Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT00602667
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-02
First Post:
2008-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Risk-Adapted Therapy for Young Children With Embryonal Brain Tumors, Choroid Plexus Carcinoma, High Grade Glioma or Ependymoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D018335', 'term': 'Rhabdoid Tumor'}, {'id': 'D016545', 'term': 'Choroid Plexus Neoplasms'}], 'ancestors': [{'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D018193', 'term': 'Neoplasms, Complex and Mixed'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D002551', 'term': 'Cerebral Ventricle Neoplasms'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D060828', 'term': 'Induction Chemotherapy'}, {'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D014750', 'term': 'Vincristine'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D019772', 'term': 'Topotecan'}, {'id': 'D000069347', 'term': 'Erlotinib Hydrochloride'}, {'id': 'D014747', 'term': 'Vinblastine'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012074', 'term': 'Remission Induction'}, {'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D011799', 'term': 'Quinazolines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'amar.gajjar@stjude.org', 'phone': '866-278-5833', 'title': 'Amar Gajjar, MD', 'organization': "St. Jude Children's Research Hospital"}, 'certainAgreement': {'otherDetails': 'MSA states Site is unable to publish until all completed case report forms have been delivered to Sponsor, (Study Completion). Site shall have the right to publish after publication of a multi-center publication coordinated by the Sponsor or (12) mths. after Study Completion; provided, that prior to any such publication or public release of such data, Site shall furnish Sponsor with a copy of any proposed publication at least (45)days in advance of the proposed publication or presentation date.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Results for the some of the secondary objectives are not available yet. These results will be posted as they become available.'}}, 'adverseEventsModule': {'timeFrame': 'All adverse events grades 3, 4, and 5 which occur during treatment and for 30 days after the end of treatment, and events which occur later than 30 days after the end of treatment which are felt to be at least possibly related to treatment, to the time of off study, were collected with some exceptions noted in the additional description section, up to 6 years..', 'description': 'Per protocol, some grade 3 and 4 hematologic toxicities, grade 3 elevation in serum ALT or AST, grade 3 and 4 electrolyte abnormalities, and total parenteral nutrition or intravenous fluids administered to prevent significant weight loss/malnutrition were not collected, especially if they occurred from the beginning of induction chemotherapy. The one patient in the high-risk group who did not start therapy due to early disease progression was excluded from adverse event results.', 'eventGroups': [{'id': 'EG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic or high grade glioma histology will receive induction chemotherapy and low-risk therapy.', 'otherNumAtRisk': 57, 'deathsNumAtRisk': 57, 'otherNumAffected': 55, 'seriousNumAtRisk': 57, 'deathsNumAffected': 10, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with M0 medulloblastoma or nodular desmoplastic histology with less than a GTR, other histologic diagnoses with no metastatic disease, will receive induction chemotherapy and intermediate-risk therapy.', 'otherNumAtRisk': 156, 'deathsNumAtRisk': 156, 'otherNumAffected': 145, 'seriousNumAtRisk': 156, 'deathsNumAffected': 58, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease will receive induction chemotherapy and high-risk therapy.', 'otherNumAtRisk': 76, 'deathsNumAtRisk': 77, 'otherNumAffected': 70, 'seriousNumAtRisk': 76, 'deathsNumAffected': 49, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Febrile neutropenia', 'notes': 'Fever of unknown origin without clinically or microbiologically documented infection (ANC \\<1.0 x 10e9/L, fever \\>=38.5 degrees C)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 83, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 169, 'numAffected': 92}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 120, 'numAffected': 48}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neutrophils/granulocytes (ANC/AGC)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 60, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 124, 'numAffected': 57}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 20, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Leukocytes (total WBC)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 38, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 83, 'numAffected': 45}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 11, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 32, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 29, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 20, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection, Catheter-related', 'notes': 'Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 19, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils, Catheter-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 26, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Platelets', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 19, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 13, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Rash/desquamation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mucositis/stomatitis (functional/symptomatic), Oral cavity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Colitis, infectious (e.g., Clostridium difficile)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 12, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection, Skin (cellulitis)', 'notes': 'Documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection, Blood', 'notes': 'Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mucositis/stomatitis (clinical exam), Oral cavity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils, Blood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hearing: patients with/without baseline audiogram and enrolled in a monitoring program', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection, Upper airway NOS', 'notes': 'Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection, Urinary tract NOS', 'notes': 'Documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'ALT, SGPT (serum glutamic pyruvic transaminase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'seriousEvents': [{'term': 'Hearing: patients with/without baseline audiogram and enrolled in a monitoring program', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neutrophils/granulocytes (ANC/AGC)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Platelets', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fatigue (asthenia, lethargy, malaise)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mucositis/stomatitis (clinical exam), Oral cavity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Perforation, GI, Duodenum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hemorrhage/Bleeding - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L), Pharynx', 'notes': 'Documented clinically or microbiologically', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection, Upper airway NOS', 'notes': 'Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils, Blood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils, Catheter-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils, Eye NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Acidosis (metabolic or respiratory)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Irritability (children <3 years of age)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neurology - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neuropathy: motor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Somnolence/depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Speech impairment (e.g., dysphasia or aphasia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dyspnea (shortness of breath)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pneumonitis/pulmonary infiltrates', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pulmonary/Upper Respiratory - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils, Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Probability of Progression-free Survival (PFS) for Medulloblastoma Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Medulloblastoma patients \\<3 years of age; histological diagnosis of desmoplastic nodular (DN)/medulloblastoma with extensive nodularity (MBEN); no evidence of metastatic disease (M0); and a surgical gross total resection (GTR) or near total resection (NTR) defined as residual tumor or imaging abnormality (not definite for residual tumor) with a size of less than 1 cm\\^2 on post-op computed tomography (CT) or magnetic resonance imaging (MRI) \\[R0\\])'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Medulloblastoma patients \\<3 years of age, M0, and either R0 resection with any other medullo histology other than DN/MBEN (i.e., classic or large cell anaplastic (LCA)), or with a subtotal resection (with a residual tumor or imaging abnormality with a size of \\>1 cm\\^2 on post-op imaging (R+), and DN/MBEN). Children 3-5 years of age were also included in this group High Risk'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Medulloblastoma patients \\<3 years of age with evidence of metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '73.9', 'groupId': 'OG000', 'lowerLimit': '56.5', 'upperLimit': '91.3'}, {'value': '46.9', 'groupId': 'OG001', 'lowerLimit': '30.2', 'upperLimit': '63.6'}, {'value': '30.8', 'groupId': 'OG002', 'lowerLimit': '14.1', 'upperLimit': '47.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From date on treatment until date of first progression or relapse or disease related death or date of last contact, estimated at 1 year after treatment', 'description': 'Progression was defined as 25% increase in the size of any measurable lesion; the appearance of a new lesion; or the conversion of negative cerebrospinal fluid (CSF) cytology to positive. Defined as the time interval from date on treatment until the date of first progression, medulloblastoma-related death or date of last contact for patients who have not experienced an event. All eligible medulloblastoma patients who received any methotrexate are included in this analysis.', 'unitOfMeasure': 'Percent Probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible medulloblastoma patients started methotrexate and were included (n=81). PFS estimates are reported by risk group.'}, {'type': 'PRIMARY', 'title': 'Percent Probability of Progression-free Survival (PFS) for Medulloblastoma Patients by DNA Methylation Subgroup', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-risk SHH Patients', 'description': 'Sonic hedgehog (SHH) medulloblastoma subgroup patients in the low-risk group'}, {'id': 'OG001', 'title': 'Intermediate-risk SHH Patients', 'description': 'Sonic hedgehog (SHH) medulloblastoma subgroup patients in the intermediate-risk group'}, {'id': 'OG002', 'title': 'High-risk SHH Patients', 'description': 'Sonic hedgehog (SHH) medulloblastoma subgroup patients in the high-risk group'}, {'id': 'OG003', 'title': 'Low-risk Group 3 Patients', 'description': 'Group 3 (G3) medulloblastoma subgroup patients in the low-risk group'}, {'id': 'OG004', 'title': 'Intermediate-risk Group 3 Patients', 'description': 'Group 3 medulloblastoma subgroup patients in the intermediate-risk group'}, {'id': 'OG005', 'title': 'High-risk Group 3 Patients', 'description': 'Group 3 medulloblastoma subgroup patients in the high-risk group'}, {'id': 'OG006', 'title': 'Low-risk Group 4 Patients', 'description': 'Group 4 (G4) medulloblastoma subgroup patients in the low-risk group'}, {'id': 'OG007', 'title': 'Intermediate-risk Group 4 Patients', 'description': 'Group 4 (G4) medulloblastoma subgroup patients in the intermediate-risk group'}, {'id': 'OG008', 'title': 'High-risk Group 4 Patients', 'description': 'Group 4 medulloblastoma subgroup patients in the high-risk group'}], 'classes': [{'categories': [{'measurements': [{'value': '73.9', 'groupId': 'OG000', 'lowerLimit': '56.5', 'upperLimit': '91.3'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '19.0', 'upperLimit': '81.0'}, {'value': '54.5', 'groupId': 'OG002', 'lowerLimit': '27.3', 'upperLimit': '81.7'}, {'value': '30.8', 'groupId': 'OG004', 'lowerLimit': '8.5', 'upperLimit': '53.1'}, {'value': '9.1', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '21.1'}, {'value': '62.5', 'groupId': 'OG007', 'lowerLimit': '31.9', 'upperLimit': '93.1'}, {'value': '50.0', 'groupId': 'OG008', 'lowerLimit': '1.0', 'upperLimit': '99.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From date on treatment to date of first progression or relapse or disease related death or date of last contact, estimated at 1 year after treatment', 'description': 'Defined as the time interval from date on treatment until the date of first progression, medulloblastoma-related death or date of last contact for patients who have not experienced an event. Eligible medulloblastoma patients who received any methotrexate and had molecularly confirmed medulloblastoma are included in this analysis. Five patients were excluded as 3 had no archival tissue available and 2 were found to not be medulloblastoma by methylation profile.', 'unitOfMeasure': 'Percent Probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients with molecularly confirmed medulloblastoma (n=76) were included. PFS estimates are reported by methylation subgroup and risk group. There were no low-risk group 3 or group 4 patients.'}, {'type': 'PRIMARY', 'title': 'Percent Probability of Event-free Survival (EFS) for Medulloblastoma Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Medulloblastoma patients \\<3 years of age; histological diagnosis of desmoplastic nodular (DN)/medulloblastoma with extensive nodularity (MBEN); no evidence of metastatic disease (M0); and a surgical gross total resection (GTR) or near total resection (NTR) defined as residual tumor or imaging abnormality (not definite for residual tumor) with a size of less than 1 cm\\^2 on post-op computed tomography (CT) or magnetic resonance imaging (MRI) \\[R0\\])'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Medulloblastoma patients \\<3 years of age, M0, and either R0 resection with any other medullo histology other than DN/MBEN (i.e., classic or large cell anaplastic (LCA)), or with a subtotal resection (with a residual tumor or imaging abnormality with a size of \\>1 cm\\^2 on post-op imaging (R+), and DN/MBEN). Children 3-5 years of age were also included in this group High Risk'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Medulloblastoma patients \\<3 years of age with evidence of metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '73.9', 'groupId': 'OG000', 'lowerLimit': '56.5', 'upperLimit': '91.3'}, {'value': '46.9', 'groupId': 'OG001', 'lowerLimit': '30.2', 'upperLimit': '63.6'}, {'value': '30.8', 'groupId': 'OG002', 'lowerLimit': '14.1', 'upperLimit': '47.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From date on treatment to date of first progression, relapse, second malignancy or death from any cause or to date of last contact, estimated at 1 year after', 'description': 'Defined as the time interval from date on treatment until the date of first progression, second malignancy or death due to any cause; or date of last contact for patients who have not experienced an event. All eligible medulloblastoma patients who received any methotrexate are included in this analysis.', 'unitOfMeasure': 'Percent Probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible medulloblastoma patients (n=81) were included. EFS estimates are reported by risk group.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Chromosomal Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Medulloblastoma patients \\<3 years of age; histological diagnosis of desmoplastic nodular (DN)/medulloblastoma with extensive nodularity (MBEN); no evidence of metastatic disease (M0); and a surgical gross total resection (GTR) or near total resection (NTR) defined as residual tumor or imaging abnormality (not definite for residual tumor) with a size of less than 1 cm\\^2 on post-op computed tomography (CT) or magnetic resonance imaging (MRI) \\[R0\\])'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Medulloblastoma patients \\<3 years of age, M0, and either R0 resection with any other medullo histology other than DN/MBEN (i.e., classic or large cell anaplastic (LCA)), or with a subtotal resection (with a residual tumor or imaging abnormality with a size of \\>1 cm\\^2 on post-op imaging (R+), and DN/MBEN). Children 3-5 years of age were also included in this group High Risk'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Medulloblastoma patients \\<3 years of age with evidence of metastatic disease'}], 'classes': [{'title': 'chr2p gain/amplification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'chr2p loss/deletion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'chr2q gain/amplification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'chr2q loss/deletion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'chr6p gain/amplification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'chr6p loss/deletion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'chr6q gain/amplification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'chr6q loss/deletion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'chr8p gain/amplification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'chr8p loss/deletion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'chr8q gain/amplification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'chr8q loss/deletion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'chr9p gain/amplification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'chr9p loss/deletion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'chr9q gain/amplification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'chr9q loss/deletion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'chr10p gain/amplification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'chr10p loss/deletion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'chr10q gain/amplification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'chr10q loss/deletion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'chr20p gain/amplification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'chr20p loss/deletion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'chr20q gain/amplification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'chr20q loss/deletion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment', 'description': 'Amplifications and deletions (gains and losses) for chromosomes of interest are shown in the table of measured values.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible medulloblastoma patients (n=81) were included in these analyses. 23 of 23 low risk patients had data available for this objective, as did 27/32 and 24/26 intermediate and high risk patients.'}, {'type': 'SECONDARY', 'title': 'Numbers of Patients With Gene Alterations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Medulloblastoma patients \\<3 years of age; histological diagnosis of desmoplastic nodular (DN)/medulloblastoma with extensive nodularity (MBEN); no evidence of metastatic disease (M0); and a surgical gross total resection (GTR) or near total resection (NTR) defined as residual tumor or imaging abnormality (not definite for residual tumor) with a size of less than 1 cm\\^2 on post-op computed tomography (CT) or magnetic resonance imaging (MRI) \\[R0\\])'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Medulloblastoma patients \\<3 years of age, M0, and either R0 resection with any other medullo histology other than DN/MBEN (i.e., classic or large cell anaplastic (LCA)), or with a subtotal resection (with a residual tumor or imaging abnormality with a size of \\>1 cm\\^2 on post-op imaging (R+), and DN/MBEN). Children 3-5 years of age were also included in this group High Risk'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Medulloblastoma patients \\<3 years of age with evidence of metastatic disease'}], 'classes': [{'title': 'PTCH1 alteration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'SUFU alteration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'KMT2D alteration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'SMO alteration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'BCOR alteration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'PTEN alteration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'BRCA2 alteration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'GLI2 alteration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'SMARCA4 alteration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'TP53 alteration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'MYCN alteration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment', 'description': 'Gene alterations, which include single nucleotide variants (SNPs), amplifications, deletions, translocations, indels, and germline alterations are shown for specific genes of interest in the results table.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible medulloblastoma patients (n=81) were included in these analyses. Not all patients had data available for each gene.'}, {'type': 'SECONDARY', 'title': 'Numbers of Patients With Molecular Abnormalities by Tumor Type', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-risk SHH Patients', 'description': 'Sonic hedgehog (SHH) medulloblastoma subgroup patients in the low-risk group'}, {'id': 'OG001', 'title': 'Intermediate-risk SHH Patients', 'description': 'Sonic hedgehog (SHH) medulloblastoma subgroup patients in the intermediate-risk group'}, {'id': 'OG002', 'title': 'High-risk SHH Patients', 'description': 'Sonic hedgehog (SHH) medulloblastoma subgroup patients in the high-risk group'}, {'id': 'OG003', 'title': 'Low-risk Group 3 Patients', 'description': 'Group 3 (G3) medulloblastoma subgroup patients in the low-risk group'}, {'id': 'OG004', 'title': 'Intermediate-risk Group 3 Patients', 'description': 'Group 3 medulloblastoma subgroup patients in the intermediate-risk group'}, {'id': 'OG005', 'title': 'High-risk Group 3 Patients', 'description': 'Group 3 medulloblastoma subgroup patients in the high-risk group'}, {'id': 'OG006', 'title': 'Low-risk Group 4 Patients', 'description': 'Group 4 (G4) medulloblastoma subgroup patients in the low-risk group'}, {'id': 'OG007', 'title': 'Intermediate-risk Group 4 Patients', 'description': 'Group 4 (G4) medulloblastoma subgroup patients in the intermediate-risk group'}, {'id': 'OG008', 'title': 'High-risk Group 4 Patients', 'description': 'Group 4 medulloblastoma subgroup patients in the high-risk group'}], 'classes': [{'title': 'PTCH1 alteration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'SUFU alteration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'KMT2D alteration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'SMO alteration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'BCOR alteration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'PTEN alteration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'BRCA2 alteration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'GLI2 alteration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'SMARCA4 alteration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'TP53 alteration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'MYCN amplification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': 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'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'chr8q gain/amplification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '7', 'groupId': 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{'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'chr9p gain/amplification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'chr9p loss/deletion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '11', 'groupId': 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'OG002'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'chr9q loss/deletion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'chr10p gain/amplification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'chr10p loss/deletion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'chr10q gain/amplification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'chr10q loss/deletion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'chr20p gain/amplification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': 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'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'chr20q gain/amplification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'chr20q loss/deletion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment', 'description': 'Alterations included single nucleotide variants (SNPs), amplifications, deletions, translocations, indels, and germline alterations. Cytogenetic information shows gains and losses as specified in the table of measured values.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients with molecularly confirmed medulloblastoma (n=76) were included in these analyses. Not all patients had data available for each gene.'}, {'type': 'SECONDARY', 'title': 'Number of Successful Collections for Frozen and Fixed Tumor Samples', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic or high grade glioma histology will receive induction chemotherapy and low-risk therapy.'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with (M0) medulloblastoma or nodular desmoplastic histology with less than a GTR, other histologic diagnoses with no metastatic disease, will receive induction chemotherapy and intermediate-risk therapy.'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease will receive induction chemotherapy and high-risk therapy.'}], 'classes': [{'title': 'Number with frozen tumor tissue', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}]}, {'title': 'Number with fixed tumor tissue', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment', 'description': 'Successful collections will be defined as the number of patients who have frozen/fixed tumor samples available.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible patients enrolled (n=290) were included in this analysis. The numbers of patients with pre-study samples were considered for these results.'}, {'type': 'SECONDARY', 'title': 'Event-free Survival (EFS) Compared to Historical Controls', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SJYC07 Low-risk Medulloblastoma Patients', 'description': 'Medulloblastoma patients \\<3 years of age; histological diagnosis of desmoplastic nodular (DN)/medulloblastoma with extensive nodularity (MBEN); no evidence of metastatic disease (M0); and a surgical gross total resection (GTR) or near total resection (NTR) defined as residual tumor or imaging abnormality (not definite for residual tumor) with a size of less than 1 cm\\^2 on post-op computed tomography (CT) or magnetic resonance imaging (MRI) \\[R0\\])'}, {'id': 'OG001', 'title': 'SJYC07 Intermediate-risk Medulloblastoma Patients', 'description': 'SJYC07 medulloblastoma patients \\<3 years of age, no evidence of metastatic disease (M0), and either R0 resection with any other medullo histology other than histological diagnosis of desmoplastic nodular (DN)/medulloblastoma with extensive nodularity (MBEN) (i.e., classic or large cell anaplastic (LCA)), or with a subtotal resection (with a residual tumor or imaging abnormality with a size of \\>1 cm\\^2 on post-op imaging (R+), and DN/MBEN). Children 3-5 years of age were also included in this group'}, {'id': 'OG002', 'title': 'SJYC07 High-risk Medulloblastoma Patients', 'description': 'SJYC07 medulloblastoma patients \\<3 years of age with evidence of metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '73.9', 'groupId': 'OG000', 'lowerLimit': '56.5', 'upperLimit': '91.3'}, {'value': '46.9', 'groupId': 'OG001', 'lowerLimit': '30.2', 'upperLimit': '63.6'}, {'value': '30.8', 'groupId': 'OG002', 'lowerLimit': '14.1', 'upperLimit': '47.5'}]}]}], 'analyses': [{'groupIds': ['OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.99', 'ciLowerLimit': '1.17', 'ciUpperLimit': '21.23', 'groupDescription': 'The historical control included 10 medulloblastoma patients treated during 1998-2006 who would have been classified as intermediate risk according to SJYC07 criteria (section 13.1.3 of protocol).', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.86', 'ciLowerLimit': '0.40', 'ciUpperLimit': '1.84', 'groupDescription': 'The historical control included 14 medulloblastoma patients treated during 1998-2006 who would have been classified as high risk according to SJYC07 criteria (section 13.1.3 of protocol).', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From date on treatment until date of first event (progression, second malignancy or death) or until date of last contact, assessed up to 10 years', 'description': 'EFS was measured from the date of initial treatment to the earliest date of disease progression, second malignancy or death for patients who fail; and to the date of last contact for patients who remain at risk for failure. 1-year EFS estimates are reported by risk group. EFS was compared to St. Jude historical cohorts by risk group using hazard ratios with 95% confidence intervals.', 'unitOfMeasure': 'Percent probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible medulloblastoma patients who received any methotrexate were included in this analysis. Hazard ratios with 95% confidence intervals are reported and compare SJYC07 patients to historical controls in each risk group. As there were too few low-risk historical controls, no hazard ratio is included for the low-risk group.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) Compared to Historical Controls', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SJYC07 Low-risk Medulloblastoma Patients', 'description': 'Medulloblastoma patients \\<3 years of age; histological diagnosis of desmoplastic nodular (DN)/medulloblastoma with extensive nodularity (MBEN); no evidence of metastatic disease (M0); and a surgical gross total resection (GTR) or near total resection (NTR) defined as residual tumor or imaging abnormality (not definite for residual tumor) with a size of less than 1 cm\\^2 on post-op computed tomography (CT) or magnetic resonance imaging (MRI) \\[R0\\])'}, {'id': 'OG001', 'title': 'SJYC07 Intermediate-risk Medulloblastoma Patients', 'description': 'SJYC07 medulloblastoma patients \\<3 years of age, no evidence of metastatic disease (M0), and either R0 resection with any other medullo histology other than histological diagnosis of desmoplastic nodular (DN)/medulloblastoma with extensive nodularity (MBEN) (i.e., classic or large cell anaplastic (LCA)), or with a subtotal resection (with a residual tumor or imaging abnormality with a size of \\>1 cm\\^2 on post-op imaging (R+), and DN/MBEN). Children 3-5 years of age were also included in this group'}, {'id': 'OG002', 'title': 'SJYC07 High-risk Medulloblastoma Patients', 'description': 'SJYC07 medulloblastoma patients \\<3 years of age with evidence of metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '84.4', 'groupId': 'OG001', 'lowerLimit': '72.1', 'upperLimit': '96.7'}, {'value': '61.5', 'groupId': 'OG002', 'lowerLimit': '43.9', 'upperLimit': '79.1'}]}]}], 'analyses': [{'groupIds': ['OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.85', 'ciLowerLimit': '0.42', 'ciUpperLimit': '8.22', 'groupDescription': 'The historical control included 10 medulloblastoma patients treated during 1998-2006 who would have been classified as intermediate risk according to SJYC07 criteria (section 13.1.3 of protocol).', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.75', 'ciLowerLimit': '0.31', 'ciUpperLimit': '1.79', 'groupDescription': 'The historical control included 14 medulloblastoma patients treated during 1998-2006 who would have been classified as high risk according to SJYC07 criteria (section 13.1.3 of protocol).', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '1 year after treatment initiation of last patient', 'description': 'OS was measured from the date of initial treatment to date of death or to date of last contact for survivors. 1-year OS estimates were reported by risk group. OS was compared to St. Jude historical cohorts by risk group using hazard ratios with 95% confidence intervals.', 'unitOfMeasure': 'Percent probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible medulloblastoma patients who received any methotrexate were included in this analysis. Hazard ratios with 95% confidence intervals are reported and compare SJYC07 patients to historical controls in each risk group. As there were too few low-risk historical controls, no hazard ratio is included for the low-risk group.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Objective Responses Rate to Induction Chemotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intermediate-Risk Group', 'description': 'Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease'}, {'id': 'OG001', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '58.3', 'groupId': 'OG000', 'lowerLimit': '50.2', 'upperLimit': '66.2'}, {'value': '21.1', 'groupId': 'OG001', 'lowerLimit': '12.5', 'upperLimit': '31.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From on-study date to 2 months after completion of induction chemotherapy (up to 4 months after on-study date)', 'description': 'For patients treated in the intermediate and high risk strata with residual or metastatic disease we will estimate the stratum-specific objective response rate (complete response (CR) or partial response \\[ PR\\]). All patients who receive at least 1 -dose of methotrexate are evaluable for response. Objective responses must be sustained for at least eight weeks.', 'unitOfMeasure': 'Percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible intermediate and high risk group patients who received at least 1 dose of methotrexate were included in this analysis. One of the high risk patients did not start therapy and was excluded.'}, {'type': 'SECONDARY', 'title': 'Feasibility and Toxicity of Administering Vinblastine With Induction Chemotherapy for Patients With Metastatic Disease as Measured by the Percentage of Courses Delayed for More Than 7 Days Due to Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}]}, {'units': 'courses', 'counts': [{'value': '263', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '6.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From on-study date up to 4 months after on-study date', 'description': 'For the subset of patients with metastatic disease (high-risk group patients), during induction, the proportion percentage of courses during which subsequent chemotherapy administration was delayed for more than 7 days due to toxicity will be calculated. Patients were to receive 4 courses of induction and then consolidation chemotherapy.', 'unitOfMeasure': 'Percentage of courses delayed', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'courses', 'denomUnitsSelected': 'courses', 'populationDescription': 'Eligible high-risk group patients who started therapy were included in this analysis (n=76). 1 patient enrolled on the high-risk arm did not start therapy due to early disease progression and was excluded. Courses 2-4 of induction and the 1st consolidation course were used in this analysis. 76 patients (with 263 courses) were included.'}, {'type': 'SECONDARY', 'title': 'Feasibility and Toxicity of Administering Consolidation Therapy Including Cyclophosphamide and Pharmacokinetically Targeted Topotecan to Patients With Metastatic Disease Based on the Percentage of Courses Delayed for More Than 7 Days Due to Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}, {'units': 'courses', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '8.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At completion of consolidation therapy (up to 6 months after on-study date)', 'description': 'For the subset of patients with metastatic disease (high-risk group patients), during consolidation, we will calculate the number and proportion of courses during which subsequent chemotherapy administration was delayed for more than 7 days due to toxicity. Patients were to received 2 courses of consolidation chemotherapy and then maintenance therapy.', 'unitOfMeasure': 'Percentage of courses delayed', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'courses', 'denomUnitsSelected': 'courses', 'populationDescription': 'Eligible high-risk group patients who started therapy were included. Course 2 of consolidation and the 1st course of maintenance were used in this analysis and assessed for delays \\>7 days due to toxicity. Of the 76 high-risk patients that started induction therapy, 50 started consolidation (with 47 courses included in this analysis).'}, {'type': 'SECONDARY', 'title': 'Percent of Patients With Sustained Objective Responses Rate After Consolidation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '13.2', 'groupId': 'OG000', 'lowerLimit': '4.4', 'upperLimit': '28.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks after completion of consolidation therapy (up to 8 months after on-study date)', 'description': 'For patients enrolled on the high-risk arm with measurable residual disease after induction treated with consolidation therapy, we will estimate the objective response (complete response (CR)/partial response (PR)) rate after consolidation therapy with a 95% confidence interval. Objective responses must be sustained for at least eight weeks. All patients who receive at least 1 dose of cyclophosphamide or topotecan during consolidation are evaluable for response.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 50 high-risk patients that started consolidation chemotherapy, 38 had measurable residual disease after induction and were included in this result.'}, {'type': 'SECONDARY', 'title': 'Feasibility and Toxicity of Administering Oral Maintenance Therapy in Children <3 Years of Age as Measured by the Percentage of Total Scheduled Maintenance Doses Received', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients \\<3 years of age with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic or high grade glioma histology will receive induction chemotherapy and low-risk therapy.'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients \\<3 years of age with M0 medulloblastoma or nodular desmoplastic histology with less than a GTR, other histologic diagnoses with no metastatic disease, will receive induction chemotherapy and intermediate-risk therapy.'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients \\<3 years of age with central nervous system (CNS) metastatic disease will receive induction chemotherapy and high-risk therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '96', 'spread': '8', 'groupId': 'OG000'}, {'value': '91', 'spread': '23', 'groupId': 'OG001'}, {'value': '98', 'spread': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From start of oral maintenance therapy (approximately 6 months after on-study date) to completion of oral maintenance therapy (up to 1 year after on-study date)', 'description': 'These data are based on patient diaries. For children \\<3 years of age, we will calculate the percentage of total scheduled doses each patient received per course for each of the oral maintenance courses and report the overall average number percentage of doses received per course across patients. If patients received all planned doses, their percentage would be 100%. If the average percentage was less than 75%, then feasibility would be in question.', 'unitOfMeasure': 'Percentage of scheduled doses received', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients less than 3 years of age (n=273) constituted the study population for this analysis; 167 of these patients started the first course of maintenance and were included in this analysis (50 low-risk, 87 intermediate-risk, and 30 high-risk patients).'}, {'type': 'SECONDARY', 'title': 'Percent of PET Scans With Loss of Signal Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}, {'units': 'Scans', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intermediate Risk Group', 'description': 'Patients with M0 medulloblastoma or nodular desmoplastic histology with less than a GTR, other histologic diagnoses with no metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'spread': '27', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 3 times during RT consolidation', 'description': 'Measures will be analyzed for intermediate risk participants who receive proton beam therapy (PBT) and who consent. This objective aims to assess the feasibility of using post-proton beam therapy (PBT) positron emission tomography (PET) as an in-vivo dosimetric and distal edge verification system in this patient population. To quantify the decay in signal, 134 scans from 53 patients were analyzed by recording the mean activation value (MAV), the average recorded PET signal from activation, within the target volume. With each patient being given the same dose, the percent standard deviation in the MAV can serve as a quantitative representation of signal loss due to radioactive decay.', 'unitOfMeasure': 'mean activation value (MAV)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Scans', 'denomUnitsSelected': 'Scans', 'populationDescription': 'Intermediate risk patients treated at St. Jude were eligible to receive proton beam therapy through referral to the University of Florida Proton Therapy Institute. Patients electing to receive PBT and post-treatment PET scans after the delivery of one treatment beam were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Concentration of Cerebrospinal Fluid Neurotransmitters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Neurotransmitter Studies', 'description': 'Patients with neurotransmitter studies'}], 'classes': [{'title': 'Dopamine concentration at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.16', 'groupId': 'OG000', 'lowerLimit': '0.18', 'upperLimit': '4586.18'}]}]}, {'title': 'Dopamine concentration at completion of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.70', 'groupId': 'OG000', 'lowerLimit': '0.82', 'upperLimit': '39.16'}]}]}, {'title': 'Dopamine concentration at 12 months off treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.43', 'groupId': 'OG000', 'lowerLimit': '2.20', 'upperLimit': '486.46'}]}]}, {'title': 'Dopamine concentration at 24 months off treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.46', 'groupId': 'OG000', 'lowerLimit': '0.04', 'upperLimit': '1093.28'}]}]}, {'title': 'Dopamine concentration at 36 months off treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.05', 'groupId': 'OG000', 'lowerLimit': '0.11', 'upperLimit': '9.32'}]}]}, {'title': '3,4-dihydroxyphenylacetic acid concentration at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.56', 'groupId': 'OG000', 'lowerLimit': '0.91', 'upperLimit': '11.24'}]}]}, {'title': '3,4-dihydroxyphenylacetic acid concentration at completion of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.62', 'groupId': 'OG000', 'lowerLimit': '0.82', 'upperLimit': '9.91'}]}]}, {'title': '3,4-dihydroxyphenylacetic acid concentration at 12 months off treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.04', 'groupId': 'OG000', 'lowerLimit': '0.51', 'upperLimit': '6.55'}]}]}, {'title': '3,4-dihydroxyphenylacetic acid concentration at 24 months off treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.52', 'groupId': 'OG000', 'lowerLimit': '0.31', 'upperLimit': '6.70'}]}]}, {'title': '3,4-dihydroxyphenylacetic acid concentration at 36 months off treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.38', 'upperLimit': '3.10'}]}]}, {'title': 'Hydroxytryptamine concentration at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.38', 'groupId': 'OG000', 'lowerLimit': '0.12', 'upperLimit': '13.94'}]}]}, {'title': 'Hydroxytryptamine concentration at completion of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.01', 'groupId': 'OG000', 'lowerLimit': '0.06', 'upperLimit': '15.01'}]}]}, {'title': 'Hydroxytryptamine concentration at 12 months off treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '0.06', 'upperLimit': '8.46'}]}]}, {'title': 'Hydroxytryptamine concentration at 24 months off treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.44', 'groupId': 'OG000', 'lowerLimit': '1.01', 'upperLimit': '7.70'}]}]}, {'title': 'Hydroxytryptamine concentration at 36 months off treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.62', 'groupId': 'OG000', 'lowerLimit': '0.29', 'upperLimit': '8.85'}]}]}, {'title': 'Hydroxyindoleacetic acid concentration at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '52.03', 'groupId': 'OG000', 'lowerLimit': '30.02', 'upperLimit': '400.35'}]}]}, {'title': 'Hydroxyindoleacetic acid concentration at completion of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '52.72', 'groupId': 'OG000', 'lowerLimit': '27.42', 'upperLimit': '110.24'}]}]}, {'title': 'Hydroxyindoleacetic acid concentration at 12 months off treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35.72', 'groupId': 'OG000', 'lowerLimit': '24.58', 'upperLimit': '51.60'}]}]}, {'title': 'Hydroxyindoleacetic acid concentration at 24 months off treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33.98', 'groupId': 'OG000', 'lowerLimit': '25.69', 'upperLimit': '45.63'}]}]}, {'title': 'Hydroxyindoleacetic acid concentration at 36 months off treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31.56', 'groupId': 'OG000', 'lowerLimit': '16.09', 'upperLimit': '53.04'}]}]}, {'title': 'Homovanillic acid concentration at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '82.44', 'groupId': 'OG000', 'lowerLimit': '34.57', 'upperLimit': '565.30'}]}]}, {'title': 'Homovanillic acid concentration at completion of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '114.13', 'groupId': 'OG000', 'lowerLimit': '73.43', 'upperLimit': '179.21'}]}]}, {'title': 'Homovanillic acid concentration at 12 months off treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '68.28', 'groupId': 'OG000', 'lowerLimit': '40.78', 'upperLimit': '146.84'}]}]}, {'title': 'Homovanillic acid concentration at 24 months off treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '88.27', 'groupId': 'OG000', 'lowerLimit': '55.27', 'upperLimit': '166.99'}]}]}, {'title': 'Homovanillic acid concentration at 36 months off treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '79.78', 'groupId': 'OG000', 'lowerLimit': '35.40', 'upperLimit': '152.51'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, at the completion of therapy, and every 12 months up to 36 months after off therapy date', 'description': 'Concentrations of various neurotransmitters in cerebrospinal fluid were measured at 5 timepoints. The median concentration of each neurotransmitter at each time point was calculated and provided with a full range.', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who had cerebrospinal fluid neurotransmitter studies performed. Seventeen patients had studies performed.'}, {'type': 'SECONDARY', 'title': 'Number and Type of Genetic Polymorphisms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Number of Patients With Neurotransmitter Studies', 'description': 'Number of patients with neurotransmitter studies'}], 'classes': [{'title': 'rs6323', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'rs4680', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'rs6280', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At study enrollment (Day 0)', 'description': 'Types of genetic polymorphisms of neurotransmitters were examined. We studied 3 genetic polymorphisms; these were types of genetic polymorphisms involved in dopamine metabolism. They were as follows: rs6323, rs4680, and rs6280.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Three genetic polymorphisms involved in dopamine metabolism (rs6323, rs4680, and rs6280) were studied in 17 patients with CNS neurotransmitter studies.'}, {'type': 'SECONDARY', 'title': 'Pharmacogenetic Variation on Central Nervous System Transmitters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Neurotransmitter Studies', 'description': 'Patients with neurotransmitter studies'}], 'classes': [{'title': 'Genetic Polymorphisms for monoamine oxidase A (MAOA) rs6323', 'categories': [{'title': 'AA', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'AG', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'CC', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'GG', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'TC', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'TG', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'TT', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Genetic Polymorphisms for catecholamine-O-methyltransferase (COMT) rs4680', 'categories': [{'title': 'AA', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'AG', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'CC', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'GG', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'TC', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'TG', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'TT', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Genetic Polymorphisms for dopamine receptor D (DRD3) rs6280', 'categories': [{'title': 'AA', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'AG', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'CC', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'GG', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'TC', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'TG', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'TT', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At study enrollment (Day 0)', 'description': 'Frequencies of genetic polymorphisms were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who had neurotransmitter studies performed. Seventeen patients had studies performed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Endocrinopathy', 'timeFrame': 'Baseline, end of therapy, and at 6- and 24-months after completion of therapy', 'description': 'Serial GH testing (at baseline, the end of therapy, and at 6 and 24 months after completion of therapy) will be performed on consenting patients in order to estimate longitudinal change in GH secretion as measured by mean peak GH values, with the intent to explore associations with radiation dose to the hypothalamus. Since determination of proton- or photon-based radiotherapy is not based on randomization, it will not be possible to compare the endocrine outcome between the patients with and without PBT. However, the differences between these two clinical cohorts with respect to clinical and demographic variables of interest will be summarized via descriptive statistics.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Longitudinal Change in Growth Hormone Secretion', 'timeFrame': 'Baseline, end of therapy, and at 6- and 24-months after completion of therapy', 'description': 'The intent of this objective is to estimate the longitudinal change in abnormal GH secretion as measured by mean peak GH values via a mixed effects model for the patients who receive PBT.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Methotrexate Clearance in Induction Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '5.69', 'groupId': 'OG000', 'lowerLimit': '2.19', 'upperLimit': '11.08'}, {'value': '6.06', 'groupId': 'OG001', 'lowerLimit': '3.07', 'upperLimit': '10.69'}, {'value': '5.65', 'groupId': 'OG002', 'lowerLimit': '1.71', 'upperLimit': '9.45'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-infusion and 6, 23, 42, 66 hours from start of Methotrexate (MTX)', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 1. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate clearance are obtained using post hoc analysis.', 'unitOfMeasure': 'L/h/m^2', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who received methotrexate during induction cycle 1 and had samples collected for PK analysis'}, {'type': 'SECONDARY', 'title': 'Methotrexate Clearance in Induction Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '5.47', 'groupId': 'OG000', 'lowerLimit': '2.43', 'upperLimit': '10.56'}, {'value': '5.70', 'groupId': 'OG001', 'lowerLimit': '2.71', 'upperLimit': '8.98'}, {'value': '5.70', 'groupId': 'OG002', 'lowerLimit': '2.78', 'upperLimit': '8.79'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-infusion and 6, 23, 42, 66 hours from start of MTX', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 2. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate clearance are obtained using post hoc analysis.', 'unitOfMeasure': 'L/h/m^2', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who received methotrexate during induction cycle 2 and had samples collected for PK analysis.'}, {'type': 'SECONDARY', 'title': 'Methotrexate Clearance in Induction Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '5.68', 'groupId': 'OG000', 'lowerLimit': '1.93', 'upperLimit': '9.61'}, {'value': '5.78', 'groupId': 'OG001', 'lowerLimit': '2.59', 'upperLimit': '9.27'}, {'value': '5.81', 'groupId': 'OG002', 'lowerLimit': '2.78', 'upperLimit': '10.20'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-infusion and 6, 23, 42, 66 hours from start of MTX', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 3. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate clearance are obtained using post hoc analysis.', 'unitOfMeasure': 'L/h/m^2', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who received methotrexate during induction cycle 3 and had samples collected for PK analysis.'}, {'type': 'SECONDARY', 'title': 'Methotrexate Clearance in Induction Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '5.75', 'groupId': 'OG000', 'lowerLimit': '2.14', 'upperLimit': '9.65'}, {'value': '5.89', 'groupId': 'OG001', 'lowerLimit': '2.95', 'upperLimit': '8.84'}, {'value': '5.79', 'groupId': 'OG002', 'lowerLimit': '2.36', 'upperLimit': '9.16'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-infusion and 6, 23, 42, 66 hours from start of MTX', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 4. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate clearance are obtained using post hoc analysis.', 'unitOfMeasure': 'L/h/m^2', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who received methotrexate during induction cycle 4 and had samples collected for PK analysis.'}, {'type': 'SECONDARY', 'title': 'Methotrexate Volume of Central Compartment in Induction Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '11.63', 'groupId': 'OG000', 'lowerLimit': '7.09', 'upperLimit': '29.58'}, {'value': '13.70', 'groupId': 'OG001', 'lowerLimit': '7.03', 'upperLimit': '28.21'}, {'value': '13.25', 'groupId': 'OG002', 'lowerLimit': '5.65', 'upperLimit': '20.89'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-infusion and 6, 23, 42, 66 hours from start of MTX', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 1. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate volume of central compartment are obtained using post hoc analysis.', 'unitOfMeasure': 'L/m^2', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who received methotrexate during induction cycle 1 and had samples collected for PK analysis.'}, {'type': 'SECONDARY', 'title': 'Methotrexate Volume of Central Compartment in Induction Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '13.77', 'groupId': 'OG000', 'lowerLimit': '5.88', 'upperLimit': '28.19'}, {'value': '13.73', 'groupId': 'OG001', 'lowerLimit': '6.47', 'upperLimit': '31.45'}, {'value': '13.62', 'groupId': 'OG002', 'lowerLimit': '6.87', 'upperLimit': '22.39'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-infusion and 6, 23, 42, 66 hours from start of MTX', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 2. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate volume of central compartment are obtained using post hoc analysis.', 'unitOfMeasure': 'L/m^2', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who received methotrexate during induction cycle 2 and had samples collected for PK analysis.'}, {'type': 'SECONDARY', 'title': 'Methotrexate Volume of Central Compartment in Induction Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '12.70', 'groupId': 'OG000', 'lowerLimit': '6.27', 'upperLimit': '28.90'}, {'value': '13.55', 'groupId': 'OG001', 'lowerLimit': '7.31', 'upperLimit': '24.48'}, {'value': '13.87', 'groupId': 'OG002', 'lowerLimit': '6.84', 'upperLimit': '22.88'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-infusion and 6, 23, 42, 66 hours from start of MTX', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 3. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate volume of central compartment are obtained using post hoc analysis.', 'unitOfMeasure': 'L/m^2', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who received methotrexate during induction cycle 3 and had samples collected for PK analysis.'}, {'type': 'SECONDARY', 'title': 'Methotrexate AUC0-66h in Induction Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '1797', 'groupId': 'OG000', 'lowerLimit': '993', 'upperLimit': '5029'}, {'value': '1813', 'groupId': 'OG001', 'lowerLimit': '1029', 'upperLimit': '3584'}, {'value': '1821', 'groupId': 'OG002', 'lowerLimit': '1053', 'upperLimit': '3631'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-infusion and 6, 23, 42, 66 hours from start of MTX', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 1. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate AUC0-66h (area under concentration curve from time 0 to 66 hours post-dose) are obtained using post hoc analysis.', 'unitOfMeasure': 'µmol·h/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who received methotrexate during induction cycle 1 and had samples collected for PK analysis.'}, {'type': 'SECONDARY', 'title': 'Methotrexate AUC0-66h in Induction Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '1900', 'groupId': 'OG000', 'lowerLimit': '1042', 'upperLimit': '3267'}, {'value': '1902', 'groupId': 'OG001', 'lowerLimit': '1225', 'upperLimit': '3742'}, {'value': '1879', 'groupId': 'OG002', 'lowerLimit': '1229', 'upperLimit': '3271'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-infusion and 6, 23, 42, 66 hours from start of MTX', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 2. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate AUC0-66h (area under concentration curve from time 0 to 66 hours post-dose) are obtained using post hoc analysis.', 'unitOfMeasure': 'µmol·h/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who received methotrexate during induction cycle 2 and had samples collected for PK analysis.'}, {'type': 'SECONDARY', 'title': 'Methotrexate Volume of Central Compartment in Induction Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '12.64', 'groupId': 'OG000', 'lowerLimit': '7.16', 'upperLimit': '22.92'}, {'value': '13.31', 'groupId': 'OG001', 'lowerLimit': '7.93', 'upperLimit': '21.51'}, {'value': '13.68', 'groupId': 'OG002', 'lowerLimit': '6.94', 'upperLimit': '21.82'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-infusion and 6, 23, 42, 66 hours from start of MTX', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 4. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate volume of central compartment are obtained using post hoc analysis.', 'unitOfMeasure': 'L/m^2', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who received methotrexate during induction cycle 4 and had samples collected for PK analysis.'}, {'type': 'SECONDARY', 'title': 'Methotrexate AUC0-66h in Induction Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '1872', 'groupId': 'OG000', 'lowerLimit': '1145', 'upperLimit': '3501'}, {'value': '1879', 'groupId': 'OG001', 'lowerLimit': '1187', 'upperLimit': '3756'}, {'value': '1831', 'groupId': 'OG002', 'lowerLimit': '979', 'upperLimit': '3139'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-infusion and 6, 23, 42, 66 hours from start of MTX', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 3. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate AUC0-66h (area under concentration curve from time 0 to 66 hours post-dose) are obtained using post hoc analysis.', 'unitOfMeasure': 'µmol·h/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who received methotrexate during induction cycle 3 and had samples collected for PK analysis.'}, {'type': 'SECONDARY', 'title': 'Methotrexate AUC0-66h in Induction Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '1804', 'groupId': 'OG000', 'lowerLimit': '1141', 'upperLimit': '3504'}, {'value': '1841', 'groupId': 'OG001', 'lowerLimit': '1245', 'upperLimit': '3727'}, {'value': '1886', 'groupId': 'OG002', 'lowerLimit': '1219', 'upperLimit': '3491'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-infusion and 6, 23, 42, 66 hours from start of MTX', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 4. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate AUC0-66h (area under concentration curve from time 0 to 66 hours post-dose) are obtained using post hoc analysis.', 'unitOfMeasure': 'µmol·h/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who received methotrexate during induction cycle 4 and had samples collected for PK analysis.'}, {'type': 'SECONDARY', 'title': 'Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '0.49', 'groupId': 'OG000', 'lowerLimit': '0.22', 'upperLimit': '3.68'}, {'value': '0.57', 'groupId': 'OG001', 'lowerLimit': '0.15', 'upperLimit': '4.61'}, {'value': '0.61', 'groupId': 'OG002', 'lowerLimit': '0.14', 'upperLimit': '2.09'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '42 hours from start of MTX', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 1. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate concentration at 42 hours post-dose are obtained using post hoc analysis.', 'unitOfMeasure': 'µmol/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who received methotrexate during induction cycle 1 and had samples collected for PK analysis.'}, {'type': 'SECONDARY', 'title': 'Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '0.75', 'groupId': 'OG000', 'lowerLimit': '0.19', 'upperLimit': '3.09'}, {'value': '0.72', 'groupId': 'OG001', 'lowerLimit': '0.26', 'upperLimit': '7.61'}, {'value': '0.69', 'groupId': 'OG002', 'lowerLimit': '0.24', 'upperLimit': '1.49'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '42 hours from start of MTX', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 2. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate concentration at 42 hours post-dose are obtained using post hoc analysis.', 'unitOfMeasure': 'µmol/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who received methotrexate during induction cycle 2 and had samples collected for PK analysis.'}, {'type': 'SECONDARY', 'title': 'Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '0.65', 'groupId': 'OG000', 'lowerLimit': '0.20', 'upperLimit': '2.88'}, {'value': '0.70', 'groupId': 'OG001', 'lowerLimit': '0.16', 'upperLimit': '4.34'}, {'value': '0.58', 'groupId': 'OG002', 'lowerLimit': '0.24', 'upperLimit': '1.96'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '42 hours from start of MTX', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 3. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate concentration at 42 hours post-dose are obtained using post hoc analysis.', 'unitOfMeasure': 'µmol/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who received methotrexate during induction cycle 3 and had samples collected for PK analysis.'}, {'type': 'SECONDARY', 'title': 'Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '0.64', 'groupId': 'OG000', 'lowerLimit': '0.26', 'upperLimit': '3.12'}, {'value': '0.64', 'groupId': 'OG001', 'lowerLimit': '0.22', 'upperLimit': '3.22'}, {'value': '0.55', 'groupId': 'OG002', 'lowerLimit': '0.20', 'upperLimit': '1.79'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '42 hours from start of MTX', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 4. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate concentration at 42 hours post-dose are obtained using post hoc analysis.', 'unitOfMeasure': 'µmol/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who received methotrexate during induction cycle 4 and had samples collected for PK analysis.'}, {'type': 'SECONDARY', 'title': 'Cyclophosphamide Clearance in Induction Chemotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '2.40', 'groupId': 'OG000', 'lowerLimit': '1.16', 'upperLimit': '9.15'}, {'value': '2.23', 'groupId': 'OG001', 'lowerLimit': '1.23', 'upperLimit': '8.95'}, {'value': '2.25', 'groupId': 'OG002', 'lowerLimit': '0.84', 'upperLimit': '3.40'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion', 'description': 'Cyclophosphamide plasma concentration-time data are collected on day 9 in one cycle of induction chemotherapy. Individual estimates of cyclophosphamide clearance are obtained using post hoc analysis.', 'unitOfMeasure': 'L/h/m^2', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who received cyclophosphamide during a cycle of induction therapy and had samples collected for PK analysis..'}, {'type': 'SECONDARY', 'title': 'Cyclophosphamide Clearance in Consolidation Chemotherapy Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '2.39', 'groupId': 'OG000', 'lowerLimit': '1.65', 'upperLimit': '3.44'}, {'value': '2.08', 'groupId': 'OG001', 'lowerLimit': '1.97', 'upperLimit': '2.62'}, {'value': '2.43', 'groupId': 'OG002', 'lowerLimit': '1.29', 'upperLimit': '3.21'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion', 'description': 'Cyclophosphamide plasma concentration-time data are collected in consolidation cycle 1. Individual estimates of cyclophosphamide clearance are obtained using post hoc analysis.', 'unitOfMeasure': 'L/h/m^2', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who received cyclophosphamide during consolidation cycle 1 and had samples collected for PK analysis.'}, {'type': 'SECONDARY', 'title': 'Cyclophosphamide Clearance in Consolidation Chemotherapy Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '2.48', 'groupId': 'OG000', 'lowerLimit': '1.97', 'upperLimit': '3.35'}, {'value': '2.55', 'groupId': 'OG001', 'lowerLimit': '2.19', 'upperLimit': '2.93'}, {'value': '2.37', 'groupId': 'OG002', 'lowerLimit': '1.61', 'upperLimit': '3.16'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion', 'description': 'Cyclophosphamide plasma concentration-time data are collected in consolidation cycle 2. Individual estimates of cyclophosphamide clearance are obtained using post hoc analysis.', 'unitOfMeasure': 'L/h/m^2', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who received cyclophosphamide during consolidation cycle 2 and had samples collected for PK analysis.'}, {'type': 'SECONDARY', 'title': 'Cyclophosphamide Apparent Oral Clearance in Maintenance Chemotherapy Cycle A1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '2.95', 'groupId': 'OG000', 'lowerLimit': '2.05', 'upperLimit': '3.89'}, {'value': '2.83', 'groupId': 'OG001', 'lowerLimit': '2.23', 'upperLimit': '5.14'}, {'value': '2.74', 'groupId': 'OG002', 'lowerLimit': '2.23', 'upperLimit': '4.02'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose, 0.5, 1.75, 3 and 6 hours post-dose', 'description': 'Cyclophosphamide plasma concentration-time data are collected on day 1 of maintenance cycle A1. Individual estimates of cyclophosphamide apparent oral clearance are obtained using post hoc analysis.', 'unitOfMeasure': 'L/h/m^2', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who received cyclophosphamide during maintenance cycle A1 and had samples collected for PK analysis.'}, {'type': 'SECONDARY', 'title': 'Cyclophosphamide AUC0-24h in Induction Chemotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '2070', 'groupId': 'OG000', 'lowerLimit': '592', 'upperLimit': '4158'}, {'value': '2150', 'groupId': 'OG001', 'lowerLimit': '615', 'upperLimit': '3430'}, {'value': '2105', 'groupId': 'OG002', 'lowerLimit': '1523', 'upperLimit': '5121'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion', 'description': 'Cyclophosphamide plasma concentration-time data are collected on day 9 in one cycle of induction chemotherapy. Individual estimates of cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis.', 'unitOfMeasure': 'µmol·h/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who received cyclophosphamide during a cycle of induction therapy and had samples collected for PK analysis.'}, {'type': 'SECONDARY', 'title': 'Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '1968', 'groupId': 'OG000', 'lowerLimit': '1480', 'upperLimit': '2869'}, {'value': '1504', 'groupId': 'OG001', 'lowerLimit': '617', 'upperLimit': '2511'}, {'value': '868', 'groupId': 'OG002', 'lowerLimit': '660', 'upperLimit': '1498'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion', 'description': 'Cyclophosphamide plasma concentration-time data are collected in consolidation cycle 1. Individual estimates of cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis.', 'unitOfMeasure': 'µmol·h/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who received cyclophosphamide during consolidation cycle 1 and had samples collected for PK analysis.'}, {'type': 'SECONDARY', 'title': '4-OH Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '96.8', 'groupId': 'OG000', 'lowerLimit': '63.0', 'upperLimit': '124.4'}, {'value': '48.7', 'groupId': 'OG001', 'lowerLimit': '25.8', 'upperLimit': '124.6'}, {'value': '39.8', 'groupId': 'OG002', 'lowerLimit': '25.5', 'upperLimit': '59.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion', 'description': '4-OH cyclophosphamide plasma concentration-time data are collected in consolidation cycle 1. Individual estimates of 4-OH cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis.', 'unitOfMeasure': 'µmol·h/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who received cyclophosphamide during consolidation cycle 1 and had samples collected for PK analysis.'}, {'type': 'SECONDARY', 'title': 'Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '1966', 'groupId': 'OG000', 'lowerLimit': '1437', 'upperLimit': '2519'}, {'value': '799', 'groupId': 'OG001', 'lowerLimit': '740', 'upperLimit': '2303'}, {'value': '899', 'groupId': 'OG002', 'lowerLimit': '700', 'upperLimit': '1240'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion', 'description': 'Cyclophosphamide plasma concentration-time data are collected in consolidation cycle 2. Individual estimates of cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis.', 'unitOfMeasure': 'µmol·h/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who received cyclophosphamide during consolidation cycle 2 and had samples collected for PK analysis.'}, {'type': 'SECONDARY', 'title': 'Cyclophosphamide AUC0-24h in Maintenance Chemotherapy Cycle A1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '39.9', 'groupId': 'OG000', 'lowerLimit': '25.3', 'upperLimit': '51.3'}, {'value': '38.7', 'groupId': 'OG001', 'lowerLimit': '21.2', 'upperLimit': '54.9'}, {'value': '42.2', 'groupId': 'OG002', 'lowerLimit': '28.0', 'upperLimit': '53.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose, 0.5, 1.75, 3, 6, and 24 hours post-dose', 'description': 'Cyclophosphamide plasma concentration-time data are collected on day 1 of maintenance cycle A1. Individual estimates of cyclophosphamide AUC0-24h are obtained using post hoc analysis.', 'unitOfMeasure': 'µmol·h/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who received cyclophosphamide during maintenance cycle A1 and had samples collected for PK analysis.'}, {'type': 'SECONDARY', 'title': '4-OH Cyclophosphamide AUC0-24h in Induction Chemotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '116.4', 'groupId': 'OG000', 'lowerLimit': '74.6', 'upperLimit': '200.3'}, {'value': '111.3', 'groupId': 'OG001', 'lowerLimit': '71.4', 'upperLimit': '181.0'}, {'value': '109.1', 'groupId': 'OG002', 'lowerLimit': '65.0', 'upperLimit': '175.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion', 'description': '4-OH cyclophosphamide plasma concentration-time data are collected on day 9 in one cycle of induction chemotherapy. Individual estimates of 4-OH cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis.', 'unitOfMeasure': 'µmol·h/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who received cyclophosphamide during a cycle of induction therapy and had samples collected for PK analysis.'}, {'type': 'SECONDARY', 'title': '4-OH Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '95.9', 'groupId': 'OG000', 'lowerLimit': '81.7', 'upperLimit': '131.1'}, {'value': '49.5', 'groupId': 'OG001', 'lowerLimit': '39.5', 'upperLimit': '84.5'}, {'value': '43.5', 'groupId': 'OG002', 'lowerLimit': '30.8', 'upperLimit': '72.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion', 'description': '4-OH cyclophosphamide plasma concentration-time data are collected in consolidation cycle 2. Individual estimates of 4-OH cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis.', 'unitOfMeasure': 'µmol·h/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who received cyclophosphamide during consolidation cycle 2 and had samples collected for PK analysis.'}, {'type': 'SECONDARY', 'title': '4-OH Cyclophosphamide AUC0-24h in Maintenance Chemotherapy Cycle A1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '1.98', 'groupId': 'OG000', 'lowerLimit': '0.98', 'upperLimit': '3.01'}, {'value': '1.96', 'groupId': 'OG001', 'lowerLimit': '1.12', 'upperLimit': '3.08'}, {'value': '1.82', 'groupId': 'OG002', 'lowerLimit': '1.19', 'upperLimit': '2.40'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose, 0.5, 1.75, 3, 6, and 24 hours post-dose', 'description': '4-OH cyclophosphamide plasma concentration-time data are collected on day 1 of maintenance cycle A1. Individual estimates of 4-OH cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis.', 'unitOfMeasure': 'µmol·h/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who received cyclophosphamide during maintenance cycle A1 and had samples collected for PK analysis.'}, {'type': 'SECONDARY', 'title': 'CEPM AUC0-24h in Induction Chemotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '140.2', 'groupId': 'OG000', 'lowerLimit': '50.1', 'upperLimit': '453.0'}, {'value': '137.8', 'groupId': 'OG001', 'lowerLimit': '80.4', 'upperLimit': '328.9'}, {'value': '135.3', 'groupId': 'OG002', 'lowerLimit': '57.6', 'upperLimit': '591.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion', 'description': 'Carboxyethylphosphoramide mustard (CEPM) plasma concentration-time data are collected on day 9 in one induction cycle. Individual estimates of CEPM AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis.', 'unitOfMeasure': 'µmol·h/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who received cyclophosphamide during a cycle of induction therapy and had samples collected for PK analysis.'}, {'type': 'SECONDARY', 'title': 'CEPM AUC0-24h in Consolidation Chemotherapy Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '128.9', 'groupId': 'OG000', 'lowerLimit': '90.8', 'upperLimit': '272.9'}, {'value': '62.2', 'groupId': 'OG001', 'lowerLimit': '48.8', 'upperLimit': '193.9'}, {'value': '51.8', 'groupId': 'OG002', 'lowerLimit': '18.9', 'upperLimit': '97.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion', 'description': 'Carboxyethylphosphoramide mustard (CEPM) plasma concentration-time data are collected in consolidation cycle 1. Individual estimates of CEPM AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis.', 'unitOfMeasure': 'µmol·h/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who received cyclophosphamide during consolidation cycle 1 and had samples collected for PK analysis.'}, {'type': 'SECONDARY', 'title': 'CEPM AUC0-24h in Consolidation Chemotherapy Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '132.7', 'groupId': 'OG000', 'lowerLimit': '89.7', 'upperLimit': '244.0'}, {'value': '46.8', 'groupId': 'OG001', 'lowerLimit': '41.9', 'upperLimit': '69.0'}, {'value': '44.0', 'groupId': 'OG002', 'lowerLimit': '21.1', 'upperLimit': '73.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion', 'description': 'Carboxyethylphosphoramide mustard (CEPM) plasma concentration-time data are collected in consolidation cycle 2. Individual estimates of CEPM AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis.', 'unitOfMeasure': 'µmol·h/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who received cyclophosphamide during consolidation cycle 2 and had samples collected for PK analysis.'}, {'type': 'SECONDARY', 'title': 'CEPM AUC0-24h in Maintenance Chemotherapy Cycle A1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '1.59', 'groupId': 'OG000', 'lowerLimit': '0.75', 'upperLimit': '3.48'}, {'value': '1.65', 'groupId': 'OG001', 'lowerLimit': '0.68', 'upperLimit': '3.64'}, {'value': '1.41', 'groupId': 'OG002', 'lowerLimit': '0.64', 'upperLimit': '3.96'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose, 0.5, 1.75, 3, 6, and 24 hours post-dose', 'description': 'Carboxyethylphosphoramide mustard (CEPM) plasma concentration-time data are collected on day 1 of maintenance cycle A1. Individual estimates of CEPM AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis.', 'unitOfMeasure': 'µmol·h/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who received cyclophosphamide during maintenance cycle A1 and had samples collected for PK analysis.'}, {'type': 'SECONDARY', 'title': 'Participants With Empirical Dosage Achieving Target System Exposure of Intravenous Topotecan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intermediate-Risk Group', 'description': 'Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease'}, {'id': 'OG001', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Pre-infusion, 5 min., 1, and 3 hours from end of infusion', 'description': 'Number of participants who successfully achieve target systemic exposure of intravenous topotecan after an empiric dosage during consolidation phase of therapy are reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who received topotecan with empirical dosage during consolidation therapy were included in this analysis. Per protocol, low-risk and intermediate-risk patients did not receive topotecan during consolidation unless they experienced disease progression during induction. One such intermediate-risk patient was included.'}, {'type': 'SECONDARY', 'title': 'Participants With PK-guided Dosage Adjustment Achieving Target System Exposure of Intravenous Topotecan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intermediate-Risk Group', 'description': 'Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease'}, {'id': 'OG001', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Pre-infusion, 5 min., 1, and 3 hours from end of infusion', 'description': 'Number of participants who successfully achieve target systemic exposure of intravenous topotecan after a pharmacokinetic-guided dosage adjustment during consolidation phase of therapy are reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who received topotecan with PK-guided dosage adjustment during consolidation therapy were included in this analysis. Per protocol, low-risk and intermediate-risk patients did not receive topotecan during consolidation unless they experienced disease progression during induction. One such intermediate-risk patient was included.'}, {'type': 'SECONDARY', 'title': 'Topotecan Clearance in Consolidation Chemotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intermediate-Risk Group', 'description': 'Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease'}, {'id': 'OG001', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '30.3', 'groupId': 'OG000', 'lowerLimit': '30.3', 'upperLimit': '30.3'}, {'value': '26.40', 'groupId': 'OG001', 'lowerLimit': '6.8', 'upperLimit': '43.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-infusion, 5 min., 1, and 3 hours from end of infusion', 'description': 'Topotecan plasma concentration-time data are collected on day 1 of consolidation cycle 1 after a single IV dose. Individual estimates of topotecan clearance are obtained using post hoc analysis.', 'unitOfMeasure': 'L/h/m^2', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who received intravenous topotecan during consolidation cycle 1 and had PK samples collected were included in this analysis. Per protocol, low- and intermediate-risk patients did not receive topotecan during consolidation unless they experienced disease progression during induction. One such intermediate-risk patient was included.'}, {'type': 'SECONDARY', 'title': 'Topotecan Apparent Oral Clearance in Maintenance Chemotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '41.4', 'groupId': 'OG000', 'lowerLimit': '12.3', 'upperLimit': '54.6'}, {'value': '41.0', 'groupId': 'OG001', 'lowerLimit': '24.4', 'upperLimit': '62.7'}, {'value': '44.6', 'groupId': 'OG002', 'lowerLimit': '18.1', 'upperLimit': '57.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose, 0.25, 1.5 and 6 hours post-dose', 'description': 'Topotecan plasma concentration-time data are collected on day 1 of maintenance cycle A1 after a single oral dose. Individual estimates of topotecan apparent oral clearance are obtained using post hoc analysis.', 'unitOfMeasure': 'L/h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who received oral topotecan during maintenance therapy cycle A1 and had samples collected for PK analysis.'}, {'type': 'SECONDARY', 'title': 'Topotecan AUC0-24h in Consolidation Chemotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intermediate-Risk Group', 'description': 'Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease'}, {'id': 'OG001', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000', 'lowerLimit': '117', 'upperLimit': '117'}, {'value': '116', 'groupId': 'OG001', 'lowerLimit': '90', 'upperLimit': '262'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-infusion, 5 min., 1, 3, and 24 hours from end of infusion', 'description': 'Topotecan plasma concentration-time data are collected on day 1 of consolidation cycle 1 after a single IV dose. Individual estimates of topotecan AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis.', 'unitOfMeasure': 'µg·h/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who received intravenous topotecan during consolidation cycle 1 and had PK samples collected were included in this analysis. Per protocol, low- and intermediate-risk patients did not receive topotecan during consolidation unless they experienced disease progression during induction. One such intermediate-risk patient was included.'}, {'type': 'SECONDARY', 'title': 'Topotecan AUC0-24h in Maintenance Chemotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '10.90', 'groupId': 'OG000', 'lowerLimit': '9.04', 'upperLimit': '24.36'}, {'value': '11.60', 'groupId': 'OG001', 'lowerLimit': '7.93', 'upperLimit': '20.50'}, {'value': '10.33', 'groupId': 'OG002', 'lowerLimit': '7.96', 'upperLimit': '16.61'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose, 0.25, 1.5, 6, and 24 hours post-dose', 'description': 'Topotecan plasma concentration-time data are collected on day 1 of maintenance cycle A1 after a single oral dose. Individual estimates of topotecan AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis.', 'unitOfMeasure': 'µg·h/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who received oral topotecan during maintenance therapy cycle A1 and had samples collected for PK analysis.'}, {'type': 'SECONDARY', 'title': 'Erlotinib Apparent Oral Clearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '6.53', 'groupId': 'OG000', 'lowerLimit': '3.13', 'upperLimit': '18.55'}, {'value': '7.79', 'groupId': 'OG001', 'lowerLimit': '3.87', 'upperLimit': '16.84'}, {'value': '8.40', 'groupId': 'OG002', 'lowerLimit': '5.96', 'upperLimit': '10.46'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose, 1, 2, 4, 8, and 24 hours post-dose', 'description': 'Erlotinib plasma concentration-time data are collected on day 1 of maintenance cycle B2. Individual estimates of erlotinib apparent oral clearance are obtained using post hoc analysis.', 'unitOfMeasure': 'L/h/m^2', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who received oral erlotinib during maintenance therapy cycle B2 and had samples collected for PK analysis.'}, {'type': 'SECONDARY', 'title': 'Erlotinib Apparent Volume of Central Compartment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '72.9', 'groupId': 'OG000', 'lowerLimit': '39.5', 'upperLimit': '233.7'}, {'value': '61.7', 'groupId': 'OG001', 'lowerLimit': '41.3', 'upperLimit': '119.0'}, {'value': '104.8', 'groupId': 'OG002', 'lowerLimit': '47.6', 'upperLimit': '109.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose, 1, 2, 4, 8, and 24 hours post-dose', 'description': 'Erlotinib plasma concentration-time data are collected on day 1 of maintenance cycle B2. Individual estimates of erlotinib apparent volume of central compartment are obtained using post hoc analysis.', 'unitOfMeasure': 'L/m^2', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who received oral erlotinib during maintenance therapy cycle B2 and had samples collected for PK analysis.'}, {'type': 'SECONDARY', 'title': 'Erlotinib AUC0-24h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '31.0', 'groupId': 'OG000', 'lowerLimit': '7.2', 'upperLimit': '64.8'}, {'value': '23.5', 'groupId': 'OG001', 'lowerLimit': '12.5', 'upperLimit': '48.6'}, {'value': '22.0', 'groupId': 'OG002', 'lowerLimit': '13.8', 'upperLimit': '33.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose, 1, 2, 4, 8, and 24 hours post-dose', 'description': 'Erlotinib plasma concentration-time data are collected on day 1 of maintenance cycle B2. Individual estimates of erlotinib AUC0-24h (area under concentration curve from 0 to 24 hours post-dose) are obtained using post hoc analysis.', 'unitOfMeasure': 'µmol·h/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who received oral erlotinib during maintenance therapy cycle B2 and had samples collected for PK analysis.'}, {'type': 'SECONDARY', 'title': 'OSI-420 AUC0-24h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '2.17', 'groupId': 'OG000', 'lowerLimit': '0.73', 'upperLimit': '5.98'}, {'value': '1.81', 'groupId': 'OG001', 'lowerLimit': '1.17', 'upperLimit': '6.97'}, {'value': '1.62', 'groupId': 'OG002', 'lowerLimit': '1.25', 'upperLimit': '2.93'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose, 1, 2, 4, 8, and 24 hours post-dose', 'description': 'Erlotinib metabolite OSI-420 plasma concentration-time data are collected on day 1 of maintenance cycle B2. Individual estimates of OSI-420 AUC0-24h (area under concentration curve from 0 to 24 hours post-dose) are obtained using post hoc analysis.', 'unitOfMeasure': 'µmol·h/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who received oral erlotinib during maintenance therapy cycle B2 and had samples collected for PK analysis.'}, {'type': 'SECONDARY', 'title': 'Rate of Local Disease Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intermediate-risk Patients Who Received Focal Radiation', 'description': 'Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a surgical gross total resection (GTR), other histologic diagnoses with no metastatic disease who received induction chemotherapy and intermediate-risk therapy that included focal radiation.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.2', 'groupId': 'OG000', 'lowerLimit': '7.2', 'upperLimit': '19.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year after completion of radiation therapy for last patient', 'description': 'Local failure was defined as the interval from end of RT to date of local failure (or combined local + distant failure). Competing events were distant failure or second malignancy. Patients without an event were censored at date of last contact. The 1-year cumulative incidence was estimated and reported with a 95% confidence interval.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible intermediate-risk patients who received focal radiation were included in this analysis. Of the 156 intermediate risk patients, 121 started radiation.'}, {'type': 'SECONDARY', 'title': 'Rate of Distant Disease Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intermediate-risk Patients Who Received Focal Radiation', 'description': 'Patients with M0 medulloblastoma or nodular desmoplastic histology with less than a GTR, other histologic diagnoses with no metastatic disease who received induction chemotherapy and intermediate-risk therapy that included focal radiation.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.6', 'groupId': 'OG000', 'lowerLimit': '17.8', 'upperLimit': '33.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year after completion of radiation therapy for last patient', 'description': 'Distant failure was defined as the interval from end of RT to date of distant failure (or combined local + distant failure). Competing events were local failure or second malignancy. Patients without an event were censored at date of last contact. The 1-year cumulative incidence was estimated and reported with a 95% confidence interval.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible intermediate-risk patients who received focal radiation were included in this analysis. Of the 156 intermediate risk patients, 121 started radiation.'}, {'type': 'SECONDARY', 'title': 'Neurocognitive Performance Related to Global Cognitive Functioning as Measured by Cognitive Composite Scores and Estimated IQ Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic (M0) medulloblastoma, nodular desmoplastic or high grade glioma histology will receive induction chemotherapy and low-risk therapy.'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with M0 medulloblastoma or nodular desmoplastic histology with less than a GTR, other histologic diagnoses with no metastatic disease, will receive induction chemotherapy and intermediate-risk therapy.'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease will receive induction chemotherapy and high-risk therapy.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '88.6', 'spread': '17.6', 'groupId': 'OG000'}, {'value': '91.0', 'spread': '15.4', 'groupId': 'OG001'}, {'value': '87.4', 'spread': '22.3', 'groupId': 'OG002'}]}]}, {'title': 'Prior to Maintenance Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '91.1', 'spread': '16.8', 'groupId': 'OG000'}, {'value': '92.3', 'spread': '15.1', 'groupId': 'OG001'}, {'value': '94.8', 'spread': '19.0', 'groupId': 'OG002'}]}]}, {'title': 'Completion of Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '85.8', 'spread': '17.5', 'groupId': 'OG000'}, {'value': '93.4', 'spread': '15.3', 'groupId': 'OG001'}, {'value': '76.8', 'spread': '18.6', 'groupId': 'OG002'}]}]}, {'title': '12 Months Off Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '89.2', 'spread': '21.3', 'groupId': 'OG000'}, {'value': '89.9', 'spread': '15.6', 'groupId': 'OG001'}, {'value': '83.3', 'spread': '18.3', 'groupId': 'OG002'}]}]}, {'title': '24 Months Off Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '97.6', 'spread': '16.7', 'groupId': 'OG000'}, {'value': '89.4', 'spread': '19.0', 'groupId': 'OG001'}, {'value': '77.7', 'spread': '21.0', 'groupId': 'OG002'}]}]}, {'title': '36 Months Off Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '92.4', 'spread': '26.0', 'groupId': 'OG000'}, {'value': '89.9', 'spread': '16.2', 'groupId': 'OG001'}, {'value': '81.3', 'spread': '17.4', 'groupId': 'OG002'}]}]}, {'title': '48 Months Off Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '85.3', 'spread': '24.1', 'groupId': 'OG000'}, {'value': '91.3', 'spread': '18.4', 'groupId': 'OG001'}, {'value': '85.2', 'spread': '27.4', 'groupId': 'OG002'}]}]}, {'title': '60 Months Off Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '82.0', 'spread': '25.6', 'groupId': 'OG000'}, {'value': '85.3', 'spread': '17.9', 'groupId': 'OG001'}, {'value': '71.5', 'spread': '18.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy', 'description': 'Global cognitive functioning was measured based on Cognitive Composite Scores from the Bayley III instrument for subjects \\<3 years of age and on estimated IQ scores from the Stanford Binet V instrument for subjects ≥3 years of age. Higher scores indicate better performance. The normative mean is 100 with a standard deviation of 15.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients with scores at any of the data collection timepoints were included. Sample sizes differ across timepoints as not all subjects had scores for all timepoints.'}, {'type': 'SECONDARY', 'title': 'Neurocognitive Performance Related to Attention as Measured by Attention Problems T-scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic (M0) medulloblastoma, nodular desmoplastic or high grade glioma histology will receive induction chemotherapy and low-risk therapy.'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with M0 medulloblastoma or nodular desmoplastic histology with less than a GTR, other histologic diagnoses with no metastatic disease, will receive induction chemotherapy and intermediate-risk therapy.'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease will receive induction chemotherapy and high-risk therapy.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '51.7', 'spread': '10.9', 'groupId': 'OG000'}, {'value': '49.6', 'spread': '9.5', 'groupId': 'OG001'}, {'value': '49.2', 'spread': '9.1', 'groupId': 'OG002'}]}]}, {'title': 'Prior to Maintenance Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '53.5', 'spread': '9.5', 'groupId': 'OG000'}, {'value': '51.3', 'spread': '9.9', 'groupId': 'OG001'}, {'value': '52.4', 'spread': '4.6', 'groupId': 'OG002'}]}]}, {'title': 'Completion of Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '52.6', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '50.9', 'spread': '9.4', 'groupId': 'OG001'}, {'value': '43.3', 'spread': '12.7', 'groupId': 'OG002'}]}]}, {'title': '12 Months Off Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '56.2', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '53.9', 'spread': '10.2', 'groupId': 'OG001'}, {'value': '53.9', 'spread': '13.0', 'groupId': 'OG002'}]}]}, {'title': '24 Months Off Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '54.5', 'spread': '10.6', 'groupId': 'OG000'}, {'value': '55.3', 'spread': '10.1', 'groupId': 'OG001'}, {'value': '49.8', 'spread': '12.6', 'groupId': 'OG002'}]}]}, {'title': '36 Months Off Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '53.3', 'spread': '8.3', 'groupId': 'OG000'}, {'value': '55.1', 'spread': '9.8', 'groupId': 'OG001'}, {'value': '53.3', 'spread': '12.2', 'groupId': 'OG002'}]}]}, {'title': '48 Months Off Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '56.4', 'spread': '10.4', 'groupId': 'OG000'}, {'value': '55.5', 'spread': '10.1', 'groupId': 'OG001'}, {'value': '55.3', 'spread': '10.3', 'groupId': 'OG002'}]}]}, {'title': '60 Months Off Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '51.9', 'spread': '11.5', 'groupId': 'OG000'}, {'value': '57.7', 'spread': '12.0', 'groupId': 'OG001'}, {'value': '58.8', 'spread': '12.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy', 'description': 'Scores measuring attention were obtained from the Attention Problems T-score on the BASC-2 instrument which is a parent report. Higher scores indicate more attention problems. The normative mean is 50 with a standard deviation of 10.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients with scores at any of the data collection timepoints were included. Sample sizes differ across timepoints as not all subjects had scores for all timepoints.'}, {'type': 'SECONDARY', 'title': 'Neurocognitive Performance Related to Processing Speed as Measured by Visual Matching Standard Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic (M0) medulloblastoma, nodular desmoplastic or high grade glioma histology will receive induction chemotherapy and low-risk therapy.'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with M0 medulloblastoma or nodular desmoplastic histology with less than a GTR, other histologic diagnoses with no metastatic disease, will receive induction chemotherapy and intermediate-risk therapy.'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease will receive induction chemotherapy and high-risk therapy.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '119.0', 'groupId': 'OG000'}, {'value': '96.5', 'spread': '11.0', 'groupId': 'OG001'}, {'value': '107.0', 'groupId': 'OG002'}]}]}, {'title': 'Prior to Maintenance Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '89.0', 'groupId': 'OG000'}, {'value': '97.6', 'spread': '12.3', 'groupId': 'OG001'}, {'value': '109.5', 'spread': '2.1', 'groupId': 'OG002'}]}]}, {'title': 'Completion of Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '105.3', 'spread': '20.2', 'groupId': 'OG000'}, {'value': '100.2', 'spread': '15.2', 'groupId': 'OG001'}]}]}, {'title': '12 Months Off Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '96.8', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '93.1', 'spread': '13.3', 'groupId': 'OG001'}, {'value': '71.0', 'groupId': 'OG002'}]}]}, {'title': '24 Months Off Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '98.4', 'spread': '16.6', 'groupId': 'OG000'}, {'value': '90.2', 'spread': '15.3', 'groupId': 'OG001'}, {'value': '89.3', 'spread': '13.3', 'groupId': 'OG002'}]}]}, {'title': '36 Months Off Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '101.6', 'spread': '15.8', 'groupId': 'OG000'}, {'value': '89.7', 'spread': '20.2', 'groupId': 'OG001'}, {'value': '89.8', 'spread': '12.4', 'groupId': 'OG002'}]}]}, {'title': '48 Months Off Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '93.2', 'spread': '23.9', 'groupId': 'OG000'}, {'value': '87.6', 'spread': '14.7', 'groupId': 'OG001'}, {'value': '78.7', 'spread': '17.0', 'groupId': 'OG002'}]}]}, {'title': '60 Months Off Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '86.3', 'spread': '36.2', 'groupId': 'OG000'}, {'value': '84.6', 'spread': '17.1', 'groupId': 'OG001'}, {'value': '65.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy', 'description': 'Scores measuring processing speed were obtained based on the visual matching standard score from the Woodcock Johnson III instrument. Higher scores indicate better performance. The normative mean is 100 with a standard deviation of 15.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients with scores at any of the data collection timepoints were included. Sample sizes differ across timepoints as not all subjects had scores for all timepoints.'}, {'type': 'SECONDARY', 'title': 'Neurocognitive Performance Related to Executive Functioning as Measured by Global Executive Composite T-scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic (M0) medulloblastoma, nodular desmoplastic or high grade glioma histology will receive induction chemotherapy and low-risk therapy.'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with M0 medulloblastoma or nodular desmoplastic histology with less than a GTR, other histologic diagnoses with no metastatic disease, will receive induction chemotherapy and intermediate-risk therapy.'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease will receive induction chemotherapy and high-risk therapy.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '59.2', 'spread': '16.0', 'groupId': 'OG000'}, {'value': '49.6', 'spread': '9.7', 'groupId': 'OG001'}, {'value': '52.4', 'spread': '13.1', 'groupId': 'OG002'}]}]}, {'title': 'Prior to Maintenance Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '54.3', 'spread': '9.9', 'groupId': 'OG000'}, {'value': '52.5', 'spread': '12.3', 'groupId': 'OG001'}, {'value': '49.3', 'spread': '11.9', 'groupId': 'OG002'}]}]}, {'title': 'Completion of Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '55.3', 'spread': '11.9', 'groupId': 'OG000'}, {'value': '50.6', 'spread': '10.1', 'groupId': 'OG001'}, {'value': '45.3', 'spread': '14.7', 'groupId': 'OG002'}]}]}, {'title': '12 Months Off Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '57.9', 'spread': '13.7', 'groupId': 'OG000'}, {'value': '56.5', 'spread': '14.3', 'groupId': 'OG001'}, {'value': '60.1', 'spread': '20.0', 'groupId': 'OG002'}]}]}, {'title': '24 Months Off Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '59.9', 'spread': '16.5', 'groupId': 'OG000'}, {'value': '55.1', 'spread': '13.6', 'groupId': 'OG001'}, {'value': '52.1', 'spread': '9.6', 'groupId': 'OG002'}]}]}, {'title': '36 Months Off Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '55.7', 'spread': '12.8', 'groupId': 'OG000'}, {'value': '57.7', 'spread': '11.8', 'groupId': 'OG001'}, {'value': '58.2', 'spread': '11.1', 'groupId': 'OG002'}]}]}, {'title': '48 Months Off Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '60.3', 'spread': '16.8', 'groupId': 'OG000'}, {'value': '55.6', 'spread': '11.7', 'groupId': 'OG001'}, {'value': '49.5', 'spread': '10.6', 'groupId': 'OG002'}]}]}, {'title': '60 Months Off Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '55.1', 'spread': '11.8', 'groupId': 'OG000'}, {'value': '58.3', 'spread': '15.0', 'groupId': 'OG001'}, {'value': '55.2', 'spread': '13.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy', 'description': 'Scores measuring executive functioning were obtained from Global Executive Composite (GEC) T-scores, which were obtained from the Behavior Rating Inventory of Executive Function (BRIEF) instrument which is a parent report. Higher scores indicate more problems. The normative mean is 50 with a standard deviation of 10.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients with scores at any of the data collection timepoints were included. Sample sizes differ across timepoints as not all subjects had scores for all timepoints.'}, {'type': 'SECONDARY', 'title': 'Neurocognitive Performance Related to Working Memory as Measured by Working Memory T-scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic (M0) medulloblastoma, nodular desmoplastic or high grade glioma histology will receive induction chemotherapy and low-risk therapy.'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with M0 medulloblastoma or nodular desmoplastic histology with less than a GTR, other histologic diagnoses with no metastatic disease, will receive induction chemotherapy and intermediate-risk therapy.'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease will receive induction chemotherapy and high-risk therapy.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '63.2', 'spread': '16.0', 'groupId': 'OG000'}, {'value': '51.6', 'spread': '10.8', 'groupId': 'OG001'}, {'value': '57.0', 'spread': '13.6', 'groupId': 'OG002'}]}]}, {'title': 'Prior to Maintenance Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '58.7', 'spread': '10.7', 'groupId': 'OG000'}, {'value': '55.5', 'spread': '13.3', 'groupId': 'OG001'}, {'value': '54.1', 'spread': '11.1', 'groupId': 'OG002'}]}]}, {'title': 'Completion of Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '60.8', 'spread': '14.9', 'groupId': 'OG000'}, {'value': '54.9', 'spread': '11.1', 'groupId': 'OG001'}, {'value': '49.0', 'spread': '16.8', 'groupId': 'OG002'}]}]}, {'title': '12 Months Off Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '64.4', 'spread': '16.1', 'groupId': 'OG000'}, {'value': '60.4', 'spread': '14.5', 'groupId': 'OG001'}, {'value': '67.7', 'spread': '22.3', 'groupId': 'OG002'}]}]}, {'title': '24 Months Off Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '63.6', 'spread': '17.8', 'groupId': 'OG000'}, {'value': '59.4', 'spread': '14.7', 'groupId': 'OG001'}, {'value': '55.4', 'spread': '13.3', 'groupId': 'OG002'}]}]}, {'title': '36 Months Off Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '59.3', 'spread': '13.9', 'groupId': 'OG000'}, {'value': '62.0', 'spread': '14.2', 'groupId': 'OG001'}, {'value': '61.7', 'spread': '8.6', 'groupId': 'OG002'}]}]}, {'title': '48 Months Off Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '60.9', 'spread': '16.1', 'groupId': 'OG000'}, {'value': '60.0', 'spread': '13.1', 'groupId': 'OG001'}, {'value': '54.5', 'spread': '12.8', 'groupId': 'OG002'}]}]}, {'title': '60 Months Off Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '56.8', 'spread': '13.3', 'groupId': 'OG000'}, {'value': '60.6', 'spread': '14.3', 'groupId': 'OG001'}, {'value': '61.0', 'spread': '15.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy', 'description': 'Scores measuring working memory were obtained from Working Memory T-scores, which were obtained from the Behavior Rating Inventory of Executive Function (BRIEF) instrument which is a parent report. 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Higher scores indicate better performance. The normative mean is 100 with a standard deviation of 15.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients with scores at any of the data collection timepoints were included. Sample sizes differ across timepoints as not all subjects had scores for all timepoints.'}, {'type': 'SECONDARY', 'title': 'Neurocognitive Performance Related to Visual-spatial Reasoning as Measured by Visual Motor Integration (VMI) T-scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic (M0) medulloblastoma, nodular desmoplastic or high grade glioma histology will receive induction chemotherapy and low-risk therapy.'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with M0 medulloblastoma or nodular desmoplastic histology with less than a GTR, other histologic diagnoses with no metastatic disease, will receive induction chemotherapy and intermediate-risk therapy.'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease will receive induction chemotherapy and high-risk therapy.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '62.0', 'groupId': 'OG000'}, {'value': '47.5', 'spread': '16.3', 'groupId': 'OG001'}, {'value': '37.3', 'spread': '11.9', 'groupId': 'OG002'}]}]}, {'title': 'Prior to Maintenance Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '39.0', 'spread': '17.0', 'groupId': 'OG000'}, {'value': '44.6', 'spread': '12.6', 'groupId': 'OG001'}, {'value': '53.0', 'spread': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Completion Of Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '40.0', 'spread': '13.6', 'groupId': 'OG000'}, {'value': '48.5', 'spread': '8.6', 'groupId': 'OG001'}, {'value': '46.0', 'groupId': 'OG002'}]}]}, {'title': '12 Months Off Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '43.1', 'spread': '18.2', 'groupId': 'OG000'}, {'value': '43.8', 'spread': '11.1', 'groupId': 'OG001'}, {'value': '39.0', 'spread': '9.2', 'groupId': 'OG002'}]}]}, {'title': '24 Months Off Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '48.2', 'spread': '11.5', 'groupId': 'OG000'}, {'value': '43.6', 'spread': '10.3', 'groupId': 'OG001'}, {'value': '32.0', 'spread': '16.0', 'groupId': 'OG002'}]}]}, {'title': '36 Months Off Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '45.6', 'spread': '14.1', 'groupId': 'OG000'}, {'value': '41.3', 'spread': '8.9', 'groupId': 'OG001'}, {'value': '36.8', 'spread': '13.6', 'groupId': 'OG002'}]}]}, {'title': '48 Months Off Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '44.2', 'spread': '23.5', 'groupId': 'OG000'}, {'value': '43.6', 'spread': '7.3', 'groupId': 'OG001'}, {'value': '44.3', 'spread': '10.1', 'groupId': 'OG002'}]}]}, {'title': '60 Months Off Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '39.4', 'spread': '16.7', 'groupId': 'OG000'}, {'value': '40.6', 'spread': '9.2', 'groupId': 'OG001'}, {'value': '34.0', 'spread': '15.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy', 'description': 'Scores measuring visual-spatial reasoning were obtained from VMI T-scores on the Beery VMI instrument. 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Sample sizes differ across timepoints as not all subjects had scores for all timepoints.'}, {'type': 'SECONDARY', 'title': 'Neurocognitive Performance Related to Visual-spatial Reasoning as Measured by Visual Perception T-scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic (M0) medulloblastoma, nodular desmoplastic or high grade glioma histology will receive induction chemotherapy and low-risk therapy.'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with M0 medulloblastoma or nodular desmoplastic histology with less than a GTR, other histologic diagnoses with no metastatic disease, will receive induction chemotherapy and intermediate-risk therapy.'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease will receive induction chemotherapy and high-risk therapy.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '66.0', 'groupId': 'OG000'}, {'value': '31.6', 'spread': '12.2', 'groupId': 'OG001'}, {'value': '33.7', 'spread': '9.5', 'groupId': 'OG002'}]}]}, {'title': 'Prior to Maintenance Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '32.0', 'spread': '7.1', 'groupId': 'OG000'}, {'value': '40.2', 'spread': '12.2', 'groupId': 'OG001'}, {'value': '56.0', 'spread': '8.5', 'groupId': 'OG002'}]}]}, {'title': 'Completion of Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '39.0', 'spread': '16.4', 'groupId': 'OG000'}, {'value': '39.8', 'spread': '12.3', 'groupId': 'OG001'}, {'value': '18.5', 'spread': '26.2', 'groupId': 'OG002'}]}]}, {'title': '12 Months Off Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '42.3', 'spread': '14.7', 'groupId': 'OG000'}, {'value': '41.0', 'spread': '14.5', 'groupId': 'OG001'}, {'value': '33.0', 'groupId': 'OG002'}]}]}, {'title': '24 Months Off Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '43.4', 'spread': '15.0', 'groupId': 'OG000'}, {'value': '40.1', 'spread': '13.4', 'groupId': 'OG001'}, {'value': '32.0', 'spread': '8.9', 'groupId': 'OG002'}]}]}, {'title': '36 Months Off Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '51.2', 'spread': '17.8', 'groupId': 'OG000'}, {'value': '41.0', 'spread': '13.6', 'groupId': 'OG001'}, {'value': '48.8', 'spread': '18.7', 'groupId': 'OG002'}]}]}, {'title': '48 Months Off Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '48.6', 'spread': '24.9', 'groupId': 'OG000'}, {'value': '46.1', 'spread': '11.3', 'groupId': 'OG001'}, {'value': '42.7', 'spread': '8.3', 'groupId': 'OG002'}]}]}, {'title': '60 Months Off Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '43.1', 'spread': '18.8', 'groupId': 'OG000'}, {'value': '42.3', 'spread': '13.3', 'groupId': 'OG001'}, {'value': '36.0', 'spread': '12.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy', 'description': 'Scores measuring visual-spatial reasoning were obtained from Visual Perception T-scores on the Beery Visual Motor Integration (VMI) instrument. Higher scores indicate better performance. The normative mean is 50 with a standard deviation of 10.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients with scores at any of the data collection timepoints were included. Sample sizes differ across timepoints as not all subjects had scores for all timepoints.'}, {'type': 'SECONDARY', 'title': 'Change in Neurostructure, Especially White Matter Volume and Integrity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic (M0) medulloblastoma, nodular desmoplastic or high grade glioma histology will receive induction chemotherapy and low-risk therapy.'}, {'id': 'OG001', 'title': 'Intermediate-risk Group', 'description': 'Patients with M0 medulloblastoma or nodular desmoplastic histology with less than a GTR, other histologic diagnoses with no metastatic disease, will receive induction chemotherapy and intermediate-risk therapy.'}, {'id': 'OG002', 'title': 'High-risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease will receive induction chemotherapy and high-risk therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0019', 'groupId': 'OG000', 'lowerLimit': '0.0016', 'upperLimit': '0.0022'}, {'value': '0.0016', 'groupId': 'OG001', 'lowerLimit': '0.0015', 'upperLimit': '0.0018'}, {'value': '0.0017', 'groupId': 'OG002', 'lowerLimit': '0.0015', 'upperLimit': '0.0019'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months)', 'description': 'Quantitative MRI measures Fractional Anisotropy (FA) change per month in right frontal-lobe over time in each risk group will be assessed using a random effects model incorporating various covariates. Covariates to be considered include age at diagnosis, time since diagnosis and risk-arm. Differences in quantitative MRI measures of neurostructure volume and integrity between patient groups will be evaluated as a metric of structural neurotoxicity of therapy.\n\nFractional anisotropy (FA) is a scalar unitless measure that quantifies the degree of anisotropy of a diffusion process, particularly in the context of diffusion tensor imaging (DTI) used in MRI scans. FA values range from 0 to 1', 'unitOfMeasure': 'Change in FA per month', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible infratentorial medulloblastoma, ependymoma, and pineoblastoma patients(n=75) were included.'}, {'type': 'SECONDARY', 'title': 'Change in Neurostructure, Especially White Matter Volume and Integrity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic or high grade glioma histology will receive induction chemotherapy and low-risk therapy.'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with (M0) medulloblastoma or nodular desmoplastic histology with less than a GTR, other histologic diagnoses with no metastatic disease, will receive induction chemotherapy and intermediate-risk therapy.'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease will receive induction chemotherapy and high-risk therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0019', 'groupId': 'OG000', 'lowerLimit': '0.0015', 'upperLimit': '0.0022'}, {'value': '0.0017', 'groupId': 'OG001', 'lowerLimit': '0.0015', 'upperLimit': '0.0018'}, {'value': '0.0017', 'groupId': 'OG002', 'lowerLimit': '0.0014', 'upperLimit': '0.0019'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months)', 'description': 'Quantitative MRI measures Fractional Anisotropy (FA) change per month in left frontal lobe over time in each risk group will be assessed using a random effects model incorporating various covariates. Covariates to be considered include age at diagnosis, time since diagnosis and risk-arm. Differences in quantitative MRI measures of neurostructure volume and integrity between patient groups will be evaluated as a metric of structural neurotoxicity of therapy.\n\nFractional anisotropy (FA) is a scalar unitless measure that quantifies the degree of anisotropy of a diffusion process, particularly in the context of diffusion tensor imaging (DTI) used in MRI scans. FA values range from 0 to 1', 'unitOfMeasure': 'change in FA per month', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible infratentorial medulloblastoma, ependymoma, and pineoblastoma patients(n=75) were included.'}, {'type': 'SECONDARY', 'title': 'Change in Neurostructure, Especially White Matter Volume and Integrity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic or high grade glioma histology will receive induction chemotherapy and low-risk therapy.'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with (M0) medulloblastoma or nodular desmoplastic histology with less than a GTR, other histologic diagnoses with no metastatic disease, will receive induction chemotherapy and intermediate-risk therapy.'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease will receive induction chemotherapy and high-risk therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0015', 'groupId': 'OG000', 'lowerLimit': '0.0012', 'upperLimit': '0.0019'}, {'value': '0.0014', 'groupId': 'OG001', 'lowerLimit': '0.0012', 'upperLimit': '0.0015'}, {'value': '0.0016', 'groupId': 'OG002', 'lowerLimit': '0.0013', 'upperLimit': '0.0018'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months)', 'description': 'Quantitative MRI measures Fractional Anisotropy (FA) change per month in right parietal lobe over time in each risk group will be assessed using a random effects model incorporating various covariates. Covariates to be considered include age at diagnosis, time since diagnosis and risk-arm. Differences in quantitative MRI measures of neurostructure volume and integrity between patient groups will be evaluated as a metric of structural neurotoxicity of therapy.\n\nFractional anisotropy (FA) is a scalar unitless measure that quantifies the degree of anisotropy of a diffusion process, particularly in the context of diffusion tensor imaging (DTI) used in MRI scans. FA values range from 0 to 1', 'unitOfMeasure': 'Change in FA per month', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible infratentorial medulloblastoma, ependymoma, and pineoblastoma patients(n=75) were included.'}, {'type': 'SECONDARY', 'title': 'Change in Neurostructure, Especially White Matter Volume and Integrity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic or high grade glioma histology will receive induction chemotherapy and low-risk therapy.'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with (M0) medulloblastoma or nodular desmoplastic histology with less than a GTR, other histologic diagnoses with no metastatic disease, will receive induction chemotherapy and intermediate-risk therapy.'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease will receive induction chemotherapy and high-risk therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0016', 'groupId': 'OG000', 'lowerLimit': '0.0012', 'upperLimit': '0.002'}, {'value': '0.0014', 'groupId': 'OG001', 'lowerLimit': '0.0012', 'upperLimit': '0.0016'}, {'value': '0.0016', 'groupId': 'OG002', 'lowerLimit': '0.0013', 'upperLimit': '0.0018'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months)', 'description': 'Quantitative MRI measures Fractional Anisotropy (FA) change per month in left parietal lobe over time in each risk group will be assessed using a random effects model incorporating various covariates. Covariates to be considered include age at diagnosis, time since diagnosis and risk-arm. Differences in quantitative MRI measures of neurostructure volume and integrity between patient groups will be evaluated as a metric of structural neurotoxicity of therapy.\n\nFractional anisotropy (FA) is a scalar unitless measure that quantifies the degree of anisotropy of a diffusion process, particularly in the context of diffusion tensor imaging (DTI) used in MRI scans. FA values range from 0 to 1', 'unitOfMeasure': 'Change in FA per month', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible infratentorial medulloblastoma, ependymoma, and pineoblastoma patients(n=75) were included'}, {'type': 'SECONDARY', 'title': 'Change in Neurostructure, Especially White Matter Volume and Integrity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic or high grade glioma histology will receive induction chemotherapy and low-risk therapy.'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with (M0) medulloblastoma or nodular desmoplastic histology with less than a GTR, other histologic diagnoses with no metastatic disease, will receive induction chemotherapy and intermediate-risk therapy.'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease will receive induction chemotherapy and high-risk therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0016', 'groupId': 'OG000', 'lowerLimit': '0.0013', 'upperLimit': '0.0019'}, {'value': '0.0015', 'groupId': 'OG001', 'lowerLimit': '0.0014', 'upperLimit': '0.0017'}, {'value': '0.0013', 'groupId': 'OG002', 'lowerLimit': '0.0011', 'upperLimit': '0.0016'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months)', 'description': 'Quantitative MRI measures Fractional Anisotropy (FA) change per month in right occipital lobe over time in each risk group will be assessed using a random effects model incorporating various covariates. Covariates to be considered include age at diagnosis, time since diagnosis and risk-arm. Differences in quantitative MRI measures of neurostructure volume and integrity between patient groups will be evaluated as a metric of structural neurotoxicity of therapy.\n\nFractional anisotropy (FA) is a scalar unitless measure that quantifies the degree of anisotropy of a diffusion process, particularly in the context of diffusion tensor imaging (DTI) used in MRI scans. FA values range from 0 to 1', 'unitOfMeasure': 'Change in FA per month', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible infratentorial medulloblastoma, ependymoma, and pineoblastoma patients(n=75) were included.'}, {'type': 'SECONDARY', 'title': 'Change in Neurostructure, Especially White Matter Volume and Integrity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic or high grade glioma histology will receive induction chemotherapy and low-risk therapy.'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with (M0) medulloblastoma or nodular desmoplastic histology with less than a GTR, other histologic diagnoses with no metastatic disease, will receive induction chemotherapy and intermediate-risk therapy.'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease will receive induction chemotherapy and high-risk therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0021', 'groupId': 'OG000', 'lowerLimit': '0.0017', 'upperLimit': '0.0025'}, {'value': '0.0020', 'groupId': 'OG001', 'lowerLimit': '0.0018', 'upperLimit': '0.0022'}, {'value': '0.0015', 'groupId': 'OG002', 'lowerLimit': '0.0012', 'upperLimit': '0.0018'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months)', 'description': 'Quantitative MRI measures Fractional Anisotropy (FA) change per month in left occipital lobe over time in each risk group will be assessed using a random effects model incorporating various covariates. Covariates to be considered include age at diagnosis, time since diagnosis and risk-arm. Differences in quantitative MRI measures of neurostructure volume and integrity between patient groups will be evaluated as a metric of structural neurotoxicity of therapy.\n\nFractional anisotropy (FA) is a scalar unitless measure that quantifies the degree of anisotropy of a diffusion process, particularly in the context of diffusion tensor imaging (DTI) used in MRI scans. FA values range from 0 to 1', 'unitOfMeasure': 'Change in FA per month', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible infratentorial medulloblastoma, ependymoma, and pineoblastoma patients(n=75) were included.'}, {'type': 'SECONDARY', 'title': 'Change in Neurostructure, Especially White Matter Volume and Integrity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic or high grade glioma histology will receive induction chemotherapy and low-risk therapy.'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with (M0) medulloblastoma or nodular desmoplastic histology with less than a GTR, other histologic diagnoses with no metastatic disease, will receive induction chemotherapy and intermediate-risk therapy.'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease will receive induction chemotherapy and high-risk therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0014', 'groupId': 'OG000', 'lowerLimit': '0.0012', 'upperLimit': '0.0017'}, {'value': '0.0013', 'groupId': 'OG001', 'lowerLimit': '0.0011', 'upperLimit': '0.0014'}, {'value': '0.0013', 'groupId': 'OG002', 'lowerLimit': '0.0011', 'upperLimit': '0.0015'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months)', 'description': 'Quantitative MRI measures Fractional Anisotropy (FA) change per month in right temporal lobe over time in each risk group will be assessed using a random effects model incorporating various covariates. Covariates to be considered include age at diagnosis, time since diagnosis and risk-arm. Differences in quantitative MRI measures of neurostructure volume and integrity between patient groups will be evaluated as a metric of structural neurotoxicity of therapy.\n\nFractional anisotropy (FA) is a scalar unitless measure that quantifies the degree of anisotropy of a diffusion process, particularly in the context of diffusion tensor imaging (DTI) used in MRI scans. FA values range from 0 to 1', 'unitOfMeasure': 'Change in FA per month', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible infratentorial medulloblastoma, ependymoma, and pineoblastoma patients(n=75) were included.'}, {'type': 'SECONDARY', 'title': 'Change in Neurostructure, Especially White Matter Volume and Integrity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic or high grade glioma histology will receive induction chemotherapy and low-risk therapy.'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with (M0) medulloblastoma or nodular desmoplastic histology with less than a GTR, other histologic diagnoses with no metastatic disease, will receive induction chemotherapy and intermediate-risk therapy.'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease will receive induction chemotherapy and high-risk therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0014', 'groupId': 'OG000', 'lowerLimit': '0.0011', 'upperLimit': '0.0017'}, {'value': '0.0013', 'groupId': 'OG001', 'lowerLimit': '0.0011', 'upperLimit': '0.0014'}, {'value': '0.0014', 'groupId': 'OG002', 'lowerLimit': '0.0011', 'upperLimit': '0.0016'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months)', 'description': 'Quantitative MRI measures Fractional Anisotropy (FA) change per month in left temporal lobe over time in each risk group will be assessed using a random effects model incorporating various covariates. Covariates to be considered include age at diagnosis, time since diagnosis and risk-arm. Differences in quantitative MRI measures of neurostructure volume and integrity between patient groups will be evaluated as a metric of structural neurotoxicity of therapy.\n\nFractional anisotropy (FA) is a scalar unitless measure that quantifies the degree of anisotropy of a diffusion process, particularly in the context of diffusion tensor imaging (DTI) used in MRI scans. FA values range from 0 to 1', 'unitOfMeasure': 'Change in FA per month', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible infratentorial medulloblastoma, ependymoma, and pineoblastoma patients(n=75) were included.'}, {'type': 'SECONDARY', 'title': 'Change in Quantitative Magnetic Resonance (MR) Measures in the Frontal Lobe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0019', 'groupId': 'OG000', 'lowerLimit': '0.0016', 'upperLimit': '0.0022'}, {'value': '0.0017', 'groupId': 'OG001', 'lowerLimit': '0.0015', 'upperLimit': '0.0018'}, {'value': '0.0017', 'groupId': 'OG002', 'lowerLimit': '0.0014', 'upperLimit': '0.0019'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months)', 'description': 'Quantitative MRI measures Fractional Anisotropy (FA) change per month in frontal lobe over time in each risk group will be assessed using a random effects model incorporating various covariates. Covariates to be considered include age at diagnosis, time since diagnosis and risk-arm. Differences in quantitative MRI measures of neurostructure volume and integrity between patient groups will be evaluated as a metric of structural neurotoxicity of therapy.\n\nFractional anisotropy (FA) is a scalar unitless measure that quantifies the degree of anisotropy of a diffusion process, particularly in the context of diffusion tensor imaging (DTI) used in MRI scans. FA values range from 0 to 1', 'unitOfMeasure': 'Change in FA per month', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible infratentorial medulloblastoma, ependymoma, and pineoblastoma patients(n=75) were included.'}, {'type': 'SECONDARY', 'title': 'Change in Quantitative MR Measures in the Right Frontal-parietal Regions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic or high grade glioma histology will receive induction chemotherapy and low-risk therapy.'}, {'id': 'OG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with (M0) medulloblastoma or nodular desmoplastic histology with less than a GTR, other histologic diagnoses with no metastatic disease, will receive induction chemotherapy and intermediate-risk therapy.'}, {'id': 'OG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease will receive induction chemotherapy and high-risk therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0017', 'groupId': 'OG000', 'lowerLimit': '0.0014', 'upperLimit': '0.0021'}, {'value': '0.0015', 'groupId': 'OG001', 'lowerLimit': '0.0014', 'upperLimit': '0.0017'}, {'value': '0.0016', 'groupId': 'OG002', 'lowerLimit': '0.0014', 'upperLimit': '0.0019'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months)', 'description': 'Quantitative MRI measures Fractional Anisotropy (FA) change per month in right frontal-parietal region over time in each risk group will be assessed using a random effects model incorporating various covariates. Covariates to be considered include age at diagnosis, time since diagnosis and risk-arm. Differences in quantitative MRI measures of neurostructure volume and integrity between patient groups will be evaluated as a metric of structural neurotoxicity of therapy.\n\nFractional anisotropy (FA) is a scalar unitless measure that quantifies the degree of anisotropy of a diffusion process, particularly in the context of diffusion tensor imaging (DTI) used in MRI scans. FA values range from 0 to 1', 'unitOfMeasure': 'Change in FA per month', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible infratentorial medulloblastoma, ependymoma, and pineoblastoma patients(n=75) were included.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic (M0) medulloblastoma, nodular desmoplastic or high grade glioma histology will receive induction chemotherapy and low-risk therapy.'}, {'id': 'FG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with M0 medulloblastoma or nodular desmoplastic histology with less than a GTR, other histologic diagnoses with no metastatic disease, will receive induction chemotherapy and intermediate-risk therapy.'}, {'id': 'FG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease will receive induction chemotherapy and high-risk therapy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '156'}, {'groupId': 'FG002', 'numSubjects': '77'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '75'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '81'}, {'groupId': 'FG002', 'numSubjects': '63'}]}], 'dropWithdraws': [{'type': 'Still on Therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Family request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Excessive toxicity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Second malignancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '48'}, {'groupId': 'FG002', 'numSubjects': '45'}]}, {'type': 'Progressive disease prior to therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '293 participants were enrolled between December 17, 2007 and April 19, 2017.', 'preAssignmentDetails': 'Of the 293 participants enrolled, 3 were ineligible and removed from study, leaving 290 eligible patients. Eighty-one (81) of the 290 eligible patients enrolled had histologically confirmed medulloblastoma; medulloblastoma patients are the focus of the primary study objectives.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '290', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Low-Risk Group', 'description': 'Patients with gross total resection (GTR)/no evidence of metastatic (M0) medulloblastoma, nodular desmoplastic or high grade glioma histology will receive induction chemotherapy and low-risk therapy.'}, {'id': 'BG001', 'title': 'Intermediate-Risk Group', 'description': 'Patients with M0 medulloblastoma or nodular desmoplastic histology with less than a GTR, other histologic diagnoses with no metastatic disease, will receive induction chemotherapy and intermediate-risk therapy.'}, {'id': 'BG002', 'title': 'High-Risk Group', 'description': 'Patients with central nervous system (CNS) metastatic disease will receive induction chemotherapy and high-risk therapy.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '17.0', 'spread': '10.0', 'groupId': 'BG000'}, {'value': '22.9', 'spread': '12.8', 'groupId': 'BG001'}, {'value': '19.3', 'spread': '10.4', 'groupId': 'BG002'}, {'value': '20.8', 'spread': '11.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '16.1', 'groupId': 'BG000', 'lowerLimit': '0.2', 'upperLimit': '35.2'}, {'value': '21.9', 'groupId': 'BG001', 'lowerLimit': '1.8', 'upperLimit': '60.6'}, {'value': '20.0', 'groupId': 'BG002', 'lowerLimit': '0.9', 'upperLimit': '36.9'}, {'value': '20.1', 'groupId': 'BG003', 'lowerLimit': '0.2', 'upperLimit': '60.6'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'months', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '131', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '159', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity', 'categories': [{'title': 'Mexican/Chicano', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'NOS Spanish, Hispanic, Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}, {'title': 'Non Spanish speaking, Non Hispanic', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '231', 'groupId': 'BG003'}]}, {'title': 'Puerto Rican', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'South or Central American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Unknown', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'American Indian/Alaskan/White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'American Indian/Alaskan Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}, {'title': 'Asian and White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Black', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}, {'title': 'Black and White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Multiple Race (NOS)', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}, {'title': 'Other', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Unknown', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '220', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Participants were patients with newly diagnosed tumors of the CNS, including medulloblastoma, supratentorial primitive neuroectodermal tumor (PNET), pineoblastoma, atypical teratoid rhabdoid tumor (ATRT), choroid plexus carcinoma, ependymoma, and high-grade glioma. All eligible patients enrolled were included in the baseline characteristics.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-24', 'size': 2753377, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-01-04T19:43', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 293}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2008-01-10', 'resultsFirstSubmitDate': '2018-09-26', 'studyFirstSubmitQcDate': '2008-01-24', 'lastUpdatePostDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-04', 'studyFirstPostDateStruct': {'date': '2008-01-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Probability of Progression-free Survival (PFS) for Medulloblastoma Patients', 'timeFrame': 'From date on treatment until date of first progression or relapse or disease related death or date of last contact, estimated at 1 year after treatment', 'description': 'Progression was defined as 25% increase in the size of any measurable lesion; the appearance of a new lesion; or the conversion of negative cerebrospinal fluid (CSF) cytology to positive. Defined as the time interval from date on treatment until the date of first progression, medulloblastoma-related death or date of last contact for patients who have not experienced an event. All eligible medulloblastoma patients who received any methotrexate are included in this analysis.'}, {'measure': 'Percent Probability of Progression-free Survival (PFS) for Medulloblastoma Patients by DNA Methylation Subgroup', 'timeFrame': 'From date on treatment to date of first progression or relapse or disease related death or date of last contact, estimated at 1 year after treatment', 'description': 'Defined as the time interval from date on treatment until the date of first progression, medulloblastoma-related death or date of last contact for patients who have not experienced an event. Eligible medulloblastoma patients who received any methotrexate and had molecularly confirmed medulloblastoma are included in this analysis. Five patients were excluded as 3 had no archival tissue available and 2 were found to not be medulloblastoma by methylation profile.'}, {'measure': 'Percent Probability of Event-free Survival (EFS) for Medulloblastoma Patients', 'timeFrame': 'From date on treatment to date of first progression, relapse, second malignancy or death from any cause or to date of last contact, estimated at 1 year after', 'description': 'Defined as the time interval from date on treatment until the date of first progression, second malignancy or death due to any cause; or date of last contact for patients who have not experienced an event. All eligible medulloblastoma patients who received any methotrexate are included in this analysis.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Chromosomal Abnormalities', 'timeFrame': 'Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment', 'description': 'Amplifications and deletions (gains and losses) for chromosomes of interest are shown in the table of measured values.'}, {'measure': 'Numbers of Patients With Gene Alterations', 'timeFrame': 'Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment', 'description': 'Gene alterations, which include single nucleotide variants (SNPs), amplifications, deletions, translocations, indels, and germline alterations are shown for specific genes of interest in the results table.'}, {'measure': 'Numbers of Patients With Molecular Abnormalities by Tumor Type', 'timeFrame': 'Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment', 'description': 'Alterations included single nucleotide variants (SNPs), amplifications, deletions, translocations, indels, and germline alterations. Cytogenetic information shows gains and losses as specified in the table of measured values.'}, {'measure': 'Number of Successful Collections for Frozen and Fixed Tumor Samples', 'timeFrame': 'Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment', 'description': 'Successful collections will be defined as the number of patients who have frozen/fixed tumor samples available.'}, {'measure': 'Event-free Survival (EFS) Compared to Historical Controls', 'timeFrame': 'From date on treatment until date of first event (progression, second malignancy or death) or until date of last contact, assessed up to 10 years', 'description': 'EFS was measured from the date of initial treatment to the earliest date of disease progression, second malignancy or death for patients who fail; and to the date of last contact for patients who remain at risk for failure. 1-year EFS estimates are reported by risk group. EFS was compared to St. Jude historical cohorts by risk group using hazard ratios with 95% confidence intervals.'}, {'measure': 'Overall Survival (OS) Compared to Historical Controls', 'timeFrame': '1 year after treatment initiation of last patient', 'description': 'OS was measured from the date of initial treatment to date of death or to date of last contact for survivors. 1-year OS estimates were reported by risk group. OS was compared to St. Jude historical cohorts by risk group using hazard ratios with 95% confidence intervals.'}, {'measure': 'Percentage of Patients With Objective Responses Rate to Induction Chemotherapy', 'timeFrame': 'From on-study date to 2 months after completion of induction chemotherapy (up to 4 months after on-study date)', 'description': 'For patients treated in the intermediate and high risk strata with residual or metastatic disease we will estimate the stratum-specific objective response rate (complete response (CR) or partial response \\[ PR\\]). All patients who receive at least 1 -dose of methotrexate are evaluable for response. Objective responses must be sustained for at least eight weeks.'}, {'measure': 'Feasibility and Toxicity of Administering Vinblastine With Induction Chemotherapy for Patients With Metastatic Disease as Measured by the Percentage of Courses Delayed for More Than 7 Days Due to Toxicity', 'timeFrame': 'From on-study date up to 4 months after on-study date', 'description': 'For the subset of patients with metastatic disease (high-risk group patients), during induction, the proportion percentage of courses during which subsequent chemotherapy administration was delayed for more than 7 days due to toxicity will be calculated. Patients were to receive 4 courses of induction and then consolidation chemotherapy.'}, {'measure': 'Feasibility and Toxicity of Administering Consolidation Therapy Including Cyclophosphamide and Pharmacokinetically Targeted Topotecan to Patients With Metastatic Disease Based on the Percentage of Courses Delayed for More Than 7 Days Due to Toxicity', 'timeFrame': 'At completion of consolidation therapy (up to 6 months after on-study date)', 'description': 'For the subset of patients with metastatic disease (high-risk group patients), during consolidation, we will calculate the number and proportion of courses during which subsequent chemotherapy administration was delayed for more than 7 days due to toxicity. Patients were to received 2 courses of consolidation chemotherapy and then maintenance therapy.'}, {'measure': 'Percent of Patients With Sustained Objective Responses Rate After Consolidation', 'timeFrame': '8 weeks after completion of consolidation therapy (up to 8 months after on-study date)', 'description': 'For patients enrolled on the high-risk arm with measurable residual disease after induction treated with consolidation therapy, we will estimate the objective response (complete response (CR)/partial response (PR)) rate after consolidation therapy with a 95% confidence interval. Objective responses must be sustained for at least eight weeks. All patients who receive at least 1 dose of cyclophosphamide or topotecan during consolidation are evaluable for response.'}, {'measure': 'Feasibility and Toxicity of Administering Oral Maintenance Therapy in Children <3 Years of Age as Measured by the Percentage of Total Scheduled Maintenance Doses Received', 'timeFrame': 'From start of oral maintenance therapy (approximately 6 months after on-study date) to completion of oral maintenance therapy (up to 1 year after on-study date)', 'description': 'These data are based on patient diaries. For children \\<3 years of age, we will calculate the percentage of total scheduled doses each patient received per course for each of the oral maintenance courses and report the overall average number percentage of doses received per course across patients. If patients received all planned doses, their percentage would be 100%. If the average percentage was less than 75%, then feasibility would be in question.'}, {'measure': 'Percent of PET Scans With Loss of Signal Intensity', 'timeFrame': 'Up to 3 times during RT consolidation', 'description': 'Measures will be analyzed for intermediate risk participants who receive proton beam therapy (PBT) and who consent. This objective aims to assess the feasibility of using post-proton beam therapy (PBT) positron emission tomography (PET) as an in-vivo dosimetric and distal edge verification system in this patient population. To quantify the decay in signal, 134 scans from 53 patients were analyzed by recording the mean activation value (MAV), the average recorded PET signal from activation, within the target volume. With each patient being given the same dose, the percent standard deviation in the MAV can serve as a quantitative representation of signal loss due to radioactive decay.'}, {'measure': 'Concentration of Cerebrospinal Fluid Neurotransmitters', 'timeFrame': 'Baseline, at the completion of therapy, and every 12 months up to 36 months after off therapy date', 'description': 'Concentrations of various neurotransmitters in cerebrospinal fluid were measured at 5 timepoints. The median concentration of each neurotransmitter at each time point was calculated and provided with a full range.'}, {'measure': 'Number and Type of Genetic Polymorphisms', 'timeFrame': 'At study enrollment (Day 0)', 'description': 'Types of genetic polymorphisms of neurotransmitters were examined. We studied 3 genetic polymorphisms; these were types of genetic polymorphisms involved in dopamine metabolism. They were as follows: rs6323, rs4680, and rs6280.'}, {'measure': 'Pharmacogenetic Variation on Central Nervous System Transmitters', 'timeFrame': 'At study enrollment (Day 0)', 'description': 'Frequencies of genetic polymorphisms were reported.'}, {'measure': 'Number of Participants With Endocrinopathy', 'timeFrame': 'Baseline, end of therapy, and at 6- and 24-months after completion of therapy', 'description': 'Serial GH testing (at baseline, the end of therapy, and at 6 and 24 months after completion of therapy) will be performed on consenting patients in order to estimate longitudinal change in GH secretion as measured by mean peak GH values, with the intent to explore associations with radiation dose to the hypothalamus. Since determination of proton- or photon-based radiotherapy is not based on randomization, it will not be possible to compare the endocrine outcome between the patients with and without PBT. However, the differences between these two clinical cohorts with respect to clinical and demographic variables of interest will be summarized via descriptive statistics.'}, {'measure': 'Longitudinal Change in Growth Hormone Secretion', 'timeFrame': 'Baseline, end of therapy, and at 6- and 24-months after completion of therapy', 'description': 'The intent of this objective is to estimate the longitudinal change in abnormal GH secretion as measured by mean peak GH values via a mixed effects model for the patients who receive PBT.'}, {'measure': 'Methotrexate Clearance in Induction Cycle 1', 'timeFrame': 'Pre-infusion and 6, 23, 42, 66 hours from start of Methotrexate (MTX)', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 1. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate clearance are obtained using post hoc analysis.'}, {'measure': 'Methotrexate Clearance in Induction Cycle 2', 'timeFrame': 'Pre-infusion and 6, 23, 42, 66 hours from start of MTX', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 2. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate clearance are obtained using post hoc analysis.'}, {'measure': 'Methotrexate Clearance in Induction Cycle 3', 'timeFrame': 'Pre-infusion and 6, 23, 42, 66 hours from start of MTX', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 3. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate clearance are obtained using post hoc analysis.'}, {'measure': 'Methotrexate Clearance in Induction Cycle 4', 'timeFrame': 'Pre-infusion and 6, 23, 42, 66 hours from start of MTX', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 4. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate clearance are obtained using post hoc analysis.'}, {'measure': 'Methotrexate Volume of Central Compartment in Induction Cycle 1', 'timeFrame': 'Pre-infusion and 6, 23, 42, 66 hours from start of MTX', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 1. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate volume of central compartment are obtained using post hoc analysis.'}, {'measure': 'Methotrexate Volume of Central Compartment in Induction Cycle 2', 'timeFrame': 'Pre-infusion and 6, 23, 42, 66 hours from start of MTX', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 2. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate volume of central compartment are obtained using post hoc analysis.'}, {'measure': 'Methotrexate Volume of Central Compartment in Induction Cycle 3', 'timeFrame': 'Pre-infusion and 6, 23, 42, 66 hours from start of MTX', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 3. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate volume of central compartment are obtained using post hoc analysis.'}, {'measure': 'Methotrexate AUC0-66h in Induction Cycle 1', 'timeFrame': 'Pre-infusion and 6, 23, 42, 66 hours from start of MTX', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 1. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate AUC0-66h (area under concentration curve from time 0 to 66 hours post-dose) are obtained using post hoc analysis.'}, {'measure': 'Methotrexate AUC0-66h in Induction Cycle 2', 'timeFrame': 'Pre-infusion and 6, 23, 42, 66 hours from start of MTX', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 2. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate AUC0-66h (area under concentration curve from time 0 to 66 hours post-dose) are obtained using post hoc analysis.'}, {'measure': 'Methotrexate Volume of Central Compartment in Induction Cycle 4', 'timeFrame': 'Pre-infusion and 6, 23, 42, 66 hours from start of MTX', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 4. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate volume of central compartment are obtained using post hoc analysis.'}, {'measure': 'Methotrexate AUC0-66h in Induction Cycle 3', 'timeFrame': 'Pre-infusion and 6, 23, 42, 66 hours from start of MTX', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 3. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate AUC0-66h (area under concentration curve from time 0 to 66 hours post-dose) are obtained using post hoc analysis.'}, {'measure': 'Methotrexate AUC0-66h in Induction Cycle 4', 'timeFrame': 'Pre-infusion and 6, 23, 42, 66 hours from start of MTX', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 4. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate AUC0-66h (area under concentration curve from time 0 to 66 hours post-dose) are obtained using post hoc analysis.'}, {'measure': 'Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 1', 'timeFrame': '42 hours from start of MTX', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 1. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate concentration at 42 hours post-dose are obtained using post hoc analysis.'}, {'measure': 'Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 2', 'timeFrame': '42 hours from start of MTX', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 2. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate concentration at 42 hours post-dose are obtained using post hoc analysis.'}, {'measure': 'Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 3', 'timeFrame': '42 hours from start of MTX', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 3. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate concentration at 42 hours post-dose are obtained using post hoc analysis.'}, {'measure': 'Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 4', 'timeFrame': '42 hours from start of MTX', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 4. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate concentration at 42 hours post-dose are obtained using post hoc analysis.'}, {'measure': 'Cyclophosphamide Clearance in Induction Chemotherapy', 'timeFrame': 'Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion', 'description': 'Cyclophosphamide plasma concentration-time data are collected on day 9 in one cycle of induction chemotherapy. Individual estimates of cyclophosphamide clearance are obtained using post hoc analysis.'}, {'measure': 'Cyclophosphamide Clearance in Consolidation Chemotherapy Cycle 1', 'timeFrame': 'Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion', 'description': 'Cyclophosphamide plasma concentration-time data are collected in consolidation cycle 1. Individual estimates of cyclophosphamide clearance are obtained using post hoc analysis.'}, {'measure': 'Cyclophosphamide Clearance in Consolidation Chemotherapy Cycle 2', 'timeFrame': 'Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion', 'description': 'Cyclophosphamide plasma concentration-time data are collected in consolidation cycle 2. Individual estimates of cyclophosphamide clearance are obtained using post hoc analysis.'}, {'measure': 'Cyclophosphamide Apparent Oral Clearance in Maintenance Chemotherapy Cycle A1', 'timeFrame': 'Pre-dose, 0.5, 1.75, 3 and 6 hours post-dose', 'description': 'Cyclophosphamide plasma concentration-time data are collected on day 1 of maintenance cycle A1. Individual estimates of cyclophosphamide apparent oral clearance are obtained using post hoc analysis.'}, {'measure': 'Cyclophosphamide AUC0-24h in Induction Chemotherapy', 'timeFrame': 'Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion', 'description': 'Cyclophosphamide plasma concentration-time data are collected on day 9 in one cycle of induction chemotherapy. Individual estimates of cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis.'}, {'measure': 'Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 1', 'timeFrame': 'Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion', 'description': 'Cyclophosphamide plasma concentration-time data are collected in consolidation cycle 1. Individual estimates of cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis.'}, {'measure': '4-OH Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 1', 'timeFrame': 'Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion', 'description': '4-OH cyclophosphamide plasma concentration-time data are collected in consolidation cycle 1. Individual estimates of 4-OH cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis.'}, {'measure': 'Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 2', 'timeFrame': 'Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion', 'description': 'Cyclophosphamide plasma concentration-time data are collected in consolidation cycle 2. Individual estimates of cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis.'}, {'measure': 'Cyclophosphamide AUC0-24h in Maintenance Chemotherapy Cycle A1', 'timeFrame': 'Pre-dose, 0.5, 1.75, 3, 6, and 24 hours post-dose', 'description': 'Cyclophosphamide plasma concentration-time data are collected on day 1 of maintenance cycle A1. Individual estimates of cyclophosphamide AUC0-24h are obtained using post hoc analysis.'}, {'measure': '4-OH Cyclophosphamide AUC0-24h in Induction Chemotherapy', 'timeFrame': 'Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion', 'description': '4-OH cyclophosphamide plasma concentration-time data are collected on day 9 in one cycle of induction chemotherapy. Individual estimates of 4-OH cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis.'}, {'measure': '4-OH Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 2', 'timeFrame': 'Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion', 'description': '4-OH cyclophosphamide plasma concentration-time data are collected in consolidation cycle 2. Individual estimates of 4-OH cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis.'}, {'measure': '4-OH Cyclophosphamide AUC0-24h in Maintenance Chemotherapy Cycle A1', 'timeFrame': 'Pre-dose, 0.5, 1.75, 3, 6, and 24 hours post-dose', 'description': '4-OH cyclophosphamide plasma concentration-time data are collected on day 1 of maintenance cycle A1. Individual estimates of 4-OH cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis.'}, {'measure': 'CEPM AUC0-24h in Induction Chemotherapy', 'timeFrame': 'Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion', 'description': 'Carboxyethylphosphoramide mustard (CEPM) plasma concentration-time data are collected on day 9 in one induction cycle. Individual estimates of CEPM AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis.'}, {'measure': 'CEPM AUC0-24h in Consolidation Chemotherapy Cycle 1', 'timeFrame': 'Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion', 'description': 'Carboxyethylphosphoramide mustard (CEPM) plasma concentration-time data are collected in consolidation cycle 1. Individual estimates of CEPM AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis.'}, {'measure': 'CEPM AUC0-24h in Consolidation Chemotherapy Cycle 2', 'timeFrame': 'Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion', 'description': 'Carboxyethylphosphoramide mustard (CEPM) plasma concentration-time data are collected in consolidation cycle 2. Individual estimates of CEPM AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis.'}, {'measure': 'CEPM AUC0-24h in Maintenance Chemotherapy Cycle A1', 'timeFrame': 'Pre-dose, 0.5, 1.75, 3, 6, and 24 hours post-dose', 'description': 'Carboxyethylphosphoramide mustard (CEPM) plasma concentration-time data are collected on day 1 of maintenance cycle A1. Individual estimates of CEPM AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis.'}, {'measure': 'Participants With Empirical Dosage Achieving Target System Exposure of Intravenous Topotecan', 'timeFrame': 'Pre-infusion, 5 min., 1, and 3 hours from end of infusion', 'description': 'Number of participants who successfully achieve target systemic exposure of intravenous topotecan after an empiric dosage during consolidation phase of therapy are reported.'}, {'measure': 'Participants With PK-guided Dosage Adjustment Achieving Target System Exposure of Intravenous Topotecan', 'timeFrame': 'Pre-infusion, 5 min., 1, and 3 hours from end of infusion', 'description': 'Number of participants who successfully achieve target systemic exposure of intravenous topotecan after a pharmacokinetic-guided dosage adjustment during consolidation phase of therapy are reported.'}, {'measure': 'Topotecan Clearance in Consolidation Chemotherapy', 'timeFrame': 'Pre-infusion, 5 min., 1, and 3 hours from end of infusion', 'description': 'Topotecan plasma concentration-time data are collected on day 1 of consolidation cycle 1 after a single IV dose. Individual estimates of topotecan clearance are obtained using post hoc analysis.'}, {'measure': 'Topotecan Apparent Oral Clearance in Maintenance Chemotherapy', 'timeFrame': 'Pre-dose, 0.25, 1.5 and 6 hours post-dose', 'description': 'Topotecan plasma concentration-time data are collected on day 1 of maintenance cycle A1 after a single oral dose. Individual estimates of topotecan apparent oral clearance are obtained using post hoc analysis.'}, {'measure': 'Topotecan AUC0-24h in Consolidation Chemotherapy', 'timeFrame': 'Pre-infusion, 5 min., 1, 3, and 24 hours from end of infusion', 'description': 'Topotecan plasma concentration-time data are collected on day 1 of consolidation cycle 1 after a single IV dose. Individual estimates of topotecan AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis.'}, {'measure': 'Topotecan AUC0-24h in Maintenance Chemotherapy', 'timeFrame': 'Pre-dose, 0.25, 1.5, 6, and 24 hours post-dose', 'description': 'Topotecan plasma concentration-time data are collected on day 1 of maintenance cycle A1 after a single oral dose. Individual estimates of topotecan AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis.'}, {'measure': 'Erlotinib Apparent Oral Clearance', 'timeFrame': 'Pre-dose, 1, 2, 4, 8, and 24 hours post-dose', 'description': 'Erlotinib plasma concentration-time data are collected on day 1 of maintenance cycle B2. Individual estimates of erlotinib apparent oral clearance are obtained using post hoc analysis.'}, {'measure': 'Erlotinib Apparent Volume of Central Compartment', 'timeFrame': 'Pre-dose, 1, 2, 4, 8, and 24 hours post-dose', 'description': 'Erlotinib plasma concentration-time data are collected on day 1 of maintenance cycle B2. Individual estimates of erlotinib apparent volume of central compartment are obtained using post hoc analysis.'}, {'measure': 'Erlotinib AUC0-24h', 'timeFrame': 'Pre-dose, 1, 2, 4, 8, and 24 hours post-dose', 'description': 'Erlotinib plasma concentration-time data are collected on day 1 of maintenance cycle B2. Individual estimates of erlotinib AUC0-24h (area under concentration curve from 0 to 24 hours post-dose) are obtained using post hoc analysis.'}, {'measure': 'OSI-420 AUC0-24h', 'timeFrame': 'Pre-dose, 1, 2, 4, 8, and 24 hours post-dose', 'description': 'Erlotinib metabolite OSI-420 plasma concentration-time data are collected on day 1 of maintenance cycle B2. Individual estimates of OSI-420 AUC0-24h (area under concentration curve from 0 to 24 hours post-dose) are obtained using post hoc analysis.'}, {'measure': 'Rate of Local Disease Progression', 'timeFrame': '1 year after completion of radiation therapy for last patient', 'description': 'Local failure was defined as the interval from end of RT to date of local failure (or combined local + distant failure). Competing events were distant failure or second malignancy. Patients without an event were censored at date of last contact. The 1-year cumulative incidence was estimated and reported with a 95% confidence interval.'}, {'measure': 'Rate of Distant Disease Progression', 'timeFrame': '1 year after completion of radiation therapy for last patient', 'description': 'Distant failure was defined as the interval from end of RT to date of distant failure (or combined local + distant failure). Competing events were local failure or second malignancy. Patients without an event were censored at date of last contact. The 1-year cumulative incidence was estimated and reported with a 95% confidence interval.'}, {'measure': 'Neurocognitive Performance Related to Global Cognitive Functioning as Measured by Cognitive Composite Scores and Estimated IQ Scores', 'timeFrame': 'Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy', 'description': 'Global cognitive functioning was measured based on Cognitive Composite Scores from the Bayley III instrument for subjects \\<3 years of age and on estimated IQ scores from the Stanford Binet V instrument for subjects ≥3 years of age. Higher scores indicate better performance. The normative mean is 100 with a standard deviation of 15.'}, {'measure': 'Neurocognitive Performance Related to Attention as Measured by Attention Problems T-scores', 'timeFrame': 'Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy', 'description': 'Scores measuring attention were obtained from the Attention Problems T-score on the BASC-2 instrument which is a parent report. Higher scores indicate more attention problems. The normative mean is 50 with a standard deviation of 10.'}, {'measure': 'Neurocognitive Performance Related to Processing Speed as Measured by Visual Matching Standard Scores', 'timeFrame': 'Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy', 'description': 'Scores measuring processing speed were obtained based on the visual matching standard score from the Woodcock Johnson III instrument. Higher scores indicate better performance. The normative mean is 100 with a standard deviation of 15.'}, {'measure': 'Neurocognitive Performance Related to Executive Functioning as Measured by Global Executive Composite T-scores', 'timeFrame': 'Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy', 'description': 'Scores measuring executive functioning were obtained from Global Executive Composite (GEC) T-scores, which were obtained from the Behavior Rating Inventory of Executive Function (BRIEF) instrument which is a parent report. Higher scores indicate more problems. The normative mean is 50 with a standard deviation of 10.'}, {'measure': 'Neurocognitive Performance Related to Working Memory as Measured by Working Memory T-scores', 'timeFrame': 'Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy', 'description': 'Scores measuring working memory were obtained from Working Memory T-scores, which were obtained from the Behavior Rating Inventory of Executive Function (BRIEF) instrument which is a parent report. Higher scores indicate more problems. The normative mean is 50 with a standard deviation of 10.'}, {'measure': 'Neurocognitive Performance Related to Verbal Fluency as Measured by Retrieval Fluency Standard Scores', 'timeFrame': 'Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy', 'description': 'Scores measuring verbal fluency were obtained from Retrieval Fluency standard scores on the Woodcock Johnson III instrument. Higher scores indicate better performance. The normative mean is 100 with a standard deviation of 15.'}, {'measure': 'Neurocognitive Performance Related to Visual-spatial Reasoning as Measured by Visual Motor Integration (VMI) T-scores', 'timeFrame': 'Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy', 'description': 'Scores measuring visual-spatial reasoning were obtained from VMI T-scores on the Beery VMI instrument. Higher scores indicate better performance. The normative mean is 50 with standard deviation of 10.'}, {'measure': 'Neurocognitive Performance Related to Visual-spatial Reasoning as Measured by Visual Perception T-scores', 'timeFrame': 'Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy', 'description': 'Scores measuring visual-spatial reasoning were obtained from Visual Perception T-scores on the Beery Visual Motor Integration (VMI) instrument. Higher scores indicate better performance. The normative mean is 50 with a standard deviation of 10.'}, {'measure': 'Change in Neurostructure, Especially White Matter Volume and Integrity', 'timeFrame': 'From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months)', 'description': 'Quantitative MRI measures Fractional Anisotropy (FA) change per month in right frontal-lobe over time in each risk group will be assessed using a random effects model incorporating various covariates. Covariates to be considered include age at diagnosis, time since diagnosis and risk-arm. Differences in quantitative MRI measures of neurostructure volume and integrity between patient groups will be evaluated as a metric of structural neurotoxicity of therapy.\n\nFractional anisotropy (FA) is a scalar unitless measure that quantifies the degree of anisotropy of a diffusion process, particularly in the context of diffusion tensor imaging (DTI) used in MRI scans. FA values range from 0 to 1'}, {'measure': 'Change in Neurostructure, Especially White Matter Volume and Integrity', 'timeFrame': 'From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months)', 'description': 'Quantitative MRI measures Fractional Anisotropy (FA) change per month in left frontal lobe over time in each risk group will be assessed using a random effects model incorporating various covariates. Covariates to be considered include age at diagnosis, time since diagnosis and risk-arm. Differences in quantitative MRI measures of neurostructure volume and integrity between patient groups will be evaluated as a metric of structural neurotoxicity of therapy.\n\nFractional anisotropy (FA) is a scalar unitless measure that quantifies the degree of anisotropy of a diffusion process, particularly in the context of diffusion tensor imaging (DTI) used in MRI scans. FA values range from 0 to 1'}, {'measure': 'Change in Neurostructure, Especially White Matter Volume and Integrity', 'timeFrame': 'From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months)', 'description': 'Quantitative MRI measures Fractional Anisotropy (FA) change per month in right parietal lobe over time in each risk group will be assessed using a random effects model incorporating various covariates. Covariates to be considered include age at diagnosis, time since diagnosis and risk-arm. Differences in quantitative MRI measures of neurostructure volume and integrity between patient groups will be evaluated as a metric of structural neurotoxicity of therapy.\n\nFractional anisotropy (FA) is a scalar unitless measure that quantifies the degree of anisotropy of a diffusion process, particularly in the context of diffusion tensor imaging (DTI) used in MRI scans. FA values range from 0 to 1'}, {'measure': 'Change in Neurostructure, Especially White Matter Volume and Integrity', 'timeFrame': 'From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months)', 'description': 'Quantitative MRI measures Fractional Anisotropy (FA) change per month in left parietal lobe over time in each risk group will be assessed using a random effects model incorporating various covariates. Covariates to be considered include age at diagnosis, time since diagnosis and risk-arm. Differences in quantitative MRI measures of neurostructure volume and integrity between patient groups will be evaluated as a metric of structural neurotoxicity of therapy.\n\nFractional anisotropy (FA) is a scalar unitless measure that quantifies the degree of anisotropy of a diffusion process, particularly in the context of diffusion tensor imaging (DTI) used in MRI scans. FA values range from 0 to 1'}, {'measure': 'Change in Neurostructure, Especially White Matter Volume and Integrity', 'timeFrame': 'From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months)', 'description': 'Quantitative MRI measures Fractional Anisotropy (FA) change per month in right occipital lobe over time in each risk group will be assessed using a random effects model incorporating various covariates. Covariates to be considered include age at diagnosis, time since diagnosis and risk-arm. Differences in quantitative MRI measures of neurostructure volume and integrity between patient groups will be evaluated as a metric of structural neurotoxicity of therapy.\n\nFractional anisotropy (FA) is a scalar unitless measure that quantifies the degree of anisotropy of a diffusion process, particularly in the context of diffusion tensor imaging (DTI) used in MRI scans. FA values range from 0 to 1'}, {'measure': 'Change in Neurostructure, Especially White Matter Volume and Integrity', 'timeFrame': 'From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months)', 'description': 'Quantitative MRI measures Fractional Anisotropy (FA) change per month in left occipital lobe over time in each risk group will be assessed using a random effects model incorporating various covariates. Covariates to be considered include age at diagnosis, time since diagnosis and risk-arm. Differences in quantitative MRI measures of neurostructure volume and integrity between patient groups will be evaluated as a metric of structural neurotoxicity of therapy.\n\nFractional anisotropy (FA) is a scalar unitless measure that quantifies the degree of anisotropy of a diffusion process, particularly in the context of diffusion tensor imaging (DTI) used in MRI scans. FA values range from 0 to 1'}, {'measure': 'Change in Neurostructure, Especially White Matter Volume and Integrity', 'timeFrame': 'From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months)', 'description': 'Quantitative MRI measures Fractional Anisotropy (FA) change per month in right temporal lobe over time in each risk group will be assessed using a random effects model incorporating various covariates. Covariates to be considered include age at diagnosis, time since diagnosis and risk-arm. Differences in quantitative MRI measures of neurostructure volume and integrity between patient groups will be evaluated as a metric of structural neurotoxicity of therapy.\n\nFractional anisotropy (FA) is a scalar unitless measure that quantifies the degree of anisotropy of a diffusion process, particularly in the context of diffusion tensor imaging (DTI) used in MRI scans. FA values range from 0 to 1'}, {'measure': 'Change in Neurostructure, Especially White Matter Volume and Integrity', 'timeFrame': 'From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months)', 'description': 'Quantitative MRI measures Fractional Anisotropy (FA) change per month in left temporal lobe over time in each risk group will be assessed using a random effects model incorporating various covariates. Covariates to be considered include age at diagnosis, time since diagnosis and risk-arm. Differences in quantitative MRI measures of neurostructure volume and integrity between patient groups will be evaluated as a metric of structural neurotoxicity of therapy.\n\nFractional anisotropy (FA) is a scalar unitless measure that quantifies the degree of anisotropy of a diffusion process, particularly in the context of diffusion tensor imaging (DTI) used in MRI scans. FA values range from 0 to 1'}, {'measure': 'Change in Quantitative Magnetic Resonance (MR) Measures in the Frontal Lobe', 'timeFrame': 'From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months)', 'description': 'Quantitative MRI measures Fractional Anisotropy (FA) change per month in frontal lobe over time in each risk group will be assessed using a random effects model incorporating various covariates. Covariates to be considered include age at diagnosis, time since diagnosis and risk-arm. Differences in quantitative MRI measures of neurostructure volume and integrity between patient groups will be evaluated as a metric of structural neurotoxicity of therapy.\n\nFractional anisotropy (FA) is a scalar unitless measure that quantifies the degree of anisotropy of a diffusion process, particularly in the context of diffusion tensor imaging (DTI) used in MRI scans. FA values range from 0 to 1'}, {'measure': 'Change in Quantitative MR Measures in the Right Frontal-parietal Regions', 'timeFrame': 'From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months)', 'description': 'Quantitative MRI measures Fractional Anisotropy (FA) change per month in right frontal-parietal region over time in each risk group will be assessed using a random effects model incorporating various covariates. Covariates to be considered include age at diagnosis, time since diagnosis and risk-arm. Differences in quantitative MRI measures of neurostructure volume and integrity between patient groups will be evaluated as a metric of structural neurotoxicity of therapy.\n\nFractional anisotropy (FA) is a scalar unitless measure that quantifies the degree of anisotropy of a diffusion process, particularly in the context of diffusion tensor imaging (DTI) used in MRI scans. FA values range from 0 to 1'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['untreated childhood medulloblastoma', 'untreated childhood supratentorial primitive neuroectodermal tumor', 'untreated childhood pineoblastoma', 'childhood atypical teratoid/rhabdoid tumor', 'childhood choroid plexus tumor', 'childhood high grade glioma', 'newly diagnosed childhood ependymoma'], 'conditions': ['Brain and Central Nervous System Tumors']}, 'referencesModule': {'references': [{'pmid': '33945291', 'type': 'DERIVED', 'citation': 'Ali JS, Ashford JM, Swain MA, Harder LL, Carlson-Green BL, Miller JM, Wallace J, Kaner RJ, Billups CA, Onar-Thomas A, Merchant TE, Gajjar A, Conklin HM. Predictors of Cognitive Performance Among Infants Treated for Brain Tumors: Findings From a Multisite, Prospective, Longitudinal Trial. J Clin Oncol. 2021 Jul 20;39(21):2350-2358. doi: 10.1200/JCO.20.01687. Epub 2021 May 4.'}, {'pmid': '33502920', 'type': 'DERIVED', 'citation': 'Kumar R, Smith KS, Deng M, Terhune C, Robinson GW, Orr BA, Liu APY, Lin T, Billups CA, Chintagumpala M, Bowers DC, Hassall TE, Hansford JR, Khuong-Quang DA, Crawford JR, Bendel AE, Gururangan S, Schroeder K, Bouffet E, Bartels U, Fisher MJ, Cohn R, Partap S, Kellie SJ, McCowage G, Paulino AC, Rutkowski S, Fleischhack G, Dhall G, Klesse LJ, Leary S, Nazarian J, Kool M, Wesseling P, Ryzhova M, Zheludkova O, Golanov AV, McLendon RE, Packer RJ, Dunham C, Hukin J, Fouladi M, Faria CC, Pimentel J, Walter AW, Jabado N, Cho YJ, Perreault S, Croul SE, Zapotocky M, Hawkins C, Tabori U, Taylor MD, Pfister SM, Klimo P Jr, Boop FA, Ellison DW, Merchant TE, Onar-Thomas A, Korshunov A, Jones DTW, Gajjar A, Ramaswamy V, Northcott PA. Clinical Outcomes and Patient-Matched Molecular Composition of Relapsed Medulloblastoma. J Clin Oncol. 2021 Mar 1;39(7):807-821. doi: 10.1200/JCO.20.01359. Epub 2021 Jan 27.'}, {'pmid': '29778738', 'type': 'DERIVED', 'citation': 'Robinson GW, Rudneva VA, Buchhalter I, Billups CA, Waszak SM, Smith KS, Bowers DC, Bendel A, Fisher PG, Partap S, Crawford JR, Hassall T, Indelicato DJ, Boop F, Klimo P, Sabin ND, Patay Z, Merchant TE, Stewart CF, Orr BA, Korbel JO, Jones DTW, Sharma T, Lichter P, Kool M, Korshunov A, Pfister SM, Gilbertson RJ, Sanders RP, Onar-Thomas A, Ellison DW, Gajjar A, Northcott PA. Risk-adapted therapy for young children with medulloblastoma (SJYC07): therapeutic and molecular outcomes from a multicentre, phase 2 trial. Lancet Oncol. 2018 Jun;19(6):768-784. doi: 10.1016/S1470-2045(18)30204-3. Epub 2018 May 16.'}], 'seeAlsoLinks': [{'url': 'http://www.stjude.org', 'label': "St. Jude Children's Research Hospital"}, {'url': 'http://www.stjude.org/protocols', 'label': 'Clinical Trials Open at St. Jude'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: In this study a combination of anti-cancer drugs (chemotherapy) is used to treat brain tumors in young children. Using chemotherapy gives the brain more time to develop before radiation is given. The chemotherapy in this study includes the drug methotrexate. This drug was an important part of the two clinical trials which resulted in the best survival results for children less than 3 years of age with medulloblastoma. Most patients treated on this trial will also receive radiation which is carefully targeted to the area of the tumor. This type of radiation (focal conformal or proton beam radiotherapy) may result in fewer problems with thinking and learning than radiation to the whole brain and spinal cord.\n\nPURPOSE: This clinical trial is studying how well giving combination chemotherapy together with radiation therapy works in treating young patients with newly diagnosed central nervous system tumors.', 'detailedDescription': "All patients with medulloblastoma who were diagnosed prior to their 3rd birthday will contribute to both the biology and therapeutic primary objectives of this protocol. Furthermore patients who were ≥3 and \\<5 years old at the time of diagnosis will also be included in the cohort for these primary objectives as long as they meet the eligibility criteria as outlined in Amendment 8.0 of this protocol. Patients in the 3-5 year old age cohort who enrolled on previous versions of this protocol and who do not meet the criteria as outlined in Amendment 8.0 of this protocol will be excluded from the outcome analyses of the biology and therapeutic primary objectives of the protocol.\n\nOBJECTIVES:\n\nPrimary\n\n* To identify patterns of methylation profiling that are associated with progression-free survival among young pediatric patients with medulloblastoma treated with risk-adapted therapy.\n* To estimate the event-free survival distribution of young medulloblastoma patients treated with risk-adapted therapy.\n\nSecondary\n\n* To perform high-resolution genome-wide analyses of chromosomal abnormalities and gene expression patterns, and evaluate the relationship of these to other clinicopathological variables.\n* To evaluate specific tumor types for molecular abnormalities with suspected prognostic or therapeutic significance.\n* To evaluate the feasibility of collecting frozen and fixed tumor samples for analysis using high-resolution molecular biology tools.\n* To estimate the event-free and overall survival of patients treated with the proposed risk-adapted therapy regimen, and to descriptively compare these survival rates to historical controls.\n* To estimate the rates of local and distant disease progression in patients treated with focal radiotherapy (RT) to the post-operative tumor bed using a 5 mm clinical target volume margin.\n* To estimate the objective response rate (sustained for 8 weeks) to induction chemotherapy including high-dose intravenous methotrexate for patients with residual or metastatic disease.\n* To evaluate the feasibility and toxicity of administering low-dose intravenous vinblastine in conjunction with induction chemotherapy to patients with metastatic disease.\n* To evaluate the feasibility and toxicity of administering consolidation therapy including cyclophosphamide and pharmacokinetically targeted topotecan to patients with metastatic disease, and to estimate the sustained (for 8 weeks) objective response rate (complete response and partial response) to such therapy in patients with measurable residual disease after induction.\n* To evaluate the feasibility and toxicity of administering oral maintenance therapy in young children.\n* To use quantitative magnetic resonance (MR) measures (volumetric, diffusion, and perfusion) of young brain tumor patients receiving chemotherapy including high-dose intravenous methotrexate to assess impact of treatment on developing brain.\n* To investigate the feasibility of using PET as an in-vivo dosimetric and distal edge verification system for patients treated with proton beam therapy (for participants enrolled at St Jude only).\n\nOUTLINE: This is a multicenter study. Patients are stratified according to disease risk (low-risk vs intermediate-risk vs high-risk). Therapy consists of risk adapted induction, consolidation and maintenance chemotherapy. Focal irradiation is given to intermediate risk patients who have reached at least 12 months of age upon completion of induction. Intermediate risk patients who have not will receive low risk chemotherapy to delay RT until the age of 12 months.\n\nPatients may consent to provide tumor tissue and blood samples for biological studies. Tumor tissues are analyzed for the activation of the wnt signaling pathway (β-catenin), activation of the shh signaling pathway (Gli-1/SFRP1), and ERBB2; validation of novel patterns of gene expression via immunohistochemical (IHC) analysis; loss of chromosomes 6, 8p, 9q22, isochromosome 17q; amplification of MYCC, MYCN, and MYCL; validation of genetic abnormalities via interphase fluorescence in situ hybridization (iFISH); construction of gene expression profiles via microarray analysis; single nucleotide polymorphism (SNP) analysis for DNA purity and integrity using UV spectrophotometry and agarose gel electrophoresis; amplification of DNA via PCR and a combination of previously published and 'in-house' generated primers; potential oncogenes and tumor suppressor genes via DNA sequence analysis; expression of a number of cell signal proteins implicated in the biology of medulloblastoma via western blot; expression of additional proteins encoded by genes associated through SNP and gene expression array analysis with clinical disease behavior; and differential expression pattern of genes detected using microarray analysis via RT-PCR. DNA extraction and construction of tissue microarrays (TMAs) from tumor tissue will also be used for future IHC and FISH analysis. Blood samples are analyzed for constitutional DNA from patients whose tumors contain gene mutations via sequence analysis of constitutional DNA; cyclophosphamide and its metabolites via liquid chromatography mass spectroscopy method; topotecan lactone via isocratic high-performance liquid chromatography assay with fluorescence detection; and alpha-1-acid glycoprotein (AAGP) concentrations via immunoturbidimetric assay.\n\nAfter completion of study treatment, patients are followed every 6 months for 5 years."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Histologically confirmed newly diagnosed CNS tumors of any of the following :\n\n* Medulloblastoma (all histologic subtypes, including medullomyoblastoma and melanotic medulloblastoma)\n* Supratentorial primitive neuroectodermal tumor (PNET) (including CNS neuroblastoma or ganglioneuroblastoma, medulloepithelioma, and ependymoblastoma)\n* Pineoblastoma\n* Atypical teratoid rhabdoid tumor (ATRT)\n* Choroid plexus carcinoma\n* High grade glioma (including anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic ganglioglioma, pleomorphic xanthoastrocytoma with anaplastic features, high-grade astroblastoma , anaplastic pilocytic astrocytoma, malignant glioneuronal tumor, glioblastoma multiforme), or gliosarcoma,\n* Ependymoma (including all ependymoma histological variants)\n* Age \\< 3 years at time of diagnosis for all histological diagnosis. Medulloblastoma patients ≥ 3 and \\< 5years old at diagnosis who have non-metastatic disease with no more than 1cm2 of residual tumor are also eligible.\n\n * Meets criteria for 1 of the following risk groups:\n* Low-risk group:\n\n * Histologically confirmed nodular desmoplastic medulloblastoma, including medulloblastoma with extensive nodularity\n\n * Focal areas of anaplasia or other atypical features suggesting more aggressive phenotype in a tumor otherwise considered nodular desmoplastic should be treated on the intermediate-risk group, with final risk stratification at the discretion of principal investigator and study pathologist\n * No evidence of CNS metastasis 7 to 28 days after surgery by MRI and cytologic examination of lumbar cerebrospinal fluid (CSF)\n\n * Ventricular CSF from a shunt or Ommaya reservoir may be used to rule out M1 disease when lumbar puncture is medically contraindicated\n * Intermediate-risk group assignment when there is no other evidence of metastasis and CSF sampling is not possible\n * Gross total resection, defined as residual tumor or imaging abnormality (not definitive for residual tumor) with a size of \\< 1 cm2 confirmed on postoperative CT scan or MRI\n * Brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size \\< 1 cm2) and otherwise meets criteria for the low-risk group, the patient will be classified as low-risk\n * Desmoplastic medulloblastoma patients who are ≥3 -\\<5 years of age will NOT be eligible for the low risk arm of the protocol.\n* Intermediate-risk group:\n\n * Histologically confirmed nodular desmoplastic medulloblastoma with less than gross total resection and no evidence of metastasis\n * Any eligible histologic diagnosis other than desmoplastic medulloblastoma with no evidence of CNS metastasis\n * Medulloblastoma patients who are ≥3 and \\< 5 yrs of age irrespective of histology and with no evidence of CNS metastasis\n* High-risk group:\n\n * Any eligible histologic diagnosis with evidence of CNS metastasis\n * Patients with extraneural metastasis are eligible for treatment on the high-risk group\n\nPATIENT CHARACTERISTICS:\n\n* Lansky performance status ≥ 30 (except for posterior fossa syndrome)\n* WBC \\> 2,000/mm3\n* Platelets \\> 50,000/mm3 (without support)\n* Hemoglobin \\> 8 g/dL (with or without support)\n* ANC \\> 500/mm3\n* Serum creatinine \\< 3 times upper limit of normal (ULN)\n* ALT \\< 5 times ULN\n* Total bilirubin \\< 3 times ULN\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* No more than 31 days since prior definitive surgery\n* No prior radiotherapy or chemotherapy other than corticosteroid therapy'}, 'identificationModule': {'nctId': 'NCT00602667', 'briefTitle': 'Risk-Adapted Therapy for Young Children With Embryonal Brain Tumors, Choroid Plexus Carcinoma, High Grade Glioma or Ependymoma', 'organization': {'class': 'OTHER', 'fullName': "St. Jude Children's Research Hospital"}, 'officialTitle': 'Risk-Adapted Therapy for Young Children With Embryonal Brain Tumors, Choroid Plexus Carcinoma, High Grade Glioma or Ependymoma', 'orgStudyIdInfo': {'id': 'SJYC07'}, 'secondaryIdInfos': [{'id': 'R01CA154619', 'link': 'https://reporter.nih.gov/quickSearch/R01CA154619', 'type': 'NIH'}, {'id': 'NCI-2011-01193', 'type': 'REGISTRY', 'domain': 'NCI Clinical Trial Registration Program'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low-Risk Patients', 'description': 'Patients with GTR/M0 medulloblastoma, nodular desmoplastic or high grade glioma histology will receive induction chemotherapy and low-risk therapy.\n\nNote: Accrual to the low-risk medulloblastoma cohort is closed as of 12/2/2015. Accrual to the low-risk high grade glioma remains open.', 'interventionNames': ['Drug: Induction Chemotherapy', 'Drug: Low-Risk Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'High-Risk Patients', 'description': 'Patients with CNS metastatic disease will receive induction chemotherapy and high-risk therapy.', 'interventionNames': ['Drug: Induction Chemotherapy', 'Drug: High-Risk Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Intermediate-Risk Therapy', 'description': 'Patients with M0 medulloblastoma or nodular desmoplastic histology with less than a GTR, other histologic diagnoses with no metastatic disease, will receive induction chemotherapy and intermediate-risk therapy.', 'interventionNames': ['Drug: Induction Chemotherapy', 'Drug: Intermediate-Risk Therapy']}], 'interventions': [{'name': 'Induction Chemotherapy', 'type': 'DRUG', 'otherNames': ['MTX (methotrexate)', 'Oncovin(R) (vincristine)', 'Platinol-AQ(R) (cisplatin)', 'Cytoxan(R) (cyclophosphamide)'], 'description': 'All patients will receive 4 identical cycles of induction chemotherapy including highdose (5 g/m2 or 2.5g/m2 for patients less than or equal to 31 days of age at enrollment) intravenous methotrexate and standard dose vincristine, cisplatin, and cyclophosphamide.', 'armGroupLabels': ['High-Risk Patients', 'Intermediate-Risk Therapy', 'Low-Risk Patients']}, {'name': 'Low-Risk Therapy', 'type': 'DRUG', 'otherNames': ['Cytoxan(R) (cyclophosphamide)', 'Paraplatin(R) (carboplatin)', 'Vepesid(R), VP-16 (etoposide)', 'Hycamptin(R) (topotecan)', 'Tarceva(TM) (erlotinib)'], 'description': 'Induction will be followed by further conventional chemotherapy with carboplatin, cyclophosphamide, and etoposide. After consolidation, patients will receive 6 cycles of oral maintenance chemotherapy with cyclophosphamide, topotecan, and depending on the diagnosis, either erlotinib or etoposide (VP-16).', 'armGroupLabels': ['Low-Risk Patients']}, {'name': 'High-Risk Therapy', 'type': 'DRUG', 'otherNames': ['Velban(R) (vinblastine)', 'Cytoxan(R) (cyclophosphamide)', 'Hycamptin(R) (topotecan)', 'Tarceva(TM) (erlotinib)', 'Vepesid(R), VP-16 (etoposide)'], 'description': 'High risk patients will also receive vinblastine with each course of induction chemotherapy. Induction will be followed by either chemotherapy with targeted intravenous topotecan and cyclophosphamide or optional craniospinal irradiation (CSI). CSI will be offered only to patients who reach 3 years of age by the end of induction only. After consolidation, all patients will receive 6 cycles of oral maintenance chemotherapy with cyclophosphamide, topotecan, and depending on the diagnosis, either erlotinib or etoposide (VP-16).', 'armGroupLabels': ['High-Risk Patients']}, {'name': 'Intermediate-Risk Therapy', 'type': 'DRUG', 'otherNames': ['Cytoxan(R) (cyclophosphamide)', 'Hycamptin(R) (topotecan)', 'Tarceva(TM) (erlotinib)', 'Vepesid(R), VP-16 (etoposide)'], 'description': 'Induction will be followed by consolidation focal radiotherapy (RT) to the tumor bed. Patients less than 12 months old upon completion of induction will receive low risk chemotherapy to delay RT until the age of 12 months. After consolidation, patients will receive 6 cycles of oral maintenance chemotherapy with cyclophosphamide, topotecan, and depending on the diagnosis, either erlotinib or etoposide (VP-16).\n\nNote: The option to receive focal proton beam irradiation was suspended 10/29/2015. Focal photon beam irradiation continues as part of the treatment plan.', 'armGroupLabels': ['Intermediate-Risk Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': "Lucile Packard Children's Hospital at Stanford University Medical Center", 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': "Rady Children's Hospital", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '55102', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': "Children's Hospitals and Clinics of Minnesota - St. Paul", 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': "St. Jude Children's Research Hospital", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center at Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '4029', 'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': "Lady Cilento Children's Hospital, Brisbane", 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}], 'overallOfficials': [{'name': 'Amar Gajjar, MD', 'role': 'STUDY_CHAIR', 'affiliation': "St. Jude Children's Research Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Jude Children's Research Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Florida', 'class': 'OTHER'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'The Pew Charitable Trusts', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}