 mg/kg, 0.4 mg/kg, 0.8 mg/kg) as a slow infusion over 3-5 minutes over 2 days.'}], 'classes': [{'title': 'GSK2586881 concentration at Pre-dose on Day 1', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No concentration values detected for Pre-dose.', 'groupId': 'OG000'}]}]}, {'title': 'GSK2586881 concentration at 5 minutes on Day 1', 'categories': [{'measurements': [{'value': '2854.0', 'spread': '595.47', 'groupId': 'OG000'}]}]}, {'title': 'GSK2586881 concentration at 10 minutes on Day 1', 'categories': [{'measurements': [{'value': '2692.8', 'spread': '629.78', 'groupId': 'OG000'}]}]}, {'title': 'GSK2586881 concentration at 2 hours on Day 1', 'categories': [{'measurements': [{'value': '2047.4', 'spread': '497.19', 'groupId': 'OG000'}]}]}, {'title': 'GSK2586881 concentration at 6 hours on Day 1', 'categories': [{'measurements': [{'value': '5460.0', 'spread': '3213.96', 'groupId': 'OG000'}]}]}, {'title': 'GSK2586881 concentration at 10 hours on Day 1', 'categories': [{'measurements': [{'value': '10276.6', 'spread': '2641.49', 'groupId': 'OG000'}]}]}, {'title': 'GSK2586881 concentration at 12 hours on Day 1', 'categories': [{'measurements': [{'value': '8265.4', 'spread': '1905.29', 'groupId': 'OG000'}]}]}, {'title': 'GSK2586881 concentration at 0 hours on Day 2', 'categories': [{'measurements': [{'value': '3621.6', 'spread': '2654.21', 'groupId': 'OG000'}]}]}, {'title': 'GSK2586881 concentration at 1 hour on Day 2', 'categories': [{'measurements': [{'value': '17558.6', 'spread': '4359.04', 'groupId': 'OG000'}]}]}, {'title': 'GSK2586881 concentration at 12 hours on Day 2', 'categories': [{'measurements': [{'value': '7237.8', 'spread': '4281.27', 'groupId': 'OG000'}]}]}, {'title': 'GSK2586881 concentration at 24 hours on Day 2', 'categories': [{'measurements': [{'value': '3517.8', 'spread': '2433.49', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours (Day 1), 0 hours, 1 hour, 12 hours, 24 hours (Day 2)', 'description': 'Blood samples for pharmacokinetic analysis of GSK2586881 were collected Pre-dose, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours (Day 1), 0 hours, 1 hour, 12 hours, 24 hours (Day 2). Data has been presented for GSK2586881 Plasma Pharmacokinetic Concentration versus time data for Part A', 'unitOfMeasure': 'nano grams per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic - Part A Population was defined as participants in the All Subjects - Part A population for whom a pharmacokinetic sample was obtained and analyzed and a result reported and received an active dose of GSK2586881.'}, {'type': 'SECONDARY', 'title': 'Analysis of GSK2586881 Plasma Pharmacokinetic Concentration (Part B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B (GSK2586881 BID)', 'description': 'Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.'}], 'classes': [{'title': 'GSK2586881 concentration at Pre-dose on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No concentration values detected for Pre-dose.', 'groupId': 'OG000'}]}]}, {'title': 'GSK2586881 concentration at 0.5 hours on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5489.3', 'spread': '1727.81', 'groupId': 'OG000'}]}]}, {'title': 'GSK2586881 concentration at 2 hours on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4334.0', 'spread': '1880.42', 'groupId': 'OG000'}]}]}, {'title': 'GSK2586881 concentration at 6 hours on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5065.4', 'spread': '8679.92', 'groupId': 'OG000'}]}]}, {'title': 'GSK2586881 concentration at 12 hours on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1815.9', 'spread': '809.52', 'groupId': 'OG000'}]}]}, {'title': 'GSK2586881 concentration at 0 hours on Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2115.3', 'spread': '1164.12', 'groupId': 'OG000'}]}]}, {'title': 'GSK2586881 concentration at 0 hours on Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2306.6', 'spread': '1356.75', 'groupId': 'OG000'}]}]}, {'title': 'GSK2586881 concentration at 0.5 hours on Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6810.4', 'spread': '3135.66', 'groupId': 'OG000'}]}]}, {'title': 'GSK2586881 concentration at 2 hours on Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6060.7', 'spread': '2956.33', 'groupId': 'OG000'}]}]}, {'title': 'GSK2586881 concentration at 6 hours on Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3808.9', 'spread': '1953.82', 'groupId': 'OG000'}]}]}, {'title': 'GSK2586881 concentration at 12 hours on Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2416.6', 'spread': '1601.08', 'groupId': 'OG000'}]}]}, {'title': 'GSK2586881 concentration at 18 hours on Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2701.6', 'spread': '1874.28', 'groupId': 'OG000'}]}]}, {'title': 'GSK2586881 concentration at 24 hours on Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2254.7', 'spread': '1233.58', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0.5 Hours, 2 hours, 6 hours, 12 hours (Day 1), 0 hours (Day 2), 0 hours, 0.5 hours, 2 hours, 6 hours, 12 hours, 18 hours and 24 hours (Day 3)', 'description': 'Blood samples for pharmacokinetic analysis of GSK2586881 were collected Pre-dose, 0.5 Hours, 2 hours, 6 hours, 12 hours (Day 1), 0 hours (Day 2), 0 hours, 0.5 hours, 2 hours, 6 hours, 12 hours, 18 hours and 24 hours (Day 3). Data has been presented for GSK2586881 Plasma Pharmacokinetic Concentration versus time data for Part B.', 'unitOfMeasure': 'nanograms per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic - Part B Population was defined as participants in the All Subjects - Part B population for whom a pharmacokinetic sample was obtained and analyzed and a result reported and received an active dose of GSK2586881. Only those participants with data available at the indicated time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Analysis of Pharmacokinetic Parameter Clearance (CL) for GSK2586881 (Part A)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A', 'description': 'Eligible participants received multiple single intravenous escalating doses of GSK2586881 (0.1 milligrams per kg \\[mg/kg\\], 0.2 mg/kg, 0.4 mg/kg, 0.8 mg/kg) as a slow infusion over 3-5 minutes over 2 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.384', 'spread': '0.0886', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0 hour, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours, 24 hours, 25 hours, 36 hours, 48 hours', 'description': 'Blood samples for pharmacokinetic analysis of GSK2586881 were collected at Pre-dose, 0 hour, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours, 24 hours, 25 hours, 36 hours and 48 hours. CL was defined as the systemic clearance of parent drug. Clearance was calculated for individual participant and geometric mean of the values from all participants was reported.', 'unitOfMeasure': 'liters per hour', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic - Part A Population.'}, {'type': 'SECONDARY', 'title': 'Analysis Pharmacokinetic Parameter Clearance (CL) for GSK2586881 (Part B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B (GSK2586881 BID)', 'description': 'Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.698', 'spread': '0.0608', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0 hour, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours, 24 hours, 25 hours, 36 hours, 48 hours', 'description': 'Blood samples for pharmacokinetic analysis of GSK2586881 were collected at Pre-dose, 0 hour, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours, 24 hours, 25 hours, 36 hours and 48 hours. CL was defined as the systemic clearance of parent drug. Clearance was calculated for individual participant and geometric mean of the values from all participants was reported.', 'unitOfMeasure': 'liters per hour', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic - Part B Population.'}, {'type': 'SECONDARY', 'title': 'Pharmacodynamic/Biomarker Analysis (Renin-angiotensin System Cascade Biomarkers) to Include Angiotensin (Ang) II and Ang (1-7) Upto Day 2 (Part A)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A', 'description': 'Eligible participants received multiple single intravenous escalating doses of GSK2586881 (0.1 milligrams per kg \\[mg/kg\\], 0.2 mg/kg, 0.4 mg/kg, 0.8 mg/kg) as a slow infusion over 3-5 minutes over 2 days.'}], 'classes': [{'title': 'AngII at Pre-dose on Day 1', 'categories': [{'measurements': [{'value': '26.5', 'groupId': 'OG000', 'lowerLimit': '14.0', 'upperLimit': '50.1'}]}]}, {'title': 'AngII at 5 minutes on Day 1', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000', 'lowerLimit': '3.2', 'upperLimit': '18.4'}]}]}, {'title': 'AngII at 10 minutes on Day 1', 'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000', 'lowerLimit': '3.4', 'upperLimit': '11.3'}]}]}, {'title': 'AngII at 2 hours on Day 1', 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '17.4'}]}]}, {'title': 'AngII at 6 hours on Day 1', 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '22.3'}]}]}, {'title': 'AngII at 10 hours on Day 1', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '10.3'}]}]}, {'title': 'AngII at 12 hours on Day 1', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '13.9'}]}]}, {'title': 'AngII at 0 hours on Day 2', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '13.3'}]}]}, {'title': 'AngII at 1 hour on Day 2', 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '70.9'}]}]}, {'title': 'AngII at 12 hours on Day 2', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '15.5'}]}]}, {'title': 'AngII at 24 hours on Day 2', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '10.5'}]}]}, {'title': 'Ang1-7 at Pre-dose on Day 1', 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '21.4'}]}]}, {'title': 'Ang1-7 at 5 minutes on Day 1', 'categories': [{'measurements': [{'value': '28.7', 'groupId': 'OG000', 'lowerLimit': '10.9', 'upperLimit': '75.8'}]}]}, {'title': 'Ang1-7 at 10 minutes on Day 1', 'categories': [{'measurements': [{'value': '25.7', 'groupId': 'OG000', 'lowerLimit': '11.6', 'upperLimit': '56.8'}]}]}, {'title': 'Ang1-7 at 2 hours on Day 1', 'categories': [{'measurements': [{'value': '18.7', 'groupId': 'OG000', 'lowerLimit': '6.4', 'upperLimit': '54.1'}]}]}, {'title': 'Ang1-7 at 6 hours on Day 1', 'categories': [{'measurements': [{'value': '22.8', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '97.9'}]}]}, {'title': 'Ang1-7 at 10 hours on Day 1', 'categories': [{'measurements': [{'value': '16.8', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '243.5'}]}]}, {'title': 'Ang1-7 at 12 hours on Day 1', 'categories': [{'measurements': [{'value': '15.1', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '183.2'}]}]}, {'title': 'Ang1-7 at 0 hours on Day 2', 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '130.1'}]}]}, {'title': 'Ang1-7 at 1 hour on Day 2', 'categories': [{'measurements': [{'value': '20.9', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '331.3'}]}]}, {'title': 'Ang1-7 at 12 hours on Day 2', 'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '138.4'}]}]}, {'title': 'Ang1-7 at 24 hours on Day 2', 'categories': [{'measurements': [{'value': '5.2', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '122.2'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours (Day 1) and 0 hours, 1 hour, 12 hours and 24 hours (Day 2).', 'description': 'Renin-angiotensin system cascade biomarkers included Ang II and Ang (1-7). Blood samples for biomarker analyses were collected at Pre-dose, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours (Day 1) and 0 hours, 1 hour, 12 hours and 24 hours on Day 2.', 'unitOfMeasure': 'picograms per milliliter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Subjects - Part A Population'}, {'type': 'SECONDARY', 'title': 'Pharmacodynamic/Biomarker Analysis (Renin-angiotensin System Cascade Biomarkers) to Include Ang II/ Ang (1-7) Upto Day 2 (Part A)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A', 'description': 'Eligible participants received multiple single intravenous escalating doses of GSK2586881 (0.1 milligrams per kg \\[mg/kg\\], 0.2 mg/kg, 0.4 mg/kg, 0.8 mg/kg) as a slow infusion over 3-5 minutes over 2 days.'}], 'classes': [{'title': 'AngII/ Ang1-7 at Pre-dose on Day 1', 'categories': [{'measurements': [{'value': '6.167', 'groupId': 'OG000', 'lowerLimit': '1.372', 'upperLimit': '27.721'}]}]}, {'title': 'AngII/ Ang1-7 at 5 minutes on Day 1', 'categories': [{'measurements': [{'value': '0.268', 'groupId': 'OG000', 'lowerLimit': '0.099', 'upperLimit': '0.722'}]}]}, {'title': 'AngII/ Ang1-7 at 10 minutes on Day 1', 'categories': [{'measurements': [{'value': '0.241', 'groupId': 'OG000', 'lowerLimit': '0.095', 'upperLimit': '0.608'}]}]}, {'title': 'AngII/ Ang1-7 at 2 hours on Day 1', 'categories': [{'measurements': [{'value': '0.210', 'groupId': 'OG000', 'lowerLimit': '0.036', 'upperLimit': '1.226'}]}]}, {'title': 'AngII/ Ang1-7 at 6 hours on Day 1', 'categories': [{'measurements': [{'value': '0.190', 'groupId': 'OG000', 'lowerLimit': '0.032', 'upperLimit': '1.138'}]}]}, {'title': 'AngII/ Ang1-7 at 10 hours on Day 1', 'categories': [{'measurements': [{'value': '0.118', 'groupId': 'OG000', 'lowerLimit': '0.024', 'upperLimit': '0.583'}]}]}, {'title': 'AngII/ Ang1-7 at 12 hours on Day 1', 'categories': [{'measurements': [{'value': '0.221', 'groupId': 'OG000', 'lowerLimit': '0.012', 'upperLimit': '3.959'}]}]}, {'title': 'AngII/ Ang1-7 at 0 hours on Day 2', 'categories': [{'measurements': [{'value': '0.182', 'groupId': 'OG000', 'lowerLimit': '0.018', 'upperLimit': '1.831'}]}]}, {'title': 'AngII/ Ang1-7 at 1 hour on Day 2', 'categories': [{'measurements': [{'value': '0.206', 'groupId': 'OG000', 'lowerLimit': '0.017', 'upperLimit': '2.421'}]}]}, {'title': 'AngII/ Ang1-7 at 12 hours on Day 2', 'categories': [{'measurements': [{'value': '0.094', 'groupId': 'OG000', 'lowerLimit': '0.007', 'upperLimit': '1.268'}]}]}, {'title': 'AngII/ Ang1-7 at 24 hours on Day 2', 'categories': [{'measurements': [{'value': '0.290', 'groupId': 'OG000', 'lowerLimit': '0.030', 'upperLimit': '2.801'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours (Day 1) and 0 hours, 1 hour, 12 hours and 24 hours (Day 2).', 'description': 'Renin-angiotensin system cascade biomarkers included Ang II/Ang (1-7). Blood samples for biomarker analyses were collected at Pre-dose, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours on Day 1 and 0 hours, 1 hour, 12 hours and 24 hours on Day 2.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Subjects - Part A Population.'}, {'type': 'SECONDARY', 'title': 'Pharmacodynamic/Biomarker Analysis (Renin-angiotensin System Cascade Biomarkers) to Include Ang II, Ang (1-7) and Ang (1-5) Upto Day 5(Part B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B (Placebo BID)', 'description': 'Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.'}, {'id': 'OG001', 'title': 'Part B (GSK2586881 BID)', 'description': 'Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.'}], 'classes': [{'title': 'AngII at 0.5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.14', 'groupId': 'OG000', 'lowerLimit': '7.890', 'upperLimit': '25.065'}, {'value': '2.44', 'groupId': 'OG001', 'lowerLimit': '1.400', 'upperLimit': '4.095'}]}]}, {'title': 'AngII at 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.05', 'groupId': 'OG000', 'lowerLimit': '6.658', 'upperLimit': '21.146'}, {'value': '2.80', 'groupId': 'OG001', 'lowerLimit': '1.585', 'upperLimit': '4.735'}]}]}, {'title': 'AngII at 6 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.00', 'groupId': 'OG000', 'lowerLimit': '6.084', 'upperLimit': '19.518'}, {'value': '2.89', 'groupId': 'OG001', 'lowerLimit': '1.620', 'upperLimit': '4.997'}]}]}, {'title': 'AngII at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.90', 'groupId': 'OG000', 'lowerLimit': '5.920', 'upperLimit': '19.824'}, {'value': '3.33', 'groupId': 'OG001', 'lowerLimit': '1.853', 'upperLimit': '5.727'}]}]}, {'title': 'AngII at 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.35', 'groupId': 'OG000', 'lowerLimit': '4.506', 'upperLimit': '15.378'}, {'value': '2.41', 'groupId': 'OG001', 'lowerLimit': '1.389', 'upperLimit': '4.178'}]}]}, {'title': 'AngII at 48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.10', 'groupId': 'OG000', 'lowerLimit': '4.219', 'upperLimit': '15.071'}, {'value': '3.74', 'groupId': 'OG001', 'lowerLimit': '2.232', 'upperLimit': '6.677'}]}]}, {'title': 'AngII at 48.5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.63', 'groupId': 'OG000', 'lowerLimit': '4.514', 'upperLimit': '15.961'}, {'value': '2.89', 'groupId': 'OG001', 'lowerLimit': '1.727', 'upperLimit': '5.178'}]}]}, {'title': 'AngII at 50 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.82', 'groupId': 'OG000', 'lowerLimit': '3.551', 'upperLimit': '12.510'}, {'value': '2.58', 'groupId': 'OG001', 'lowerLimit': '1.534', 'upperLimit': '4.570'}]}]}, {'title': 'AngII at 54 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.03', 'groupId': 'OG000', 'lowerLimit': '3.770', 'upperLimit': '12.850'}, {'value': '2.32', 'groupId': 'OG001', 'lowerLimit': '1.338', 'upperLimit': '4.146'}]}]}, {'title': 'AngII at 60 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.02', 'groupId': 'OG000', 'lowerLimit': '3.883', 'upperLimit': '12.768'}, {'value': '2.38', 'groupId': 'OG001', 'lowerLimit': '1.374', 'upperLimit': '4.179'}]}]}, {'title': 'AngII at 66 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.33', 'groupId': 'OG000', 'lowerLimit': '4.156', 'upperLimit': 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'0.718', 'ciUpperLimit': '2.087', 'groupDescription': 'Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.7730', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.24', 'ciLowerLimit': '0.705', 'ciUpperLimit': '2.113', 'groupDescription': 'Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.8951', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.45', 'ciLowerLimit': '0.814', 'ciUpperLimit': '2.604', 'groupDescription': 'Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9324', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.57', 'ciLowerLimit': '0.276', 'ciUpperLimit': '1.183', 'groupDescription': 'Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 96 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.8982', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.63', 'ciLowerLimit': '0.351', 'ciUpperLimit': '1.257', 'groupDescription': 'Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9998', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.22', 'ciLowerLimit': '1.910', 'ciUpperLimit': '8.905', 'groupDescription': 'Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9993', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.67', 'ciLowerLimit': '1.689', 'ciUpperLimit': '7.970', 'groupDescription': 'Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '1.0000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.26', 'ciLowerLimit': '2.392', 'ciUpperLimit': '11.754', 'groupDescription': 'Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9713', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.25', 'ciLowerLimit': '0.972', 'ciUpperLimit': '5.136', 'groupDescription': 'Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9649', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.19', 'ciLowerLimit': '0.940', 'ciUpperLimit': '4.975', 'groupDescription': 'Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.8749', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.59', 'ciLowerLimit': '0.711', 'ciUpperLimit': '3.473', 'groupDescription': 'Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9566', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.99', 'ciLowerLimit': '0.899', 'ciUpperLimit': '4.342', 'groupDescription': 'Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9549', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.91', 'ciLowerLimit': '0.862', 'ciUpperLimit': '4.173', 'groupDescription': 'Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9275', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.81', 'ciLowerLimit': '0.816', 'ciUpperLimit': '4.005', 'groupDescription': 'Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.7483', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.32', 'ciLowerLimit': '0.584', 'ciUpperLimit': '3.007', 'groupDescription': 'Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6480', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.17', 'ciLowerLimit': '0.516', 'ciUpperLimit': '2.675', 'groupDescription': 'Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9038', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.76', 'ciLowerLimit': '0.741', 'ciUpperLimit': '4.170', 'groupDescription': 'Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.7339', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.38', 'ciLowerLimit': '0.490', 'ciUpperLimit': '3.915', 'groupDescription': 'Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 96 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.7714', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.38', 'ciLowerLimit': '0.651', 'ciUpperLimit': '3.321', 'groupDescription': 'Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '0.5 hours, 2 hours, 6 hours, 12 hours, 24 hours, 48 hours, 48.5 hours, 50 hours, 54 hours, 60 hours, 66 hours, 72 hours, 96 hours and 120 hours upto Day 5.', 'description': 'Renin-angiotensin system cascade biomarkers included Ang II, Ang (1-7) and Ang (1-5). Blood samples for biomarker analyses were collected 0.5 hours, 2 hours, 6 hours, 12 hours, 24 hours, 48 hours, 48.5 hours, 50 hours, 54 hours, 60 hours, 66 hours, 72 hours, 96 hours and 120 hours upto Day 5. Data has been presented for median along with the 95% credible interval.', 'unitOfMeasure': 'picograms per milliliter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The All Subjects - Part B Population. Only those participants available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Pharmacodynamic/Biomarker Analysis (Renin-angiotensin System Cascade Biomarkers) to Include Ang II/Ang (1-5) and Ang II/Ang (1-7) Upto Day 5(Part B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B (Placebo BID)', 'description': 'Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.'}, {'id': 'OG001', 'title': 'Part B (GSK2586881 BID)', 'description': 'Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.'}], 'classes': [{'title': 'Ang II/Ang1-5 at 0.5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.35', 'groupId': 'OG000', 'lowerLimit': '2.463', 'upperLimit': '7.664'}, {'value': '0.29', 'groupId': 'OG001', 'lowerLimit': '0.175', 'upperLimit': '0.488'}]}]}, {'title': 'Ang II/Ang1-5 at 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.82', 'groupId': 'OG000', 'lowerLimit': '2.150', 'upperLimit': '6.713'}, {'value': '0.38', 'groupId': 'OG001', 'lowerLimit': '0.227', 'upperLimit': '0.645'}]}]}, {'title': 'Ang II/Ang1-5 at 6 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.20', 'groupId': 'OG000', 'lowerLimit': '1.793', 'upperLimit': '5.619'}, {'value': '0.36', 'groupId': 'OG001', 'lowerLimit': '0.211', 'upperLimit': '0.629'}]}]}, {'title': 'Ang II/Ang1-5 at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.90', 'groupId': 'OG000', 'lowerLimit': '1.605', 'upperLimit': '5.215'}, {'value': '0.72', 'groupId': 'OG001', 'lowerLimit': '0.414', 'upperLimit': '1.270'}]}]}, {'title': 'Ang II/Ang1-5 at 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.35', 'groupId': 'OG000', 'lowerLimit': '1.296', 'upperLimit': '4.276'}, {'value': '0.68', 'groupId': 'OG001', 'lowerLimit': '0.383', 'upperLimit': '1.182'}]}]}, {'title': 'Ang II/Ang1-5 at 48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.68', 'groupId': 'OG000', 'lowerLimit': '1.481', 'upperLimit': '4.757'}, {'value': '0.85', 'groupId': 'OG001', 'lowerLimit': '0.497', 'upperLimit': '1.445'}]}]}, {'title': 'Ang II/Ang1-5 at 48.5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.90', 'groupId': 'OG000', 'lowerLimit': '1.606', 'upperLimit': '5.164'}, {'value': '0.56', 'groupId': 'OG001', 'lowerLimit': '0.328', 'upperLimit': '0.959'}]}]}, {'title': 'Ang II/Ang1-5 at 50 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.11', 'groupId': 'OG000', 'lowerLimit': '1.181', 'upperLimit': '3.740'}, {'value': '0.53', 'groupId': 'OG001', 'lowerLimit': '0.311', 'upperLimit': '0.909'}]}]}, {'title': 'Ang II/Ang1-5 at 54 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.21', 'groupId': 'OG000', 'lowerLimit': '1.249', 'upperLimit': '3.885'}, {'value': '0.68', 'groupId': 'OG001', 'lowerLimit': '0.385', 'upperLimit': '1.191'}]}]}, {'title': 'Ang II/Ang1-5 at 60 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.52', 'groupId': 'OG000', 'lowerLimit': '1.445', 'upperLimit': '4.412'}, {'value': '0.86', 'groupId': 'OG001', 'lowerLimit': '0.496', 'upperLimit': '1.501'}]}]}, {'title': 'Ang II/Ang1-5 at 66 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.90', 'groupId': 'OG000', 'lowerLimit': '1.669', 'upperLimit': '5.036'}, {'value': '0.64', 'groupId': 'OG001', 'lowerLimit': '0.370', 'upperLimit': '1.105'}]}]}, {'title': 'Ang II/Ang1-5 at 72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.91', 'groupId': 'OG000', 'lowerLimit': '1.620', 'upperLimit': '5.153'}, {'value': '0.76', 'groupId': 'OG001', 'lowerLimit': '0.429', 'upperLimit': '1.335'}]}]}, {'title': 'Ang II/Ang1-5 at 96 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.72', 'groupId': 'OG000', 'lowerLimit': '0.870', 'upperLimit': '3.387'}, {'value': '1.41', 'groupId': 'OG001', 'lowerLimit': '0.738', 'upperLimit': '2.695'}]}]}, {'title': 'Ang II/Ang1-5 at 120 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.93', 'groupId': 'OG000', 'lowerLimit': '1.058', 'upperLimit': '3.508'}, {'value': '1.53', 'groupId': 'OG001', 'lowerLimit': '0.768', 'upperLimit': '2.872'}]}]}, {'title': 'Ang II/Ang1-7 at 0.5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.10', 'groupId': 'OG000', 'lowerLimit': '1.681', 'upperLimit': '5.669'}, {'value': '0.19', 'groupId': 'OG001', 'lowerLimit': '0.110', 'upperLimit': '0.342'}]}]}, {'title': 'Ang II/Ang1-7 at 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.52', 'groupId': 'OG000', 'lowerLimit': '1.379', 'upperLimit': '4.611'}, {'value': '0.24', 'groupId': 'OG001', 'lowerLimit': '0.135', 'upperLimit': '0.432'}]}]}, {'title': 'Ang II/Ang1-7 at 6 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.63', 'groupId': 'OG000', 'lowerLimit': '1.456', 'upperLimit': '4.767'}, {'value': '0.20', 'groupId': 'OG001', 'lowerLimit': '0.109', 'upperLimit': '0.378'}]}]}, {'title': 'Ang II/Ang1-7 at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.50', 'groupId': 'OG000', 'lowerLimit': '1.352', 'upperLimit': '4.675'}, {'value': '0.49', 'groupId': 'OG001', 'lowerLimit': '0.267', 'upperLimit': '0.913'}]}]}, {'title': 'Ang II/Ang1-7 at 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.11', 'groupId': 'OG000', 'lowerLimit': '1.127', 'upperLimit': '3.990'}, {'value': '0.37', 'groupId': 'OG001', 'lowerLimit': '0.200', 'upperLimit': '0.671'}]}]}, {'title': 'Ang II/Ang1-7 at 48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.61', 'groupId': 'OG000', 'lowerLimit': '0.843', 'upperLimit': '3.105'}, {'value': '0.65', 'groupId': 'OG001', 'lowerLimit': '0.363', 'upperLimit': '1.146'}]}]}, {'title': 'Ang II/Ang1-7 at 48.5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.18', 'groupId': 'OG000', 'lowerLimit': '1.147', 'upperLimit': '4.165'}, {'value': '0.51', 'groupId': 'OG001', 'lowerLimit': '0.291', 'upperLimit': '0.917'}]}]}, {'title': 'Ang II/Ang1-7 at 50 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.51', 'groupId': 'OG000', 'lowerLimit': '0.799', 'upperLimit': '2.887'}, {'value': '0.42', 'groupId': 'OG001', 'lowerLimit': '0.233', 'upperLimit': '0.747'}]}]}, {'title': 'Row 23Ang II/Ang1-7 at 54 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.64', 'groupId': 'OG000', 'lowerLimit': '0.872', 'upperLimit': '3.105'}, {'value': '0.40', 'groupId': 'OG001', 'lowerLimit': '0.213', 'upperLimit': '0.719'}]}]}, {'title': 'Ang II/Ang1-7 at 60 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.55', 'groupId': 'OG000', 'lowerLimit': '0.817', 'upperLimit': '2.945'}, {'value': '0.48', 'groupId': 'OG001', 'lowerLimit': '0.264', 'upperLimit': '0.878'}]}]}, {'title': 'Ang II/Ang1-7 at 66 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.81', 'groupId': 'OG000', 'lowerLimit': '0.964', 'upperLimit': '3.354'}, {'value': '0.45', 'groupId': 'OG001', 'lowerLimit': '0.246', 'upperLimit': '0.825'}]}]}, {'title': 'Ang II/Ang1-7 at 72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.75', 'groupId': 'OG000', 'lowerLimit': '0.931', 'upperLimit': '3.295'}, {'value': '0.42', 'groupId': 'OG001', 'lowerLimit': '0.219', 'upperLimit': '0.796'}]}]}, {'title': 'Ang II/Ang1-7 at 96 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.02', 'groupId': 'OG000', 'lowerLimit': '0.951', 'upperLimit': '4.323'}, {'value': '0.69', 'groupId': 'OG001', 'lowerLimit': '0.335', 'upperLimit': '1.406'}]}]}, {'title': 'Ang II/Ang1-7 at 120 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.66', 'groupId': 'OG000', 'lowerLimit': '0.826', 'upperLimit': '3.178'}, {'value': '0.64', 'groupId': 'OG001', 'lowerLimit': '0.311', 'upperLimit': '1.568'}]}]}], 'analyses': [{'pValue': '1.0000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '0.032', 'ciUpperLimit': '0.140', 'groupDescription': 'Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '1.0000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '0.048', 'ciUpperLimit': '0.209', 'groupDescription': 'Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '1.0000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.11', 'ciLowerLimit': '0.054', 'ciUpperLimit': '0.243', 'groupDescription': 'Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9996', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.25', 'ciLowerLimit': '0.113', 'ciUpperLimit': '0.547', 'groupDescription': 'Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9991', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.29', 'ciLowerLimit': '0.130', 'ciUpperLimit': '0.634', 'groupDescription': 'Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9979', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.32', 'ciLowerLimit': '0.149', 'ciUpperLimit': '0.682', 'groupDescription': 'Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '1.0000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciPctValue': '95', 'paramValue': '0.19', 'ciLowerLimit': '0.091', 'ciUpperLimit': '0.417', 'groupDescription': 'Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9998', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.25', 'ciLowerLimit': '0.119', 'ciUpperLimit': '0.539', 'groupDescription': 'Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9985', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.31', 'ciLowerLimit': '0.141', 'ciUpperLimit': '0.666', 'groupDescription': 'Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9977', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.34', 'ciLowerLimit': '0.162', 'ciUpperLimit': '0.730', 'groupDescription': 'Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9999', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.22', 'ciLowerLimit': '0.105', 'ciUpperLimit': '0.468', 'groupDescription': 'Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9996', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.26', 'ciLowerLimit': '0.119', 'ciUpperLimit': '0.570', 'groupDescription': 'Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.6621', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '0.319', 'ciUpperLimit': '2.136', 'groupDescription': 'Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 96 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.7085', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.79', 'ciLowerLimit': '0.324', 'ciUpperLimit': '1.847', 'groupDescription': 'Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '1.0000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '0.028', 'ciUpperLimit': '0.140', 'groupDescription': 'Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '1.0000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '0.043', 'ciUpperLimit': '0.216', 'groupDescription': 'Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '1.0000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.08', 'ciLowerLimit': '0.034', 'ciUpperLimit': '0.177', 'groupDescription': 'Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9998', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.20', 'ciLowerLimit': '0.086', 'ciUpperLimit': '0.453', 'groupDescription': 'Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9999', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.17', 'ciLowerLimit': '0.075', 'ciUpperLimit': '0.400', 'groupDescription': 'Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9863', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.40', 'ciLowerLimit': '0.173', 'ciUpperLimit': '0.901', 'groupDescription': 'Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9998', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.24', 'ciLowerLimit': '0.103', 'ciUpperLimit': '0.529', 'groupDescription': 'Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9992', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.28', 'ciLowerLimit': '0.119', 'ciUpperLimit': '0.626', 'groupDescription': 'Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9995', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.24', 'ciLowerLimit': '0.102', 'ciUpperLimit': '0.561', 'groupDescription': 'Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9964', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.31', 'ciLowerLimit': '0.131', 'ciUpperLimit': '0.729', 'groupDescription': 'Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9995', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.25', 'ciLowerLimit': '0.107', 'ciUpperLimit': '0.584', 'groupDescription': 'Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9993', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.24', 'ciLowerLimit': '0.098', 'ciUpperLimit': '0.578', 'groupDescription': 'Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours', 'statisticalMethod': 'Ratio of Active/Placebo', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9781', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.34', 'ciLowerLimit': '0.119', 'ciUpperLimit': '0.969', 'groupDescription': 'Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 96 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9375', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.38', 'ciLowerLimit': '0.154', 'ciUpperLimit': '1.341', 'groupDescription': 'Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '0.5 hours, 2 hours, 6 hours, 12 hours, 24 hours, 48 hours, 48.5 hours, 50 hours, 54 hours, 60 hours, 66 hours, 72 hours, 96 hours and 120 hours upto Day 5.', 'description': 'Renin-angiotensin system cascade biomarkers included Ang II/Ang (1-5) and Ang II/Ang (1-7) and). Blood samples for biomarker analyses were collected 0.5 hours, 2 hours, 6 hours, 12 hours, 24 hours, 48 hours, 48.5 hours, 50 hours, 54 hours, 60 hours, 66 hours, 72 hours, 96 hours and 120 hours upto Day 5. Data has been presented for median along with the 95% credible interval.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The All Subjects - Part B Population. Only those participants available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Measures of Oxygenation Including Level of Positive End Expiratory Pressure (PEEP), Peak Ventilatory Pressures and Plateau Ventilatory Pressures Upto Day 7 (Part B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B (Placebo BID)', 'description': 'Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.'}, {'id': 'OG001', 'title': 'Part B (GSK2586881 BID)', 'description': 'Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.'}], 'classes': [{'title': 'PEEP at 0.5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000', 'lowerLimit': '8.87', 'upperLimit': '12.18'}, {'value': '9.6', 'groupId': 'OG001', 'lowerLimit': '8.23', 'upperLimit': '11.54'}]}]}, {'title': 'PEEP at 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.9', 'groupId': 'OG000', 'lowerLimit': '8.51', 'upperLimit': '11.69'}, {'value': '9.6', 'groupId': 'OG001', 'lowerLimit': '8.23', 'upperLimit': '11.60'}]}]}, {'title': 'PEEP at 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.9', 'groupId': 'OG000', 'lowerLimit': '8.48', 'upperLimit': '11.62'}, {'value': '9.7', 'groupId': 'OG001', 'lowerLimit': '8.26', 'upperLimit': '11.72'}]}]}, {'title': 'PEEP at 4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.7', 'groupId': 'OG000', 'lowerLimit': '8.30', 'upperLimit': '11.29'}, {'value': '9.6', 'groupId': 'OG001', 'lowerLimit': '8.21', 'upperLimit': '11.56'}]}]}, {'title': 'PEEP at 6 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.6', 'groupId': 'OG000', 'lowerLimit': '8.28', 'upperLimit': '11.14'}, {'value': '9.5', 'groupId': 'OG001', 'lowerLimit': '8.21', 'upperLimit': '11.32'}]}]}, {'title': 'PEEP at 8 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.7', 'groupId': 'OG000', 'lowerLimit': '8.38', 'upperLimit': '11.18'}, {'value': '9.6', 'groupId': 'OG001', 'lowerLimit': '8.25', 'upperLimit': '11.19'}]}]}, {'title': 'PEEP at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000', 'lowerLimit': '8.56', 'upperLimit': '11.38'}, {'value': '9.5', 'groupId': 'OG001', 'lowerLimit': '8.13', 'upperLimit': '10.87'}]}]}, {'title': 'PEEP at 18 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000', 'lowerLimit': '8.79', 'upperLimit': '11.71'}, {'value': '9.6', 'groupId': 'OG001', 'lowerLimit': '8.23', 'upperLimit': '11.13'}]}]}, {'title': 'PEEP at 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.7', 'groupId': 'OG000', 'lowerLimit': '8.39', 'upperLimit': '11.36'}, {'value': '9.3', 'groupId': 'OG001', 'lowerLimit': '8.13', 'upperLimit': '10.76'}]}]}, {'title': 'PEEP at 24.5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.7', 'groupId': 'OG000', 'lowerLimit': '8.39', 'upperLimit': '11.37'}, {'value': '9.3', 'groupId': 'OG001', 'lowerLimit': '8.14', 'upperLimit': '10.78'}]}]}, {'title': 'PEEP at 25 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.7', 'groupId': 'OG000', 'lowerLimit': '8.41', 'upperLimit': '11.38'}, {'value': '8.6', 'groupId': 'OG001', 'lowerLimit': '7.47', 'upperLimit': '9.89'}]}]}, {'title': 'PEEP at 26 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '8.13', 'upperLimit': '11.01'}, {'value': '9.3', 'groupId': 'OG001', 'lowerLimit': '8.11', 'upperLimit': '10.78'}]}]}, {'title': 'PEEP at 28 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000', 'lowerLimit': '7.89', 'upperLimit': '10.70'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '8.02', 'upperLimit': '10.79'}]}]}, {'title': 'PEEP at 30 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000', 'lowerLimit': '8.20', 'upperLimit': '11.11'}, {'value': '9.3', 'groupId': 'OG001', 'lowerLimit': '7.89', 'upperLimit': '10.78'}]}]}, {'title': 'PEEP at 32 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000', 'lowerLimit': '7.84', 'upperLimit': '10.63'}, {'value': '9.2', 'groupId': 'OG001', 'lowerLimit': '7.79', 'upperLimit': '10.66'}]}]}, {'title': 'PEEP at 36 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.3', 'groupId': 'OG000', 'lowerLimit': '7.91', 'upperLimit': '10.96'}, {'value': '9.0', 'groupId': 'OG001', 'lowerLimit': '7.75', 'upperLimit': '10.55'}]}]}, {'title': 'PEEP at 42 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.6', 'groupId': 'OG000', 'lowerLimit': '8.21', 'upperLimit': '11.31'}, {'value': '8.9', 'groupId': 'OG001', 'lowerLimit': '7.59', 'upperLimit': '10.39'}]}]}, {'title': 'PEEP at 48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.6', 'groupId': 'OG000', 'lowerLimit': '8.20', 'upperLimit': '11.38'}, {'value': '8.8', 'groupId': 'OG001', 'lowerLimit': '7.52', 'upperLimit': '10.40'}]}]}, {'title': 'PEEP at 48.5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.6', 'groupId': 'OG000', 'lowerLimit': '8.19', 'upperLimit': '11.42'}, {'value': '8.8', 'groupId': 'OG001', 'lowerLimit': '7.57', 'upperLimit': '10.47'}]}]}, {'title': 'PEEP at 49 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.6', 'groupId': 'OG000', 'lowerLimit': '8.17', 'upperLimit': '11.44'}, {'value': '8.6', 'groupId': 'OG001', 'lowerLimit': '7.43', 'upperLimit': 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'categories': [{'measurements': [{'value': '24.8', 'groupId': 'OG000', 'lowerLimit': '21.36', 'upperLimit': '28.57'}, {'value': '23.3', 'groupId': 'OG001', 'lowerLimit': '20.18', 'upperLimit': '26.82'}]}]}, {'title': 'Plateau ventilatory pressure at 48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.6', 'groupId': 'OG000', 'lowerLimit': '20.32', 'upperLimit': '27.73'}, {'value': '23.1', 'groupId': 'OG001', 'lowerLimit': '20.10', 'upperLimit': '27.18'}]}]}, {'title': 'Plateau ventilatory pressure at 48.5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.1', 'groupId': 'OG000', 'lowerLimit': '19.89', 'upperLimit': '27.11'}, {'value': '25.2', 'groupId': 'OG001', 'lowerLimit': '22.01', 'upperLimit': '29.38'}]}]}, {'title': 'Plateau 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'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.5', 'groupId': 'OG000', 'lowerLimit': '18.69', 'upperLimit': '27.06'}, {'value': '23.4', 'groupId': 'OG001', 'lowerLimit': '20.18', 'upperLimit': '26.99'}]}]}, {'title': 'Plateau ventilatory pressure at 66 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.5', 'groupId': 'OG000', 'lowerLimit': '19.54', 'upperLimit': '30.63'}, {'value': '23.6', 'groupId': 'OG001', 'lowerLimit': '20.10', 'upperLimit': '27.69'}]}]}, {'title': 'Plateau ventilatory pressure at 72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.7', 'groupId': 'OG000', 'lowerLimit': '17.69', 'upperLimit': '26.83'}, {'value': '25.3', 'groupId': 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'0.7108', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.906', 'ciUpperLimit': '1.179', 'groupDescription': 'Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 8 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.7445', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.918', 'ciUpperLimit': '1.190', 'groupDescription': 'Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.3759', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.863', 'ciUpperLimit': '1.115', 'groupDescription': 'Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 18 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.3980', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.859', 'ciUpperLimit': '1.118', 'groupDescription': 'Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.3231', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.849', 'ciUpperLimit': '1.103', 'groupDescription': 'Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24.5 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.1245', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.812', 'ciUpperLimit': '1.056', 'groupDescription': 'Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 25 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.4631', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.870', 'ciUpperLimit': '1.134', 'groupDescription': 'Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 26 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.1026', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.801', 'ciUpperLimit': '1.047', 'groupDescription': 'Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 28 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.3152', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.850', 'ciUpperLimit': '1.101', 'groupDescription': 'Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 30 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0762', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '0.803', 'ciUpperLimit': '1.035', 'groupDescription': 'Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 32 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0274', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.763', 'ciUpperLimit': '1.003', 'groupDescription': 'Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 36 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.3594', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.853', 'ciUpperLimit': '1.112', 'groupDescription': 'Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 42 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.7027', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.906', 'ciUpperLimit': '1.197', 'groupDescription': 'Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.8661', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '0.941', 'ciUpperLimit': '1.246', 'groupDescription': 'Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.8084', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.924', 'ciUpperLimit': '1.228', 'groupDescription': 'Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 49 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9504', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.13', 'ciLowerLimit': '0.976', 'ciUpperLimit': '1.300', 'groupDescription': 'Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.5300', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.871', 'ciUpperLimit': '1.164', 'groupDescription': 'Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 52 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.8595', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '0.942', 'ciUpperLimit': '1.243', 'groupDescription': 'Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.8802', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '0.943', 'ciUpperLimit': '1.261', 'groupDescription': 'Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 56 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9232', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.11', 'ciLowerLimit': '0.958', 'ciUpperLimit': '1.278', 'groupDescription': 'Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.7911', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.902', 'ciUpperLimit': '1.256', 'groupDescription': 'Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9946', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.28', 'ciLowerLimit': '1.059', 'ciUpperLimit': '1.514', 'groupDescription': 'Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9830', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.26', 'ciLowerLimit': '1.019', 'ciUpperLimit': '1.444', 'groupDescription': 'Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 168 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.8024', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '0.910', 'ciUpperLimit': '1.261', 'groupDescription': 'Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.4806', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.843', 'ciUpperLimit': '1.166', 'groupDescription': 'Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 1 hour', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.6658', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.869', 'ciUpperLimit': '1.223', 'groupDescription': 'Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.6131', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.856', 'ciUpperLimit': '1.212', 'groupDescription': 'Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 4 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.5795', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.856', 'ciUpperLimit': '1.197', 'groupDescription': 'Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0209', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.85', 'ciLowerLimit': '0.716', 'ciUpperLimit': '0.993', 'groupDescription': 'Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 8 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.4823', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.830', 'ciUpperLimit': '1.187', 'groupDescription': 'Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0406', 'groupIds': ['OG000', 'OG001'], 'paramType': '0.0406', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.85', 'ciLowerLimit': '0.703', 'ciUpperLimit': '1.021', 'groupDescription': 'Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 18 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.5186', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.844', 'ciUpperLimit': '1.169', 'groupDescription': 'Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.3870', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.824', 'ciUpperLimit': '1.132', 'groupDescription': 'Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24.5 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.1281', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '0.770', 'ciUpperLimit': '1.065', 'groupDescription': 'Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 25 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.4754', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.837', 'ciUpperLimit': '1.181', 'groupDescription': 'Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 26 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.5627', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.856', 'ciUpperLimit': '1.217', 'groupDescription': 'Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 28 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.5552', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.848', 'ciUpperLimit': '1.220', 'groupDescription': 'Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 30 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.5030', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.843', 'ciUpperLimit': '1.201', 'groupDescription': 'Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 32 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.5558', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.840', 'ciUpperLimit': '1.218', 'groupDescription': 'Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 36 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.2709', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.769', 'ciUpperLimit': '1.135', 'groupDescription': 'Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 42 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.4143', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.795', 'ciUpperLimit': '1.208', 'groupDescription': 'Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.7886', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '0.891', 'ciUpperLimit': '1.348', 'groupDescription': 'Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.7607', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '0.885', 'ciUpperLimit': '1.353', 'groupDescription': 'Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 49 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.8677', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.13', 'ciLowerLimit': '0.922', 'ciUpperLimit': '1.400', 'groupDescription': 'Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.7012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.847', 'ciUpperLimit': '1.302', 'groupDescription': 'Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 52 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.5156', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.805', 'ciUpperLimit': '1.230', 'groupDescription': 'Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.3524', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.783', 'ciUpperLimit': '1.178', 'groupDescription': 'Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 56 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.6380', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.845', 'ciUpperLimit': '1.292', 'groupDescription': 'Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.4003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.743', 'ciUpperLimit': '1.241', 'groupDescription': 'Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.8817', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.16', 'ciLowerLimit': '0.907', 'ciUpperLimit': '1.502', 'groupDescription': 'Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.8145', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.14', 'ciLowerLimit': '0.804', 'ciUpperLimit': '1.505', 'groupDescription': 'Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 168 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '0.5, 1, 2, 4, 6, 8, 12, 18, 24, 24.5, 25, 26, 28, 30, 32, 36, 42, 48, 48.5, 49, 50, 52, 54, 56, 60, 66, 72 and 168 hours upto Day 7', 'description': 'Measures of oxygenation included PEEP the pressure in the lungs (alveolar pressure) above atmospheric pressure (the pressure outside of the body) that exists at the end of expiration, peak ventilator pressure highest level of pressure applied to the lungs during inhalation and plateau ventilatory pressure the pressure applied to small airways and alveoli measured during an inspiratory pause on the ventilator. Assessments were performed at 0.5, 1, 2, 4, 6, 8, 12, 18, 24, 24.5, 25, 26, 28, 30, 32, 36, 42, 48, 48.5, 49, 50, 52, 54, 56, 60, 66, 72 and 168 hours upto Day 7. Data has been presented for median along with the 95% credible interval.', 'unitOfMeasure': 'centimeters of water pressure', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The All Subjects - Part B Population. Only those participants available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Measure of Oxygenation Including Fraction of Inspired Oxygen/ Partial Pressure of Oxygen in Arterial Blood (PaO2/FiO2) Ratio Via Pulse Oximetry Upto Day 7 (Part B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B (Placebo BID)', 'description': 'Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.'}, {'id': 'OG001', 'title': 'Part B (GSK2586881 BID)', 'description': 'Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.'}], 'classes': [{'title': 'PaO2/FiO2 at 0.5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '166.2', 'groupId': 'OG000', 'lowerLimit': '139.71', 'upperLimit': '201.29'}, {'value': '173.7', 'groupId': 'OG001', 'lowerLimit': '143.97', 'upperLimit': '206.37'}]}]}, {'title': 'PaO2/FiO2 at 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '178.1', 'groupId': 'OG000', 'lowerLimit': '149.67', 'upperLimit': '215.96'}, {'value': '160.2', 'groupId': 'OG001', 'lowerLimit': '132.71', 'upperLimit': '190.93'}]}]}, {'title': 'PaO2/FiO2 at 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '181.5', 'groupId': 'OG000', 'lowerLimit': '153.14', 'upperLimit': '216.76'}, {'value': '162.3', 'groupId': 'OG001', 'lowerLimit': '137.17', 'upperLimit': '192.34'}]}]}, {'title': 'PaO2/FiO2 at 4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '182.8', 'groupId': 'OG000', 'lowerLimit': '153.78', 'upperLimit': '218.35'}, {'value': '155.1', 'groupId': 'OG001', 'lowerLimit': '130.45', 'upperLimit': '183.88'}]}]}, {'title': 'PaO2/FiO2 at 6 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '173.2', 'groupId': 'OG000', 'lowerLimit': '146.00', 'upperLimit': '205.32'}, {'value': '156.7', 'groupId': 'OG001', 'lowerLimit': '130.95', 'upperLimit': '186.82'}]}]}, {'title': 'PaO2/FiO2 at 8 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '160.9', 'groupId': 'OG000', 'lowerLimit': '135.62', 'upperLimit': '191.40'}, {'value': '170.6', 'groupId': 'OG001', 'lowerLimit': '143.85', 'upperLimit': '203.91'}]}]}, {'title': 'PaO2/FiO2 at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '173.7', 'groupId': 'OG000', 'lowerLimit': '144.53', 'upperLimit': '208.14'}, {'value': '179.6', 'groupId': 'OG001', 'lowerLimit': '149.68', 'upperLimit': '214.58'}]}]}, {'title': 'PaO2/FiO2 at 18 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '180.5', 'groupId': 'OG000', 'lowerLimit': '151.11', 'upperLimit': '214.80'}, {'value': '176.8', 'groupId': 'OG001', 'lowerLimit': '147.25', 'upperLimit': '212.12'}]}]}, {'title': 'PaO2/FiO2 at 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '183.5', 'groupId': 'OG000', 'lowerLimit': '153.03', 'upperLimit': '219.67'}, {'value': '167.3', 'groupId': 'OG001', 'lowerLimit': '141.36', 'upperLimit': '199.09'}]}]}, {'title': 'PaO2/FiO2 at 24.5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '189.3', 'groupId': 'OG000', 'lowerLimit': '158.67', 'upperLimit': '226.84'}, {'value': '175.8', 'groupId': 'OG001', 'lowerLimit': '147.94', 'upperLimit': '209.31'}]}]}, {'title': 'PaO2/FiO2 at 25 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '179.6', 'groupId': 'OG000', 'lowerLimit': '150.61', 'upperLimit': '215.78'}, {'value': '167.1', 'groupId': 'OG001', 'lowerLimit': '139.64', 'upperLimit': '198.81'}]}]}, {'title': 'PaO2/FiO2 at 26 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '182.9', 'groupId': 'OG000', 'lowerLimit': '153.39', 'upperLimit': '219.07'}, {'value': '183.2', 'groupId': 'OG001', 'lowerLimit': '153.67', 'upperLimit': '217.68'}]}]}, {'title': 'PaO2/FiO2 at 28 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '191.1', 'groupId': 'OG000', 'lowerLimit': '159.67', 'upperLimit': '229.27'}, {'value': '167.9', 'groupId': 'OG001', 'lowerLimit': '140.69', 'upperLimit': '200.46'}]}]}, {'title': 'PaO2/FiO2 at 30 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '169.5', 'groupId': 'OG000', 'lowerLimit': '140.90', 'upperLimit': '205.06'}, {'value': '169.3', 'groupId': 'OG001', 'lowerLimit': '139.80', 'upperLimit': '204.89'}]}]}, {'title': 'PaO2/FiO2 at 32 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '174.2', 'groupId': 'OG000', 'lowerLimit': '143.12', 'upperLimit': '210.61'}, {'value': '155.3', 'groupId': 'OG001', 'lowerLimit': '128.84', 'upperLimit': '186.13'}]}]}, {'title': 'PaO2/FiO2 at 36 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '200.5', 'groupId': 'OG000', 'lowerLimit': '164.55', 'upperLimit': '240.83'}, {'value': '159.5', 'groupId': 'OG001', 'lowerLimit': '132.90', 'upperLimit': '191.36'}]}]}, {'title': 'PaO2/FiO2 at 42 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '172.7', 'groupId': 'OG000', 'lowerLimit': '142.65', 'upperLimit': '207.00'}, {'value': '171.0', 'groupId': 'OG001', 'lowerLimit': '143.95', 'upperLimit': '203.01'}]}]}, {'title': 'PaO2/FiO2 at 48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '169.9', 'groupId': 'OG000', 'lowerLimit': '139.20', 'upperLimit': '206.04'}, {'value': '178.2', 'groupId': 'OG001', 'lowerLimit': '148.82', 'upperLimit': '214.14'}]}]}, {'title': 'PaO2/FiO2 at 48.5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '195.8', 'groupId': 'OG000', 'lowerLimit': '159.95', 'upperLimit': '237.96'}, {'value': '175.5', 'groupId': 'OG001', 'lowerLimit': '146.24', 'upperLimit': '211.20'}]}]}, {'title': 'PaO2/FiO2 at 49 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '166.5', 'groupId': 'OG000', 'lowerLimit': '135.67', 'upperLimit': '203.47'}, {'value': '175.1', 'groupId': 'OG001', 'lowerLimit': '144.85', 'upperLimit': '211.61'}]}]}, {'title': 'PaO2/FiO2 at 50 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '168.3', 'groupId': 'OG000', 'lowerLimit': '138.07', 'upperLimit': '205.14'}, {'value': '167.5', 'groupId': 'OG001', 'lowerLimit': '137.42', 'upperLimit': '202.44'}]}]}, {'title': 'PaO2/FiO2 at 52 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '183.9', 'groupId': 'OG000', 'lowerLimit': '149.96', 'upperLimit': '227.12'}, {'value': '168.4', 'groupId': 'OG001', 'lowerLimit': '141.57', 'upperLimit': '202.76'}]}]}, {'title': 'PaO2/FiO2 at 54 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '191.6', 'groupId': 'OG000', 'lowerLimit': '156.36', 'upperLimit': '235.76'}, {'value': '172.1', 'groupId': 'OG001', 'lowerLimit': '144.47', 'upperLimit': '204.97'}]}]}, {'title': 'PaO2/FiO2 at 56 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '181.6', 'groupId': 'OG000', 'lowerLimit': '148.45', 'upperLimit': '224.06'}, {'value': '173.9', 'groupId': 'OG001', 'lowerLimit': '146.20', 'upperLimit': '206.22'}]}]}, {'title': 'PaO2/FiO2 at 60 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '170.8', 'groupId': 'OG000', 'lowerLimit': '139.25', 'upperLimit': '210.58'}, {'value': '162.4', 'groupId': 'OG001', 'lowerLimit': '135.34', 'upperLimit': '192.99'}]}]}, {'title': 'PaO2/FiO2 at 66 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '154.6', 'groupId': 'OG000', 'lowerLimit': '126.25', 'upperLimit': '189.63'}, {'value': '162.6', 'groupId': 'OG001', 'lowerLimit': '133.81', 'upperLimit': '195.44'}]}]}, {'title': 'PaO2/FiO2 at 72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '150.4', 'groupId': 'OG000', 'lowerLimit': '119.68', 'upperLimit': '188.02'}, {'value': '153.3', 'groupId': 'OG001', 'lowerLimit': '128.23', 'upperLimit': '183.15'}]}]}, {'title': 'PaO2/FiO2 at 168 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '198.9', 'groupId': 'OG000', 'lowerLimit': '163.04', 'upperLimit': '266.41'}, {'value': '168.9', 'groupId': 'OG001', 'lowerLimit': '143.77', 'upperLimit': '196.40'}]}]}], 'analyses': [{'pValue': '0.6468', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.765', 'ciUpperLimit': '1.321', 'groupDescription': 'PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.1965', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.658', 'ciUpperLimit': '1.136', 'groupDescription': 'PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 1 hour', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.1681', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.694', 'ciUpperLimit': '1.129', 'groupDescription': 'PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0877', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.85', 'ciLowerLimit': '0.669', 'ciUpperLimit': '1.075', 'groupDescription': 'PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 4 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.2011', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.715', 'ciUpperLimit': '1.159', 'groupDescription': 'PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.6855', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.842', 'ciUpperLimit': '1.345', 'groupDescription': 'PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 8 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.6093', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.800', 'ciUpperLimit': '1.325', 'groupDescription': 'PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.4350', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.765', 'ciUpperLimit': '1.253', 'groupDescription': 'PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 18 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.2232', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '0.722', 'ciUpperLimit': '1.195', 'groupDescription': 'PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.2716', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.733', 'ciUpperLimit': '1.200', 'groupDescription': 'PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24.5 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.2866', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.726', 'ciUpperLimit': '1.190', 'groupDescription': 'PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 25 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.5033', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.780', 'ciUpperLimit': '1.270', 'groupDescription': 'PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 26 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.1493', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.684', 'ciUpperLimit': '1.120', 'groupDescription': 'PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 28 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.4947', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.759', 'ciUpperLimit': '1.301', 'groupDescription': 'PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 30 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.1951', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.678', 'ciUpperLimit': '1.161', 'groupDescription': 'PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 32 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0512', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '0.612', 'ciUpperLimit': '1.050', 'groupDescription': 'PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 36 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.4700', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.775', 'ciUpperLimit': '1.279', 'groupDescription': 'PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 42 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.6340', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.811', 'ciUpperLimit': '1.368', 'groupDescription': 'PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.2129', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.689', 'ciUpperLimit': '1.183', 'groupDescription': 'PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.6418', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.798', 'ciUpperLimit': '1.411', 'groupDescription': 'PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 49 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.4797', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.754', 'ciUpperLimit': '1.315', 'groupDescription': 'PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours', 'statisticalMethod': 'Ratio of Active/Placebo', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.2659', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.703', 'ciUpperLimit': '1.199', 'groupDescription': 'PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 52 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.2102', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.687', 'ciUpperLimit': '1.159', 'groupDescription': 'PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.3623', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.740', 'ciUpperLimit': '1.240', 'groupDescription': 'PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 56 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.3499', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.730', 'ciUpperLimit': '1.225', 'groupDescription': 'PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.6494', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.787', 'ciUpperLimit': '1.377', 'groupDescription': 'PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.5567', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.766', 'ciUpperLimit': '1.358', 'groupDescription': 'PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.1095', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.85', 'ciLowerLimit': '0.615', 'ciUpperLimit': '1.073', 'groupDescription': 'PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 168 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '0.5, 1, 2, 4, 6, 8, 12, 18, 24, 24.5, 25, 26, 28, 30, 32, 36, 42, 48, 48.5, 49, 50, 52, 54, 56, 60, 66, 72 and 168 hours upto Day 7', 'description': 'Measure of oxygenation included PaO2/FiO2 ratio defined as the ratio of arterial oxygen partial pressure to fractional inspired oxygen by pulse oximeter a device that measured the oxygen saturation of arterial blood in a participant by utilizing a sensor attached typically to a finger, toe, or ear to determine the percentage of oxyhemoglobin in blood pulsating through a network of capillaries.\n\nAssessments were performed at 0.5, 1, 2, 4, 6, 8, 12, 18, 24, 24.5, 25, 26, 28, 30, 32, 36, 42, 48, 48.5, 49, 50, 52, 54, 56, 60, 66, 72 and 168 hours upto Day 7. Data has been presented for median along with the 95% credible interval.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The All Subjects - Part B Population. Only those participants available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Measure of Oxygenation Index Upto Day 7 (Part B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B (Placebo BID)', 'description': 'Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.'}, {'id': 'OG001', 'title': 'Part B (GSK2586881 BID)', 'description': 'Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.'}], 'classes': [{'title': 'Oxygenation index at 0.5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000', 'lowerLimit': '7.26', 'upperLimit': '13.17'}, {'value': '10.6', 'groupId': 'OG001', 'lowerLimit': '7.71', 'upperLimit': '14.79'}]}]}, {'title': 'Oxygenation index at 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000', 'lowerLimit': '6.60', 'upperLimit': '11.82'}, {'value': '12.2', 'groupId': 'OG001', 'lowerLimit': '8.95', 'upperLimit': '16.99'}]}]}, {'title': 'Oxygenation index at 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.9', 'groupId': 'OG000', 'lowerLimit': '7.35', 'upperLimit': '12.96'}, {'value': '11.0', 'groupId': 'OG001', 'lowerLimit': '7.95', 'upperLimit': '15.15'}]}]}, {'title': 'Oxygenation index at 4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.3', 'groupId': 'OG000', 'lowerLimit': '7.01', 'upperLimit': '12.43'}, {'value': '11.6', 'groupId': 'OG001', 'lowerLimit': '8.27', 'upperLimit': '16.97'}]}]}, {'title': 'Oxygenation index at 6 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000', 'lowerLimit': '7.65', 'upperLimit': '13.46'}, {'value': '12.3', 'groupId': 'OG001', 'lowerLimit': '8.65', 'upperLimit': '18.07'}]}]}, {'title': 'Oxygenation index at 8 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000', 'lowerLimit': '7.76', 'upperLimit': '13.89'}, {'value': '12.4', 'groupId': 'OG001', 'lowerLimit': '8.86', 'upperLimit': '17.36'}]}]}, {'title': 'Oxygenation index at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.3', 'groupId': 'OG000', 'lowerLimit': '6.88', 'upperLimit': '12.61'}, {'value': '11.0', 'groupId': 'OG001', 'lowerLimit': '7.50', 'upperLimit': '16.24'}]}]}, {'title': 'Oxygenation index at 18 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.7', 'groupId': 'OG000', 'lowerLimit': '6.44', 'upperLimit': '11.52'}, {'value': '10.8', 'groupId': 'OG001', 'lowerLimit': '7.54', 'upperLimit': '16.17'}]}]}, {'title': 'Oxygenation index at 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.6', 'groupId': 'OG000', 'lowerLimit': '8.02', 'upperLimit': '14.05'}, {'value': '10.6', 'groupId': 'OG001', 'lowerLimit': '8.22', 'upperLimit': '14.39'}]}]}, {'title': 'Oxygenation index at 24.5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000', 'lowerLimit': '6.79', 'upperLimit': '11.90'}, {'value': '9.6', 'groupId': 'OG001', 'lowerLimit': '7.52', 'upperLimit': '13.14'}]}]}, {'title': 'Oxygenation index at 25 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000', 'lowerLimit': '6.74', 'upperLimit': '11.93'}, {'value': '10.5', 'groupId': 'OG001', 'lowerLimit': '8.26', 'upperLimit': '14.59'}]}]}, {'title': 'Oxygenation index at 26 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000', 'lowerLimit': '6.92', 'upperLimit': '12.16'}, {'value': '8.3', 'groupId': 'OG001', 'lowerLimit': '6.46', 'upperLimit': '11.75'}]}]}, {'title': 'Oxygenation index at 28 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000', 'lowerLimit': '6.86', 'upperLimit': '12.01'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '6.95', 'upperLimit': '13.27'}]}]}, {'title': 'Oxygenation index at 30 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000', 'lowerLimit': '7.42', 'upperLimit': '13.33'}, {'value': '9.6', 'groupId': 'OG001', 'lowerLimit': '7.23', 'upperLimit': '13.14'}]}]}, {'title': 'Oxygenation index at 32 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.7', 'groupId': 'OG000', 'lowerLimit': '7.21', 'upperLimit': '13.16'}, {'value': '10.4', 'groupId': 'OG001', 'lowerLimit': '7.61', 'upperLimit': '14.11'}]}]}, {'title': 'Oxygenation index at 36 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.7', 'groupId': 'OG000', 'lowerLimit': '6.31', 'upperLimit': '11.81'}, {'value': '10.1', 'groupId': 'OG001', 'lowerLimit': '7.29', 'upperLimit': '13.79'}]}]}, {'title': 'Oxygenation index at 42 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '6.98', 'upperLimit': '12.70'}, {'value': '10.2', 'groupId': 'OG001', 'lowerLimit': '7.13', 'upperLimit': '14.75'}]}]}, {'title': 'Oxygenation index at 48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000', 'lowerLimit': '7.58', 'upperLimit': '14.29'}, {'value': '8.8', 'groupId': 'OG001', 'lowerLimit': '6.49', 'upperLimit': '13.06'}]}]}, {'title': 'Oxygenation index at 48.5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000', 'lowerLimit': '6.78', 'upperLimit': '12.79'}, {'value': '8.4', 'groupId': 'OG001', 'lowerLimit': '6.25', 'upperLimit': '12.37'}]}]}, {'title': 'Oxygenation index at 49 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000', 'lowerLimit': '7.90', 'upperLimit': '15.04'}, {'value': '8.9', 'groupId': 'OG001', 'lowerLimit': '6.67', 'upperLimit': '12.91'}]}]}, {'title': 'Oxygenation index at 50 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000', 'lowerLimit': '7.63', 'upperLimit': '14.64'}, {'value': '9.2', 'groupId': 'OG001', 'lowerLimit': '6.84', 'upperLimit': '12.96'}]}]}, {'title': 'Oxygenation index at 52 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000', 'lowerLimit': '7.07', 'upperLimit': '13.78'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '6.68', 'upperLimit': '13.10'}]}]}, {'title': 'Oxygenation index at 54 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '6.83', 'upperLimit': '12.99'}, {'value': '9.7', 'groupId': 'OG001', 'lowerLimit': '6.32', 'upperLimit': '13.92'}]}]}, {'title': 'Oxygenation index at 56 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.3', 'groupId': 'OG000', 'lowerLimit': '6.86', 'upperLimit': '12.97'}, {'value': '8.5', 'groupId': 'OG001', 'lowerLimit': '5.75', 'upperLimit': '12.35'}]}]}, {'title': 'Oxygenation index at 60 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000', 'lowerLimit': '6.33', 'upperLimit': '12.53'}, {'value': '9.9', 'groupId': 'OG001', 'lowerLimit': '6.92', 'upperLimit': '14.34'}]}]}, {'title': 'Oxygenation index at 66 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000', 'lowerLimit': '7.27', 'upperLimit': '14.66'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '5.59', 'upperLimit': '12.88'}]}]}, {'title': 'Oxygenation index at 72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000', 'lowerLimit': '6.62', 'upperLimit': '16.36'}, {'value': '9.7', 'groupId': 'OG001', 'lowerLimit': '6.63', 'upperLimit': '13.41'}]}]}, {'title': 'Oxygenation index at 168 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000', 'lowerLimit': '4.31', 'upperLimit': '9.67'}, {'value': '6.4', 'groupId': 'OG001', 'lowerLimit': '4.38', 'upperLimit': '9.34'}]}]}], 'analyses': [{'pValue': '0.6098', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.721', 'ciUpperLimit': '1.644', 'groupDescription': 'Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9441', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.35', 'ciLowerLimit': '0.931', 'ciUpperLimit': '2.068', 'groupDescription': 'Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 1 hour', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.7173', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.12', 'ciLowerLimit': '0.749', 'ciUpperLimit': '1.621', 'groupDescription': 'Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.8292', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.26', 'ciLowerLimit': '0.810', 'ciUpperLimit': '1.949', 'groupDescription': 'Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 4 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.8008', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.23', 'ciLowerLimit': '0.775', 'ciUpperLimit': '1.832', 'groupDescription': 'Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.7905', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.20', 'ciLowerLimit': '0.776', 'ciUpperLimit': '1.799', 'groupDescription': 'Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 8 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.7566', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.17', 'ciLowerLimit': '0.737', 'ciUpperLimit': '1.958', 'groupDescription': 'Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.8349', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.25', 'ciLowerLimit': '0.812', 'ciUpperLimit': '2.050', 'groupDescription': 'Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 18 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.4739', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.713', 'ciUpperLimit': '1.527', 'groupDescription': 'Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.6291', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.763', 'ciUpperLimit': '1.647', 'groupDescription': 'Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24.5 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.8032', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.18', 'ciLowerLimit': '0.830', 'ciUpperLimit': '1.814', 'groupDescription': 'Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 25 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.3250', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '0.626', 'ciUpperLimit': '1.416', 'groupDescription': 'Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 26 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.5828', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.687', 'ciUpperLimit': '1.630', 'groupDescription': 'Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 28 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.4546', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.661', 'ciUpperLimit': '1.512', 'groupDescription': 'Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 30 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.6158', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.719', 'ciUpperLimit': '1.639', 'groupDescription': 'Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 32 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.7748', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.17', 'ciLowerLimit': '0.752', 'ciUpperLimit': '1.770', 'groupDescription': 'Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 36 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.6565', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '0.686', 'ciUpperLimit': '1.714', 'groupDescription': 'Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 42 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.2773', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '0.566', 'ciUpperLimit': '1.380', 'groupDescription': 'Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.3606', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.610', 'ciUpperLimit': '1.467', 'groupDescription': 'Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.2211', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.555', 'ciUpperLimit': '1.317', 'groupDescription': 'Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 49 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.2860', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.587', 'ciUpperLimit': '1.348', 'groupDescription': 'Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.4079', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.609', 'ciUpperLimit': '1.510', 'groupDescription': 'Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 52 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.5284', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.614', 'ciUpperLimit': '1.663', 'groupDescription': 'Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.3586', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.568', 'ciUpperLimit': '1.458', 'groupDescription': 'Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 56 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.6768', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.13', 'ciLowerLimit': '0.672', 'ciUpperLimit': '1.853', 'groupDescription': 'Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.1574', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.77', 'ciLowerLimit': '0.488', 'ciUpperLimit': '1.390', 'groupDescription': 'Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.3900', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.521', 'ciUpperLimit': '1.584', 'groupDescription': 'Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.5915', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.748', 'ciUpperLimit': '1.516', 'groupDescription': 'Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 168 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '0.5, 1, 2, 4, 6, 8, 12, 18, 24, 24.5, 25, 26, 28, 30, 32, 36, 42, 48, 48.5, 49, 50, 52, 54, 56, 60, 66, 72 and 168 hours upto Day 7', 'description': 'Oxygenation index was defined as calculation used in intensive care medicine to measure the fraction of inspired oxygen (FiO2) and its usage within the body and was computed using the equation Oxygenation Index= FiO2 x Mean Airway Pressure/Pao2. Assessments were performed at 0.5, 1, 2, 4, 6, 8, 12, 18, 24, 24.5, 25, 26, 28, 30, 32, 36, 42, 48, 48.5, 49, 50, 52, 54, 56, 60, 66, 72 and 168 hours upto Day 7. Data has been presented for median along with the 95% credible interval.', 'unitOfMeasure': 'Percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The All Subjects - Part B Population. Only those participants available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Acute Kidney Injury as Defined by Day 1 to Day 3 Change in Risk, Injury, Failure, Loss of Kidney Function, and End-stage Kidney Disease (RIFLE) Criteria Upto Day 3 (Part B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B (Placebo BID)', 'description': 'Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.'}, {'id': 'OG001', 'title': 'Part B (GSK2586881 BID)', 'description': 'Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.'}], 'classes': [{'title': 'Rifle score total, MISS', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Rifle score total, NAKI to NAKI', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Rifle score total, NAKI to R', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Rifle score total, R to NAKI', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Rifle score total, I to NAKI', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Rifle score total, I to I', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Rifle score total, Fo to I', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Rifle score GFR, MISS', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Rifle score GFR, NAKI to NAKI', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Rifle score GFR, R to I', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Rifle score GFR, I to NAKI', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Rifle score GFR, I to I', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Rifle score urine, NAKI to NAKI', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Rifle score urine, NAKI to Fo', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Rifle score urine, NAKI to R', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Rifle score urine, NAKI to I', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Rifle score urine, R to NAKI', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Rifle score urine, I to NAKI', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Rifle score urine, I to R', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Rifle score urine, Fo to NAKI', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Rifle score urine, Fo to R', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Rifle score urine, Fo to Fo', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Upto Day 3', 'description': 'The RIFLE score is made up of the glomerular filtration rate criteria (GFRC) and urine output criteria (UOC) and is defined as Risk (Serum Creatinine x 1.5 or GFR decrease \\> 25%-GFRC and \\< 0.5 milliliter/kilograms/hour \\[ml/kg/hour\\] x 6 hours-UOC), Injury (Serum Creatinine x 2 or GFR decrease \\> 50%-GFRC and \\< 0.5 ml/kg/hour x 12 hours), Failure (Serum Creatinine x 3, or GFR decrease \\> 75% \\[F=Failure\\] or Serum Creatinine \\>=4 milligrams/deciliter \\[mg/dl\\] with an acute rise \\> 0.5 mg/dl \\[Fc=Failure acute on chronic\\] and \\< 0.3 ml/kg/hour x 24 hours, or anuria x 12 hours \\[Fo=Failure oligouria\\]). Due to the duration of this study it was not possible to be calculate the designated RIFLE class Loss and RIFLE class End-stage kidney disease. Data has been presented for rifle score total, rifle score GFR and rifle score urine. Abbreviations NAKI= No acute kidney injury, R=risk, I=injury, MISS= Unable to derive score.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The All Subjects - Part B Population.'}, {'type': 'SECONDARY', 'title': 'Evaluation of Sequential Organ Failure Assessment (SOFA) Score on Day 4 and Day 7 (Part B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B (Placebo BID)', 'description': 'Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.'}, {'id': 'OG001', 'title': 'Part B (GSK2586881 BID)', 'description': 'Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.'}], 'classes': [{'title': 'Total SOFA Score at Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000', 'lowerLimit': '5.2', 'upperLimit': '9.6'}, {'value': '8.0', 'groupId': 'OG001', 'lowerLimit': '6.3', 'upperLimit': '9.7'}]}]}, {'title': 'Total SOFA Score at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '8.2'}, {'value': '6.8', 'groupId': 'OG001', 'lowerLimit': '4.1', 'upperLimit': '9.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 4 and Day 7', 'description': 'The SOFA score is a mortality prediction score that is based on the degree of dysfunction of 6 organ systems (respiratory, nervous, cardiovascular, liver, coagulation, and kidneys). The score ranges from 0-24. 0 (normal) to 4 (high degree of dysfunction) is given for each organ system, with a higher score indicating greater severity. A score of 0-6 is associated with a mortality rate of less than 10% while a score between 16 and 24 is associated with a greater than 90% mortality rate.', 'unitOfMeasure': 'Score on scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The All Subjects - Part B Population. Only those participants available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Biomarker Analysis for Serum Inflammatory Biomarkers, Markers of Neutrophil Activation, Markers of Lung Epithelial Cell Injury, Renin Levels and Aldosterone Levels Upto Day 5 (Part B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B (Placebo BID)', 'description': 'Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.'}, {'id': 'OG001', 'title': 'Part B (GSK2586881 BID)', 'description': 'Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.'}], 'classes': [{'title': 'CXCL-8 (IL-8) at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.7', 'groupId': 'OG000', 'lowerLimit': '12.21', 'upperLimit': '28.51'}, {'value': '16.6', 'groupId': 'OG001', 'lowerLimit': '11.73', 'upperLimit': '23.39'}]}]}, {'title': 'CXCL-8 (IL-8) at 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.5', 'groupId': 'OG000', 'lowerLimit': '11.52', 'upperLimit': '26.66'}, {'value': '16.8', 'groupId': 'OG001', 'lowerLimit': '11.94', 'upperLimit': '23.57'}]}]}, {'title': 'CXCL-8 (IL-8) at 48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.3', 'groupId': 'OG000', 'lowerLimit': '12.88', 'upperLimit': '39.23'}, {'value': '14.6', 'groupId': 'OG001', 'lowerLimit': '9.34', 'upperLimit': '22.79'}]}]}, {'title': 'CXCL-8 (IL-8) at 72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.5', 'groupId': 'OG000', 'lowerLimit': '8.95', 'upperLimit': '23.82'}, {'value': '14.1', 'groupId': 'OG001', 'lowerLimit': '9.79', 'upperLimit': '20.39'}]}]}, {'title': 'CXCL-8 (IL-8) at 120 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000', 'lowerLimit': '6.11', 'upperLimit': '16.82'}, {'value': '11.8', 'groupId': 'OG001', 'lowerLimit': '7.73', 'upperLimit': '17.84'}]}]}, {'title': 'IL-6 at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '316.2', 'groupId': 'OG000', 'lowerLimit': '202.69', 'upperLimit': '494.51'}, {'value': '313.9', 'groupId': 'OG001', 'lowerLimit': '210.72', 'upperLimit': '450.05'}]}]}, {'title': 'IL-6 at 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '317.9', 'groupId': 'OG000', 'lowerLimit': '167.09', 'upperLimit': '610.13'}, {'value': '231.6', 'groupId': 'OG001', 'lowerLimit': '130.64', 'upperLimit': '402.86'}]}]}, {'title': 'IL-6 at 48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '310.5', 'groupId': 'OG000', 'lowerLimit': '157.27', 'upperLimit': '642.58'}, {'value': '159.8', 'groupId': 'OG001', 'lowerLimit': '88.52', 'upperLimit': '293.27'}]}]}, {'title': 'IL-6 at 72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '249.9', 'groupId': 'OG000', 'lowerLimit': '103.53', 'upperLimit': '625.68'}, {'value': '180.7', 'groupId': 'OG001', 'lowerLimit': '87.50', 'upperLimit': '383.61'}]}]}, {'title': 'IL-6 at 120 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '142.2', 'groupId': 'OG000', 'lowerLimit': '55.63', 'upperLimit': '397.01'}, {'value': '66.2', 'groupId': 'OG001', 'lowerLimit': '27.37', 'upperLimit': '156.20'}]}]}, {'title': 'RAGE at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3746', 'groupId': 'OG000', 'lowerLimit': '2994.0', 'upperLimit': '4706.5'}, {'value': '3461', 'groupId': 'OG001', 'lowerLimit': '2886.2', 'upperLimit': '4174.2'}]}]}, {'title': 'RAGE at 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3059', 'groupId': 'OG000', 'lowerLimit': '2280.9', 'upperLimit': '4094.4'}, {'value': '3054', 'groupId': 'OG001', 'lowerLimit': '2389.0', 'upperLimit': '3868.3'}]}]}, {'title': 'RAGE at 48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2531', 'groupId': 'OG000', 'lowerLimit': '1563.5', 'upperLimit': '4073.7'}, {'value': '2480', 'groupId': 'OG001', 'lowerLimit': '1689.0', 'upperLimit': '3665.5'}]}]}, {'title': 'RAGE at 72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1936', 'groupId': 'OG000', 'lowerLimit': '1149.2', 'upperLimit': '3357.7'}, {'value': '1755', 'groupId': 'OG001', 'lowerLimit': '1140.0', 'upperLimit': '2710.0'}]}]}, {'title': 'RAGE at 120 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1252', 'groupId': 'OG000', 'lowerLimit': '724.6', 'upperLimit': '2267.7'}, {'value': '1292', 'groupId': 'OG001', 'lowerLimit': '779.5', 'upperLimit': '2135.8'}]}]}, {'title': 'MPO at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60161.0', 'groupId': 'OG000', 'lowerLimit': '47838.62', 'upperLimit': '75187.43'}, {'value': '65791.2', 'groupId': 'OG001', 'lowerLimit': '54185.59', 'upperLimit': '79462.44'}]}]}, {'title': 'MPO at 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55141.5', 'groupId': 'OG000', 'lowerLimit': '43437.70', 'upperLimit': '69808.68'}, {'value': '69059.0', 'groupId': 'OG001', 'lowerLimit': '56628.25', 'upperLimit': '84474.33'}]}]}, {'title': 'MPO at 48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58717.0', 'groupId': 'OG000', 'lowerLimit': '44179.56', 'upperLimit': '77559.82'}, {'value': '73790.1', 'groupId': 'OG001', 'lowerLimit': '58940.31', 'upperLimit': '92336.24'}]}]}, {'title': 'MPO at 72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42521.0', 'groupId': 'OG000', 'lowerLimit': '28395.50', 'upperLimit': '63099.18'}, {'value': '60700.1', 'groupId': 'OG001', 'lowerLimit': '43874.43', 'upperLimit': '84341.04'}]}]}, {'title': 'MPO at 120 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32313.1', 'groupId': 'OG000', 'lowerLimit': '18853.46', 'upperLimit': '55926.54'}, {'value': '47835.2', 'groupId': 'OG001', 'lowerLimit': '29762.70', 'upperLimit': '78945.65'}]}]}, {'title': 'Angiopoietin-2 at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10816.2', 'groupId': 'OG000', 'lowerLimit': '8386.58', 'upperLimit': '13875.32'}, {'value': '8981.1', 'groupId': 'OG001', 'lowerLimit': '7262.21', 'upperLimit': '11069.75'}]}]}, {'title': 'Angiopoietin-2 at 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9127.2', 'groupId': 'OG000', 'lowerLimit': '7112.04', 'upperLimit': '11768.48'}, {'value': '8973.9', 'groupId': 'OG001', 'lowerLimit': '7307.81', 'upperLimit': '11015.23'}]}]}, {'title': 'Angiopoietin-2 at 48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9546.3', 'groupId': 'OG000', 'lowerLimit': '7228.39', 'upperLimit': '12627.37'}, {'value': '9043.3', 'groupId': 'OG001', 'lowerLimit': '7276.97', 'upperLimit': '11310.46'}]}]}, {'title': 'Angiopoietin-2 at 72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8859.1', 'groupId': 'OG000', 'lowerLimit': '6597.11', 'upperLimit': '11878.90'}, {'value': '7773.7', 'groupId': 'OG001', 'lowerLimit': '6130.32', 'upperLimit': '9864.61'}]}]}, {'title': 'Angiopoietin-2 at 120 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7047.7', 'groupId': 'OG000', 'lowerLimit': '4907.43', 'upperLimit': '10244.03'}, {'value': '6604.4', 'groupId': 'OG001', 'lowerLimit': '4861.69', 'upperLimit': '9194.97'}]}]}, {'title': 'Renin at 72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.95', 'groupId': 'OG000', 'lowerLimit': '10.037', 'upperLimit': '39.134'}, {'value': '13.60', 'groupId': 'OG001', 'lowerLimit': '7.093', 'upperLimit': '26.212'}]}]}, {'title': 'Aldosterone at 72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.8', 'groupId': 'OG000', 'lowerLimit': '7.46', 'upperLimit': '179.86'}, {'value': '19.5', 'groupId': 'OG001', 'lowerLimit': '7.45', 'upperLimit': '50.56'}]}]}], 'analyses': [{'pValue': '0.06828', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.528', 'ciUpperLimit': '1.501', 'groupDescription': 'CXCL-8 (IL-8), Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.5674', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.570', 'ciUpperLimit': '1.609', 'groupDescription': 'CXCL-8 (IL-8), Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.8855', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.66', 'ciLowerLimit': '0.321', 'ciUpperLimit': '1.316', 'groupDescription': 'CXCL-8 (IL-8), Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.5358', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.531', 'ciUpperLimit': '1.760', 'groupDescription': 'CXCL-8 (IL-8), Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6990', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.17', 'ciLowerLimit': '0.622', 'ciUpperLimit': '2.155', 'groupDescription': 'CXCL-8 (IL-8), Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.5130', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.549', 'ciUpperLimit': '1.721', 'groupDescription': 'IL-6, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.7696', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.73', 'ciLowerLimit': '0.300', 'ciUpperLimit': '1.731', 'groupDescription': 'IL-6, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9254', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.51', 'ciLowerLimit': '0.203', 'ciUpperLimit': '1.289', 'groupDescription': 'IL-6, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.7088', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.72', 'ciLowerLimit': '0.216', 'ciUpperLimit': '2.419', 'groupDescription': 'IL-6, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.8787', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.47', 'ciLowerLimit': '0.112', 'ciUpperLimit': '1.690', 'groupDescription': 'IL-6, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.7338', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.714', 'ciUpperLimit': '1.197', 'groupDescription': 'RAGE, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.4955', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.703', 'ciUpperLimit': '1.415', 'groupDescription': 'RAGE, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.5264', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.541', 'ciUpperLimit': '1.788', 'groupDescription': 'RAGE, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.6183', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '0.454', 'ciUpperLimit': '1.742', 'groupDescription': 'RAGE, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.5291', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.483', 'ciUpperLimit': '2.118', 'groupDescription': 'RAGE, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.7400', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '0.828', 'ciUpperLimit': '1.448', 'groupDescription': 'MPO, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9375', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.25', 'ciLowerLimit': '0.937', 'ciUpperLimit': '1.683', 'groupDescription': 'MPO, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9118', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.26', 'ciLowerLimit': '0.896', 'ciUpperLimit': '1.771', 'groupDescription': 'MPO, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9217', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.43', 'ciLowerLimit': '0.866', 'ciUpperLimit': '2.382', 'groupDescription': 'MPO, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.8676', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.48', 'ciLowerLimit': '0.730', 'ciUpperLimit': '3.064', 'groupDescription': 'MPO, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.8835', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.609', 'ciUpperLimit': '1.135', 'groupDescription': 'Angiopoietin-2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.5446', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.723', 'ciUpperLimit': '1.330', 'groupDescription': 'Angiopoietin-2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.6267', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.679', 'ciUpperLimit': '1.333', 'groupDescription': 'Angiopoietin-2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.7668', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.612', 'ciUpperLimit': '1.260', 'groupDescription': 'Angiopoietin-2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.6100', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.588', 'ciUpperLimit': '1.509', 'groupDescription': 'Angiopoietin-2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.8159', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '0.291', 'ciUpperLimit': '1.623', 'groupDescription': 'Renin, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.7988', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.53', 'ciLowerLimit': '0.106', 'ciUpperLimit': '2.657', 'groupDescription': 'Aldosterone, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '12 hours, 24 hours, 48 hours, 72 hours and 120 hours upto Day 5', 'description': 'Serum inflammatory biomarkers included CXCL-8 \\[IL-8\\], IL-6, markers of neutrophil activation included (e.g. myeloperoxidase \\[MPO\\]), markers of lung epithelial cell injury included receptor for advanced glycation end-products \\[RAGE\\], Angiopoietin 2, along with rennin, aldosterone levels. Blood samples for biomarker analyses were collected 12 hours, 24 hours, 48 hours, 72 hours and 120 hours upto Day 5. Data has been presented for median along with the 95% credible interval.', 'unitOfMeasure': 'picograms per milliliter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The All Subjects - Part B Population. Only those participants available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Biomarker Analysis for Serum Inflammatory Biomarker C-reactive Protein (CRP) Upto Day 5 (Part B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B (Placebo BID)', 'description': 'Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.'}, {'id': 'OG001', 'title': 'Part B (GSK2586881 BID)', 'description': 'Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.'}], 'classes': [{'title': 'CRP at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.99', 'groupId': 'OG000', 'lowerLimit': '8.457', 'upperLimit': '19.919'}, {'value': '14.58', 'groupId': 'OG001', 'lowerLimit': '10.196', 'upperLimit': '20.872'}]}]}, {'title': 'CRP at 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.26', 'groupId': 'OG000', 'lowerLimit': '8.261', 'upperLimit': '15.241'}, {'value': '14.68', 'groupId': 'OG001', 'lowerLimit': '11.357', 'upperLimit': '18.895'}]}]}, {'title': 'CRP at 48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.19', 'groupId': 'OG000', 'lowerLimit': '7.716', 'upperLimit': '16.556'}, {'value': '13.71', 'groupId': 'OG001', 'lowerLimit': '9.846', 'upperLimit': '19.529'}]}]}, {'title': 'CRP at 72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.96', 'groupId': 'OG000', 'lowerLimit': '5.783', 'upperLimit': '17.406'}, {'value': '8.96', 'groupId': 'OG001', 'lowerLimit': '5.510', 'upperLimit': '14.764'}]}]}, {'title': 'CRP at 120 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.81', 'groupId': 'OG000', 'lowerLimit': '3.394', 'upperLimit': '14.053'}, {'value': '8.78', 'groupId': 'OG001', 'lowerLimit': '4.503', 'upperLimit': '17.514'}]}]}], 'analyses': [{'pValue': '0.6536', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.12', 'ciLowerLimit': '0.626', 'ciUpperLimit': '2.024', 'groupDescription': 'CRP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9066', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.30', 'ciLowerLimit': '0.876', 'ciUpperLimit': '1.955', 'groupDescription': 'CRP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.7859', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.23', 'ciLowerLimit': '0.723', 'ciUpperLimit': '2.066', 'groupDescription': 'CRP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.6058', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.413', 'ciUpperLimit': '1.963', 'groupDescription': 'CRP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.6921', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.29', 'ciLowerLimit': '0.456', 'ciUpperLimit': '3.632', 'groupDescription': 'CRP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours', 'statisticalMethod': 'Ratio of Active/Placebo', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '12 hours, 24 hours, 48 hours, 72 hours and 120 hours upto Day 5', 'description': 'Serum inflammatory biomarker included CRP. Blood samples for biomarker analyses were collected 12 hours, 24 hours, 48 hours, 72 hours and 120 hours upto Day 5. Data has been presented for median along with the 95% credible interval.', 'unitOfMeasure': 'milligrams per deciliter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The All Subjects - Part B Population. Only those participants available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Biomarker Analysis for Markers of Lung Epithelial Cell Injury Clara Cell Protein 16 [CCP16]) and Surfactant Protein D [SP-D] Upto Day 5 (Part B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B (Placebo BID)', 'description': 'Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.'}, {'id': 'OG001', 'title': 'Part B (GSK2586881 BID)', 'description': 'Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.'}], 'classes': [{'title': 'CCP-16 at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.24', 'groupId': 'OG000', 'lowerLimit': '7.771', 'upperLimit': '10.908'}, {'value': '8.45', 'groupId': 'OG001', 'lowerLimit': '7.265', 'upperLimit': '9.832'}]}]}, {'title': 'CCP-16 at 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.18', 'groupId': 'OG000', 'lowerLimit': '7.525', 'upperLimit': '11.222'}, {'value': '9.25', 'groupId': 'OG001', 'lowerLimit': '7.795', 'upperLimit': '11.116'}]}]}, {'title': 'CCP-16 at 48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.91', 'groupId': 'OG000', 'lowerLimit': '6.784', 'upperLimit': '14.461'}, {'value': '11.04', 'groupId': 'OG001', 'lowerLimit': '7.909', 'upperLimit': '15.554'}]}]}, {'title': 'CCP-16 at 72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.04', 'groupId': 'OG000', 'lowerLimit': '7.232', 'upperLimit': '11.367'}, {'value': '8.94', 'groupId': 'OG001', 'lowerLimit': '7.439', 'upperLimit': '10.795'}]}]}, {'title': 'CCP-16 at 120 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.94', 'groupId': 'OG000', 'lowerLimit': '7.067', 'upperLimit': '11.382'}, {'value': '7.22', 'groupId': 'OG001', 'lowerLimit': '5.714', 'upperLimit': '9.115'}]}]}, {'title': 'SP-D at 12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '304.71', 'groupId': 'OG000', 'lowerLimit': '260.328', 'upperLimit': '357.195'}, {'value': '384.58', 'groupId': 'OG001', 'lowerLimit': '338.077', 'upperLimit': '438.326'}]}]}, {'title': 'SP-D at 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '348.51', 'groupId': 'OG000', 'lowerLimit': '287.860', 'upperLimit': '421.778'}, {'value': '442.35', 'groupId': 'OG001', 'lowerLimit': '377.745', 'upperLimit': '518.505'}]}]}, {'title': 'SP-D at 48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '307.00', 'groupId': 'OG000', 'lowerLimit': '230.616', 'upperLimit': '405.042'}, {'value': '494.70', 'groupId': 'OG001', 'lowerLimit': '391.578', 'upperLimit': '628.342'}]}]}, {'title': 'SP-D at 72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '281.79', 'groupId': 'OG000', 'lowerLimit': '199.927', 'upperLimit': '398.960'}, {'value': '465.15', 'groupId': 'OG001', 'lowerLimit': '344.549', 'upperLimit': '625.405'}]}]}, {'title': 'SP-D at 120 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '229.94', 'groupId': 'OG000', 'lowerLimit': '149.118', 'upperLimit': '349.968'}, {'value': '350.31', 'groupId': 'OG001', 'lowerLimit': '238.257', 'upperLimit': '518.552'}]}]}], 'analyses': [{'pValue': '0.7934', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.737', 'ciUpperLimit': '1.140', 'groupDescription': 'CCP-16, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.5205', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.782', 'ciUpperLimit': '1.317', 'groupDescription': 'CCP-16, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.6682', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.12', 'ciLowerLimit': '0.673', 'ciUpperLimit': '1.865', 'groupDescription': 'CCP-16, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.5304', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.744', 'ciUpperLimit': '1.315', 'groupDescription': 'CCP-16, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9078', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.81', 'ciLowerLimit': '0.582', 'ciUpperLimit': '1.112', 'groupDescription': 'CCP-16, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9907', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.26', 'ciLowerLimit': '1.042', 'ciUpperLimit': '1.526', 'groupDescription': 'SP-D, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9973', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.27', 'ciLowerLimit': '1.005', 'ciUpperLimit': '1.606', 'groupDescription': 'SP-D, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9954', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.61', 'ciLowerLimit': '1.130', 'ciUpperLimit': '2.331', 'groupDescription': 'SP-D, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9830', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.65', 'ciLowerLimit': '1.045', 'ciUpperLimit': '2.588', 'groupDescription': 'SP-D, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9312', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Active/Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.52', 'ciLowerLimit': '0.867', 'ciUpperLimit': '2.737', 'groupDescription': 'SP-D, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours', 'statisticalMethod': 'Bayesian repeated measures model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '12 hours, 24 hours, 48 hours, 72 hours and 120 hours upto Day 5', 'description': 'Markers of lung epithelial cell injury included CCP16 and SP-D. Blood samples for biomarker analyses were collected 12 hours, 24 hours, 48 hours, 72 hours and 120 hours upto Day 5. Data has been presented for median along with the 95% credible interval.', 'unitOfMeasure': 'nanograms per milliliter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The All Subjects - Part B Population. Only those participants available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Immunogenicity Assessment With Respect to Anti-Acetychollinesterase2 (ACE2) Binding Antibodies at Follow-up Day 14 and Follow-up Day 28 (Part A)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A', 'description': 'Eligible participants received multiple single intravenous escalating doses of GSK2586881 (0.1 milligrams per kg \\[mg/kg\\], 0.2 mg/kg, 0.4 mg/kg, 0.8 mg/kg) as a slow infusion over 3-5 minutes over 2 days.'}], 'classes': [{'title': 'Day 14, Screening positive Confirmed negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, Screening positive and Confirmed positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 14, Screening negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, Screening positive Confirmed negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 28, Screening positive and Confirmed positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'As there were no positive values at screening assay.', 'groupId': 'OG000'}]}]}, {'title': 'Row 6, Screening negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Follow-up (Day 14) and follow-up (Day 28)', 'description': 'Blood samples for immunogenicity analysis were collected at follow-up (Day 14) and follow-up (Day 28). Antibodies to GSK2586881 were measured using a validated electrochemiluminescence bridging assay. All pre-dose and post-dose samples were first tested for Anti-ACE2 binding antibodies by screening and confirmation assay steps. The post-dose samples tested positive for anti-ACE2 binding antibodies were further characterized for anti-ACE2 neutralizing antibodies. Testing was conducted using a tiered approach; samples were first tested in a screening assay, only samples found positive in this assay were tested in the confirmation assay.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The All Subjects - Part A Population. Only those participants available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Immunogenicity Assessment With Respect to Anti-ACE2 Binding Antibodies at Follow-up Day 14 and Follow-up Day 28 (Part B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B (Placebo BID)', 'description': 'Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.'}, {'id': 'OG001', 'title': 'Part B (GSK2586881 BID)', 'description': 'Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.'}], 'classes': [{'title': 'Day 14, Screening positive Confirmed negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 14, Screening positive and Confirmed positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'As there were no positive values at screening assay.', 'groupId': 'OG001'}]}]}, {'title': 'Day 14, Screening negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Day 28, Screening positive Confirmed negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 28, Screening positive and Confirmed positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'As there were no positive values at screening assay.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'As there were no positive values at screening assay.', 'groupId': 'OG001'}]}]}, {'title': 'Day 28, Screening negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Follow-up (Day 14 )and follow-up (Day 28)', 'description': 'Blood samples for immunogenicity analysis were collected at follow-up (Day 14) and follow-up (Day 28). Antibodies to GSK2586881 were measured using a validated electrochemiluminescence bridging assay. All pre-dose and post-dose samples were first tested for Anti-ACE2 binding antibodies by screening and confirmation assay steps. The post-dose samples tested positive for anti-ACE2 binding antibodies were further characterized for anti-ACE2 neutralizing antibodies. Testing was conducted using a tiered approach; samples were first tested in a screening assay, only samples found positive in this assay were tested in the confirmation assay.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The All Subjects - Part B Population. Only those participants available at the specified time points were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part A', 'description': 'Eligible participants received multiple single intravenous escalating doses of GSK2586881 (0.1 milligrams per kilograms \\[mg/kg\\], 0.2 mg/kg, 0.4 mg/kg, 0.8 mg/kg) as a slow infusion over 3-5 minutes over 2 days.'}, {'id': 'FG001', 'title': 'Part B (Placebo BID)', 'description': 'Eligible participants received intravenous matching placebo (saline solution) twice daily (BID) as a slow infusion over 3-5 minutes for 3 days.'}, {'id': 'FG002', 'title': 'Part B (GSK2586881 BID)', 'description': 'Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.'}], 'periods': [{'title': 'Part A', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Part B', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol-defined stopping criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was conducted across 5 centers in United States and 5 centers in Canada from 20 September 2012 to 06 October 2014.', 'preAssignmentDetails': 'A total of 46 participants were randomized for this study of which 44 participants (5 participants in Part A and 39 participants in Part B) received at least one dose of study medication.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Part A', 'description': 'Eligible participants received multiple single intravenous escalating doses of GSK2586881 (0.1 mg/kg, 0.2 mg/kg, 0.4 mg/kg, 0.8 mg/kg) as a slow infusion over 3-5 minutes over 2 days.'}, {'id': 'BG001', 'title': 'Part B (Placebo BID)', 'description': 'Eligible participants received intravenous matching placebo (saline solution) BID as a slow infusion over 3-5 minutes for 3 days.'}, {'id': 'BG002', 'title': 'Part B (GSK2586881 BID)', 'description': 'Eligible participants received intravenous dose of 0.4 mg/kg BID of GSK2586881 as a slow infusion over 3-5 minutes for 3 days.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18-80 years', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'dispFirstSubmitDate': '2015-03-19', 'completionDateStruct': {'date': '2014-10-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-31', 'studyFirstSubmitDate': '2012-01-26', 'dispFirstSubmitQcDate': '2015-03-19', 'resultsFirstSubmitDate': '2017-07-23', 'studyFirstSubmitQcDate': '2012-05-10', 'dispFirstPostDateStruct': {'date': '2015-04-08', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-09-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-31', 'studyFirstPostDateStruct': {'date': '2012-05-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart Rate Assessments Upto Day 7 (Part B)', 'timeFrame': 'Up to Day 7', 'description': 'Vital sign included heart rate. Assessments were performed at Pre-dose, 0.5 hours, 2 hours, 6 hours and 12 hours on Day 1, 0 hours on Day 2 at 0 hours, 0.5 hours, 2 hours, 6 hours, 12 hours, 18 hours and 24 hours on Day 3 and at follow-up on Day 7.'}, {'measure': 'Diastolic and Systolic Blood Pressure Assessments Upto Day 7 (Part B)', 'timeFrame': 'Up to Day 7', 'description': 'Vital sign included systolic blood pressure and diastolic blood pressure. Assessments were performed at Pre-dose, 0.5 hours, 2 hours, 6 hours and 12 hours on Day 1, 0 hours on Day 2 at 0 hours, 0.5 hours, 2 hours, 6 hours, 12 hours, 18 hours and 24 hours on Day 3 and at follow-up on Day 7.'}, {'measure': 'Electrocardiogram (ECG) Parameters, Including PR, QRS, QT, and QTCU and RR Intervals Upto Day 7 (Part B)', 'timeFrame': 'Up to Day 7', 'description': 'Single 12-lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QTCU and RR intervals. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.'}, {'measure': 'Hematology Parameters Basophils, Eosinophil, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count Upto Day 7 (Part B)', 'timeFrame': 'Up to Day 7', 'description': 'Hematology parameters included basophils, eosinophil, lymphocytes, monocytes, total neutrophils, platelet count and white blood cell count. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.'}, {'measure': 'Hematology Parameters Red Blood Cell Count and Reticulocyte Count Assessment Upto Day 7 (Part B)', 'timeFrame': 'Up to Day 7', 'description': 'Hematology parameters included red blood cell count and reticulocyte count. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.'}, {'measure': 'Hematology Parameter Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Assessment Upto Day 7 (Part B)', 'timeFrame': 'Up to Day 7', 'description': 'Hematology parameters included hemoglobin and MCHC. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.'}, {'measure': 'Hematology Parameter Mean Corpuscle Volume (MCV) Assessment Upto Day 7 (Part B)', 'timeFrame': 'Up to Day 7', 'description': 'Hematology parameter included MCV. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.'}, {'measure': 'Hematology Parameter Mean Corpuscle Hemoglobin (MCH) Assessment Upto Day 7 (Part B)', 'timeFrame': 'Up to Day 7', 'description': 'Hematology parameter included MCH. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.'}, {'measure': 'Hematology Parameter Hematocrit Assessment Upto Day 7 (Part B)', 'timeFrame': 'Up to Day 7', 'description': 'Hematology parameter included hematocrit. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.'}, {'measure': 'Clinical Chemistry Parameters Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen Assessment Upto Day 7 (Part B)', 'timeFrame': 'Up to Day 7', 'description': 'Clinical chemistry parameters included calcium, chloride, carbon dioxide, glucose, potassium, sodium, Urea/Blood urea nitrogen. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.'}, {'measure': 'Clinical Chemistry Parameters Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Assessment Upto Day 7 (Part B)', 'timeFrame': 'Up to Day 7', 'description': 'Clinical chemistry parameters included direct bilirubin, total bilirubin, creatinine and uric acid. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.'}, {'measure': 'Clinical Chemistry Parameters Alkaline Phosphatase, Asparatate Amino Transferase, Alanine Amino Transferase, Gamma Glutamyl Transferase Assessment Upto Day 7 (Part B)', 'timeFrame': 'Up to Day 7', 'description': 'Clinical chemistry parameters included alkaline phosphatase, asparatate amino transferase, alanine amino transferase, gamma glutamyl transferase. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.'}, {'measure': 'Clinical Chemistry Parameters Albumin and Total Protein Assessment Upto Day 7 (Part B)', 'timeFrame': 'Up to Day 7', 'description': 'Clinical chemistry parameters included albumin and total protein. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.'}, {'measure': 'Number of Participant With Adverse Event (AE) and Serious Adverse Event (SAE) Assessment Upto Day 7 (Part A)', 'timeFrame': 'Up to Day 7', 'description': 'An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury.'}, {'measure': 'Number of Par With AE and Serious Adverse Event (SAE) Assessment Upto Day 7 (Part B)', 'timeFrame': 'Up to Day 7', 'description': 'An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury.'}], 'secondaryOutcomes': [{'measure': 'Analysis of GSK2586881 Plasma Pharmacokinetic Concentration (Part A)', 'timeFrame': 'Pre-dose, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours (Day 1), 0 hours, 1 hour, 12 hours, 24 hours (Day 2)', 'description': 'Blood samples for pharmacokinetic analysis of GSK2586881 were collected Pre-dose, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours (Day 1), 0 hours, 1 hour, 12 hours, 24 hours (Day 2). Data has been presented for GSK2586881 Plasma Pharmacokinetic Concentration versus time data for Part A'}, {'measure': 'Analysis of GSK2586881 Plasma Pharmacokinetic Concentration (Part B)', 'timeFrame': 'Pre-dose, 0.5 Hours, 2 hours, 6 hours, 12 hours (Day 1), 0 hours (Day 2), 0 hours, 0.5 hours, 2 hours, 6 hours, 12 hours, 18 hours and 24 hours (Day 3)', 'description': 'Blood samples for pharmacokinetic analysis of GSK2586881 were collected Pre-dose, 0.5 Hours, 2 hours, 6 hours, 12 hours (Day 1), 0 hours (Day 2), 0 hours, 0.5 hours, 2 hours, 6 hours, 12 hours, 18 hours and 24 hours (Day 3). Data has been presented for GSK2586881 Plasma Pharmacokinetic Concentration versus time data for Part B.'}, {'measure': 'Analysis of Pharmacokinetic Parameter Clearance (CL) for GSK2586881 (Part A)', 'timeFrame': 'Pre-dose, 0 hour, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours, 24 hours, 25 hours, 36 hours, 48 hours', 'description': 'Blood samples for pharmacokinetic analysis of GSK2586881 were collected at Pre-dose, 0 hour, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours, 24 hours, 25 hours, 36 hours and 48 hours. CL was defined as the systemic clearance of parent drug. Clearance was calculated for individual participant and geometric mean of the values from all participants was reported.'}, {'measure': 'Analysis Pharmacokinetic Parameter Clearance (CL) for GSK2586881 (Part B)', 'timeFrame': 'Pre-dose, 0 hour, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours, 24 hours, 25 hours, 36 hours, 48 hours', 'description': 'Blood samples for pharmacokinetic analysis of GSK2586881 were collected at Pre-dose, 0 hour, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours, 24 hours, 25 hours, 36 hours and 48 hours. CL was defined as the systemic clearance of parent drug. Clearance was calculated for individual participant and geometric mean of the values from all participants was reported.'}, {'measure': 'Pharmacodynamic/Biomarker Analysis (Renin-angiotensin System Cascade Biomarkers) to Include Angiotensin (Ang) II and Ang (1-7) Upto Day 2 (Part A)', 'timeFrame': 'Pre-dose, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours (Day 1) and 0 hours, 1 hour, 12 hours and 24 hours (Day 2).', 'description': 'Renin-angiotensin system cascade biomarkers included Ang II and Ang (1-7). Blood samples for biomarker analyses were collected at Pre-dose, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours (Day 1) and 0 hours, 1 hour, 12 hours and 24 hours on Day 2.'}, {'measure': 'Pharmacodynamic/Biomarker Analysis (Renin-angiotensin System Cascade Biomarkers) to Include Ang II/ Ang (1-7) Upto Day 2 (Part A)', 'timeFrame': 'Pre-dose, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours (Day 1) and 0 hours, 1 hour, 12 hours and 24 hours (Day 2).', 'description': 'Renin-angiotensin system cascade biomarkers included Ang II/Ang (1-7). Blood samples for biomarker analyses were collected at Pre-dose, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours on Day 1 and 0 hours, 1 hour, 12 hours and 24 hours on Day 2.'}, {'measure': 'Pharmacodynamic/Biomarker Analysis (Renin-angiotensin System Cascade Biomarkers) to Include Ang II, Ang (1-7) and Ang (1-5) Upto Day 5(Part B)', 'timeFrame': '0.5 hours, 2 hours, 6 hours, 12 hours, 24 hours, 48 hours, 48.5 hours, 50 hours, 54 hours, 60 hours, 66 hours, 72 hours, 96 hours and 120 hours upto Day 5.', 'description': 'Renin-angiotensin system cascade biomarkers included Ang II, Ang (1-7) and Ang (1-5). Blood samples for biomarker analyses were collected 0.5 hours, 2 hours, 6 hours, 12 hours, 24 hours, 48 hours, 48.5 hours, 50 hours, 54 hours, 60 hours, 66 hours, 72 hours, 96 hours and 120 hours upto Day 5. Data has been presented for median along with the 95% credible interval.'}, {'measure': 'Pharmacodynamic/Biomarker Analysis (Renin-angiotensin System Cascade Biomarkers) to Include Ang II/Ang (1-5) and Ang II/Ang (1-7) Upto Day 5(Part B)', 'timeFrame': '0.5 hours, 2 hours, 6 hours, 12 hours, 24 hours, 48 hours, 48.5 hours, 50 hours, 54 hours, 60 hours, 66 hours, 72 hours, 96 hours and 120 hours upto Day 5.', 'description': 'Renin-angiotensin system cascade biomarkers included Ang II/Ang (1-5) and Ang II/Ang (1-7) and). Blood samples for biomarker analyses were collected 0.5 hours, 2 hours, 6 hours, 12 hours, 24 hours, 48 hours, 48.5 hours, 50 hours, 54 hours, 60 hours, 66 hours, 72 hours, 96 hours and 120 hours upto Day 5. Data has been presented for median along with the 95% credible interval.'}, {'measure': 'Measures of Oxygenation Including Level of Positive End Expiratory Pressure (PEEP), Peak Ventilatory Pressures and Plateau Ventilatory Pressures Upto Day 7 (Part B)', 'timeFrame': '0.5, 1, 2, 4, 6, 8, 12, 18, 24, 24.5, 25, 26, 28, 30, 32, 36, 42, 48, 48.5, 49, 50, 52, 54, 56, 60, 66, 72 and 168 hours upto Day 7', 'description': 'Measures of oxygenation included PEEP the pressure in the lungs (alveolar pressure) above atmospheric pressure (the pressure outside of the body) that exists at the end of expiration, peak ventilator pressure highest level of pressure applied to the lungs during inhalation and plateau ventilatory pressure the pressure applied to small airways and alveoli measured during an inspiratory pause on the ventilator. Assessments were performed at 0.5, 1, 2, 4, 6, 8, 12, 18, 24, 24.5, 25, 26, 28, 30, 32, 36, 42, 48, 48.5, 49, 50, 52, 54, 56, 60, 66, 72 and 168 hours upto Day 7. Data has been presented for median along with the 95% credible interval.'}, {'measure': 'Measure of Oxygenation Including Fraction of Inspired Oxygen/ Partial Pressure of Oxygen in Arterial Blood (PaO2/FiO2) Ratio Via Pulse Oximetry Upto Day 7 (Part B)', 'timeFrame': '0.5, 1, 2, 4, 6, 8, 12, 18, 24, 24.5, 25, 26, 28, 30, 32, 36, 42, 48, 48.5, 49, 50, 52, 54, 56, 60, 66, 72 and 168 hours upto Day 7', 'description': 'Measure of oxygenation included PaO2/FiO2 ratio defined as the ratio of arterial oxygen partial pressure to fractional inspired oxygen by pulse oximeter a device that measured the oxygen saturation of arterial blood in a participant by utilizing a sensor attached typically to a finger, toe, or ear to determine the percentage of oxyhemoglobin in blood pulsating through a network of capillaries.\n\nAssessments were performed at 0.5, 1, 2, 4, 6, 8, 12, 18, 24, 24.5, 25, 26, 28, 30, 32, 36, 42, 48, 48.5, 49, 50, 52, 54, 56, 60, 66, 72 and 168 hours upto Day 7. Data has been presented for median along with the 95% credible interval.'}, {'measure': 'Measure of Oxygenation Index Upto Day 7 (Part B)', 'timeFrame': '0.5, 1, 2, 4, 6, 8, 12, 18, 24, 24.5, 25, 26, 28, 30, 32, 36, 42, 48, 48.5, 49, 50, 52, 54, 56, 60, 66, 72 and 168 hours upto Day 7', 'description': 'Oxygenation index was defined as calculation used in intensive care medicine to measure the fraction of inspired oxygen (FiO2) and its usage within the body and was computed using the equation Oxygenation Index= FiO2 x Mean Airway Pressure/Pao2. Assessments were performed at 0.5, 1, 2, 4, 6, 8, 12, 18, 24, 24.5, 25, 26, 28, 30, 32, 36, 42, 48, 48.5, 49, 50, 52, 54, 56, 60, 66, 72 and 168 hours upto Day 7. Data has been presented for median along with the 95% credible interval.'}, {'measure': 'Number of Participants With Acute Kidney Injury as Defined by Day 1 to Day 3 Change in Risk, Injury, Failure, Loss of Kidney Function, and End-stage Kidney Disease (RIFLE) Criteria Upto Day 3 (Part B)', 'timeFrame': 'Upto Day 3', 'description': 'The RIFLE score is made up of the glomerular filtration rate criteria (GFRC) and urine output criteria (UOC) and is defined as Risk (Serum Creatinine x 1.5 or GFR decrease \\> 25%-GFRC and \\< 0.5 milliliter/kilograms/hour \\[ml/kg/hour\\] x 6 hours-UOC), Injury (Serum Creatinine x 2 or GFR decrease \\> 50%-GFRC and \\< 0.5 ml/kg/hour x 12 hours), Failure (Serum Creatinine x 3, or GFR decrease \\> 75% \\[F=Failure\\] or Serum Creatinine \\>=4 milligrams/deciliter \\[mg/dl\\] with an acute rise \\> 0.5 mg/dl \\[Fc=Failure acute on chronic\\] and \\< 0.3 ml/kg/hour x 24 hours, or anuria x 12 hours \\[Fo=Failure oligouria\\]). Due to the duration of this study it was not possible to be calculate the designated RIFLE class Loss and RIFLE class End-stage kidney disease. Data has been presented for rifle score total, rifle score GFR and rifle score urine. Abbreviations NAKI= No acute kidney injury, R=risk, I=injury, MISS= Unable to derive score.'}, {'measure': 'Evaluation of Sequential Organ Failure Assessment (SOFA) Score on Day 4 and Day 7 (Part B)', 'timeFrame': 'Day 4 and Day 7', 'description': 'The SOFA score is a mortality prediction score that is based on the degree of dysfunction of 6 organ systems (respiratory, nervous, cardiovascular, liver, coagulation, and kidneys). The score ranges from 0-24. 0 (normal) to 4 (high degree of dysfunction) is given for each organ system, with a higher score indicating greater severity. A score of 0-6 is associated with a mortality rate of less than 10% while a score between 16 and 24 is associated with a greater than 90% mortality rate.'}, {'measure': 'Biomarker Analysis for Serum Inflammatory Biomarkers, Markers of Neutrophil Activation, Markers of Lung Epithelial Cell Injury, Renin Levels and Aldosterone Levels Upto Day 5 (Part B)', 'timeFrame': '12 hours, 24 hours, 48 hours, 72 hours and 120 hours upto Day 5', 'description': 'Serum inflammatory biomarkers included CXCL-8 \\[IL-8\\], IL-6, markers of neutrophil activation included (e.g. myeloperoxidase \\[MPO\\]), markers of lung epithelial cell injury included receptor for advanced glycation end-products \\[RAGE\\], Angiopoietin 2, along with rennin, aldosterone levels. Blood samples for biomarker analyses were collected 12 hours, 24 hours, 48 hours, 72 hours and 120 hours upto Day 5. Data has been presented for median along with the 95% credible interval.'}, {'measure': 'Biomarker Analysis for Serum Inflammatory Biomarker C-reactive Protein (CRP) Upto Day 5 (Part B)', 'timeFrame': '12 hours, 24 hours, 48 hours, 72 hours and 120 hours upto Day 5', 'description': 'Serum inflammatory biomarker included CRP. Blood samples for biomarker analyses were collected 12 hours, 24 hours, 48 hours, 72 hours and 120 hours upto Day 5. Data has been presented for median along with the 95% credible interval.'}, {'measure': 'Biomarker Analysis for Markers of Lung Epithelial Cell Injury Clara Cell Protein 16 [CCP16]) and Surfactant Protein D [SP-D] Upto Day 5 (Part B)', 'timeFrame': '12 hours, 24 hours, 48 hours, 72 hours and 120 hours upto Day 5', 'description': 'Markers of lung epithelial cell injury included CCP16 and SP-D. Blood samples for biomarker analyses were collected 12 hours, 24 hours, 48 hours, 72 hours and 120 hours upto Day 5. Data has been presented for median along with the 95% credible interval.'}, {'measure': 'Immunogenicity Assessment With Respect to Anti-Acetychollinesterase2 (ACE2) Binding Antibodies at Follow-up Day 14 and Follow-up Day 28 (Part A)', 'timeFrame': 'Follow-up (Day 14) and follow-up (Day 28)', 'description': 'Blood samples for immunogenicity analysis were collected at follow-up (Day 14) and follow-up (Day 28). Antibodies to GSK2586881 were measured using a validated electrochemiluminescence bridging assay. All pre-dose and post-dose samples were first tested for Anti-ACE2 binding antibodies by screening and confirmation assay steps. The post-dose samples tested positive for anti-ACE2 binding antibodies were further characterized for anti-ACE2 neutralizing antibodies. Testing was conducted using a tiered approach; samples were first tested in a screening assay, only samples found positive in this assay were tested in the confirmation assay.'}, {'measure': 'Immunogenicity Assessment With Respect to Anti-ACE2 Binding Antibodies at Follow-up Day 14 and Follow-up Day 28 (Part B)', 'timeFrame': 'Follow-up (Day 14 )and follow-up (Day 28)', 'description': 'Blood samples for immunogenicity analysis were collected at follow-up (Day 14) and follow-up (Day 28). Antibodies to GSK2586881 were measured using a validated electrochemiluminescence bridging assay. All pre-dose and post-dose samples were first tested for Anti-ACE2 binding antibodies by screening and confirmation assay steps. The post-dose samples tested positive for anti-ACE2 binding antibodies were further characterized for anti-ACE2 neutralizing antibodies. Testing was conducted using a tiered approach; samples were first tested in a screening assay, only samples found positive in this assay were tested in the confirmation assay.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['rhACE2', 'Acute Respiratory Distress Syndrome (ARDS)', 'Acute Lung Injury', 'GSK2586881', 'critical care'], 'conditions': ['Lung Injury, Acute']}, 'referencesModule': {'references': [{'pmid': '28877748', 'type': 'DERIVED', 'citation': 'Khan A, Benthin C, Zeno B, Albertson TE, Boyd J, Christie JD, Hall R, Poirier G, Ronco JJ, Tidswell M, Hardes K, Powley WM, Wright TJ, Siederer SK, Fairman DA, Lipson DA, Bayliffe AI, Lazaar AL. A pilot clinical trial of recombinant human angiotensin-converting enzyme 2 in acute respiratory distress syndrome. Crit Care. 2017 Sep 7;21(1):234. doi: 10.1186/s13054-017-1823-x.'}]}, 'descriptionModule': {'briefSummary': 'This is an early phase (phase IIa), randomized, multi-center study in subjects with acute lung injury (ALI) or acute respiratory distress syndrome (ARDS). The purpose of this study is to investigate the safety of GSK2586881 and to determine what effects it has on people with Acute Lung Injury (ALI) or Acute Respiratory Distress Syndrome (ARDS).\n\nThe study has two parts: Part A will be an open-label investigation in five subjects. Part B will be a double-blind, placebo controlled investigation and will involve approximately 60 subjects.', 'detailedDescription': 'The acute respiratory distress syndrome (ARDS) is a form of severe acute lung injury (ALI) characterized by hypoxemic respiratory failure (the lungs are unable to absorb oxygen to the arterial blood) and non-cardiogenic pulmonary edema (accumulation of fluid in the lungs). The syndrome may be caused by direct or indirect injury to the lungs. It is associated with a mortality rate of up to 40-50%. There are no marketed pharmacologic therapies for this devastating syndrome.\n\nThis study aims to assess the safety, tolerability and pharmacodynamics of GSK2586881, a recombinant human angiotensin converting enzyme type 2 (rhACE2).\n\nACE2 is involved in the Renin-Angiotensin System (RAS), which controls blood pressure, electrolytes and intravascular fluid volume. A key function of rhACE2 is believed to be the cleavage of Angiotensin II (Ang II) to Ang (1-7), which have opposing physiological roles. Elevated levels of Ang II are associated with vasoconstriction, inflammation, fibrosis, vascular leak, and sodium absorption. Ang (1-7) appears to be a counterregulatory protein in the RAS; associated with vasodilation, anti-proliferation, antiinflammation, and reduced vascular leak. It has been observed that levels of Ang II are increased in humans with ALI/ ARDS. It is expected that the reduction of Ang II should have a positive impact on ALI and ARDS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female, 18 - 80 years of age (inclusive)\n* Diagnosis of ALI with acute onset of PaO2/FiO2 ratio less than or equal to 300, and bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph. The infiltrates may be patchy, diffuse, homogeneous, or asymmetric, and requirement for positive pressure ventilation via an endotracheal tube, and no clinical evidence of left atrial hypertension\n* Cause of ALI thought to be associated with infection, sepsis, pneumonia, aspiration, or similar as judged by the PI and/or medical monitor\n* The subject must be randomized into the study within 48 hours from the time of diagnosis of ALI\n* Period of hemodynamic stability (e.g. 4-6 hours) prior to the initiation of study treatment not requiring resuscitative measures with stable pressor requirements. In this study low-dose arginine vasopressin is not considered a pressor, and is permitted in Parts A and B.\n* If mechanically ventilated, duration of mechanical ventilation must be less than 72 hours before dosing begins\n* BMI within the range 19.0 - 38.0 kg/m2 inclusive\n* The subject or legal decision maker is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.\n* QTcB or QTcF less than 450 msec; or QTc less than 480 msec in subjects with Bundle Branch Block.\n* Alanine aminotransferase (ALT) less than 5 x Upper Limit of Normal (ULN); bilirubin less than or equal to 1.5 x ULN.\n\nExclusion Criteria:\n\n* Subjects whose clinical condition is deteriorating rapidly or any subject for whom the investigator does not consider there is a reasonable expectation that they will be able to complete the study.\n* Known positive Hepatitis B surface antigen, Hepatitis C antibody or HIV antibody\n* Current or chronic history of liver disease (Child Pugh score of greater than or equal to 10), or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).\n* Known history of substance abuse or alcohol abuse, within 6 months of the study causing chronic liver disease such as cirrhosis, chronic ascites or portal hypertension, or known evidence of withdrawal syndrome within the past 6 months.\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* Inability to discontinue use of Angiotensin converting enzyme type 1 inhibitors or Angiotensin receptor blockers.\n* Patients requiring high doses of loop diuretics with significant intravascular volume depletion, as assessed clinically\n* History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation\n* Pregnant females as determined by positive serum or urine hCG test prior to dosing\n* Lactating females\n* Unwillingness or inability to follow the procedures outlined in the protocol\n* Subject is legally incapacitated (e.g. a prisoner)\n* History of sensitivity to heparin or heparin-induced thrombocytopenia\n* Unstable Hemoglobin (Hb less than 7) at time of drug infusion\n* Malignancy or other irreversible condition for which 6 month mortality is estimated to be greater than 50%\n* Arterial blood pH less than 7.1 or serum HCO3 - less than 15 (if ABG not available) before infusion is started\n* Known severe chronic respiratory disease:\n* known Forced Expiratory Volume in 1 second (FEV1)/ Forced Vital Capacity (FVC) less than 45% predicted, or\n* known chronic hypercapnia (PaCO2 greater than 45 mmHg) or chronic hypoxemia (PaO2 less than 55 mmHg) on FiO2 =0.21, or\n* known FEV1 less than 15 ml/kg (e.g. 1L for 70 kg person), or\n* known radiographic evidence of chronic interstitial infiltration, or\n* known hospitalization within the past six months for respiratory failure (PaCO2 greater than 50 mmHg or PaO2 less than 55 mmHg, or oxygen saturation less than 88% on FiO2 = 0.21), or\n* known chronic restrictive, obstructive, neuromuscular, chest wall, or pulmonary vascular disease resulting in severe exercise restriction\n* Known history of neuromuscular disease that would affect time on mechanical ventilation or impairs ability to ventilate spontaneously\n* Vasculitis with diffuse alveolar hemorrhage\n* Lung transplantation\n* Pre-existing renal failure on hemodialysis or peritoneal dialysis requiring renal replacement therapy\n* A patient will be excluded if in the judgement of the Principle Investigator or GSK medical monitor their participation could jeopardize the health of the subject or the integrity of the study."}, 'identificationModule': {'nctId': 'NCT01597635', 'briefTitle': 'The Safety, Tolerability, PK and PD of GSK2586881 in Patients With Acute Lung Injury', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Two Part Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2586881 in Patients With Acute Lung Injury', 'orgStudyIdInfo': {'id': '114622'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A', 'description': '4 increasing doses of GSK2586881 given over 2 days', 'interventionNames': ['Drug: Dose 1 GSK2586881', 'Drug: Dose 2 GSK2586881', 'Drug: Dose 3 GSK2586881', 'Drug: Dose 4 GSK2586881']}, {'type': 'EXPERIMENTAL', 'label': 'Part B', 'description': 'Repeat Medium-High dose of GSK2586881 (or placebo) over 3 days', 'interventionNames': ['Drug: Dose 3 GSK2586881', 'Drug: Placebo (saline)']}], 'interventions': [{'name': 'Dose 1 GSK2586881', 'type': 'DRUG', 'description': 'Low dose GSK2586881 administered intravenously', 'armGroupLabels': ['Part A']}, {'name': 'Dose 2 GSK2586881', 'type': 'DRUG', 'description': 'Medium dose GSK2586881 administered intravenously', 'armGroupLabels': ['Part A']}, {'name': 'Dose 3 GSK2586881', 'type': 'DRUG', 'description': 'Medium-High dose GSK2586881 administered intravenously', 'armGroupLabels': ['Part A', 'Part B']}, {'name': 'Dose 4 GSK2586881', 'type': 'DRUG', 'description': 'High dose GSK2586881 administered intravenously', 'armGroupLabels': ['Part A']}, {'name': 'Placebo (saline)', 'type': 'DRUG', 'description': 'Administered intravenously to match intervention', 'armGroupLabels': ['Part B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '60611', 'city': 'Chicago', 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'South Carolina', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': 'V5Z 1M9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V6Z 1Y6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'B3H 2Y9', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'K7L 2V7', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}, {'zip': 'J4V 2H1', 'city': 'Greenfield Park', 'state': 'Quebec', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 45.48649, 'lon': -73.46223}}, {'zip': 'G1V 4G5', 'city': 'Sainte-Foy', 'state': 'Quebec', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 46.78139, 'lon': -71.29217}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}