Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2026-01-28 @ 8:34 PM
Study NCT ID:
NCT02014103
Status:
COMPLETED
Last Update Posted:
2024-10-15
First Post:
2013-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Conversion From Brand to Generic Tacrolimus in High Risk Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016559', 'term': 'Tacrolimus'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rita.alloway@uc.edu', 'phone': '513.558.1568', 'title': 'Rita Alloway', 'organization': 'University of Cincinnati'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Data was collected during the 6 week period enrolled in the pharmacokinetic study', 'eventGroups': [{'id': 'EG000', 'title': 'Accord', 'description': 'Subjects receiving the Accord formulation', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 22, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Astellas', 'description': 'Subjects receiving the Astellas formulation', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 14, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Dr. Reddys', 'description': 'Subjects receiving the Dr Reddy formulation', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 20, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Mylan', 'description': 'Subjects receiving the Mylan formulation', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 22, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Panacea', 'description': 'Subjects receiving the Panacea formulation', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 23, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Sandoz', 'description': 'Subjects receiving the Sandoz formulation', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 13, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anxiety, tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 53, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'leukopenia, thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'hypertension, tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'ear erythemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'dehydration, hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 53, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'nausea, vomitting, diarhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'muscle aches', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'respiratory tract infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'lost venous access', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'study related issues', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'difficult urinating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'allergies', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'eye redness, itching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'administrative issues', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 53, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Compare AUC 0-12hr of Each Tacrolimus Formulation in Expressor and Non Expressor Transplant Recipients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expressors', 'description': 'Subjects with at least one \\*1 allele of CYP3A5'}, {'id': 'OG001', 'title': 'Non-expressors', 'description': 'Subjects homozygous for the \\*3 CYP3A5 allele'}], 'classes': [{'title': 'Accord', 'categories': [{'measurements': [{'value': '112.35', 'groupId': 'OG000', 'lowerLimit': '95.83', 'upperLimit': '131.72'}, {'value': '92.37', 'groupId': 'OG001', 'lowerLimit': '81.14', 'upperLimit': '105.15'}]}]}, {'title': 'Astellas', 'categories': [{'measurements': [{'value': '97.04', 'groupId': 'OG000', 'lowerLimit': '82.77', 'upperLimit': '113.77'}, {'value': '84.16', 'groupId': 'OG001', 'lowerLimit': '73.93', 'upperLimit': '95.81'}]}]}, {'title': 'Dr. Reddys', 'categories': [{'measurements': [{'value': '110.63', 'groupId': 'OG000', 'lowerLimit': '85.83', 'upperLimit': '117.98'}, {'value': '83.96', 'groupId': 'OG001', 'lowerLimit': '73.75', 'upperLimit': '95.58'}]}]}, {'title': 'Mylan', 'categories': [{'measurements': [{'value': '96.83', 'groupId': 'OG000', 'lowerLimit': '82.59', 'upperLimit': '113.53'}, {'value': '85.53', 'groupId': 'OG001', 'lowerLimit': '75.13', 'upperLimit': '97.37'}]}]}, {'title': 'Panacea', 'categories': [{'measurements': [{'value': '100.58', 'groupId': 'OG000', 'lowerLimit': '85.79', 'upperLimit': '117.92'}, {'value': '89.38', 'groupId': 'OG001', 'lowerLimit': '78.51', 'upperLimit': '101.75'}]}]}, {'title': 'Sandoz', 'categories': [{'measurements': [{'value': '98.68', 'groupId': 'OG000', 'lowerLimit': '84.17', 'upperLimit': '115.70'}, {'value': '87.60', 'groupId': 'OG001', 'lowerLimit': '76.95', 'upperLimit': '99.73'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Geometric Accord/Astellas Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '115.78', 'ciLowerLimit': '107.04', 'ciUpperLimit': '125.22', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG000'], 'paramType': 'Geometric Dr. Reddys/Astellas Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '103.7', 'ciLowerLimit': '95.91', 'ciUpperLimit': '112.12', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG000'], 'paramType': 'Geometric Mylan/Astellas Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '99.79', 'ciLowerLimit': '92.30', 'ciUpperLimit': '107.89', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG000'], 'paramType': 'Geometric Panacea/Astellas Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '103.65', 'ciLowerLimit': '95.83', 'ciUpperLimit': '112.11', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 and Cmax parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG000'], 'paramType': 'Geometric Sandoz/Astellas Ratio X100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '101.70', 'ciLowerLimit': '94.03', 'ciUpperLimit': '110.0', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 and parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG000'], 'paramType': 'Geometric Accord/Dr Reddys Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '111.64', 'ciLowerLimit': '103.26', 'ciUpperLimit': '120.70', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG000'], 'paramType': 'Geometric Accord/Mylan Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '116.02', 'ciLowerLimit': '107.27', 'ciUpperLimit': '125.49', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG000'], 'paramType': 'Geometric Accord/Panacea Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '111.70', 'ciLowerLimit': '103.27', 'ciUpperLimit': '120.81', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG000'], 'paramType': 'Geometric Accord/Sandoz Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '113.84', 'ciLowerLimit': '105.30', 'ciUpperLimit': '123.08', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG000'], 'paramType': 'Geometric Dr Reddys/Mylan Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '103.92', 'ciLowerLimit': '96.08', 'ciUpperLimit': '112.40', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG000'], 'paramType': 'Geometric Dr Reddys/Panacea Ratio x 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '100.05', 'ciLowerLimit': '92.50', 'ciUpperLimit': '108.21', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG000'], 'paramType': 'Geometric Dr Reddys/Sandoz Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '101.97', 'ciLowerLimit': '94.28', 'ciUpperLimit': '110.29', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG000'], 'paramType': 'Geometric Mylan/Panacea Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '96.28', 'ciLowerLimit': '89.05', 'ciUpperLimit': '104.09', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG000'], 'paramType': 'Geometric Mylan/Sandoz Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '98.12', 'ciLowerLimit': '90.72', 'ciUpperLimit': '106.12', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG000'], 'paramType': 'Geometric Panacea/Sandoz Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '101.92', 'ciLowerLimit': '94.27', 'ciUpperLimit': '110.19', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG001'], 'paramType': 'Geometric Accord/Astellas Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '109.75', 'ciLowerLimit': '100.42', 'ciUpperLimit': '119.25', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG001'], 'paramType': 'Geometric Dr Reddys/Astellas Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '99.76', 'ciLowerLimit': '91.28', 'ciUpperLimit': '109.03', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG001'], 'paramType': 'Geometric Mylan/Astellas Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '101.63', 'ciLowerLimit': '92.99', 'ciUpperLimit': '111.06', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG001'], 'paramType': 'Geometric Panacea/Astellas Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '106.20', 'ciLowerLimit': '97.17', 'ciUpperLimit': '116.06', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG001'], 'paramType': 'Geometric Sandoz/Astellas Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '104.09', 'ciLowerLimit': '95.25', 'ciUpperLimit': '113.75', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG001'], 'paramType': 'Geometric Accord/Dr Reddy Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '110.02', 'ciLowerLimit': '100.66', 'ciUpperLimit': '120.24', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG001'], 'paramType': 'Geometric Accord/Mylan Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '108.00', 'ciLowerLimit': '98.82', 'ciUpperLimit': '118.02', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG001'], 'paramType': 'Geometric Accord/Panacea Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '103.34', 'ciLowerLimit': '94.56', 'ciUpperLimit': '112.94', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG001'], 'paramType': 'Geometric Accord/Sandoz Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '105.44', 'ciLowerLimit': '96.48', 'ciUpperLimit': '115.23', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG001'], 'paramType': 'Geometric Dr Reddys/Mylan Ration X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '98.16', 'ciLowerLimit': '89.82', 'ciUpperLimit': '107.28', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG001'], 'paramType': 'Geometric Dr. Reddys/Panacea Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '93.93', 'ciLowerLimit': '85.96', 'ciUpperLimit': '102.65', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG001'], 'paramType': 'Geometric Dr Reddys/Sandoz Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '95.84', 'ciLowerLimit': '87.69', 'ciUpperLimit': '104.74', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG001'], 'paramType': 'Geometric Mylan/Panacea Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '95.69', 'ciLowerLimit': '87.56', 'ciUpperLimit': '104.58', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG001'], 'paramType': 'Geometric Mylan/Sandoz Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '97.63', 'ciLowerLimit': '89.34', 'ciUpperLimit': '107.71', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG001'], 'paramType': 'Geometric Pancea/Sandoz Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '102.03', 'ciLowerLimit': '93.36', 'ciUpperLimit': '111.51', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}], 'paramType': 'MEAN', 'timeFrame': 'Whole blood samples were collected immediately prior to dosing, at 1, 1.5, 1.75, 2, 2.5, 3 and 4 hours following dosing. Subjects were then instructed to performed fingersticks using dried blood spot cards at 8 and 12 hours post dose.', 'description': 'Report the geometric mean and 95% confidence interval for AUC 0-12hr (ng\\*hr/ml) for each formulation in expressor and non expressor transplant recipients', 'unitOfMeasure': 'ng*hr/ml', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Compare Cmax of Each Tacrolimus Formulation in Expressor and Non Expressor Transplant Recipients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Expressors', 'description': 'Subjects with at least one \\*1 allele of CYP3A5'}, {'id': 'OG001', 'title': 'Non-expressors', 'description': 'Subjects homozygous for the \\*3 CYP3A5 allele'}], 'classes': [{'title': 'Accord', 'categories': [{'measurements': [{'value': '21.72', 'groupId': 'OG000', 'lowerLimit': '17.43', 'upperLimit': '27.07'}, {'value': '15.07', 'groupId': 'OG001', 'lowerLimit': '13.02', 'upperLimit': '17.44'}]}]}, {'title': 'Astellas', 'categories': [{'measurements': [{'value': '15.31', 'groupId': 'OG000', 'lowerLimit': '12.29', 'upperLimit': '19.07'}, {'value': '13.34', 'groupId': 'OG001', 'lowerLimit': '11.53', 'upperLimit': '15.44'}]}]}, {'title': 'Dr. Reddys', 'categories': [{'measurements': [{'value': '15.94', 'groupId': 'OG000', 'lowerLimit': '12.79', 'upperLimit': '19.86'}, {'value': '13.58', 'groupId': 'OG001', 'lowerLimit': '11.73', 'upperLimit': '15.71'}]}]}, {'title': 'Mylan', 'categories': [{'measurements': [{'value': '17.76', 'groupId': 'OG000', 'lowerLimit': '14.26', 'upperLimit': '22.13'}, {'value': '15.15', 'groupId': 'OG001', 'lowerLimit': '13.09', 'upperLimit': '17.53'}]}]}, {'title': 'Panacea', 'categories': [{'measurements': [{'value': '16.67', 'groupId': 'OG000', 'lowerLimit': '13.38', 'upperLimit': '20.78'}, {'value': '13.23', 'groupId': 'OG001', 'lowerLimit': '11.43', 'upperLimit': '15.31'}]}]}, {'title': 'Sandoz', 'categories': [{'measurements': [{'value': '14.40', 'groupId': 'OG000', 'lowerLimit': '11.56', 'upperLimit': '17.94'}, {'value': '12.75', 'groupId': 'OG001', 'lowerLimit': '11.02', 'upperLimit': '14.76'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Geometric Accord/Astellas Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '141.91', 'ciLowerLimit': '125.73', 'ciUpperLimit': '160.16', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG000'], 'paramType': 'Geometric Dr Reddys/Astellas Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '104.13', 'ciLowerLimit': '92.33', 'ciUpperLimit': '117.45', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG000'], 'paramType': 'Geometric Mylan/Astellas Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '116.02', 'ciLowerLimit': '102.87', 'ciUpperLimit': '130.87', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG000'], 'paramType': 'Geometric Panacea/Astellas Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '108.92', 'ciLowerLimit': '96.51', 'ciUpperLimit': '122.94', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG000'], 'paramType': 'Geometric Sandoz/Astellas Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '94.06', 'ciLowerLimit': '83.33', 'ciUpperLimit': '106.16', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG000'], 'paramType': 'Geometric Accord/Dr. Reddys Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '136.27', 'ciLowerLimit': '120.82', 'ciUpperLimit': '153.70', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG000'], 'paramType': 'Geometric Accord/Mylan Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '122.31', 'ciLowerLimit': '108.37', 'ciUpperLimit': '138.04', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG000'], 'paramType': 'Geometric Accord/Panacea Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '130.28', 'ciLowerLimit': '115.43', 'ciUpperLimit': '147.04', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG000'], 'paramType': 'Geometric Accord/Sandoz Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '150.88', 'ciLowerLimit': '133.77', 'ciUpperLimit': '170.18', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG000'], 'paramType': 'Geometric Dr. Reddys/Mylan Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '89.75', 'ciLowerLimit': '79.52', 'ciUpperLimit': '101.30', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG000'], 'paramType': 'Geometric Dr Reddys/Panacea Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '95.60', 'ciLowerLimit': '84.71', 'ciUpperLimit': '107.90', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG000'], 'paramType': 'Geometric Dr Reddys/Sandoz Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '110.72', 'ciLowerLimit': '98.10', 'ciUpperLimit': '124.96', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG000'], 'paramType': 'Geometric Mylan/Panacea Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '106.52', 'ciLowerLimit': '94.44', 'ciUpperLimit': '120.15', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG000'], 'paramType': 'Geometric Mylan/Sandoz Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '123.36', 'ciLowerLimit': '109.30', 'ciUpperLimit': '139.23', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG000'], 'paramType': 'Geometric Panacea/Sandoz Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '115.81', 'ciLowerLimit': '102.68', 'ciUpperLimit': '130.62', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG001'], 'paramType': 'Geometric Accord/Astellas Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '112.96', 'ciLowerLimit': '100.32', 'ciUpperLimit': '127.20', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG001'], 'paramType': 'Geometric Dr Reddys/Astellas Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '101.75', 'ciLowerLimit': '90.37', 'ciUpperLimit': '114.57', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG001'], 'paramType': 'Geometric Mylan/Astella Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '113.52', 'ciLowerLimit': '100.82', 'ciUpperLimit': '127.83', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG001'], 'paramType': 'Geometric Panacea/Astellas Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '99.16', 'ciLowerLimit': '88.06', 'ciUpperLimit': '111.64', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG001'], 'paramType': 'Geometric Sandoz/Astellas Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '95.57', 'ciLowerLimit': '84.89', 'ciUpperLimit': '107.61', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG001'], 'paramType': 'Geometric Accord/Dr Reddy Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '111.01', 'ciLowerLimit': '98.59', 'ciUpperLimit': '125.00', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG001'], 'paramType': 'Geometric Accord/Mylan Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '99.51', 'ciLowerLimit': '88.38', 'ciUpperLimit': '112.04', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG001'], 'paramType': 'Geometric Accord/Panacea Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '113.93', 'ciLowerLimit': '101.18', 'ciUpperLimit': '128.28', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG001'], 'paramType': 'Geometric Accord/Sandoz Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '118.19', 'ciLowerLimit': '104.96', 'ciUpperLimit': '133.08', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG001'], 'paramType': 'Geometric Dr Reddys/Mylan', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '89.64', 'ciLowerLimit': '79.61', 'ciUpperLimit': '100.93', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG001'], 'paramType': 'Geometric Dr. Reddys/Panacea Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '102.63', 'ciLowerLimit': '91.15', 'ciUpperLimit': '115.55', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG001'], 'paramType': 'Geometric Dr. Reddys/Sandoz Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '106.46', 'ciLowerLimit': '94.55', 'ciUpperLimit': '119.88', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG001'], 'paramType': 'Geometric Mylan/Panacea Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '114.49', 'ciLowerLimit': '110.68', 'ciUpperLimit': '128.92', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG001'], 'paramType': 'Geometric Mylan/Sandoz Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '118.77', 'ciLowerLimit': '105.48', 'ciUpperLimit': '133.74', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}, {'groupIds': ['OG001'], 'paramType': 'Geometric Panacea/Sandoz Ratio X 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '103.74', 'ciLowerLimit': '92.13', 'ciUpperLimit': '116.81', 'estimateComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125', 'groupDescription': 'Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Bioequivalence is established when 90% confidence interval falls within 80-125'}], 'paramType': 'MEAN', 'timeFrame': 'Whole blood samples were collected immediately prior to dosing, at 1, 1.5, 1.75, 2, 2.5, 3 and 4 hours following dosing. Subjects were then instructed to performed fingersticks using dried blood spot cards at 8 and 12 hours post dose.', 'description': 'Report the geometric mean and 95% confidence interval for Cmax (ng/ml) for each formulation in expressor and non expressor transplant recipients', 'unitOfMeasure': 'ng/ml', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'To Compare the Safety and Efficacy of Each Tacrolimus Formulation in Stable Transplant Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}, {'value': '53', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Accord', 'description': 'Subjects receiving the Accord formulation'}, {'id': 'OG001', 'title': 'Astellas', 'description': 'Subjects receiving the Astellas formulation'}, {'id': 'OG002', 'title': 'Dr. Reddys', 'description': 'Subjects receiving the Dr Reddy formulation'}, {'id': 'OG003', 'title': 'Mylan', 'description': 'Subjects receiving the Mylan formulation'}, {'id': 'OG004', 'title': 'Panacea', 'description': 'Subjects receiving the Panacea formulation'}, {'id': 'OG005', 'title': 'Sandoz', 'description': 'Subjects receiving the Sandoz formulation'}], 'classes': [{'title': 'All cause mortality', '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'}]}]}, {'title': 'Serious Adverse Events', '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'}]}]}, {'title': 'Total Other Adverse Events (not including Serious)', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}]}]}, {'title': 'Nervous system', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Blood and Lymphatic system', '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'}]}]}, {'title': 'Cardiac', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Ear and labyrinth', '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'}]}]}, {'title': 'Metabolism and Nutrition', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Gastrointestinal', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Respiratory, thoracic, and mediastinal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Musculoskeletal and connective tissue', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Reproductive system and breast disorders', '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'}]}]}, {'title': 'Infections and infestations', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Skin and subcutaneous tissue', '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'}]}]}, {'title': 'Psychiatric', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Vascular', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Investigations', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Renal and urinary', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Allergies', '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'}]}]}, {'title': 'Eye Disorder', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Endocrine', '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'}]}]}, {'title': 'General disorders and administrative site conditions', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed at baseline and weekly for 6 weeks at each pharmacokinetic profile', 'description': 'Conduct safety lab testing specific to transplanted organ function and clinical assessments for adverse events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the PK population with available data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Expressors', 'description': 'Subjects with at least one \\*1 allele of CYP3A5'}, {'id': 'FG001', 'title': 'Non-expressors', 'description': 'Subjects homozygous for the \\*3 CYP3A5 allele'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'Did Receive Allocated Intervention', 'comment': 'One patient did not receive intervention due to elevated SrCr at baseline', 'achievements': [{'comment': 'One patient did not receive intervention due to elevated SrCr at baseline', 'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'Discontinued Intervention', 'achievements': [{'comment': '6 interventions were discontinued. 5 due to protocol defined medication non adherence and one due to lack of venous access', 'groupId': 'FG000', 'numSubjects': '6'}, {'comment': '5 discontinued intervention Patient unable to complete PK due to personal reasons (2), tacrolimus dose adjustment required during PK (2), and protocol defined nonadherence (1)', 'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Number Subjects Receiving Accord', 'comment': 'Subjects were randomized to a sequence of formulation administration for each period. Subjects were withdrawn or dropped out at various periods of the study. The subjects who received identified formulation during the study period of participation are counted.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'Number Subjects Receiving Astellas', 'comment': 'Subjects were randomized to a sequence of formulation administration for each period. Subjects were withdrawn or dropped out at various periods of the study. The subjects who received identified formulation during the study period of participation are counted.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'Number Subjects Receiving Dr. Reddy', 'comment': 'Subjects were randomized to a sequence of formulation administration for each period. Subjects were withdrawn or dropped out at various periods of the study. The subjects who received identified formulation during the study period of participation are counted.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'Number Subjects Receiving Mylan', 'comment': 'Subjects were randomized to a sequence of formulation administration for each period. Subjects were withdrawn or dropped out at various periods of the study. The subjects who received identified formulation during the study period of participation are counted.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'Number Subjects Receiving Panacea', 'comment': 'Subjects were randomized to a sequence of formulation administration for each period. Subjects were withdrawn or dropped out at various periods of the study. The subjects who received identified formulation during the study period of participation are counted.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'Number Subjects Receiving Sandoz', 'comment': 'Subjects were randomized to a sequence of formulation administration for each period. Subjects were withdrawn or dropped out at various periods of the study. The subjects who received identified formulation during the study period of participation are counted.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'Excluded From Analysis', 'achievements': [{'comment': 'Two were excluded from analysis for nonadherence within 48hr of PK visit', 'groupId': 'FG000', 'numSubjects': '2'}, {'comment': '4 were excluded from analysis. One dure to nonadherence within 48hour of PK visit and 3 due to drug interactions during study period', 'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost venous access', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Expressors', 'description': 'Subjects with at least one \\*1 allele of CYP3A5'}, {'id': 'BG001', 'title': 'Non-expressors', 'description': 'Subjects homozygous for the \\*3 CYP3A5 allele'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.5', 'groupId': 'BG000', 'lowerLimit': '46.0', 'upperLimit': '62.0'}, {'value': '57', 'groupId': 'BG001', 'lowerLimit': '44.0', 'upperLimit': '62.0'}, {'value': '56.25', 'groupId': 'BG002', 'lowerLimit': '44', 'upperLimit': '62'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-10', 'studyFirstSubmitDate': '2013-10-21', 'resultsFirstSubmitDate': '2024-08-23', 'studyFirstSubmitQcDate': '2013-12-17', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-10', 'studyFirstPostDateStruct': {'date': '2013-12-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare AUC 0-12hr of Each Tacrolimus Formulation in Expressor and Non Expressor Transplant Recipients', 'timeFrame': 'Whole blood samples were collected immediately prior to dosing, at 1, 1.5, 1.75, 2, 2.5, 3 and 4 hours following dosing. Subjects were then instructed to performed fingersticks using dried blood spot cards at 8 and 12 hours post dose.', 'description': 'Report the geometric mean and 95% confidence interval for AUC 0-12hr (ng\\*hr/ml) for each formulation in expressor and non expressor transplant recipients'}, {'measure': 'Compare Cmax of Each Tacrolimus Formulation in Expressor and Non Expressor Transplant Recipients', 'timeFrame': 'Whole blood samples were collected immediately prior to dosing, at 1, 1.5, 1.75, 2, 2.5, 3 and 4 hours following dosing. Subjects were then instructed to performed fingersticks using dried blood spot cards at 8 and 12 hours post dose.', 'description': 'Report the geometric mean and 95% confidence interval for Cmax (ng/ml) for each formulation in expressor and non expressor transplant recipients'}], 'secondaryOutcomes': [{'measure': 'To Compare the Safety and Efficacy of Each Tacrolimus Formulation in Stable Transplant Subjects', 'timeFrame': 'Assessed at baseline and weekly for 6 weeks at each pharmacokinetic profile', 'description': 'Conduct safety lab testing specific to transplanted organ function and clinical assessments for adverse events.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bioequivalence', 'tacrolimus', 'transplant', 'CYP3A5 expressors/non expressors'], 'conditions': ['Complication of Transplant']}, 'descriptionModule': {'briefSummary': 'The prospective study will compare the relative bioavailability at steady-state pharmacokinetics of 6 tacrolimus formulations in a prospective, 6-way cross-over study including CYP3A5 expressors (n=30) and non-expressor (n=30) transplant patients.', 'detailedDescription': 'Comparison of the relative bioavailability and steady-state pharmacokinetics of 6 tacrolimus formulations in a prospective, 6-way cross-over study including CYP3A5 expressors (n=30) and non-expressor (n=30) transplant patients. Six tacrolimus formulations will be tested and each patient will receive each formulation once. As we proposed to test bioequivalence in the steady-state, patients will receive the test formulations for one week prior to pharmacokinetic evaluation. The pharmacokinetic evaluation will incorporate limited sampling strategies with a focus on fully characterizing the Cmax out to hour 4 post dose. Subsequent PK sampling and trough blood concentrations will be monitored on a daily basis using dried blood spots that the study subjects will collect by themselves at home. It will be critical that the patients are adherent to their test medication to ensure that they have reached steady state. This will be monitored using test diaries, pill counts and MEMS caps (Medication Event Monitoring System (MEMS), AARDEX Corp, Palo Alto, CA. Bioequivalence will be tested using average bioequivalence metrics. A combination of limited sampling strategy and dry spot analysis in combination with population pharmacokinetic modeling will be utilized to fully characterize the PK profile of these formulations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria\n\n1. 18 years or older\n2. Able to participate and willing to give written informed consent/ assent/ consent by parent or legal guardian and to comply with the study visits and restrictions.\n3. Subject who has received a primary or secondary transplant.\n4. Subject who is at least 6 months post-transplant and on a stable dose of tacrolimus as defined by physician, one tacrolimus trough level within the physician defined target range within past 6 months and one additional trough level during the screening period within 30% of the physician defined target range.\n5. BMI less than or equal to 40.\n\nExclusion criteria\n\n1. Evidence of any acute rejection\n2. Subjects who require dialysis within 6 months prior to study entry\n3. Recipients of multiple organ transplants\n4. Subjects who have tested positive for HBsAG or HIV, or who are recipients of organ from donors who are known to be HBsAG or HIV positive. Virology screening at the time of transplant.\n5. HepC positive subjects with liver biopsy proven recurrent disease considered relevant by physician oversight.\n6. Subjects with any severe medical condition requiring acute or chronic treatment that in the investigator's opinion would interfere with study participation\n7. History of malignancy, treated or untreated, with the past 2 years with the exception of carcinoma in situ or excised basal cell carcinoma, or hepatocellular carcinoma prior to transplant.\n8. GFR ≤ 35 ml/min measured as estimated using the MDRD4 formula\n9. Subjects with AST, ALT, total bilirubin ≥ 3 X ULN or other evidence of severe liver disease\n10. Subjects with white blood cell (WBC) count ≤2,000/ mm3 or with thrombocytopenia (platelet count ≤ 75,000/ mm3), with an absolute neutrophil count of ≤ 1,500/ mm3 or hemoglobin \\<8g/dL)\n11. Subjects with clinically significant infections, requiring therapy, which, in the investigator's opinion, would interfere with the objectives of the study\n12. Other mental or physical conditions which in the investigator's opinion, are considered clinically significant\n13. Presence of intractable immunosuppressant complications or side effects resulting in dose adjustment of tacrolimus\n14. Subjects who have been exposed to an investigational therapy within 30 days prior to enrollment or 5 half-lives of the investigational product, whichever is greater.\n15. An anticipated change in the immunosuppressive regimen during subject participation other than that required by the protocol\n16. Subject with severe GI disturbance or diarrhea which could interfere with tacrolimus absorption\n17. Severe diabetic gastroparesis\n18. Initiation of any medications that could interfere with tacrolimus blood levels, including OTC medications, herbal supplements, grapefruit or grapefruit juice.\n19. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive BhCG laboratory test (\\> 5 mIU/mL)\n20. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are: 1) women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner; 2)women whose partners have been sterilized by vasectomy or 3)using a highly effective method of birth control (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices (IUDs); periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) is not acceptable."}, 'identificationModule': {'nctId': 'NCT02014103', 'briefTitle': 'Conversion From Brand to Generic Tacrolimus in High Risk Transplant Recipients', 'organization': {'class': 'OTHER', 'fullName': 'University of Cincinnati'}, 'officialTitle': 'Evaluation of Clinical and Safety Outcomes Associated With Conversion From Brand-Name to Generic Tacrolimus Products in High Risk Transplant Recipients', 'orgStudyIdInfo': {'id': '13-223-SOL-00102'}, 'secondaryIdInfos': [{'id': 'FDA', 'type': 'OTHER_GRANT', 'domain': 'HHSF223201310224C'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sequence 1', 'description': "Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 1: Formulation Sandoz, Panacea, Accord, Mylan, Dr. Reddy's, Astellas\n\nPatients will be receiving the same tacrolimus dose identified at baseline for each formulation.", 'interventionNames': ['Drug: Prograf', 'Drug: Tacrolimus, Sandoz', 'Drug: Tacrolimus, Reddy Laboratory', 'Drug: Tacrolimus, Mylan', 'Drug: Tacrolimus, Accord', 'Drug: Tacrolimus, Pancea Biotech Limited']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sequence 2', 'description': "Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 2: Formulation Accord, Sandoz, Dr. Reddy's, Panacea, Astellas, Mylan\n\nPatients will be receiving the same tacrolimus dose identified at baseline for each formulation.", 'interventionNames': ['Drug: Prograf', 'Drug: Tacrolimus, Sandoz', 'Drug: Tacrolimus, Reddy Laboratory', 'Drug: Tacrolimus, Mylan', 'Drug: Tacrolimus, Accord', 'Drug: Tacrolimus, Pancea Biotech Limited']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sequence 3', 'description': 'Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 3: Formulation Dr. Reddys, Accord, Astellas, Sandoz, Mylan, Panacea\n\nPatients will be receiving the same tacrolimus dose identified at baseline for each formulation.', 'interventionNames': ['Drug: Prograf', 'Drug: Tacrolimus, Sandoz', 'Drug: Tacrolimus, Reddy Laboratory', 'Drug: Tacrolimus, Mylan', 'Drug: Tacrolimus, Accord', 'Drug: Tacrolimus, Pancea Biotech Limited']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sequence 4', 'description': "Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 4: Formulation Astellas, Dr. Reddy's, Mylan, Accord, Panacea, Sandoz\n\nPatients will be receiving the same tacrolimus dose identified at baseline for each formulation.", 'interventionNames': ['Drug: Prograf', 'Drug: Tacrolimus, Sandoz', 'Drug: Tacrolimus, Reddy Laboratory', 'Drug: Tacrolimus, Mylan', 'Drug: Tacrolimus, Accord', 'Drug: Tacrolimus, Pancea Biotech Limited']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sequence 5', 'description': "Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 5: Formulation Mylan, Astellas, Panacea, Dr. Reddy's, Sandoz, Accord\n\nPatients will be receiving the same tacrolimus dose identified at baseline for each formulation.", 'interventionNames': ['Drug: Prograf', 'Drug: Tacrolimus, Sandoz', 'Drug: Tacrolimus, Reddy Laboratory', 'Drug: Tacrolimus, Mylan', 'Drug: Tacrolimus, Accord', 'Drug: Tacrolimus, Pancea Biotech Limited']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sequence 6', 'description': "Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 6: Formulation Panacea, Mylan, Sandoz, Astellas, Accord, Dr. Reddy's\n\nPatients will be receiving the same tacrolimus dose identified at baseline for each formulation.", 'interventionNames': ['Drug: Prograf', 'Drug: Tacrolimus, Sandoz', 'Drug: Tacrolimus, Reddy Laboratory', 'Drug: Tacrolimus, Mylan', 'Drug: Tacrolimus, Accord', 'Drug: Tacrolimus, Pancea Biotech Limited']}], 'interventions': [{'name': 'Prograf', 'type': 'DRUG', 'description': 'Administration of each formulation will be determined by sequence.', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3', 'Sequence 4', 'Sequence 5', 'Sequence 6']}, {'name': 'Tacrolimus, Sandoz', 'type': 'DRUG', 'otherNames': ['Sandoz tacrolimus'], 'description': 'Administration of each formulation will be determined by sequence.', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3', 'Sequence 4', 'Sequence 5', 'Sequence 6']}, {'name': 'Tacrolimus, Reddy Laboratory', 'type': 'DRUG', 'otherNames': ["Reddy's Laboratory tacrolimus"], 'description': 'Administration of each formulation will be determined by sequence.', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3', 'Sequence 4', 'Sequence 5', 'Sequence 6']}, {'name': 'Tacrolimus, Mylan', 'type': 'DRUG', 'otherNames': ['Mylan tacrolimus'], 'description': 'Administration of each formulation will be determined by sequence.', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3', 'Sequence 4', 'Sequence 5', 'Sequence 6']}, {'name': 'Tacrolimus, Accord', 'type': 'DRUG', 'otherNames': ['Accord Healthcare tacrolimus'], 'description': 'Administration of each formulation will be determined by sequence.', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3', 'Sequence 4', 'Sequence 5', 'Sequence 6']}, {'name': 'Tacrolimus, Pancea Biotech Limited', 'type': 'DRUG', 'otherNames': ['Panacea Biotech Limited tacrolimus'], 'description': 'Administration of each formulation will be determined by sequence.', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3', 'Sequence 4', 'Sequence 5', 'Sequence 6']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati Medical Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Rita R Alloway, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cincinnati'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cincinnati', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Colorado, Denver', 'class': 'OTHER'}, {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Professor', 'investigatorFullName': 'Rita Alloway', 'investigatorAffiliation': 'University of Cincinnati'}}}}