Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009396', 'term': 'Wilms Tumor'}], 'ancestors': [{'id': 'D018193', 'term': 'Neoplasms, Complex and Mixed'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020266', 'term': 'Radiotherapy, Conformal'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D014965', 'term': 'X-Rays'}, {'id': 'D003609', 'term': 'Dactinomycin'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}, {'id': 'D019220', 'term': 'High-Energy Shock Waves'}, {'id': 'D014750', 'term': 'Vincristine'}], 'ancestors': [{'id': 'D011881', 'term': 'Radiotherapy, Computer-Assisted'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D011839', 'term': 'Radiation, Ionizing'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'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': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'resultsreportingcoordinator@childrensoncologygroup.org', 'phone': '626-447-0064', 'title': 'Results Reporting Coordinator', 'organization': "Children's Oncology Group"}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Adverse Events were reported for eligible patients only.', 'eventGroups': [{'id': 'EG000', 'title': 'Very Low Risk Disease', 'description': 'Nephrectomy and Re-evaluation', 'otherNumAtRisk': 116, 'otherNumAffected': 0, 'seriousNumAtRisk': 116, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Low Risk, Stage I or II, no LOH', 'description': 'Low risk, stage I or II, no loss of heterozygosity (LOH).', 'otherNumAtRisk': 51, 'otherNumAffected': 2, 'seriousNumAtRisk': 51, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Standard Risk, Stage I or II, With LOH', 'description': 'Standard Risk, Stage I or II, with loss of heterozygosity (LOH).', 'otherNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 32, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Standard Risk, Stage III', 'description': 'Nephrectomy/Biopsy, Chemotherapy', 'otherNumAtRisk': 535, 'otherNumAffected': 31, 'seriousNumAtRisk': 535, 'seriousNumAffected': 20}, {'id': 'EG004', 'title': 'High Risk', 'description': 'High risk.', 'otherNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'seriousNumAffected': 1}], 'otherEvents': [{'term': '11600-Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 535, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '14900-Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 535, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '15000-Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 535, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '33300-Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 535, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '33900-Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 535, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '36400-Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 535, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '40600-Hepatobiliary disorders - Other specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 535, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '41400-Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 535, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '41600-Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 535, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '42500-Hyperuricemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 535, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '42700-Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 535, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '42900-Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 535, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '43100-Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 535, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '43600-Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 535, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '44800-Infections and infestations - Other specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 535, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '47000-Intraoperative gastrointestinal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 535, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'CTCv4'}, {'term': '58300-Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 535, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '66800-Postoperative hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 535, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'CTCv4'}, {'term': '71300-Renal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 535, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '71500-Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 535, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '71600-Respiratory thoracic and mediastinal disorders - Ot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 535, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '73700-Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 535, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '75700-Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 535, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '79600-Thromboembolic event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 535, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '87900-Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 535, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}], 'seriousEvents': [{'term': '24600-Death NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 535, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '36700-Gastrointestinal disorders - Other specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 535, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '37200-General disorders and administration site conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 535, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '40000-Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 535, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '51900-Leukemia secondary to oncology chemotherapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 535, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'CTCv4'}, {'term': '55700-Multi-organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 535, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '58000-Neoplasms benign malignant and unspecified (incl cy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 535, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'CTCv4'}, {'term': '73600-Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 535, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '73700-Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 535, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '75700-Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 535, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Event Free Survival Probability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '535', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Very Low Risk', 'description': 'Very Low Risk'}, {'id': 'OG001', 'title': 'Standard Risk, Stage I or II, With LOH', 'description': 'Standard Risk, Stage I or II, with LOH'}, {'id': 'OG002', 'title': 'Standard Risk, Stage III', 'description': 'Standard Risk, Stage III'}], 'classes': [{'categories': [{'measurements': [{'value': '0.88', 'groupId': 'OG000', 'lowerLimit': '0.79', 'upperLimit': '0.98'}, {'value': '0.87', 'groupId': 'OG001', 'lowerLimit': '0.73', 'upperLimit': '1.00'}, {'value': '0.88', 'groupId': 'OG002', 'lowerLimit': '0.85', 'upperLimit': '0.91'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 years', 'description': 'Probability of no relapse, secondary malignancy, or death after 4 year in the study.', 'unitOfMeasure': 'Probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible very low risk or standard risk patients'}, {'type': 'PRIMARY', 'title': 'Overall Survival (OS) Probability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '535', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Very Low Risk', 'description': 'Very Low Risk'}, {'id': 'OG001', 'title': 'Standard Risk, Stage I or II, With LOH', 'description': 'Standard Risk, Stage I or II, with LOH'}, {'id': 'OG002', 'title': 'Standard Risk, Stage III', 'description': 'Standard Risk, Stage III'}], 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '1'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '1'}, {'value': '0.97', 'groupId': 'OG002', 'lowerLimit': '0.95', 'upperLimit': '0.99'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 years', 'description': 'Probability of being alive after 4 years in the study.', 'unitOfMeasure': 'Probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible very low risk or standard risk patients'}, {'type': 'SECONDARY', 'title': 'Incidence of Contralateral Kidney Lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Very Low Risk', 'description': 'Very Low Risk'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During follow-up', 'description': 'Number of contralateral kidney lesions during follow-up.', 'unitOfMeasure': 'Lesions', 'reportingStatus': 'POSTED', 'populationDescription': 'Very low risk patients treated by nephrectomy and observation only.'}, {'type': 'SECONDARY', 'title': 'Incidence of Renal Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Very Low Risk', 'description': 'Very Low Risk'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During follow-up', 'description': 'Number of renal failures defined as requiring dialysis or renal transplant as determined by low GFR during follow-up', 'unitOfMeasure': 'Incidents', 'reportingStatus': 'POSTED', 'populationDescription': 'Very low risk patients that have metachronous relapse.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Stage I/II', 'description': 'Patients who have either Very Low Risk Disease, Low Risk Stage I or II no LOH, and Standard Risk, Stage I or II with LOH prior to final Risk Group Assignment'}, {'id': 'FG001', 'title': 'Stage III', 'description': 'Patients who have either Standard Risk, Stage III and High Risk Patients prior to final Risk Group Assignment.'}, {'id': 'FG002', 'title': 'Very Low Risk Disease', 'description': 'Treatment arm. Nephrectomy and re-evaluation,very low-risk disease.'}, {'id': 'FG003', 'title': 'Low Risk, Stage I or II, no LOH', 'description': 'Treatment arm. Low risk, stage I or II, no loss of heterozygosity (LOH).'}, {'id': 'FG004', 'title': 'Standard Risk, Stage I or II With LOH', 'description': 'Treatment arm. Standard Risk, Stage I or II with LOH.'}, {'id': 'FG005', 'title': 'Standard Risk, Stage III', 'description': 'Treatment arm. Standard Risk, Stage III.'}, {'id': 'FG006', 'title': 'High Risk', 'description': 'Treatment arm. High risk.'}], 'periods': [{'title': 'Initial Staging', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '211'}, {'groupId': 'FG001', 'numSubjects': '597'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '203'}, {'groupId': 'FG001', 'numSubjects': '588'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}, {'title': 'Final Risk Group Assignment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '119'}, {'groupId': 'FG003', 'numSubjects': '52'}, {'groupId': 'FG004', 'numSubjects': '32'}, {'groupId': 'FG005', 'numSubjects': '548'}, {'groupId': 'FG006', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '116'}, {'groupId': 'FG003', 'numSubjects': '49'}, {'groupId': 'FG004', 'numSubjects': '31'}, {'groupId': 'FG005', 'numSubjects': '503'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '45'}, {'groupId': 'FG006', 'numSubjects': '39'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '19'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '8'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '13'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Enrollment onto another COG study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '28'}]}, {'type': 'Stage III Wilms tumor with LOH', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '11'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'BG000'}, {'value': '597', 'groupId': 'BG001'}, {'value': '808', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Stage I or II', 'description': 'Patients who have either Very Low Risk Disease, Low Risk Stage I or II no LOH, and Standard Risk, Stage I or II with LOH prior to final Risk Group Assignment.'}, {'id': 'BG001', 'title': 'Stage III', 'description': 'Patients who have either Standard Risk, Stage III and High Risk Patients prior to final Risk Group Assignment.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '23.91', 'spread': '24.37', 'groupId': 'BG000'}, {'value': '50.62', 'spread': '30.89', 'groupId': 'BG001'}, {'value': '43.64', 'spread': '31.83', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '318', 'groupId': 'BG001'}, {'value': '428', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '279', 'groupId': 'BG001'}, {'value': '380', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '165', 'groupId': 'BG000'}, {'value': '482', 'groupId': 'BG001'}, {'value': '647', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '141', 'groupId': 'BG000'}, {'value': '417', 'groupId': 'BG001'}, {'value': '558', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Stage I or II: Patients who have either Very Low Risk Disease, Low Risk Stage I or II no LOH, and Standard Risk, Stage I or II with LOH prior to final Risk Group Assignment. Stage III: Patients who have either Standard Risk, Stage III and High Risk Patients prior to final Risk Group Assignment.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 808}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2006-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-30', 'studyFirstSubmitDate': '2006-07-13', 'resultsFirstSubmitDate': '2016-10-26', 'studyFirstSubmitQcDate': '2006-07-13', 'lastUpdatePostDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-05', 'studyFirstPostDateStruct': {'date': '2006-07-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event Free Survival Probability', 'timeFrame': '4 years', 'description': 'Probability of no relapse, secondary malignancy, or death after 4 year in the study.'}, {'measure': 'Overall Survival (OS) Probability', 'timeFrame': '4 years', 'description': 'Probability of being alive after 4 years in the study.'}], 'secondaryOutcomes': [{'measure': 'Incidence of Contralateral Kidney Lesions', 'timeFrame': 'During follow-up', 'description': 'Number of contralateral kidney lesions during follow-up.'}, {'measure': 'Incidence of Renal Failure', 'timeFrame': 'During follow-up', 'description': 'Number of renal failures defined as requiring dialysis or renal transplant as determined by low GFR during follow-up'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Stage I Kidney Wilms Tumor', 'Stage II Kidney Wilms Tumor', 'Stage III Kidney Wilms Tumor']}, 'referencesModule': {'references': [{'pmid': '31449468', 'type': 'DERIVED', 'citation': "Dix DB, Fernandez CV, Chi YY, Mullen EA, Geller JI, Gratias EJ, Khanna G, Kalapurakal JA, Perlman EJ, Seibel NL, Ehrlich PF, Malogolowkin M, Anderson J, Gastier-Foster J, Shamberger RC, Kim Y, Grundy PE, Dome JS; AREN0532 and AREN0533 study committees. Augmentation of Therapy for Combined Loss of Heterozygosity 1p and 16q in Favorable Histology Wilms Tumor: A Children's Oncology Group AREN0532 and AREN0533 Study Report. J Clin Oncol. 2019 Oct 20;37(30):2769-2777. doi: 10.1200/JCO.18.01972. Epub 2019 Aug 26."}, {'pmid': '29211618', 'type': 'DERIVED', 'citation': "Fernandez CV, Mullen EA, Chi YY, Ehrlich PF, Perlman EJ, Kalapurakal JA, Khanna G, Paulino AC, Hamilton TE, Gow KW, Tochner Z, Hoffer FA, Withycombe JS, Shamberger RC, Kim Y, Geller JI, Anderson JR, Grundy PE, Dome JS. Outcome and Prognostic Factors in Stage III Favorable-Histology Wilms Tumor: A Report From the Children's Oncology Group Study AREN0532. J Clin Oncol. 2018 Jan 20;36(3):254-261. doi: 10.1200/JCO.2017.73.7999. Epub 2017 Dec 6."}, {'pmid': '27811504', 'type': 'DERIVED', 'citation': "Fernandez CV, Perlman EJ, Mullen EA, Chi YY, Hamilton TE, Gow KW, Ferrer FA, Barnhart DC, Ehrlich PF, Khanna G, Kalapurakal JA, Bocking T, Huff V, Tian J, Geller JI, Grundy PE, Anderson JR, Dome JS, Shamberger RC. Clinical Outcome and Biological Predictors of Relapse After Nephrectomy Only for Very Low-risk Wilms Tumor: A Report From Children's Oncology Group AREN0532. Ann Surg. 2017 Apr;265(4):835-840. doi: 10.1097/SLA.0000000000001716."}]}, 'descriptionModule': {'briefSummary': "This phase III trial is studying vincristine, dactinomycin, and doxorubicin with or without radiation therapy or observation only to see how well they work in treating patients undergoing surgery for newly diagnosed stage I, stage II, or stage III Wilms' tumor. Drugs used in chemotherapy, such as vincristine, dactinomycin, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors.Giving these treatments after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient.", 'detailedDescription': "PRIMARY OBJECTIVES:\n\nI. Evaluate the overall and event-free survival of younger patients with newly diagnosed stage I favorable histology Wilms' tumor (\\< 2 years of age and \\< 550gms) treated with nephrectomy only (very low risk), or with newly diagnosed stage III favorable histology Wilms tumor with possible nephrectomy followed by vincristine, dactinomycin, doxorubicin hydrochloride, and radiotherapy (standard risk).\n\nSECONDARY OBJECTIVES:\n\nI. Determine the effects of adding doxorubicin hydrochloride to the regimen for patients with stage I or II favorable histology found to have a high-risk biological marker.\n\nII. Determine whether the omission of adjuvant therapy increases the incidence of contralateral kidney lesions in patients with very low-risk disease treated by nephrectomy and observation only.\n\nIII. Determine whether the omission of adjuvant therapy increases the incidence of renal failure in patients with very low-risk disease who have metachronous relapse.\n\nIV. Correlate study outcomes in patients with standard-risk disease with biological data from tissue collections on protocol study COG-AREN03B2.\n\nOUTLINE: This is a multicenter study. Patients are stratified according to clinical and biological risk factors (very low risk vs standard risk).\n\nSTRATUM I: (very low-risk disease) Patients undergo nephrectomy only. If they meet criteria, they are then observed periodically for 5 years. Patients with recurrent disease undergo surgery (immediate or delayed) and receive chemotherapy as in stratum III. Patients with no metachronous renal disease receive radiotherapy. Patients with metachronous disease undergo renal-sparing surgery and chemotherapy as in stratum III, but no radiotherapy. Treatment continues for up to 25 weeks.\n\nSTRATUM II: (standard-risk, stage I or II disease with adverse biological marker) Patients undergo nephrectomy. Between 9 and 14 days post-nephrectomy, patients receive vincristine IV beginning on day 1, every week for 10 weeks then every 3 weeks for a total of 15 doses. Patients receive dactinomycin IV beginning day 1, alternating every 3 weeks with doxorubicin hydrochloride IV for a total of 5 doses of dactinomycin and 4 doses of doxorubicin. Treatment continues for up to 25 weeks.\n\nSTRATUM III: (standard-risk, stage III disease) Patients undergo nephrectomy, if feasible, or biopsy. For patients who undergo biopsy only, definitive surgery is undertaken at week 7 or 13. Between 9 and 14 days post-nephrectomy, patients receive vincristine IV beginning on day 1 every week for 10 weeks then every 3 weeks for a total of 15 doses. Patients receive dactinomycin IV beginning day 1, alternating every 3 weeks with doxorubicin hydrochloride IV for a total of 5 doses of dactinomycin and 4 dose of doxorubicin hydrochloride. Patients undergo radiotherapy over 5-7 days after nephrectomy. Treatment continues for up to 25 weeks.\n\nAdditionally, patients undergo chest X-ray, computed tomography (CT) or magnetic resonance imaging (MRI), ultrasound, echocardiography, and blood sample collection throughout the study.\n\nAfter completion of study treatment, patients are followed periodically for up to 8 years."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '29 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically confirmed Wilms' tumor\n\n * Newly diagnosed stage I-III disease\n * Favorable histology\n* No moderate- or high-risk Wilms' predisposition syndromes\n* Must meet 1 of the following disease stratification categories:\n\n * Very low-risk disease\n\n * Stage I disease\n * Age \\< 2 years\n * Tumor weight \\< 550 g\n * Regional lymph nodes histologically negative (must have been sampled)\n * No pulmonary metastases on CT scan of chest\n * No synchronous bilateral Wilms tumors (Stage V)\n * Not predisposed to develop bilateral Wilms tumors, defined as unilateral Wilms tumor and any of the following:\n\n * Aniridia\n * Beckwith-Wiedemann syndrome\n * Simpson-Golabi-Behmel syndrome\n * Denys-Drash syndrome or other associated genito-urinary anomalies\n * Multicentric WT or unilateral WT with contralateral nephrogenic rest(s) in a child \\< 1 year of age\n * Diffuse hyperplastic perilobar nephroblastomatosis\n * Standard-risk disease meeting 1 of the following criteria:\n\n * Disease does not require radiotherapy\n\n * LOH at chromosomes 1p and 16q for stage I or II\n * Stage I disease meeting 1 of the following criteria:\n\n * Age ≥ 2 years to age \\< 30 years\n * Tumor weight ≥ 500 g\n * Stage II disease\n\n * Age \\< 30 years\n * Any tumor weight\n * Disease requires radiotherapy\n\n * No LOH at chromosomes 1p and 16q\\*\n * Stage III disease\n* Must be enrolled on protocol COG-AREN03B2\n* Karnofsky performance status (PS) 50-100% for patients \\> 16 years old\n* Lansky PS 50-100% for patients ≤ 16 years old\n* Bilirubin (direct) ≤ 1.5 times upper limit of normal (ULN)\n* AST or ALT \\< 2.5 times ULN\n* Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by radionuclide angiogram (standard-risk disease)\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patient must use effective contraception\n* No prior tumor-directed chemotherapy or radiotherapy\n\n * Patients transferring from AREN03B2 with LOH 1p and 16q allowed"}, 'identificationModule': {'nctId': 'NCT00352534', 'briefTitle': "Vincristine, Dactinomycin, and Doxorubicin With or Without Radiation Therapy or Observation Only in Treating Younger Patients Who Are Undergoing Surgery for Newly Diagnosed Stage I, Stage II, or Stage III Wilms' Tumor", 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': 'Treatment for Very Low and Standard Risk Favorable Histology Wilms Tumor', 'orgStudyIdInfo': {'id': 'AREN0532'}, 'secondaryIdInfos': [{'id': 'NCI-2009-01067', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '06-936'}, {'id': 'AREN0532'}, {'id': 'CDR0000487540'}, {'id': 'AREN0532', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'AREN0532', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U10CA098543', 'link': 'https://reporter.nih.gov/quickSearch/U10CA098543', 'type': 'NIH'}, {'id': 'U10CA180886', 'link': 'https://reporter.nih.gov/quickSearch/U10CA180886', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stratum I (very low-risk disease)', 'description': 'Patients undergo nephrectomy only. If they meet criteria, they are then observed periodically for 5 years. Patients with recurrent disease undergo surgery (immediate or delayed) and receive chemotherapy as in stratum III. Patients with no metachronous renal disease receive radiotherapy. Patients with metachronous disease undergo renal-sparing surgery and chemotherapy as in stratum III, but no radiotherapy. Treatment continues for up to 25 weeks. Additionally, patients undergo chest X-ray, CT or MRI, ultrasound, echocardiography, and blood sample collection throughout the study.', 'interventionNames': ['Radiation: 3-Dimensional Conformal Radiation Therapy', 'Procedure: Biospecimen Collection', 'Procedure: Chest Radiography', 'Procedure: Computed Tomography', 'Biological: Dactinomycin', 'Drug: Doxorubicin Hydrochloride', 'Procedure: Echocardiography Test', 'Procedure: Magnetic Resonance Imaging', 'Procedure: Therapeutic Conventional Surgery', 'Procedure: Ultrasound Imaging', 'Drug: Vincristine Sulfate']}, {'type': 'EXPERIMENTAL', 'label': 'Stratum II (standard-risk, stage I or II)', 'description': 'Patients undergo nephrectomy. Between 9 and 14 days post-nephrectomy, patients receive vincristine IV beginning on day 1, every week for 10 weeks then every 3 weeks for a total of 15 doses. Patients receive dactinomycin IV beginning day 1, alternating every 3 weeks with doxorubicin hydrochloride IV for a total of 5 doses of dactinomycin and 4 doses of doxorubicin. Treatment continues for up to 25 weeks. Additionally, patients undergo chest X-ray, CT or MRI, ultrasound, echocardiography, and blood sample collection throughout the study.', 'interventionNames': ['Radiation: 3-Dimensional Conformal Radiation Therapy', 'Procedure: Biospecimen Collection', 'Procedure: Chest Radiography', 'Procedure: Computed Tomography', 'Biological: Dactinomycin', 'Drug: Doxorubicin Hydrochloride', 'Procedure: Echocardiography Test', 'Procedure: Magnetic Resonance Imaging', 'Procedure: Therapeutic Conventional Surgery', 'Procedure: Ultrasound Imaging', 'Drug: Vincristine Sulfate']}, {'type': 'EXPERIMENTAL', 'label': 'Stratum III (standard-risk, stage III)', 'description': 'Patients undergo nephrectomy, if feasible, or biopsy. For patients who undergo biopsy only, definitive surgery is undertaken at week 7 or 13. Between 9 and 14 days post-nephrectomy, patients receive vincristine IV beginning on day 1 every week for 10 weeks then every 3 weeks for a total of 15 doses. Patients receive dactinomycin IV beginning day 1, alternating every 3 weeks with doxorubicin hydrochloride IV for a total of 5 doses of dactinomycin and 4 dose of doxorubicin hydrochloride. Patients undergo radiotherapy over 5-7 days after nephrectomy. Treatment continues for up to 25 weeks. Additionally, patients undergo chest X-ray, CT or MRI, ultrasound, echocardiography, and blood sample collection throughout the study.', 'interventionNames': ['Radiation: 3-Dimensional Conformal Radiation Therapy', 'Procedure: Biospecimen Collection', 'Procedure: Chest Radiography', 'Procedure: Computed Tomography', 'Biological: Dactinomycin', 'Drug: Doxorubicin Hydrochloride', 'Procedure: Echocardiography Test', 'Procedure: Magnetic Resonance Imaging', 'Procedure: Therapeutic Conventional Surgery', 'Procedure: Ultrasound Imaging', 'Drug: Vincristine Sulfate']}], 'interventions': [{'name': '3-Dimensional Conformal Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['3-dimensional radiation therapy', '3D Conformal', '3D CONFORMAL RADIATION THERAPY', '3D CRT', '3D radiotherapy', '3D-CRT', 'Conformal Therapy', 'Radiation Conformal Therapy', 'Radiation, 3D Conformal', 'Three dimensional external beam radiation therapy (procedure)'], 'description': 'Patients undergo radiotherapy', 'armGroupLabels': ['Stratum I (very low-risk disease)', 'Stratum II (standard-risk, stage I or II)', 'Stratum III (standard-risk, stage III)']}, {'name': 'Biospecimen Collection', 'type': 'PROCEDURE', 'otherNames': ['Biological Sample Collection', 'Biospecimen Collected', 'Specimen Collection'], 'description': 'Undergo blood sample collection', 'armGroupLabels': ['Stratum I (very low-risk disease)', 'Stratum II (standard-risk, stage I or II)', 'Stratum III (standard-risk, stage III)']}, {'name': 'Chest Radiography', 'type': 'PROCEDURE', 'otherNames': ['Chest X-ray'], 'description': 'Undergo chest X-ray', 'armGroupLabels': ['Stratum I (very low-risk disease)', 'Stratum II (standard-risk, stage I or II)', 'Stratum III (standard-risk, stage III)']}, {'name': 'Computed Tomography', 'type': 'PROCEDURE', 'otherNames': ['CAT', 'CAT Scan', 'Computed Axial Tomography', 'Computerized Axial Tomography', 'Computerized axial tomography (procedure)', 'Computerized Tomography', 'Computerized Tomography (CT) scan', 'CT', 'CT Scan', 'tomography'], 'description': 'Undergo CT', 'armGroupLabels': ['Stratum I (very low-risk disease)', 'Stratum II (standard-risk, stage I or II)', 'Stratum III (standard-risk, stage III)']}, {'name': 'Dactinomycin', 'type': 'BIOLOGICAL', 'otherNames': ['Actinomycin A IV', 'Actinomycin C1', 'Actinomycin D', 'Actinomycin I1', 'Actinomycin IV', 'Actinomycin X 1', 'Actinomycin-[thr-val-pro-sar-meval]', 'Cosmegen', 'DACT', 'Dactinomycine', 'Lyovac Cosmegen', 'Meractinomycin'], 'description': 'Given IV', 'armGroupLabels': ['Stratum I (very low-risk disease)', 'Stratum II (standard-risk, stage I or II)', 'Stratum III (standard-risk, stage III)']}, {'name': 'Doxorubicin Hydrochloride', 'type': 'DRUG', 'otherNames': ['5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)', 'ADM', 'Adriacin', 'Adriamycin', 'Adriamycin Hydrochloride', 'Adriamycin PFS', 'Adriamycin RDF', 'ADRIAMYCIN, HYDROCHLORIDE', 'Adriamycine', 'Adriblastina', 'Adriblastine', 'Adrimedac', 'Chloridrato de Doxorrubicina', 'DOX', 'DOXO-CELL', 'Doxolem', 'Doxorubicin HCl', 'Doxorubicin.HCl', 'Doxorubin', 'Farmiblastina', 'FI 106', 'FI-106', 'FI106', 'hydroxydaunorubicin', 'Rubex'], 'description': 'Given IV', 'armGroupLabels': ['Stratum I (very low-risk disease)', 'Stratum II (standard-risk, stage I or II)', 'Stratum III (standard-risk, stage III)']}, {'name': 'Echocardiography Test', 'type': 'PROCEDURE', 'otherNames': ['EC', 'Echocardiography'], 'description': 'Undergo echocardiography', 'armGroupLabels': ['Stratum I (very low-risk disease)', 'Stratum II (standard-risk, stage I or II)', 'Stratum III (standard-risk, stage III)']}, {'name': 'Magnetic Resonance Imaging', 'type': 'PROCEDURE', 'otherNames': ['Magnetic Resonance', 'Magnetic Resonance Imaging (MRI)', 'Magnetic resonance imaging (procedure)', 'Magnetic Resonance Imaging Scan', 'Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance', 'MR', 'MR Imaging', 'MRI', 'MRI Scan', 'MRIs', 'NMR Imaging', 'NMRI', 'Nuclear Magnetic Resonance Imaging', 'sMRI', 'Structural MRI'], 'description': 'Undergo MRI', 'armGroupLabels': ['Stratum I (very low-risk disease)', 'Stratum II (standard-risk, stage I or II)', 'Stratum III (standard-risk, stage III)']}, {'name': 'Therapeutic Conventional Surgery', 'type': 'PROCEDURE', 'description': 'Undergo surgery', 'armGroupLabels': ['Stratum I (very low-risk disease)', 'Stratum II (standard-risk, stage I or II)', 'Stratum III (standard-risk, stage III)']}, {'name': 'Ultrasound Imaging', 'type': 'PROCEDURE', 'otherNames': ['2-Dimensional Grayscale Ultrasound Imaging', '2-Dimensional Ultrasound Imaging', '2D-US', 'Ultrasonography', 'Ultrasound', 'Ultrasound Test', 'Ultrasound, Medical', 'US'], 'description': 'Undergo ultrasound', 'armGroupLabels': ['Stratum I (very low-risk disease)', 'Stratum II (standard-risk, stage I or II)', 'Stratum III (standard-risk, stage III)']}, {'name': 'Vincristine Sulfate', 'type': 'DRUG', 'otherNames': ['Kyocristine', 'Leurocristine Sulfate', 'Leurocristine, sulfate', 'Oncovin', 'Vincasar', 'Vincosid', 'Vincrex', 'Vincristine, sulfate'], 'description': 'Given IV', 'armGroupLabels': ['Stratum I (very low-risk disease)', 'Stratum II (standard-risk, stage I or II)', 'Stratum III (standard-risk, stage III)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': "Children's Hospital of Alabama", 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham Cancer Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36604', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'USA Health Strada Patient Care Center', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenix Childrens Hospital', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85719', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner University Medical Center - Tucson', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72202-3591', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Children's Hospital", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90242', 'city': 'Downey', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Downey Medical Center', 'geoPoint': {'lat': 33.94001, 'lon': -118.13257}}, {'zip': '91010', 'city': 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'country': 'United States', 'facility': "Valley Children's Hospital", 'geoPoint': {'lat': 36.96134, 'lon': -120.06072}}, {'zip': '94609', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': "UCSF Benioff Children's Hospital Oakland", 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '94611', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente-Oakland', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital of Orange County", 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': "Lucile Packard Children's Hospital Stanford University", 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Sutter 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