Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-27 @ 11:56 PM
Study NCT ID:
NCT01318993
Status:
TERMINATED
Last Update Posted:
2017-09-14
First Post:
2011-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Open-Label Extension Study of GSK1605786A
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina', 'Brazil', 'Greece', 'Ireland']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C583420', 'term': 'CCX282-B'}]}}, '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': 'On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 112 weeks).', 'description': 'On-treatment SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who enrolled in the study except those who did not take at least one dose of investigational product.', 'eventGroups': [{'id': 'EG000', 'title': 'GSK1605786A', 'description': 'Eligible participants received oral GSK1605786A 500 mg BID for 216 weeks and were followed-up till 220 weeks. The participants who prematurely discontinued the study were followed by for last 4 weeks after receiving the last dose of the study drug.', 'otherNumAtRisk': 398, 'deathsNumAtRisk': 398, 'otherNumAffected': 295, 'seriousNumAtRisk': 398, 'deathsNumAffected': 0, 'seriousNumAffected': 41}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 42}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 49}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': "Crohn's Disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 49}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 20}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 66}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastrointestinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Large intestinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Subileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Campylobacter gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lobar pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Shigella infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Multiple sclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myoclonus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Incisional hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Postoperative ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Liver function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Drug ineffective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Colon neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bartholinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Intermittent claudication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 398, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Any Adverse Events (AE) and Any Serious Adverse Events (SAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1605786A 500 mg BID', 'description': 'Eligible participants received oral GSK1605786A 500 mg BID for 216 weeks and were followed-up till 220 weeks. The participants who prematurely discontinued the study were followed by for last 4 weeks after receiving the last dose of the study drug.'}], 'classes': [{'title': 'Any AE', 'categories': [{'measurements': [{'value': '303', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 112', '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 SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect. The Safety population consisted of all participants who enrolled in the study except those who did not take \\>=1 dose of investigational product.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (Week 0) in Systolic and Diastolic Blood Pressure (SBP and DBP) Over Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1605786A 500 mg BID', 'description': 'Eligible participants received oral GSK1605786A 500 mg BID for 216 weeks and were followed-up till 220 weeks. The participants who prematurely discontinued the study were followed by for last 4 weeks after receiving the last dose of the study drug.'}], 'classes': [{'title': 'SBP, Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '11.39', 'groupId': 'OG000'}]}]}, {'title': 'SBP, Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '337', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '11.46', 'groupId': 'OG000'}]}]}, {'title': 'SBP, Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '13.12', 'groupId': 'OG000'}]}]}, {'title': 'SBP, Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '12.69', 'groupId': 'OG000'}]}]}, {'title': 'SBP, Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '12.64', 'groupId': 'OG000'}]}]}, {'title': 'SBP, Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '13.22', 'groupId': 'OG000'}]}]}, {'title': 'SBP, Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '13.00', 'groupId': 'OG000'}]}]}, {'title': 'SBP, Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '13.15', 'groupId': 'OG000'}]}]}, {'title': 'SBP, Week 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.4', 'spread': '18.65', 'groupId': 'OG000'}]}]}, {'title': 'SBP, Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.4', 'spread': '10.72', 'groupId': 'OG000'}]}]}, {'title': 'SBP, Week 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '13.44', 'groupId': 'OG000'}]}]}, {'title': 'SBP, 4 week post treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '13.56', 'groupId': 'OG000'}]}]}, {'title': 'DBP, Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '8.58', 'groupId': 'OG000'}]}]}, {'title': 'DBP, Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '337', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '8.18', 'groupId': 'OG000'}]}]}, {'title': 'DBP, Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '9.21', 'groupId': 'OG000'}]}]}, {'title': 'DBP, Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '10.17', 'groupId': 'OG000'}]}]}, {'title': 'DBP, Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '9.80', 'groupId': 'OG000'}]}]}, {'title': 'DBP, Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '9.02', 'groupId': 'OG000'}]}]}, {'title': 'DBP, Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '10.59', 'groupId': 'OG000'}]}]}, {'title': 'DBP, Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '10.03', 'groupId': 'OG000'}]}]}, {'title': 'DBP, Week 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.4', 'spread': '11.00', 'groupId': 'OG000'}]}]}, {'title': 'DBP, Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'spread': '9.33', 'groupId': 'OG000'}]}]}, {'title': 'DBP, Week 108, n=6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '9.52', 'groupId': 'OG000'}]}]}, {'title': 'DBP, 4 week post treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '9.91', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0) and up to Week 112', 'description': 'The SBP and DBP values were obtained as part of vital sign monitoring and measured after the participant was at rest in the supine position for at least 5 minutes. Baseline value was recorded at Week 0. Change from Baseline measurements in SBP and DBP were assessed at Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108 and 4 weeks post-treatment. The Baseline value is defined as the value at Week 0. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.', 'unitOfMeasure': 'millimeters of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only participants available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (Week 0) in Heart Rate (HR) Over Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1605786A 500 mg BID', 'description': 'Eligible participants received oral GSK1605786A 500 mg BID for 216 weeks and were followed-up till 220 weeks. The participants who prematurely discontinued the study were followed by for last 4 weeks after receiving the last dose of the study drug.'}], 'classes': [{'title': 'HR, Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '10.92', 'groupId': 'OG000'}]}]}, {'title': 'HR, Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '337', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '11.41', 'groupId': 'OG000'}]}]}, {'title': 'HR, Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '11.93', 'groupId': 'OG000'}]}]}, {'title': 'HR, Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '12.56', 'groupId': 'OG000'}]}]}, {'title': 'HR, Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '12.35', 'groupId': 'OG000'}]}]}, {'title': 'HR, Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '13.16', 'groupId': 'OG000'}]}]}, {'title': 'HR, Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '12.85', 'groupId': 'OG000'}]}]}, {'title': 'HR, Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '12.39', 'groupId': 'OG000'}]}]}, {'title': 'HR, Week 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '15.44', 'groupId': 'OG000'}]}]}, {'title': 'HR, Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.9', 'spread': '17.01', 'groupId': 'OG000'}]}]}, {'title': 'HR, Week 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.7', 'spread': '12.83', 'groupId': 'OG000'}]}]}, {'title': 'HR, 4 week post treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '12.89', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0) and up to Week 112', 'description': 'The HR values were obtained as part of vital sign monitoring and measured after the participant was at rest in the supine position for at least 5 minutes. Change from Baseline in HR was assessed at Week 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108 and 4 weeks post-treatment. The Baseline value is defined as the value at Week 0. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only participants available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Shifts From Baseline (Week 0) for the Indicated Hematology Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1605786A 500 mg BID', 'description': 'Eligible participants received oral GSK1605786A 500 mg BID for 216 weeks and were followed-up till 220 weeks. The participants who prematurely discontinued the study were followed by for last 4 weeks after receiving the last dose of the study drug.'}], 'classes': [{'title': 'Platelets, shift to low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, shift to normal or no change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '394', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '325', 'groupId': 'OG000'}]}]}, {'title': 'Platelets, shift to high', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}, {'title': 'NL, shift to low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'NL, shift to normal or no change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '284', 'groupId': 'OG000'}]}]}, {'title': 'NL, shift to high', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytes, shift to low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytes, shift to normal or no change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '292', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytes, shift to high', 'denoms': [{'units': 'Participants', 'counts': [{'value': '392', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Monocytes, shift to low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Monocytes, shift to normal or no change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '372', 'groupId': 'OG000'}]}]}, {'title': 'Monocytes, shift to high', 'denoms': [{'units': 'Participants', 'counts': [{'value': '383', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Eosinophils, shift to normal or no change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '366', 'groupId': 'OG000'}]}]}, {'title': 'Eosinophils, shift to high', 'denoms': [{'units': 'Participants', 'counts': [{'value': '382', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Basophils, shift to normal or no change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '395', 'groupId': 'OG000'}]}]}, {'title': 'Basophils, shift to high', 'denoms': [{'units': 'Participants', 'counts': [{'value': '394', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, shift to low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, shift to normal or no change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '312', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, shift to high', 'denoms': [{'units': 'Participants', 'counts': [{'value': '392', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Band cells, shift to normal or no change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Band cells, shift to high', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'RBC Count, shift to low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '293', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}]}]}, {'title': 'RBC Count, shift to normal or no change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '322', 'groupId': 'OG000'}]}]}, {'title': 'RBC Count, shift to high', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin, shift to low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin, shift to normal or no change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '320', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin, shift to high', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'WBC Count, shift to low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'WBC Count, shift to normal or no change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '289', 'groupId': 'OG000'}]}]}, {'title': 'WBC Count, shift to high', 'denoms': [{'units': 'Participants', 'counts': [{'value': '313', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}]}]}, {'title': 'Segmented (Seg) NL, shift to low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Seg NL, shift to normal or no change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '283', 'groupId': 'OG000'}]}]}, {'title': 'Seg NL, shift to high', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Week 0) and up to Week 112', 'description': 'Hematology parameters measured included platelets, neutrophils (NL), lymphocytes, monocytes, eosinophils, basophils, hematocrit, band cells, red blood cell (RBC) count, hemoglobin, white blood cell (WBC) count, and segmented (seg) NL. The Baseline value is defined as the value obtained at Week 0. The number of participants with the indicated hematology parameters data reference range shifts from Baseline (defined as shift to low, shift to normal or no change, shift to high) until 4 weeks post treatment are presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only the participants available at the time of analysis were included.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Shifts From Baseline (Week 0) for the Indicated Clinical Chemistry Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1605786A 500 mg BID', 'description': 'Eligible participants received oral GSK1605786A 500 mg BID for 216 weeks and were followed-up till 220 weeks. The participants who prematurely discontinued the study were followed by for last 4 weeks after receiving the last dose of the study drug.'}], 'classes': [{'title': 'Total Protein, shift to low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': 'Total Protein, shift to normal or no change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '367', 'groupId': 'OG000'}]}]}, {'title': 'Total Protein, shift to high', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Phosphorous, shift to low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '369', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}]}]}, {'title': 'Phosphorous, shift to normal or no change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '283', 'groupId': 'OG000'}]}]}, {'title': 'Phosphorous, shift to high', 'denoms': [{'units': 'Participants', 'counts': [{'value': '385', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, shift to low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '372', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, shift to normal or no change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '373', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, shift to high', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, shift to low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '392', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, shift to normal or no change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '376', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, shift to high', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, shift to low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, shift to normal or no change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '360', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, shift to high', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Chloride, shift to low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Chloride, shift to normal or no change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '361', 'groupId': 'OG000'}]}]}, {'title': 'Chloride, shift to high', 'denoms': [{'units': 'Participants', 'counts': [{'value': '381', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Calcium, shift to low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '363', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}]}]}, {'title': 'Calcium, shift to normal or no change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '340', 'groupId': 'OG000'}]}]}, {'title': 'Calcium, shift to high', 'denoms': [{'units': 'Participants', 'counts': [{'value': '394', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, shift to low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, shift to normal or no change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '279', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, shift to high', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}]}]}, {'title': 'GGT, shift to normal or no change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '330', 'groupId': 'OG000'}]}]}, {'title': 'GGT, shift to high', 'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}, {'title': 'TB, shift to normal or no change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '391', 'groupId': 'OG000'}]}]}, {'title': 'TB, shift to high', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'DB, shift to normal or no change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '397', 'groupId': 'OG000'}]}]}, {'title': 'DB, shift to high', 'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'ALP, shift to low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'ALP, shift to normal or no change, n=397', 'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '357', 'groupId': 'OG000'}]}]}, {'title': 'ALP, shift to high, n=370', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'ALT, shift to low, n=0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'ALT, shift to normal or no change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '349', 'groupId': 'OG000'}]}]}, {'title': 'ALT, shift to high', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}]}]}, {'title': 'AST, shift to low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'AST, shift to normal or no change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '362', 'groupId': 'OG000'}]}]}, {'title': 'AST, shift to high', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'BUN/Urea, shift to low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '367', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}]}]}, {'title': 'BUN/Urea, shift to normal or no change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '345', 'groupId': 'OG000'}]}]}, {'title': 'BUN/Urea, shift to high', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, shift to low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, shift to normal or no change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '335', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, shift to high', 'denoms': [{'units': 'Participants', 'counts': [{'value': '392', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Uric Acid, shift to low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '382', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Uric Acid, shift to normal or no change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '350', 'groupId': 'OG000'}]}]}, {'title': 'Uric Acid, shift to high', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Bicarbonate, shift to low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}]}]}, {'title': 'Bicarbonate, shift to normal or no change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '303', 'groupId': 'OG000'}]}]}, {'title': 'Bicarbonate, shift to high', 'denoms': [{'units': 'Participants', 'counts': [{'value': '394', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'LDH, shift to normal or no change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '386', 'groupId': 'OG000'}]}]}, {'title': 'LDH, shift to high', 'denoms': [{'units': 'Participants', 'counts': [{'value': '392', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Cholesterol, shift to normal or no change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '330', 'groupId': 'OG000'}]}]}, {'title': 'Cholesterol, shift to high', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}]}]}, {'title': 'CK, shift to normal or no change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '357', 'groupId': 'OG000'}]}]}, {'title': 'CK, shift to high', 'denoms': [{'units': 'Participants', 'counts': [{'value': '386', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Week 0) and up to Week 112', 'description': "Clinical chemistry parameters included platelets, total protein, phosphorous, albumin, sodium, potassium, chloride, calcium, glucose, gamma-glutamyl transferase, total bilirubin (TB), direct bilirubin (DB), alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN)/urea, creatinine, uric acid, bicarbonate, lactate dehydrogenase, cholesterol, alkaline phosphatase (ALP), gamma glutamyl transferases (GGT), and creatine kinase. The Baseline value is defined as the value obtained at Week 0. The number of participants with the indicated clinical chemistry parameters' data reference range shifts from Baseline (defined as shift to low, shift to normal or no change, or shift to high) until 4 weeks post-treatment are presented.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only participants available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (Week 0) in ALT, AST, ALP, and GGT as a Function of Liver Function Test (LFT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1605786A 500 mg BID', 'description': 'Eligible participants received oral GSK1605786A 500 mg BID for 216 weeks and were followed-up till 220 weeks. The participants who prematurely discontinued the study were followed by for last 4 weeks after receiving the last dose of the study drug.'}], 'classes': [{'title': 'ALT, Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '374', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.2', 'spread': '11.33', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '365', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19.3', 'spread': '43.93', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '348', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.0', 'spread': '18.98', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.0', 'spread': '23.94', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.1', 'spread': '16.17', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.7', 'spread': '17.07', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.2', 'spread': '13.77', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.9', 'spread': '32.94', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.2', 'spread': '10.77', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.1', 'spread': '20.11', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.7', 'spread': '12.25', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.8', 'spread': '10.74', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.6', 'spread': '11.49', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.4', 'spread': '12.77', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.0', 'spread': '7.61', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.7', 'spread': '7.74', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.0', 'spread': '10.20', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.1', 'spread': '6.55', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Week 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.4', 'spread': '7.11', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.8', 'spread': '6.03', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Week 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.7', 'spread': '7.69', 'groupId': 'OG000'}]}]}, {'title': 'ALT, 4 week post treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.9', 'spread': '22.52', 'groupId': 'OG000'}]}]}, {'title': 'AST, Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '373', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.9', 'spread': '6.87', 'groupId': 'OG000'}]}]}, {'title': 'AST, Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '365', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.6', 'spread': '19.31', 'groupId': 'OG000'}]}]}, {'title': 'AST, Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '348', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.6', 'spread': '9.56', 'groupId': 'OG000'}]}]}, {'title': 'AST, Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.7', 'spread': '14.11', 'groupId': 'OG000'}]}]}, {'title': 'AST, Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.4', 'spread': '9.51', 'groupId': 'OG000'}]}]}, {'title': 'AST, Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19.2', 'spread': '25.75', 'groupId': 'OG000'}]}]}, {'title': 'AST, Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.8', 'spread': '8.76', 'groupId': 'OG000'}]}]}, {'title': 'AST, Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19.4', 'spread': '21.90', 'groupId': 'OG000'}]}]}, {'title': 'AST, Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.8', 'spread': '7.92', 'groupId': 'OG000'}]}]}, {'title': 'AST, Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.6', 'spread': '12.59', 'groupId': 'OG000'}]}]}, {'title': 'AST, Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.1', 'spread': '8.55', 'groupId': 'OG000'}]}]}, {'title': 'AST, Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.4', 'spread': '8.01', 'groupId': 'OG000'}]}]}, {'title': 'AST, Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.4', 'spread': '7.68', 'groupId': 'OG000'}]}]}, {'title': 'AST, Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.7', 'spread': '8.66', 'groupId': 'OG000'}]}]}, {'title': 'AST, Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.6', 'spread': '6.11', 'groupId': 'OG000'}]}]}, {'title': 'AST, Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.1', 'spread': '5.71', 'groupId': 'OG000'}]}]}, {'title': 'AST, Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.4', 'spread': '6.07', 'groupId': 'OG000'}]}]}, {'title': 'AST, Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.2', 'spread': '3.80', 'groupId': 'OG000'}]}]}, {'title': 'AST, Week 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.2', 'spread': '4.96', 'groupId': 'OG000'}]}]}, {'title': 'AST, Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19.7', 'spread': '5.92', 'groupId': 'OG000'}]}]}, {'title': 'AST, Week 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.2', 'spread': '4.22', 'groupId': 'OG000'}]}]}, {'title': 'AST, 4 week post treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19.6', 'spread': '13.82', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '374', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '81.1', 'spread': '26.52', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '365', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '82.3', 'spread': '27.61', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '348', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '82.0', 'spread': '27.46', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '81.3', 'spread': '25.60', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '81.3', 'spread': '25.60', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '81.1', 'spread': '26.31', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '80.8', 'spread': '26.50', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '80.8', 'spread': '22.68', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '83.4', 'spread': '23.51', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '83.3', 'spread': '25.45', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '84.5', 'spread': '25.03', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '83.8', 'spread': '24.89', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '82.8', 'spread': '22.31', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '81.5', 'spread': '20.35', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '81.5', 'spread': '25.02', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '79.0', 'spread': '18.80', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '78.9', 'spread': '20.55', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '78.1', 'spread': '19.76', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Week 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '78.4', 'spread': '21.76', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '78.2', 'spread': '20.67', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Week 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '81.5', 'spread': '19.64', 'groupId': 'OG000'}]}]}, {'title': 'ALP, 4 week post treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '82.7', 'spread': '31.50', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '374', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31.2', 'spread': '23.61', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '365', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '34.0', 'spread': '32.84', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '347', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '32.9', 'spread': '28.44', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '32.6', 'spread': '24.78', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31.7', 'spread': '26.63', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33.0', 'spread': '29.49', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '32.3', 'spread': '28.17', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '32.3', 'spread': '26.99', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33.5', 'spread': '30.74', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35.2', 'spread': '34.85', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35.1', 'spread': '31.75', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '34.0', 'spread': '29.18', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '34.2', 'spread': '29.22', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30.9', 'spread': '19.33', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31.6', 'spread': '29.92', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29.3', 'spread': '18.45', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '32.6', 'spread': '23.50', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '32.2', 'spread': '25.30', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Week 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33.7', 'spread': '28.66', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '34.1', 'spread': '29.97', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Week 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24.5', 'spread': '11.62', 'groupId': 'OG000'}]}]}, {'title': 'GGT, 4 week post treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31.7', 'spread': '30.19', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0) and up to Week 112', 'description': 'Changes in Baseline in ALP, ALT, AST, and GGT were assessed to monitor liver function. Blood samples were taken at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72, 84, 96, 108, and 4 Weeks post-treatment. The last value on or prior to the treatment start date was considered the Baseline value. Change from Baseline was calculated as the post-Baseline value at the time point indicated minus the value at Baseline.', 'unitOfMeasure': 'International Unit per Liter (IU/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only participants available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (Week 0) in Total Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1605786A 500 mg BID', 'description': 'Eligible participants received oral GSK1605786A 500 mg BID for 216 weeks and were followed-up till 220 weeks. The participants who prematurely discontinued the study were followed by for last 4 weeks after receiving the last dose of the study drug.'}], 'classes': [{'title': 'TB, Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '374', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.9', 'spread': '2.85', 'groupId': 'OG000'}]}]}, {'title': 'TB, Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '365', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.1', 'spread': '3.24', 'groupId': 'OG000'}]}]}, {'title': 'TB, Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '348', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.8', 'spread': '2.76', 'groupId': 'OG000'}]}]}, {'title': 'TB, Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.8', 'spread': '2.61', 'groupId': 'OG000'}]}]}, {'title': 'TB, Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.1', 'spread': '2.91', 'groupId': 'OG000'}]}]}, {'title': 'TB, Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.7', 'spread': '2.54', 'groupId': 'OG000'}]}]}, {'title': 'TB, Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.0', 'spread': '2.78', 'groupId': 'OG000'}]}]}, {'title': 'TB, Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.9', 'spread': '2.99', 'groupId': 'OG000'}]}]}, {'title': 'TB, Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.2', 'spread': '2.80', 'groupId': 'OG000'}]}]}, {'title': 'TB, Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.0', 'spread': '2.70', 'groupId': 'OG000'}]}]}, {'title': 'TB, Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.9', 'spread': '2.58', 'groupId': 'OG000'}]}]}, {'title': 'TB, Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.1', 'spread': '2.42', 'groupId': 'OG000'}]}]}, {'title': 'TB, Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.4', 'spread': '3.01', 'groupId': 'OG000'}]}]}, {'title': 'TB, Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.4', 'spread': '2.56', 'groupId': 'OG000'}]}]}, {'title': 'TB, Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.0', 'spread': '2.35', 'groupId': 'OG000'}]}]}, {'title': 'TB, Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.0', 'spread': '2.57', 'groupId': 'OG000'}]}]}, {'title': 'TB, Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.3', 'spread': '2.05', 'groupId': 'OG000'}]}]}, {'title': 'TB, Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.1', 'spread': '2.38', 'groupId': 'OG000'}]}]}, {'title': 'TB, Week 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.2', 'spread': '2.44', 'groupId': 'OG000'}]}]}, {'title': 'TB, Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.1', 'spread': '2.29', 'groupId': 'OG000'}]}]}, {'title': 'TB, Week 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.0', 'spread': '1.79', 'groupId': 'OG000'}]}]}, {'title': 'TB, 4 week post treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.4', 'spread': '4.11', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0) and up to Week 112', 'description': 'Changes from Baseline (Week 0) in total bilirubin (TB) was assessed to monitor liver function. Blood samples were taken at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72, 84, 96, 108, and 4 Weeks post-treatment. The last value on or prior to the treatment start date was considered the Baseline value. Change from Baseline was calculated as the post-Baseline value at the time point indicated minus the value at Baseline.', 'unitOfMeasure': 'micromole/Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only participants available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (Week 0) in Albumin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1605786A 500 mg BID', 'description': 'Eligible participants received oral GSK1605786A 500 mg BID for 216 weeks and were followed-up till 220 weeks. The participants who prematurely discontinued the study were followed by for last 4 weeks after receiving the last dose of the study drug.'}], 'classes': [{'title': 'Albumin, Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '39.4', 'spread': '5.68', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '39.8', 'spread': '4.76', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40.4', 'spread': '4.88', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '317', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40.0', 'spread': '4.80', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40.5', 'spread': '4.94', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40.3', 'spread': '4.56', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '37.9', 'spread': '5.40', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '42.2', 'spread': '3.30', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '41.0', 'spread': '4.28', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40.1', 'spread': '5.54', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35.8', 'spread': '8.01', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '41.4', 'spread': '4.81', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '41.5', 'spread': '3.02', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '41.0', 'spread': 'NA', 'comment': 'SD could not be calculated since only 1 participant was analyzed.', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '41.0', 'spread': '5.22', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '41.3', 'spread': '6.22', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '41.4', 'spread': '4.38', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '42.0', 'spread': '4.89', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, Week 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '41.9', 'spread': '4.20', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '43.2', 'spread': '2.28', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, Week 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '44.7', 'spread': '3.72', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, 4 week post treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40.6', 'spread': '4.46', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0) and up to Week 112', 'description': 'Change from Baseline in albumin was assessed to monitor liver function. Blood samples were taken at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72, 84, 96, 108, and 4 Weeks post treatment. The last value on or prior to the treatment start date (Week 0) was considered the Baseline value. Change from Baseline was calculated as the post-Baseline value at the time point indicated minus the value at Baseline.', 'unitOfMeasure': 'Grams/Liter (G/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only participants available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With the Indicated Change From Baseline (Week 0) in Corrected QT Interval (QTc) Value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1605786A 500 mg BID', 'description': 'Eligible participants received oral GSK1605786A 500 mg BID for 216 weeks and were followed-up till 220 weeks. The participants who prematurely discontinued the study were followed by for last 4 weeks after receiving the last dose of the study drug.'}], 'classes': [{'title': 'QTcB, Week 24,<30, n=70', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}]}]}, {'title': 'QTcB, Week 24, 30-<60, n=70', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'QTcB, Week 24, >=60, n=70', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'QTcB, Week 48,<30, n=35', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': 'QTcB, Week 48, 30-<60, n=35', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'QTcB, Week 48, >=60, n=35', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'QTcB, Week 72,<30, n=17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'QTcB, Week 72, 30-<60, n=17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'QTcB, Week 72, >=60, n=17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'QTcB, Week 108,<30, n=3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'QTcB, Week 108, 30-<60, n=3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'QTcB, Week 108, >=60, n=3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'QTcB, 4 Weeks Post Treatment, <30, n=96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}]}]}, {'title': 'QTcB, 4 Weeks Post Treatment, 30-<60, n=96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'QTcB, 4 Weeks Post Treatment, >=60, n=96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'QTcF, Week 24,<30, n=23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'QTcF, Week 24, 30-<60, n=23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'QTcF, Week 24, >=60, n=23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'QTcF, Week 48,<30, n=13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'QTcF, Week 48, 30-<60, n=13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'QTcB, Week 48, >=60, n=13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'QTcF, Week 72,<30, n=7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'QTcF, Week 72, 30-<60, n=7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'QTcF, Week 72, >=60, n=7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'QTcF, Week 108,<30, n=2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'QTcF, Week 108, 30-<60, n=2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'QTcF, Week 108, >=60, n=2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'QTcF, 4 Weeks Post Treatment, <30, n=32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'QTcF, 4 Weeks Post Treatment, 30-<60, n=32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'QTcF, 4 Weeks Post Treatment, >=60, n=32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (week 0) and Weeks 24, 48, 72, 108, and 112 (4 weeks post treatment)', 'description': "QTc is the corrected QT interval as measured by the electrocardiogram (ECG). ECG parameters including the change from Baseline in the QTc interval values QTcF and QTcB were summarised. The QTcF is Fridericia's formula and defined as the QT interval/cubed root of the R-R interval. The QTcB is the Bazett's formula defined as the QT/squared root of the R-R interval. The number of participants with change from Baseline in the QTcF and QTcB intervals of \\>30, 30 to \\<60 and \\>=60 milliseconds were assessed at Week 24, 48, 72, 108, and Week 112. The last value on or prior to the treatment start date was considered the Baseline value (Week 0). Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only participants available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': "Change From Baseline (Week 0) in Crohn's Disease Activity Index (CDAI) Score Over 108 Weeks", 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1605786A 500 mg BID', 'description': 'Eligible participants received oral GSK1605786A 500 mg BID for 216 weeks and were followed-up till 220 weeks. The participants who prematurely discontinued the study were followed by for last 4 weeks after receiving the last dose of the study drug.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-76.0', 'spread': '92.79', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-89.2', 'spread': '102.87', 'groupId': 'OG000'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-103.6', 'spread': '113.63', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-116.6', 'spread': '109.42', 'groupId': 'OG000'}]}]}, {'title': 'Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-121.3', 'spread': '111.29', 'groupId': 'OG000'}]}]}, {'title': 'Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-110.4', 'spread': '104.18', 'groupId': 'OG000'}]}]}, {'title': 'Week 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-121.4', 'spread': '115.70', 'groupId': 'OG000'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-91.0', 'spread': '80.00', 'groupId': 'OG000'}]}]}, {'title': 'Week 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-50.7', 'spread': '19.86', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0) and up to 108 weeks', 'description': 'The CDAI score was determined by interactive voice response relationship (IVRS) based on the combination of participant,investigator entries, standardized weight determination, and Hematocrit values received from the central laboratory. The Baseline CDAI score was recorded pre-dose on Week 0. Change from Baseline is the value at indicated time point minus the Baseline value. Remissions are defined as participants with CDAI score of \\< 150 points. No imputation for missing data was performed. The assessment was based on questionnaire like number of liquid stool in past 7 days, abdominal pain, other symptoms, antidiarrheal use, abdominal mass, anemia, and body weight. The total score is summation of all individual sub-scores. CDAI scoring scale ranges from 0-500 and a score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population. Only the participants available at the time of assessment were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants in Clinical Remission (CDAI Score Less Than 150) for All Participants, for Participants in Remission at Baseline (Week 0), and for Participants Not in Remission at Baseline Over 108 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1605786A 500 mg BID', 'description': 'Eligible participants received oral GSK1605786A 500 mg BID for 216 weeks and were followed-up till 220 weeks. The participants who prematurely discontinued the study were followed by for last 4 weeks after receiving the last dose of the study drug.'}], 'classes': [{'title': 'Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000', 'lowerLimit': '5.8', 'upperLimit': '11.3'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35.0', 'groupId': 'OG000', 'lowerLimit': '28.9', 'upperLimit': '41.2'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '41.2', 'groupId': 'OG000', 'lowerLimit': '33.4', 'upperLimit': '49.0'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '52.6', 'groupId': 'OG000', 'lowerLimit': '42.6', 'upperLimit': '62.5'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '54.4', 'groupId': 'OG000', 'lowerLimit': '42.6', 'upperLimit': '66.2'}]}]}, {'title': 'Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '53.7', 'groupId': 'OG000', 'lowerLimit': '38.4', 'upperLimit': '68.9'}]}]}, {'title': 'Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '51.9', 'groupId': 'OG000', 'lowerLimit': '33.0', 'upperLimit': '70.7'}]}]}, {'title': 'Week 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '55.6', 'groupId': 'OG000', 'lowerLimit': '32.6', 'upperLimit': '78.5'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000', 'lowerLimit': '35.9', 'upperLimit': '97.5'}]}]}, {'title': 'Week 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '86.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Week 0) and up to 108 weeks', 'description': 'The CDAI score was determined by interactive voice response relationship (IVRS) based on the combination of participant and investigator entries and standardized weight determination. Haematocrit values received from the central laboratory on the day of the visit were to be utilized for calculation of the CDAI scores. The Baseline (Week 0) CDAI score was defined as the last evaluation prior to or on the date the first dose of investigational product is taken. The CDAI score was measured over 108 weeks although it was planned to be measured till 112 weeks. Remissions are defined as subjects with CDAI score of \\< 150 points. Percentages are based on the number of subjects with observed data. No imputation for missing data was performed. Combined data for participants with remission at Baseline and without remission at Baseline has been presented.', 'unitOfMeasure': 'Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population. Only the participants available at the time of assessment were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Response (CDAI Decrease of at Least 100 Points From Baseline ([Week 0] of Prior Induction Study) in the Sub-population of Non-responders at Study Entry Over 112 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1605786A 500 mg BID', 'description': 'Eligible participants received oral GSK1605786A 500 mg BID for 216 weeks and were followed-up till 220 weeks. The participants who prematurely discontinued the study were followed by for last 4 weeks after receiving the last dose of the study drug.'}], 'timeFrame': 'Baseline (Week 0) and up to 112 weeks', 'description': 'The CDAI score was determined by interactive voice response relationship (IVRS) based on the combination of participant and investigator entries and standardized weight determination. Haematocrit values received from the central laboratory on the day of the visit were to be utilized for calculation of the CDAI scores. The Baseline (Week 0) CDAI score was defined as the last evaluation prior to or on the date the first dose of investigational product was taken. Remissions are defined as subjects with CDAI score of \\< 150 points. Percentages are based on the number of subjects with observed data. No imputation for missing data was performed.', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population was planned to be analyzed for this study.However, this outcome measure was not analyzed due to termination of study and no data was collected for this outcome measure.'}, {'type': 'SECONDARY', 'title': "Change From Baseline (Week 0) in Inflammatory Bowel Disease Questionnaire (IBDQ), Short Form Health Survey (SF-36) Version 2, EuroQol 5 Dimensional (EQ-5D), Work and Productivity Activity Impairment-Crohn's Disease (WPAI-CD) and Disability Over 112 Weeks", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1605786A 500 mg BID', 'description': 'Eligible participants received oral GSK1605786A 500 mg BID for 216 weeks and were followed-up till 220 weeks. The participants who prematurely discontinued the study were followed by for last 4 weeks after receiving the last dose of the study drug.'}], 'timeFrame': 'Baseline (Week 0) and up to 112 weeks', 'description': 'IBDQ, SF-36, EQ-5D, WPAI-CD, and disability scores were all health outcome related scores that were based on assessment of participants based on different questionnaire. Each scoring scale had different range and participants were planned to be rated separately based on each scale.', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population was planned to be analyzed for this study. However, this outcome measure was not analyzed due to termination of study and no data was collected for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GSK1605786A', 'description': 'Eligible participants received oral GSK1605786A 500 mg BID for 216 weeks and were followed-up till 220 weeks. The participants who prematurely discontinued the study were followed by for last 4 weeks after receiving the last dose of the study drug.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '398'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '398'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '53'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '121'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Protocol based stopping criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Study closed or terminated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '174'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}]}]}], 'recruitmentDetails': 'Participants were eligible to enter the study if they completed the placebo-controlled induction study CCX114151; completed the maintenance study CCX114157 at Week 52; or withdrew from the maintenance study CCX114157. A total of such 800 participants were planned to be enrolled.', 'preAssignmentDetails': 'All participants entered the study at a Baseline visit, Week 0, and received GSK1605786A 500 milligrams (mg), twice daily (BID) for 216 weeks.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'GSK1605786A 500 mg BID', 'description': 'Eligible participants received oral GSK1605786A 500 mg BID for 216 weeks and were followed-up till 220 weeks. The participants who prematurely discontinued the study were followed by for last 4 weeks after receiving the last dose of the study drug.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.5', 'spread': '11.99', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '213', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '185', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '351', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The safety population included all the participants who received at least one dose of the study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 399}}, 'statusModule': {'whyStopped': "This study was terminated due to the lack of efficacy of GSK1605786A in Crohn's disease based on the results of Study CCX114151.", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-04-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'dispFirstSubmitDate': '2014-03-13', 'completionDateStruct': {'date': '2013-10-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-16', 'studyFirstSubmitDate': '2011-03-03', 'dispFirstSubmitQcDate': '2014-03-13', 'resultsFirstSubmitDate': '2017-07-05', 'studyFirstSubmitQcDate': '2011-03-17', 'dispFirstPostDateStruct': {'date': '2014-04-11', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-09-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-16', 'studyFirstPostDateStruct': {'date': '2011-03-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Any Adverse Events (AE) and Any Serious Adverse Events (SAE)', 'timeFrame': 'Up to Week 112', '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 SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect. The Safety population consisted of all participants who enrolled in the study except those who did not take \\>=1 dose of investigational product.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline (Week 0) in Systolic and Diastolic Blood Pressure (SBP and DBP) Over Period', 'timeFrame': 'Baseline (Week 0) and up to Week 112', 'description': 'The SBP and DBP values were obtained as part of vital sign monitoring and measured after the participant was at rest in the supine position for at least 5 minutes. Baseline value was recorded at Week 0. Change from Baseline measurements in SBP and DBP were assessed at Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108 and 4 weeks post-treatment. The Baseline value is defined as the value at Week 0. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.'}, {'measure': 'Change From Baseline (Week 0) in Heart Rate (HR) Over Period', 'timeFrame': 'Baseline (week 0) and up to Week 112', 'description': 'The HR values were obtained as part of vital sign monitoring and measured after the participant was at rest in the supine position for at least 5 minutes. Change from Baseline in HR was assessed at Week 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108 and 4 weeks post-treatment. The Baseline value is defined as the value at Week 0. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.'}, {'measure': 'Number of Participants With Shifts From Baseline (Week 0) for the Indicated Hematology Parameters', 'timeFrame': 'Baseline (Week 0) and up to Week 112', 'description': 'Hematology parameters measured included platelets, neutrophils (NL), lymphocytes, monocytes, eosinophils, basophils, hematocrit, band cells, red blood cell (RBC) count, hemoglobin, white blood cell (WBC) count, and segmented (seg) NL. The Baseline value is defined as the value obtained at Week 0. The number of participants with the indicated hematology parameters data reference range shifts from Baseline (defined as shift to low, shift to normal or no change, shift to high) until 4 weeks post treatment are presented.'}, {'measure': 'Number of Participants With Shifts From Baseline (Week 0) for the Indicated Clinical Chemistry Parameters', 'timeFrame': 'Baseline (Week 0) and up to Week 112', 'description': "Clinical chemistry parameters included platelets, total protein, phosphorous, albumin, sodium, potassium, chloride, calcium, glucose, gamma-glutamyl transferase, total bilirubin (TB), direct bilirubin (DB), alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN)/urea, creatinine, uric acid, bicarbonate, lactate dehydrogenase, cholesterol, alkaline phosphatase (ALP), gamma glutamyl transferases (GGT), and creatine kinase. The Baseline value is defined as the value obtained at Week 0. The number of participants with the indicated clinical chemistry parameters' data reference range shifts from Baseline (defined as shift to low, shift to normal or no change, or shift to high) until 4 weeks post-treatment are presented."}, {'measure': 'Change From Baseline (Week 0) in ALT, AST, ALP, and GGT as a Function of Liver Function Test (LFT)', 'timeFrame': 'Baseline (Week 0) and up to Week 112', 'description': 'Changes in Baseline in ALP, ALT, AST, and GGT were assessed to monitor liver function. Blood samples were taken at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72, 84, 96, 108, and 4 Weeks post-treatment. The last value on or prior to the treatment start date was considered the Baseline value. Change from Baseline was calculated as the post-Baseline value at the time point indicated minus the value at Baseline.'}, {'measure': 'Change From Baseline (Week 0) in Total Bilirubin', 'timeFrame': 'Baseline (Week 0) and up to Week 112', 'description': 'Changes from Baseline (Week 0) in total bilirubin (TB) was assessed to monitor liver function. Blood samples were taken at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72, 84, 96, 108, and 4 Weeks post-treatment. The last value on or prior to the treatment start date was considered the Baseline value. Change from Baseline was calculated as the post-Baseline value at the time point indicated minus the value at Baseline.'}, {'measure': 'Change From Baseline (Week 0) in Albumin', 'timeFrame': 'Baseline (Week 0) and up to Week 112', 'description': 'Change from Baseline in albumin was assessed to monitor liver function. Blood samples were taken at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72, 84, 96, 108, and 4 Weeks post treatment. The last value on or prior to the treatment start date (Week 0) was considered the Baseline value. Change from Baseline was calculated as the post-Baseline value at the time point indicated minus the value at Baseline.'}, {'measure': 'Number of Participants With the Indicated Change From Baseline (Week 0) in Corrected QT Interval (QTc) Value', 'timeFrame': 'Baseline (week 0) and Weeks 24, 48, 72, 108, and 112 (4 weeks post treatment)', 'description': "QTc is the corrected QT interval as measured by the electrocardiogram (ECG). ECG parameters including the change from Baseline in the QTc interval values QTcF and QTcB were summarised. The QTcF is Fridericia's formula and defined as the QT interval/cubed root of the R-R interval. The QTcB is the Bazett's formula defined as the QT/squared root of the R-R interval. The number of participants with change from Baseline in the QTcF and QTcB intervals of \\>30, 30 to \\<60 and \\>=60 milliseconds were assessed at Week 24, 48, 72, 108, and Week 112. The last value on or prior to the treatment start date was considered the Baseline value (Week 0). Change from Baseline was calculated as the post-Baseline value minus the value at Baseline."}, {'measure': "Change From Baseline (Week 0) in Crohn's Disease Activity Index (CDAI) Score Over 108 Weeks", 'timeFrame': 'Baseline (Week 0) and up to 108 weeks', 'description': 'The CDAI score was determined by interactive voice response relationship (IVRS) based on the combination of participant,investigator entries, standardized weight determination, and Hematocrit values received from the central laboratory. The Baseline CDAI score was recorded pre-dose on Week 0. Change from Baseline is the value at indicated time point minus the Baseline value. Remissions are defined as participants with CDAI score of \\< 150 points. No imputation for missing data was performed. The assessment was based on questionnaire like number of liquid stool in past 7 days, abdominal pain, other symptoms, antidiarrheal use, abdominal mass, anemia, and body weight. The total score is summation of all individual sub-scores. CDAI scoring scale ranges from 0-500 and a score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.'}, {'measure': 'Percentage of Participants in Clinical Remission (CDAI Score Less Than 150) for All Participants, for Participants in Remission at Baseline (Week 0), and for Participants Not in Remission at Baseline Over 108 Weeks', 'timeFrame': 'Baseline (Week 0) and up to 108 weeks', 'description': 'The CDAI score was determined by interactive voice response relationship (IVRS) based on the combination of participant and investigator entries and standardized weight determination. Haematocrit values received from the central laboratory on the day of the visit were to be utilized for calculation of the CDAI scores. The Baseline (Week 0) CDAI score was defined as the last evaluation prior to or on the date the first dose of investigational product is taken. The CDAI score was measured over 108 weeks although it was planned to be measured till 112 weeks. Remissions are defined as subjects with CDAI score of \\< 150 points. Percentages are based on the number of subjects with observed data. No imputation for missing data was performed. Combined data for participants with remission at Baseline and without remission at Baseline has been presented.'}, {'measure': 'Percentage of Participants Achieving Response (CDAI Decrease of at Least 100 Points From Baseline ([Week 0] of Prior Induction Study) in the Sub-population of Non-responders at Study Entry Over 112 Weeks', 'timeFrame': 'Baseline (Week 0) and up to 112 weeks', 'description': 'The CDAI score was determined by interactive voice response relationship (IVRS) based on the combination of participant and investigator entries and standardized weight determination. Haematocrit values received from the central laboratory on the day of the visit were to be utilized for calculation of the CDAI scores. The Baseline (Week 0) CDAI score was defined as the last evaluation prior to or on the date the first dose of investigational product was taken. Remissions are defined as subjects with CDAI score of \\< 150 points. Percentages are based on the number of subjects with observed data. No imputation for missing data was performed.'}, {'measure': "Change From Baseline (Week 0) in Inflammatory Bowel Disease Questionnaire (IBDQ), Short Form Health Survey (SF-36) Version 2, EuroQol 5 Dimensional (EQ-5D), Work and Productivity Activity Impairment-Crohn's Disease (WPAI-CD) and Disability Over 112 Weeks", 'timeFrame': 'Baseline (Week 0) and up to 112 weeks', 'description': 'IBDQ, SF-36, EQ-5D, WPAI-CD, and disability scores were all health outcome related scores that were based on assessment of participants based on different questionnaire. Each scoring scale had different range and participants were planned to be rated separately based on each scale.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ["GSK1605786A; Inflammatory Bowel Disease; Crohn's disease; long-term treatment; quality of life; CCR9 antagonist"], 'conditions': ["Crohn's Disease"]}, 'descriptionModule': {'briefSummary': "An open-label study to evaluate the safety and effectiveness of GSK1605786A 500 mg twice daily over 108 weeks in adult subjects with Crohn's disease. Subjects completing previous GSK-sponsored studies with GSK1605786A or subjects who withdraw early from Study CCX114157 (maintenance study of GSK1605786A) due to worsening of Crohn's disease requiring a treatment change may be eligible to participate. The primary objective is to evaluate the safety of GSK1605786A, as assessed by recording of adverse events, clinical laboratory parameters, vital signs and electrocardiogram. Secondary objectives will include assessments of effectiveness of long-term treatment with GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36v2, EQ-5D, Work and Productivity Activity Impairment-Crohn's Disease (WPAI-CD) and receipt of disability.", 'detailedDescription': "This is a multi-centre, open-label extension study to assess the long-term safety, tolerability and effectiveness of GSK1605786A in subjects with Crohn's disease. Subjects will enter the study via one of three routes:\n\n1. completion of the placebo-controlled induction study, CCX114151, without achieving clinical response (CDAI decrease of at least 100 points) or clinical remission (CDAI score less than 150) at Week 12 or completion of any other GSK-sponsored induction study as designated by the sponsor\n2. completion of maintenance study CCX114157 at Week 52\n3. withdrawal from maintenance study CCX114157 due to worsening of Crohn's disease and requiring a treatment change.\n\nThe primary objective is to evaluate the safety of GSK1605786A, as assessed by recording of adverse events, clinical laboratory parameters, vital signs and electrocardiogram. Secondary objectives will include assessments of effectiveness of long-term treatment with GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36v2, EQ-5D, Work and Productivity Activity Impairment-Crohn's Disease (WPAI-CD) and disability.\n\nIt is estimated that approximately 800 subjects will be enrolled in total. All subjects will enter the study at baseline (Week 0) and commence oral treatment with GSK1605786A 500 mg twice daily.\n\nThe study will be conducted for 108 weeks. Once the results of the induction study CCX114151 are known, the risk-to-benefit ratio will be re-assessed and the study duration may be amended.\n\nStudy assessments for Crohn's disease will be performed every 12 weeks through Week 108. At week 12, the investigator will make a determination of whether the subject is receiving clinical benefit, and subjects who are not receiving clinical benefit must be withdrawn. More frequent blood draws are required for liver function testing only; every 2 weeks for the first 12 weeks, then every 4 weeks up to Week 52, and every 12 weeks after Week 60 for the duration of the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Previous participation in a GSK-sponsored study with GSK1605786A\n* Written informed consent prior to any study-specific procedures\n* Female subjects: To be eligible, females of child-bearing potential must be sexually inactive or commit to consistent and correct use of a contraceptive method of birth control with less than 1% failure rate\n\nExclusion Criteria:\n\n* If female, is pregnant, has a positive pregnancy test or is breast-feeding, or is planning to become pregnant\n* Subjects with known or suspected coeliac disease or a positive screening test for anti-tissue transglutaminase antibodies should have been excluded from enrolment into any induction study. Subjects in whom a diagnosis of coeliac disease is subsequently suspected should be tested for anti-tissue transglutaminase antibodies and excluded or withdrawn from the study upon positive test result\n* Fixed symptomatic stenoses or strictures of small bowel or colon\n* Enterocutaneous, abdominal or pelvic fistulae likely to require surgery during the study period\n* Current sepsis or infections requiring intravenous antibiotic therapy greater than 2 weeks\n* Evidence of hepatic dysfunction or viral hepatitis\n* Subjects who have demonstrated safety or tolerability issues during participation in a previous study with GSK1605786A which, in the opinion of the investigator, was possibly related to study treatment and poses an unacceptable risk to the subject.'}, 'identificationModule': {'nctId': 'NCT01318993', 'acronym': 'SHIELD-3', 'briefTitle': 'Open-Label Extension Study of GSK1605786A', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "An 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