Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-31 @ 8:03 PM
Study NCT ID:
NCT01106833
Status:
COMPLETED
Last Update Posted:
2018-12-05
First Post:
2010-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Chronic Graft-versus-Host Disease Treatment (BMT CTN 0801)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], 'ancestors': [{'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020123', 'term': 'Sirolimus'}, {'id': 'D065095', 'term': 'Calcineurin Inhibitors'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D016559', 'term': 'Tacrolimus'}, {'id': 'D003524', 'term': 'Cyclosporins'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'amendizabal@emmes.com', 'phone': '301-251-1161', 'title': 'Adam Mendizabal, PhD', 'organization': 'The Emmes Corporation'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Three years post-randomization', 'eventGroups': [{'id': 'EG000', 'title': 'Sirolimus, Calcineurin Inhibitor, and Prednisone', 'description': 'Sirolimus + calcineurin inhibitor + prednisone\n\nSirolimus + calcineurin inhibitor + prednisone: The target serum level for sirolimus is 3-12 ng/mL.\n\nThe target serum level for tacrolimus is 5-10 ng/mL. The target serum level for cyclosporine is 120-200 ng/mL.\n\nPrednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day.', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 0, 'seriousNumAtRisk': 66, 'deathsNumAffected': 16, 'seriousNumAffected': 13}, {'id': 'EG001', 'title': 'Sirolimus and Prednisone', 'description': 'Sirolimus + prednisone\n\nSirolimus + prednisone: The target serum level for sirolimus is 3-12 ng/mL.\n\nPrednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day.', 'otherNumAtRisk': 72, 'deathsNumAtRisk': 72, 'otherNumAffected': 0, 'seriousNumAtRisk': 72, 'deathsNumAffected': 13, 'seriousNumAffected': 12}], 'seriousEvents': [{'term': 'Thrombotic thrombocytopenic purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Splenectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Participants With Treatment Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus, Calcineurin Inhibitor, and Prednisone', 'description': 'Sirolimus + calcineurin inhibitor + prednisone\n\nSirolimus + calcineurin inhibitor + prednisone: The target serum level for sirolimus is 3-12 ng/mL.\n\nThe target serum level for tacrolimus is 5-10 ng/mL. The target serum level for cyclosporine is 120-200 ng/mL.\n\nPrednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day.'}, {'id': 'OG001', 'title': 'Sirolimus and Prednisone', 'description': 'Sirolimus + prednisone\n\nSirolimus + prednisone: The target serum level for sirolimus is 3-12 ng/mL.\n\nPrednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day.'}], 'classes': [{'title': 'Phase II: 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'Phase III: 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.63', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided testing was performed using a significance level of 0.05', 'groupDescription': 'The null hypothesis is that the proportion of participants with treatment success at 6 months is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.44', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided testing was performed using a significance level of 0.05', 'groupDescription': 'The null hypothesis is that the proportion of participants with treatment success at 24 months is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months and 24 months post-randomization', 'description': 'Treatment success was evaluated at 6 months in Phase II and is defined as a complete or partial response without secondary systemic immunosuppressive therapy and no recurrent malignancy or death. In Phase III, treatment success was evaluated at 24 months and is defined as a complete response without secondary systemic immunosuppressive therapy and no recurrent malignancy or death.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Twelve participants withdrew study consent between 6 and 24 months post-randomization, so are excluded from the analysis of treatment success at 24 months.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus, Calcineurin Inhibitor, and Prednisone', 'description': 'Sirolimus + calcineurin inhibitor + prednisone\n\nSirolimus + calcineurin inhibitor + prednisone: The target serum level for sirolimus is 3-12 ng/mL.\n\nThe target serum level for tacrolimus is 5-10 ng/mL. The target serum level for cyclosporine is 120-200 ng/mL.\n\nPrednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day.'}, {'id': 'OG001', 'title': 'Sirolimus and Prednisone', 'description': 'Sirolimus + prednisone\n\nSirolimus + prednisone: The target serum level for sirolimus is 3-12 ng/mL.\n\nPrednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day.'}], 'classes': [{'title': '6 Months', 'categories': [{'measurements': [{'value': '85.5', 'groupId': 'OG000', 'lowerLimit': '74.0', 'upperLimit': '92.2'}, {'value': '91.7', 'groupId': 'OG001', 'lowerLimit': '82.4', 'upperLimit': '96.2'}]}]}, {'title': '24 Months', 'categories': [{'measurements': [{'value': '74.0', 'groupId': 'OG000', 'lowerLimit': '61.1', 'upperLimit': '83.2'}, {'value': '81.5', 'groupId': 'OG001', 'lowerLimit': '70.3', 'upperLimit': '88.8'}]}]}], 'analyses': [{'pValue': '0.205', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided testing was performed using a significance level of 0.05', 'groupDescription': 'The null hypothesis is that the rate of overall survival during the first two years post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '6 months and 24 months post-randomization', 'description': 'Overall survival is defined as survival of death from any cause.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Progression-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus, Calcineurin Inhibitor, and Prednisone', 'description': 'Sirolimus + calcineurin inhibitor + prednisone\n\nSirolimus + calcineurin inhibitor + prednisone: The target serum level for sirolimus is 3-12 ng/mL.\n\nThe target serum level for tacrolimus is 5-10 ng/mL. The target serum level for cyclosporine is 120-200 ng/mL.\n\nPrednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day.'}, {'id': 'OG001', 'title': 'Sirolimus and Prednisone', 'description': 'Sirolimus + prednisone\n\nSirolimus + prednisone: The target serum level for sirolimus is 3-12 ng/mL.\n\nPrednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day.'}], 'classes': [{'title': '6 Months', 'categories': [{'measurements': [{'value': '84.0', 'groupId': 'OG000', 'lowerLimit': '72.2', 'upperLimit': '91.0'}, {'value': '90.3', 'groupId': 'OG001', 'lowerLimit': '80.7', 'upperLimit': '95.2'}]}]}, {'title': '24 Months', 'categories': [{'measurements': [{'value': '67.3', 'groupId': 'OG000', 'lowerLimit': '53.9', 'upperLimit': '77.5'}, {'value': '78.6', 'groupId': 'OG001', 'lowerLimit': '67.1', 'upperLimit': '86.5'}]}]}], 'analyses': [{'pValue': '0.141', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided testing was performed using a significance level of 0.05', 'groupDescription': 'The null hypothesis is that the rate of progression-free survival during the first two years post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '6 months and 24 months post-randomization', 'description': 'Progression-free Survival is defined as survival without malignancy relapse. Relapse and death are considered failures for this endpoint.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Failure-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus, Calcineurin Inhibitor, and Prednisone', 'description': 'Sirolimus + calcineurin inhibitor + prednisone\n\nSirolimus + calcineurin inhibitor + prednisone: The target serum level for sirolimus is 3-12 ng/mL.\n\nThe target serum level for tacrolimus is 5-10 ng/mL. The target serum level for cyclosporine is 120-200 ng/mL.\n\nPrednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day.'}, {'id': 'OG001', 'title': 'Sirolimus and Prednisone', 'description': 'Sirolimus + prednisone\n\nSirolimus + prednisone: The target serum level for sirolimus is 3-12 ng/mL.\n\nPrednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day.'}], 'classes': [{'title': '6 Months', 'categories': [{'measurements': [{'value': '74.7', 'groupId': 'OG000', 'lowerLimit': '62.3', 'upperLimit': '81.4'}, {'value': '73.6', 'groupId': 'OG001', 'lowerLimit': '61.5', 'upperLimit': '79.9'}]}]}, {'title': '24 Months', 'categories': [{'measurements': [{'value': '46.2', 'groupId': 'OG000', 'lowerLimit': '33.4', 'upperLimit': '58.1'}, {'value': '48.6', 'groupId': 'OG001', 'lowerLimit': '36.5', 'upperLimit': '59.7'}]}]}], 'analyses': [{'pValue': '0.775', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided testing was performed using a significance level of 0.05', 'groupDescription': 'The null hypothesis is that the rate of failure-free survival during the first two years post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '6 months and 24 months post-randomization', 'description': 'Failure-free Survival is defined as survival without malignancy progression or initiation of secondary therapy for chronic GVHD. Progression, initiation of secondary therapy for chronic GVHD, and death are considered failures for this endpoint.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus, Calcineurin Inhibitor, and Prednisone', 'description': 'Sirolimus + calcineurin inhibitor + prednisone\n\nSirolimus + calcineurin inhibitor + prednisone: The target serum level for sirolimus is 3-12 ng/mL.\n\nThe target serum level for tacrolimus is 5-10 ng/mL. The target serum level for cyclosporine is 120-200 ng/mL.\n\nPrednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day.'}, {'id': 'OG001', 'title': 'Sirolimus and Prednisone', 'description': 'Sirolimus + prednisone\n\nSirolimus + prednisone: The target serum level for sirolimus is 3-12 ng/mL.\n\nPrednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day.'}], 'classes': [{'title': '6 Months', 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '12.2'}, {'value': '1.4', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '6.7'}]}]}, {'title': '24 Months', 'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000', 'lowerLimit': '7.2', 'upperLimit': '25.1'}, {'value': '10.1', 'groupId': 'OG001', 'lowerLimit': '4.4', 'upperLimit': '18.6'}]}]}], 'analyses': [{'pValue': '0.396', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided testing was performed using a significance level of 0.05', 'groupDescription': 'The null hypothesis is that the rate of relapse during the first two years post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.', 'statisticalMethod': "Gray's test", 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Death without relapse was treated as a competing risk'}], 'paramType': 'NUMBER', 'timeFrame': '6 months and 24 months post-randomization', 'description': 'Relapse is defined as recurrence of the primary malignancy. Death is considered a competing risk for this endpoint.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Secondary Immunosuppressive Therapy Initiated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus, Calcineurin Inhibitor, and Prednisone', 'description': 'Sirolimus + calcineurin inhibitor + prednisone\n\nSirolimus + calcineurin inhibitor + prednisone: The target serum level for sirolimus is 3-12 ng/mL.\n\nThe target serum level for tacrolimus is 5-10 ng/mL. The target serum level for cyclosporine is 120-200 ng/mL.\n\nPrednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day.'}, {'id': 'OG001', 'title': 'Sirolimus and Prednisone', 'description': 'Sirolimus + prednisone\n\nSirolimus + prednisone: The target serum level for sirolimus is 3-12 ng/mL.\n\nPrednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day.'}], 'classes': [{'title': '6 Months', 'categories': [{'measurements': [{'value': '12.9', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '22.5'}, {'value': '13.9', 'groupId': 'OG001', 'lowerLimit': '7.1', 'upperLimit': '23.0'}]}]}, {'title': '24 months', 'categories': [{'measurements': [{'value': '29.4', 'groupId': 'OG000', 'lowerLimit': '18.5', 'upperLimit': '41.2'}, {'value': '38.5', 'groupId': 'OG001', 'lowerLimit': '27.1', 'upperLimit': '49.8'}]}]}], 'analyses': [{'pValue': '0.219', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided testing was performed using a significance level of 0.05', 'groupDescription': 'The null hypothesis is that the rate of initiation of secondary immunosuppressive therapy for chronic GVHD during the first two years post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.', 'statisticalMethod': "Gray's test", 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Death without initiation of secondary therapy is considered a competing risk for this endpoint'}], 'paramType': 'NUMBER', 'timeFrame': '6 months and 24 months post-randomization', 'description': 'The percentage of participants initiating secondary immunosuppressive therapy for chronic GVHD is described. Death is considered a competing risk for this endpoint.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Discontinuation of Systemic Immunosuppressive Therapy at Two Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus, Calcineurin Inhibitor, and Prednisone', 'description': 'Sirolimus + calcineurin inhibitor + prednisone\n\nSirolimus + calcineurin inhibitor + prednisone: The target serum level for sirolimus is 3-12 ng/mL.\n\nThe target serum level for tacrolimus is 5-10 ng/mL. The target serum level for cyclosporine is 120-200 ng/mL.\n\nPrednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day.'}, {'id': 'OG001', 'title': 'Sirolimus and Prednisone', 'description': 'Sirolimus + prednisone\n\nSirolimus + prednisone: The target serum level for sirolimus is 3-12 ng/mL.\n\nPrednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '10.9', 'upperLimit': '31.0'}, {'value': '23.2', 'groupId': 'OG001', 'lowerLimit': '14.0', 'upperLimit': '33.8'}]}]}], 'analyses': [{'pValue': '0.706', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided testing was performed using a significance level of 0.05', 'groupDescription': 'The null hypothesis is that the rate of discontinuation of systemic immunosuppressive therapy during the first two years post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.', 'statisticalMethod': "Gray's test", 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Death without discontinuation of systemic immunosuppressive therapy is considered a competing risk for this endpoint'}], 'paramType': 'NUMBER', 'timeFrame': '2 years post-randomization', 'description': 'The percentage of participants discontinuing all systemic immunosuppressive therapy by two years post-randomization is described. Death is considered a competing risk for this endpoint.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Prednisone Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus, Calcineurin Inhibitor, and Prednisone', 'description': 'Sirolimus + calcineurin inhibitor + prednisone\n\nSirolimus + calcineurin inhibitor + prednisone: The target serum level for sirolimus is 3-12 ng/mL.\n\nThe target serum level for tacrolimus is 5-10 ng/mL. The target serum level for cyclosporine is 120-200 ng/mL.\n\nPrednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day.'}, {'id': 'OG001', 'title': 'Sirolimus and Prednisone', 'description': 'Sirolimus + prednisone\n\nSirolimus + prednisone: The target serum level for sirolimus is 3-12 ng/mL.\n\nPrednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '1.2'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '2.1'}]}]}, {'title': '6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.8'}]}]}, {'title': '1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.8'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.9'}]}]}], 'analyses': [{'pValue': '0.127', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided testing was performed using a significance level of 0.05', 'groupDescription': 'The null hypothesis is that the median prednisone dose at baseline is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.562', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided testing was performed using a significance level of 0.05', 'groupDescription': 'The null hypothesis is that the median prednisone dose at 6 months post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.129', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided testing was performed using a significance level of 0.05', 'groupDescription': 'The null hypothesis is that the median prednisone dose at 1 year post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 6 months, and 1 year post-randomization', 'description': 'Daily dose of prednisone is described by treatment arm at baseline, 6 months, and 1 year post-randomization.', 'unitOfMeasure': 'mg/kg/day', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcomes are analyzed in participants that were alive and completed assessments.'}, {'type': 'SECONDARY', 'title': 'Change in Prednisone Dose From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus, Calcineurin Inhibitor, and Prednisone', 'description': 'Sirolimus + calcineurin inhibitor + prednisone\n\nSirolimus + calcineurin inhibitor + prednisone: The target serum level for sirolimus is 3-12 ng/mL.\n\nThe target serum level for tacrolimus is 5-10 ng/mL. The target serum level for cyclosporine is 120-200 ng/mL.\n\nPrednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day.'}, {'id': 'OG001', 'title': 'Sirolimus and Prednisone', 'description': 'Sirolimus + prednisone\n\nSirolimus + prednisone: The target serum level for sirolimus is 3-12 ng/mL.\n\nPrednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day.'}], 'classes': [{'title': '6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'groupId': 'OG000', 'lowerLimit': '-1.1', 'upperLimit': '0.3'}, {'value': '-0.6', 'groupId': 'OG001', 'lowerLimit': '-1.7', 'upperLimit': '0.2'}]}]}, {'title': '1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '0.8'}, {'value': '-0.7', 'groupId': 'OG001', 'lowerLimit': '-1.9', 'upperLimit': '-0.1'}]}]}], 'analyses': [{'pValue': '0.586', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided testing was performed using a significance level of 0.05', 'groupDescription': 'The null hypothesis is that the median change in prednisone dose from baseline to 6 months post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.140', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided testing was performed using a significance level of 0.05', 'groupDescription': 'The null hypothesis is that the median change in prednisone dose from baseline to 1 year post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '6 months and 1 year post-randomization', 'description': 'Change in the daily dose of prednisone from baseline, the time of randomization, is described by treatment arm at 6 months and 1 year post-randomization.', 'unitOfMeasure': 'mg/kg/day', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcomes are analyzed in participants that were alive and completed assessments.'}, {'type': 'SECONDARY', 'title': 'Serum Creatinine Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus, Calcineurin Inhibitor, and Prednisone', 'description': 'Sirolimus + calcineurin inhibitor + prednisone\n\nSirolimus + calcineurin inhibitor + prednisone: The target serum level for sirolimus is 3-12 ng/mL.\n\nThe target serum level for tacrolimus is 5-10 ng/mL. The target serum level for cyclosporine is 120-200 ng/mL.\n\nPrednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day.'}, {'id': 'OG001', 'title': 'Sirolimus and Prednisone', 'description': 'Sirolimus + prednisone\n\nSirolimus + prednisone: The target serum level for sirolimus is 3-12 ng/mL.\n\nPrednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '1.8'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '1.6'}]}]}, {'title': '6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '2.6'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '1.6'}]}]}, {'title': '1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '2.4'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '1.7'}]}]}], 'analyses': [{'pValue': '0.582', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided testing was performed using a significance level of 0.05', 'groupDescription': 'The null hypothesis is that the median serum creatinine level at baseline is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.208', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided testing was performed using a significance level of 0.05', 'groupDescription': 'The null hypothesis is that the median serum creatinine level at 6 months post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.431', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided testing was performed using a significance level of 0.05', 'groupDescription': 'The null hypothesis is that the median serum creatinine level at 1 year post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 6 months, and 1 year post-randomization', 'description': 'Creatinine level is described by treatment arm at baseline, 6 months, and 1 year post-randomization.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcomes are analyzed in participants that were alive and completed assessments.'}, {'type': 'SECONDARY', 'title': 'Change in Serum Creatinine Level From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus, Calcineurin Inhibitor, and Prednisone', 'description': 'Sirolimus + calcineurin inhibitor + prednisone\n\nSirolimus + calcineurin inhibitor + prednisone: The target serum level for sirolimus is 3-12 ng/mL.\n\nThe target serum level for tacrolimus is 5-10 ng/mL. The target serum level for cyclosporine is 120-200 ng/mL.\n\nPrednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day.'}, {'id': 'OG001', 'title': 'Sirolimus and Prednisone', 'description': 'Sirolimus + prednisone\n\nSirolimus + prednisone: The target serum level for sirolimus is 3-12 ng/mL.\n\nPrednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day.'}], 'classes': [{'title': '6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '-0.8', 'upperLimit': '1.8'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-0.6', 'upperLimit': '1.1'}]}]}, {'title': '1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-0.5', 'upperLimit': '1.2'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-0.5', 'upperLimit': '0.6'}]}]}], 'analyses': [{'pValue': '0.147', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided testing was performed using a significance level of 0.05', 'groupDescription': 'The null hypothesis is that the median change in serum creatinine level from baseline to 6 months post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.863', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided testing was performed using a significance level of 0.05', 'groupDescription': 'The null hypothesis is that the median change in serum creatinine level from baseline to 1 year post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '6 months and 1 year post-randomization', 'description': 'Change in creatinine level from baseline, the time of randomization, is described by treatment arm at 6 months and 1 year post-randomization.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcomes are analyzed in participants that were alive and completed assessments.'}, {'type': 'SECONDARY', 'title': 'Patient-reported Chronic GVHD Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus, Calcineurin Inhibitor, and Prednisone', 'description': 'Sirolimus + calcineurin inhibitor + prednisone\n\nSirolimus + calcineurin inhibitor + prednisone: The target serum level for sirolimus is 3-12 ng/mL.\n\nThe target serum level for tacrolimus is 5-10 ng/mL. The target serum level for cyclosporine is 120-200 ng/mL.\n\nPrednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day.'}, {'id': 'OG001', 'title': 'Sirolimus and Prednisone', 'description': 'Sirolimus + prednisone\n\nSirolimus + prednisone: The target serum level for sirolimus is 3-12 ng/mL.\n\nPrednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'title': 'None', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Relapsed', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Initiated Secondary Therapy', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Dead', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'title': 'None', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Relapsed', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Initiated Secondary Therapy', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}, {'title': 'Dead', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'title': 'None', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Relapsed', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Initiated Secondary Therapy', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'title': 'Dead', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'title': 'None', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Relapsed', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Initiated Secondary Therapy', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}, {'title': 'Dead', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.620', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided testing was performed using a significance level of 0.05', 'groupDescription': 'The null hypothesis is that the proportions of patients in the patient-reported severity and vital status categories considered at baseline are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.258', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided testing was performed using a significance level of 0.05', 'groupDescription': 'The null hypothesis is that the proportions of patients in the patient-reported severity and vital status categories considered at 6 months post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.036', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided testing was performed using a significance level of 0.05', 'groupDescription': 'The null hypothesis is that the proportions of patients in the patient-reported severity and vital status categories considered at 1 year post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.369', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided testing was performed using a significance level of 0.05', 'groupDescription': 'The null hypothesis is that the proportions of patients in the patient-reported severity and vital status categories considered at 2 years post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, 6 months, 1 year, and 2 years post-randomization', 'description': "Each patient's perception of the severity of the chronic GVHD was collected at baseline and at 6 months, 1 year, and 2 years post-randomization. Severity is categorized as none, mild, moderate, and severe.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcomes are analyzed in participants that were alive and completed assessments.'}, {'type': 'SECONDARY', 'title': 'Provider-reported Chronic GVHD Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus, Calcineurin Inhibitor, and Prednisone', 'description': 'Sirolimus + calcineurin inhibitor + prednisone\n\nSirolimus + calcineurin inhibitor + prednisone: The target serum level for sirolimus is 3-12 ng/mL.\n\nThe target serum level for tacrolimus is 5-10 ng/mL. The target serum level for cyclosporine is 120-200 ng/mL.\n\nPrednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day.'}, {'id': 'OG001', 'title': 'Sirolimus and Prednisone', 'description': 'Sirolimus + prednisone\n\nSirolimus + prednisone: The target serum level for sirolimus is 3-12 ng/mL.\n\nPrednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'title': 'None', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Relapsed', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Initiated Secondary Therapy', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Dead', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'title': 'None', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Relapsed', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Initiated Secondary Therapy', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}, {'title': 'Dead', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'title': 'None', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Relapsed', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Initiated Secondary Therapy', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'title': 'Dead', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'title': 'None', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Relapsed', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Initiated Secondary Therapy', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}, {'title': 'Dead', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.450', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided testing was performed using a significance level of 0.05', 'groupDescription': 'The null hypothesis is that the proportions of patients in the provider-reported severity and vital status categories considered at baseline are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.301', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided testing was performed using a significance level of 0.05', 'groupDescription': 'The null hypothesis is that the proportions of patients in the provider-reported severity and vital status categories considered at 6 months post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.750', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided testing was performed using a significance level of 0.05', 'groupDescription': 'The null hypothesis is that the proportions of patients in the provider-reported severity and vital status categories considered at 1 year post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.444', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided testing was performed using a significance level of 0.05', 'groupDescription': 'The null hypothesis is that the proportions of patients in the provider-reported severity and vital status categories considered at 2 years post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, 6 months, 1 year, and 2 years post-randomization', 'description': "Each patient's care provider's perception of the severity of the chronic GVHD was collected at baseline and at 6 months, 1 year, and 2 years post-randomization. Severity is categorized as none, mild, moderate, and severe.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcomes are analyzed in participants that were alive and whose providers completed assessments.'}, {'type': 'SECONDARY', 'title': 'NIH Consensus Criteria Chronic GVHD Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus, Calcineurin Inhibitor, and Prednisone', 'description': 'Sirolimus + calcineurin inhibitor + prednisone\n\nSirolimus + calcineurin inhibitor + prednisone: The target serum level for sirolimus is 3-12 ng/mL.\n\nThe target serum level for tacrolimus is 5-10 ng/mL. The target serum level for cyclosporine is 120-200 ng/mL.\n\nPrednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day.'}, {'id': 'OG001', 'title': 'Sirolimus and Prednisone', 'description': 'Sirolimus + prednisone\n\nSirolimus + prednisone: The target serum level for sirolimus is 3-12 ng/mL.\n\nPrednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'title': 'None', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}, {'title': 'Relapsed', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Initiated Secondary Therapy', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Dead', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'title': 'None', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}, {'title': 'Relapsed', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Initiated Secondary Therapy', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}, {'title': 'Dead', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'title': 'None', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Relapsed', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Initiated Secondary Therapy', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'title': 'Dead', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'title': 'None', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Relapsed', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Initiated Secondary Therapy', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}, {'title': 'Dead', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.238', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided testing was performed using a significance level of 0.05', 'groupDescription': 'The null hypothesis is that the proportions of patients in the NIH Consensus Criteria severity and vital status categories considered at baseline are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.546', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided testing was performed using a significance level of 0.05', 'groupDescription': 'The null hypothesis is that the proportions of patients in the NIH Consensus Criteria severity and vital status categories considered at 6 months post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.756', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided testing was performed using a significance level of 0.05', 'groupDescription': 'The null hypothesis is that the proportions of patients in the NIH Consensus Criteria severity and vital status categories considered at 1 year post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.554', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided testing was performed using a significance level of 0.05', 'groupDescription': 'The null hypothesis is that the proportions of patients in the NIH Consensus Criteria severity and vital status categories considered at 2 years post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, 6 months, 1 year, and 2 years post-randomization', 'description': 'Chronic GVHD severity was determined at baseline and at 6 months, 1 year, and 2 years post-randomization per the 2005 NIH Consensus Criteria (Filipovich et al. 2005). Severity is categorized as none, mild, moderate, and severe.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcomes are analyzed in participants that were alive and whose clinical assessments were completed.'}, {'type': 'SECONDARY', 'title': 'SF-36 Physical Component Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus, Calcineurin Inhibitor, and Prednisone', 'description': 'Sirolimus + calcineurin inhibitor + prednisone\n\nSirolimus + calcineurin inhibitor + prednisone: The target serum level for sirolimus is 3-12 ng/mL.\n\nThe target serum level for tacrolimus is 5-10 ng/mL. The target serum level for cyclosporine is 120-200 ng/mL.\n\nPrednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day.'}, {'id': 'OG001', 'title': 'Sirolimus and Prednisone', 'description': 'Sirolimus + prednisone\n\nSirolimus + prednisone: The target serum level for sirolimus is 3-12 ng/mL.\n\nPrednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '38', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': '2 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '42', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': '6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '43', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': '1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '43', 'spread': '1.7', 'groupId': 'OG001'}]}]}, {'title': '2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '43', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.685', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided testing was performed using a significance level of 0.05', 'groupDescription': 'The null hypothesis is that the mean PCS scores at baseline are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Independent samples t-test'}, {'pValue': '0.105', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided testing was performed using a significance level of 0.05', 'groupDescription': 'The null hypothesis is that the mean PCS scores at 2 months are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Independent samples t-test'}, {'pValue': '0.039', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided testing was performed using a significance level of 0.05', 'groupDescription': 'The null hypothesis is that the mean PCS scores at 6 months are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Independent samples t-test'}, {'pValue': '0.278', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided testing was performed using a significance level of 0.05', 'groupDescription': 'The null hypothesis is that the mean PCS scores at 1 year are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Independent samples t-test'}, {'pValue': '0.804', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided testing was performed using a significance level of 0.05', 'groupDescription': 'The null hypothesis is that the mean PCS scores at 2 years are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Independent samples t-test'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2 months, 6 months, 1 year, and 2 years post-randomization', 'description': 'The Medical Outcome Study SF-36 Physical Component Summary (PCS) is a subscale of the SF-36 intended to measure physical well-being. It is scored on a scale of 0-100, with higher scores indicating higher levels of well-being.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcomes are analyzed in participants that were alive and completed assessments.'}, {'type': 'SECONDARY', 'title': 'SF-36 Mental Component Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus, Calcineurin Inhibitor, and Prednisone', 'description': 'Sirolimus + calcineurin inhibitor + prednisone\n\nSirolimus + calcineurin inhibitor + prednisone: The target serum level for sirolimus is 3-12 ng/mL.\n\nThe target serum level for tacrolimus is 5-10 ng/mL. The target serum level for cyclosporine is 120-200 ng/mL.\n\nPrednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day.'}, {'id': 'OG001', 'title': 'Sirolimus and Prednisone', 'description': 'Sirolimus + prednisone\n\nSirolimus + prednisone: The target serum level for sirolimus is 3-12 ng/mL.\n\nPrednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '48', 'spread': '1.4', 'groupId': 'OG001'}]}]}, {'title': '2 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '50', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': '6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '48', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': '1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '46', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': '2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '50', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.631', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided testing was performed using a significance level of 0.05', 'groupDescription': 'The null hypothesis is that the mean MCS scores at baseline are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Independent samples t-test'}, {'pValue': '0.759', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided testing was performed using a significance level of 0.05', 'groupDescription': 'The null hypothesis is that the mean MCS scores at 2 months are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Independent samples t-test'}, {'pValue': '0.391', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided testing was performed using a significance level of 0.05', 'groupDescription': 'The null hypothesis is that the mean MCS scores at 6 months are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Independent samples t-test'}, {'pValue': '0.222', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided testing was performed using a significance level of 0.05', 'groupDescription': 'The null hypothesis is that the mean MCS scores at 1 year are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Independent samples t-test'}, {'pValue': '0.527', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided testing was performed using a significance level of 0.05', 'groupDescription': 'The null hypothesis is that the mean MCS scores at 2 years are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Independent samples t-test'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2 months, 6 months, 1 year, and 2 years post-randomization', 'description': 'The Medical Outcome Study SF-36 Mental Component Summary (MCS) is a subscale of the SF-36 intended to measure mental well-being. It is scored on a scale of 0-100, with higher scores indicating higher levels of well-being.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcomes are analyzed in participants that were alive and completed assessments.'}, {'type': 'SECONDARY', 'title': 'FACT-BMT Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus, Calcineurin Inhibitor, and Prednisone', 'description': 'Sirolimus + calcineurin inhibitor + prednisone\n\nSirolimus + calcineurin inhibitor + prednisone: The target serum level for sirolimus is 3-12 ng/mL.\n\nThe target serum level for tacrolimus is 5-10 ng/mL. The target serum level for cyclosporine is 120-200 ng/mL.\n\nPrednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day.'}, {'id': 'OG001', 'title': 'Sirolimus and Prednisone', 'description': 'Sirolimus + prednisone\n\nSirolimus + prednisone: The target serum level for sirolimus is 3-12 ng/mL.\n\nPrednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '103', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '104', 'spread': '2.5', 'groupId': 'OG001'}]}]}, {'title': '2 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '105', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '110', 'spread': '2.4', 'groupId': 'OG001'}]}]}, {'title': '6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '109', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '109', 'spread': '3.4', 'groupId': 'OG001'}]}]}, {'title': '1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '114', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '110', 'spread': '3.6', 'groupId': 'OG001'}]}]}, {'title': '2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '119', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '113', 'spread': '3.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.763', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided testing was performed using a significance level of 0.05', 'groupDescription': 'The null hypothesis is that the mean FACT-BMT scores at baseline are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Independent samples t-test'}, {'pValue': '0.133', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided testing was performed using a significance level of 0.05', 'groupDescription': 'The null hypothesis is that the mean FACT-BMT scores at 2 months are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Independent samples t-test'}, {'pValue': '0.953', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided testing was performed using a significance level of 0.05', 'groupDescription': 'The null hypothesis is that the mean FACT-BMT scores at 6 months are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Independent samples t-test'}, {'pValue': '0.398', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided testing was performed using a significance level of 0.05', 'groupDescription': 'The null hypothesis is that the mean FACT-BMT scores at 1 year are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Independent samples t-test'}, {'pValue': '0.309', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided testing was performed using a significance level of 0.05', 'groupDescription': 'The null hypothesis is that the mean FACT-BMT scores at 2 years are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Independent samples t-test'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2 months, 6 months, 1 year, and 2 years post-randomization', 'description': "The Functional Assessment of Cancer Therapy-Bone Marrow Transplant scale (FACT-BMT) is a quality of life instrument that assesses the effects of bone marrow transplantation (BMT) on a patient's physical, social/family, emotional, and functional well-being while taking into consideration BMT-specific concerns. The assessment has 37 questions, each scored on a Likert scale from 0-4. The overall score is computed by adding scores of the questions and falls in the range 0-148, with higher scores indicating higher levels of overall well-being.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcomes are analyzed in participants that were alive and completed assessments.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sirolimus, Calcineurin Inhibitor, and Prednisone', 'description': 'Sirolimus + calcineurin inhibitor + prednisone\n\nSirolimus + calcineurin inhibitor + prednisone: The target serum level for sirolimus is 3-12 ng/mL.\n\nThe target serum level for tacrolimus is 5-10 ng/mL. The target serum level for cyclosporine is 120-200 ng/mL.\n\nPrednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day.'}, {'id': 'FG001', 'title': 'Sirolimus and Prednisone', 'description': 'Sirolimus + prednisone\n\nSirolimus + prednisone: The target serum level for sirolimus is 3-12 ng/mL.\n\nPrednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '77'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '77'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sirolimus, Calcineurin Inhibitor, and Prednisone', 'description': 'Sirolimus + calcineurin inhibitor + prednisone\n\nSirolimus + calcineurin inhibitor + prednisone: The target serum level for sirolimus is 3-12 ng/mL.\n\nThe target serum level for tacrolimus is 5-10 ng/mL. The target serum level for cyclosporine is 120-200 ng/mL.\n\nPrednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day.'}, {'id': 'BG001', 'title': 'Sirolimus and Prednisone', 'description': 'Sirolimus + prednisone\n\nSirolimus + prednisone: The target serum level for sirolimus is 3-12 ng/mL.\n\nPrednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '50.9', 'spread': '14.2', 'groupId': 'BG000'}, {'value': '47.4', 'spread': '16.1', 'groupId': 'BG001'}, {'value': '49.1', 'spread': '15.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Less Than 20', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': '20 - 40', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': '41 - 60', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}, {'title': 'Over 60', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Age in years', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}], 'categories': [{'title': 'White', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}, {'title': 'Non-white', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Unknown / Not Answered', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Primary Disease', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Acute Leukemia', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': 'Chronic Leukemia', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'MDS / MPS', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Lymphoma', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Graft Type', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Bone Marrow', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Peripheral Blood Stem Cells', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}, {'title': 'Single Cord Blood', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Double Cord Blood', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Donor Type', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Related', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}, {'title': 'Unrelated', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Donor type is described only for bone marrow and peripheral blood cell transplants.'}, {'title': 'Conditioning Regimen Intensity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Myeloablative', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}, {'title': 'Non-myeloablative or Reduced Intensity', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Donor Age', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '44.4', 'spread': '15.2', 'groupId': 'BG000'}, {'value': '38.5', 'spread': '12.9', 'groupId': 'BG001'}, {'value': '41.3', 'spread': '14.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Donor Gender', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Donor/Recipient Gender Matching', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female Donor, Female Recipient', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Female Donor, Male Recipient', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'Male Donor, Female Recipient', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Male Donor, Male Recipient', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Unknown Donor Gender', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis population includes only participants deemed to be eligible per Endpoint Review Committee adjudication. Thirteen enrolled participants were classified as ineligible (8 on the Sirolimus+Calcineurin Inhibitor+Prednisone arm and 5 on the Sirolimus+Prednisone arm) and are excluded from the analysis.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2012-07-09', 'size': 1694342, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-07-03T11:45', 'hasProtocol': True}, {'date': '2016-05-20', 'size': 718304, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-07-03T11:56', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 151}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-13', 'studyFirstSubmitDate': '2010-04-16', 'resultsFirstSubmitDate': '2018-07-18', 'studyFirstSubmitQcDate': '2010-04-16', 'lastUpdatePostDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-18', 'studyFirstPostDateStruct': {'date': '2010-04-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Participants With Treatment Success', 'timeFrame': '6 months and 24 months post-randomization', 'description': 'Treatment success was evaluated at 6 months in Phase II and is defined as a complete or partial response without secondary systemic immunosuppressive therapy and no recurrent malignancy or death. In Phase III, treatment success was evaluated at 24 months and is defined as a complete response without secondary systemic immunosuppressive therapy and no recurrent malignancy or death.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Overall Survival', 'timeFrame': '6 months and 24 months post-randomization', 'description': 'Overall survival is defined as survival of death from any cause.'}, {'measure': 'Percentage of Participants With Progression-free Survival', 'timeFrame': '6 months and 24 months post-randomization', 'description': 'Progression-free Survival is defined as survival without malignancy relapse. Relapse and death are considered failures for this endpoint.'}, {'measure': 'Percentage of Participants With Failure-free Survival', 'timeFrame': '6 months and 24 months post-randomization', 'description': 'Failure-free Survival is defined as survival without malignancy progression or initiation of secondary therapy for chronic GVHD. Progression, initiation of secondary therapy for chronic GVHD, and death are considered failures for this endpoint.'}, {'measure': 'Percentage of Participants With Relapse', 'timeFrame': '6 months and 24 months post-randomization', 'description': 'Relapse is defined as recurrence of the primary malignancy. Death is considered a competing risk for this endpoint.'}, {'measure': 'Percentage of Participants With Secondary Immunosuppressive Therapy Initiated', 'timeFrame': '6 months and 24 months post-randomization', 'description': 'The percentage of participants initiating secondary immunosuppressive therapy for chronic GVHD is described. Death is considered a competing risk for this endpoint.'}, {'measure': 'Percentage of Participants With Discontinuation of Systemic Immunosuppressive Therapy at Two Years', 'timeFrame': '2 years post-randomization', 'description': 'The percentage of participants discontinuing all systemic immunosuppressive therapy by two years post-randomization is described. Death is considered a competing risk for this endpoint.'}, {'measure': 'Prednisone Dose', 'timeFrame': 'Baseline, 6 months, and 1 year post-randomization', 'description': 'Daily dose of prednisone is described by treatment arm at baseline, 6 months, and 1 year post-randomization.'}, {'measure': 'Change in Prednisone Dose From Baseline', 'timeFrame': '6 months and 1 year post-randomization', 'description': 'Change in the daily dose of prednisone from baseline, the time of randomization, is described by treatment arm at 6 months and 1 year post-randomization.'}, {'measure': 'Serum Creatinine Level', 'timeFrame': 'Baseline, 6 months, and 1 year post-randomization', 'description': 'Creatinine level is described by treatment arm at baseline, 6 months, and 1 year post-randomization.'}, {'measure': 'Change in Serum Creatinine Level From Baseline', 'timeFrame': '6 months and 1 year post-randomization', 'description': 'Change in creatinine level from baseline, the time of randomization, is described by treatment arm at 6 months and 1 year post-randomization.'}, {'measure': 'Patient-reported Chronic GVHD Severity', 'timeFrame': 'Baseline, 6 months, 1 year, and 2 years post-randomization', 'description': "Each patient's perception of the severity of the chronic GVHD was collected at baseline and at 6 months, 1 year, and 2 years post-randomization. Severity is categorized as none, mild, moderate, and severe."}, {'measure': 'Provider-reported Chronic GVHD Severity', 'timeFrame': 'Baseline, 6 months, 1 year, and 2 years post-randomization', 'description': "Each patient's care provider's perception of the severity of the chronic GVHD was collected at baseline and at 6 months, 1 year, and 2 years post-randomization. Severity is categorized as none, mild, moderate, and severe."}, {'measure': 'NIH Consensus Criteria Chronic GVHD Severity', 'timeFrame': 'Baseline, 6 months, 1 year, and 2 years post-randomization', 'description': 'Chronic GVHD severity was determined at baseline and at 6 months, 1 year, and 2 years post-randomization per the 2005 NIH Consensus Criteria (Filipovich et al. 2005). Severity is categorized as none, mild, moderate, and severe.'}, {'measure': 'SF-36 Physical Component Summary', 'timeFrame': 'Baseline, 2 months, 6 months, 1 year, and 2 years post-randomization', 'description': 'The Medical Outcome Study SF-36 Physical Component Summary (PCS) is a subscale of the SF-36 intended to measure physical well-being. It is scored on a scale of 0-100, with higher scores indicating higher levels of well-being.'}, {'measure': 'SF-36 Mental Component Summary', 'timeFrame': 'Baseline, 2 months, 6 months, 1 year, and 2 years post-randomization', 'description': 'The Medical Outcome Study SF-36 Mental Component Summary (MCS) is a subscale of the SF-36 intended to measure mental well-being. It is scored on a scale of 0-100, with higher scores indicating higher levels of well-being.'}, {'measure': 'FACT-BMT Score', 'timeFrame': 'Baseline, 2 months, 6 months, 1 year, and 2 years post-randomization', 'description': "The Functional Assessment of Cancer Therapy-Bone Marrow Transplant scale (FACT-BMT) is a quality of life instrument that assesses the effects of bone marrow transplantation (BMT) on a patient's physical, social/family, emotional, and functional well-being while taking into consideration BMT-specific concerns. The assessment has 37 questions, each scored on a Likert scale from 0-4. The overall score is computed by adding scores of the questions and falls in the range 0-148, with higher scores indicating higher levels of overall well-being."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chronic Graft-versus-Host Disease (cGVHD)'], 'conditions': ['Chronic GVHD']}, 'referencesModule': {'references': [{'pmid': '16338616', 'type': 'BACKGROUND', 'citation': 'Filipovich AH, Weisdorf D, Pavletic S, Socie G, Wingard JR, Lee SJ, Martin P, Chien J, Przepiorka D, Couriel D, Cowen EW, Dinndorf P, Farrell A, Hartzman R, Henslee-Downey J, Jacobsohn D, McDonald G, Mittleman B, Rizzo JD, Robinson M, Schubert M, Schultz K, Shulman H, Turner M, Vogelsang G, Flowers ME. National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: I. Diagnosis and staging working group report. Biol Blood Marrow Transplant. 2005 Dec;11(12):945-56. doi: 10.1016/j.bbmt.2005.09.004.'}, {'pmid': '29954931', 'type': 'DERIVED', 'citation': "Carpenter PA, Logan BR, Lee SJ, Weisdorf DJ, Johnston L, Costa LJ, Kitko CL, Bolanos-Meade J, Sarantopoulos S, Alousi AM, Abhyankar S, Waller EK, Mendizabal A, Zhu J, O'Brien KA, Lazaryan A, Wu J, Nemecek ER, Pavletic SZ, Cutler CS, Horowitz MM, Arora M; BMT CTN.. A phase II/III randomized, multicenter trial of prednisone/sirolimus versus prednisone/ sirolimus/calcineurin inhibitor for the treatment of chronic graft-versus-host disease: BMT CTN 0801. Haematologica. 2018 Nov;103(11):1915-1924. doi: 10.3324/haematol.2018.195123. Epub 2018 Jun 28."}]}, 'descriptionModule': {'briefSummary': 'This study is designed as a combined Phase II/III, randomized, open label, multicenter, prospective comparative study of sirolimus plus prednisone versus sirolimus/calcineurin-inhibitor plus prednisone for the treatment of chronic GVHD. Patients will be stratified by transplant center and will be randomized to an experimental arm of one of the two pre-specified experimental arms (sirolimus + prednisone or the comparator arm of sirolimus + calcineurin inhibitor + prednisone) in a 1:1 ratio.', 'detailedDescription': 'Background: Chronic GVHD is a medical condition that can become very serious. Chronic GVHD is a common development after allogeneic transplant that occurs when the donor cells attack and damage tissues. The primary purpose of this study is to compare treatment regimens that contain sirolimus without a calcineurin inhibitor to a comparator regimen of sirolimus with a calcineurin inhibitor and evaluate how well chronic GVHD responds to treatment. The combinations of medications in this study are:\n\n* Sirolimus + calcineurin inhibitor + prednisone\n* Sirolimus + prednisone\n\nThe goal is to select a treatment regimen for further comparison in the Phase III trial.\n\nDesign Narrative: The intent is to enroll subjects at the start of initial therapy for chronic GVHD, or before their chronic GVHD is refractory to glucocorticoid therapy, or is chronically dependent upon glucocorticoid therapy and multiple secondary systemic immunosuppressive agents. Patients will be stratified by transplant center and will be randomized to one of two arms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Suitable candidates are patients with classic chronic GVHD or overlap syndrome (classic chronic plus acute GVHD)that is: a)Previously untreated (newly diagnosed) as defined by having received \\< 14 days of prednisone (or equivalent) before enrollment/randomization to study therapy; b)Previously treated but inadequately responding after ≤ 16 weeks of initial therapy with prednisone and/or calcineurin inhibitor (CNI) ± additional non-sirolimus agent (started at the time of chronic GVHD diagnosis).\n* Patient or guardian willing and able to provide informed consent.\n* Stated willingness to use contraception in women of childbearing potential.\n* Stated willingness of patient to comply with study procedures and reporting requirements.\n\nExclusion Criteria:\n\n* Patients with late persistent acute GVHD or recurrent acute GVHD only.\n* Inability to begin prednisone therapy at a dose of greater than 0.5 mg/kg/day.\n* Receiving sirolimus for treatment of chronic GVHD (sirolimus for prophylaxis or treatment of acute GVHD is acceptable).\n* Already receiving sirolimus (for prophylaxis or treatment of acute GVHD) with prednisone at ≥ 0.25 mg/kg/day (or equivalent) ± additional agents.\n* Receiving therapy for chronic GVHD for more than 16 weeks.\n* Invasive fungal or viral infection not responding to appropriate antifungal or antiviral therapies.\n* Inadequate renal function defined as measured creatinine clearance less than 50 mL/min/1.73 m\\^2 based on the Cockcroft-Gault formula (adults) or Schwartz formula (age less than or equal to 12 years). Adults: estimated creatinine clearance rate (eCCr) (mL/min/) = (140 - age) x mass (kg) x (0.85 if female)/72 x serum creatinine (mg/dL; Creatinine clearance (mL/min/1.73m\\^2) = eCCr x 1.73/Body Surface Area (BSA) (m\\^2); Children: eCCr (mL/min/1.73 m\\^2) = k x height (cm) / serum creatinine (mg/dL) k = 0.33 (pre-term), 0.45 (full term to 1 year old), 0.55 (age 1-12 years).\n* Inability to tolerate oral medications.\n* Absolute neutrophil count less than 1500 per microliter.\n* Requirement for platelet transfusions.\n* Pregnancy (positive serum β-HCG) or breastfeeding.\n* Receiving any treatment for persistent, progressive or recurrent malignancy.\n* Progressive or recurrent malignancy defined other than by quantitative molecular assays.\n* Known hypersensitivity to sirolimus.'}, 'identificationModule': {'nctId': 'NCT01106833', 'briefTitle': 'Chronic Graft-versus-Host Disease Treatment (BMT CTN 0801)', 'organization': {'class': 'OTHER', 'fullName': 'Medical College of Wisconsin'}, 'officialTitle': 'A Phase II/III Randomized, Multicenter Trial Comparing Sirolimus Plus Prednisone and Sirolimus/Calcineurin Inhibitor Plus Prednisone for the Treatment of Chronic Graft-versus-Host Disease (BMT CTN Protocol #0801)', 'orgStudyIdInfo': {'id': 'BMTCTN0801'}, 'secondaryIdInfos': [{'id': 'U01HL069294', 'link': 'https://reporter.nih.gov/quickSearch/U01HL069294', 'type': 'NIH'}, {'id': 'BMT CTN 0801', 'type': 'OTHER', 'domain': 'Blood and Marrow Transplant Clinical Trials Network'}, {'id': 'U01HL06929406', 'type': 'OTHER_GRANT', 'domain': 'National Cancer Institute (NCI)'}, {'id': '5U24CA076518', 'link': 'https://reporter.nih.gov/quickSearch/5U24CA076518', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'calcineurin inhibitor', 'description': 'Sirolimus + calcineurin inhibitor + prednisone', 'interventionNames': ['Drug: Sirolimus + calcineurin inhibitor + prednisone']}, {'type': 'EXPERIMENTAL', 'label': 'Sirolimus and prednisone', 'description': 'Sirolimus + prednisone', 'interventionNames': ['Drug: Sirolimus + prednisone']}], 'interventions': [{'name': 'Sirolimus + calcineurin inhibitor + prednisone', 'type': 'DRUG', 'otherNames': ['Rapamune', 'Prograf', 'Neorall', 'Gengraf'], 'description': 'The target serum level for sirolimus is 3-12 ng/mL. The target serum level for tacrolimus is 5-10 ng/mL. The target serum level for cyclosporine is 120-200 ng/mL.\n\nPrednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day.', 'armGroupLabels': ['calcineurin inhibitor']}, {'name': 'Sirolimus + prednisone', 'type': 'DRUG', 'otherNames': ['Rapamune'], 'description': 'The target serum level for sirolimus is 3-12 ng/mL.\n\nPrednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day.', 'armGroupLabels': ['Sirolimus and prednisone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010-3000', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope National Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego Medical Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Hospital and Clinics', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '32610-0277', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida College of Medicine (Shands)', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Blood & Marrow Transplant Program at Northside Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60637-1470', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Hospital', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '21231', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48105-2967', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Medical Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University, Barnes Jewish Hospital', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68198-7680', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hackensack University Medical Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '10174', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '55905', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27599-7305', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina Hospital at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '45236', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Jewish Hospital BMT Program', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44106-5061', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals of Cleveland/ Case Western', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma Medical Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97239-3098', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University (A) and (P)', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15224', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Western Pennsylvania Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas/MD Anderson CRC', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Transplant Institute', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University/MCV Hospitals', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98109-1024', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Research Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53792-5156', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Hospital and Clinics', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Mary Horowitz, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Center for International Blood and Marrow Transplant Research'}]}, 'ipdSharingStatementModule': {'url': 'https://biolincc.nhlbi.nih.gov/home/', 'timeFrame': 'Within 6 months of official study closure at participating sites.', 'ipdSharing': 'YES', 'description': 'Findings will be published in a manuscript', 'accessCriteria': 'Available to the public'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical College of Wisconsin', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'Blood and Marrow Transplant Clinical Trials Network', 'class': 'NETWORK'}, {'name': 'National Marrow Donor Program', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}