Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT00870818
Status:
TERMINATED
Last Update Posted:
2023-08-09
First Post:
2009-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Protege Extension Trial - Long Term Follow Up Trial for Subjects Who Completed the Protege Study (CP-MGA031-01)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'SRowland@proventionbio.com', 'phone': '443-987-0797', 'title': 'Sharon Rowland', 'organization': 'Provention Bio, Inc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'No formal inferential analyses were conducted due to limited number of participants. Data are summarized as mean change from baseline, both from Protégé and Extension baselines, for C-peptide AUC, HbA1c, insulin, and fasting C-peptide. Only existing data are summarized, no last observation carried forward imputation was performed. Patient reported outcomes were collected and summarized as mean change from baseline. However, only change from baseline from Extension could be summarized.'}}, 'adverseEventsModule': {'timeFrame': 'Throughout the study, up to 15 months', 'description': 'Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.', 'eventGroups': [{'id': 'EG000', 'title': 'Open-label Herold Regimen', 'description': 'Patients who had been assigned to Herold Regimen in Segment 1 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 8, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Double-blind Herold Regimen', 'description': 'Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets', 'otherNumAtRisk': 73, 'deathsNumAtRisk': 73, 'otherNumAffected': 2, 'seriousNumAtRisk': 73, 'deathsNumAffected': 1, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'Double-blind 33.3% Herold Regimen', 'description': 'Patients who had been assigned to 33.3% Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 1, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Double-blind Curtailed Herold Regimen', 'description': 'Patients who had been assigned to Curtailed Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 10, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG004', 'title': 'Double-blind Placebo', 'description': 'Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 4, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Fungal skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Epstein-Barr virus antibody positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pharyngitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tinea infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diabetic neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diabetic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Liver disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diabetic nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEddra'}, {'term': 'Diabetes mellitus inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypoglycaemic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Appendicitis perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Varicella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Caustic injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Iritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Number of Participants Who Experience an Adverse Event, Serious Adverse Event or Adverse Event of Special Interest.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-label Herold Regimen', 'description': 'Patients who had been assigned to Herold Regimen in Segment 1 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG001', 'title': 'Double-blind Herold Regimen', 'description': 'Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG002', 'title': 'Double-blind 33.3% Herold Regimen', 'description': 'Patients who had been assigned to 33.3% Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG003', 'title': 'Double-blind Curtailed Herold Regimen', 'description': 'Patients who had been assigned to Curtailed Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG004', 'title': 'Double-blind Placebo', 'description': 'Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Duration of study participation up to 15 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects in Segment 2 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and Hemoglobin A1c (HbA1c) Level of Less Than 6.5%.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-label Herold Regimen', 'description': 'Patients who had been assigned to Herold Regimen in Segment 1 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG001', 'title': 'Double-blind Herold Regimen', 'description': 'Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG002', 'title': 'Double-blind 33.3% Herold Regimen', 'description': 'Patients who had been assigned to 33.3% Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG003', 'title': 'Double-blind Curtailed Herold Regimen', 'description': 'Patients who had been assigned to Curtailed Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG004', 'title': 'Double-blind Placebo', 'description': 'Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 6', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Because the study was terminated early with a limited number of subjects and subject visits, the data are only summarized. Too few data are available for meaningful analysis.'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects in Segment 2 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and Hemoglobin A1c (HbA1c) Level of Less Than 6.5%.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-label Herold Regimen', 'description': 'Patients who had been assigned to Herold Regimen in Segment 1 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG001', 'title': 'Double-blind Herold Regimen', 'description': 'Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG002', 'title': 'Double-blind 33.3% Herold Regimen', 'description': 'Patients who had been assigned to 33.3% Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG003', 'title': 'Double-blind Curtailed Herold Regimen', 'description': 'Patients who had been assigned to Curtailed Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG004', 'title': 'Double-blind Placebo', 'description': 'Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 12', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Because the study was terminated early with a limited number of subjects and subject visits, the data are only summarized. Too few data are available for meaningful analysis.'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects With HbA1c <6.5%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-label Herold Regimen', 'description': 'Patients who had been assigned to Herold Regimen in Segment 1 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG001', 'title': 'Double-blind Herold Regimen', 'description': 'Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG002', 'title': 'Double-blind 33.3% Herold Regimen', 'description': 'Patients who had been assigned to 33.3% Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG003', 'title': 'Double-blind Curtailed Herold Regimen', 'description': 'Patients who had been assigned to Curtailed Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG004', 'title': 'Double-blind Placebo', 'description': 'Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 6', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean HbA1c at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-label Herold Regimen', 'description': 'Patients who had been assigned to Herold Regimen in Segment 1 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG001', 'title': 'Double-blind Herold Regimen', 'description': 'Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG002', 'title': 'Double-blind 33.3% Herold Regimen', 'description': 'Patients who had been assigned to 33.3% Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG003', 'title': 'Double-blind Curtailed Herold Regimen', 'description': 'Patients who had been assigned to Curtailed Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG004', 'title': 'Double-blind Placebo', 'description': 'Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}], 'classes': [{'categories': [{'measurements': [{'value': '8.24', 'spread': '2.063', 'groupId': 'OG000'}, {'value': '8.25', 'spread': '0.262', 'groupId': 'OG001'}, {'value': '8.25', 'spread': '2.709', 'groupId': 'OG002'}, {'value': '7.83', 'spread': '1.489', 'groupId': 'OG003'}, {'value': '8.10', 'spread': '1.009', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'unitOfMeasure': 'percentage of glycosylated hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Because the study was terminated early with a limited number of subjects and subject visits, the data are only summarized. Too few data are available for meaningful analysis.'}, {'type': 'SECONDARY', 'title': 'Mean HbA1c at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-label Herold Regimen', 'description': 'Patients who had been assigned to Herold Regimen in Segment 1 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG001', 'title': 'Double-blind Herold Regimen', 'description': 'Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG002', 'title': 'Double-blind 33.3% Herold Regimen', 'description': 'Patients who had been assigned to 33.3% Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG003', 'title': 'Double-blind Curtailed Herold Regimen', 'description': 'Patients who had been assigned to Curtailed Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG004', 'title': 'Double-blind Placebo', 'description': 'Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}], 'classes': [{'categories': [{'measurements': [{'value': '7.81', 'spread': '2.155', 'groupId': 'OG000'}, {'value': '6.30', 'spread': '0.141', 'groupId': 'OG001'}, {'value': '6.35', 'spread': '0.354', 'groupId': 'OG002'}, {'value': '6.05', 'spread': '0.778', 'groupId': 'OG003'}, {'value': '6.95', 'spread': '0.919', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 12', 'unitOfMeasure': 'percentage of glycosylated hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Because the study was terminated early with a limited number of subjects and subject visits, the data are only summarized. Too few data are available for meaningful analysis.'}, {'type': 'SECONDARY', 'title': 'C-peptide Area Under the Curve (AUC) at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-label Herold Regimen', 'description': 'Patients who had been assigned to Herold Regimen in Segment 1 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG001', 'title': 'Double-blind Herold Regimen', 'description': 'Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG002', 'title': 'Double-blind 33.3% Herold Regimen', 'description': 'Patients who had been assigned to 33.3% Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG003', 'title': 'Double-blind Curtailed Herold Regimen', 'description': 'Patients who had been assigned to Curtailed Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG004', 'title': 'Double-blind Placebo', 'description': 'Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}], 'classes': [{'categories': [{'measurements': [{'value': '0.30', 'spread': '0.195', 'groupId': 'OG000'}, {'value': '0.45', 'spread': '0.360', 'groupId': 'OG001'}, {'value': '0.25', 'spread': '0.301', 'groupId': 'OG002'}, {'value': '0.25', 'spread': '0.248', 'groupId': 'OG003'}, {'value': '0.37', 'spread': '0.399', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 6', 'description': 'This outcome measure summarizes the mean and standard deviation of the observed value.', 'unitOfMeasure': 'min*nmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Because the study was terminated early with a limited number of subjects and subject visits, the data are only summarized. Too few data are available for meaningful analysis.'}, {'type': 'SECONDARY', 'title': 'C-peptide AUC at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-label Herold Regimen', 'description': 'Patients who had been assigned to Herold Regimen in Segment 1 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG001', 'title': 'Double-blind Herold Regimen', 'description': 'Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG002', 'title': 'Double-blind 33.3% Herold Regimen', 'description': 'Patients who had been assigned to 33.3% Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG003', 'title': 'Double-blind Curtailed Herold Regimen', 'description': 'Patients who had been assigned to Curtailed Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG004', 'title': 'Double-blind Placebo', 'description': 'Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}], 'classes': [{'categories': [{'measurements': [{'value': '0.32', 'spread': '0.183', 'groupId': 'OG000'}, {'value': '0.56', 'spread': '0.123', 'groupId': 'OG001'}, {'value': '0.26', 'spread': '0.276', 'groupId': 'OG002'}, {'value': '0.59', 'spread': '0.036', 'groupId': 'OG003'}, {'value': '0.19', 'spread': '0.058', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 12', 'description': 'This outcome measure summarizes the mean and standard deviation of the observed value.', 'unitOfMeasure': 'min*nmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Because the study was terminated early with a limited number of subjects and subject visits, the data are only summarized. Too few data are available for meaningful analysis.'}, {'type': 'SECONDARY', 'title': 'Total Daily Insulin Usage at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-label Herold Regimen', 'description': 'Patients who had been assigned to Herold Regimen in Segment 1 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG001', 'title': 'Double-blind Herold Regimen', 'description': 'Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG002', 'title': 'Double-blind 33.3% Herold Regimen', 'description': 'Patients who had been assigned to 33.3% Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG003', 'title': 'Double-blind Curtailed Herold Regimen', 'description': 'Patients who had been assigned to Curtailed Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG004', 'title': 'Double-blind Placebo', 'description': 'Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}], 'classes': [{'categories': [{'measurements': [{'value': '0.71', 'spread': '0.362', 'groupId': 'OG000'}, {'value': '0.71', 'spread': '0.451', 'groupId': 'OG001'}, {'value': '0.64', 'spread': '0.274', 'groupId': 'OG002'}, {'value': '0.81', 'spread': '0.433', 'groupId': 'OG003'}, {'value': '0.60', 'spread': '0.251', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 6', 'unitOfMeasure': 'units/kg/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Daily Insulin Usage at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-label Herold Regimen', 'description': 'Patients who had been assigned to Herold Regimen in Segment 1 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG001', 'title': 'Double-blind Herold Regimen', 'description': 'Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG002', 'title': 'Double-blind 33.3% Herold Regimen', 'description': 'Patients who had been assigned to 33.3% Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG003', 'title': 'Double-blind Curtailed Herold Regimen', 'description': 'Patients who had been assigned to Curtailed Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG004', 'title': 'Double-blind Placebo', 'description': 'Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}], 'classes': [{'categories': [{'measurements': [{'value': '0.67', 'spread': '0.280', 'groupId': 'OG000'}, {'value': '0.47', 'spread': '0.073', 'groupId': 'OG001'}, {'value': '0.49', 'spread': '0.076', 'groupId': 'OG002'}, {'value': '0.40', 'spread': '0.147', 'groupId': 'OG003'}, {'value': '0.76', 'spread': '0.272', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 12', 'unitOfMeasure': 'units/kg/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Values for Participant-reported Outcomes on the 5-dimension European Quality of Life Questionnaire. (EQ-5D)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-label Herold Regimen', 'description': 'Patients who had been assigned to Herold Regimen in Segment 1 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG001', 'title': 'Double-blind Herold Regimen', 'description': 'Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG002', 'title': 'Double-blind 33.3% Herold Regimen', 'description': 'Patients who had been assigned to 33.3% Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG003', 'title': 'Double-blind Curtailed Herold Regimen', 'description': 'Patients who had been assigned to Curtailed Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG004', 'title': 'Double-blind Placebo', 'description': 'Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}], 'classes': [{'categories': [{'measurements': [{'value': '5.3', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '1.25', 'groupId': 'OG001'}, {'value': '5.2', 'spread': '0.63', 'groupId': 'OG002'}, {'value': '5.1', 'spread': '0.30', 'groupId': 'OG003'}, {'value': '5.7', 'spread': '1.12', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 6', 'description': 'The EQ-5D is a self-reported survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 3-level severity ranking that ranges from "no problems", "some problems", and "extreme problems". The lowest possible score is 5 and the highest possible score is 15. Lower scores indicate better quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Because the study was terminated early with a limited number of subjects and subject visits, the data are only summarized. Too few data are available for meaningful analysis.'}, {'type': 'SECONDARY', 'title': 'Mean Values for Participant-reported Outcomes on the EQ-5D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-label Herold Regimen', 'description': 'Patients who had been assigned to Herold Regimen in Segment 1 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG001', 'title': 'Double-blind Herold Regimen', 'description': 'Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG002', 'title': 'Double-blind 33.3% Herold Regimen', 'description': 'Patients who had been assigned to 33.3% Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG003', 'title': 'Double-blind Curtailed Herold Regimen', 'description': 'Patients who had been assigned to Curtailed Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG004', 'title': 'Double-blind Placebo', 'description': 'Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}], 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '6.52', 'spread': '2.12', 'groupId': 'OG001'}, {'value': '5.0', 'spread': '0.00', 'groupId': 'OG002'}, {'value': '5.0', 'spread': '0.00', 'groupId': 'OG003'}, {'value': '6.0', 'spread': '1.41', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 12', 'description': 'The EQ-5D is a self-reported survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 3-level severity ranking that ranges from "no problems", "some problems", and "extreme problems". The lowest possible score is 5 and the highest possible score is 15. Lower scores indicate better quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Because the study was terminated early with a limited number of subjects and subject visits, the data are only summarized. Too few data are available for meaningful analysis.'}, {'type': 'SECONDARY', 'title': 'Pediatric Quality of Life Questionnaire Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-label Herold Regimen', 'description': 'Patients who had been assigned to Herold Regimen in Segment 1 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG001', 'title': 'Double-blind Herold Regimen', 'description': 'Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG002', 'title': 'Double-blind 33.3% Herold Regimen', 'description': 'Patients who had been assigned to 33.3% Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG003', 'title': 'Double-blind Curtailed Herold Regimen', 'description': 'Patients who had been assigned to Curtailed Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG004', 'title': 'Double-blind Placebo', 'description': 'Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}], 'classes': [{'categories': [{'measurements': [{'value': '7.7', 'spread': '6.82', 'groupId': 'OG000'}, {'value': '13.5', 'spread': '13.07', 'groupId': 'OG001'}, {'value': '12.2', 'spread': '8.82', 'groupId': 'OG002'}, {'value': '9.3', 'spread': '10.52', 'groupId': 'OG003'}, {'value': '13.8', 'spread': '15.66', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 6', 'description': 'The 23-item PEDs QL generic core scales were designed to measure the core dimensions of health (physical, emotional, social and school functioning). Answers are scored from 0 meaning never to 4 meaning almost always. Lower scores indicated higher quality of life. Items on the questionnaire were reversely scored and linearly transformed to a 0-100 scale, so that higher scores indicated better patient reported outcome. The mean was computed as the sum of the items over the number of items answered (to account for missing data). If more than 50% of the items in the scale were missing, the score was not computed.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pediatric patients who completed the questionnaire. Because the study was terminated early with a limited number of subjects and subject visits, the data are only summarized. Too few data are available for meaningful analysis.'}, {'type': 'SECONDARY', 'title': 'Pediatric Quality of Life Questionnaire Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-label Herold Regimen', 'description': 'Patients who had been assigned to Herold Regimen in Segment 1 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG001', 'title': 'Double-blind Herold Regimen', 'description': 'Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG002', 'title': 'Double-blind 33.3% Herold Regimen', 'description': 'Patients who had been assigned to 33.3% Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG003', 'title': 'Double-blind Curtailed Herold Regimen', 'description': 'Patients who had been assigned to Curtailed Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG004', 'title': 'Double-blind Placebo', 'description': 'Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}], 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'spread': '6.39', 'groupId': 'OG000'}, {'value': '21.0', 'spread': '26.87', 'groupId': 'OG001'}, {'value': '6.5', 'spread': '2.12', 'groupId': 'OG002'}, {'value': '11.0', 'spread': '9.90', 'groupId': 'OG003'}, {'value': '30.5', 'spread': '7.78', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 12', 'description': 'The 23-item PEDs QL generic core scales were designed to measure the core dimensions of health (physical, emotional, social and school functioning). Answers are scored from 0 meaning never to 4 meaning almost always. Lower scores indicated higher quality of life. Items on the questionnaire were reversely scored and linearly transformed to a 0-100 scale, so that higher scores indicated better patient reported outcome. The mean was computed as the sum of the items over the number of items answered (to account for missing data). If more than 50% of the items in the scale were missing, the score was not computed.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pediatric patients completing PedQL questionnaire. Because the study was terminated early with a limited number of subjects and subject visits, the data are only summarized. Too few data are available for meaningful analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Cells by Immunophenotype', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-label Herold Regimen', 'description': 'Patients who had been assigned to Herold Regimen in Segment 1 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG001', 'title': 'Double-blind Herold Regimen', 'description': 'Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG002', 'title': 'Double-blind 33.3% Herold Regimen', 'description': 'Patients who had been assigned to 33.3% Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG003', 'title': 'Double-blind Curtailed Herold Regimen', 'description': 'Patients who had been assigned to Curtailed Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG004', 'title': 'Double-blind Placebo', 'description': 'Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}], 'classes': [{'title': '%CD25+/FOXp3+ [of CD4+]', 'categories': [{'measurements': [{'value': '0.4', 'spread': '1.87', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '1.35', 'groupId': 'OG001'}, {'value': '4.8', 'spread': '1.00', 'groupId': 'OG002'}, {'value': '6.0', 'spread': '1.28', 'groupId': 'OG003'}, {'value': '4.5', 'spread': '1.46', 'groupId': 'OG004'}]}]}, {'title': '%CD25+/FOXp3+ [of CD8+]', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '0.10', 'groupId': 'OG002'}, {'value': '0.7', 'spread': '0.46', 'groupId': 'OG003'}, {'value': '0.6', 'spread': '0.35', 'groupId': 'OG004'}]}]}, {'title': '%CD3+/CD16,CD56+', 'categories': [{'measurements': [{'value': '6.7', 'spread': '4.39', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '1.52', 'groupId': 'OG001'}, {'value': '7.7', 'spread': '2.85', 'groupId': 'OG002'}, {'value': '4.8', 'spread': '1.63', 'groupId': 'OG003'}, {'value': '4.2', 'spread': '1.02', 'groupId': 'OG004'}]}]}, {'title': '%CD3-/CD16,CD56+', 'categories': [{'measurements': [{'value': '8.9', 'spread': '3.32', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '3.23', 'groupId': 'OG001'}, {'value': '6.4', 'spread': '3.09', 'groupId': 'OG002'}, {'value': '10.7', 'spread': '4.31', 'groupId': 'OG003'}, {'value': '5.8', 'spread': '2.11', 'groupId': 'OG004'}]}]}, {'title': '%CD40+ [of CD4+]', 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.48', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '0.89', 'groupId': 'OG002'}, {'value': '0.8', 'spread': '0.54', 'groupId': 'OG003'}, {'value': '0.8', 'spread': '0.52', 'groupId': 'OG004'}]}]}, {'title': '%CD69+ [of CD4+]', 'categories': [{'measurements': [{'value': '0.9', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.09', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '1.20', 'groupId': 'OG002'}, {'value': '0.1', 'spread': '0.12', 'groupId': 'OG003'}, {'value': '0.1', 'spread': '0.10', 'groupId': 'OG004'}]}]}, {'title': '%CD69+ [of CD8+]', 'categories': [{'measurements': [{'value': '3.7', 'spread': '1.71', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '0.23', 'groupId': 'OG001'}, {'value': '3.4', 'spread': '1.39', 'groupId': 'OG002'}, {'value': '3.4', 'spread': '1.25', 'groupId': 'OG003'}, {'value': '4.2', 'spread': '1.16', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 6', 'unitOfMeasure': 'Percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Human Anti-human Antibody (HAHA) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-label Herold Regimen', 'description': 'Patients who had been assigned to Herold Regimen in Segment 1 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG001', 'title': 'Double-blind Herold Regimen', 'description': 'Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG002', 'title': 'Double-blind 33.3% Herold Regimen', 'description': 'Patients who had been assigned to 33.3% Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG003', 'title': 'Double-blind Curtailed Herold Regimen', 'description': 'Patients who had been assigned to Curtailed Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'OG004', 'title': 'Double-blind Placebo', 'description': 'Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}], 'classes': [{'title': 'Month 6', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 6 and 12', 'description': 'Patients with HAHA levels \\> 0.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Open-label Herold Regimen', 'description': 'Patients who had been assigned to Herold Regimen in Segment 1 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'FG001', 'title': 'Double-blind Herold Regimen', 'description': 'Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'FG002', 'title': 'Double-blind 33.3% Herold Regimen', 'description': 'Patients who had been assigned to 33.3% Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'FG003', 'title': 'Double-blind Curtailed Herold Regimen', 'description': 'Patients who had been assigned to Curtailed Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'FG004', 'title': 'Double-blind Placebo', 'description': 'Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '73'}, {'groupId': 'FG002', 'numSubjects': '38'}, {'groupId': 'FG003', 'numSubjects': '38'}, {'groupId': 'FG004', 'numSubjects': '38'}]}, {'type': 'Completed 6 Months', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '11'}]}, {'type': 'Completed 12 Months', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Completed 18 Months', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Completed 21 Months', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '73'}, {'groupId': 'FG002', 'numSubjects': '38'}, {'groupId': 'FG003', 'numSubjects': '38'}, {'groupId': 'FG004', 'numSubjects': '38'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '70'}, {'groupId': 'FG002', 'numSubjects': '36'}, {'groupId': 'FG003', 'numSubjects': '36'}, {'groupId': 'FG004', 'numSubjects': '38'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}, {'value': '219', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Open-label Herold Regimen', 'description': 'Patients who had been assigned to Herold Regimen in Segment 1 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'BG001', 'title': 'Double-blind Herold Regimen', 'description': 'Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'BG002', 'title': 'Double-blind 33.3% Herold Regimen', 'description': 'Patients who had been assigned to 33.3% Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'BG003', 'title': 'Double-blind Curtailed Herold Regimen', 'description': 'Patients who had been assigned to Curtailed Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'BG004', 'title': 'Double-blind Placebo', 'description': 'Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.\n\nBlood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies\n\nPatient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.\n\nAnalysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14.0', 'groupId': 'BG000', 'lowerLimit': '10.0', 'upperLimit': '34.0'}, {'value': '18.0', 'groupId': 'BG001', 'lowerLimit': '9.0', 'upperLimit': '35.0'}, {'value': '18.5', 'groupId': 'BG002', 'lowerLimit': '10.0', 'upperLimit': '31.0'}, {'value': '16.0', 'groupId': 'BG003', 'lowerLimit': '8.0', 'upperLimit': '32.0'}, {'value': '16.5', 'groupId': 'BG004', 'lowerLimit': '10.0', 'upperLimit': '34.0'}, {'value': '18.0', 'groupId': 'BG005', 'lowerLimit': '8.0', 'upperLimit': '35.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '74', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '145', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}, {'value': '214', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '72', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '146', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '65', 'groupId': 'BG005'}]}]}, {'title': 'Czechia', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '27', 'groupId': 'BG005'}]}]}, {'title': 'India', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '71', 'groupId': 'BG005'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}]}]}, {'title': 'Ukraine', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}]}]}, {'title': 'Estonia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}]}]}, {'title': 'Latvia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}, {'title': 'Sweden', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 219}}, 'statusModule': {'whyStopped': 'Business decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-19', 'studyFirstSubmitDate': '2009-03-26', 'resultsFirstSubmitDate': '2023-03-08', 'studyFirstSubmitQcDate': '2009-03-26', 'lastUpdatePostDateStruct': {'date': '2023-08-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-07-19', 'studyFirstPostDateStruct': {'date': '2009-03-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Number of Participants Who Experience an Adverse Event, Serious Adverse Event or Adverse Event of Special Interest.', 'timeFrame': 'Duration of study participation up to 15 months'}], 'secondaryOutcomes': [{'measure': 'Proportion of Subjects in Segment 2 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and Hemoglobin A1c (HbA1c) Level of Less Than 6.5%.', 'timeFrame': 'Month 6'}, {'measure': 'Proportion of Subjects in Segment 2 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and Hemoglobin A1c (HbA1c) Level of Less Than 6.5%.', 'timeFrame': 'Month 12'}, {'measure': 'Proportion of Subjects With HbA1c <6.5%', 'timeFrame': 'Month 6'}, {'measure': 'Mean HbA1c at 6 Months', 'timeFrame': '6 months'}, {'measure': 'Mean HbA1c at 12 Months', 'timeFrame': 'Month 12'}, {'measure': 'C-peptide Area Under the Curve (AUC) at 6 Months', 'timeFrame': 'Month 6', 'description': 'This outcome measure summarizes the mean and standard deviation of the observed value.'}, {'measure': 'C-peptide AUC at 12 Months', 'timeFrame': 'Month 12', 'description': 'This outcome measure summarizes the mean and standard deviation of the observed value.'}, {'measure': 'Total Daily Insulin Usage at 6 Months', 'timeFrame': 'Month 6'}, {'measure': 'Total Daily Insulin Usage at 12 Months', 'timeFrame': 'Month 12'}, {'measure': 'Mean Values for Participant-reported Outcomes on the 5-dimension European Quality of Life Questionnaire. (EQ-5D)', 'timeFrame': 'Month 6', 'description': 'The EQ-5D is a self-reported survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 3-level severity ranking that ranges from "no problems", "some problems", and "extreme problems". The lowest possible score is 5 and the highest possible score is 15. Lower scores indicate better quality of life.'}, {'measure': 'Mean Values for Participant-reported Outcomes on the EQ-5D', 'timeFrame': 'Month 12', 'description': 'The EQ-5D is a self-reported survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 3-level severity ranking that ranges from "no problems", "some problems", and "extreme problems". The lowest possible score is 5 and the highest possible score is 15. Lower scores indicate better quality of life.'}, {'measure': 'Pediatric Quality of Life Questionnaire Total Score', 'timeFrame': 'Month 6', 'description': 'The 23-item PEDs QL generic core scales were designed to measure the core dimensions of health (physical, emotional, social and school functioning). Answers are scored from 0 meaning never to 4 meaning almost always. Lower scores indicated higher quality of life. Items on the questionnaire were reversely scored and linearly transformed to a 0-100 scale, so that higher scores indicated better patient reported outcome. The mean was computed as the sum of the items over the number of items answered (to account for missing data). If more than 50% of the items in the scale were missing, the score was not computed.'}, {'measure': 'Pediatric Quality of Life Questionnaire Total Score', 'timeFrame': 'Month 12', 'description': 'The 23-item PEDs QL generic core scales were designed to measure the core dimensions of health (physical, emotional, social and school functioning). Answers are scored from 0 meaning never to 4 meaning almost always. Lower scores indicated higher quality of life. Items on the questionnaire were reversely scored and linearly transformed to a 0-100 scale, so that higher scores indicated better patient reported outcome. The mean was computed as the sum of the items over the number of items answered (to account for missing data). If more than 50% of the items in the scale were missing, the score was not computed.'}, {'measure': 'Percentage of Cells by Immunophenotype', 'timeFrame': 'Month 6'}, {'measure': 'Human Anti-human Antibody (HAHA) Levels', 'timeFrame': 'Month 6 and 12', 'description': 'Patients with HAHA levels \\> 0.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Teplizumab', 'Protege', 'MGA031', 'Monoclonal antibody', 'Type 1 Diabetes Mellitus', 'T1DM', 'MacroGenics'], 'conditions': ['Type 1 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the long term safety and efficacy in subjects with Type 1 Diabetes Mellitus who completed the Protege Study (CP-MGA031-01).', 'detailedDescription': 'The primary objective of the extension study is to assess long-term safety, with particular focus on the development of serious adverse events (SAEs), adverse events of special interest (AESIs) including opportunistic infections and lymphoproliferative disease, and other immediately reportable events (IREs), in subjects with recent-onset T1DM who complete CP-MGA031-01.\n\nThe secondary objectives of the extension study are to: 1) assess long-term efficacy; 2) evaluate immunological effects(North America only); 3) measure anti-teplizumab antibody levels;4) assess Health Related Quality of Life Questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '37 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Complete Protocol CP-MGA031-01 (i.e., all subjects who complete Study Day 728, regardless of how many doses of study drug are received).\n2. Provide written informed consent.\n\nExclusion Criteria:\n\nNone'}, 'identificationModule': {'nctId': 'NCT00870818', 'briefTitle': 'Protege Extension Trial - Long Term Follow Up Trial for Subjects Who Completed the Protege Study (CP-MGA031-01)', 'organization': {'class': 'INDUSTRY', 'fullName': 'MacroGenics'}, 'officialTitle': 'An Extension of Study CP-MGA031-01 to Evaluate the Long-Term Efficacy and Safety of Teplizumab (MGA031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Patients With Recent-Onset Type 1 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'CP-MGA031-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Double-blind Herold Regimen', 'description': 'Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.', 'interventionNames': ['Diagnostic Test: Blood samples for safety', 'Behavioral: Patient reported outcome questionnaires', 'Diagnostic Test: Analysis of T-cell subsets']}, {'type': 'EXPERIMENTAL', 'label': 'Double-blind 33.3% Herold Regimen', 'description': 'Patients who had been assigned to 33.3% Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.', 'interventionNames': ['Diagnostic Test: Blood samples for safety', 'Behavioral: Patient reported outcome questionnaires', 'Diagnostic Test: Analysis of T-cell subsets']}, {'type': 'EXPERIMENTAL', 'label': 'Double-blind Curtailed Herold Regimen', 'description': 'Patients who had been assigned to Curtailed Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.', 'interventionNames': ['Diagnostic Test: Blood samples for safety', 'Behavioral: Patient reported outcome questionnaires', 'Diagnostic Test: Analysis of T-cell subsets']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Double-blind Placebo', 'description': 'Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.', 'interventionNames': ['Diagnostic Test: Blood samples for safety', 'Behavioral: Patient reported outcome questionnaires', 'Diagnostic Test: Analysis of T-cell subsets']}, {'type': 'EXPERIMENTAL', 'label': 'Open-label Herold Regimen', 'description': 'Patients who had been assigned to Herold Regimen in Segment 1 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.', 'interventionNames': ['Diagnostic Test: Blood samples for safety', 'Behavioral: Patient reported outcome questionnaires', 'Diagnostic Test: Analysis of T-cell subsets']}], 'interventions': [{'name': 'Blood samples for safety', 'type': 'DIAGNOSTIC_TEST', 'description': 'serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies', 'armGroupLabels': ['Double-blind 33.3% Herold Regimen', 'Double-blind Curtailed Herold Regimen', 'Double-blind Herold Regimen', 'Double-blind Placebo', 'Open-label Herold Regimen']}, {'name': 'Patient reported outcome questionnaires', 'type': 'BEHAVIORAL', 'description': 'EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.', 'armGroupLabels': ['Double-blind 33.3% Herold Regimen', 'Double-blind Curtailed Herold Regimen', 'Double-blind Herold Regimen', 'Double-blind Placebo', 'Open-label Herold Regimen']}, {'name': 'Analysis of T-cell subsets', 'type': 'DIAGNOSTIC_TEST', 'description': 'CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets', 'armGroupLabels': ['Double-blind 33.3% Herold Regimen', 'Double-blind Curtailed Herold Regimen', 'Double-blind Herold Regimen', 'Double-blind Placebo', 'Open-label Herold Regimen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Diabetes Associates', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MacroGenics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}