Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2025-12-25 @ 11:09 PM
Study NCT ID:
NCT00256867
Status:
COMPLETED
Last Update Posted:
2018-07-02
First Post:
2005-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study In Patients With Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, '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': 'SAEs and nSAEs were recorded up to Week 16', 'description': 'Safety population was used to record AEs', 'eventGroups': [{'id': 'EG000', 'title': 'FDC RSG/SIMV 4/40 mg', 'description': 'Participants received FDC RSG/SIMV 4/40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL at Visit 4a (Week 6), the treatment doses were up titrated to FDC RSG/SIMV 4/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 45, 'otherNumAffected': 4, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'FDC RSG/SIMV 4/80 mg', 'description': 'Participants received FDC RSG/SIMV 4/80 mg and SIMV 40 mg matching placebo once a day for 16 weeks.', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 4, 'seriousNumAtRisk': 44, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'FDC RSG/SIMV 8/40 mg', 'description': 'Participants received FDC RSG/SIMV 8/40 mg once a day and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to FDC RSG/SIMV 8/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 42, 'otherNumAffected': 3, 'seriousNumAtRisk': 45, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'FDC RSG/SIMV 8/80 mg', 'description': 'Participants received FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks.', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 45, 'otherNumAffected': 10, 'seriousNumAtRisk': 46, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'RSG 4 mg', 'description': 'Participants received RSG 4.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL evaluated at Visit 4a (Week 6), the treatment doses were titrated up to RSG/SIMV 4/40 mg once a day from Week 6 till Week 16.', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 47, 'otherNumAffected': 4, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'RSG 8 mg', 'description': 'Participants received RSG 8.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to RSG/SIMV 8/40 mg once a day from Week 6 till Week 16.', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 43, 'otherNumAffected': 4, 'seriousNumAtRisk': 46, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG006', 'title': 'SIMV 40 mg', 'description': 'Participants received SIMV 40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to SIMV/SIMV 40/40 mg once a day from Week 6 till Week 16.', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 44, 'otherNumAffected': 5, 'seriousNumAtRisk': 46, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'SIMV 80 mg', 'description': 'Participants received SIMV/SIMV 40/40 mg once a day for 16 weeks.', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 6, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 47, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 48, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Median Percent Change From Baseline to Week 6 in LDL-c in FDC and RSG Monotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All FDC RSG/SIMV Groups', 'description': 'In this arm, all the participants were pooled who received FDC RSG/SIMV 4/40 mg, FDC RSG/SIMV 4/80 mg, FDC RSG/SIMV 8/40 mg, FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'All RSG Monotherapy Groups', 'description': 'In this arm, all the participants were pooled who received RSG 4 and 8mg, and matching placebo once a day for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-39.9', 'groupId': 'OG000', 'lowerLimit': '-69', 'upperLimit': '56'}, {'value': '5.4', 'groupId': 'OG001', 'lowerLimit': '-31', 'upperLimit': '67'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio Expressed as percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-37.186', 'ciLowerLimit': '-41.219', 'ciUpperLimit': '-32.879', 'estimateComment': 'Estimation parameter was Ratio to RSG Group expressed as percent difference from RSG group. Based on ANCOVA : Log(value) - log(baseline)= log(baseline) + sex + country + Treatment + Prior Sulfonylurea use', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Week 0) and Week 6', 'description': 'Median percent change from Baseline to Week 6 in LDL-c in FDC and RSG monotherapy was reported. Percent change from Baseline = 100\\*(exponent \\[change on log scale\\]-1). Baseline assessments were recorded at Visit 3 (Week 0). For a missing Baseline value, the Baseline value were replaced by the last pre-treatment measurement, if available. The hypothesis of treatment difference was tested at a 0.05 significance level based on two-sided tests. The point estimates and corresponding 95% confidence intervals for treatment differences was calculated. Treatment differences were assessed within the context of an analysis of covariance (ANCOVA) with terms for treatment, gender, current sulfonylurea use (at baseline), country, and Baseline measurement. ANCOVA for LDL-c were performed based on log-transformed data.', 'unitOfMeasure': 'Percent change in LDL-c', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population comprised of all participants who were randomized and had at least one On-Therapy value for an efficacy assessment. The Intent-to-Treat population with last observation carried forward (LOCF) was used for efficacy analyses. Only those participants available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Week 16 in Glycosylated Hemoglobin A1c (HbA1c) in FDC and SIMV Monotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All SIM Monotherapy Groups', 'description': 'In this arm, all the participants were pooled who received SIM 40 and 80 mg, and matching placebo once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'All FDC RSG/SIMV Groups', 'description': 'In this arm, all the participants were pooled who received FDC RSG/SIMV 4/40 mg, FDC RSG/SIMV 4/80 mg, FDC RSG/SIMV 8/40 mg, FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.01', 'spread': '1.131', 'groupId': 'OG000'}, {'value': '-0.83', 'spread': '1.093', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.82', 'ciLowerLimit': '-1.09', 'ciUpperLimit': '-0.55', 'estimateComment': 'Change = Baseline + sex + country + Treatment + Prior Sulfonylurea use', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0) and Week 16', 'description': 'Mean change from Baseline to Week 16 in HbA1c in FDC and SIMV monotherapy was reported. Change from Baseline was computed as (Visit value - Baseline value). Baseline assessments were recorded at Visit 3 (Week 0). For a missing Baseline value, the Baseline value were replaced by the last pre-treatment measurement, if available. The hypothesis of treatment difference was tested at a 0.05 significance level based on two-sided tests. The point estimates and corresponding 95% confidence intervals for treatment differences was calculated. Treatment differences were assessed within the context of ANCOVA with terms for treatment, gender, current sulfonylurea use (at Baseline), country, and Baseline measurement.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat with LOCF. Only those participants available at the specified time point were analyzed.'}, {'type': 'SECONDARY', 'title': 'Median Percent Change From Baseline to Week 6 in LDL-c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '41', 'groupId': 'OG005'}, {'value': '42', 'groupId': 'OG006'}, {'value': '46', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'FDC RSG/SIMV 4/40 mg', 'description': 'Participants received FDC RSG/SIMV 4/40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL at Visit 4a (Week 6), the treatment doses were up titrated to FDC RSG/SIMV 4/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.'}, {'id': 'OG001', 'title': 'FDC RSG/SIMV 4/80 mg', 'description': 'Participants received FDC RSG/SIMV 4/80 mg and SIMV 40 mg matching placebo once a day for 16 weeks.'}, {'id': 'OG002', 'title': 'FDC RSG/SIMV 8/40 mg', 'description': 'Participants received FDC RSG/SIMV 8/40 mg once a day and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to FDC RSG/SIMV 8/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.'}, {'id': 'OG003', 'title': 'FDC RSG/SIMV 8/80 mg', 'description': 'Participants received FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks.'}, {'id': 'OG004', 'title': 'RSG 4 mg', 'description': 'Participants received RSG 4.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL evaluated at Visit 4a (Week 6), the treatment doses were titrated up to RSG/SIMV 4/40 mg once a day from Week 6 till Week 16.'}, {'id': 'OG005', 'title': 'RSG 8 mg', 'description': 'Participants received RSG 8.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to RSG/SIMV 8/40 mg once a day from Week 6 till Week 16.'}, {'id': 'OG006', 'title': 'SIMV 40 mg', 'description': 'Participants received SIMV 40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to SIMV/SIMV 40/40 mg once a day from Week 6 till Week 16.'}, {'id': 'OG007', 'title': 'SIMV 80 mg', 'description': 'Participants received SIMV/SIMV 40/40 mg once a day for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-32.7', 'groupId': 'OG000', 'lowerLimit': '-62', 'upperLimit': '39'}, {'value': '-39.4', 'groupId': 'OG001', 'lowerLimit': '-67', 'upperLimit': '56'}, {'value': '-39.0', 'groupId': 'OG002', 'lowerLimit': '-64', 'upperLimit': '17'}, {'value': '-44.4', 'groupId': 'OG003', 'lowerLimit': '-69', 'upperLimit': '18'}, {'value': '5.6', 'groupId': 'OG004', 'lowerLimit': '-31', 'upperLimit': '67'}, {'value': '5.4', 'groupId': 'OG005', 'lowerLimit': '-26', 'upperLimit': '62'}, {'value': '-34.0', 'groupId': 'OG006', 'lowerLimit': '-65', 'upperLimit': '75'}, {'value': '-44.2', 'groupId': 'OG007', 'lowerLimit': '-73', 'upperLimit': '28'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Week 0) and Week 6', 'description': 'Percent change from Baseline = 100\\*(exponent \\[change on log scale\\]-1). Baseline assessments were recorded at Visit 3 (Week 0). For a missing Baseline value, the Baseline value were replaced by the last pre-treatment measurement, if available.', 'unitOfMeasure': 'Percent change in LDL-c', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat with LOCF. Only those participants available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Week 16 in HbA1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '46', 'groupId': 'OG004'}, {'value': '43', 'groupId': 'OG005'}, {'value': '43', 'groupId': 'OG006'}, {'value': '47', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'FDC RSG/SIMV 4/40 mg', 'description': 'Participants received FDC RSG/SIMV 4/40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL at Visit 4a (Week 6), the treatment doses were up titrated to FDC RSG/SIMV 4/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.'}, {'id': 'OG001', 'title': 'FDC RSG/SIMV 4/80 mg', 'description': 'Participants received FDC RSG/SIMV 4/80 mg and SIMV 40 mg matching placebo once a day for 16 weeks.'}, {'id': 'OG002', 'title': 'FDC RSG/SIMV 8/40 mg', 'description': 'Participants received FDC RSG/SIMV 8/40 mg once a day and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to FDC RSG/SIMV 8/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.'}, {'id': 'OG003', 'title': 'FDC RSG/SIMV 8/80 mg', 'description': 'Participants received FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks.'}, {'id': 'OG004', 'title': 'RSG 4 mg', 'description': 'Participants received RSG 4.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL evaluated at Visit 4a (Week 6), the treatment doses were titrated up to RSG/SIMV 4/40 mg once a day from Week 6 till Week 16.'}, {'id': 'OG005', 'title': 'RSG 8 mg', 'description': 'Participants received RSG 8.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to RSG/SIMV 8/40 mg once a day from Week 6 till Week 16.'}, {'id': 'OG006', 'title': 'SIMV 40 mg', 'description': 'Participants received SIMV 40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to SIMV/SIMV 40/40 mg once a day from Week 6 till Week 16.'}, {'id': 'OG007', 'title': 'SIMV 80 mg', 'description': 'Participants received SIMV/SIMV 40/40 mg once a day for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.52', 'spread': '0.966', 'groupId': 'OG000'}, {'value': '-0.54', 'spread': '1.285', 'groupId': 'OG001'}, {'value': '-1.24', 'spread': '1.035', 'groupId': 'OG002'}, {'value': '-1.06', 'spread': '0.901', 'groupId': 'OG003'}, {'value': '-1.04', 'spread': '0.964', 'groupId': 'OG004'}, {'value': '-1.31', 'spread': '1.216', 'groupId': 'OG005'}, {'value': '0.00', 'spread': '0.989', 'groupId': 'OG006'}, {'value': '-0.02', 'spread': '1.258', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0) and Week 16', 'description': 'Change from Baseline was computed as (Visit value - Baseline value). Baseline assessments were recorded at Visit 3 (Week 0). For a missing Baseline value, the Baseline value were replaced by the last pre-treatment measurement, if available.', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat with LOCF. Only those participants available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Week 16 in Fasting Plasma Glucose (FPG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '43', 'groupId': 'OG005'}, {'value': '43', 'groupId': 'OG006'}, {'value': '46', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'FDC RSG/SIMV 4/40 mg', 'description': 'Participants received FDC RSG/SIMV 4/40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL at Visit 4a (Week 6), the treatment doses were up titrated to FDC RSG/SIMV 4/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.'}, {'id': 'OG001', 'title': 'FDC RSG/SIMV 4/80 mg', 'description': 'Participants received FDC RSG/SIMV 4/80 mg and SIMV 40 mg matching placebo once a day for 16 weeks.'}, {'id': 'OG002', 'title': 'FDC RSG/SIMV 8/40 mg', 'description': 'Participants received FDC RSG/SIMV 8/40 mg once a day and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to FDC RSG/SIMV 8/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.'}, {'id': 'OG003', 'title': 'FDC RSG/SIMV 8/80 mg', 'description': 'Participants received FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks.'}, {'id': 'OG004', 'title': 'RSG 4 mg', 'description': 'Participants received RSG 4.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL evaluated at Visit 4a (Week 6), the treatment doses were titrated up to RSG/SIMV 4/40 mg once a day from Week 6 till Week 16.'}, {'id': 'OG005', 'title': 'RSG 8 mg', 'description': 'Participants received RSG 8.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to RSG/SIMV 8/40 mg once a day from Week 6 till Week 16.'}, {'id': 'OG006', 'title': 'SIMV 40 mg', 'description': 'Participants received SIMV 40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to SIMV/SIMV 40/40 mg once a day from Week 6 till Week 16.'}, {'id': 'OG007', 'title': 'SIMV 80 mg', 'description': 'Participants received SIMV/SIMV 40/40 mg once a day for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.31', 'spread': '2.202', 'groupId': 'OG000'}, {'value': '-1.29', 'spread': '3.365', 'groupId': 'OG001'}, {'value': '-2.10', 'spread': '2.018', 'groupId': 'OG002'}, {'value': '-1.90', 'spread': '2.176', 'groupId': 'OG003'}, {'value': '-1.88', 'spread': '2.386', 'groupId': 'OG004'}, {'value': '-2.23', 'spread': '1.621', 'groupId': 'OG005'}, {'value': '0.43', 'spread': '2.526', 'groupId': 'OG006'}, {'value': '0.37', 'spread': '2.483', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0) and Week 16', 'description': 'Change from Baseline was computed as (Visit value - Baseline value). Baseline assessments were recorded at Visit 3 (Week 0). For a missing Baseline value, the Baseline value were replaced by the last pre-treatment measurement, if available.', 'unitOfMeasure': 'Millimol per litre (mmol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat with LOCF. Only those participants available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participant With LDL<100 mg/dL (2.59 mmol/L) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All RSG Monotherapy Groups', 'description': 'In this arm, all the participants were pooled who received RSG 4 and 8mg, and matching placebo once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'All FDC RSG/SIMV Groups', 'description': 'In this arm, all the participants were pooled who received FDC RSG/SIMV 4/40 mg, FDC RSG/SIMV 4/80 mg, FDC RSG/SIMV 8/40 mg, FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '36.32', 'ciLowerLimit': '16.52', 'ciUpperLimit': '79.85', 'estimateComment': 'Odds (logistic regression:log odds=Baseline + sex + Treatment + Prior Sulfonylurea use) of having an LDL-c \\< 100 mg/dL at Week 6 on All FDC RSG/SIMV groups compared to All RSG monotherapy groups', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 6', 'description': 'Number of participants achieving American Diabetes Association (ADA) target of LDL\\<100 mg/dL (2.59 mmol/L) at Week 6 was compared between the FDC groups and the all SIMV group using logistic regression with terms for treatment, Baseline value, gender and current sulfonylurea use (at Baseline) in the model.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat with LOCF. Only those participants available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With HbA1c < 7.0% or Reduction of HbA1c ≥ 0.7% at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All SIM Monotherapy Groups', 'description': 'In this arm, all the participants were pooled who received SIM 40 and 80 mg, and matching placebo once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'All FDC RSG/SIMV Groups', 'description': 'In this arm, all the participants were pooled who received FDC RSG/SIMV 4/40 mg, FDC RSG/SIMV 4/80 mg, FDC RSG/SIMV 8/40 mg, FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.05', 'ciLowerLimit': '2.32', 'ciUpperLimit': '7.07', 'estimateComment': 'Odds (logistic regression: log odds=Baseline + sex + Treatment + Prior SU use) of having an HbA1c \\< 7% or reduction of HbA1c \\>= 0.7% at Week 16 on All FDC group compared to Simv group.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 16', 'description': 'Number of participants achieving ADA target of HbA1c \\< 7.0% or reduction of HbA1c ≥ 0.7% at Week 16 was compared between the FDC groups and the RSG groups groups using logistic regression with terms for treatment, Baseline value, gender and current sulfonylurea use (at Baseline) in the model.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat with LOCF. Only those participants available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With FPG< 126 mg/dL (7.0 mmol/L) or Reduction of FPG ≥ 30 mg/dL (1.67 mmol/L) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All SIM Monotherapy Groups', 'description': 'In this arm, all the participants were pooled who received SIM 40 and 80 mg, and matching placebo once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'All FDC RSG/SIMV Groups', 'description': 'In this arm, all the participants were pooled who received FDC RSG/SIMV 4/40 mg, FDC RSG/SIMV 4/80 mg, FDC RSG/SIMV 8/40 mg, FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.93', 'ciLowerLimit': '2.21', 'ciUpperLimit': '7', 'estimateComment': 'Odds (logistic regression:log odds=Baseline + sex + Treatment + Prior SU use) of having an FPG \\< 7.0 mmol/L or reduction of FPG \\>= 1.67 mmol/L at Week 16 on All FDC group compared to Simv group.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 16', 'description': 'Number of participants achieving ADA target of FPG\\< 126 mg/dL (7.0 mmol/L) or reduction of FPG ≥ 30 mg/dL (1.67 mmol/L) at Week 16 was compared between the all SIM monotherapy group and the all FDC RSG/SIMV groups using logistic regression with terms for treatment, Baseline value, gender and current sulfonylurea use (at Baseline) in the model.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat with LOCF. Only those participants available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '43', 'groupId': 'OG005'}, {'value': '43', 'groupId': 'OG006'}, {'value': '46', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'FDC RSG/SIMV 4/40 mg', 'description': 'Participants received FDC RSG/SIMV 4/40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL at Visit 4a (Week 6), the treatment doses were up titrated to FDC RSG/SIMV 4/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.'}, {'id': 'OG001', 'title': 'FDC RSG/SIMV 4/80 mg', 'description': 'Participants received FDC RSG/SIMV 4/80 mg and SIMV 40 mg matching placebo once a day for 16 weeks.'}, {'id': 'OG002', 'title': 'FDC RSG/SIMV 8/40 mg', 'description': 'Participants received FDC RSG/SIMV 8/40 mg once a day and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to FDC RSG/SIMV 8/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.'}, {'id': 'OG003', 'title': 'FDC RSG/SIMV 8/80 mg', 'description': 'Participants received FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks.'}, {'id': 'OG004', 'title': 'RSG 4 mg', 'description': 'Participants received RSG 4.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL evaluated at Visit 4a (Week 6), the treatment doses were titrated up to RSG/SIMV 4/40 mg once a day from Week 6 till Week 16.'}, {'id': 'OG005', 'title': 'RSG 8 mg', 'description': 'Participants received RSG 8.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to RSG/SIMV 8/40 mg once a day from Week 6 till Week 16.'}, {'id': 'OG006', 'title': 'SIMV 40 mg', 'description': 'Participants received SIMV 40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to SIMV/SIMV 40/40 mg once a day from Week 6 till Week 16.'}, {'id': 'OG007', 'title': 'SIMV 80 mg', 'description': 'Participants received SIMV/SIMV 40/40 mg once a day for 16 weeks.'}], 'classes': [{'title': 'Systolic BP, High', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Systolic BP, Low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'Diastolic BP, High', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Diastolic BP, Low', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'Heart Rate, Low', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 16', 'description': 'The potential clinical importance ranges (low and high) of the vital sign parameters were for systolic blood pressure (\\<85 and \\>160 millimeter of mercury \\[mmHg\\]), diastolic blood pressure (\\<45 and \\>100 mmHg) and heart rate (\\<40 and \\>110 beats per minute). Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important vital parameter findings at any visit were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population comprised of all participants who were randomized and received at least one dose of study medication. Only those participants available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'On-Therapy Change From Baseline in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}, {'value': '46', 'groupId': 'OG006'}, {'value': '47', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'FDC RSG/SIMV 4/40 mg', 'description': 'Participants received FDC RSG/SIMV 4/40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL at Visit 4a (Week 6), the treatment doses were up titrated to FDC RSG/SIMV 4/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.'}, {'id': 'OG001', 'title': 'FDC RSG/SIMV 4/80 mg', 'description': 'Participants received FDC RSG/SIMV 4/80 mg and SIMV 40 mg matching placebo once a day for 16 weeks.'}, {'id': 'OG002', 'title': 'FDC RSG/SIMV 8/40 mg', 'description': 'Participants received FDC RSG/SIMV 8/40 mg once a day and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to FDC RSG/SIMV 8/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.'}, {'id': 'OG003', 'title': 'FDC RSG/SIMV 8/80 mg', 'description': 'Participants received FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks.'}, {'id': 'OG004', 'title': 'RSG 4 mg', 'description': 'Participants received RSG 4.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL evaluated at Visit 4a (Week 6), the treatment doses were titrated up to RSG/SIMV 4/40 mg once a day from Week 6 till Week 16.'}, {'id': 'OG005', 'title': 'RSG 8 mg', 'description': 'Participants received RSG 8.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to RSG/SIMV 8/40 mg once a day from Week 6 till Week 16.'}, {'id': 'OG006', 'title': 'SIMV 40 mg', 'description': 'Participants received SIMV 40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to SIMV/SIMV 40/40 mg once a day from Week 6 till Week 16.'}, {'id': 'OG007', 'title': 'SIMV 80 mg', 'description': 'Participants received SIMV/SIMV 40/40 mg once a day for 16 weeks.'}], 'classes': [{'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '42', 'groupId': 'OG005'}, {'value': '43', 'groupId': 'OG006'}, {'value': '46', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '3.45', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '2.83', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '1.80', 'groupId': 'OG002'}, {'value': '0.4', 'spread': '1.85', 'groupId': 'OG003'}, {'value': '0.5', 'spread': '2.07', 'groupId': 'OG004'}, {'value': '0.8', 'spread': '2.66', 'groupId': 'OG005'}, {'value': '-0.5', 'spread': '1.84', 'groupId': 'OG006'}, {'value': '-0.2', 'spread': '1.93', 'groupId': 'OG007'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}, {'value': '42', 'groupId': 'OG006'}, {'value': '37', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '4.39', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '2.75', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '2.51', 'groupId': 'OG002'}, {'value': '1.1', 'spread': '3.98', 'groupId': 'OG003'}, {'value': '1.4', 'spread': '4.41', 'groupId': 'OG004'}, {'value': '2.2', 'spread': '3.94', 'groupId': 'OG005'}, {'value': '-0.5', 'spread': '3.26', 'groupId': 'OG006'}, {'value': '-1.5', 'spread': '3.57', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 16', 'description': 'Baseline assessments were recorded at Visit 3 (Week 0). For a missing Baseline value, the Baseline value were replaced by the last pre-treatment measurement, if available. Change from Baseline was computed as: Visit value - Baseline Value.', 'unitOfMeasure': 'Kilogram', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}, {'value': '46', 'groupId': 'OG006'}, {'value': '47', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'FDC RSG/SIMV 4/40 mg', 'description': 'Participants received FDC RSG/SIMV 4/40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL at Visit 4a (Week 6), the treatment doses were up titrated to FDC RSG/SIMV 4/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.'}, {'id': 'OG001', 'title': 'FDC RSG/SIMV 4/80 mg', 'description': 'Participants received FDC RSG/SIMV 4/80 mg and SIMV 40 mg matching placebo once a day for 16 weeks.'}, {'id': 'OG002', 'title': 'FDC RSG/SIMV 8/40 mg', 'description': 'Participants received FDC RSG/SIMV 8/40 mg once a day and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to FDC RSG/SIMV 8/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.'}, {'id': 'OG003', 'title': 'FDC RSG/SIMV 8/80 mg', 'description': 'Participants received FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks.'}, {'id': 'OG004', 'title': 'RSG 4 mg', 'description': 'Participants received RSG 4.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL evaluated at Visit 4a (Week 6), the treatment doses were titrated up to RSG/SIMV 4/40 mg once a day from Week 6 till Week 16.'}, {'id': 'OG005', 'title': 'RSG 8 mg', 'description': 'Participants received RSG 8.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to RSG/SIMV 8/40 mg once a day from Week 6 till Week 16.'}, {'id': 'OG006', 'title': 'SIMV 40 mg', 'description': 'Participants received SIMV 40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to SIMV/SIMV 40/40 mg once a day from Week 6 till Week 16.'}, {'id': 'OG007', 'title': 'SIMV 80 mg', 'description': 'Participants received SIMV/SIMV 40/40 mg once a day for 16 weeks.'}], 'classes': [{'title': '0-1, Red Blood Cells/HPF', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}]}, {'title': '1-3, Red Blood Cells/HPF', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': '10-15, Red Blood Cells/HPF', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': '15-25, Red Blood Cells/HPF', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': '3-5, Red Blood Cells/HPF', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': '5-10, Red Blood Cells/HPF', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': '50-100, Red Blood Cells/HPF', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'None seen, Red Blood Cells/HPF', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}]}]}, {'title': '0-1, White Blood Cells/HPF', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}]}]}, {'title': '1-3, White Blood Cells/HPF', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': '10-15, White Blood Cells/HPF', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': '15-25, White Blood Cells/HPF', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': '25-50, White Blood Cells/HPF', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': '3-5, White Blood Cells/HPF', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': '5-10, White Blood Cells/HPF', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}]}, {'title': '50-100, White Blood Cells/HPF', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Innumerable, White Blood Cells/HPF', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}]}, {'title': 'None seen, White Blood Cells/HPF', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 16', 'description': 'Urine samples were observed for red blood cells and white blood cells. the results were reported as cells per high-power field (cells/HPF). The number of participants with cells in urine were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}, {'value': '46', 'groupId': 'OG006'}, {'value': '47', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'FDC RSG/SIMV 4/40 mg', 'description': 'Participants received FDC RSG/SIMV 4/40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL at Visit 4a (Week 6), the treatment doses were up titrated to FDC RSG/SIMV 4/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.'}, {'id': 'OG001', 'title': 'FDC RSG/SIMV 4/80 mg', 'description': 'Participants received FDC RSG/SIMV 4/80 mg and SIMV 40 mg matching placebo once a day for 16 weeks.'}, {'id': 'OG002', 'title': 'FDC RSG/SIMV 8/40 mg', 'description': 'Participants received FDC RSG/SIMV 8/40 mg once a day and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to FDC RSG/SIMV 8/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.'}, {'id': 'OG003', 'title': 'FDC RSG/SIMV 8/80 mg', 'description': 'Participants received FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks.'}, {'id': 'OG004', 'title': 'RSG 4 mg', 'description': 'Participants received RSG 4.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL evaluated at Visit 4a (Week 6), the treatment doses were titrated up to RSG/SIMV 4/40 mg once a day from Week 6 till Week 16.'}, {'id': 'OG005', 'title': 'RSG 8 mg', 'description': 'Participants received RSG 8.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to RSG/SIMV 8/40 mg once a day from Week 6 till Week 16.'}, {'id': 'OG006', 'title': 'SIMV 40 mg', 'description': 'Participants received SIMV 40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to SIMV/SIMV 40/40 mg once a day from Week 6 till Week 16.'}, {'id': 'OG007', 'title': 'SIMV 80 mg', 'description': 'Participants received SIMV/SIMV 40/40 mg once a day for 16 weeks.'}], 'classes': [{'title': 'Any AEs', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}, {'value': '21', 'groupId': 'OG007'}]}]}, {'title': 'Any SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 16', 'description': 'AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population.'}, {'type': 'SECONDARY', 'title': 'Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}, {'value': '46', 'groupId': 'OG006'}, {'value': '47', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'FDC RSG/SIMV 4/40 mg', 'description': 'Participants received FDC RSG/SIMV 4/40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL at Visit 4a (Week 6), the treatment doses were up titrated to FDC RSG/SIMV 4/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.'}, {'id': 'OG001', 'title': 'FDC RSG/SIMV 4/80 mg', 'description': 'Participants received FDC RSG/SIMV 4/80 mg and SIMV 40 mg matching placebo once a day for 16 weeks.'}, {'id': 'OG002', 'title': 'FDC RSG/SIMV 8/40 mg', 'description': 'Participants received FDC RSG/SIMV 8/40 mg once a day and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to FDC RSG/SIMV 8/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.'}, {'id': 'OG003', 'title': 'FDC RSG/SIMV 8/80 mg', 'description': 'Participants received FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks.'}, {'id': 'OG004', 'title': 'RSG 4 mg', 'description': 'Participants received RSG 4.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL evaluated at Visit 4a (Week 6), the treatment doses were titrated up to RSG/SIMV 4/40 mg once a day from Week 6 till Week 16.'}, {'id': 'OG005', 'title': 'RSG 8 mg', 'description': 'Participants received RSG 8.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to RSG/SIMV 8/40 mg once a day from Week 6 till Week 16.'}, {'id': 'OG006', 'title': 'SIMV 40 mg', 'description': 'Participants received SIMV 40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to SIMV/SIMV 40/40 mg once a day from Week 6 till Week 16.'}, {'id': 'OG007', 'title': 'SIMV 80 mg', 'description': 'Participants received SIMV/SIMV 40/40 mg once a day for 16 weeks.'}], 'classes': [{'title': 'Hematocrit, Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}, {'value': '44', 'groupId': 'OG006'}, {'value': '46', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Hemoglobin, Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}, {'value': '44', 'groupId': 'OG006'}, {'value': '46', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}]}, {'title': 'White Blood Cells count, Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}, {'value': '44', 'groupId': 'OG006'}, {'value': '46', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Platelet Count, High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}, {'value': '44', 'groupId': 'OG006'}, {'value': '46', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Alanine Amino Transferase, High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}, {'value': '44', 'groupId': 'OG006'}, {'value': '46', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Aspartate Amino Transferase, High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}, {'value': '44', 'groupId': 'OG006'}, {'value': '46', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'Carbon Dioxide content / Bicarbonate, Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '46', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}, {'value': '44', 'groupId': 'OG006'}, {'value': '46', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Creatine Kinase, High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}, {'value': '44', 'groupId': 'OG006'}, {'value': '46', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Gamma Glutamyl Transferase, High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}, {'value': '44', 'groupId': 'OG006'}, {'value': '46', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'Calcium, Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}, {'value': '44', 'groupId': 'OG006'}, {'value': '46', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Potassium, High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}, {'value': '44', 'groupId': 'OG006'}, {'value': '46', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 16', 'description': 'The clinical chemistry parameters analyzed were sodium, potassium, bicarbonate, chloride, calcium, total protein, albumin, creatinine total bilirubin, blood urea nitrogen, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transpeptidase, and alkaline phosphatase. The hematology parameters analyzed were hemoglobin, hematocrit, platelet count, total white cell count. Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important hematology findings at any visit were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fixed Dose Combination (FDC) 4/40 Milligram (mg)', 'description': 'Participants received FDC of rosiglitazone (RSG) 4.0 mg and simvastatin (SIMV) 40 mg (FDC 4/40) and matching placebo once a day for 16 weeks. In case of the participants who had Low Density Lipoprotein-cholesterol (LDL-c) \\> 130 milligram per deciliter (mg/dL) at Visit 4a (Week 6) the treatment doses were up titrated to FDC RSG/SIMV 4/40 mg and SIMV 40 mg from Week 6 till Week 16.'}, {'id': 'FG001', 'title': 'FDC 4/80 mg', 'description': 'Participants received FDC RSG/SIMV 4/80 mg and SIMV 40 mg matching placebo once a day for 16 weeks.'}, {'id': 'FG002', 'title': 'FDC 8/40 mg', 'description': 'Participants received FDC RSG/SIMV 8/40 mg once a day and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to FDC RSG/SIMV 8/40 mg and SIMV 40 mg from Week 6 till Week 16.'}, {'id': 'FG003', 'title': 'FDC 8/80 mg', 'description': 'Participants received FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks.'}, {'id': 'FG004', 'title': 'RSG 4mg', 'description': 'Participants received RSG 4.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL evaluated at Visit 4a (Week 6), the treatment doses were titrated up to RSG/SIMV 4/40 mg once a day from Week 6 till Week 16.'}, {'id': 'FG005', 'title': 'RSG 8mg', 'description': 'Participants received RSG 8.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to RSG/SIMV 8/40 mg once a day from Week 6 till Week 16.'}, {'id': 'FG006', 'title': 'SIMV 40mg', 'description': 'Participants received SIMV 40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to SIMV/SIMV 40/40 mg once a day from Week 6 till Week 16.'}, {'id': 'FG007', 'title': 'SIMV 80mg', 'description': 'Participants received SIMV/SIMV 40/40 mg once a day for 16 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '45'}, {'groupId': 'FG003', 'numSubjects': '46'}, {'groupId': 'FG004', 'numSubjects': '48'}, {'groupId': 'FG005', 'numSubjects': '46'}, {'groupId': 'FG006', 'numSubjects': '46'}, {'groupId': 'FG007', 'numSubjects': '47'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '39'}, {'groupId': 'FG002', 'numSubjects': '40'}, {'groupId': 'FG003', 'numSubjects': '40'}, {'groupId': 'FG004', 'numSubjects': '41'}, {'groupId': 'FG005', 'numSubjects': '40'}, {'groupId': 'FG006', 'numSubjects': '41'}, {'groupId': 'FG007', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '2'}]}, {'type': 'Fasting plasma glucose >240 mg/dL', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Glycemia over 13.3 millimole per litre', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}]}, {'type': "Investigator's Decision", 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Non-compliance with study medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}]}, {'type': 'Participant travelled Overseas', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Participant out of assessment window', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Withdrawal by participant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was conducted between 17 April 2005 and 21 December 2006 at 68 centers in five countries including United States, Canada, Australia, Mexico, and the Philippines. A total of 370 participants were randomized of which 1 participant did not received study medication remaining 369 participants were included in safety population.', 'preAssignmentDetails': 'Out of the 369 participants from safety population, 12 participants received at least one dose but did not have at least one On-Therapy value for any efficacy assessment, the remaining 357 participants were included in Intent- to-Treat population.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}, {'value': '48', 'groupId': 'BG004'}, {'value': '46', 'groupId': 'BG005'}, {'value': '46', 'groupId': 'BG006'}, {'value': '47', 'groupId': 'BG007'}, {'value': '369', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': 'FDC RSG/SIMV 4/40 mg', 'description': 'Participants received FDC RSG/SIMV 4/40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL at Visit 4a (Week 6), the treatment doses were up titrated to FDC RSG/SIMV 4/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.'}, {'id': 'BG001', 'title': 'FDC RSG/SIMV 4/80 mg', 'description': 'Participants received FDC RSG/SIMV 4/80 mg and SIMV 40 mg matching placebo once a day for 16 weeks.'}, {'id': 'BG002', 'title': 'FDC RSG/SIMV 8/40 mg', 'description': 'Participants received FDC RSG/SIMV 8/40 mg once a day and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to FDC RSG/SIMV 8/40 mg and SIMV 40 mg once a day from Week 6 till Week 16.'}, {'id': 'BG003', 'title': 'FDC RSG/SIMV 8/80 mg', 'description': 'Participants received FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks.'}, {'id': 'BG004', 'title': 'RSG 4mg', 'description': 'Participants received RSG 4.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL evaluated at Visit 4a (Week 6), the treatment doses were titrated up to RSG/SIMV 4/40 mg once a day from Week 6 till Week 16.'}, {'id': 'BG005', 'title': 'RSG 8mg', 'description': 'Participants received RSG 8.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to RSG/SIMV 8/40 mg once a day from Week 6 till Week 16.'}, {'id': 'BG006', 'title': 'SIMV 40mg', 'description': 'Participants received SIMV 40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \\>130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to SIMV/SIMV 40/40 mg once a day from Week 6 till Week 16.'}, {'id': 'BG007', 'title': 'SIMV 80mg', 'description': 'Participants received SIMV/SIMV 40/40 mg once a day for 16 weeks.'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55', 'spread': '9.13', 'groupId': 'BG000'}, {'value': '55.1', 'spread': '10.31', 'groupId': 'BG001'}, {'value': '56.9', 'spread': '9.07', 'groupId': 'BG002'}, {'value': '55', 'spread': '8.65', 'groupId': 'BG003'}, {'value': '53.8', 'spread': '11.37', 'groupId': 'BG004'}, {'value': '54.6', 'spread': '9.93', 'groupId': 'BG005'}, {'value': '53.4', 'spread': '9.03', 'groupId': 'BG006'}, {'value': '53.5', 'spread': '10.49', 'groupId': 'BG007'}, {'value': '54.6', 'spread': '9.76', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '25', 'groupId': 'BG005'}, {'value': '25', 'groupId': 'BG006'}, {'value': '25', 'groupId': 'BG007'}, {'value': '190', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '21', 'groupId': 'BG005'}, {'value': '21', 'groupId': 'BG006'}, {'value': '22', 'groupId': 'BG007'}, {'value': '179', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African American/African Heritage', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '26', 'groupId': 'BG008'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}]}]}, {'title': 'Asian - Central/South Asian Heritage', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '23', 'groupId': 'BG008'}]}]}, {'title': 'Asian - East Asian Heritage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}]}]}, {'title': 'Asian - South East Asian Heritage', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '11', 'groupId': 'BG007'}, {'value': '67', 'groupId': 'BG008'}]}]}, {'title': 'Native Hawaiian or other Pacific Islander', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}]}]}, {'title': 'White - Arabic/North African Heritage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}]}]}, {'title': 'White -White/Caucasian/European Heritage', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}, {'value': '27', 'groupId': 'BG005'}, {'value': '28', 'groupId': 'BG006'}, {'value': '20', 'groupId': 'BG007'}, {'value': '203', 'groupId': 'BG008'}]}]}, {'title': 'Mixed Race', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '31', 'groupId': 'BG008'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Population comprised of all participants who were randomized and received at least one dose of study medication. No race information available for one participant in arm SIMV 40mg.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 369}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08-18', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2006-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-02', 'studyFirstSubmitDate': '2005-11-18', 'resultsFirstSubmitDate': '2017-08-24', 'studyFirstSubmitQcDate': '2005-11-21', 'lastUpdatePostDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-24', 'studyFirstPostDateStruct': {'date': '2005-11-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2006-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Median Percent Change From Baseline to Week 6 in LDL-c in FDC and RSG Monotherapy', 'timeFrame': 'Baseline (Week 0) and Week 6', 'description': 'Median percent change from Baseline to Week 6 in LDL-c in FDC and RSG monotherapy was reported. Percent change from Baseline = 100\\*(exponent \\[change on log scale\\]-1). Baseline assessments were recorded at Visit 3 (Week 0). For a missing Baseline value, the Baseline value were replaced by the last pre-treatment measurement, if available. The hypothesis of treatment difference was tested at a 0.05 significance level based on two-sided tests. The point estimates and corresponding 95% confidence intervals for treatment differences was calculated. Treatment differences were assessed within the context of an analysis of covariance (ANCOVA) with terms for treatment, gender, current sulfonylurea use (at baseline), country, and Baseline measurement. ANCOVA for LDL-c were performed based on log-transformed data.'}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline to Week 16 in Glycosylated Hemoglobin A1c (HbA1c) in FDC and SIMV Monotherapy', 'timeFrame': 'Baseline (Week 0) and Week 16', 'description': 'Mean change from Baseline to Week 16 in HbA1c in FDC and SIMV monotherapy was reported. Change from Baseline was computed as (Visit value - Baseline value). Baseline assessments were recorded at Visit 3 (Week 0). For a missing Baseline value, the Baseline value were replaced by the last pre-treatment measurement, if available. The hypothesis of treatment difference was tested at a 0.05 significance level based on two-sided tests. The point estimates and corresponding 95% confidence intervals for treatment differences was calculated. Treatment differences were assessed within the context of ANCOVA with terms for treatment, gender, current sulfonylurea use (at Baseline), country, and Baseline measurement.'}, {'measure': 'Median Percent Change From Baseline to Week 6 in LDL-c', 'timeFrame': 'Baseline (Week 0) and Week 6', 'description': 'Percent change from Baseline = 100\\*(exponent \\[change on log scale\\]-1). Baseline assessments were recorded at Visit 3 (Week 0). For a missing Baseline value, the Baseline value were replaced by the last pre-treatment measurement, if available.'}, {'measure': 'Mean Change From Baseline to Week 16 in HbA1c', 'timeFrame': 'Baseline (Week 0) and Week 16', 'description': 'Change from Baseline was computed as (Visit value - Baseline value). Baseline assessments were recorded at Visit 3 (Week 0). For a missing Baseline value, the Baseline value were replaced by the last pre-treatment measurement, if available.'}, {'measure': 'Mean Change From Baseline to Week 16 in Fasting Plasma Glucose (FPG)', 'timeFrame': 'Baseline (Week 0) and Week 16', 'description': 'Change from Baseline was computed as (Visit value - Baseline value). Baseline assessments were recorded at Visit 3 (Week 0). For a missing Baseline value, the Baseline value were replaced by the last pre-treatment measurement, if available.'}, {'measure': 'Number of Participant With LDL<100 mg/dL (2.59 mmol/L) at Week 6', 'timeFrame': 'Week 6', 'description': 'Number of participants achieving American Diabetes Association (ADA) target of LDL\\<100 mg/dL (2.59 mmol/L) at Week 6 was compared between the FDC groups and the all SIMV group using logistic regression with terms for treatment, Baseline value, gender and current sulfonylurea use (at Baseline) in the model.'}, {'measure': 'Number of Participants With HbA1c < 7.0% or Reduction of HbA1c ≥ 0.7% at Week 16', 'timeFrame': 'Up to Week 16', 'description': 'Number of participants achieving ADA target of HbA1c \\< 7.0% or reduction of HbA1c ≥ 0.7% at Week 16 was compared between the FDC groups and the RSG groups groups using logistic regression with terms for treatment, Baseline value, gender and current sulfonylurea use (at Baseline) in the model.'}, {'measure': 'Number of Participants With FPG< 126 mg/dL (7.0 mmol/L) or Reduction of FPG ≥ 30 mg/dL (1.67 mmol/L) at Week 16', 'timeFrame': 'Week 16', 'description': 'Number of participants achieving ADA target of FPG\\< 126 mg/dL (7.0 mmol/L) or reduction of FPG ≥ 30 mg/dL (1.67 mmol/L) at Week 16 was compared between the all SIM monotherapy group and the all FDC RSG/SIMV groups using logistic regression with terms for treatment, Baseline value, gender and current sulfonylurea use (at Baseline) in the model.'}, {'measure': 'On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate', 'timeFrame': 'Up to Week 16', 'description': 'The potential clinical importance ranges (low and high) of the vital sign parameters were for systolic blood pressure (\\<85 and \\>160 millimeter of mercury \\[mmHg\\]), diastolic blood pressure (\\<45 and \\>100 mmHg) and heart rate (\\<40 and \\>110 beats per minute). Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important vital parameter findings at any visit were reported.'}, {'measure': 'On-Therapy Change From Baseline in Body Weight', 'timeFrame': 'Up to Week 16', 'description': 'Baseline assessments were recorded at Visit 3 (Week 0). For a missing Baseline value, the Baseline value were replaced by the last pre-treatment measurement, if available. Change from Baseline was computed as: Visit value - Baseline Value.'}, {'measure': 'Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine', 'timeFrame': 'Up to Week 16', 'description': 'Urine samples were observed for red blood cells and white blood cells. the results were reported as cells per high-power field (cells/HPF). The number of participants with cells in urine were reported.'}, {'measure': 'Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE)', 'timeFrame': 'Up to Week 16', 'description': 'AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.'}, {'measure': 'Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline', 'timeFrame': 'Up to Week 16', 'description': 'The clinical chemistry parameters analyzed were sodium, potassium, bicarbonate, chloride, calcium, total protein, albumin, creatinine total bilirubin, blood urea nitrogen, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transpeptidase, and alkaline phosphatase. The hematology parameters analyzed were hemoglobin, hematocrit, platelet count, total white cell count. Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important hematology findings at any visit were reported.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Type 2 diabetes Type II'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'availIpds': [{'id': 'AVS101946', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'AVS101946', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'AVS101946', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'AVS101946', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'AVS101946', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'AVS101946', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'AVS101946', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Annotated Case Report Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the effect of medicines for type 2 diabetes and lipids control. This study will require about 6 office visits for lab tests and examinations. All study related medicines and medical examinations will be provided at no cost to the subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* A clinical diagnosis type 2 diabetes mellitus.\n* Women must not be pregnant or breastfeeding during the study and 30 days after the study.\n* Must sign an informed consent form at the study clinic.\n\nExclusion criteria:\n\n* Severe chronic diseases that would prevent from participating and completing the study by investigator's judgement.\n* Use of an investigational drug within 30 days or 5 half lives before first dose of study medication.\n* Insulin use for \\> 1 week in past 3 months."}, 'identificationModule': {'nctId': 'NCT00256867', 'briefTitle': 'A Study In Patients With Type 2 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 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